Acceptance Criteria for Portable Oxygen Concentrators Used On Board Aircraft, 33097-33122 [2016-11918]

Download as PDF Vol. 81 Tuesday, No. 100 May 24, 2016 Part V Department of Transportation mstockstill on DSK3G9T082PROD with RULES3 Federal Aviation Administration 14 CFR Parts 1, 11, 121, et al. Acceptance Criteria for Portable Oxygen Concentrators Used On Board Aircraft; Final Rule VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\24MYR3.SGM 24MYR3 33098 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 1, 11, 121, 125, and 135 Office of the Secretary For information on where to obtain copies of rulemaking documents and other information related to this final rule, see ‘‘How to Obtain Additional Information’’ in the SUPPLEMENTARY INFORMATION section of this document. ADDRESSES: 14 CFR Part 382 [Docket No.: FAA–2014–0554; Amdt. Nos. 1–69, 11–59, 121–374, 125–65, and 135–133] RIN 2120–AK32 Acceptance Criteria for Portable Oxygen Concentrators Used On Board Aircraft Federal Aviation Administration (FAA) and Office of the Secretary (OST), Department of Transportation (DOT). ACTION: Final rule. AGENCY: This final rule replaces the existing process by which the Federal Aviation Administration (Agency or FAA) approves portable oxygen concentrators (POC) for use on board aircraft in air carrier operations, commercial operations, and certain other operations using large aircraft. The FAA currently assesses each POC make and model on a case-by-case basis and if the FAA determines that a particular POC is safe for use on board an aircraft, the FAA conducts rulemaking to identify the specific POC model in an FAA regulation. This final rule replaces the current process and allows passengers to use a POC on board an aircraft if the POC satisfies certain acceptance criteria and bears a label indicating conformance with the acceptance criteria. The labeling requirement only affects POCs intended for use on board aircraft that were not previously approved for use on aircraft by the FAA. Additionally, this rulemaking will eliminate redundant operational requirements and paperwork requirements related to the physician’s statement. As a result, this rulemaking will reduce burdens for POC manufacturers, passengers who use POCs while traveling, and affected aircraft operators. This final rule also makes conforming amendments to the Department of Transportation’s (Department or DOT) rule implementing the Air Carrier Access Act (ACAA) to require carriers to accept all POC models that meet FAA acceptance criteria as detailed in this rule. DATES: The amendments to 14 CFR 1.1, 1.2, 121.574, 125.219, and 135.91 are SUMMARY: mstockstill on DSK3G9T082PROD with RULES3 effective June 23, 2016. The amendments to 14 CFR 11.201, 121.306, 125.204, 135.144, 382,27, and 382.133, and the removal of Special Federal Aviation Regulation No. 106 are effective August 22, 2016. For technical questions concerning this action, contact DK Deaderick, 121 Air Carrier Operations Branch, Air Transportation Division, Flight Standards Service, Federal Aviation Administration, AFS–220, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267–7480; email dk.deaderick@faa.gov. For questions regarding the Department’s disability regulation (14 CFR part 382), contact Clereece Kroha, Senior Attorney, Office of Aviation Enforcement and Proceedings, Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366–9041; email clereece.kroha@dot.gov. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Overview of Final Rule B. Summary of Cost Savings II. Authority for This Rulemaking III. Background A. Statement of the Problem B. Summary of the NPRM C. Differences Between Notice of Proposed Rulemaking and Final Rule D. General Overview of Comments IV. Discussion of Public Comments and Final Rule A. Applicability, Effective Dates and Compliance B. Definition of Portable Oxygen Concentrator C. Portable Oxygen Concentrator Acceptance Criteria 1. Food and Drug Administration Clearance or Approval 2. Radio Frequency Emissions 3. Hazardous Materials 4. Maximum Oxygen Pressure D. Manufacturer Label E. Manufacturer Determination of Conformance to Acceptance Criteria F. Prohibition on Smoking or Open Flame G. Operational Requirements 1. Exit Seats 2. Stowage of Portable Oxygen Concentrators H. Discussion of Special Federal Aviation Regulation No. 106 Requirements Excluded From Final Rule 1. Special Federal Aviation Regulation No. 106 Requirements Addressed in Existing Regulations 2. Special Federal Aviation Regulation No. 106 Requirements Excluded in Their Entirety I. Miscellaneous J. Technical Amendments K. Nondiscrimination on the Basis of Disability in Air Travel 1. Mandatory Acceptance of POCs That Meet FAA Acceptance Criteria 2. Other Amendments to 14 CFR Part 382 V. Regulatory Notices and Analyses A. Regulatory Evaluation B. Regulatory Flexibility Determination C. International Trade Impact Assessment D. Unfunded Mandates Assessment E. Paperwork Reduction Act F. International Compatibility and Cooperation G. Environmental Analysis VI. Executive Order Determinations A. Executive Order 13132, Federalism B. Executive Order 13211, Regulations That Significantly Affect Energy Supply, Distribution, or Use VII. How To Obtain Additional Information A. Rulemaking Documents B. Comments Submitted to the Docket C. Small Business Regulatory Enforcement Fairness Act I. Executive Summary A. Overview of Final Rule This final rule affects the use of POCs on board aircraft in operations conducted under title 14 of the Code of Federal Regulations (14 CFR) parts 121, 125, and 135, by replacing the existing FAA case-by-case approval process for each make and model of POC in Special Federal Aviation Regulation (SFAR) No. 106, with FAA acceptance criteria. Under SFAR No. 106, each time the FAA approves a specific model of POC for use on board aircraft, the agency updates the list of approved POCs in the SFAR.1 This final rule removes SFAR No. 106 and replaces it with POC acceptance criteria and specific labeling requirements to identify POCs that conform to the acceptance criteria. POCs that conform to the final rule acceptance criteria will be allowed on board aircraft without additional FAA review and rulemaking. As with existing requirements for FAA approval of POCs that may be used on aircraft, the final rule acceptance criteria and labeling requirement only apply to POCs intended for use on board aircraft. Table 1 provides a comparison of the final rule acceptance criteria and 1 POCs identified in the SFAR are referred to in this preamble as SFAR-approved POCs or SFARapproved devices. VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\24MYR3.SGM 24MYR3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 33099 labeling requirement with related SFAR No. 106. TABLE 1—COMPARISON OF FINAL RULE ACCEPTANCE CRITERIA AND LABELING REQUIREMENT WITH RELATED SFAR NO. 106 REQUIREMENTS Related SFAR No. 106 requirements Food and Drug Administration (FDA) clearance to market the device. Hazardous materials ............ Radio frequency (RF) emissions. Identification of POCs safe for use on board aircraft. Final rule acceptance criteria and labeling requirement The POC must be regulated by the FDA (section 2(2)) Note: To satisfy this requirement, manufacturers provide the FAA with the FDA letter granting approval to market the device (the FDA response to a manufacturer’s 510(k) submission). The POC may not contain hazardous materials as determined by the Pipeline and Hazardous Materials Safety Administration (section 2(1)). Note: To satisfy this requirement, manufacturers currently provide the FAA with a Pipeline and Hazardous Materials Safety Administration (PHMSA) determination letter stating that the POC is not subject to the Hazardous Materials Regulations (HMR) (49 CFR parts 171–180). Operator must determine that POC does not cause interference with the electrical, navigation or communication equipment on the aircraft on which the device is to be used (section 3(a)(1)). Note: To satisfy this requirement, it is current practice for operators to use testing data provided by POC manufacturers regarding the RF emissions of a specific POC model. Manufacturers currently complete testing in accordance with RTCA standard 160G, Section 21, Category M. POC model must be identified in SFAR No. 106 as approved for use on board aircraft prior to use on board aircraft in part 121, 125, and 135 operations (sections 2, 3(a)). Note: Specific POCs approved for use on board aircraft are identified in SFAR No. 106 by manufacturer and model name. Although some POC manufacturers affix a label indicating FAA approval for use on board aircraft, there is no current FAA requirement for a label indicating this approval. The POC manufacturer has received FDA clearance to legally market the device in the United States. This final rule requires all POC models to conform to the acceptance criteria.2 Further, any POC model that was not previously identified in SFAR No. 106 as approved for use on aircraft must also bear a label indicating conformance with the acceptance criteria before it may be used on board an aircraft. This label will facilitate passenger and crew recognition of POCs that may be used in the cabin during all phases of flight. The POC must not contain any hazardous materials subject to the HMR, except as provided for batteries in the exceptions for crewmembers and passengers (49 CFR 175.10). The maximum oxygen pressure generated by the POC must fall below the threshold for the definition of a compressed gas as per the HMR. The POC’s RF emissions do not interfere with aircraft systems. In order to be used on aircraft, a label must be affixed to the POC indicating compliance with acceptance criteria pertaining to FDA clearance to market the device, hazardous materials, and RF emission limits. POC models identified in existing SFAR No. 106 satisfy the acceptance criteria and will be exempt from the labeling requirement. These POC models will continue to be identified in the regulatory text. SFAR-approved POC models need not bear a label. The final rule regulatory text includes a list of POCs approved in accordance with SFAR No. 106 so that passengers and crewmembers can continue to identify these POCs as approved for use on board aircraft. In addition, this final rule eliminates SFAR No. 106 requirements related to POC use on board aircraft that are addressed elsewhere in titles 14 or 49 of the CFR. This final rule also eliminates specific SFAR No. 106 requirements applicable to passengers that are not necessary for safe POC use on board aircraft, and impose an unnecessary and unreasonable paperwork burden on POC-using passengers and their physicians as well as crewmembers and aircraft operators. This final rule also increases accessibility in air travel for passengers who require oxygen therapy during flight. Table 2 summarizes the final rule disposition of all SFAR No. 106 provisions. TABLE 2—SUMMARY OF SFAR NO. 106 PROVISIONS AND DISPOSITION IN FINAL RULE mstockstill on DSK3G9T082PROD with RULES3 Summary of SFAR No. 106 provision Description of disposition in final rule • Requirement that the POC is legally marketed in the United States in accordance with FDA requirements (section 2(2)). • Requirement for operator to determine that POC does not cause interference with the electrical, navigation or communication equipment on the aircraft on which the device is to be used (section 3(a)(1)). SFAR No. 106 Provisions Reflected in Acceptance Criteria and Labeling Requirement. 2 POC models previously listed as approved for use on board aircraft in SFAR No. 106 received approval because they satisfied the criteria set forth in SFAR No. 106. The POC acceptance criteria VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 identified in this final rule are based on existing SFAR No. 106 requirements that must be satisfied before the FAA identifies a POC in SFAR No. 106 as approved for use on aircraft. Thus, a POC model PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 identified in SFAR No. 106 satisfies the acceptance criteria. E:\FR\FM\24MYR3.SGM 24MYR3 33100 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations TABLE 2—SUMMARY OF SFAR NO. 106 PROVISIONS AND DISPOSITION IN FINAL RULE—Continued Description of disposition in final rule Summary of SFAR No. 106 provision • Prohibition on POCs containing hazardous materials as determined by the Pipeline and Hazardous Materials Safety Administration (section 2(1)). • POC model must be identified in SFAR No. 106 prior to use in part 121, 125, and 135 operations (sections 2, 3(a))*. • Prohibition on smoking or open flame near POC (section 3(a)(2)) ............................................ • Prohibition on seating a passenger using a POC in an exit seat (section 3(a)(4)). ................... • Requirement to stow POC during movement on the surface, takeoff, and landing (section 3(a)(3)). • POC model must be identified in SFAR No. 106 prior to use in part 121, 125, and 135 operations (sections 2, 3( a))*. • ‘‘Whenever the pilot in command turns off the ‘‘Fasten Seat Belt’’ sign, or otherwise signifies that permission is granted to move about the passenger cabin, passengers operating their portable oxygen concentrator may continue to operate it while moving about the cabin.’’ (section 3(a)(6)). • Requirement for POC user to ensure that POC batteries in carry-on baggage are protected from short circuit and are packaged in a manner that protects them from physical damage (section 3(b)(6)). • ‘‘Whenever the pilot in command turns off the ‘‘Fasten Seat Belt’’ sign, or otherwise signifies that permission is granted to move about the passenger cabin, passengers operating their portable oxygen concentrator may continue to operate it while moving about the cabin.’’ (section 3(a)(6)). • Requirement for POC user to ensure that POC batteries in carry-on baggage are protected from short circuit and are packaged in a manner that protects them from physical damage (section 3(b)(6)). • Requirements for POC user to obtain a physician’s statement and provide notice to pilot and aircraft operator regarding POC use and contents of physician statement (sections 3(a)(5) and 3(b)(3)). • Requirement for POC user to be capable of responding to alarms or to travel with a person who can perform these functions (section 3(b)(1)). • Requirement for POC user to ensure that the POC is free of petroleum products or signs of excessive wear or abuse (section 3(b)(2)). • Prohibition on use of salves and lotions unless ‘‘oxygen approved’’ (section 3(b)(4)) • Requirement for passenger to carry a sufficient number of batteries for duration of flight (section 3(b)(5))**. SFAR No. 106 Provisions Retained. SFAR No. 106 Provisions Eliminated Because Addressed in Other Existing Regulations. SFAR No. 106 Provisions Eliminated Because Addressed in Other Existing Regulations. SFAR No. 106 Provisions Eliminated in Their Entirety. mstockstill on DSK3G9T082PROD with RULES3 * The list of POCs currently identified in SFAR No. 106 will be maintained in parts 121, 125 and 135. A detailed discussion regarding the identification of POCs that conform to the acceptance criteria is provided in the preamble discussion, ‘‘Manufacturer Label.’’ ** Air carriers may require passengers using a POC to bring an adequate number of batteries to power a POC. See 14 CFR 382.133. This final rule also includes several conforming changes to 14 CFR part 382 to ensure that the Department’s rule requiring carriers to accommodate passengers with disabilities who are traveling with POCs is consistent with the FAA changes to POC carriage and use on aircraft. Finally, the amendments provided in this final rule are consistent with the retrospective regulatory review requirements of Executive Order 13563. On January 18, 2011, the President signed Executive Order 13563, Improving Regulation and Regulatory Review. Among other things, Section 6 of that Executive Order directs agencies to conduct a retrospective analysis of existing rules. Specifically, Executive Order 13563 provides that ‘‘[t]o facilitate the periodic review of existing significant regulations, agencies shall consider how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 them in accordance with what has been learned.’’ Consistent with Executive Order 13563, the FAA routinely evaluates existing regulations and other requirements. The FAA works to identify unnecessary, duplicative, or ineffective regulations and to mitigate the impacts of those regulations, where possible, without compromising safety. As part of the FAA’s continuing obligation to review its regulations, the agency conducted an analysis of SFAR No. 106 and determined that it involves several unnecessary burdens. As a result of this determination and the resulting final rule amendments, the final rule will provide relief to POC manufacturers, passengers who use a POC, aircraft operators and the FAA. The final rule will provide relief to POC manufacturers and the FAA by eliminating the SFAR No. 106 POC approval process, to passengers who use a POC by eliminating the FAA requirement to obtain a physician’s statement, and to aircraft operators by eliminating the requirements for PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 crewmember review of the physician’s statement and pilot in command (PIC) notification. The quantification of benefits follows the same methodology as the proposed rule as the agency did not receive negative comments on this methodology. The agency presents cost savings in Table 3 below. The total cost savings from this final rule is $39.5 million ($27.6 million at 7% present value and $33.6 million at 3% present value). The largest cost savings of $39 million occurs from the reduction of crew time to review the physician’s statement. These are the same estimated benefits and costs as presented for the proposed rule and since the FAA received no comments regarding these estimates, there are no changes to this final rule. B. Summary of Cost Savings The FAA estimates that manufacturers will save $108,000 over ten years because they will no longer have to petition the FAA for rulemaking with each new device they want to add to the list of POCs approved for use E:\FR\FM\24MYR3.SGM 24MYR3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations during flight on board aircraft. These cost savings will be reduced slightly because manufacturers will incur an estimated total one-time cost of $22,000 to comply with the labeling requirement. The FAA estimated additional cost savings because of the discontinuation of certain requirements 33101 from SFAR No. 106. Table 3 presents total estimated cost savings. TABLE 3—TOTAL ESTIMATED COST SAVINGS Cost savings 7% Present value savings 3% Present value savings FAA Savings—No SFAR ............................................................................................................. Manufacturer Savings—No petition for rulemaking ..................................................................... Removal of FAA requirement for user to obtain a physician’s statement for POC use on aircraft .......................................................................................................................................... Removal of FAA requirement for crew review of physician’s statement and PIC notification .... $91,644 108,000 $68,871 75,853 $80,519 92,126 569,961 38,726,085 401,645 27,083,677 486,914 32,972,652 Total Cost Savings ............................................................................................................... 39,495,690 27,630,045 33,632,212 II. Authority for This Rulemaking The FAA’s authority to issue rules on aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency’s authority. This rulemaking is promulgated under the authority described in 49 U.S.C. 106(f), which vests final authority in the Administrator for carrying out all functions, powers, and duties of the administration relating to the promulgation of regulations and rules, and section 44701(a)(5), which requires the Administrator to promulgate regulations and minimum standards for other practices, methods, and procedures necessary for safety in air commerce and national security. Further, 49 U.S.C. 41705 provides the Secretary of Transportation the authority to prohibit discrimination against a qualified individual with a disability in air travel. mstockstill on DSK3G9T082PROD with RULES3 III. Background A. Statement of the Problem On July 12, 2005, the FAA published a final rule adding SFAR No. 106 to part 121 of title 14 (70 FR 40156). The final rule adding SFAR No. 106 permitted the use of POCs identified in the SFAR to address the needs of passengers requiring oxygen therapy while traveling on board aircraft. Prior to SFAR No. 106, passengers could carry and operate equipment generating, storing or dispensing medical oxygen on board an aircraft only if the equipment was furnished by the certificate holder and certain other conditions prescribed in 14 CFR 121.547, 125.219 and 135.91 were satisfied. In 2005, only a limited number of air carriers provided compressed medical oxygen, for a fee, to passengers who required medical oxygen therapy during flight. Because compressed VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 oxygen is considered a hazardous material, it was an expensive and logistically challenging exercise for air carriers to provide medical oxygen. Today, virtually no certificate holders conducting part 121 operations provide in-flight medical oxygen for a fee to passengers. Further, passengers requiring oxygen therapy during travel also faced difficulty coordinating service between the carrier and the medical oxygen supplier to ensure coverage at the terminal, on board the aircraft, and gateto-gate. Sometimes, passengers would spend at least part of the time travelling without medical oxygen due to service problems with the oxygen supplier. In 2002, POCs were brought to the attention of the FAA as a new portable technology for dispensing medical oxygen for purposes of oxygen therapy. POCs work by filtering nitrogen from the air and providing the POC user with oxygen at a concentration of approximately 90 percent. Thus, POCs do not require the same level of special handling as compressed oxygen. However, due to existing FAA regulations applicable to the use of devices that dispense oxygen (§§ 121.574, 125.219, and 135.91), including POCs, the FAA informed the POC community that an exemption would be required for a passenger to carry on and operate a POC that the passenger supplied for his or her own use (i.e., not furnished by the aircraft operator). Rather than wait for petitions for exemption from the existing regulations (§§ 121.574, 125.219, and 135.91), the FAA completed rulemaking to address the issue of passenger-supplied POCs by adding SFAR No. 106 to title 14. See 69 FR 42324 (July 14, 2004) and 70 FR 40156 (July 12, 2005). SFAR No. 106 allows passengers to carry and operate their own POC on board an aircraft if the FAA has approved the specific POC model for use on board aircraft and PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 identified the POC model in the SFAR.3 As a result of SFAR No. 106, the FAA has mitigated the challenges faced by passengers requiring oxygen therapy during travel and has increased the accessibility to air travel for many passengers requiring oxygen therapy by allowing passengers to supply their own POCs for use during air travel. Passengers may not use a POC on board an aircraft in part 121, 125, or 135 operations unless the FAA has identified the device they wish to use in SFAR No. 106 as approved for use in such operations. In 2005, SFAR No. 106 identified the first specific POC models approved for use on board aircraft. Although the agency intended SFAR No. 106 to serve as a special, temporary regulation, until POC performance standards (acceptance criteria) could be developed, it has remained in place for the last decade. See 70 FR at 40158– 40159. During this time, the FAA has amended SFAR No. 106 seven times to identify additional POC models that may be used on board aircraft.4 This process is time-consuming for POC manufacturers because they must petition the FAA for rulemaking to add their POC model to the SFAR list if they want their POC to be approved for use on board aircraft. Together with a petition for rulemaking, manufacturers provide the FAA with documentation required for the FAA to make a determination whether the POC satisfies the requirements of the SFAR. This process is also time-consuming for the FAA because each time the FAA 3 Initially, SFAR No. 106 applied to part 119 certificate holders conducting operations under part 121. In a technical amendment published January 12, 2007 (72 FR 1442), the FAA extended the requirements of SFAR No. 106 to part 119 certificate holders conducting operations under parts 125 and 135. 4 71 FR 53956 (Sept. 12, 2006); 74 FR 2354 (Jan. 15, 2009); 75 FR 742 (Jan. 6, 2010); 75 FR 39632 (July 12, 2010); 77 FR 4220 (Jan. 27, 2012); 77 FR 63221 (Oct. 16, 2012); and 79 FR 6018 (Feb. 3, 2014). E:\FR\FM\24MYR3.SGM 24MYR3 33102 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations approves a new POC for use on board aircraft, the FAA must complete rulemaking to add the newly approved POC model to SFAR No. 106. Over the last ten years, FAA regulations and guidance regarding the use of POCs on aircraft, POC technology itself, and air carrier programs concerning the use of POCs on board their aircraft have rapidly evolved. The combined result of these initiatives is an increase in accessibility to air travel for many passengers who require oxygen therapy during flight. In keeping with the Department’s ongoing commitment to increase accessibility to air travel, this final rule removes certain burdensome and time-consuming requirements that were put in place to ensure safety when POC technology was first introduced for use on board aircraft but are no longer necessary. mstockstill on DSK3G9T082PROD with RULES3 B. Summary of the NPRM On September 19, 2014, the FAA published an NPRM entitled ‘‘Acceptance Criteria for Portable Oxygen Concentrators Used On Board Aircraft’’ in which the FAA proposed to replace SFAR No. 106 with acceptance criteria for POCs to be used by passengers on board aircraft in operations conducted under parts 121, 125 and 135. See 79 FR 56288. In the NPRM, the FAA proposed to replace the burdensome SFAR No. 106 POC approval process with acceptance criteria based on SFAR No. 106 requirements, and an additional requirement for POCs (carried and used on board aircraft) to bear a label indicating compliance with these acceptance criteria. The FAA proposed, however, that all SFAR-approved POCs would be excluded from the labeling requirement. Further, the proposed acceptance criteria and labeling requirements would only affect POCs intended for use on board aircraft. The FAA also proposed to eliminate several redundant operational requirements as well as paperwork requirements related to the physician’s statement, which are not necessary for aviation safety. The comment period for this NPRM closed November 18, 2014. C. Differences Between Notice of Proposed Rulemaking and Final Rule The final rule differs from the NPRM as follows: • Replaces the proposed prescriptive requirement for radio frequency (RF) emissions evaluation with a performance-based standard that allows POC manufacturers to determine the means by which to assess whether its POC will radiate RF emissions that interfere with aircraft systems. VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 • Modifies verbiage for required label text. • Retains the SFAR No. 106 prohibition on exit row seating for passengers using a POC and the SFAR No. 106 requirements pertaining to POC stowage. • Amends 14 CFR part 382 to ensure that it is consistent with the FAA changes to POC carriage and use on aircraft. D. General Overview of Comments The FAA received 33 comments on the NPRM. Commenters included 21 individuals or anonymous commenters, the Airline Pilots Association (ALPA), Airlines for America (A4A), the Association of Flight Attendants (AFA), American Airlines, Delta Air Lines, Main Clinic Supply, Phillips Respironics, BPR Medical Limited, Oxygen to Go (OTG), the Mayo Clinic, and one commenter identified as the past president of the Airlines Medical Directors Association (AMDA). Although the FAA received general support for the NPRM from many commenters, some commenters recommended modifications to the proposed acceptance criteria, POC labeling requirements, and issues related to the identification of POCs that may be used on board aircraft. Other commenters did not support the elimination of certain SFAR No. 106 provisions, including those pertaining to exit row seating for passengers using a POC, POC stowage, the physician’s statement and passenger notification of intended POC use to the PIC and aircraft operator. Comments are addressed in the preamble discussion entitled, ‘‘Discussion of Public Comments and Final Rule.’’ The agency also received a request from OTG to reopen the comment period. The agency denied this request, because the agency satisfied the requirement of the Administrative Procedure Act to publish a general notice of a proposed rule in the Federal Register. See 5 U.S.C. 553. Both the request to reopen the comment period and the agency’s response to this request can be found in the docket for this rulemaking. IV. Discussion of Public Comments and Final Rule A. Applicability, Effective Dates and Compliance Currently, SFAR No. 106 applies only to those POC models intended for use on board aircraft in operations conducted under parts 121, 125, and 135 of title 14 of the Code of Federal Regulations. SFAR No. 106 authorizes PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 the use of specific POCs on board aircraft in operations conducted under parts 121, 125, or 135, if the conditions in the SFAR are satisfied. Consistent with SFAR No. 106 and the NPRM, this final rule applies only to those POC models intended for use on board aircraft in part 121, 125, and 135 operations, and like SFAR No. 106 it does not create a requirement for operators to allow POC use. The Department’s requirements for air carriers to allow the use of a POC on board an aircraft (designed to have a maximum capacity of more than 19 passenger seats) continue to be found in 14 CFR 382.133. In the NPRM, the agency proposed an effective date of 90 days after publication of the final rule in the Federal Register. Because the agency did not propose a separate compliance date, compliance would also be required 90 days after publication in the Federal Register. The agency seeks to allow compliance with this final rule as soon as possible. The agency recognizes, however, that affected aircraft operators may need to revise operating manuals and training programs, and expects these revisions to occur within the normal course of business. Accordingly, the SFAR will remain in place until August 22, 2016 and compliance with the new rule will be permitted beginning on August 22, 2016 to allow a sufficient amount of time for operating manuals and training programs to be amended in the normal course of business. B. Definition of Portable Oxygen Concentrator As proposed, this final rule defines ‘‘portable oxygen concentrator’’ in 14 CFR 1.1 as a medical device that separates oxygen from other gasses in ambient air and dispenses this concentrated oxygen to the user. This definition is consistent with the description of POCs in existing SFAR No. 106. The § 1.1 definition of a POC added by this final rule is also consistent with Advisory Circular (AC) 120–95, Portable Oxygen Concentrators,5 as well as the device description used by POC manufacturers and the Food and Drug Administration (FDA) (the federal agency with primary regulatory authority over POCs for medical use).6 5 AC 120–95B defines POCs as ‘‘small, portable devices that work by separating oxygen from nitrogen and other gasses in the air and providing the user with oxygen at a concentration of more than 90 percent . . .’’ 6 Portable oxygen concentrators are a subset of portable oxygen generators defined by the FDA in 21 CFR 868.5440. E:\FR\FM\24MYR3.SGM 24MYR3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations By including this definition in § 1.1, the FAA distinguishes POCs from portable oxygen generators and other medical devices that use compressed or liquid oxygen for medical oxygen therapy. Devices that use compressed or liquid oxygen must satisfy separate and more rigorous requirements to mitigate the risks they present. mstockstill on DSK3G9T082PROD with RULES3 C. Portable Oxygen Concentrator Acceptance Criteria Under SFAR No. 106, the FAA allows the carriage and use of specific POC models only if they are identified in the SFAR as approved for use on board aircraft. A POC may be identified in the SFAR only after the POC manufacturer has petitioned the FAA for rulemaking (to add the POC to the SFAR) and has demonstrated to the FAA that the specific POC model satisfies the requirements of the SFAR (i.e., the POC must be regulated by the FDA and the POC may not contain hazardous materials as determined by PHMSA). Each time the FAA approves a specific model of POC for use on board an aircraft, the agency must update the list of POCs in the SFAR through rulemaking. Additionally, the aircraft operator is responsible for determining that the POC does not cause interference with aircraft equipment. The FAA notes that in practice, aircraft operators use data supplied by POC manufacturers to the FAA to determine compliance with the requirement to ensure that a POC will not interfere with aircraft equipment. In the NPRM, the agency proposed to replace the SFAR No. 106 case-by-case POC approval and rulemaking with requirements for POCs used on board aircraft to conform to specified acceptance criteria and to bear a label indicating that the device conforms to these criteria. The proposal further stated that POCs conforming to the acceptance criteria and bearing the appropriate label would be allowed on board aircraft without further rulemaking. The proposed acceptance criteria are summarized as follows: • The POC manufacturer complies with all FDA requirements to legally market the device in the United States. • The POC does not contain any hazardous materials subject to the HMR except as provided for in the exceptions for crewmembers and passengers in 49 CFR 175.10 for batteries used to power electronic devices when operator approval is not required. • The maximum oxygen pressure generated by the POC must fall below the threshold for the definition of a compressed gas per the HMR. VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 • The POC radio frequency (RF) emissions must fall below the threshold permitted in RTCA standard 160G, Section 21, Category M. As addressed in more detail in this section of the preamble discussion, this final rule adopts the proposal with modifications to the RF emissions acceptance criterion and labeling requirement. 1. Food and Drug Administration Clearance or Approval POCs are medical devices regulated by the FDA in accordance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and title 21 of the CFR. Accordingly, manufacturers must obtain FDA clearance or approval prior to marketing a POC within the United States, and must comply with certain provisions in title 21 of the CFR, including but not limited to device registration and listing (21 CFR part 807), labeling (21 CFR part 801), adverse event reporting (21 CFR part 803), and good manufacturing practice requirements (21 CFR part 820). SFAR No. 106 requires all POCs used on board aircraft in operations conducted under 14 CFR parts 121, 125, and 135 to be legally marketed as a POC, in compliance with FDA regulations. The purpose of this requirement is to ensure the device is actually what the manufacturer holds it out to be—a POC. To demonstrate compliance with this requirement, POC manufacturers submit evidence that the device has been cleared or approved by the FDA for marketing in the United States. The FAA accepts FDA premarket clearance in response to a 510(k) submission as evidence the device may be marketed in the United States.7 In the NPRM, the agency proposed to continue to require any POC used on board an aircraft to be cleared or approved by the FDA for marketing in the United States prior to such use. However, given that FDA requirements for legal marketing of a POC in the United States already apply to POCs, independent of the SFAR, manufacturers would no longer need to submit evidence of this clearance or approval to the FAA to demonstrate compliance because it would be 7 A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to premarket approval. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. If FDA makes a finding of substantial equivalence, the device is considered ‘‘cleared.’’ Additional information regarding the 510(k) process is available at www.fda.gov. PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 33103 unnecessarily burdensome. Rather, the FAA proposed that POCs conforming to the proposed acceptance criteria, including the manufacturer’s authority to legally market the device as a POC, would be identified by a label affixed to the device. This final rule adopts this proposed acceptance criterion without change. 2. Radio Frequency Emissions Sections 121.306, 125.204, and 135.144 place responsibility on the aircraft operator for determining which portable electronic devices (PED) may be safely used on its aircraft. Although the agency recognizes POCs as a type of PED, SFAR No. 106, includes a requirement for an aircraft operator to make a determination that the device does not cause interference with the electrical, navigation, or communication system of the aircraft in which the device will be used. The SFAR No. 106, section 3(a)(1) requirement pertaining to POC interference with aircraft equipment has the same effect as the requirements in §§ 121.306, 125.204, and 135.144 pertaining to all PEDs. Each operator may establish a method to make a determination regarding the effects of PEDs on its aircraft’s avionics systems. Historically, FAA guidance material (i.e., AC 91.21–1 and AC 120– 95) identified one method of compliance with the SFAR and §§ 121.306, 125.204, and 135.144 by recommending the operator complete device-by-device evaluations of RF emissions.8 These evaluations involve comparing the device’s RF emissions against the current RTCA DO–160 standards for installed airborne equipment. The FAA identified RTCA DO–160, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21, Category M in guidance material for medical PEDs (including POCs intended for use on aircraft) because it established safe and conservative RF emissions limits for installed aircraft systems. Consistent with the historical deviceby-device approach to RF emissions evaluation and agency guidance, it is current practice for POC manufacturers to provide the RTCA test compliance statements to the FAA.9 Although 8 The term EMC was used throughout the NPRM however, EMC is a broad term used for installed aircraft electrical systems. Where appropriate, the FAA has replaced the term EMC with RF emissions in this final rule preamble because when a deviceby-device examination of a PED is conducted, the operator would consider the RF emissions of that device. 9 Currently, POC manufacturers provide the RTCA DO–160 Section 21 test qualification statements to the FAA; the FAA then makes the E:\FR\FM\24MYR3.SGM Continued 24MYR3 33104 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES3 section 3(a)(1) of SFAR No. 106 places the burden upon the aircraft operator to assess the impact of a POC on the aircraft, the FAA has accepted as proof of non-interference, RF emissions test qualification statements (provided by POC manufacturers) that show a specific POC does not exceed certain maximum RF emissions thresholds established by RTCA in DO–160, Environmental Conditions and Test Procedures for Airborne Equipment.10 On October 31, 2013, the agency announced a new means of compliance with §§ 121.306, 125.204, and 135.144, allowing operators to expand the use of passenger supplied and operated PEDs throughout all phases of flight, based on a determination by the operator that the aircraft systems themselves are PED tolerant (i.e., aircraft systems safety risk assessment showing the systems meet the requirements of RTCA DO–307 or another PED tolerance assessment). See Information for Operators (InFO) 13010 and InFO 13010SUP.11 The agency does not, however, require aircraft systems safety risk assessment of PED tolerance in accordance with InFO13010 and InFO 13010SUP. These assessment methods provide one means for airplane operators to demonstrate compliance with §§ 121.306, 125.204, and 135.144 and allow PEDs to be used on board aircraft. It is up to each aircraft operator to determine whether to expand the use of passenger supplied and operated PEDs via a determination of PED tolerance for certain aircraft types. The FAA estimates that eighty percent of part 121 air carriers (which comprise an estimated 98% of total part 121 passenger enplanements in 2013) and several of the largest part 135 air carriers have expanded PED use according to InFO 13010 and InFO 13010SUP. The remaining operators continue to rely on individual PED evaluations. In the NPRM, the agency proposed to require the RF emissions for each POC intended for use on board aircraft to be tested in accordance with RTCA DO– 160G, Section 21, Category M. The agency also proposed to add POCs to the list of devices excepted from the general RTCA test qualification statements available on its Web site for aircraft operators to use to demonstrate compliance with section 3(a)(1) of the SFAR. The RTCA compliance statements may be viewed at http://www.faa.gov/about/initiatives/cabin_safety/ portable_oxygen/. 10 See AC 120–95, Portable Oxygen Concentrators. The FAA notes that while RTCA made significant changes to DO–160 since edition E was issued (December 9, 2004) and cited in agency guidance, Section 21, Category M (applicable to POCs) was not revised in either DO– 160F or DO–160G. 11 All InFOs can be found at http://www.faa.gov/ other_visit/aviation_industry/airline_operators/ airline_safety/info/all_infos/. VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 PED non-interference requirements in §§ 121.306, 125.204, and 135.144 to eliminate redundancy with the POCspecific non-interference requirements. This final rule retains a POC-specific non-interference requirement, modified to reflect a performance-based standard. The Agency recognizes that the majority of operators conducting part 121 operations and several of the larger operators conducting part 135 operations have already conducted aircraft systems safety risk assessments for PED tolerance in accordance with InFO 13010 and InFO 13010SUP with results allowing for continuous use of PEDs from gate to gate. A determination that an aircraft is ‘‘PED tolerant’’ would make an independent assessment of RF emissions for any PED used on that aircraft unnecessary. Nevertheless, because of the need to ensure service for passengers who require oxygen therapy during air travel, the FAA believes it is necessary to maintain a regulatory structure to ensure that passengers may continue to use POCs on board aircraft even if the aircraft operator has not determined that the aircraft is ‘‘PED tolerant.’’ Therefore, consistent with the SFAR and the NPRM, this final rule retains a requirement to assess POC RF emissions as one of the POC acceptance criteria. (The agency notes that POCs previously approved by the FAA for use on aircraft in accordance with SFAR No. 106 that demonstrated RF emissions below the maximum emissions threshold in DO–160G, Section 21, Category M would not need to be retested or reassessed by the operators prior to use on board aircraft because those prior assessments remain valid.) Delta Air Lines generally supported inclusion of RTCA DO–160, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21, Category M, in the proposed acceptance criteria. Recognizing, however, that FDA may require RF emissions assessments that may test to standards that could be used to demonstrate compliance with the FAA prohibition on PEDs interference with aircraft systems, the agency sought comment on whether POC manufacturers complete RF emissions assessments in accordance with requirements by other federal agencies that could also be used to demonstrate compliance with the generally applicable PED requirements. The agency did not receive any comments related to this specific issue except as provided by Delta. After further review of the proposal and other RF emissions assessments that POC manufacturers may conduct (e.g., International Standards Organization (ISO) 7137 and PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 the FDA recognized EMC standards for Class II medical devices in IEC 60601– 1–2 edition 4.0), the agency has determined that the proposed requirement to use RTCA DO–160 as the only means by which to evaluate POC RF emissions was overly prescriptive. Historically, the FAA identified RTCA DO–160 Section 21, Category M in guidance material for medical portable electronic devices intended for use on board aircraft. Although POCs are not installed aircraft systems, the agency identified RTCA DO–160 as one method to demonstrate compliance with the PED non-interference requirement because RTCA DO–160 establishes safe and conservative RF emissions limits for installed aircraft systems. The agency recognizes, however, that there are other methods to assess POC RF emissions and ensure that POC use will not cause interference with aircraft systems. Thus, this final rule includes a performancebased RF emissions acceptance criterion that allows POC manufacturers to determine how to assess whether their POC meets the aircraft system noninterference requirement before they affix a label to the device confirming that this criterion has been satisfied. Guidance material in AC 91.21–1C identifies examples of methods appropriate to ensure compliance with this requirement, including RTCA DO– 160 and other industry EMC standards identified in the AC. The FAA emphasizes, however, that FDA approval or clearance to market a POC does not necessarily mean that the POC complies with the FAA’s aircraft system non-interference requirement. In addition to Delta’s comment, an individual commented that the POC manufacturer should include the electromagnetic interference test results on the POC label, eliminating the need for the air carrier to test the device. The agency clarifies that the purpose of the label is to identify those devices that conform to the FAA acceptance criteria. One of those criteria prohibits the POC from radiating radio frequency emissions that interfere with aircraft systems. Therefore, a device that bears the required label must also not radiate RF emissions such that it causes interference with aircraft systems. The POC manufacturer identifies devices that meet this and other criteria by affixing a label. In this way, the label indicates that the device will not radiate RF emissions that cause interference with aircraft systems and does not need to be retested by the aircraft operator. Thus, adding specific test results to the label would be unnecessary. E:\FR\FM\24MYR3.SGM 24MYR3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES3 3. Hazardous Materials SFAR No. 106 allows passengers to use one of the specific POCs identified in the SFAR only if the POC does not contain hazardous materials as determined by PHMSA.12 See SFAR No. 106, section 2(1). The PHMSA determination required by SFAR No. 106 is one of the prerequisites that must be satisfied for the FAA to identify a POC in the SFAR. PHMSA issues this determination via a letter, at the request of the POC manufacturer and after PHMSA reviews manufacturer-supplied information regarding the POC. POCs typically operate using either rechargeable batteries (usually lithium ion) or AC/DC electrical power via an external power cord. Although the POC units themselves are not considered hazardous materials, the lithium ion batteries typically used to power POCs are hazardous materials.13 See 49 CFR 172.101, Hazardous Materials Table. However, lithium ion batteries are conditionally excepted from certain requirements of the HMR (e.g. UN specification packaging and labeling) if they meet certain size limitations (100 Wh), package limitations, and comply with package marking and battery testing conditions of the HMR. See 49 CFR 173.185(c). These exceptions only apply when the POC units are transported as cargo.14 Other HMR exceptions are provided in 49 CFR 175.10 that apply to POC units containing lithium ion batteries and associated spare batteries when carried on board aircraft by passengers and crewmembers. See 49 CFR 12 PHMSA is responsible for regulating and ensuring the safe and secure movement of hazardous materials by all modes of transportation, including aviation. To minimize threats to life, property or the environment due to hazardous materials related incidents, PHMSA’s Office of Hazardous Materials Safety develops the HMR and standards for classifying, handling and packaging shipments of hazardous materials within the United States. 13 49 CFR 105.5 defines a hazardous material as a substance or material that the Secretary of Transportation has determined is capable of posing an unreasonable risk to health, safety, and property when transported in commerce, and has been designated as hazardous under section 5103 of Federal hazardous materials transportation law (49 U.S.C. 5103). The term includes hazardous substances, hazardous wastes, marine pollutants, elevated temperature materials, materials designated as hazardous in the Hazardous Materials Table (see 49 CFR 172.101), and materials that meet the defining criteria for hazard classes and divisions in part 173 of subchapter C of this chapter. 14 The PHMSA final rule, Hazardous Materials: Transportation of Lithium Batteries, recently removed 49 CFR 172.102(c)(1), Code/Special Provision 188 and relocated it, in part to 173.185. See (79 FR 46012, (August 6, 2014)). Currently, conditional exceptions for the transportation of small batteries as cargo can be found in 49 CFR 173.185. VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 175.10(a)(18). In accordance with the exceptions in § 175.10(a)(18), passengers may bring an unlimited number of lithium ion batteries up to 100 Wh per battery to power their POC. Further, as a result of recent amendments, § 175.10(a)(18) also authorizes the aircraft operator to allow passengers and crewmembers to carry on board as spares up to two batteries that are larger than 100 Wh but do not exceed 160 Wh only if certain criteria are met.15 The PHMSA determination letters required by the SFAR were limited to a determination regarding the HMR exceptions for a POC unit containing small lithium ion batteries (i.e., 100 Wh or 8g equivalent lithium content or less) for transportation as cargo as these are the exceptions that would apply to a manufacturer for transportation of a POC unit from the point of manufacture to the point of retail sale (although the size limits that distinguish a small lithium ion battery are the same for both the transportation of such batteries as cargo as well as for the passenger and crewmember exceptions). Existing PHMSA determinations for SFARapproved POCs, however, do not include an assessment of each individual air carrier’s policies pertaining to the allowance for larger batteries carried as spares. Consistent with the proposal in the NPRM, this final rule eliminates the SFAR No. 106 provision requiring a PHMSA determination that the POC does not contain hazardous materials. Instead, this final rule prohibits POCs used on board aircraft from containing hazardous materials subject to the HMR and references the HMR. Further, as noted above, POC users may carry an unlimited number of small spare lithium ion batteries (i.e., lithium ion batteries up to 100 Wh per battery) and up to two larger spare lithium ion batteries (i.e., batteries larger than 100 Wh but that do not exceed 160 Wh) in accordance with the exceptions for hazardous materials carried by aircraft passengers and crewmembers as is the case today.16 See 49 CFR 175.10(a)(18). 15 The revisions to the HMR exceptions for hazardous materials carried by aircraft passengers and crewmembers have resulted in a more conservative approach to the carriage of lithium ion batteries used to power PEDs than the previous requirements under 49 CFR 175.10(a)(18)(2014 ed.). The current passenger and crewmember exceptions include a new requirement for approval by the air operator for the carriage of spare lithium ion batteries larger than 100 Wh (approximately 8 grams) and have reduced the maximum Watt-hours for spare lithium ion batteries from 300 Wh (approximately 25 grams) to 160 Wh. 16 The NPRM discussion regarding the SFAR limitation on hazardous materials took an overly conservative approach in the discussion pertaining PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 33105 There is no safety basis for requiring the PHMSA ‘‘no hazardous materials’’ determination letter as a prerequisite to the use of a POC on board an aircraft. The HMR conditional exceptions provided in §§ 175.10 and 173.185 apply to passengers, crew and the POC manufacturer, respectively, independent of the SFAR and this final rule. Further, the FAA does not require a PHMSA determination letter prior to passenger carriage of any other PED that may contain hazardous materials and POCs do not present any unique hazardous materials safety issues that would be mitigated by the requirement to obtain a PHMSA determination letter. Pursuant to 49 CFR 175.10(a)(18), passengers seeking to use a POC powered by a spare lithium ion battery that is over 100 Wh but less than 160 Wh are permitted to do so only with the approval of the operator. Given that the POC manufacturer cannot assume knowledge of and approval by each carrier regarding passenger and crewmember carriage of larger batteries, under this final rule, a POC manufacturer will be unable to label a POC as conforming to the final rule acceptance criteria if the POC has an installed lithium battery larger than 100 Wh. The final rule regulatory text clarifies the conditions under which POCs used on aircraft may contain batteries as a power source, including this limitation. Nonetheless, the passenger is ultimately responsible for compliance with the exceptions in § 175.10(a)(18) for spare batteries used to power a POC. For example, if a passenger wants to bring a spare lithium ion battery larger than 100 Wh into the aircraft cabin to power a POC unit, the passenger is responsible for compliance with § 175.10(a)(18) and reviewing airline acceptance policies. A manufacturer must only affix a label to a POC powered by an installed lithium ion battery that does not exceed 100 Wh because the manufacturer cannot ensure compliance with the 49 CFR 175.10(a)(18) condition under which a passenger may carry and use a battery that exceeds 100 Wh (i.e., approval by an aircraft operator with which a passenger may choose to fly). Adhering to this limitation will facilitate passenger carriage and use of POCs on board aircraft and ensure that there are no restrictions on the number of spare lithium ion batteries less than 100 Wh that can be carried on board the aircraft for full operability of the POC throughout the duration of the flight(s). to limitations on spare batteries carried by aircraft passengers and crewmembers. E:\FR\FM\24MYR3.SGM 24MYR3 33106 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES3 Finally, although the FAA did not receive any comments regarding its proposal to remove the requirement for a PHMSA determination of no hazardous materials, the agency notes that an individual commented that the rules pertaining to lithium ion batteries must be updated, citing potential lithium ion battery hazards. The agency finds that revisions to the requirements applicable to passenger carriage of lithium ion batteries generally, are outside of the scope of the proposal because the proposal was narrowly tailored to address only POC carriage and use on aircraft. Further, PHMSA recently updated the requirements applicable to lithium ion batteries as part of a comprehensive rulemaking addressing the transportation of lithium batteries. See 79 FR 46012 (August 6, 2014). As a result of this update, PHMSA regulations pertaining to lithium ion batteries are now harmonized with the International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transportation of Dangerous Goods by Air. Through the rulemaking process, PHMSA determined that harmonization with the ICAO Technical Instructions pertaining to lithium ion batteries used to power PEDs carried by passengers and crewmembers on aircraft provides an appropriate level of safety. 4. Maximum Oxygen Pressure As previously discussed, the SFAR No. 106 approval process requires POC manufacturers to obtain a PHMSA determination letter stating the POC device does not contain any hazardous materials. As part of this determination, PHMSA reviews information provided by the POC manufacturer regarding the oxygen pressure generated by a POC. If the POC generates oxygen pressure of 200 kPa gauge (29.0 psig/43.8 psia) or greater at 20 °C (68 °F), PHMSA would classify the POC as an article containing Hazard Class 2, Division 2.2 (nonflammable, non-poisonous compressed gas) and the POC would be subject to the applicable HMR (49 CFR 173.115). However, a POC does not contain a compressed gas subject to the HMR if it generates an oxygen pressure below this threshold. In the NPRM, the agency proposed to include as a POC acceptance criterion a design limitation that would restrict POCs used on aircraft from generating a maximum oxygen pressure of 200 kPa gauge (29.0 psig/43.8 psia) at 20 °C (68 °F), or more. The agency did not receive any comments on this proposal. The final rule includes the proposed POC design limitation as one of the POC acceptance criterion so as to ensure that VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 newly manufactured POCs used on board aircraft will continue to incorporate this existing design limitation, thus ensuring that POCs will not present the hazards associated with devices that generate compressed oxygen. Accordingly, as proposed, the final rule establishes a maximum oxygen pressure allowed for POCs intended for use on board aircraft. A POC designed to generate a maximum oxygen pressure of 200 kPa gauge (29.0 psig/43.8 psia) at 20 °C (68 °F), or more, would constitute a hazardous material and thus be subject to the HMR. As such, it must not be labeled as meeting the standards for use on board aircraft. The agency has determined that inclusion of the requirement regarding oxygen pressurization does not overlap with 49 CFR 173.115 or the general prohibition on hazardous materials in this final rule, because it applies a design standard regarding the operation of the device. Further, it addresses concentrated oxygen that falls below the pressure threshold for the definition of compressed gasses subject to 49 CFR 173.115. D. Manufacturer Label The FAA does not currently require POCs to bear a label indicating FAA approval and compliance with the SFAR. Aircraft operators, crewmembers, and passengers must identify POCs approved for use on aircraft by reviewing the list of FAA-approved devices in the SFAR. In the NPRM, the FAA proposed to require POCs that satisfied the proposed acceptance criteria and were intended for use on aircraft to bear a label indicating that the device satisfies these criteria as a condition of its carriage and use on aircraft. However, the NPRM excluded SFAR-approved POCs from the labeling requirement. The FAA also proposed specific label attributes. The proposed label would be required to contain the following statement in red text: ‘‘The manufacturer of this portable oxygen concentrator has determined this device conforms to all applicable FAA requirements for portable oxygen concentrator carriage and use on board aircraft.’’ Finally, the agency proposed that the label would have to be applied in a manner to ensure it remains affixed for the life of the POC. Identification of POCs that satisfy acceptance criteria: The agency sought comment on the potential safety benefits and associated burdens of extending the proposed labeling requirement to all POC models currently identified in SFAR No. 106—existing and newly PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 manufactured or just newly manufactured. Several commenters expressed concern regarding the exclusion of existing SFAR-approved POCs from the proposed POC labeling requirement. A4A, the Mayo Clinic and two individuals commented that the labeling requirement should extend to all POC models that may be used on board aircraft (those that are currently identified in SFAR No. 106 and those subsequently determined by their manufacturers to satisfy the proposed acceptance criteria). The individuals cited concern regarding potential confusion due to the two methods (i.e., review label and review list of SFAR-approved POCs) by which to identify POCs that may be used on aircraft as the basis for requiring all POCs to be labeled. The Mayo Clinic suggested that POC manufacturers could retrofit existing SFAR-approved devices through an inexpensive labeling method such as a sticker to resolve its concerns about potential health care provider confusion regarding which POCs may be used on aircraft. A4A noted that air carrier employees with responsibility for determining device acceptability should be able to make this determination efficiently, without having to refer to the CFR. A4A also stated that its comments on extending the labeling requirement to POCs approved under the SFAR should only be applied to newly manufactured POCs because retrofitting existing devices would be unreasonably burdensome. Philips Respironics objected to the extension of the labeling requirement to existing SFAR-approved POCs citing a significant burden and stating that passengers and aircraft operators would have sufficient means by which to identify POCs that may be used on board aircraft. The final rule retains the proposal to label POCs that have not been previously identified in SFAR No. 106 as approved for use on aircraft. SFARapproved POCs will continue to be identified in §§ 121.574, 125.219, and 135.91. The labeling requirement provides a simple, efficient and effective method by which to identify POCs that may be used on aircraft. In order to determine whether a POC may be used on an aircraft, a POC user or an aircraft operator need only examine the POC to determine whether it bears the label required by this final rule. As is the case today, for those POCs that do not bear the required label, a POC user and aircraft operator need only verify that the model is identified in the regulatory E:\FR\FM\24MYR3.SGM 24MYR3 mstockstill on DSK3G9T082PROD with RULES3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations text—the same process that is currently used to identify SFAR-approved POCs. The FAA maintains that it is not necessary or practical to require POC manufacturers to label POCs previously identified in SFAR No. 106 as approved for use on board aircraft. POC models previously identified in SFAR No. 106 as approved for use on board aircraft have satisfied the SFAR No. 106 criteria and would also satisfy the proposed acceptance criteria. Further, the FAA expects that the use of SFAR-approved POC models will lessen over time as those POCs age and their users replace those older models with newer ones, obviating the need to retrofit existing SFAR-approved POC models with a label. Although the agency appreciates the intent of the Mayo Clinic’s comment regarding a ‘‘bridging strategy’’ by which adhesive stickers could be used to identify previously manufactured SFAR-approved POCs, a label used to satisfy the requirements of this final rule must be sufficiently durable so as to remain affixed to the POC for the life of the device and prevent the transfer to another type of oxygen dispensing device, such as a device that uses compressed oxygen. In comments related to the identification of SFAR-approved POCs, Delta Air Lines suggested that the list of SFAR-approved POCs provided in the proposed regulatory text was incomplete because it did not identify all devices that the FAA previously approved in accordance with the SFAR. The list of SFAR-approved POCs identified in the proposed and final rule regulatory text is identical to the list of POCs identified in SFAR No. 106. The agency stresses that SFAR approval is device-specific. For instance, while the SFAR identifies the SeQual Eclipse as approved for use on aircraft, the approval does not extend to any other variants of SeQual Eclipse models that were not specifically reviewed and approved for use on aircraft by the FAA and identified in the SFAR. Thus, only those specific POCs identified in the SFAR by manufacturer and model name are currently approved for use on aircraft. This final rule continues to identify those SFAR-approved devices as they appear in the SFAR, since those SFAR-approved POCs need not bear a label as a condition of their use on aircraft. Delta Air Lines further commented that the FAA should update the list of POCs approved under SFAR No. 106 with the names of all POCs currently under review by the FAA, in accordance with the SFAR prior to publication of the final rule. This final rule includes a VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 list of all POCs approved by the FAA under the SFAR. FAA identification of POCs that satisfy acceptance criteria: Several commenters raised issues related to the FAA listing of POCs that satisfy the FAA acceptance criteria. A4A suggested that the FAA maintain a list of POC devices that meet the FAA’s proposed acceptance criteria to keep industry and the public updated with compliant POCs. A4A further explained that the FAA should maintain a list of POCs that meet the acceptance criteria because of challenges for aircraft operators in determining whether a POC satisfies the acceptance criteria, especially in the instance in which a manufacturer incorrectly labels a device. The FAA disagrees with A4A’s comment that unless the FAA maintains a list of POCs that satisfy the acceptance criteria, POC identification will be unnecessarily burdensome. The process of examining a POC to determine whether it bears a label is less burdensome than the existing process of examining a POC to identify the model name and then verifying that the model is identified in the SFAR. In either case, a crewmember of an aircraft operator must examine the POC. A4A also recommended that the FAA maintain a list of POCs that are labeled as conforming to FAA requirements for POC use on board aircraft to track POCs that are subsequently determined to be non-compliant. However, the FAA has alternate appropriate methods by which to notify aircraft operators in the unlikely event that a POC intended for use on aircraft is no longer compliant with FAA requirements. For example, the FAA can provide such notice through a Safety Alert for Operators (SAFO) or an InFO, as appropriate. All SAFOs and InFOs are made available on the agency’s Web site. Label attributes: The final rule requires the label to contain the following statement in red text: ‘‘The manufacturer of this POC has determined this device conforms to all applicable FAA requirements for POC carriage and use on board aircraft.’’ The purpose of this verbiage is to facilitate identification of devices that conform to the acceptance criteria and the red color is expected to draw attention to the text. Consistent with the NPRM, this final rule also requires a labeling method that ensures the label remains affixed to the POC for the life of the device. The purpose of this requirement is to ensure the label is durable and cannot be transferred to another type of oxygen dispensing device (such as a device that uses compressed oxygen). PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 33107 Several commenters suggested changes related to the proposed label that would standardize label features in addition to the proposed required text and color. A4A commented that the FAA should mandate additional specific label attributes so that labels are identical and can be easily recognized by gate agents. Philips Respironics commented that the proposed label text is overly burdensome due to the length of the text and the color requirement. This commenter proposed an alternate label that states, ‘‘Complies with FAA requirements for airline use’’ and includes an airplane graphic. Together with this alternate label, Philips Respironics suggested a POC manual update to further describe the label. Main Clinic Supply supported the label example included in the Philips Respironics comment. The agency has considered comments regarding additional standard label features but has determined that it is unnecessary to require standardized features beyond the proposed label verbiage and text color. The use of red text is sufficient to draw attention to the label identifying a POC that may be carried and used on board an aircraft. The specific label language proposed in the NPRM and included in this final rule is necessary to facilitate the identification of the device as a POC that satisfies the acceptance criteria for POCs intended for use on board aircraft. A more generic or general label such as the label proposed by Philips Respironics and supported by Main Clinic Supply would not effectively serve this purpose. The agency is aware that manufacturers of some POC models approved under SFAR No. 106 may have voluntarily applied labels similar to the label recommended by Philips Respironics and Main Clinic Supply. The FAA determined, however, that the label proposed by commenters could hinder a passenger’s ability to use an SFAR-approved POC by introducing confusion into the POC identification process due to multiple similar labels (i.e., labels currently affixed to some SFAR-approved POCs and the label proposed by commenters). The only label that may be used to determine compliance with this final rule and to ascertain whether a POC may be used on board an aircraft is a label that exhibits the verbiage and color criteria specifically provided in this final rule. Further, the FAA analyzed the costs associated with the NPRM labeling requirement and estimated that the requirement would not result in a significant burden. Commenters did not challenge the FAA assumptions that E:\FR\FM\24MYR3.SGM 24MYR3 33108 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES3 provide a basis for the estimate of the labeling costs in the NPRM. Given that the final rule label verbiage includes only minimal changes from the proposed label verbiage, the final rule is not expected to result in a significant burden to POC manufacturers. Additionally, the FAA notes that, although the agency supports the Philips Respironics comment regarding POC manufacturer manual updates to describe the label, it would reach beyond the scope of the proposal for the FAA to require POC manufacturers to include additional information in the POC user manual. However, the FAA encourages manufacturers to inform POC users of issues pertaining to POC use on board aircraft. Finally, A4A commented that if the POC acceptance criteria were to change, the FAA should change the label requirements to distinguish those POCs that meet the new acceptance criteria from those that do not meet the new acceptance criteria. The agency will consider this comment if it finds that a future rulemaking is required to revise POC acceptance criteria. E. Manufacturer Determination of Conformance to Acceptance Criteria Two individuals questioned whether the FAA should rely on POC manufacturers to determine that a POC is safe and fits within the regulatory requirements. One of the individual commenters recommended that POC manufacturers demonstrate compliance with the acceptance criteria to the FAA before labeling the device as satisfying those criteria. In a related comment, Delta Airlines recommended that the FAA should require POC manufacturers to provide airlines with the data that demonstrates compliance with the acceptance criteria at the airlines’ request. The FAA employs a range of oversight approaches throughout title 14. The process in this final rule that allows manufacturers to self-certify that their POC conforms to all applicable requirements for use on board aircraft and to affix a label that can be reviewed by aircraft operators and passengers is consistent with other existing agency oversight practices. For example, child restraint system (CRS) manufacturers self-certify (via a label) that their CRS meets all applicable performance criteria and is approved for use on aircraft. In another example, the Technical Standard Order (TSO) program involves a process where a manufacturer makes statements of conformance to the standards in a particular TSO for many different types of articles used on aircraft. VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 In the case of POCs, the FAA has determined that the devices present minimal risk to aircraft operations. Additionally, the proposed and final rule acceptance criteria for POCs leverage existing regulatory requirements that are applicable to POCs and relevant to the safe carriage and use of POCs, including the use of POCs on board aircraft. The purpose of the label applied by POC manufacturers is to facilitate aircraft operator and passenger identification of devices that meet the acceptance criteria required for POCs intended for use on board aircraft. Accordingly, a case-by-case POC approval process is unnecessarily burdensome to mitigate any potential risk presented by POCs. An aircraft operator seeking specific information regarding a POC may reach out to a POC manufacturer without FAA regulation. The agency also notes that POC user manuals and POC manufacturer Web sites also provide information pertaining to the attributes and functions of the associated POCs. F. Prohibition on Smoking or Open Flame SFAR No. 106 prohibits smoking or open flame within 10 feet of any person using a POC. In the NPRM, the agency proposed to retain this restriction. The agency did not receive any comments on the proposal to retain the SFAR prohibition on smoking or open flame near a person using a POC. Accordingly, the final rule includes this proposal without change. Although the risk posed by concentrated oxygen is minimal when generated at a pressure below that which would trigger the application of the HMR, given the unique environment of an aircraft, the agency has determined that it is reasonable to provide an additional margin of safety by prohibiting smoking or open flame in the vicinity of a person using a POC. Accordingly, the agency will maintain the existing prohibition on smoking or open flame within 10 feet of a person using a POC by extending the smoking prohibitions in existing §§ 121.574, 125.219, and 135.91 to POCs and adding language to specifically prohibit an open flame. The smoking prohibition in existing §§ 121.574, 125.219, and 135.91 effectively results in a prohibition on an open flame. However, given the risks created by smoking near a person using medical oxygen and the storage of such oxygen, in this final rule the agency will ensure that this restriction is clear by explicitly prohibiting an open flame in addition to smoking. PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 Finally, as proposed, this final rule amends the regulatory text in § 125.219(b) to prohibit smoking not only within 10 feet of where medical oxygen is being used but also within 10 feet of where it is stored. This amendment is consistent with the preamble for the final rule issuing § 125.219 as well as the prohibitions on smoking within 10 feet of the location of medical oxygen storage or use in §§ 121.574 and 135.91. See 45 FR 67214, 67230 (October 9, 1980). G. Operational Requirements 1. Exit Seats Section 3(a)(4) of SFAR No. 106 prohibits a person using a POC from sitting in an exit row. The FAA proposed to eliminate this SFAR No. 106 provision from the final rule. AFA and an anonymous commenter recommended that the FAA retain the provision in SFAR No. 106 prohibiting a passenger from using a POC while sitting in an exit row. Both commenters noted that POC tubing would create obstacles in the exit row. AFA stated that generally, certificate holders should have the responsibility for determining the suitability of passengers who occupy exit seats; however, they maintained that an explicit restriction on exit row seating would eliminate any ambiguity about a POC user’s ability to assist in an emergency. The FAA agrees with commenters in that a passenger’s ability to perform exit row functions could be impeded by the presence of the device, possibly creating a tripping hazard and an obstacle to egress. Thus, although §§ 121.585 and 135.129 require the certificate holder to determine the suitability for passengers it permits to occupy exit seats, the final rule retains the SFAR No. 106 provision prohibiting passengers using a POC from sitting in exit seats to eliminate any potential ambiguity pertaining to whether a passenger using a POC may occupy an exit seat. 2. Stowage of Portable Oxygen Concentrators SFAR No. 106, section 3(a)(3) states that during movement on the surface, takeoff, and landing, the POC must either be stowed under the seat in front of the user, or in another approved stowage location, so as not to block the aisle way or entryway into a row. Further, SFAR No. 106 limits the location of POC use to a seat location that does not restrict any passenger’s access to, or use of, any required emergency or regular exit, or the aisle(s) in the passenger compartment. However, FAA regulations in parts 121, E:\FR\FM\24MYR3.SGM 24MYR3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 125, and 135, also address the stowage of carry-on items and carriage of cargo in the passenger cabin to ensure an appropriate stowage location and that emergency exit row access is not hindered by carry-on items or cargo. See §§ 121.285, 121.589, 125.183, and 135.87. Thus, the FAA proposed to eliminate the POC stowage requirement in SFAR No. 106. AFA recommended that the FAA retain the requirements in section 3(a)(3) of SFAR No. 106 that pertain to POC stowage. AFA stated that, for consistency with existing medical oxygen rules that require certificateholder provided equipment to be ‘‘appropriately secured,’’ (§§ 121.574, 125.219 and 135.91) the final rule regulatory text should continue to address stowage requirements for passengers’ POCs. The commenter stated that some operators might conclude that only devices furnished by the certificate holder are required to be secured or stowed unless POC stowage is specifically addressed. Although the FAA continues to expect that POC stowage will be addressed in an operator’s carry-on baggage program in accordance with the requirements of 14 CFR 121.285, 121.589, 125.183 and 135.87, the FAA agrees with the commenter that retaining and specifically addressing POC stowage (and thereby reinforcing POC stowage requirements) could increase the likelihood of safe stowage of passenger supplied POCs. Accordingly, as found in SFAR No. 106, this final rule includes a specific requirement for POCs to be stowed during movement on the surface, takeoff, and landing. Notably, the user manuals for 18 of the POC models currently approved under SFAR No. 106 specify oxygen tube length. Every manual specifying oxygen tube length indicates the associated POC has at least 7 feet of tubing, which is long enough to allow a passenger to use a device stowed under a seat. mstockstill on DSK3G9T082PROD with RULES3 H. Discussion of Special Federal Aviation Regulation No. 106 Requirements Excluded From Final Rule The FAA has determined that many of the requirements included in SFAR No. 106 are overly prescriptive or redundant with existing rules and are therefore not necessary. Accordingly, the FAA has not retained them in this final rule. A discussion of the SFAR No. 106 requirements excluded from this final rule follows. VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 1. Special Federal Aviation Regulation No. 106 Requirements Addressed in Existing Regulations a. Passenger Movement About the Cabin While Using a Portable Oxygen Concentrator SFAR No. 106, section 3(a)(6) states that when the PIC turns off the ‘‘Fasten Seat Belt Sign,’’ or otherwise grants permission to move about the passenger cabin, passengers may continue to use their POC while moving about the cabin. The agency included this provision in SFAR No. 106 in response to commenters’ concerns that the agency should allow passengers using a POC to operate the device for the entirety of the flight, if necessary. Therefore, in the final rule implementing SFAR No. 106, the agency stated that passengers are allowed to use a POC for the duration of the flight, including during movement on the surface, takeoff, and landing. The agency also stated that once passengers were allowed to move about the cabin of the aircraft, they would be allowed to bring the POC with them. See 70 FR at 40159. In the NPRM, the agency proposed to remove section 3(a)(6) of the SFAR. Section 3(a)(6) of the SFAR is unnecessary because there are no regulations directed at passengers using a POC that would limit their movement about the cabin when passenger movement is permitted by the PIC. Accordingly, as proposed in the NPRM, the final rule does not include a provision similar to section 3(a)(6) of the SFAR. The agency did not receive any comments on the proposed elimination of this SFAR No. 106 provision. b. Protection of Batteries From Short Circuit SFAR No. 106, section 3(b)(6) requires passengers to ensure all POC batteries carried on board the aircraft in carry-on baggage are protected from short circuit and packaged in a manner that protects them from physical damage. Batteries protected from short circuit include: (1) Those designed with recessed battery terminals; or (2) those packaged so that the battery terminals do not contact metal objects (including the battery terminals of other batteries). Additionally, when a passenger carries a POC on board an aircraft as carry-on baggage, and does not intend to use the POC during the flight, the passenger must remove the battery and package it separately unless the POC contains at least two effective protective features to prevent accidental operation and potential overheating of the battery within the POC during transport. PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 33109 The FAA proposed to eliminate the SFAR No. 106 provisions applicable to spare batteries carried by passengers on board aircraft for use in POCs because they are unnecessary. The portion of SFAR No. 106, section 3(b)(6) addressing spare batteries is redundant with PHMSA regulations applicable to spare lithium batteries carried by passengers on board aircraft. See 49 CFR 175.10(a)(18). A4A commented that the FAA should strongly recommend that POC manufacturers include a carrying case for spare lithium battery packs to ensure battery isolation and insulation. The FAA supports any action a POC manufacturer takes to facilitate passenger, crewmember, and operator compliance with the requirements for the safe carriage of lithium ion batteries on board aircraft, including spares. However, the agency does not agree that the commenter’s recommendation is necessary because PHMSA has identified the requirements for safe carriage of spare lithium batteries used to power all PEDs carried by aircraft passengers or crewmembers. See 49 CFR 175.10(a)(18). PHMSA requires all lithium batteries to be of a type proven to meet the requirements of each test, including Test T.7 (Overcharge), in Part III, Subsection 38.3 of the UN Manual of Tests and Criteria. See 49 CFR 173.185 and 175.10(a)(18). Additionally, PHMSA requires spare lithium batteries carried on board aircraft to be carried in the cabin in carry-on baggage and individually protected from short circuit to mitigate the risk of a fire during flight (e.g., by placement in original retail packaging, by otherwise insulating terminals by taping over exposed terminals, or by placing each battery in a separate plastic bag or protective pouch). See 49 CFR 175.10(a)(18). The agency notes that the SFAR diverges from PHMSA requirements pertaining to installed batteries. See 49 CFR 175.10(a)(18). The SFAR requires a passenger to remove a POC battery if the device does not have at least two features that prevent accidental operation. The HMR, however, do not require an installed battery to be removed from any PED, which would include a POC that is not in use. See 49 CFR 175.10(a)(18). Based on the analysis of currently approved POCs and PHMSA requirements applicable to lithium ion batteries carried by passengers and crewmembers to power PEDs, an independent FAA requirement for two protective features as a prerequisite to leaving an installed battery in a POC is unnecessary. The agency reviewed the E:\FR\FM\24MYR3.SGM 24MYR3 33110 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 24 SFAR-approved POCs and determined those POCs all have at least two design features preventing inadvertent or accidental operation. Thus, batteries may remain in SFARapproved POCs while those POCs are not in use. In addition, current PHMSA regulations address the safe transportation of lithium ion batteries as well as passenger carriage of lithium ion batteries. Lithium batteries must be of a type proven to meet the requirements of each test, including Test T.7 (Overcharge), in Section 38.3 of the UN Manual of Tests and Criteria. See 49 CFR 173.185. Based on the analysis of SFARapproved POCs and the applicable HMR, an independent FAA requirement for two protective features as a prerequisite to leaving an installed battery in a POC is unnecessary. All POCs currently used on board aircraft are equipped with two protective features and all lithium ion batteries must be designed to satisfy the overcharge test protection, therefore, the risk of a fire originating from the battery is minimal. Accordingly, this final rule eliminates SFAR No. 106, section 3(b)(6) from title 14. 2. Special Federal Aviation Regulation No. 106 Requirements Excluded in Their Entirety mstockstill on DSK3G9T082PROD with RULES3 a. Physician Statement and Pilot in Command and Aircraft Operator Notification Requirements Section 3(b)(3) of SFAR No. 106 requires passengers intending to use a POC to have a written statement signed by a licensed physician, and kept in that person’s possession that states whether the user of the device has the physical and cognitive ability to see, hear, and understand the device’s aural and visual cautions and warnings and is able, without assistance, to take the appropriate action in response to those cautions and warnings; states whether or not oxygen use is medically necessary for all or a portion of the duration of the trip; and specifies the maximum oxygen flow rate corresponding to the pressure in the cabin of the aircraft under normal operating conditions. Section 3(b)(3) of SFAR No. 106 further requires a passenger to inform the aircraft operator that he or she intends to use a POC on board the aircraft and to allow the crew of the aircraft to review the contents of the physician’s statement. Similarly, section 3(a)(5) of SFAR No. 106 requires PIC notification whenever a passenger brings and intends to use a POC on VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 board the aircraft. The PIC must be apprised of the physician’s written statement required by section 3(b)(3) of the SFAR including the nature of the passenger’s oxygen needs and the passenger’s ability to understand operational and warning information presented by the POC. As proposed, the FAA will no longer require POC-using passengers to present a physician’s statement, to notify the aircraft operator and PIC of their intended POC use, to inform the PIC of the contents of their physician’s statement, and, to allow the crew of the aircraft to review the content of their physician’s statement. The FAA received comments related to these proposals from two POC suppliers (Main Clinic Supply and OTG), the Mayo Clinic, AMDA, and a number of individuals. The FAA has reviewed and considered all comments regarding the physician’s statement and pre-flight notification of POC use. Physician statement: Two individual commenters supported the FAA proposal to relieve passengers from obtaining a physician’s statement as a condition of their use of a POC on aircraft. Main Clinic Supply supported the proposal to relieve passengers from having to provide a physician statement commenting that the current requirement for a written, signed physician statement for every flight is not practical, causes many delays, and may inhibit POC users’ air travel. Main Clinic Supply also stated that physicians and their staff do not have the resources to provide POC training to patients, explaining that the POC user must be responsible for reading the POC operating manual and asking the necessary questions of their oxygen provider. OTG, AMDA, the Mayo Clinic, and some individual commenters did not support the FAA proposal to remove the requirement for passengers to carry a physician’s statement as a condition of POC use on aircraft. OTG, AMDA, and some individual commenters indicated that removal of the existing physician’s statement and notification requirements would cause diversions, impact passenger travel, and be costly to the airlines. Generally, commenters asserted that the FAA should retain the SFAR No. 106 requirement for a physician’s statement because it ensures that passengers seeking to use a POC on board an aircraft have consulted with a physician regarding POC use in the aircraft environment prior to travel. Commenters also challenged statements in the NPRM regarding POC function in the aircraft environment. PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 The Mayo Clinic commented that it is particularly important for individuals who have ‘‘poor respiratory reserve’’ to have health care provider oversight. In this regard, the physician statement is a form of ‘‘safety net’’ to trigger these conversations between passengers and their treating providers. It is critical that these conversations occur prior to air travel since decompensation on board a flight may require urgent response. OTG and some individual commenters commented that additional interaction between a POC user and his or her physician is necessary to educate passengers with limited experience with POC use; to address discrepancies between the POC prescription and the POC provided by a supplier; and to help the POC user account for the effects of cabin pressurization on POC use. OTG indicated in its comments that the flow rate on a POC prescription may not be appropriate for cabin altitudes. In a related comment, the Mayo Clinic stated, ‘‘[A]lthough a physician or other health care provider with prescribing privileges writes prescriptions for devices to deliver supplemental oxygen, many providers are unfamiliar with the physiology of altitude.’’ OTG also commented that, in its experience, a large percentage of physicians and the majority of passengers incorrectly assume aircraft cabins are pressurized to sea level. OTG stated that based on this assumption, physicians do not provide their POC-using patients with recommendations regarding oxygen flow adjustments during air travel when most will require higher flow rates in a pressurized cabin than at sea level. OTG further asserted that the POC will not produce the same percentage of oxygen in a pressurized cabin and the oxygen saturation level of the passenger will be decreased due to the normal physics of the partial pressure of the oxygen on pulmonary tissue. The agency clarifies that SFAR No. 106 does not specifically require a passenger to obtain a new physician’s statement prior to each flight. See 70 FR at 40161. Also, SFAR No. 106 does not require the physician’s statement to account for the duration of a specific flight, variables that may arise in flight conditions, changes in a patient’s oxygen needs over time, or variables that may arise in connection with an individual’s medical condition. Further, commenters noted that not all physicians may be familiar with effects of cabin pressure or realize that aircraft are not pressurized to sea level. For these reasons, while the SFAR No. 106 requirement for a physician’s statement may result in a one-time conversation about a passenger’s POC use on an E:\FR\FM\24MYR3.SGM 24MYR3 mstockstill on DSK3G9T082PROD with RULES3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations aircraft at some point in time, the requirement to obtain such a statement may not provide the POC education and ‘‘safety net’’ expected by commenters. The FAA appreciates and concurs with comments regarding the need for vigilance and understanding of all nuances associated with POC use on aircraft. The agency appreciates and has considered commenters’ concerns about the physiology of flight and its relationship to POC use. The FAA emphasizes that pre-flight preparation on the part of the POC-using passenger, working closely with an appropriate medical professional, should always occur when traveling with any medical device. While preparation may differ for each POC-using passenger, depending on the aircraft and kind of operation included in his or her travel plans, passengers may wish to consider such factors with their medical professional such as past experience using a POC, cabin pressurization, layovers, length of flight, and pre-flight activities that could lead to compromised lung function in flight. The FAA also encourages POCusing passengers to carry documentation regarding the device they intend to use including any pertinent documentation provided to them by a medical professional or any medical certificate required by the carriers in accordance with the Department’s air travel disability regulation in 14 CFR 382.23. However, the FAA believes that retaining the SFAR No. 106 requirement for a physician’s statement as evidence of this medical consultation is not the most effective education tool in those circumstances in which the physiology of altitude could come to bear on POC use and should not be relied on as the means to address the range of variables potentially affecting passengers using POCs during flight. The FAA has determined that it is more effective to provide reasoned guidance and public outreach to educate POC users and physicians regarding considerations pertaining to POC use during flight in a pressurized cabin. The FAA provides information on passenger health and safety on its Web site (e.g., http:// www.faa.gov/passengers/fly_safe/ health/comprehensive/). The FAA has also updated the POC-specific guidance in AC–120–95B and expects to update its Web site with information a passenger may want to consider when traveling with a POC. As is the case with in flight use of any medical device, passengers who need to use a POC on board an aircraft should always consult with an appropriate medical professional and their chosen air carrier before traveling. Doing so VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 ensures that passengers are prepared for each flight they take, particularly if, as one commenter noted a prescription may not address adjustments that may be appropriate for POC use on a pressurized aircraft. However, the FAA has determined that the specific, regulatory requirement set forth in the SFAR requiring POC-using passengers to obtain, present, and allow for scrutiny of a physician’s statement, as a condition of admission on board an aircraft is particularly burdensome for passengers seeking to use a POC during air travel. The FAA intended for the SFAR to provide a framework, not previously available, under which persons with a need to use personal oxygen therapy could use their own devices during a flight, thereby increasing accessibility to air travel for POC-using passengers. With more than 10 years of experience with POC technology and POC use on aircraft, the FAA has determined that the requirement for a passenger to provide for aircraft operator, crewmember, and PIC scrutiny, a physician statement pertaining to a medical device that the passenger is solely responsible for during the flight, was an overly conservative addition to the POC oversight framework. Removing the requirement to obtain a physician’s statement affects a paperwork requirement; it does not affect passengers’ responsibility to be prepared for travel. The purpose of this final rule is to continue to provide POCusing passengers access to air travel, while addressing device safety for aircraft use; it is not intended (and is not within FAA authority) to set forth a standard of medical care for POC-using passengers. Further, the FAA does not require passengers who supply any other medical device for their own use during a flight to provide a physician’s statement as a condition of device usage during flight. Additionally, as mentioned previously, existing DOT requirements in 14 CFR part 382 continue to include a provision to further mitigate the possibility of medical events including those that could result in a diversion. Sections 382.23(b) and 382.133 authorize carriers to require a passenger needing medical oxygen inflight to provide a medical certificate to ensure the passenger can complete the flight safely without requiring extraordinary medical assistance during the flight. AMDA indicated that the FAA should conduct additional research regarding the potential impact of the elimination of the physician’s statement. The FAA has determined that additional research is not necessary at this time because the PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 33111 FAA expects physician consultation to continue as appropriate for the use of any medical device, and that pre-flight notice of POC use on the aircraft will continue in light of the requirement for each aircraft operator to determine whether the POC bears the label required for use on board aircraft. The purpose of the SFAR and the FAA’s action in this final rule is to address continued use of POCs on aircraft without compromising the safety of the aircraft operation. The agency has determined the SFAR No. 106 requirement for a physician statement creates an unnecessary burden that may not ultimately serve the purpose contemplated by commenters. The FAA emphasizes that removing the requirement to obtain a physician’s statement affects a paperwork requirement; it does not affect passengers’ responsibility to be prepared for travel, including obtaining a medical certificate if the carrier chooses to require one as allowed by 14 CFR 382.23 and 382.133. All passengers using a medical device in an aircraft environment are responsible for preparing for the flight such that they can ensure that the device will function properly during the flight and provide the requisite medical support. Therefore, as proposed, this final rule discontinues the SFAR requirement for a physician statement. PIC and aircraft operator notification: OTG, AMDA, and several individual commenters did not support the proposal to remove the requirements for pre-flight notification of the aircraft operator and PIC regarding POC use on board an aircraft. These commenters, however, did not provide specific reasons for maintaining the notification requirements. One anonymous commenter asserted that advance notice that a passenger expects to use a POC would allow crewmembers to prioritize actions during multiple cabin events. Under this final rule, the PIC and aircraft operator (through a crewmember or gate agent) will continue to receive notice of a passenger’s POC use during flight as the operator determines during pre-boarding procedures whether the device has the label now required for POC use on the aircraft. Accordingly, as proposed, the FAA discontinues the specific requirement for passengers to notify the aircraft operator and PIC of intended POC use during a flight because a specific notification requirement is unnecessary. OTG also stated that several POCrelated incidents have occurred in flight but did not provide any specific examples, information, or data regarding such diversions or incidents. OTG E:\FR\FM\24MYR3.SGM 24MYR3 33112 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations further stated that the FAA should have contacted ‘‘air-to-ground’’ medical service providers to document POCrelated incidents. The agency reviewed air carrier safety data collected from 2005 through 2014—a period of nearly 10 years—and found no instances of POC malfunction during flight or any related medical incident or diversion. This review included information from several accident, incident, and voluntary reporting databases.17 Further, no ‘‘airto-ground’’ medical service providers contacted the agency regarding any POC incidents, nor did they provide any comments to the agency in this regard during the open comment period. Although the FAA is removing the requirement for pre-flight notification, under existing DOT requirements in 14 CFR part 382, carriers continue to be permitted to require individuals who wish to use a POC on aircraft to contact them 48 hours before scheduled departure. Carriers are permitted to require this pre-flight notification so they can ensure that a passenger knows the expected maximum flight duration and can use this information in determining the number of spare batteries that he or she will need to power the POC during the flight. mstockstill on DSK3G9T082PROD with RULES3 b. Portable Oxygen Concentrator Alarms SFAR No. 106, section 3(b)(1) requires a passenger using a POC on board an aircraft to be capable of hearing the unit’s alarms and seeing alarm light indicators. SFAR No. 106 also requires passengers using a POC to have the cognitive ability to take appropriate action in response to the various POC caution alarms, warning alarms, and alarm light indicators, or travel with someone capable of performing those functions. In the NPRM, the FAA proposed to eliminate the requirement for a passenger using a POC on board an aircraft to be capable of hearing the unit’s alarms and seeing alarm light indicators. An anonymous commenter stated that the FAA should retain this requirement because a continuous audio alarm could be very disruptive and compound other abnormal events occurring in the cabin. The commenter added that the absence of alarm events over the last 10 years does not mean that an alarm event will not occur in the 17 Voluntary Disclosure Reporting Program (VDRP), Service Difficulty Reporting System (SDRS), National Transportation Safety Board Aviation Accident and Incident Data Systems (NTSB), National Aeronautics and Space Administration Aviation Safety Reporting System (ASRS) and FAA Accident/Incident Data System (AIDS). VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 future. Additionally, OTG commented that in its experience, an individual may not be able to respond to alarms even if a physician states that the individual can respond to the POC alarms. Crewmembers receive training on how to respond to unanticipated events that may arise on board the aircraft including disruptions in the cabin and other abnormal events. Further, it is a passenger’s responsibility to read the POC operator’s manual and direct questions to their physician to ensure understanding of oxygen flow settings and the appropriate responses to alarms. The SFAR No. 106 requirements pertaining to POC alarms are based on information in the user manual of the first POC approved by the FAA. See 69 FR at 42325. Based on a review of 20 user manuals for POCs identified in SFAR No. 106, the agency has determined POC alarms may provide information regarding the general operation of the POC, as well as information regarding the power source and detection of the POC user’s breath. Since these alarms help ensure the device functions as intended, the FAA believes that removing this requirement will not affect aviation safety. The FAA also emphasizes that it has not identified any incidents regarding POC malfunctions on board aircraft during the period of time that POCs have been permitted on aircraft. A 10year look-back period includes data from almost 78 million domestic flights with no adverse POC incidents. See http://www.transtats.bts.gov/Data_ Elements.aspx?Data=2. The agency has determined that this is sufficient data to provide an appropriate indicator of future POC safety. Therefore, as proposed, this final rule eliminates the SFAR No. 106 requirement pertaining to alarms (section 3(b)(1)). c. Ensuring the Portable Oxygen Concentrator is Free of Petroleum Products SFAR No. 106, section 3(b)(2) requires a passenger using a POC to ensure the POC is free of oil, grease, or other petroleum products and is in good condition free from damage or other signs of excessive wear or abuse. This provision is similar to a warning statement found in the user manual of the first POC approved by the FAA and to a provision in the medical oxygen rules (§§ 121.574, 125.219, and 135.91). See 69 FR at 42325. The agency proposed to eliminate this SFAR No. 106 provision. OTG commented that for passengers who rent their POCs, the condition of the device and its batteries is dependent on the purveyor of the equipment. The PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 FAA expects POC users to ensure that a POC they intend to use is in good condition so that it may function properly to provide the needed oxygen therapy whether the POC user is on the ground or on an aircraft. Further, while petroleum products may accelerate an existing fire, the volume of petroleum products necessary to accelerate a fire is unlikely to be found on the exterior of a POC, and this concern is not addressed as a specific requirement for other PEDs carried on board aircraft. Therefore, this final rule eliminates the requirements in section 3(b)(2) of SFAR No. 106 because the requirements are unnecessary. d. Use of Salves and Lotions SFAR No. 106, section 3(b)(4) states only oxygen approved lotions or salves may be used by persons using a POC on board an aircraft. In the NPRM, the FAA proposed to eliminate this prohibition in its entirety and did not receive any comments on this proposal. The requirement in SFAR No. 106, section 3(b)(4) came from the user manual of the first POC approved by the FAA. The FAA believes it is the passenger’s responsibility to ensure he or she is using products that meet the POC manufacturer’s requirements for salve and lotion usage with a POC. The risks and responsibilities associated with lotions or salves that are not oxygen approved or are petroleumbased are addressed in the preceding discussion on the elimination of the requirement for the user to ensure that the POC is free from petroleum products. Therefore, as proposed, this final rule does not retain the prohibition in section 3(b)(4) of SFAR No. 106. e. Carriage of a Sufficient Number of Batteries SFAR No. 106, section 3(b)(5) requires passengers intending to use a POC during a flight to obtain from the aircraft operator, or by other means, the duration of the planned flight and carry a sufficient number of batteries to power the device for the duration of the oxygen use specified in the passenger’s physician statement, including a conservative estimate of any unanticipated delays. In the NPRM, the agency proposed to eliminate this SFAR No. 106 requirement. Delta Air Lines commented that this final rule should retain the battery carriage requirements found in SFAR No. 106 and current 14 CFR 382.133(f)(2) because passengers often mistakenly assume that electrical outlets are available to power portable medical devices. The FAA is not aware of any specific incidents of confusion E:\FR\FM\24MYR3.SGM 24MYR3 mstockstill on DSK3G9T082PROD with RULES3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations regarding availability of electrical outlets to power POCs. FAA guidance (AC 120–95B as well as previous editions of this AC) addresses aircraft operator and passenger issues pertaining to the use of electrical outlets to power POCs. Further, many air carriers, including the commenter, disclose applicable policies on their Web sites regarding the availability and use of on board electrical outlets for electronic devices intended for use during flight. The FAA encourages air carriers to continue this practice. Additionally, as noted in the Delta Air Lines comment, existing DOT regulations (14 CFR part 382) permit carriers to require an individual traveling with a POC to bring an adequate number of fully charged batteries into the cabin that will power the POC for no less than 150% of the expected maximum flight duration. See current 14 CFR 382.133(f)(2), revised by this rule to 14 CFR 382.133(h)(2). Part 382 also requires carriers to inform passengers who advise the carriers of their intent to use a POC on board an aircraft about the maximum duration of the flight segment. See 14 CFR 382.133(f)(1), revised by this rule to 14 CFR 382.133(h)(1). OTG commented that it is almost impossible for the average passenger to assess the amount of battery power that they may need for the duration of a trip due to time zone changes, the effect of flow rate on battery duration and mistaken assumptions about their ability to recharge batteries between flights. OTG also indicated that POC manufacturer manuals are ‘‘overly optimistic’’ about battery duration, often basing their assumptions on data from new batteries. The Mayo Clinic commented that many passengers only use a POC temporarily, during a flight, and thus are unfamiliar with the device. The Mayo Clinic added that an FAA requirement for passengers using a POC to carry a certain amount of battery power, would serve as a reminder for the passenger and his or her health care provider regarding the necessity of sufficient power for POC use, noting that the consequences of inadequate supplemental oxygen could result in the need to administer medical oxygen during the flight or divert the aircraft. The FAA maintains that it is the passengers’ responsibility to understand the performance of their POC and its battery life under varying conditions and ensure their POC will enable them to adhere to their physician’s instructions. All manuals for the POCs identified in SFAR No. 106 have liter flow and battery duration charts to help VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 users make informed decisions regarding the number of spare batteries they need to bring to power the device and it is the responsibility of passengers using a POC during air travel to be familiar with the manual and consult their physician and POC provider as necessary. As highlighted by OTG, passengers may also want to consider the age of the device and the batteries as they assess the batteries required to power the POC for the amount of time required. The intent of the SFAR and this rulemaking is to allow passengers needing oxygen therapy during a flight to have ready access to a device that can supply that therapy, not to oversee passenger medical care. Thus, as proposed, the FAA has eliminated the SFAR requirement to carry a certain amount of battery power. However, the Department continues to allow airlines to require individuals using POCs inflight to bring an adequate number of fully charged batteries based on the battery manufacturer’s estimate of the hours of battery life while the POC is in use and the maximum duration of the flight. Also, to facilitate a passenger’s ability to prepare for POC use during a flight, in AC 120–95B, published with this final rule, the FAA has provided references to the DOT requirements regarding the carriage of spare batteries. The FAA also expects to update its Web site with information a passenger may want to consider when traveling with a POC. I. Miscellaneous BPR Medical Limited recommended that the six continuous flow POCs approved under SFAR No. 106 should be retrofitted with an accessory to stop the flow of oxygen in the event that the POC tubing ignites. BPR states that during testing for fire propagation in tubing, BPR found that where a pulse dose mechanism provides oxygen, a fire that has developed will automatically be extinguished and will not propagate along the tubing to the oxygen source. The commenter added that while having a means to stop the flow of oxygen may be more of a concern where cigarettes might be a source of ignition, there are other possible sources of ignition on aircraft such as electro-static discharge from blankets. FDA has recently recognized a POC performance standard (ISO 80601–2– 69:2014) that includes a clause stating that the device shall be equipped with a means to stop the flow of gas towards the patient in the case that the accessory (tubing) becomes ignited. This standard will be considered as the FDA approves or clears new POC models. PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 33113 Additionally, the previous FDA recognized performance standard for POCs (ISO 8359:1996 including Amendment 1 (2012)) stated that POCs shall include a means to prevent the propagation of fire back through the oxygen concentrator outlet in the case that the tubing ignites. Although it is not clear whether all of the continuous flow devices approved under the SFAR include this means to prevent fire propagation, the FDA is allowing continued use of these devices and is not requiring existing POCs to be modified to comply with the performance standard the agency currently recognizes (ISO 80601–2– 69:2014). Nevertheless, the commenter’s suggestion to retrofit continuous flow POCs with an accessory to extinguish fire propagation in tubing is outside of the scope of the proposal and a prohibition on the use of continuous flow POCs on aircraft is not supported by aviation safety data. As previously noted, the FAA reviewed data from VDRP, SDRS, NTSB, ASRS and AIDS, and has not found any instances of POC malfunction during flight since the agency first published the SFAR. The FAA also researched the service difficulty report (SDR) database for the period beginning the time SFAR No. 106 published (July 12, 2005) through December 2014, and ran multiple queries for the terms fires, blankets, POCs, electrostatic discharges, and insulation materials. This research covers a period where almost 78 million U.S. domestic flights occurred, revealing no SDRs related to POCs. See http:// www.transtats.bts.gov/Data_ Elements.aspx?Data=2. Finally, although the FAA has not identified a single instance of a fire due to passenger’s use of a POC on an aircraft, passenger-carrying aircraft are equipped with effective mitigation (i.e., fire resistant cabin materials and fire extinguishers) if a fire should occur. See 14 CFR 25.853, 23.853, 121.215, 121.309, 125.113 and 135.155. Accordingly, the agency has determined that no aviation safety data exists that would support further FAA action to preclude continuous flow POC models from use onboard aircraft. J. Technical Amendments This final rule makes two technical amendments. First, it updates a cross reference to the HMR that appears in §§ 121.574(a)(3), 125.219(a)(3), and 135.91(a)(3) and pertains to the definition of a compressed gas. Second, it removes the OMB Control No. 2120– 0702 from § 11.201(b) because the information collection burdens E:\FR\FM\24MYR3.SGM 24MYR3 33114 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES3 associated with this control number cease to be effective when SFAR No. 106 is removed from title 14. K. Nondiscrimination on the Basis of Disability in Air Travel The Air Carrier Access Act (ACAA) prohibits discrimination by U.S. and foreign carriers against passengers with disabilities. See 49 U.S.C. 41705. Part 382 of title 14 contains detailed standards and requirements to implement the ACAA and to ensure that carriers provide nondiscriminatory service to passengers with disabilities. With regard to POCs, part 382 establishes a framework to ensure accessibility for passengers using POCs and other respiratory assistive devices on aircraft, subject to applicable aviation safety, security, and hazardous materials regulations. In this final rule, the FAA revises its acceptance criteria on POCs, based on which air carriers may choose to, but are not required to, accept those POCs meeting FAA’s criteria. On the other hand, part 382 mandates that carriers must accept POCs if they meet the FAA’s acceptance criteria. Accordingly, this final rule includes amendments to 14 CFR part 382 to remove the references to SFAR No. 106, to ensure that the requirements of part 382 are consistent with the new acceptance criteria and labeling requirements set forth by the FAA in this rule, and to ensure the continued use of the POCs previously approved under SFAR No. 106, as permitted by the FAA. When amending regulations, the Administrative Procedure Act (APA) generally requires agencies to publish a notice of proposed rulemaking and give interested persons an opportunity to comment. However, the APA authorizes agencies to dispense with notice and comment if the agency finds for good cause that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(3)(B). ‘‘Good cause’’ exists in situations in which notice unavoidably prevents the due and required execution of agency functions or when an agency finds that due and timely execution of its functions is impeded by the notice otherwise required by the APA. In this case, the agency finds that there is good cause to conclude that providing notice and public comment for the Department’s conforming amendments is unnecessary, impracticable and contrary to the public interest. Notice and public comment are impracticable because they would cause undue delay. Providing additional notice and comment would be VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 impracticable and contrary to the public interest because during the delay caused by providing notice and public comment, the Department’s disability regulations would be inconsistent with FAA regulations. This could potentially cause confusion and affect disabled individuals’ ability to bring necessary medical devices on flights. Notice and comment on these conforming amendments is also unnecessary because the public has already had an opportunity to comment on the substantive issues addressed by this rulemaking. The Department is making minor amendments to part 382 that simply conform the Department’s disability regulations to the FAA’s safety regulations. The Department does not believe that it would receive new substantive comments, in addition to those already received and addressed in this document, if it sought comment on the conforming amendments. For these reasons the Department has determined that the notice and comment rulemaking process is unnecessary, impracticable, and contrary to the public interest for these conforming amendments. 1. Mandatory Acceptance of POCs That Meet FAA Acceptance Criteria In 2008, DOT amended part 382 to include a provision requiring covered carriers to permit a passenger with a disability to use an SFAR-approved POC on all covered flights. More specifically, part 382 requires U.S. carriers to permit an individual with a disability to use an SFAR-approved POC, a ventilator, a respirator, or a continuous positive airway pressure machine (CPAP machine) on all flights unless the device does not meet applicable FAA requirements for medical portable electronic devices and does not display a manufacturer’s label that indicates the device meets those FAA requirements. See 14 CFR 382.133(a). Foreign carriers must permit individuals with a disability to use a POC of a kind equivalent to a SFAR- approved POC, a ventilator, a respirator, or a CPAP machine for use on U.S. carriers in the passenger cabin on all covered flights unless the device does not meet the requirements for medical portable electronic devices set by the foreign carrier’s government if such requirements exist and/or the POC does not display a manufacturer’s label that indicates the device meets those requirements. See 14 CFR 382.133(b). In 2009, because the SFAR-approved POCs were not required to have labels under the FAA’s regulations, DOT issued guidance encouraging carriers to allow passengers to use these approved POCs even if the device had not been PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 labeled, although carriers were not legally obligated to do so.18 Since then, airlines have largely implemented a policy to allow passengers to use SFARapproved POCs even if they do not have labels. In this final rule, the Department is amending its disability regulation to ensure that, consistent with the FAA’s actions in this rule, passengers with SFAR-approved POCs continue to be permitted to use these devices on aircraft, regardless of whether they are labeled, and that passengers with other POCs that satisfy the FAA acceptance criteria and labeling requirements will be able to use those POCs on their flights. As the FAA’s regulations are enabling rules, these changes in the Department’s disability regulation require carriers covered by part 382 to accept these POCs for air travel. 2. Other Amendments to 14 CFR Part 382 The Department is revising § 382.133(c)(3) (redesignated as § 382.133(e)(3)) by eliminating the reference to SFAR No. 106 with respect to the packaging and protection of spare batteries carried in an aircraft cabin, as this final rule removes the SFAR from the CFR. Instead, the Department is referring directly to the applicable PHMSA requirements. The Department is also revising § 382.133(c)(6) (redesignated as § 382.133(e)(6) in this final rule) by eliminating the reference to federal aviation regulations with respect to the physicians statement, as in this final rule the FAA eliminates the SFAR No. 106 requirement for a physician’s statement. The Department, however, is retaining the reference to § 382.23(b)(1)(ii) that permits carriers to require a medical certificate from passengers who need medical oxygen during a flight. In that regard, there is also no change to our rules that permit a U.S. carrier or a foreign carrier to ensure that the passengers traveling with POCs have sufficient numbers of spare batteries to power the POC for up to 150% of the maximum flight duration. V. Regulatory Notices and Analyses A. Regulatory Evaluation Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a 18 See, Notice—The Use of Passenger-supplied Electronic Respiratory Assistive Devices on Aircraft, October 28, 2009, https://www.transportation.gov/ sites/dot.gov/files/docs/Notice_10_28_09.pdf. E:\FR\FM\24MYR3.SGM 24MYR3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96–354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96–39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA’s analysis of the economic impacts of this final rule. We suggest readers seeking greater detail read the full regulatory evaluation, a copy of which we have placed in the docket for this rulemaking. In conducting these analyses, FAA has determined that this final rule: (1) Has benefits that justify its costs, (2) is not an economically ‘‘significant regulatory action’’ as defined in section 3(f) of Executive Order 12866, (3) is not ‘‘significant’’ as defined in DOT’s Regulatory Policies and Procedures; (4) will not have a significant economic impact on a substantial number of small entities; (5) will not create unnecessary obstacles to the foreign commerce of the United States; and (6) will not impose an unfunded mandate on state, local, or tribal governments, or on the private sector by exceeding the threshold identified above. These analyses are summarized below. Total Benefits and Costs of This Rule The total cost savings from this final rule is $39.5 million ($27.6 million at 7% present value and $33.6 million at 3% present value). The largest cost savings of $39 million occurs from the reduction of crew time to review the physician’s statement. The FAA estimated that POC manufacturers that are expected to market POCs for use on aircraft will save a total of $108,000 over the ten year analysis period because the FAA will no longer require POC models to be identified in SFAR No. 106 prior to their use on aircraft. As a result of this action, POC manufacturers will no longer incur the administrative costs of petitioning the FAA which the FAA estimated would be $108,000. Further, because the manufacturer will no longer have to await resolution of that petition in order for a POC to be permitted for use on aircraft they will be able to introduce these devices sooner to the market. The FAA estimates that the cost of this final rule will be a one-time total cost of $22,000 incurred by all those POC manufacturers who comply with this final rule to modify a label and the associated costs that manufacturers will incur to change their current labeling process to affix a label with the language on the devices. Assumptions: • Present Value Discount rates—7% and 3% • Period of Analysis—ten years • 24 new POCs over ten years 33115 Entities Potentially Affected by This Rule: • POC manufacturers • Passengers carrying POCs on board aircraft • Physicians providing written statements to POC users • Aircraft operators (including crewmembers) Benefits of this Rule The replacement of the SFAR No. 106 device approval process with a process by which POC manufacturers label those devices that satisfy FAA acceptance criteria, will shorten the time for manufacturers to begin selling new POC models that can be used on aircraft. Therefore, one benefit of this rule will be to eliminate delays and enable manufacturers to bring their devices to market sooner. Further the FAA estimates total industry cost savings of $108,000 because manufacturers will no longer incur the administrative costs of petitioning the FAA for each new device. These cost savings easily exceed the labeling costs. Furthermore, this final rule will result in cost savings because POC-using passengers will no longer have to obtain a physician’s written statement as a prerequisite to bringing POCs on board aircraft in parts 121, 125, and 135 operations. The largest cost-savings will accrue to airline crews as there will no longer be a requirement for the crew to review the contents of the physician’s statement and to notify the pilot in command about the contents of the physician’s statement and the intention of the passenger to use the POC on board. The quantified cost savings of this final rule are summarized in table 4. TABLE 4—TOTAL ESTIMATED COST SAVINGS FROM FINAL RULE Cost savings 7% present value savings 3% present value savings $91,644 108,000 $68,871 75,853 $80,519 92,126 569,961 38,726,085 401,645 27,083,677 486,914 32,972,652 Total Cost Savings ............................................................................................................... mstockstill on DSK3G9T082PROD with RULES3 FAA Savings—No SFAR ............................................................................................................. Manufacturer Savings—No petition for rulemaking ..................................................................... Removal of FAA requirement for user to obtain a physician’s statement for POC use on aircraft .......................................................................................................................................... Removal of FAA requirement for crew review of physician’s statement and PIC notification .... $39,495,690 $27,630,045 $33,632,212 The FAA also identified another benefit that it did not quantify. This benefit comes from the use of a performance-based RF emissions acceptance criterion. Currently the manufacturers provide radiated RF emissions tests results showing that the device does not exceed thresholds VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 established in Section 21 Category M of RTCA DO–160 to the FAA which posts these results on its Web site for aircraft operators to access. This final rule will include a performance-based RF emissions acceptance criterion that allows POC manufacturers to determine how to assess whether their POC meets PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 the RF emissions limits for use on aircraft before they affix a label to the device confirming that this criterion has been satisfied. This might save manufacturers some cost if they can demonstrate in a less expensive way that their device meets the RF emissions criteria and will not degrade safety as E:\FR\FM\24MYR3.SGM 24MYR3 33116 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations the alternative method is an equivalent level of safety to the RTCA standard. Costs of This Rule As estimated in the NPRM, the FAA expects that POC manufacturers will incur costs of $22,000 to modify labels that they already affix to the POC, to contain the language required by this rule. mstockstill on DSK3G9T082PROD with RULES3 B. Regulatory Flexibility Determination The Regulatory Flexibility Act of 1980 (Pub. L. 96–354) (RFA) establishes ‘‘as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.’’ The RFA covers a wide-range of small entities, including small businesses, not-forprofit organizations, and small governmental jurisdictions. Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA. However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear. This final rule is expected to reduce SFAR No. 106 requirements that currently result in a burden on POC manufacturers who produce POC devices for use on aircraft. This final rule will also result in small costs to manufacturers by requiring POCs intended for use on aircraft to bear a label indicating the device meets FAA requirements for use on board aircraft. The FAA learned from five of the small POC manufacturers that they might incur a one-time cost ranging from $200 to $1,500 which averages $0.20 to $1 per label.19 These costs will be offset by cost 19 A sixth manufacturer that was contacted estimated costs of $10,200, but this manufacturer is not a small business. VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 savings because manufacturers will no longer have to petition for rulemaking and lose marketing time awaiting a final regulatory action. One manufacturer stated these cost savings are worth $4,500 for each petition. The FAA identified nine companies that produce POCs intended for use on board aircraft. The FAA determined that the appropriate North American Industry Classification System (NAICS) codes of these manufacturers are 339112 and 339113 and the threshold for determining whether a company is a small business is 500 employees for those industries. Through online research, the FAA found data 20 indicating that six of the nine manufacturers are small entities and concluded that a substantial number of manufacturers are small entities. However, the FAA does not expect the rule to impose a significant economic impact on any of these small entities because the estimated cost savings of no longer having to petition the FAA (estimated at $4,500 per manufacturer) exceed the estimated costs of modifying the label (estimated at $2,400 per manufacturer) to comply with this final rule. Also, there is a benefit to POC manufacturers, in that the manufacturers will receive revenue sooner because they will be able to market new portable oxygen concentrators sooner. Although a substantial number of operators conducting parts 121, 125 and 135 operations are small entities, all parts 121, 125 and 135 operators are expected to experience cost savings because the proposal will no longer require the PIC to be apprised when a passenger brings and intends to use a POC on board the aircraft and be informed on the contents of the physician’s statement as does SFAR No. 106. The FAA did not receive comments on the initial regulatory flexibility analysis where we first discussed these cost savings. Therefore, as provided in section 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities. C. International Trade Impact Assessment The Trade Agreements Act of 1979 (Pub. L. 96–39), as amended by the Uruguay Round Agreements Act (Pub. L. 103–465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. 20 http://www.manta.com/. PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this final rule and determined that it will have only a domestic impact and therefore no effect on international trade. D. Unfunded Mandates Assessment Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a ‘‘significant regulatory action.’’ The FAA currently uses an inflation-adjusted value of $155.0 million in lieu of $100 million. This final rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply. E. Paperwork Reduction Act The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this final rule. F. International Compatibility and Cooperation In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to ICAO Standards and Recommended Practices to the maximum extent practicable. Annex 18 to the Convention on International Civil Aviation requires that dangerous goods are carried in accordance with the ICAO Technical Instructions on the Transport of Dangerous Goods by Air. The ICAO Technical Instructions do not contain specific provisions for POCs but Part 8 of the ICAO Technical Instructions (passenger and crew exceptions) allows for their carriage on board aircraft as portable medical electronic devices subject to certain conditions. Although the format is different, the conditions in E:\FR\FM\24MYR3.SGM 24MYR3 33117 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations Part 8 pertaining to batteries used to power POCs are the same as the allowances given in 49 CFR 175.10(a)(18). G. Environmental Analysis FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5–6.6 and involves no extraordinary circumstances. VI. Executive Order Determinations A. Executive Order 13132, Federalism The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. The agency determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, does not have Federalism implications. B. Executive Order 13211, Regulations That Significantly Affect Energy Supply, Distribution, or Use The FAA analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it is not a ‘‘significant energy action’’ under the executive order and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. VII. How To Obtain Additional Information A. Rulemaking Documents An electronic copy of a rulemaking document may be obtained by using the Internet — 1. Search the Federal eRulemaking Portal (http://www.regulations.gov); 2. Visit the FAA’s Regulations and Policies Web page at http:// www.faa.gov/regulations_policies/ or 3. Access the Government Publishing Office’s Web page at http:// www.gpo.gov/fdsys/. Copies may also be obtained by sending a request (identified by notice, amendment, or docket number of this rulemaking) to the Federal Aviation Administration, Office of Rulemaking, ARM–1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267–9677. 14 CFR Part 382 B. Comments Submitted to the Docket Comments received may be viewed by going to http://www.regulations.gov and following the online instructions to search the docket number for this action. Anyone is able to search the electronic form of all comments received into any of the FAA’s dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). PART 1—DEFINITIONS AND ABBREVIATIONS C. Small Business Regulatory Enforcement Fairness Act The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the Internet, visit http:// www.faa.gov/regulations_policies/ rulemaking/sbre_act/. * List of Subjects PART 11—GENERAL RULEMAKING PROCEDURES 14 CFR Part 1 Air transportation. The Amendment In consideration of the foregoing, the Federal Aviation Administration and the Office of the Secretary amend chapters I and II of title 14, Code of Federal Regulations as follows: 1. The authority citation for part 1 continues to read as follows: ■ Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701. 2. Amend § 1.1 by adding a definition for ‘‘portable oxygen concentrator’’ in alphabetical order to read as follows: ■ § 1.1 General definitions. * * * * Portable oxygen concentrator means a medical device that separates oxygen from other gasses in ambient air and dispenses this concentrated oxygen to the user. * * * * * ■ 3. Amend § 1.2 by adding the abbreviation ‘‘POC’’ in alphabetical order to read as follows: § 1.2 Abbreviations * * * * * POC means portable oxygen concentrator. * * * * * 4. The authority citation for part 11 continues to read as follows: ■ 14 CFR Part 11 Reporting and recordkeeping requirements. Authority: 49 U.S.C. 106(f), 106(g), 40101, 40103, 40105, 40109, 40113, 44110, 44502, 44701–44702, 44711, and 46102. 14 CFR Part 121 Air carriers, Aircraft, Aviation safety, Charter flights, Safety, Transportation. ■ 14 CFR Part 125 Aircraft, Aviation safety. § 11.201 Office of Management and Budget (OMB) control numbers assigned under the Paperwork Reduction Act. 14 CFR Part 135 Air taxis, Aircraft, Aviation safety. * 14 CFR part or section identified and described mstockstill on DSK3G9T082PROD with RULES3 Air Carriers, Consumer protection, Individuals with disabilities. 5. In § 11.201, amend the table in paragraph (b) by revising the entry for part 121 to read as follows: * * (b) * * * * * Current OMB control No. * * * * * * * Part 121 .................................................................................................... 2120–0008, 2120–0028, 2120–0535, 2120–0571, 2120–0600, 2120– 0606, 2120–0614, 2120–0616, 2120–0631, 2120–0651, 2120–0653, 2120–0691, 2120–0739, 2120–0760, 2120–0766. * VerDate Sep<11>2014 * 18:14 May 23, 2016 * Jkt 238001 PO 00000 * Frm 00021 Fmt 4701 * Sfmt 4700 E:\FR\FM\24MYR3.SGM * 24MYR3 * 33118 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations PART 121—OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL OPERATIONS 6. The authority citation for part 121 continues to read as follows: ■ Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40119, 41706, 42301 preceding note added by Public Law 112–95, sec. 412, 126 Stat. 89, 44101, 44701–44702, 44705, 44709– 44711, 44713, 44716–44717, 44722, 44729, 44732, 46105; Public Law 111–216, 124 Stat. 2348 (49 U.S.C. 44701 note); Public Law 112– 95, 126 Stat. 62 (49 U.S.C. 44732 note). Special Federal Aviation Regulation No. 106 [Removed] 7. Remove Special Federal Aviation Regulation No. 106. ■ 8. Amend § 121.306 as follows: ■ a. In paragraph (b)(4), remove ‘‘or’’ following the semicolon; ■ b. Redesignate paragraph (b)(5) as paragraph (b)(6); ■ c. Add new paragraph (b)(5); and ■ d. In paragraph (c), remove the reference ‘‘(b)(5)’’ and add in its place ‘‘(b)(6)’’. The addition reads as follows: ■ § 121.306 Portable electronic devices. * * * * * (b)* * * (5) Portable oxygen concentrators that comply with the requirements in § 121.574; or * * * * * ■ 9. Amend § 121.574 as follows: ■ a. Revise the section heading; ■ b. Revise paragraph (a) introductory text; ■ c. In paragraph (a)(3), remove the reference ‘‘49 CFR 173.300(a)’’ and add in its place ‘‘49 CFR 173.115(b)’’; ■ d. Revise paragraph (b); and ■ e. Add paragraph (e). The revisions and addition read as follows: mstockstill on DSK3G9T082PROD with RULES3 § 121.574 Oxygen and portable oxygen concentrators for medical use by passengers. (a) A certificate holder may allow a passenger to carry and operate equipment for the storage, generation, or dispensing of oxygen when all of the conditions in paragraphs (a) through (d) of this section are satisfied. Beginning August 22, 2016, a certificate holder may allow a passenger to carry and operate a portable oxygen concentrator when the conditions in paragraphs (b) and (e) of this section are satisfied. * * * * * (b) No person may smoke or create an open flame and no certificate holder may allow any person to smoke or create an open flame within 10 feet of oxygen storage and dispensing VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 equipment carried in accordance with paragraph (a) of this section or a portable oxygen concentrator carried and operated in accordance with paragraph (e) of this section. * * * * * (e) Portable oxygen concentrators—(1) Acceptance criteria. A passenger may carry or operate a portable oxygen concentrator for personal use on board an aircraft and a certificate holder may allow a passenger to carry or operate a portable oxygen concentrator on board an aircraft operated under this part during all phases of flight if the portable oxygen concentrator satisfies all of the requirements in this paragraph (e): (i) Is legally marketed in the United States in accordance with Food and Drug Administration requirements in title 21 of the CFR; (ii) Does not radiate radio frequency emissions that interfere with aircraft systems; (iii) Generates a maximum oxygen pressure of less than 200 kPa gauge (29.0 psig/43.8 psia) at 20 °C (68 °F); (iv) Does not contain any hazardous materials subject to the Hazardous Materials Regulations (49 CFR parts 171 through 180) except as provided in 49 CFR 175.10 for batteries used to power portable electronic devices and that do not require aircraft operator approval; and (v) Bears a label on the exterior of the device applied in a manner that ensures the label will remain affixed for the life of the device and containing the following certification statement in red lettering: ‘‘The manufacturer of this POC has determined this device conforms to all applicable FAA acceptance criteria for POC carriage and use on board aircraft.’’ The label requirements in this paragraph (e)(1)(v) do not apply to the following portable oxygen concentrators approved by the FAA for use on board aircraft prior to May 24, 2016: (A) AirSep Focus; (B) AirSep FreeStyle; (C) AirSep FreeStyle 5; (D) AirSep LifeStyle; (E) Delphi RS–00400; (F) DeVilbiss Healthcare iGo; (G) Inogen One; (H) Inogen One G2; (I) Inogen One G3; (J) Inova Labs LifeChoice; (K) Inova Labs LifeChoice Activox; (L) International Biophysics LifeChoice; (M) Invacare Solo2; (N) Invacare XPO2; (O) Oxlife Independence Oxygen Concentrator; (P) Oxus RS–00400; (Q) Precision Medical EasyPulse; PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 (R) Respironics EverGo; (S) Respironics SimplyGo; (T) SeQual Eclipse; (U) SeQual eQuinox Oxygen System (model 4000); (V) SeQual Oxywell Oxygen System (model 4000); (W) SeQual SAROS; and (X) VBox Trooper Oxygen Concentrator. (2) Operating requirements. Portable oxygen concentrators that satisfy the acceptance criteria identified in paragraph (e)(1) of this section may be carried or operated by a passenger on an aircraft provided the aircraft operator ensures that all of the conditions in this paragraph (e)(2) are satisfied: (i) Exit seats. No person operating a portable oxygen concentrator is permitted to occupy an exit seat. (ii) Stowage of device. During movement on the surface, takeoff and landing, the device must be stowed under the seat in front of the user, or in another approved stowage location so that it does not block the aisle way or the entryway to the row. If the device is to be operated by the user, it must be operated only at a seat location that does not restrict any passenger’s access to, or use of, any required emergency or regular exit, or the aisle(s) in the passenger compartment. PART 125—CERTIFICATION AND OPERATIONS: AIRPLANES HAVING A SEATING CAPACITY OF 20 OR MORE PASSENGERS OR A MAXIMUM PAYLOAD CAPACITY OF 6,000 POUNDS OR MORE; AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT 10. The authority citation for part 125 continues to read as follows: ■ Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701–44702, 44705, 44710–44711, 44713, 44716–44717, 44722. Special Federal Aviation Regulation No. 106 [Removed] 11. Remove Special Federal Aviation Regulation No. 106. ■ 12. Amend § 125.204 as follows: ■ a. In paragraph (b)(4), remove ‘‘or’’ following the semicolon; ■ b. Redesignate paragraph (b)(5) as paragraph (b)(6); ■ c. Add new paragraph (b)(5); and ■ d. In paragraph (c), remove the reference ‘‘(b)(5)’’ and add in its place ‘‘(b)(6)’’. The addition reads as follows: ■ § 125.204 * Portable electronic devices. * * (b) * * * E:\FR\FM\24MYR3.SGM 24MYR3 * * Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations (5) Portable oxygen concentrators that comply with the requirements in § 125.219; or * * * * * ■ 13. Amend § 125.219 as follows: ■ a. Revise the section heading; ■ b. Revise paragraph (a) introductory text; ■ c. In paragraph (a)(1)(iii), after the semicolon, remove ‘‘and’’; ■ d. Redesignate paragraph (a)(1)(iv) as paragraph (a)(1)(v); ■ e. Add new paragraph (a)(1)(iv); ■ f. In paragraph (a)(3), remove the reference ‘‘title 49 CFR 173.300(a)’’ and add in its place ‘‘49 CFR 173.115(b)’’; ■ g. Revise paragraph (b); and ■ h. Add paragraph (f). The revisions and additions read as follows: mstockstill on DSK3G9T082PROD with RULES3 § 125.219 Oxygen and portable oxygen concentrators for medical use by passengers. (a) Except as provided in paragraphs (d) and (f) of this section, no certificate holder may allow the carriage or operation of equipment for the storage, generation or dispensing of medical oxygen unless the conditions in paragraphs (a) through (c) of this section are satisfied. Beginning August 22, 2016, a certificate holder may allow a passenger to carry and operate a portable oxygen concentrator when the conditions in paragraphs (b) and (f) of this section are satisfied. (1) * * * (iv) Constructed so that all valves, fittings, and gauges are protected from damage during that carriage or operation; and * * * * * (b) No person may smoke or create an open flame and no certificate holder may allow any person to smoke or create an open flame within 10 feet of oxygen storage and dispensing equipment carried under paragraph (a) of this section or a portable oxygen concentrator carried and operated under paragraph (f) of this section. * * * * * (f) Portable oxygen concentrators—(1) Acceptance criteria. A passenger may carry or operate a portable oxygen concentrator for personal use on board an aircraft and a certificate holder may allow a passenger to carry or operate a portable oxygen concentrator on board an aircraft operated under this part during all phases of flight if the portable oxygen concentrator satisfies all of the requirements in this paragraph (f): (i) Is legally marketed in the United States in accordance with Food and Drug Administration requirements in title 21 of the CFR; VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 (ii) Does not radiate radio frequency emissions that interfere with aircraft systems; (iii) Generates a maximum oxygen pressure of less than 200 kPa gauge (29.0 psig/43.8 psia) at 20 °C (68 °F); (iv) Does not contain any hazardous materials subject to the Hazardous Materials Regulations (49 CFR parts 171 through 180) except as provided in 49 CFR 175.10 for batteries used to power portable electronic devices and that do not require aircraft operator approval; and (v) Bears a label on the exterior of the device applied in a manner that ensures the label will remain affixed for the life of the device and containing the following certification statement in red lettering: ‘‘The manufacturer of this POC has determined this device conforms to all applicable FAA acceptance criteria for POC carriage and use on board aircraft.’’ The label requirements in this paragraph (f)(1)(v) do not apply to the following portable oxygen concentrators approved by the FAA for use on board aircraft prior to May 24, 2016: (A) AirSep Focus; (B) AirSep FreeStyle; (C) AirSep FreeStyle 5; (D) AirSep LifeStyle; (E) Delphi RS–00400; (F) DeVilbiss Healthcare iGo; (G) Inogen One; (H) Inogen One G2; (I) Inogen One G3; (J) Inova Labs LifeChoice; (K) Inova Labs LifeChoice Activox; (L) International Biophysics LifeChoice; (M) Invacare Solo2; (N) Invacare XPO2; (O) Oxlife Independence Oxygen Concentrator; (P) Oxus RS–00400; (Q) Precision Medical EasyPulse; (R) Respironics EverGo; (S) Respironics SimplyGo; (T) SeQual Eclipse; (U) SeQual eQuinox Oxygen System (model 4000); (V) SeQual Oxywell Oxygen System (model 4000); (W) SeQual SAROS; and (X) VBox Trooper Oxygen Concentrator. (2) Operating requirements. Portable oxygen concentrators that satisfy the acceptance criteria identified in paragraph (f)(1) of this section may be carried or used by a passenger on an aircraft provided the aircraft operator ensures that all of the conditions in this paragraph (f)(2) are satisfied: (i) Exit seats. No person operating a portable oxygen concentrator is permitted to occupy an exit seat. (ii) Stowage of device. During movement on the surface, takeoff and PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 33119 landing, the device must be stowed under the seat in front of the user, or in another approved stowage location so that it does not block the aisle way or the entryway to the row. If the device is to be operated by the user, it must be operated only at a seat location that does not restrict any passenger’s access to, or use of, any required emergency or regular exit, or the aisle(s) in the passenger compartment. PART 135—OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT 14. The authority citation for part 135 continues to read as follows: ■ Authority: 49 U.S.C. 106(f), 106(g), 41706, 40113, 44701–44702, 44705, 44709, 44711– 44713, 44715–44717, 44722, 44730, 45101– 45105; Public Law 112–95, 126 Stat. 58 (49 U.S.C. 44730). Special Federal Aviation Regulation No. 106 [Removed] 15. Remove Special Federal Aviation Regulation No. 106. ■ 16. Amend § 135.91 as follows: ■ a. Revise the section heading and paragraph (a) introductory text; ■ b. In paragraph (a)(1)(iii), after the semicolon, remove ‘‘and’’; ■ c. Redesignate paragraph (a)(1)(iv) as paragraph (a)(1)(v); ■ d. Add new paragraph (a)(1)(iv); ■ e. In paragraph (a)(3), remove the reference ‘‘title 49 CFR 173.300(a)’’ and add in its place ‘‘49 CFR 173.115(b)’’; ■ f. Revise paragraph (b); and ■ g. Add paragraph (f). The revisions and additions read as follows: ■ § 135.91 Oxygen and portable oxygen concentrators for medical use by passengers. (a) Except as provided in paragraphs (d) and (e) of this section, no certificate holder may allow the carriage or operation of equipment for the storage, generation or dispensing of medical oxygen unless the conditions in paragraphs (a) through (c) of this section are satisfied. Beginning August 22, 2016, a certificate holder may allow a passenger to carry and operate a portable oxygen concentrator when the conditions in paragraphs (b) and (f) of this section are satisfied. (1) * * * (iv) Constructed so that all valves, fittings, and gauges are protected from damage during carriage or operation; and * * * * * (b) No person may smoke or create an open flame and no certificate holder E:\FR\FM\24MYR3.SGM 24MYR3 mstockstill on DSK3G9T082PROD with RULES3 33120 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations may allow any person to smoke or create an open flame within 10 feet of oxygen storage and dispensing equipment carried under paragraph (a) of this section or a portable oxygen concentrator carried and operated under paragraph (f) of this section. * * * * * (f) Portable oxygen concentrators—(1) Acceptance criteria. A passenger may carry or operate a portable oxygen concentrator for personal use on board an aircraft and a certificate holder may allow a passenger to carry or operate a portable oxygen concentrator on board an aircraft operated under this part during all phases of flight if the portable oxygen concentrator satisfies all of the requirements of this paragraph (f): (i) Is legally marketed in the United States in accordance with Food and Drug Administration requirements in title 21 of the CFR; (ii) Does not radiate radio frequency emissions that interfere with aircraft systems; (iii) Generates a maximum oxygen pressure of less than 200 kPa gauge (29.0 psig/43.8 psia) at 20 °C (68 °F); (iv) Does not contain any hazardous materials subject to the Hazardous Materials Regulations (49 CFR parts 171 through 180) except as provided in 49 CFR 175.10 for batteries used to power portable electronic devices and that do not require aircraft operator approval; and (v) Bears a label on the exterior of the device applied in a manner that ensures the label will remain affixed for the life of the device and containing the following certification statement in red lettering: ‘‘The manufacturer of this POC has determined this device conforms to all applicable FAA acceptance criteria for POC carriage and use on board aircraft.’’ The label requirements in this paragraph (f)(1)(v) do not apply to the following portable oxygen concentrators approved by the FAA for use on board aircraft prior to May 24, 2016: (A) AirSep Focus; (B) AirSep FreeStyle; (C) AirSep FreeStyle 5; (D) AirSep LifeStyle; (E) Delphi RS–00400; (F) DeVilbiss Healthcare iGo; (G) Inogen One; (H) Inogen One G2; (I) Inogen One G3; (J) Inova Labs LifeChoice; (K) Inova Labs LifeChoice Activox; (L) International Biophysics LifeChoice; (M) Invacare Solo2; (N) Invacare XPO2; (O) Oxlife Independence Oxygen Concentrator; VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 (P) Oxus RS–00400; (Q) Precision Medical EasyPulse; (R) Respironics EverGo; (S) Respironics SimplyGo; (T) SeQual Eclipse; (U) SeQual eQuinox Oxygen System (model 4000); (V) SeQual Oxywell Oxygen System (model 4000); (W) SeQual SAROS; and (X) VBox Trooper Oxygen Concentrator. (2) Operating requirements. Portable oxygen concentrators that satisfy the acceptance criteria identified in paragraph (f)(1) of this section may be carried on or operated by a passenger on board an aircraft provided the aircraft operator ensures that all of the conditions in this paragraph (f)(2) are satisfied: (i) Exit seats. No person operating a portable oxygen concentrator is permitted to occupy an exit seat. (ii) Stowage of device. During movement on the surface, takeoff and landing, the device must be stowed under the seat in front of the user, or in another approved stowage location so that it does not block the aisle way or the entryway to the row. If the device is to be operated by the user, it must be operated only at a seat location that does not restrict any passenger’s access to, or use of, any required emergency or regular exit, or the aisle(s) in the passenger compartment. ■ 17. Amend § 135.144 as follows: ■ a. In paragraph (a) introductory text, remove ‘‘of the following’’; ■ b. In paragraph (b)(4), remove ‘‘or’’ following the semicolon; ■ c. Redesignate paragraph (b)(5) as paragraph (b)(6); ■ d. Add new paragraph (b)(5); and ■ e. In paragraph (c), remove the reference ‘‘(b)(5)’’ and add in its place ‘‘(b)(6)’’. The addition reads as follows: § 135.144 Portable electronic devices. * * * * * (b) * * * (5) Portable oxygen concentrators that comply with the requirements in § 135.91; or * * * * * PART 382—NONDISCRIMINATION ON THE BASIS OF DISABILITY IN AIR TRAVEL 18. The authority citation for part 382 continues to read as follows: ■ Authority: 49 U.S.C. 41705. 19. In § 382.27, revise paragraph (a) to read as follows: ■ PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 § 382.27 May a carrier require a passenger with a disability to provide advance notice in order to obtain certain specific services in connection with a flight? (a) Except as provided in paragraph (b) of this section and § 382.133(e)(4) and (5) and (f)(5) and (6), as a carrier you must not require a passenger with a disability to provide advance notice in order to obtain services or accommodations required by this part. * * * * * ■ 20. Revise § 382.133 to read as follows: § 382.133 What are the requirements concerning the evaluation and use of passenger-supplied electronic devices that assist passengers with respiration in the cabin during flight? (a) Except for on-demand air taxi operators, as a U.S. carrier conducting passenger service you must permit any individual with a disability to use in the passenger cabin during air transportation an electronic assistive device specified in paragraph (c) of this section on all aircraft originally designed to have a maximum passenger capacity of more than 19 seats unless: (1) The device does not meet applicable FAA requirements for medical portable electronic device; or (2) The device cannot be stowed and used in the passenger cabin consistent with applicable TSA, FAA, and PHMSA regulations. (b) Except for foreign carriers conducting operations of a nature equivalent to on-demand air taxi operations by a U.S. carrier, as a foreign carrier conducting passenger service you must permit any individual with a disability to use in the passenger cabin during air transportation to, from or within the United States, an electronic assistive device specified in paragraph (d) of this section on all aircraft originally designed to have a maximum passenger capacity of more than 19 seats unless: (1) The device does not meet requirements for medical portable electronic devices set by the foreign carrier’s government if such requirements exist; (2) The device does not meet requirements for medical portable electronic devices set by the FAA for U.S. carriers in circumstances where requirements for medical portable electronic devices have not been set by the foreign carrier’s government and the foreign carrier elects to apply FAA requirements for medical portable electronic devices; or (3) The device cannot be stowed and used in the passenger cabin consistent with applicable TSA, FAA and PHMSA E:\FR\FM\24MYR3.SGM 24MYR3 mstockstill on DSK3G9T082PROD with RULES3 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations regulations, and the safety or security regulations of the foreign carrier’s government. (c) Except as provided in paragraph (a) of this section, as a covered U.S. air carrier, you must accept the passenger supplied electronic assistive device in this paragraph (c): (1) A portable oxygen concentrator (POC), a ventilator, a respirator or a continuous positive airway pressure machine that displays a manufacturer’s label that indicates the device meets FAA requirements; and (2) The following POC models whether or not they are labeled: (i) AirSep Focus; (ii) AirSep FreeStyle; (iii) AirSep FreeStyle 5; (iv) AirSep LifeStyle; (v) Delphi RS–00400; (vi) DeVilbiss Healthcare iGo; (vii) Inogen One; (viii) Inogen One G2; (ix) Inogen One G3; (x) Inova Labs LifeChoice; (xi) Inova Labs LifeChoice Activox; (xii) International Biophysics LifeChoice; (xiii) Invacare Solo2; (xiv) Invacare XPO2; (xv) Oxlife Independence Oxygen Concentrator; (xvi) Oxus RS–00400; (xvii) Precision Medical EasyPulse; (xviii) Respironics EverGo; (xix) Respironics SimplyGo; (xx) SeQual Eclipse; (xxi) SeQual eQuinox Oxygen System (model 4000); (xxii) SeQual Oxywell Oxygen System (model 4000); (xxiii) SeQual SAROS; and (xxiv) VBox Trooper Oxygen Concentrator. (d) Except as provided in paragraph (b) of this section, as a covered foreign air carrier, you must accept the supplied electronic assistive devices in this paragraph (d): (1) A POC, a ventilator, a respirator or a continuous positive airway pressure machine that displays a manufacturer’s label according to FAA requirements in circumstances where requirements for labeling these devices have not been set by the foreign carrier’s government; and (2) The following POC models whether or not they are labeled: (i) AirSep Focus; (ii) AirSep FreeStyle; (iii) AirSep FreeStyle 5; (iv) AirSep LifeStyle; (v) Delphi RS–00400; (vi) DeVilbiss Healthcare iGo; (vii) Inogen One; (viii) Inogen One G2; (ix) Inogen One G3; (x) Inova Labs LifeChoice; VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 (xi) Inova Labs LifeChoice Activox; (xii) International Biophysics LifeChoice; (xiii) Invacare Solo2; (xiv) Invacare XPO2; (xv) Oxlife Independence Oxygen Concentrator; (xvi) Oxus RS–00400; (xvii) Precision Medical EasyPulse; (xviii) Respironics EverGo; (xix) Respironics SimplyGo; (xx) SeQual Eclipse; (xxi) SeQual eQuinox Oxygen System (model 4000); (xxii) SeQual Oxywell Oxygen System (model 4000); (xxiii) SeQual SAROS; and (xxiv) VBox Trooper Oxygen Concentrator. (e) As a U.S. carrier, you must provide information during the reservation process as indicated in paragraphs (e)(1) through (6) of this section upon inquiry from an individual concerning the use in the cabin during air transportation of a ventilator, respirator, continuous positive airway machine, or a POC. The information in this paragraph (e) must be provided: (1) Any applicable requirement for a manufacturer-affixed label to reflect that the device has been tested to meet applicable FAA requirements for medical portable electronic devices; (2) The maximum weight and dimensions (length, width, height) of the device to be used by an individual that can be accommodated in the aircraft cabin consistent with FAA safety requirements; (3) The requirement to bring an adequate number of batteries as outlined in paragraph (h)(2) of this section and to ensure that extra batteries carried onboard to power the device are packaged and protected from short circuit and physical damage in accordance with applicable PHMSA regulations regarding spare batteries carried by passengers in an aircraft cabin; (4) Any requirement, if applicable, that an individual contact the carrier operating the flight 48 hours before scheduled departure to learn the expected maximum duration of his/her flight in order to determine the required number of batteries for his/her particular ventilator, respirator, continuous positive airway pressure machine, or POC; (5) Any requirement, if applicable, of the carrier operating the flight for an individual planning to use such a device to check-in up to one hour before that carrier’s general check-in deadline; and (6) For POCs, the requirement of § 382.23(b)(1)(ii) to present to the PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 33121 operating carrier at the airport a physician’s statement (medical certificate). (f) As a foreign carrier operating flights to, from or within the United States, you must provide the information during the reservation process as indicated in paragraphs (f)(1) through (7) of this section upon inquiry from an individual concerning the use in the cabin during air transportation on such a flight of a ventilator, respirator, continuous positive airway machine, or POC. The information in this paragraph (f) must be provided: (1) Any applicable requirement for a manufacturer-affixed label to reflect that the device has been tested to meet requirements for medical portable electronic devices set by the foreign carrier’s government if such requirements exist; (2) Any applicable requirement for a manufacturer-affixed label to reflect that the device has been tested to meet requirements for medical portable electronic devices set by the FAA for U.S. carriers if requirements for medical portable electronic devices have not been set by the foreign carrier’s government and the foreign carrier elects to apply FAA requirements for medical portable electronic devices; (3) The maximum weight and dimensions (length, width, height) of the device to be used by an individual that can be accommodated in the aircraft cabin consistent with the safety regulations of the foreign carrier’s government; (4) The requirement to bring an adequate number of batteries as outlined in paragraph (h)(2) of this section and to ensure that extra batteries carried onboard to power the device are packaged in accordance with applicable government safety regulations; (5) Any requirement, if applicable, that an individual contact the carrier operating the flight 48 hours before scheduled departure to learn the expected maximum duration of his/her flight in order to determine the required number of batteries for his/her particular ventilator, respirator, continuous positive airway pressure machine, or POC; (6) Any requirement, if applicable, of the carrier operating the flight for an individual planning to use such a device to check-in up to one hour before that carrier’s general check-in deadline; and (7) Any requirement, if applicable, that an individual who wishes to use a POC onboard an aircraft present to the operating carrier at the airport a physician’s statement (medical certificate). E:\FR\FM\24MYR3.SGM 24MYR3 33122 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES3 (g) In the case of a codeshare itinerary, the carrier whose code is used on the flight must either inform the individual inquiring about using a ventilator, respirator, CPAP machine or POC onboard an aircraft to contact the carrier operating the flight for information about its requirements for use of such devices in the cabin, or provide such information on behalf of the codeshare carrier operating the flight. (h)(1) As a U.S. or foreign carrier subject to paragraph (a) or (b) of this section, you must inform any individual who has advised you that he or she plans to operate his/her device in the aircraft cabin, within 48 hours of his/her making a reservation or 24 hours before VerDate Sep<11>2014 18:14 May 23, 2016 Jkt 238001 the scheduled departure date of his/her flight, whichever date is earlier, of the expected maximum flight duration of each segment of his/her flight itinerary. (2) You may require an individual to bring an adequate number of fully charged batteries onboard, based on the battery manufacturer’s estimate of the hours of battery life while the device is in use and the information provided in the physician’s statement, to power the device for not less than 150% of the expected maximum flight duration. (3) If an individual does not comply with the conditions for acceptance of a medical portable electronic device as outlined in this section, you may deny boarding to the individual in PO 00000 Frm 00026 Fmt 4701 Sfmt 9990 accordance with § 382.19(c) and in that event you must provide a written explanation to the individual in accordance with § 382.19(d). Issued under authority provided by 49 U.S.C. 106(f) and 44701(a), and authority provided by 49 U.S.C. 41705, delegated at 49 CFR 1.27, in Washington, DC, on May 11, 2016. Kathryn B. Thomson, General Counsel, Department of Transportation. Michael P. Huerta, Administrator, Federal Aviation Administration. [FR Doc. 2016–11918 Filed 5–23–16; 8:45 am] BILLING CODE 4910–13–P E:\FR\FM\24MYR3.SGM 24MYR3

Agencies

[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Rules and Regulations]
[Pages 33097-33122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11918]



[[Page 33097]]

Vol. 81

Tuesday,

No. 100

May 24, 2016

Part V





Department of Transportation





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Federal Aviation Administration





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14 CFR Parts 1, 11, 121, et al.





Acceptance Criteria for Portable Oxygen Concentrators Used On Board 
Aircraft; Final Rule

Federal Register / Vol. 81 , No. 100 / Tuesday, May 24, 2016 / Rules 
and Regulations

[[Page 33098]]


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 1, 11, 121, 125, and 135

Office of the Secretary

14 CFR Part 382

[Docket No.: FAA-2014-0554; Amdt. Nos. 1-69, 11-59, 121-374, 125-65, 
and 135-133]
RIN 2120-AK32


Acceptance Criteria for Portable Oxygen Concentrators Used On 
Board Aircraft

AGENCY: Federal Aviation Administration (FAA) and Office of the 
Secretary (OST), Department of Transportation (DOT).

ACTION: Final rule.

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SUMMARY: This final rule replaces the existing process by which the 
Federal Aviation Administration (Agency or FAA) approves portable 
oxygen concentrators (POC) for use on board aircraft in air carrier 
operations, commercial operations, and certain other operations using 
large aircraft. The FAA currently assesses each POC make and model on a 
case-by-case basis and if the FAA determines that a particular POC is 
safe for use on board an aircraft, the FAA conducts rulemaking to 
identify the specific POC model in an FAA regulation. This final rule 
replaces the current process and allows passengers to use a POC on 
board an aircraft if the POC satisfies certain acceptance criteria and 
bears a label indicating conformance with the acceptance criteria. The 
labeling requirement only affects POCs intended for use on board 
aircraft that were not previously approved for use on aircraft by the 
FAA. Additionally, this rulemaking will eliminate redundant operational 
requirements and paperwork requirements related to the physician's 
statement. As a result, this rulemaking will reduce burdens for POC 
manufacturers, passengers who use POCs while traveling, and affected 
aircraft operators. This final rule also makes conforming amendments to 
the Department of Transportation's (Department or DOT) rule 
implementing the Air Carrier Access Act (ACAA) to require carriers to 
accept all POC models that meet FAA acceptance criteria as detailed in 
this rule.

DATES: The amendments to 14 CFR 1.1, 1.2, 121.574, 125.219, and 135.91 
are effective June 23, 2016. The amendments to 14 CFR 11.201, 121.306, 
125.204, 135.144, 382,27, and 382.133, and the removal of Special 
Federal Aviation Regulation No. 106 are effective August 22, 2016.

ADDRESSES: For information on where to obtain copies of rulemaking 
documents and other information related to this final rule, see ``How 
to Obtain Additional Information'' in the SUPPLEMENTARY INFORMATION 
section of this document.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning 
this action, contact DK Deaderick, 121 Air Carrier Operations Branch, 
Air Transportation Division, Flight Standards Service, Federal Aviation 
Administration, AFS-220, 800 Independence Avenue SW., Washington, DC 
20591; telephone (202) 267-7480; email dk.deaderick@faa.gov. For 
questions regarding the Department's disability regulation (14 CFR part 
382), contact Clereece Kroha, Senior Attorney, Office of Aviation 
Enforcement and Proceedings, Department of Transportation, 1200 New 
Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9041; 
email clereece.kroha@dot.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Overview of Final Rule
    B. Summary of Cost Savings
II. Authority for This Rulemaking
III. Background
    A. Statement of the Problem
    B. Summary of the NPRM
    C. Differences Between Notice of Proposed Rulemaking and Final 
Rule
    D. General Overview of Comments
IV. Discussion of Public Comments and Final Rule
    A. Applicability, Effective Dates and Compliance
    B. Definition of Portable Oxygen Concentrator
    C. Portable Oxygen Concentrator Acceptance Criteria
    1. Food and Drug Administration Clearance or Approval
    2. Radio Frequency Emissions
    3. Hazardous Materials
    4. Maximum Oxygen Pressure
    D. Manufacturer Label
    E. Manufacturer Determination of Conformance to Acceptance 
Criteria
    F. Prohibition on Smoking or Open Flame
    G. Operational Requirements
    1. Exit Seats
    2. Stowage of Portable Oxygen Concentrators
    H. Discussion of Special Federal Aviation Regulation No. 106 
Requirements Excluded From Final Rule
    1. Special Federal Aviation Regulation No. 106 Requirements 
Addressed in Existing Regulations
    2. Special Federal Aviation Regulation No. 106 Requirements 
Excluded in Their Entirety
    I. Miscellaneous
    J. Technical Amendments
    K. Nondiscrimination on the Basis of Disability in Air Travel
    1. Mandatory Acceptance of POCs That Meet FAA Acceptance 
Criteria
    2. Other Amendments to 14 CFR Part 382
V. Regulatory Notices and Analyses
    A. Regulatory Evaluation
    B. Regulatory Flexibility Determination
    C. International Trade Impact Assessment
    D. Unfunded Mandates Assessment
    E. Paperwork Reduction Act
    F. International Compatibility and Cooperation
    G. Environmental Analysis
VI. Executive Order Determinations
    A. Executive Order 13132, Federalism
    B. Executive Order 13211, Regulations That Significantly Affect 
Energy Supply, Distribution, or Use
VII. How To Obtain Additional Information
    A. Rulemaking Documents
    B. Comments Submitted to the Docket
    C. Small Business Regulatory Enforcement Fairness Act

I. Executive Summary

A. Overview of Final Rule

    This final rule affects the use of POCs on board aircraft in 
operations conducted under title 14 of the Code of Federal Regulations 
(14 CFR) parts 121, 125, and 135, by replacing the existing FAA case-
by-case approval process for each make and model of POC in Special 
Federal Aviation Regulation (SFAR) No. 106, with FAA acceptance 
criteria. Under SFAR No. 106, each time the FAA approves a specific 
model of POC for use on board aircraft, the agency updates the list of 
approved POCs in the SFAR.\1\
---------------------------------------------------------------------------

    \1\ POCs identified in the SFAR are referred to in this preamble 
as SFAR-approved POCs or SFAR-approved devices.
---------------------------------------------------------------------------

    This final rule removes SFAR No. 106 and replaces it with POC 
acceptance criteria and specific labeling requirements to identify POCs 
that conform to the acceptance criteria. POCs that conform to the final 
rule acceptance criteria will be allowed on board aircraft without 
additional FAA review and rulemaking.
    As with existing requirements for FAA approval of POCs that may be 
used on aircraft, the final rule acceptance criteria and labeling 
requirement only apply to POCs intended for use on board aircraft. 
Table 1 provides a comparison of the final rule acceptance criteria and

[[Page 33099]]

labeling requirement with related SFAR No. 106.

   Table 1--Comparison of Final Rule Acceptance Criteria and Labeling
           Requirement With Related SFAR No. 106 Requirements
------------------------------------------------------------------------
                                                         Final rule
                              Related SFAR No. 106   acceptance criteria
                                  requirements          and labeling
                                                         requirement
------------------------------------------------------------------------
Food and Drug Administration  The POC must be       The POC manufacturer
 (FDA) clearance to market     regulated by the      has received FDA
 the device.                   FDA (section 2(2)).   clearance to
                              Note: To satisfy       legally market the
                               this requirement,     device in the
                               manufacturers         United States.
                               provide the FAA
                               with the FDA letter
                               granting approval
                               to market the
                               device (the FDA
                               response to a
                               manufacturer's
                               510(k) submission).
Hazardous materials.........  The POC may not       The POC must not
                               contain hazardous     contain any
                               materials as          hazardous materials
                               determined by the     subject to the HMR,
                               Pipeline and          except as provided
                               Hazardous Materials   for batteries in
                               Safety                the exceptions for
                               Administration        crewmembers and
                               (section 2(1)).       passengers (49 CFR
                              Note: To satisfy       175.10).
                               this requirement,    The maximum oxygen
                               manufacturers         pressure generated
                               currently provide     by the POC must
                               the FAA with a        fall below the
                               Pipeline and          threshold for the
                               Hazardous Materials   definition of a
                               Safety                compressed gas as
                               Administration        per the HMR.
                               (PHMSA)
                               determination
                               letter stating that
                               the POC is not
                               subject to the
                               Hazardous Materials
                               Regulations (HMR)
                               (49 CFR parts 171-
                               180).
Radio frequency (RF)          Operator must         The POC's RF
 emissions.                    determine that POC    emissions do not
                               does not cause        interfere with
                               interference with     aircraft systems.
                               the electrical,
                               navigation or
                               communication
                               equipment on the
                               aircraft on which
                               the device is to be
                               used (section
                               3(a)(1)).
                              Note: To satisfy
                               this requirement,
                               it is current
                               practice for
                               operators to use
                               testing data
                               provided by POC
                               manufacturers
                               regarding the RF
                               emissions of a
                               specific POC model.
                               Manufacturers
                               currently complete
                               testing in
                               accordance with
                               RTCA standard 160G,
                               Section 21,
                               Category M.
Identification of POCs safe   POC model must be     In order to be used
 for use on board aircraft.    identified in SFAR    on aircraft, a
                               No. 106 as approved   label must be
                               for use on board      affixed to the POC
                               aircraft prior to     indicating
                               use on board          compliance with
                               aircraft in part      acceptance criteria
                               121, 125, and 135     pertaining to FDA
                               operations            clearance to market
                               (sections 2, 3(a)).   the device,
                              Note: Specific POCs    hazardous
                               approved for use on   materials, and RF
                               board aircraft are    emission limits.
                               identified in SFAR   POC models
                               No. 106 by            identified in
                               manufacturer and      existing SFAR No.
                               model name.           106 satisfy the
                               Although some POC     acceptance criteria
                               manufacturers affix   and will be exempt
                               a label indicating    from the labeling
                               FAA approval for      requirement. These
                               use on board          POC models will
                               aircraft, there is    continue to be
                               no current FAA        identified in the
                               requirement for a     regulatory text.
                               label indicating
                               this approval.
------------------------------------------------------------------------

    This final rule requires all POC models to conform to the 
acceptance criteria.\2\ Further, any POC model that was not previously 
identified in SFAR No. 106 as approved for use on aircraft must also 
bear a label indicating conformance with the acceptance criteria before 
it may be used on board an aircraft. This label will facilitate 
passenger and crew recognition of POCs that may be used in the cabin 
during all phases of flight.
---------------------------------------------------------------------------

    \2\ POC models previously listed as approved for use on board 
aircraft in SFAR No. 106 received approval because they satisfied 
the criteria set forth in SFAR No. 106. The POC acceptance criteria 
identified in this final rule are based on existing SFAR No. 106 
requirements that must be satisfied before the FAA identifies a POC 
in SFAR No. 106 as approved for use on aircraft. Thus, a POC model 
identified in SFAR No. 106 satisfies the acceptance criteria.
---------------------------------------------------------------------------

    SFAR-approved POC models need not bear a label. The final rule 
regulatory text includes a list of POCs approved in accordance with 
SFAR No. 106 so that passengers and crewmembers can continue to 
identify these POCs as approved for use on board aircraft.
    In addition, this final rule eliminates SFAR No. 106 requirements 
related to POC use on board aircraft that are addressed elsewhere in 
titles 14 or 49 of the CFR. This final rule also eliminates specific 
SFAR No. 106 requirements applicable to passengers that are not 
necessary for safe POC use on board aircraft, and impose an unnecessary 
and unreasonable paperwork burden on POC-using passengers and their 
physicians as well as crewmembers and aircraft operators. This final 
rule also increases accessibility in air travel for passengers who 
require oxygen therapy during flight. Table 2 summarizes the final rule 
disposition of all SFAR No. 106 provisions.

  Table 2--Summary of SFAR No. 106 Provisions and Disposition in Final
                                  Rule
------------------------------------------------------------------------
                                                     Description of
      Summary of SFAR No. 106 provision        disposition in final rule
------------------------------------------------------------------------
 Requirement that the POC is legally   SFAR No. 106 Provisions
 marketed in the United States in accordance    Reflected in Acceptance
 with FDA requirements (section 2(2)).          Criteria and Labeling
 Requirement for operator to            Requirement.
 determine that POC does not cause
 interference with the electrical, navigation
 or communication equipment on the aircraft
 on which the device is to be used (section
 3(a)(1)).

[[Page 33100]]

 
 Prohibition on POCs containing
 hazardous materials as determined by the
 Pipeline and Hazardous Materials Safety
 Administration (section 2(1)).
 POC model must be identified in SFAR
 No. 106 prior to use in part 121, 125, and
 135 operations (sections 2, 3(a))*.
 Prohibition on smoking or open flame  SFAR No. 106 Provisions
 near POC (section 3(a)(2)).                    Retained.
 Prohibition on seating a passenger
 using a POC in an exit seat (section
 3(a)(4))..
 Requirement to stow POC during
 movement on the surface, takeoff, and
 landing (section 3(a)(3)).
 POC model must be identified in SFAR
 No. 106 prior to use in part 121, 125, and
 135 operations (sections 2, 3( a))*.
 ``Whenever the pilot in command       SFAR No. 106 Provisions
 turns off the ``Fasten Seat Belt'' sign, or    Eliminated Because
 otherwise signifies that permission is         Addressed in Other
 granted to move about the passenger cabin,     Existing Regulations.
 passengers operating their portable oxygen
 concentrator may continue to operate it
 while moving about the cabin.'' (section
 3(a)(6)).
 Requirement for POC user to ensure
 that POC batteries in carry-on baggage are
 protected from short circuit and are
 packaged in a manner that protects them from
 physical damage (section 3(b)(6)).
 ``Whenever the pilot in command       SFAR No. 106 Provisions
 turns off the ``Fasten Seat Belt'' sign, or    Eliminated Because
 otherwise signifies that permission is         Addressed in Other
 granted to move about the passenger cabin,     Existing Regulations.
 passengers operating their portable oxygen
 concentrator may continue to operate it
 while moving about the cabin.'' (section
 3(a)(6)).
 Requirement for POC user to ensure
 that POC batteries in carry-on baggage are
 protected from short circuit and are
 packaged in a manner that protects them from
 physical damage (section 3(b)(6)).
 Requirements for POC user to obtain   SFAR No. 106 Provisions
 a physician's statement and provide notice     Eliminated in Their
 to pilot and aircraft operator regarding POC   Entirety.
 use and contents of physician statement
 (sections 3(a)(5) and 3(b)(3)).
 Requirement for POC user to be
 capable of responding to alarms or to travel
 with a person who can perform these
 functions (section 3(b)(1)).
 Requirement for POC user to ensure
 that the POC is free of petroleum products
 or signs of excessive wear or abuse (section
 3(b)(2)).
 Prohibition on use of salves and
 lotions unless ``oxygen approved'' (section
 3(b)(4))
 Requirement for passenger to carry a
 sufficient number of batteries for duration
 of flight (section 3(b)(5))**.
------------------------------------------------------------------------
* The list of POCs currently identified in SFAR No. 106 will be
  maintained in parts 121, 125 and 135. A detailed discussion regarding
  the identification of POCs that conform to the acceptance criteria is
  provided in the preamble discussion, ``Manufacturer Label.''
** Air carriers may require passengers using a POC to bring an adequate
  number of batteries to power a POC. See 14 CFR 382.133.

    This final rule also includes several conforming changes to 14 CFR 
part 382 to ensure that the Department's rule requiring carriers to 
accommodate passengers with disabilities who are traveling with POCs is 
consistent with the FAA changes to POC carriage and use on aircraft.
    Finally, the amendments provided in this final rule are consistent 
with the retrospective regulatory review requirements of Executive 
Order 13563. On January 18, 2011, the President signed Executive Order 
13563, Improving Regulation and Regulatory Review. Among other things, 
Section 6 of that Executive Order directs agencies to conduct a 
retrospective analysis of existing rules. Specifically, Executive Order 
13563 provides that ``[t]o facilitate the periodic review of existing 
significant regulations, agencies shall consider how best to promote 
retrospective analysis of rules that may be outmoded, ineffective, 
insufficient, or excessively burdensome, and to modify, streamline, 
expand, or repeal them in accordance with what has been learned.''
    Consistent with Executive Order 13563, the FAA routinely evaluates 
existing regulations and other requirements. The FAA works to identify 
unnecessary, duplicative, or ineffective regulations and to mitigate 
the impacts of those regulations, where possible, without compromising 
safety.
    As part of the FAA's continuing obligation to review its 
regulations, the agency conducted an analysis of SFAR No. 106 and 
determined that it involves several unnecessary burdens. As a result of 
this determination and the resulting final rule amendments, the final 
rule will provide relief to POC manufacturers, passengers who use a 
POC, aircraft operators and the FAA. The final rule will provide relief 
to POC manufacturers and the FAA by eliminating the SFAR No. 106 POC 
approval process, to passengers who use a POC by eliminating the FAA 
requirement to obtain a physician's statement, and to aircraft 
operators by eliminating the requirements for crewmember review of the 
physician's statement and pilot in command (PIC) notification. The 
quantification of benefits follows the same methodology as the proposed 
rule as the agency did not receive negative comments on this 
methodology. The agency presents cost savings in Table 3 below.
    The total cost savings from this final rule is $39.5 million ($27.6 
million at 7% present value and $33.6 million at 3% present value). The 
largest cost savings of $39 million occurs from the reduction of crew 
time to review the physician's statement. These are the same estimated 
benefits and costs as presented for the proposed rule and since the FAA 
received no comments regarding these estimates, there are no changes to 
this final rule.

B. Summary of Cost Savings

    The FAA estimates that manufacturers will save $108,000 over ten 
years because they will no longer have to petition the FAA for 
rulemaking with each new device they want to add to the list of POCs 
approved for use

[[Page 33101]]

during flight on board aircraft. These cost savings will be reduced 
slightly because manufacturers will incur an estimated total one-time 
cost of $22,000 to comply with the labeling requirement. The FAA 
estimated additional cost savings because of the discontinuation of 
certain requirements from SFAR No. 106. Table 3 presents total 
estimated cost savings.

                                      Table 3--Total Estimated Cost Savings
----------------------------------------------------------------------------------------------------------------
                                                                                    7% Present      3% Present
                                                                   Cost savings    value savings   value savings
----------------------------------------------------------------------------------------------------------------
FAA Savings--No SFAR............................................         $91,644         $68,871         $80,519
Manufacturer Savings--No petition for rulemaking................         108,000          75,853          92,126
Removal of FAA requirement for user to obtain a physician's              569,961         401,645         486,914
 statement for POC use on aircraft..............................
Removal of FAA requirement for crew review of physician's             38,726,085      27,083,677      32,972,652
 statement and PIC notification.................................
                                                                 -----------------------------------------------
    Total Cost Savings..........................................      39,495,690      27,630,045      33,632,212
----------------------------------------------------------------------------------------------------------------

II. Authority for This Rulemaking

    The FAA's authority to issue rules on aviation safety is found in 
Title 49 of the United States Code. Subtitle I, Section 106 describes 
the authority of the FAA Administrator. Subtitle VII, Aviation 
Programs, describes in more detail the scope of the agency's authority.
    This rulemaking is promulgated under the authority described in 49 
U.S.C. 106(f), which vests final authority in the Administrator for 
carrying out all functions, powers, and duties of the administration 
relating to the promulgation of regulations and rules, and section 
44701(a)(5), which requires the Administrator to promulgate regulations 
and minimum standards for other practices, methods, and procedures 
necessary for safety in air commerce and national security. Further, 49 
U.S.C. 41705 provides the Secretary of Transportation the authority to 
prohibit discrimination against a qualified individual with a 
disability in air travel.

III. Background

A. Statement of the Problem

    On July 12, 2005, the FAA published a final rule adding SFAR No. 
106 to part 121 of title 14 (70 FR 40156). The final rule adding SFAR 
No. 106 permitted the use of POCs identified in the SFAR to address the 
needs of passengers requiring oxygen therapy while traveling on board 
aircraft.
    Prior to SFAR No. 106, passengers could carry and operate equipment 
generating, storing or dispensing medical oxygen on board an aircraft 
only if the equipment was furnished by the certificate holder and 
certain other conditions prescribed in 14 CFR 121.547, 125.219 and 
135.91 were satisfied. In 2005, only a limited number of air carriers 
provided compressed medical oxygen, for a fee, to passengers who 
required medical oxygen therapy during flight. Because compressed 
oxygen is considered a hazardous material, it was an expensive and 
logistically challenging exercise for air carriers to provide medical 
oxygen. Today, virtually no certificate holders conducting part 121 
operations provide in-flight medical oxygen for a fee to passengers.
    Further, passengers requiring oxygen therapy during travel also 
faced difficulty coordinating service between the carrier and the 
medical oxygen supplier to ensure coverage at the terminal, on board 
the aircraft, and gate-to-gate. Sometimes, passengers would spend at 
least part of the time travelling without medical oxygen due to service 
problems with the oxygen supplier.
    In 2002, POCs were brought to the attention of the FAA as a new 
portable technology for dispensing medical oxygen for purposes of 
oxygen therapy. POCs work by filtering nitrogen from the air and 
providing the POC user with oxygen at a concentration of approximately 
90 percent. Thus, POCs do not require the same level of special 
handling as compressed oxygen. However, due to existing FAA regulations 
applicable to the use of devices that dispense oxygen (Sec. Sec.  
121.574, 125.219, and 135.91), including POCs, the FAA informed the POC 
community that an exemption would be required for a passenger to carry 
on and operate a POC that the passenger supplied for his or her own use 
(i.e., not furnished by the aircraft operator).
    Rather than wait for petitions for exemption from the existing 
regulations (Sec. Sec.  121.574, 125.219, and 135.91), the FAA 
completed rulemaking to address the issue of passenger-supplied POCs by 
adding SFAR No. 106 to title 14. See 69 FR 42324 (July 14, 2004) and 70 
FR 40156 (July 12, 2005). SFAR No. 106 allows passengers to carry and 
operate their own POC on board an aircraft if the FAA has approved the 
specific POC model for use on board aircraft and identified the POC 
model in the SFAR.\3\ As a result of SFAR No. 106, the FAA has 
mitigated the challenges faced by passengers requiring oxygen therapy 
during travel and has increased the accessibility to air travel for 
many passengers requiring oxygen therapy by allowing passengers to 
supply their own POCs for use during air travel.
---------------------------------------------------------------------------

    \3\ Initially, SFAR No. 106 applied to part 119 certificate 
holders conducting operations under part 121. In a technical 
amendment published January 12, 2007 (72 FR 1442), the FAA extended 
the requirements of SFAR No. 106 to part 119 certificate holders 
conducting operations under parts 125 and 135.
---------------------------------------------------------------------------

    Passengers may not use a POC on board an aircraft in part 121, 125, 
or 135 operations unless the FAA has identified the device they wish to 
use in SFAR No. 106 as approved for use in such operations. In 2005, 
SFAR No. 106 identified the first specific POC models approved for use 
on board aircraft. Although the agency intended SFAR No. 106 to serve 
as a special, temporary regulation, until POC performance standards 
(acceptance criteria) could be developed, it has remained in place for 
the last decade. See 70 FR at 40158-40159. During this time, the FAA 
has amended SFAR No. 106 seven times to identify additional POC models 
that may be used on board aircraft.\4\ This process is time-consuming 
for POC manufacturers because they must petition the FAA for rulemaking 
to add their POC model to the SFAR list if they want their POC to be 
approved for use on board aircraft. Together with a petition for 
rulemaking, manufacturers provide the FAA with documentation required 
for the FAA to make a determination whether the POC satisfies the 
requirements of the SFAR. This process is also time-consuming for the 
FAA because each time the FAA

[[Page 33102]]

approves a new POC for use on board aircraft, the FAA must complete 
rulemaking to add the newly approved POC model to SFAR No. 106.
---------------------------------------------------------------------------

    \4\ 71 FR 53956 (Sept. 12, 2006); 74 FR 2354 (Jan. 15, 2009); 75 
FR 742 (Jan. 6, 2010); 75 FR 39632 (July 12, 2010); 77 FR 4220 (Jan. 
27, 2012); 77 FR 63221 (Oct. 16, 2012); and 79 FR 6018 (Feb. 3, 
2014).
---------------------------------------------------------------------------

    Over the last ten years, FAA regulations and guidance regarding the 
use of POCs on aircraft, POC technology itself, and air carrier 
programs concerning the use of POCs on board their aircraft have 
rapidly evolved. The combined result of these initiatives is an 
increase in accessibility to air travel for many passengers who require 
oxygen therapy during flight. In keeping with the Department's ongoing 
commitment to increase accessibility to air travel, this final rule 
removes certain burdensome and time-consuming requirements that were 
put in place to ensure safety when POC technology was first introduced 
for use on board aircraft but are no longer necessary.

B. Summary of the NPRM

    On September 19, 2014, the FAA published an NPRM entitled 
``Acceptance Criteria for Portable Oxygen Concentrators Used On Board 
Aircraft'' in which the FAA proposed to replace SFAR No. 106 with 
acceptance criteria for POCs to be used by passengers on board aircraft 
in operations conducted under parts 121, 125 and 135. See 79 FR 56288. 
In the NPRM, the FAA proposed to replace the burdensome SFAR No. 106 
POC approval process with acceptance criteria based on SFAR No. 106 
requirements, and an additional requirement for POCs (carried and used 
on board aircraft) to bear a label indicating compliance with these 
acceptance criteria. The FAA proposed, however, that all SFAR-approved 
POCs would be excluded from the labeling requirement. Further, the 
proposed acceptance criteria and labeling requirements would only 
affect POCs intended for use on board aircraft. The FAA also proposed 
to eliminate several redundant operational requirements as well as 
paperwork requirements related to the physician's statement, which are 
not necessary for aviation safety.
    The comment period for this NPRM closed November 18, 2014.

C. Differences Between Notice of Proposed Rulemaking and Final Rule

    The final rule differs from the NPRM as follows:
     Replaces the proposed prescriptive requirement for radio 
frequency (RF) emissions evaluation with a performance-based standard 
that allows POC manufacturers to determine the means by which to assess 
whether its POC will radiate RF emissions that interfere with aircraft 
systems.
     Modifies verbiage for required label text.
     Retains the SFAR No. 106 prohibition on exit row seating 
for passengers using a POC and the SFAR No. 106 requirements pertaining 
to POC stowage.
     Amends 14 CFR part 382 to ensure that it is consistent 
with the FAA changes to POC carriage and use on aircraft.

D. General Overview of Comments

    The FAA received 33 comments on the NPRM. Commenters included 21 
individuals or anonymous commenters, the Airline Pilots Association 
(ALPA), Airlines for America (A4A), the Association of Flight 
Attendants (AFA), American Airlines, Delta Air Lines, Main Clinic 
Supply, Phillips Respironics, BPR Medical Limited, Oxygen to Go (OTG), 
the Mayo Clinic, and one commenter identified as the past president of 
the Airlines Medical Directors Association (AMDA).
    Although the FAA received general support for the NPRM from many 
commenters, some commenters recommended modifications to the proposed 
acceptance criteria, POC labeling requirements, and issues related to 
the identification of POCs that may be used on board aircraft. Other 
commenters did not support the elimination of certain SFAR No. 106 
provisions, including those pertaining to exit row seating for 
passengers using a POC, POC stowage, the physician's statement and 
passenger notification of intended POC use to the PIC and aircraft 
operator. Comments are addressed in the preamble discussion entitled, 
``Discussion of Public Comments and Final Rule.''
    The agency also received a request from OTG to reopen the comment 
period. The agency denied this request, because the agency satisfied 
the requirement of the Administrative Procedure Act to publish a 
general notice of a proposed rule in the Federal Register. See 5 U.S.C. 
553. Both the request to reopen the comment period and the agency's 
response to this request can be found in the docket for this 
rulemaking.

IV. Discussion of Public Comments and Final Rule

A. Applicability, Effective Dates and Compliance

    Currently, SFAR No. 106 applies only to those POC models intended 
for use on board aircraft in operations conducted under parts 121, 125, 
and 135 of title 14 of the Code of Federal Regulations. SFAR No. 106 
authorizes the use of specific POCs on board aircraft in operations 
conducted under parts 121, 125, or 135, if the conditions in the SFAR 
are satisfied.
    Consistent with SFAR No. 106 and the NPRM, this final rule applies 
only to those POC models intended for use on board aircraft in part 
121, 125, and 135 operations, and like SFAR No. 106 it does not create 
a requirement for operators to allow POC use. The Department's 
requirements for air carriers to allow the use of a POC on board an 
aircraft (designed to have a maximum capacity of more than 19 passenger 
seats) continue to be found in 14 CFR 382.133.
    In the NPRM, the agency proposed an effective date of 90 days after 
publication of the final rule in the Federal Register. Because the 
agency did not propose a separate compliance date, compliance would 
also be required 90 days after publication in the Federal Register.
    The agency seeks to allow compliance with this final rule as soon 
as possible. The agency recognizes, however, that affected aircraft 
operators may need to revise operating manuals and training programs, 
and expects these revisions to occur within the normal course of 
business. Accordingly, the SFAR will remain in place until August 22, 
2016 and compliance with the new rule will be permitted beginning on 
August 22, 2016 to allow a sufficient amount of time for operating 
manuals and training programs to be amended in the normal course of 
business.

B. Definition of Portable Oxygen Concentrator

    As proposed, this final rule defines ``portable oxygen 
concentrator'' in 14 CFR 1.1 as a medical device that separates oxygen 
from other gasses in ambient air and dispenses this concentrated oxygen 
to the user. This definition is consistent with the description of POCs 
in existing SFAR No. 106. The Sec.  1.1 definition of a POC added by 
this final rule is also consistent with Advisory Circular (AC) 120-95, 
Portable Oxygen Concentrators,\5\ as well as the device description 
used by POC manufacturers and the Food and Drug Administration (FDA) 
(the federal agency with primary regulatory authority over POCs for 
medical use).\6\
---------------------------------------------------------------------------

    \5\ AC 120-95B defines POCs as ``small, portable devices that 
work by separating oxygen from nitrogen and other gasses in the air 
and providing the user with oxygen at a concentration of more than 
90 percent . . .''
    \6\ Portable oxygen concentrators are a subset of portable 
oxygen generators defined by the FDA in 21 CFR 868.5440.

---------------------------------------------------------------------------

[[Page 33103]]

    By including this definition in Sec.  1.1, the FAA distinguishes 
POCs from portable oxygen generators and other medical devices that use 
compressed or liquid oxygen for medical oxygen therapy. Devices that 
use compressed or liquid oxygen must satisfy separate and more rigorous 
requirements to mitigate the risks they present.

C. Portable Oxygen Concentrator Acceptance Criteria

    Under SFAR No. 106, the FAA allows the carriage and use of specific 
POC models only if they are identified in the SFAR as approved for use 
on board aircraft. A POC may be identified in the SFAR only after the 
POC manufacturer has petitioned the FAA for rulemaking (to add the POC 
to the SFAR) and has demonstrated to the FAA that the specific POC 
model satisfies the requirements of the SFAR (i.e., the POC must be 
regulated by the FDA and the POC may not contain hazardous materials as 
determined by PHMSA).
    Each time the FAA approves a specific model of POC for use on board 
an aircraft, the agency must update the list of POCs in the SFAR 
through rulemaking. Additionally, the aircraft operator is responsible 
for determining that the POC does not cause interference with aircraft 
equipment. The FAA notes that in practice, aircraft operators use data 
supplied by POC manufacturers to the FAA to determine compliance with 
the requirement to ensure that a POC will not interfere with aircraft 
equipment.
    In the NPRM, the agency proposed to replace the SFAR No. 106 case-
by-case POC approval and rulemaking with requirements for POCs used on 
board aircraft to conform to specified acceptance criteria and to bear 
a label indicating that the device conforms to these criteria. The 
proposal further stated that POCs conforming to the acceptance criteria 
and bearing the appropriate label would be allowed on board aircraft 
without further rulemaking. The proposed acceptance criteria are 
summarized as follows:
     The POC manufacturer complies with all FDA requirements to 
legally market the device in the United States.
     The POC does not contain any hazardous materials subject 
to the HMR except as provided for in the exceptions for crewmembers and 
passengers in 49 CFR 175.10 for batteries used to power electronic 
devices when operator approval is not required.
     The maximum oxygen pressure generated by the POC must fall 
below the threshold for the definition of a compressed gas per the HMR.
     The POC radio frequency (RF) emissions must fall below the 
threshold permitted in RTCA standard 160G, Section 21, Category M.
    As addressed in more detail in this section of the preamble 
discussion, this final rule adopts the proposal with modifications to 
the RF emissions acceptance criterion and labeling requirement.
1. Food and Drug Administration Clearance or Approval
    POCs are medical devices regulated by the FDA in accordance with 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and 
title 21 of the CFR. Accordingly, manufacturers must obtain FDA 
clearance or approval prior to marketing a POC within the United 
States, and must comply with certain provisions in title 21 of the CFR, 
including but not limited to device registration and listing (21 CFR 
part 807), labeling (21 CFR part 801), adverse event reporting (21 CFR 
part 803), and good manufacturing practice requirements (21 CFR part 
820).
    SFAR No. 106 requires all POCs used on board aircraft in operations 
conducted under 14 CFR parts 121, 125, and 135 to be legally marketed 
as a POC, in compliance with FDA regulations. The purpose of this 
requirement is to ensure the device is actually what the manufacturer 
holds it out to be--a POC. To demonstrate compliance with this 
requirement, POC manufacturers submit evidence that the device has been 
cleared or approved by the FDA for marketing in the United States. The 
FAA accepts FDA premarket clearance in response to a 510(k) submission 
as evidence the device may be marketed in the United States.\7\
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    \7\ A 510(k) submission is a premarket submission made to FDA to 
demonstrate that the device to be marketed is at least as safe and 
effective, that is, substantially equivalent, to a legally marketed 
device (21 CFR 807.92(a)(3)) that is not subject to premarket 
approval. Submitters must compare their device to one or more 
similar legally marketed devices and make and support their 
substantial equivalency claims. If FDA makes a finding of 
substantial equivalence, the device is considered ``cleared.'' 
Additional information regarding the 510(k) process is available at 
www.fda.gov.
---------------------------------------------------------------------------

    In the NPRM, the agency proposed to continue to require any POC 
used on board an aircraft to be cleared or approved by the FDA for 
marketing in the United States prior to such use. However, given that 
FDA requirements for legal marketing of a POC in the United States 
already apply to POCs, independent of the SFAR, manufacturers would no 
longer need to submit evidence of this clearance or approval to the FAA 
to demonstrate compliance because it would be unnecessarily burdensome. 
Rather, the FAA proposed that POCs conforming to the proposed 
acceptance criteria, including the manufacturer's authority to legally 
market the device as a POC, would be identified by a label affixed to 
the device. This final rule adopts this proposed acceptance criterion 
without change.
2. Radio Frequency Emissions
    Sections 121.306, 125.204, and 135.144 place responsibility on the 
aircraft operator for determining which portable electronic devices 
(PED) may be safely used on its aircraft. Although the agency 
recognizes POCs as a type of PED, SFAR No. 106, includes a requirement 
for an aircraft operator to make a determination that the device does 
not cause interference with the electrical, navigation, or 
communication system of the aircraft in which the device will be used. 
The SFAR No. 106, section 3(a)(1) requirement pertaining to POC 
interference with aircraft equipment has the same effect as the 
requirements in Sec. Sec.  121.306, 125.204, and 135.144 pertaining to 
all PEDs.
    Each operator may establish a method to make a determination 
regarding the effects of PEDs on its aircraft's avionics systems. 
Historically, FAA guidance material (i.e., AC 91.21-1 and AC 120-95) 
identified one method of compliance with the SFAR and Sec. Sec.  
121.306, 125.204, and 135.144 by recommending the operator complete 
device-by-device evaluations of RF emissions.\8\ These evaluations 
involve comparing the device's RF emissions against the current RTCA 
DO-160 standards for installed airborne equipment. The FAA identified 
RTCA DO-160, Environmental Conditions and Test Procedures for Airborne 
Equipment, Section 21, Category M in guidance material for medical PEDs 
(including POCs intended for use on aircraft) because it established 
safe and conservative RF emissions limits for installed aircraft 
systems.
---------------------------------------------------------------------------

    \8\ The term EMC was used throughout the NPRM however, EMC is a 
broad term used for installed aircraft electrical systems. Where 
appropriate, the FAA has replaced the term EMC with RF emissions in 
this final rule preamble because when a device-by-device examination 
of a PED is conducted, the operator would consider the RF emissions 
of that device.
---------------------------------------------------------------------------

    Consistent with the historical device-by-device approach to RF 
emissions evaluation and agency guidance, it is current practice for 
POC manufacturers to provide the RTCA test compliance statements to the 
FAA.\9\ Although

[[Page 33104]]

section 3(a)(1) of SFAR No. 106 places the burden upon the aircraft 
operator to assess the impact of a POC on the aircraft, the FAA has 
accepted as proof of non-interference, RF emissions test qualification 
statements (provided by POC manufacturers) that show a specific POC 
does not exceed certain maximum RF emissions thresholds established by 
RTCA in DO-160, Environmental Conditions and Test Procedures for 
Airborne Equipment.\10\
---------------------------------------------------------------------------

    \9\ Currently, POC manufacturers provide the RTCA DO-160 Section 
21 test qualification statements to the FAA; the FAA then makes the 
RTCA test qualification statements available on its Web site for 
aircraft operators to use to demonstrate compliance with section 
3(a)(1) of the SFAR. The RTCA compliance statements may be viewed at 
http://www.faa.gov/about/initiatives/cabin_safety/portable_oxygen/.
    \10\ See AC 120-95, Portable Oxygen Concentrators. The FAA notes 
that while RTCA made significant changes to DO-160 since edition E 
was issued (December 9, 2004) and cited in agency guidance, Section 
21, Category M (applicable to POCs) was not revised in either DO-
160F or DO-160G.
---------------------------------------------------------------------------

    On October 31, 2013, the agency announced a new means of compliance 
with Sec. Sec.  121.306, 125.204, and 135.144, allowing operators to 
expand the use of passenger supplied and operated PEDs throughout all 
phases of flight, based on a determination by the operator that the 
aircraft systems themselves are PED tolerant (i.e., aircraft systems 
safety risk assessment showing the systems meet the requirements of 
RTCA DO-307 or another PED tolerance assessment). See Information for 
Operators (InFO) 13010 and InFO 13010SUP.\11\ The agency does not, 
however, require aircraft systems safety risk assessment of PED 
tolerance in accordance with InFO13010 and InFO 13010SUP. These 
assessment methods provide one means for airplane operators to 
demonstrate compliance with Sec. Sec.  121.306, 125.204, and 135.144 
and allow PEDs to be used on board aircraft. It is up to each aircraft 
operator to determine whether to expand the use of passenger supplied 
and operated PEDs via a determination of PED tolerance for certain 
aircraft types. The FAA estimates that eighty percent of part 121 air 
carriers (which comprise an estimated 98% of total part 121 passenger 
enplanements in 2013) and several of the largest part 135 air carriers 
have expanded PED use according to InFO 13010 and InFO 13010SUP. The 
remaining operators continue to rely on individual PED evaluations.
---------------------------------------------------------------------------

    \11\ All InFOs can be found at http://www.faa.gov/other_visit/aviation_industry/airline_operators/airline_safety/info/all_infos/.
---------------------------------------------------------------------------

    In the NPRM, the agency proposed to require the RF emissions for 
each POC intended for use on board aircraft to be tested in accordance 
with RTCA DO-160G, Section 21, Category M. The agency also proposed to 
add POCs to the list of devices excepted from the general PED non-
interference requirements in Sec. Sec.  121.306, 125.204, and 135.144 
to eliminate redundancy with the POC-specific non-interference 
requirements.
    This final rule retains a POC-specific non-interference 
requirement, modified to reflect a performance-based standard. The 
Agency recognizes that the majority of operators conducting part 121 
operations and several of the larger operators conducting part 135 
operations have already conducted aircraft systems safety risk 
assessments for PED tolerance in accordance with InFO 13010 and InFO 
13010SUP with results allowing for continuous use of PEDs from gate to 
gate. A determination that an aircraft is ``PED tolerant'' would make 
an independent assessment of RF emissions for any PED used on that 
aircraft unnecessary. Nevertheless, because of the need to ensure 
service for passengers who require oxygen therapy during air travel, 
the FAA believes it is necessary to maintain a regulatory structure to 
ensure that passengers may continue to use POCs on board aircraft even 
if the aircraft operator has not determined that the aircraft is ``PED 
tolerant.'' Therefore, consistent with the SFAR and the NPRM, this 
final rule retains a requirement to assess POC RF emissions as one of 
the POC acceptance criteria. (The agency notes that POCs previously 
approved by the FAA for use on aircraft in accordance with SFAR No. 106 
that demonstrated RF emissions below the maximum emissions threshold in 
DO-160G, Section 21, Category M would not need to be retested or 
reassessed by the operators prior to use on board aircraft because 
those prior assessments remain valid.)
    Delta Air Lines generally supported inclusion of RTCA DO-160, 
Environmental Conditions and Test Procedures for Airborne Equipment, 
Section 21, Category M, in the proposed acceptance criteria. 
Recognizing, however, that FDA may require RF emissions assessments 
that may test to standards that could be used to demonstrate compliance 
with the FAA prohibition on PEDs interference with aircraft systems, 
the agency sought comment on whether POC manufacturers complete RF 
emissions assessments in accordance with requirements by other federal 
agencies that could also be used to demonstrate compliance with the 
generally applicable PED requirements. The agency did not receive any 
comments related to this specific issue except as provided by Delta. 
After further review of the proposal and other RF emissions assessments 
that POC manufacturers may conduct (e.g., International Standards 
Organization (ISO) 7137 and the FDA recognized EMC standards for Class 
II medical devices in IEC 60601-1-2 edition 4.0), the agency has 
determined that the proposed requirement to use RTCA DO-160 as the only 
means by which to evaluate POC RF emissions was overly prescriptive.
    Historically, the FAA identified RTCA DO-160 Section 21, Category M 
in guidance material for medical portable electronic devices intended 
for use on board aircraft. Although POCs are not installed aircraft 
systems, the agency identified RTCA DO-160 as one method to demonstrate 
compliance with the PED non-interference requirement because RTCA DO-
160 establishes safe and conservative RF emissions limits for installed 
aircraft systems. The agency recognizes, however, that there are other 
methods to assess POC RF emissions and ensure that POC use will not 
cause interference with aircraft systems. Thus, this final rule 
includes a performance-based RF emissions acceptance criterion that 
allows POC manufacturers to determine how to assess whether their POC 
meets the aircraft system non-interference requirement before they 
affix a label to the device confirming that this criterion has been 
satisfied.
    Guidance material in AC 91.21-1C identifies examples of methods 
appropriate to ensure compliance with this requirement, including RTCA 
DO-160 and other industry EMC standards identified in the AC. The FAA 
emphasizes, however, that FDA approval or clearance to market a POC 
does not necessarily mean that the POC complies with the FAA's aircraft 
system non-interference requirement.
    In addition to Delta's comment, an individual commented that the 
POC manufacturer should include the electromagnetic interference test 
results on the POC label, eliminating the need for the air carrier to 
test the device. The agency clarifies that the purpose of the label is 
to identify those devices that conform to the FAA acceptance criteria. 
One of those criteria prohibits the POC from radiating radio frequency 
emissions that interfere with aircraft systems. Therefore, a device 
that bears the required label must also not radiate RF emissions such 
that it causes interference with aircraft systems. The POC manufacturer 
identifies devices that meet this and other criteria by affixing a 
label. In this way, the label indicates that the device will not 
radiate RF emissions that cause interference with aircraft systems and 
does not need to be retested by the aircraft operator. Thus, adding 
specific test results to the label would be unnecessary.

[[Page 33105]]

3. Hazardous Materials
    SFAR No. 106 allows passengers to use one of the specific POCs 
identified in the SFAR only if the POC does not contain hazardous 
materials as determined by PHMSA.\12\ See SFAR No. 106, section 2(1). 
The PHMSA determination required by SFAR No. 106 is one of the 
prerequisites that must be satisfied for the FAA to identify a POC in 
the SFAR. PHMSA issues this determination via a letter, at the request 
of the POC manufacturer and after PHMSA reviews manufacturer-supplied 
information regarding the POC.
---------------------------------------------------------------------------

    \12\ PHMSA is responsible for regulating and ensuring the safe 
and secure movement of hazardous materials by all modes of 
transportation, including aviation. To minimize threats to life, 
property or the environment due to hazardous materials related 
incidents, PHMSA's Office of Hazardous Materials Safety develops the 
HMR and standards for classifying, handling and packaging shipments 
of hazardous materials within the United States.
---------------------------------------------------------------------------

    POCs typically operate using either rechargeable batteries (usually 
lithium ion) or AC/DC electrical power via an external power cord. 
Although the POC units themselves are not considered hazardous 
materials, the lithium ion batteries typically used to power POCs are 
hazardous materials.\13\ See 49 CFR 172.101, Hazardous Materials Table. 
However, lithium ion batteries are conditionally excepted from certain 
requirements of the HMR (e.g. UN specification packaging and labeling) 
if they meet certain size limitations (100 Wh), package limitations, 
and comply with package marking and battery testing conditions of the 
HMR. See 49 CFR 173.185(c). These exceptions only apply when the POC 
units are transported as cargo.\14\
---------------------------------------------------------------------------

    \13\ 49 CFR 105.5 defines a hazardous material as a substance or 
material that the Secretary of Transportation has determined is 
capable of posing an unreasonable risk to health, safety, and 
property when transported in commerce, and has been designated as 
hazardous under section 5103 of Federal hazardous materials 
transportation law (49 U.S.C. 5103). The term includes hazardous 
substances, hazardous wastes, marine pollutants, elevated 
temperature materials, materials designated as hazardous in the 
Hazardous Materials Table (see 49 CFR 172.101), and materials that 
meet the defining criteria for hazard classes and divisions in part 
173 of subchapter C of this chapter.
    \14\ The PHMSA final rule, Hazardous Materials: Transportation 
of Lithium Batteries, recently removed 49 CFR 172.102(c)(1), Code/
Special Provision 188 and relocated it, in part to 173.185. See (79 
FR 46012, (August 6, 2014)). Currently, conditional exceptions for 
the transportation of small batteries as cargo can be found in 49 
CFR 173.185.
---------------------------------------------------------------------------

    Other HMR exceptions are provided in 49 CFR 175.10 that apply to 
POC units containing lithium ion batteries and associated spare 
batteries when carried on board aircraft by passengers and crewmembers. 
See 49 CFR 175.10(a)(18). In accordance with the exceptions in Sec.  
175.10(a)(18), passengers may bring an unlimited number of lithium ion 
batteries up to 100 Wh per battery to power their POC. Further, as a 
result of recent amendments, Sec.  175.10(a)(18) also authorizes the 
aircraft operator to allow passengers and crewmembers to carry on board 
as spares up to two batteries that are larger than 100 Wh but do not 
exceed 160 Wh only if certain criteria are met.\15\
---------------------------------------------------------------------------

    \15\ The revisions to the HMR exceptions for hazardous materials 
carried by aircraft passengers and crewmembers have resulted in a 
more conservative approach to the carriage of lithium ion batteries 
used to power PEDs than the previous requirements under 49 CFR 
175.10(a)(18)(2014 ed.). The current passenger and crewmember 
exceptions include a new requirement for approval by the air 
operator for the carriage of spare lithium ion batteries larger than 
100 Wh (approximately 8 grams) and have reduced the maximum Watt-
hours for spare lithium ion batteries from 300 Wh (approximately 25 
grams) to 160 Wh.
---------------------------------------------------------------------------

    The PHMSA determination letters required by the SFAR were limited 
to a determination regarding the HMR exceptions for a POC unit 
containing small lithium ion batteries (i.e., 100 Wh or 8g equivalent 
lithium content or less) for transportation as cargo as these are the 
exceptions that would apply to a manufacturer for transportation of a 
POC unit from the point of manufacture to the point of retail sale 
(although the size limits that distinguish a small lithium ion battery 
are the same for both the transportation of such batteries as cargo as 
well as for the passenger and crewmember exceptions). Existing PHMSA 
determinations for SFAR-approved POCs, however, do not include an 
assessment of each individual air carrier's policies pertaining to the 
allowance for larger batteries carried as spares.
    Consistent with the proposal in the NPRM, this final rule 
eliminates the SFAR No. 106 provision requiring a PHMSA determination 
that the POC does not contain hazardous materials. Instead, this final 
rule prohibits POCs used on board aircraft from containing hazardous 
materials subject to the HMR and references the HMR. Further, as noted 
above, POC users may carry an unlimited number of small spare lithium 
ion batteries (i.e., lithium ion batteries up to 100 Wh per battery) 
and up to two larger spare lithium ion batteries (i.e., batteries 
larger than 100 Wh but that do not exceed 160 Wh) in accordance with 
the exceptions for hazardous materials carried by aircraft passengers 
and crewmembers as is the case today.\16\ See 49 CFR 175.10(a)(18).
---------------------------------------------------------------------------

    \16\ The NPRM discussion regarding the SFAR limitation on 
hazardous materials took an overly conservative approach in the 
discussion pertaining to limitations on spare batteries carried by 
aircraft passengers and crewmembers.
---------------------------------------------------------------------------

    There is no safety basis for requiring the PHMSA ``no hazardous 
materials'' determination letter as a prerequisite to the use of a POC 
on board an aircraft. The HMR conditional exceptions provided in 
Sec. Sec.  175.10 and 173.185 apply to passengers, crew and the POC 
manufacturer, respectively, independent of the SFAR and this final 
rule. Further, the FAA does not require a PHMSA determination letter 
prior to passenger carriage of any other PED that may contain hazardous 
materials and POCs do not present any unique hazardous materials safety 
issues that would be mitigated by the requirement to obtain a PHMSA 
determination letter.
    Pursuant to 49 CFR 175.10(a)(18), passengers seeking to use a POC 
powered by a spare lithium ion battery that is over 100 Wh but less 
than 160 Wh are permitted to do so only with the approval of the 
operator. Given that the POC manufacturer cannot assume knowledge of 
and approval by each carrier regarding passenger and crewmember 
carriage of larger batteries, under this final rule, a POC manufacturer 
will be unable to label a POC as conforming to the final rule 
acceptance criteria if the POC has an installed lithium battery larger 
than 100 Wh. The final rule regulatory text clarifies the conditions 
under which POCs used on aircraft may contain batteries as a power 
source, including this limitation. Nonetheless, the passenger is 
ultimately responsible for compliance with the exceptions in Sec.  
175.10(a)(18) for spare batteries used to power a POC. For example, if 
a passenger wants to bring a spare lithium ion battery larger than 100 
Wh into the aircraft cabin to power a POC unit, the passenger is 
responsible for compliance with Sec.  175.10(a)(18) and reviewing 
airline acceptance policies.
    A manufacturer must only affix a label to a POC powered by an 
installed lithium ion battery that does not exceed 100 Wh because the 
manufacturer cannot ensure compliance with the 49 CFR 175.10(a)(18) 
condition under which a passenger may carry and use a battery that 
exceeds 100 Wh (i.e., approval by an aircraft operator with which a 
passenger may choose to fly). Adhering to this limitation will 
facilitate passenger carriage and use of POCs on board aircraft and 
ensure that there are no restrictions on the number of spare lithium 
ion batteries less than 100 Wh that can be carried on board the 
aircraft for full operability of the POC throughout the duration of the 
flight(s).

[[Page 33106]]

    Finally, although the FAA did not receive any comments regarding 
its proposal to remove the requirement for a PHMSA determination of no 
hazardous materials, the agency notes that an individual commented that 
the rules pertaining to lithium ion batteries must be updated, citing 
potential lithium ion battery hazards. The agency finds that revisions 
to the requirements applicable to passenger carriage of lithium ion 
batteries generally, are outside of the scope of the proposal because 
the proposal was narrowly tailored to address only POC carriage and use 
on aircraft. Further, PHMSA recently updated the requirements 
applicable to lithium ion batteries as part of a comprehensive 
rulemaking addressing the transportation of lithium batteries. See 79 
FR 46012 (August 6, 2014). As a result of this update, PHMSA 
regulations pertaining to lithium ion batteries are now harmonized with 
the International Civil Aviation Organization (ICAO) Technical 
Instructions for the Safe Transportation of Dangerous Goods by Air. 
Through the rulemaking process, PHMSA determined that harmonization 
with the ICAO Technical Instructions pertaining to lithium ion 
batteries used to power PEDs carried by passengers and crewmembers on 
aircraft provides an appropriate level of safety.
4. Maximum Oxygen Pressure
    As previously discussed, the SFAR No. 106 approval process requires 
POC manufacturers to obtain a PHMSA determination letter stating the 
POC device does not contain any hazardous materials. As part of this 
determination, PHMSA reviews information provided by the POC 
manufacturer regarding the oxygen pressure generated by a POC. If the 
POC generates oxygen pressure of 200 kPa gauge (29.0 psig/43.8 psia) or 
greater at 20 [deg]C (68 [deg]F), PHMSA would classify the POC as an 
article containing Hazard Class 2, Division 2.2 (non-flammable, non-
poisonous compressed gas) and the POC would be subject to the 
applicable HMR (49 CFR 173.115). However, a POC does not contain a 
compressed gas subject to the HMR if it generates an oxygen pressure 
below this threshold.
    In the NPRM, the agency proposed to include as a POC acceptance 
criterion a design limitation that would restrict POCs used on aircraft 
from generating a maximum oxygen pressure of 200 kPa gauge (29.0 psig/
43.8 psia) at 20 [deg]C (68 [deg]F), or more. The agency did not 
receive any comments on this proposal.
    The final rule includes the proposed POC design limitation as one 
of the POC acceptance criterion so as to ensure that newly manufactured 
POCs used on board aircraft will continue to incorporate this existing 
design limitation, thus ensuring that POCs will not present the hazards 
associated with devices that generate compressed oxygen. Accordingly, 
as proposed, the final rule establishes a maximum oxygen pressure 
allowed for POCs intended for use on board aircraft.
    A POC designed to generate a maximum oxygen pressure of 200 kPa 
gauge (29.0 psig/43.8 psia) at 20 [deg]C (68 [deg]F), or more, would 
constitute a hazardous material and thus be subject to the HMR. As 
such, it must not be labeled as meeting the standards for use on board 
aircraft.
    The agency has determined that inclusion of the requirement 
regarding oxygen pressurization does not overlap with 49 CFR 173.115 or 
the general prohibition on hazardous materials in this final rule, 
because it applies a design standard regarding the operation of the 
device. Further, it addresses concentrated oxygen that falls below the 
pressure threshold for the definition of compressed gasses subject to 
49 CFR 173.115.

D. Manufacturer Label

    The FAA does not currently require POCs to bear a label indicating 
FAA approval and compliance with the SFAR. Aircraft operators, 
crewmembers, and passengers must identify POCs approved for use on 
aircraft by reviewing the list of FAA-approved devices in the SFAR.
    In the NPRM, the FAA proposed to require POCs that satisfied the 
proposed acceptance criteria and were intended for use on aircraft to 
bear a label indicating that the device satisfies these criteria as a 
condition of its carriage and use on aircraft. However, the NPRM 
excluded SFAR-approved POCs from the labeling requirement.
    The FAA also proposed specific label attributes. The proposed label 
would be required to contain the following statement in red text: ``The 
manufacturer of this portable oxygen concentrator has determined this 
device conforms to all applicable FAA requirements for portable oxygen 
concentrator carriage and use on board aircraft.'' Finally, the agency 
proposed that the label would have to be applied in a manner to ensure 
it remains affixed for the life of the POC.
    Identification of POCs that satisfy acceptance criteria: The agency 
sought comment on the potential safety benefits and associated burdens 
of extending the proposed labeling requirement to all POC models 
currently identified in SFAR No. 106--existing and newly manufactured 
or just newly manufactured. Several commenters expressed concern 
regarding the exclusion of existing SFAR-approved POCs from the 
proposed POC labeling requirement. A4A, the Mayo Clinic and two 
individuals commented that the labeling requirement should extend to 
all POC models that may be used on board aircraft (those that are 
currently identified in SFAR No. 106 and those subsequently determined 
by their manufacturers to satisfy the proposed acceptance criteria).
    The individuals cited concern regarding potential confusion due to 
the two methods (i.e., review label and review list of SFAR-approved 
POCs) by which to identify POCs that may be used on aircraft as the 
basis for requiring all POCs to be labeled. The Mayo Clinic suggested 
that POC manufacturers could retrofit existing SFAR-approved devices 
through an inexpensive labeling method such as a sticker to resolve its 
concerns about potential health care provider confusion regarding which 
POCs may be used on aircraft.
    A4A noted that air carrier employees with responsibility for 
determining device acceptability should be able to make this 
determination efficiently, without having to refer to the CFR. A4A also 
stated that its comments on extending the labeling requirement to POCs 
approved under the SFAR should only be applied to newly manufactured 
POCs because retrofitting existing devices would be unreasonably 
burdensome.
    Philips Respironics objected to the extension of the labeling 
requirement to existing SFAR-approved POCs citing a significant burden 
and stating that passengers and aircraft operators would have 
sufficient means by which to identify POCs that may be used on board 
aircraft.
    The final rule retains the proposal to label POCs that have not 
been previously identified in SFAR No. 106 as approved for use on 
aircraft. SFAR-approved POCs will continue to be identified in 
Sec. Sec.  121.574, 125.219, and 135.91.
    The labeling requirement provides a simple, efficient and effective 
method by which to identify POCs that may be used on aircraft. In order 
to determine whether a POC may be used on an aircraft, a POC user or an 
aircraft operator need only examine the POC to determine whether it 
bears the label required by this final rule. As is the case today, for 
those POCs that do not bear the required label, a POC user and aircraft 
operator need only verify that the model is identified in the 
regulatory

[[Page 33107]]

text--the same process that is currently used to identify SFAR-approved 
POCs.
    The FAA maintains that it is not necessary or practical to require 
POC manufacturers to label POCs previously identified in SFAR No. 106 
as approved for use on board aircraft. POC models previously identified 
in SFAR No. 106 as approved for use on board aircraft have satisfied 
the SFAR No. 106 criteria and would also satisfy the proposed 
acceptance criteria. Further, the FAA expects that the use of SFAR-
approved POC models will lessen over time as those POCs age and their 
users replace those older models with newer ones, obviating the need to 
retrofit existing SFAR-approved POC models with a label.
    Although the agency appreciates the intent of the Mayo Clinic's 
comment regarding a ``bridging strategy'' by which adhesive stickers 
could be used to identify previously manufactured SFAR-approved POCs, a 
label used to satisfy the requirements of this final rule must be 
sufficiently durable so as to remain affixed to the POC for the life of 
the device and prevent the transfer to another type of oxygen 
dispensing device, such as a device that uses compressed oxygen.
    In comments related to the identification of SFAR-approved POCs, 
Delta Air Lines suggested that the list of SFAR-approved POCs provided 
in the proposed regulatory text was incomplete because it did not 
identify all devices that the FAA previously approved in accordance 
with the SFAR. The list of SFAR-approved POCs identified in the 
proposed and final rule regulatory text is identical to the list of 
POCs identified in SFAR No. 106. The agency stresses that SFAR approval 
is device-specific. For instance, while the SFAR identifies the SeQual 
Eclipse as approved for use on aircraft, the approval does not extend 
to any other variants of SeQual Eclipse models that were not 
specifically reviewed and approved for use on aircraft by the FAA and 
identified in the SFAR. Thus, only those specific POCs identified in 
the SFAR by manufacturer and model name are currently approved for use 
on aircraft. This final rule continues to identify those SFAR-approved 
devices as they appear in the SFAR, since those SFAR-approved POCs need 
not bear a label as a condition of their use on aircraft.
    Delta Air Lines further commented that the FAA should update the 
list of POCs approved under SFAR No. 106 with the names of all POCs 
currently under review by the FAA, in accordance with the SFAR prior to 
publication of the final rule. This final rule includes a list of all 
POCs approved by the FAA under the SFAR.
    FAA identification of POCs that satisfy acceptance criteria: 
Several commenters raised issues related to the FAA listing of POCs 
that satisfy the FAA acceptance criteria. A4A suggested that the FAA 
maintain a list of POC devices that meet the FAA's proposed acceptance 
criteria to keep industry and the public updated with compliant POCs. 
A4A further explained that the FAA should maintain a list of POCs that 
meet the acceptance criteria because of challenges for aircraft 
operators in determining whether a POC satisfies the acceptance 
criteria, especially in the instance in which a manufacturer 
incorrectly labels a device.
    The FAA disagrees with A4A's comment that unless the FAA maintains 
a list of POCs that satisfy the acceptance criteria, POC identification 
will be unnecessarily burdensome. The process of examining a POC to 
determine whether it bears a label is less burdensome than the existing 
process of examining a POC to identify the model name and then 
verifying that the model is identified in the SFAR. In either case, a 
crewmember of an aircraft operator must examine the POC.
    A4A also recommended that the FAA maintain a list of POCs that are 
labeled as conforming to FAA requirements for POC use on board aircraft 
to track POCs that are subsequently determined to be non-compliant. 
However, the FAA has alternate appropriate methods by which to notify 
aircraft operators in the unlikely event that a POC intended for use on 
aircraft is no longer compliant with FAA requirements. For example, the 
FAA can provide such notice through a Safety Alert for Operators (SAFO) 
or an InFO, as appropriate. All SAFOs and InFOs are made available on 
the agency's Web site.
    Label attributes: The final rule requires the label to contain the 
following statement in red text: ``The manufacturer of this POC has 
determined this device conforms to all applicable FAA requirements for 
POC carriage and use on board aircraft.'' The purpose of this verbiage 
is to facilitate identification of devices that conform to the 
acceptance criteria and the red color is expected to draw attention to 
the text.
    Consistent with the NPRM, this final rule also requires a labeling 
method that ensures the label remains affixed to the POC for the life 
of the device. The purpose of this requirement is to ensure the label 
is durable and cannot be transferred to another type of oxygen 
dispensing device (such as a device that uses compressed oxygen).
    Several commenters suggested changes related to the proposed label 
that would standardize label features in addition to the proposed 
required text and color. A4A commented that the FAA should mandate 
additional specific label attributes so that labels are identical and 
can be easily recognized by gate agents.
    Philips Respironics commented that the proposed label text is 
overly burdensome due to the length of the text and the color 
requirement. This commenter proposed an alternate label that states, 
``Complies with FAA requirements for airline use'' and includes an 
airplane graphic. Together with this alternate label, Philips 
Respironics suggested a POC manual update to further describe the 
label. Main Clinic Supply supported the label example included in the 
Philips Respironics comment.
    The agency has considered comments regarding additional standard 
label features but has determined that it is unnecessary to require 
standardized features beyond the proposed label verbiage and text 
color. The use of red text is sufficient to draw attention to the label 
identifying a POC that may be carried and used on board an aircraft.
    The specific label language proposed in the NPRM and included in 
this final rule is necessary to facilitate the identification of the 
device as a POC that satisfies the acceptance criteria for POCs 
intended for use on board aircraft. A more generic or general label 
such as the label proposed by Philips Respironics and supported by Main 
Clinic Supply would not effectively serve this purpose. The agency is 
aware that manufacturers of some POC models approved under SFAR No. 106 
may have voluntarily applied labels similar to the label recommended by 
Philips Respironics and Main Clinic Supply. The FAA determined, 
however, that the label proposed by commenters could hinder a 
passenger's ability to use an SFAR-approved POC by introducing 
confusion into the POC identification process due to multiple similar 
labels (i.e., labels currently affixed to some SFAR-approved POCs and 
the label proposed by commenters). The only label that may be used to 
determine compliance with this final rule and to ascertain whether a 
POC may be used on board an aircraft is a label that exhibits the 
verbiage and color criteria specifically provided in this final rule.
    Further, the FAA analyzed the costs associated with the NPRM 
labeling requirement and estimated that the requirement would not 
result in a significant burden. Commenters did not challenge the FAA 
assumptions that

[[Page 33108]]

provide a basis for the estimate of the labeling costs in the NPRM. 
Given that the final rule label verbiage includes only minimal changes 
from the proposed label verbiage, the final rule is not expected to 
result in a significant burden to POC manufacturers.
    Additionally, the FAA notes that, although the agency supports the 
Philips Respironics comment regarding POC manufacturer manual updates 
to describe the label, it would reach beyond the scope of the proposal 
for the FAA to require POC manufacturers to include additional 
information in the POC user manual. However, the FAA encourages 
manufacturers to inform POC users of issues pertaining to POC use on 
board aircraft.
    Finally, A4A commented that if the POC acceptance criteria were to 
change, the FAA should change the label requirements to distinguish 
those POCs that meet the new acceptance criteria from those that do not 
meet the new acceptance criteria. The agency will consider this comment 
if it finds that a future rulemaking is required to revise POC 
acceptance criteria.

E. Manufacturer Determination of Conformance to Acceptance Criteria

    Two individuals questioned whether the FAA should rely on POC 
manufacturers to determine that a POC is safe and fits within the 
regulatory requirements. One of the individual commenters recommended 
that POC manufacturers demonstrate compliance with the acceptance 
criteria to the FAA before labeling the device as satisfying those 
criteria. In a related comment, Delta Airlines recommended that the FAA 
should require POC manufacturers to provide airlines with the data that 
demonstrates compliance with the acceptance criteria at the airlines' 
request.
    The FAA employs a range of oversight approaches throughout title 
14. The process in this final rule that allows manufacturers to self-
certify that their POC conforms to all applicable requirements for use 
on board aircraft and to affix a label that can be reviewed by aircraft 
operators and passengers is consistent with other existing agency 
oversight practices. For example, child restraint system (CRS) 
manufacturers self-certify (via a label) that their CRS meets all 
applicable performance criteria and is approved for use on aircraft. In 
another example, the Technical Standard Order (TSO) program involves a 
process where a manufacturer makes statements of conformance to the 
standards in a particular TSO for many different types of articles used 
on aircraft.
    In the case of POCs, the FAA has determined that the devices 
present minimal risk to aircraft operations. Additionally, the proposed 
and final rule acceptance criteria for POCs leverage existing 
regulatory requirements that are applicable to POCs and relevant to the 
safe carriage and use of POCs, including the use of POCs on board 
aircraft. The purpose of the label applied by POC manufacturers is to 
facilitate aircraft operator and passenger identification of devices 
that meet the acceptance criteria required for POCs intended for use on 
board aircraft.
    Accordingly, a case-by-case POC approval process is unnecessarily 
burdensome to mitigate any potential risk presented by POCs. An 
aircraft operator seeking specific information regarding a POC may 
reach out to a POC manufacturer without FAA regulation. The agency also 
notes that POC user manuals and POC manufacturer Web sites also provide 
information pertaining to the attributes and functions of the 
associated POCs.

F. Prohibition on Smoking or Open Flame

    SFAR No. 106 prohibits smoking or open flame within 10 feet of any 
person using a POC. In the NPRM, the agency proposed to retain this 
restriction. The agency did not receive any comments on the proposal to 
retain the SFAR prohibition on smoking or open flame near a person 
using a POC. Accordingly, the final rule includes this proposal without 
change.
    Although the risk posed by concentrated oxygen is minimal when 
generated at a pressure below that which would trigger the application 
of the HMR, given the unique environment of an aircraft, the agency has 
determined that it is reasonable to provide an additional margin of 
safety by prohibiting smoking or open flame in the vicinity of a person 
using a POC. Accordingly, the agency will maintain the existing 
prohibition on smoking or open flame within 10 feet of a person using a 
POC by extending the smoking prohibitions in existing Sec. Sec.  
121.574, 125.219, and 135.91 to POCs and adding language to 
specifically prohibit an open flame.
    The smoking prohibition in existing Sec. Sec.  121.574, 125.219, 
and 135.91 effectively results in a prohibition on an open flame. 
However, given the risks created by smoking near a person using medical 
oxygen and the storage of such oxygen, in this final rule the agency 
will ensure that this restriction is clear by explicitly prohibiting an 
open flame in addition to smoking.
    Finally, as proposed, this final rule amends the regulatory text in 
Sec.  125.219(b) to prohibit smoking not only within 10 feet of where 
medical oxygen is being used but also within 10 feet of where it is 
stored. This amendment is consistent with the preamble for the final 
rule issuing Sec.  125.219 as well as the prohibitions on smoking 
within 10 feet of the location of medical oxygen storage or use in 
Sec. Sec.  121.574 and 135.91. See 45 FR 67214, 67230 (October 9, 
1980).

G. Operational Requirements

1. Exit Seats
    Section 3(a)(4) of SFAR No. 106 prohibits a person using a POC from 
sitting in an exit row. The FAA proposed to eliminate this SFAR No. 106 
provision from the final rule.
    AFA and an anonymous commenter recommended that the FAA retain the 
provision in SFAR No. 106 prohibiting a passenger from using a POC 
while sitting in an exit row. Both commenters noted that POC tubing 
would create obstacles in the exit row. AFA stated that generally, 
certificate holders should have the responsibility for determining the 
suitability of passengers who occupy exit seats; however, they 
maintained that an explicit restriction on exit row seating would 
eliminate any ambiguity about a POC user's ability to assist in an 
emergency.
    The FAA agrees with commenters in that a passenger's ability to 
perform exit row functions could be impeded by the presence of the 
device, possibly creating a tripping hazard and an obstacle to egress. 
Thus, although Sec. Sec.  121.585 and 135.129 require the certificate 
holder to determine the suitability for passengers it permits to occupy 
exit seats, the final rule retains the SFAR No. 106 provision 
prohibiting passengers using a POC from sitting in exit seats to 
eliminate any potential ambiguity pertaining to whether a passenger 
using a POC may occupy an exit seat.
2. Stowage of Portable Oxygen Concentrators
    SFAR No. 106, section 3(a)(3) states that during movement on the 
surface, takeoff, and landing, the POC must either be stowed under the 
seat in front of the user, or in another approved stowage location, so 
as not to block the aisle way or entryway into a row. Further, SFAR No. 
106 limits the location of POC use to a seat location that does not 
restrict any passenger's access to, or use of, any required emergency 
or regular exit, or the aisle(s) in the passenger compartment. However, 
FAA regulations in parts 121,

[[Page 33109]]

125, and 135, also address the stowage of carry-on items and carriage 
of cargo in the passenger cabin to ensure an appropriate stowage 
location and that emergency exit row access is not hindered by carry-on 
items or cargo. See Sec. Sec.  121.285, 121.589, 125.183, and 135.87. 
Thus, the FAA proposed to eliminate the POC stowage requirement in SFAR 
No. 106.
    AFA recommended that the FAA retain the requirements in section 
3(a)(3) of SFAR No. 106 that pertain to POC stowage. AFA stated that, 
for consistency with existing medical oxygen rules that require 
certificate-holder provided equipment to be ``appropriately secured,'' 
(Sec. Sec.  121.574, 125.219 and 135.91) the final rule regulatory text 
should continue to address stowage requirements for passengers' POCs. 
The commenter stated that some operators might conclude that only 
devices furnished by the certificate holder are required to be secured 
or stowed unless POC stowage is specifically addressed.
    Although the FAA continues to expect that POC stowage will be 
addressed in an operator's carry-on baggage program in accordance with 
the requirements of 14 CFR 121.285, 121.589, 125.183 and 135.87, the 
FAA agrees with the commenter that retaining and specifically 
addressing POC stowage (and thereby reinforcing POC stowage 
requirements) could increase the likelihood of safe stowage of 
passenger supplied POCs. Accordingly, as found in SFAR No. 106, this 
final rule includes a specific requirement for POCs to be stowed during 
movement on the surface, takeoff, and landing.
    Notably, the user manuals for 18 of the POC models currently 
approved under SFAR No. 106 specify oxygen tube length. Every manual 
specifying oxygen tube length indicates the associated POC has at least 
7 feet of tubing, which is long enough to allow a passenger to use a 
device stowed under a seat.

H. Discussion of Special Federal Aviation Regulation No. 106 
Requirements Excluded From Final Rule

    The FAA has determined that many of the requirements included in 
SFAR No. 106 are overly prescriptive or redundant with existing rules 
and are therefore not necessary. Accordingly, the FAA has not retained 
them in this final rule. A discussion of the SFAR No. 106 requirements 
excluded from this final rule follows.
1. Special Federal Aviation Regulation No. 106 Requirements Addressed 
in Existing Regulations
a. Passenger Movement About the Cabin While Using a Portable Oxygen 
Concentrator
    SFAR No. 106, section 3(a)(6) states that when the PIC turns off 
the ``Fasten Seat Belt Sign,'' or otherwise grants permission to move 
about the passenger cabin, passengers may continue to use their POC 
while moving about the cabin. The agency included this provision in 
SFAR No. 106 in response to commenters' concerns that the agency should 
allow passengers using a POC to operate the device for the entirety of 
the flight, if necessary. Therefore, in the final rule implementing 
SFAR No. 106, the agency stated that passengers are allowed to use a 
POC for the duration of the flight, including during movement on the 
surface, takeoff, and landing. The agency also stated that once 
passengers were allowed to move about the cabin of the aircraft, they 
would be allowed to bring the POC with them. See 70 FR at 40159.
    In the NPRM, the agency proposed to remove section 3(a)(6) of the 
SFAR. Section 3(a)(6) of the SFAR is unnecessary because there are no 
regulations directed at passengers using a POC that would limit their 
movement about the cabin when passenger movement is permitted by the 
PIC. Accordingly, as proposed in the NPRM, the final rule does not 
include a provision similar to section 3(a)(6) of the SFAR. The agency 
did not receive any comments on the proposed elimination of this SFAR 
No. 106 provision.
b. Protection of Batteries From Short Circuit
    SFAR No. 106, section 3(b)(6) requires passengers to ensure all POC 
batteries carried on board the aircraft in carry-on baggage are 
protected from short circuit and packaged in a manner that protects 
them from physical damage. Batteries protected from short circuit 
include: (1) Those designed with recessed battery terminals; or (2) 
those packaged so that the battery terminals do not contact metal 
objects (including the battery terminals of other batteries). 
Additionally, when a passenger carries a POC on board an aircraft as 
carry-on baggage, and does not intend to use the POC during the flight, 
the passenger must remove the battery and package it separately unless 
the POC contains at least two effective protective features to prevent 
accidental operation and potential overheating of the battery within 
the POC during transport.
    The FAA proposed to eliminate the SFAR No. 106 provisions 
applicable to spare batteries carried by passengers on board aircraft 
for use in POCs because they are unnecessary. The portion of SFAR No. 
106, section 3(b)(6) addressing spare batteries is redundant with PHMSA 
regulations applicable to spare lithium batteries carried by passengers 
on board aircraft. See 49 CFR 175.10(a)(18).
    A4A commented that the FAA should strongly recommend that POC 
manufacturers include a carrying case for spare lithium battery packs 
to ensure battery isolation and insulation. The FAA supports any action 
a POC manufacturer takes to facilitate passenger, crewmember, and 
operator compliance with the requirements for the safe carriage of 
lithium ion batteries on board aircraft, including spares. However, the 
agency does not agree that the commenter's recommendation is necessary 
because PHMSA has identified the requirements for safe carriage of 
spare lithium batteries used to power all PEDs carried by aircraft 
passengers or crewmembers. See 49 CFR 175.10(a)(18).
    PHMSA requires all lithium batteries to be of a type proven to meet 
the requirements of each test, including Test T.7 (Overcharge), in Part 
III, Sub-section 38.3 of the UN Manual of Tests and Criteria. See 49 
CFR 173.185 and 175.10(a)(18). Additionally, PHMSA requires spare 
lithium batteries carried on board aircraft to be carried in the cabin 
in carry-on baggage and individually protected from short circuit to 
mitigate the risk of a fire during flight (e.g., by placement in 
original retail packaging, by otherwise insulating terminals by taping 
over exposed terminals, or by placing each battery in a separate 
plastic bag or protective pouch). See 49 CFR 175.10(a)(18).
    The agency notes that the SFAR diverges from PHMSA requirements 
pertaining to installed batteries. See 49 CFR 175.10(a)(18). The SFAR 
requires a passenger to remove a POC battery if the device does not 
have at least two features that prevent accidental operation. The HMR, 
however, do not require an installed battery to be removed from any 
PED, which would include a POC that is not in use. See 49 CFR 
175.10(a)(18).
    Based on the analysis of currently approved POCs and PHMSA 
requirements applicable to lithium ion batteries carried by passengers 
and crewmembers to power PEDs, an independent FAA requirement for two 
protective features as a prerequisite to leaving an installed battery 
in a POC is unnecessary. The agency reviewed the

[[Page 33110]]

24 SFAR-approved POCs and determined those POCs all have at least two 
design features preventing inadvertent or accidental operation. Thus, 
batteries may remain in SFAR-approved POCs while those POCs are not in 
use.
    In addition, current PHMSA regulations address the safe 
transportation of lithium ion batteries as well as passenger carriage 
of lithium ion batteries. Lithium batteries must be of a type proven to 
meet the requirements of each test, including Test T.7 (Overcharge), in 
Section 38.3 of the UN Manual of Tests and Criteria. See 49 CFR 
173.185.
    Based on the analysis of SFAR-approved POCs and the applicable HMR, 
an independent FAA requirement for two protective features as a 
prerequisite to leaving an installed battery in a POC is unnecessary. 
All POCs currently used on board aircraft are equipped with two 
protective features and all lithium ion batteries must be designed to 
satisfy the overcharge test protection, therefore, the risk of a fire 
originating from the battery is minimal. Accordingly, this final rule 
eliminates SFAR No. 106, section 3(b)(6) from title 14.
2. Special Federal Aviation Regulation No. 106 Requirements Excluded in 
Their Entirety
a. Physician Statement and Pilot in Command and Aircraft Operator 
Notification Requirements
    Section 3(b)(3) of SFAR No. 106 requires passengers intending to 
use a POC to have a written statement signed by a licensed physician, 
and kept in that person's possession that states whether the user of 
the device has the physical and cognitive ability to see, hear, and 
understand the device's aural and visual cautions and warnings and is 
able, without assistance, to take the appropriate action in response to 
those cautions and warnings; states whether or not oxygen use is 
medically necessary for all or a portion of the duration of the trip; 
and specifies the maximum oxygen flow rate corresponding to the 
pressure in the cabin of the aircraft under normal operating 
conditions.
    Section 3(b)(3) of SFAR No. 106 further requires a passenger to 
inform the aircraft operator that he or she intends to use a POC on 
board the aircraft and to allow the crew of the aircraft to review the 
contents of the physician's statement. Similarly, section 3(a)(5) of 
SFAR No. 106 requires PIC notification whenever a passenger brings and 
intends to use a POC on board the aircraft. The PIC must be apprised of 
the physician's written statement required by section 3(b)(3) of the 
SFAR including the nature of the passenger's oxygen needs and the 
passenger's ability to understand operational and warning information 
presented by the POC.
    As proposed, the FAA will no longer require POC-using passengers to 
present a physician's statement, to notify the aircraft operator and 
PIC of their intended POC use, to inform the PIC of the contents of 
their physician's statement, and, to allow the crew of the aircraft to 
review the content of their physician's statement. The FAA received 
comments related to these proposals from two POC suppliers (Main Clinic 
Supply and OTG), the Mayo Clinic, AMDA, and a number of individuals. 
The FAA has reviewed and considered all comments regarding the 
physician's statement and pre-flight notification of POC use.
    Physician statement: Two individual commenters supported the FAA 
proposal to relieve passengers from obtaining a physician's statement 
as a condition of their use of a POC on aircraft. Main Clinic Supply 
supported the proposal to relieve passengers from having to provide a 
physician statement commenting that the current requirement for a 
written, signed physician statement for every flight is not practical, 
causes many delays, and may inhibit POC users' air travel. Main Clinic 
Supply also stated that physicians and their staff do not have the 
resources to provide POC training to patients, explaining that the POC 
user must be responsible for reading the POC operating manual and 
asking the necessary questions of their oxygen provider.
    OTG, AMDA, the Mayo Clinic, and some individual commenters did not 
support the FAA proposal to remove the requirement for passengers to 
carry a physician's statement as a condition of POC use on aircraft. 
OTG, AMDA, and some individual commenters indicated that removal of the 
existing physician's statement and notification requirements would 
cause diversions, impact passenger travel, and be costly to the 
airlines. Generally, commenters asserted that the FAA should retain the 
SFAR No. 106 requirement for a physician's statement because it ensures 
that passengers seeking to use a POC on board an aircraft have 
consulted with a physician regarding POC use in the aircraft 
environment prior to travel. Commenters also challenged statements in 
the NPRM regarding POC function in the aircraft environment.
    The Mayo Clinic commented that it is particularly important for 
individuals who have ``poor respiratory reserve'' to have health care 
provider oversight. In this regard, the physician statement is a form 
of ``safety net'' to trigger these conversations between passengers and 
their treating providers. It is critical that these conversations occur 
prior to air travel since decompensation on board a flight may require 
urgent response. OTG and some individual commenters commented that 
additional interaction between a POC user and his or her physician is 
necessary to educate passengers with limited experience with POC use; 
to address discrepancies between the POC prescription and the POC 
provided by a supplier; and to help the POC user account for the 
effects of cabin pressurization on POC use.
    OTG indicated in its comments that the flow rate on a POC 
prescription may not be appropriate for cabin altitudes. In a related 
comment, the Mayo Clinic stated, ``[A]lthough a physician or other 
health care provider with prescribing privileges writes prescriptions 
for devices to deliver supplemental oxygen, many providers are 
unfamiliar with the physiology of altitude.'' OTG also commented that, 
in its experience, a large percentage of physicians and the majority of 
passengers incorrectly assume aircraft cabins are pressurized to sea 
level. OTG stated that based on this assumption, physicians do not 
provide their POC-using patients with recommendations regarding oxygen 
flow adjustments during air travel when most will require higher flow 
rates in a pressurized cabin than at sea level. OTG further asserted 
that the POC will not produce the same percentage of oxygen in a 
pressurized cabin and the oxygen saturation level of the passenger will 
be decreased due to the normal physics of the partial pressure of the 
oxygen on pulmonary tissue.
    The agency clarifies that SFAR No. 106 does not specifically 
require a passenger to obtain a new physician's statement prior to each 
flight. See 70 FR at 40161. Also, SFAR No. 106 does not require the 
physician's statement to account for the duration of a specific flight, 
variables that may arise in flight conditions, changes in a patient's 
oxygen needs over time, or variables that may arise in connection with 
an individual's medical condition. Further, commenters noted that not 
all physicians may be familiar with effects of cabin pressure or 
realize that aircraft are not pressurized to sea level. For these 
reasons, while the SFAR No. 106 requirement for a physician's statement 
may result in a one-time conversation about a passenger's POC use on an

[[Page 33111]]

aircraft at some point in time, the requirement to obtain such a 
statement may not provide the POC education and ``safety net'' expected 
by commenters.
    The FAA appreciates and concurs with comments regarding the need 
for vigilance and understanding of all nuances associated with POC use 
on aircraft. The agency appreciates and has considered commenters' 
concerns about the physiology of flight and its relationship to POC 
use. The FAA emphasizes that pre-flight preparation on the part of the 
POC-using passenger, working closely with an appropriate medical 
professional, should always occur when traveling with any medical 
device. While preparation may differ for each POC-using passenger, 
depending on the aircraft and kind of operation included in his or her 
travel plans, passengers may wish to consider such factors with their 
medical professional such as past experience using a POC, cabin 
pressurization, layovers, length of flight, and pre-flight activities 
that could lead to compromised lung function in flight. The FAA also 
encourages POC-using passengers to carry documentation regarding the 
device they intend to use including any pertinent documentation 
provided to them by a medical professional or any medical certificate 
required by the carriers in accordance with the Department's air travel 
disability regulation in 14 CFR 382.23.
    However, the FAA believes that retaining the SFAR No. 106 
requirement for a physician's statement as evidence of this medical 
consultation is not the most effective education tool in those 
circumstances in which the physiology of altitude could come to bear on 
POC use and should not be relied on as the means to address the range 
of variables potentially affecting passengers using POCs during flight. 
The FAA has determined that it is more effective to provide reasoned 
guidance and public outreach to educate POC users and physicians 
regarding considerations pertaining to POC use during flight in a 
pressurized cabin. The FAA provides information on passenger health and 
safety on its Web site (e.g., http://www.faa.gov/passengers/fly_safe/health/comprehensive/). The FAA has also updated the POC-specific 
guidance in AC-120-95B and expects to update its Web site with 
information a passenger may want to consider when traveling with a POC.
    As is the case with in flight use of any medical device, passengers 
who need to use a POC on board an aircraft should always consult with 
an appropriate medical professional and their chosen air carrier before 
traveling. Doing so ensures that passengers are prepared for each 
flight they take, particularly if, as one commenter noted a 
prescription may not address adjustments that may be appropriate for 
POC use on a pressurized aircraft. However, the FAA has determined that 
the specific, regulatory requirement set forth in the SFAR requiring 
POC-using passengers to obtain, present, and allow for scrutiny of a 
physician's statement, as a condition of admission on board an aircraft 
is particularly burdensome for passengers seeking to use a POC during 
air travel.
    The FAA intended for the SFAR to provide a framework, not 
previously available, under which persons with a need to use personal 
oxygen therapy could use their own devices during a flight, thereby 
increasing accessibility to air travel for POC-using passengers. With 
more than 10 years of experience with POC technology and POC use on 
aircraft, the FAA has determined that the requirement for a passenger 
to provide for aircraft operator, crewmember, and PIC scrutiny, a 
physician statement pertaining to a medical device that the passenger 
is solely responsible for during the flight, was an overly conservative 
addition to the POC oversight framework. Removing the requirement to 
obtain a physician's statement affects a paperwork requirement; it does 
not affect passengers' responsibility to be prepared for travel. The 
purpose of this final rule is to continue to provide POC-using 
passengers access to air travel, while addressing device safety for 
aircraft use; it is not intended (and is not within FAA authority) to 
set forth a standard of medical care for POC-using passengers. Further, 
the FAA does not require passengers who supply any other medical device 
for their own use during a flight to provide a physician's statement as 
a condition of device usage during flight.
    Additionally, as mentioned previously, existing DOT requirements in 
14 CFR part 382 continue to include a provision to further mitigate the 
possibility of medical events including those that could result in a 
diversion. Sections 382.23(b) and 382.133 authorize carriers to require 
a passenger needing medical oxygen inflight to provide a medical 
certificate to ensure the passenger can complete the flight safely 
without requiring extraordinary medical assistance during the flight.
    AMDA indicated that the FAA should conduct additional research 
regarding the potential impact of the elimination of the physician's 
statement. The FAA has determined that additional research is not 
necessary at this time because the FAA expects physician consultation 
to continue as appropriate for the use of any medical device, and that 
pre-flight notice of POC use on the aircraft will continue in light of 
the requirement for each aircraft operator to determine whether the POC 
bears the label required for use on board aircraft.
    The purpose of the SFAR and the FAA's action in this final rule is 
to address continued use of POCs on aircraft without compromising the 
safety of the aircraft operation. The agency has determined the SFAR 
No. 106 requirement for a physician statement creates an unnecessary 
burden that may not ultimately serve the purpose contemplated by 
commenters. The FAA emphasizes that removing the requirement to obtain 
a physician's statement affects a paperwork requirement; it does not 
affect passengers' responsibility to be prepared for travel, including 
obtaining a medical certificate if the carrier chooses to require one 
as allowed by 14 CFR 382.23 and 382.133. All passengers using a medical 
device in an aircraft environment are responsible for preparing for the 
flight such that they can ensure that the device will function properly 
during the flight and provide the requisite medical support. Therefore, 
as proposed, this final rule discontinues the SFAR requirement for a 
physician statement.
    PIC and aircraft operator notification: OTG, AMDA, and several 
individual commenters did not support the proposal to remove the 
requirements for pre-flight notification of the aircraft operator and 
PIC regarding POC use on board an aircraft. These commenters, however, 
did not provide specific reasons for maintaining the notification 
requirements. One anonymous commenter asserted that advance notice that 
a passenger expects to use a POC would allow crewmembers to prioritize 
actions during multiple cabin events.
    Under this final rule, the PIC and aircraft operator (through a 
crewmember or gate agent) will continue to receive notice of a 
passenger's POC use during flight as the operator determines during 
pre-boarding procedures whether the device has the label now required 
for POC use on the aircraft. Accordingly, as proposed, the FAA 
discontinues the specific requirement for passengers to notify the 
aircraft operator and PIC of intended POC use during a flight because a 
specific notification requirement is unnecessary.
    OTG also stated that several POC-related incidents have occurred in 
flight but did not provide any specific examples, information, or data 
regarding such diversions or incidents. OTG

[[Page 33112]]

further stated that the FAA should have contacted ``air-to-ground'' 
medical service providers to document POC-related incidents.
    The agency reviewed air carrier safety data collected from 2005 
through 2014--a period of nearly 10 years--and found no instances of 
POC malfunction during flight or any related medical incident or 
diversion. This review included information from several accident, 
incident, and voluntary reporting databases.\17\ Further, no ``air-to-
ground'' medical service providers contacted the agency regarding any 
POC incidents, nor did they provide any comments to the agency in this 
regard during the open comment period.
---------------------------------------------------------------------------

    \17\ Voluntary Disclosure Reporting Program (VDRP), Service 
Difficulty Reporting System (SDRS), National Transportation Safety 
Board Aviation Accident and Incident Data Systems (NTSB), National 
Aeronautics and Space Administration Aviation Safety Reporting 
System (ASRS) and FAA Accident/Incident Data System (AIDS).
---------------------------------------------------------------------------

    Although the FAA is removing the requirement for pre-flight 
notification, under existing DOT requirements in 14 CFR part 382, 
carriers continue to be permitted to require individuals who wish to 
use a POC on aircraft to contact them 48 hours before scheduled 
departure. Carriers are permitted to require this pre-flight 
notification so they can ensure that a passenger knows the expected 
maximum flight duration and can use this information in determining the 
number of spare batteries that he or she will need to power the POC 
during the flight.
b. Portable Oxygen Concentrator Alarms
    SFAR No. 106, section 3(b)(1) requires a passenger using a POC on 
board an aircraft to be capable of hearing the unit's alarms and seeing 
alarm light indicators. SFAR No. 106 also requires passengers using a 
POC to have the cognitive ability to take appropriate action in 
response to the various POC caution alarms, warning alarms, and alarm 
light indicators, or travel with someone capable of performing those 
functions.
    In the NPRM, the FAA proposed to eliminate the requirement for a 
passenger using a POC on board an aircraft to be capable of hearing the 
unit's alarms and seeing alarm light indicators. An anonymous commenter 
stated that the FAA should retain this requirement because a continuous 
audio alarm could be very disruptive and compound other abnormal events 
occurring in the cabin. The commenter added that the absence of alarm 
events over the last 10 years does not mean that an alarm event will 
not occur in the future. Additionally, OTG commented that in its 
experience, an individual may not be able to respond to alarms even if 
a physician states that the individual can respond to the POC alarms.
    Crewmembers receive training on how to respond to unanticipated 
events that may arise on board the aircraft including disruptions in 
the cabin and other abnormal events. Further, it is a passenger's 
responsibility to read the POC operator's manual and direct questions 
to their physician to ensure understanding of oxygen flow settings and 
the appropriate responses to alarms.
    The SFAR No. 106 requirements pertaining to POC alarms are based on 
information in the user manual of the first POC approved by the FAA. 
See 69 FR at 42325. Based on a review of 20 user manuals for POCs 
identified in SFAR No. 106, the agency has determined POC alarms may 
provide information regarding the general operation of the POC, as well 
as information regarding the power source and detection of the POC 
user's breath. Since these alarms help ensure the device functions as 
intended, the FAA believes that removing this requirement will not 
affect aviation safety.
    The FAA also emphasizes that it has not identified any incidents 
regarding POC malfunctions on board aircraft during the period of time 
that POCs have been permitted on aircraft. A 10-year look-back period 
includes data from almost 78 million domestic flights with no adverse 
POC incidents. See http://www.transtats.bts.gov/Data_Elements.aspx?Data=2. The agency has determined that this is 
sufficient data to provide an appropriate indicator of future POC 
safety. Therefore, as proposed, this final rule eliminates the SFAR No. 
106 requirement pertaining to alarms (section 3(b)(1)).
c. Ensuring the Portable Oxygen Concentrator is Free of Petroleum 
Products
    SFAR No. 106, section 3(b)(2) requires a passenger using a POC to 
ensure the POC is free of oil, grease, or other petroleum products and 
is in good condition free from damage or other signs of excessive wear 
or abuse. This provision is similar to a warning statement found in the 
user manual of the first POC approved by the FAA and to a provision in 
the medical oxygen rules (Sec. Sec.  121.574, 125.219, and 135.91). See 
69 FR at 42325. The agency proposed to eliminate this SFAR No. 106 
provision.
    OTG commented that for passengers who rent their POCs, the 
condition of the device and its batteries is dependent on the purveyor 
of the equipment. The FAA expects POC users to ensure that a POC they 
intend to use is in good condition so that it may function properly to 
provide the needed oxygen therapy whether the POC user is on the ground 
or on an aircraft. Further, while petroleum products may accelerate an 
existing fire, the volume of petroleum products necessary to accelerate 
a fire is unlikely to be found on the exterior of a POC, and this 
concern is not addressed as a specific requirement for other PEDs 
carried on board aircraft. Therefore, this final rule eliminates the 
requirements in section 3(b)(2) of SFAR No. 106 because the 
requirements are unnecessary.
d. Use of Salves and Lotions
    SFAR No. 106, section 3(b)(4) states only oxygen approved lotions 
or salves may be used by persons using a POC on board an aircraft. In 
the NPRM, the FAA proposed to eliminate this prohibition in its 
entirety and did not receive any comments on this proposal.
    The requirement in SFAR No. 106, section 3(b)(4) came from the user 
manual of the first POC approved by the FAA. The FAA believes it is the 
passenger's responsibility to ensure he or she is using products that 
meet the POC manufacturer's requirements for salve and lotion usage 
with a POC. The risks and responsibilities associated with lotions or 
salves that are not oxygen approved or are petroleum-based are 
addressed in the preceding discussion on the elimination of the 
requirement for the user to ensure that the POC is free from petroleum 
products. Therefore, as proposed, this final rule does not retain the 
prohibition in section 3(b)(4) of SFAR No. 106.
e. Carriage of a Sufficient Number of Batteries
    SFAR No. 106, section 3(b)(5) requires passengers intending to use 
a POC during a flight to obtain from the aircraft operator, or by other 
means, the duration of the planned flight and carry a sufficient number 
of batteries to power the device for the duration of the oxygen use 
specified in the passenger's physician statement, including a 
conservative estimate of any unanticipated delays. In the NPRM, the 
agency proposed to eliminate this SFAR No. 106 requirement.
    Delta Air Lines commented that this final rule should retain the 
battery carriage requirements found in SFAR No. 106 and current 14 CFR 
382.133(f)(2) because passengers often mistakenly assume that 
electrical outlets are available to power portable medical devices. The 
FAA is not aware of any specific incidents of confusion

[[Page 33113]]

regarding availability of electrical outlets to power POCs. FAA 
guidance (AC 120-95B as well as previous editions of this AC) addresses 
aircraft operator and passenger issues pertaining to the use of 
electrical outlets to power POCs. Further, many air carriers, including 
the commenter, disclose applicable policies on their Web sites 
regarding the availability and use of on board electrical outlets for 
electronic devices intended for use during flight. The FAA encourages 
air carriers to continue this practice.
    Additionally, as noted in the Delta Air Lines comment, existing DOT 
regulations (14 CFR part 382) permit carriers to require an individual 
traveling with a POC to bring an adequate number of fully charged 
batteries into the cabin that will power the POC for no less than 150% 
of the expected maximum flight duration. See current 14 CFR 
382.133(f)(2), revised by this rule to 14 CFR 382.133(h)(2). Part 382 
also requires carriers to inform passengers who advise the carriers of 
their intent to use a POC on board an aircraft about the maximum 
duration of the flight segment. See 14 CFR 382.133(f)(1), revised by 
this rule to 14 CFR 382.133(h)(1).
    OTG commented that it is almost impossible for the average 
passenger to assess the amount of battery power that they may need for 
the duration of a trip due to time zone changes, the effect of flow 
rate on battery duration and mistaken assumptions about their ability 
to recharge batteries between flights. OTG also indicated that POC 
manufacturer manuals are ``overly optimistic'' about battery duration, 
often basing their assumptions on data from new batteries.
    The Mayo Clinic commented that many passengers only use a POC 
temporarily, during a flight, and thus are unfamiliar with the device. 
The Mayo Clinic added that an FAA requirement for passengers using a 
POC to carry a certain amount of battery power, would serve as a 
reminder for the passenger and his or her health care provider 
regarding the necessity of sufficient power for POC use, noting that 
the consequences of inadequate supplemental oxygen could result in the 
need to administer medical oxygen during the flight or divert the 
aircraft.
    The FAA maintains that it is the passengers' responsibility to 
understand the performance of their POC and its battery life under 
varying conditions and ensure their POC will enable them to adhere to 
their physician's instructions. All manuals for the POCs identified in 
SFAR No. 106 have liter flow and battery duration charts to help users 
make informed decisions regarding the number of spare batteries they 
need to bring to power the device and it is the responsibility of 
passengers using a POC during air travel to be familiar with the manual 
and consult their physician and POC provider as necessary. As 
highlighted by OTG, passengers may also want to consider the age of the 
device and the batteries as they assess the batteries required to power 
the POC for the amount of time required. The intent of the SFAR and 
this rulemaking is to allow passengers needing oxygen therapy during a 
flight to have ready access to a device that can supply that therapy, 
not to oversee passenger medical care.
    Thus, as proposed, the FAA has eliminated the SFAR requirement to 
carry a certain amount of battery power. However, the Department 
continues to allow airlines to require individuals using POCs inflight 
to bring an adequate number of fully charged batteries based on the 
battery manufacturer's estimate of the hours of battery life while the 
POC is in use and the maximum duration of the flight. Also, to 
facilitate a passenger's ability to prepare for POC use during a 
flight, in AC 120-95B, published with this final rule, the FAA has 
provided references to the DOT requirements regarding the carriage of 
spare batteries. The FAA also expects to update its Web site with 
information a passenger may want to consider when traveling with a POC.

I. Miscellaneous

    BPR Medical Limited recommended that the six continuous flow POCs 
approved under SFAR No. 106 should be retrofitted with an accessory to 
stop the flow of oxygen in the event that the POC tubing ignites. BPR 
states that during testing for fire propagation in tubing, BPR found 
that where a pulse dose mechanism provides oxygen, a fire that has 
developed will automatically be extinguished and will not propagate 
along the tubing to the oxygen source. The commenter added that while 
having a means to stop the flow of oxygen may be more of a concern 
where cigarettes might be a source of ignition, there are other 
possible sources of ignition on aircraft such as electro-static 
discharge from blankets.
    FDA has recently recognized a POC performance standard (ISO 80601-
2-69:2014) that includes a clause stating that the device shall be 
equipped with a means to stop the flow of gas towards the patient in 
the case that the accessory (tubing) becomes ignited. This standard 
will be considered as the FDA approves or clears new POC models.
    Additionally, the previous FDA recognized performance standard for 
POCs (ISO 8359:1996 including Amendment 1 (2012)) stated that POCs 
shall include a means to prevent the propagation of fire back through 
the oxygen concentrator outlet in the case that the tubing ignites. 
Although it is not clear whether all of the continuous flow devices 
approved under the SFAR include this means to prevent fire propagation, 
the FDA is allowing continued use of these devices and is not requiring 
existing POCs to be modified to comply with the performance standard 
the agency currently recognizes (ISO 80601-2-69:2014).
    Nevertheless, the commenter's suggestion to retrofit continuous 
flow POCs with an accessory to extinguish fire propagation in tubing is 
outside of the scope of the proposal and a prohibition on the use of 
continuous flow POCs on aircraft is not supported by aviation safety 
data. As previously noted, the FAA reviewed data from VDRP, SDRS, NTSB, 
ASRS and AIDS, and has not found any instances of POC malfunction 
during flight since the agency first published the SFAR.
    The FAA also researched the service difficulty report (SDR) 
database for the period beginning the time SFAR No. 106 published (July 
12, 2005) through December 2014, and ran multiple queries for the terms 
fires, blankets, POCs, electrostatic discharges, and insulation 
materials. This research covers a period where almost 78 million U.S. 
domestic flights occurred, revealing no SDRs related to POCs. See 
http://www.transtats.bts.gov/Data_Elements.aspx?Data=2.
    Finally, although the FAA has not identified a single instance of a 
fire due to passenger's use of a POC on an aircraft, passenger-carrying 
aircraft are equipped with effective mitigation (i.e., fire resistant 
cabin materials and fire extinguishers) if a fire should occur. See 14 
CFR 25.853, 23.853, 121.215, 121.309, 125.113 and 135.155.
    Accordingly, the agency has determined that no aviation safety data 
exists that would support further FAA action to preclude continuous 
flow POC models from use onboard aircraft.

J. Technical Amendments

    This final rule makes two technical amendments. First, it updates a 
cross reference to the HMR that appears in Sec. Sec.  121.574(a)(3), 
125.219(a)(3), and 135.91(a)(3) and pertains to the definition of a 
compressed gas. Second, it removes the OMB Control No. 2120-0702 from 
Sec.  11.201(b) because the information collection burdens

[[Page 33114]]

associated with this control number cease to be effective when SFAR No. 
106 is removed from title 14.

K. Nondiscrimination on the Basis of Disability in Air Travel

    The Air Carrier Access Act (ACAA) prohibits discrimination by U.S. 
and foreign carriers against passengers with disabilities. See 49 
U.S.C. 41705. Part 382 of title 14 contains detailed standards and 
requirements to implement the ACAA and to ensure that carriers provide 
nondiscriminatory service to passengers with disabilities.
    With regard to POCs, part 382 establishes a framework to ensure 
accessibility for passengers using POCs and other respiratory assistive 
devices on aircraft, subject to applicable aviation safety, security, 
and hazardous materials regulations. In this final rule, the FAA 
revises its acceptance criteria on POCs, based on which air carriers 
may choose to, but are not required to, accept those POCs meeting FAA's 
criteria. On the other hand, part 382 mandates that carriers must 
accept POCs if they meet the FAA's acceptance criteria. Accordingly, 
this final rule includes amendments to 14 CFR part 382 to remove the 
references to SFAR No. 106, to ensure that the requirements of part 382 
are consistent with the new acceptance criteria and labeling 
requirements set forth by the FAA in this rule, and to ensure the 
continued use of the POCs previously approved under SFAR No. 106, as 
permitted by the FAA.
    When amending regulations, the Administrative Procedure Act (APA) 
generally requires agencies to publish a notice of proposed rulemaking 
and give interested persons an opportunity to comment. However, the APA 
authorizes agencies to dispense with notice and comment if the agency 
finds for good cause that notice and public comment thereon are 
impracticable, unnecessary, or contrary to the public interest. 5 
U.S.C. 553(b)(3)(B). ``Good cause'' exists in situations in which 
notice unavoidably prevents the due and required execution of agency 
functions or when an agency finds that due and timely execution of its 
functions is impeded by the notice otherwise required by the APA.
    In this case, the agency finds that there is good cause to conclude 
that providing notice and public comment for the Department's 
conforming amendments is unnecessary, impracticable and contrary to the 
public interest. Notice and public comment are impracticable because 
they would cause undue delay. Providing additional notice and comment 
would be impracticable and contrary to the public interest because 
during the delay caused by providing notice and public comment, the 
Department's disability regulations would be inconsistent with FAA 
regulations. This could potentially cause confusion and affect disabled 
individuals' ability to bring necessary medical devices on flights.
    Notice and comment on these conforming amendments is also 
unnecessary because the public has already had an opportunity to 
comment on the substantive issues addressed by this rulemaking. The 
Department is making minor amendments to part 382 that simply conform 
the Department's disability regulations to the FAA's safety 
regulations. The Department does not believe that it would receive new 
substantive comments, in addition to those already received and 
addressed in this document, if it sought comment on the conforming 
amendments. For these reasons the Department has determined that the 
notice and comment rulemaking process is unnecessary, impracticable, 
and contrary to the public interest for these conforming amendments.
1. Mandatory Acceptance of POCs That Meet FAA Acceptance Criteria
    In 2008, DOT amended part 382 to include a provision requiring 
covered carriers to permit a passenger with a disability to use an 
SFAR-approved POC on all covered flights. More specifically, part 382 
requires U.S. carriers to permit an individual with a disability to use 
an SFAR-approved POC, a ventilator, a respirator, or a continuous 
positive airway pressure machine (CPAP machine) on all flights unless 
the device does not meet applicable FAA requirements for medical 
portable electronic devices and does not display a manufacturer's label 
that indicates the device meets those FAA requirements. See 14 CFR 
382.133(a). Foreign carriers must permit individuals with a disability 
to use a POC of a kind equivalent to a SFAR- approved POC, a 
ventilator, a respirator, or a CPAP machine for use on U.S. carriers in 
the passenger cabin on all covered flights unless the device does not 
meet the requirements for medical portable electronic devices set by 
the foreign carrier's government if such requirements exist and/or the 
POC does not display a manufacturer's label that indicates the device 
meets those requirements. See 14 CFR 382.133(b).
    In 2009, because the SFAR-approved POCs were not required to have 
labels under the FAA's regulations, DOT issued guidance encouraging 
carriers to allow passengers to use these approved POCs even if the 
device had not been labeled, although carriers were not legally 
obligated to do so.\18\ Since then, airlines have largely implemented a 
policy to allow passengers to use SFAR-approved POCs even if they do 
not have labels.
---------------------------------------------------------------------------

    \18\ See, Notice--The Use of Passenger-supplied Electronic 
Respiratory Assistive Devices on Aircraft, October 28, 2009, https://www.transportation.gov/sites/dot.gov/files/docs/Notice_10_28_09.pdf.
---------------------------------------------------------------------------

    In this final rule, the Department is amending its disability 
regulation to ensure that, consistent with the FAA's actions in this 
rule, passengers with SFAR-approved POCs continue to be permitted to 
use these devices on aircraft, regardless of whether they are labeled, 
and that passengers with other POCs that satisfy the FAA acceptance 
criteria and labeling requirements will be able to use those POCs on 
their flights. As the FAA's regulations are enabling rules, these 
changes in the Department's disability regulation require carriers 
covered by part 382 to accept these POCs for air travel.
2. Other Amendments to 14 CFR Part 382
    The Department is revising Sec.  382.133(c)(3) (redesignated as 
Sec.  382.133(e)(3)) by eliminating the reference to SFAR No. 106 with 
respect to the packaging and protection of spare batteries carried in 
an aircraft cabin, as this final rule removes the SFAR from the CFR. 
Instead, the Department is referring directly to the applicable PHMSA 
requirements.
    The Department is also revising Sec.  382.133(c)(6) (redesignated 
as Sec.  382.133(e)(6) in this final rule) by eliminating the reference 
to federal aviation regulations with respect to the physicians 
statement, as in this final rule the FAA eliminates the SFAR No. 106 
requirement for a physician's statement. The Department, however, is 
retaining the reference to Sec.  382.23(b)(1)(ii) that permits carriers 
to require a medical certificate from passengers who need medical 
oxygen during a flight. In that regard, there is also no change to our 
rules that permit a U.S. carrier or a foreign carrier to ensure that 
the passengers traveling with POCs have sufficient numbers of spare 
batteries to power the POC for up to 150% of the maximum flight 
duration.

V. Regulatory Notices and Analyses

A. Regulatory Evaluation

    Changes to Federal regulations must undergo several economic 
analyses. First, Executive Order 12866 and Executive Order 13563 direct 
that each Federal agency shall propose or adopt a

[[Page 33115]]

regulation only upon a reasoned determination that the benefits of the 
intended regulation justify its costs. Second, the Regulatory 
Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze 
the economic impact of regulatory changes on small entities. Third, the 
Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting 
standards that create unnecessary obstacles to the foreign commerce of 
the United States. In developing U.S. standards, this Trade Act 
requires agencies to consider international standards and, where 
appropriate, that they be the basis of U.S. standards. Fourth, the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies 
to prepare a written assessment of the costs, benefits, and other 
effects of proposed or final rules that include a Federal mandate 
likely to result in the expenditure by State, local, or tribal 
governments, in the aggregate, or by the private sector, of $100 
million or more annually (adjusted for inflation with base year of 
1995). This portion of the preamble summarizes the FAA's analysis of 
the economic impacts of this final rule. We suggest readers seeking 
greater detail read the full regulatory evaluation, a copy of which we 
have placed in the docket for this rulemaking.
    In conducting these analyses, FAA has determined that this final 
rule: (1) Has benefits that justify its costs, (2) is not an 
economically ``significant regulatory action'' as defined in section 
3(f) of Executive Order 12866, (3) is not ``significant'' as defined in 
DOT's Regulatory Policies and Procedures; (4) will not have a 
significant economic impact on a substantial number of small entities; 
(5) will not create unnecessary obstacles to the foreign commerce of 
the United States; and (6) will not impose an unfunded mandate on 
state, local, or tribal governments, or on the private sector by 
exceeding the threshold identified above. These analyses are summarized 
below.
Total Benefits and Costs of This Rule
    The total cost savings from this final rule is $39.5 million ($27.6 
million at 7% present value and $33.6 million at 3% present value). The 
largest cost savings of $39 million occurs from the reduction of crew 
time to review the physician's statement.
    The FAA estimated that POC manufacturers that are expected to 
market POCs for use on aircraft will save a total of $108,000 over the 
ten year analysis period because the FAA will no longer require POC 
models to be identified in SFAR No. 106 prior to their use on aircraft. 
As a result of this action, POC manufacturers will no longer incur the 
administrative costs of petitioning the FAA which the FAA estimated 
would be $108,000. Further, because the manufacturer will no longer 
have to await resolution of that petition in order for a POC to be 
permitted for use on aircraft they will be able to introduce these 
devices sooner to the market.
    The FAA estimates that the cost of this final rule will be a one-
time total cost of $22,000 incurred by all those POC manufacturers who 
comply with this final rule to modify a label and the associated costs 
that manufacturers will incur to change their current labeling process 
to affix a label with the language on the devices.
Assumptions:
     Present Value Discount rates--7% and 3%
     Period of Analysis--ten years
     24 new POCs over ten years
Entities Potentially Affected by This Rule:
     POC manufacturers
     Passengers carrying POCs on board aircraft
     Physicians providing written statements to POC users
     Aircraft operators (including crewmembers)
Benefits of this Rule
    The replacement of the SFAR No. 106 device approval process with a 
process by which POC manufacturers label those devices that satisfy FAA 
acceptance criteria, will shorten the time for manufacturers to begin 
selling new POC models that can be used on aircraft. Therefore, one 
benefit of this rule will be to eliminate delays and enable 
manufacturers to bring their devices to market sooner. Further the FAA 
estimates total industry cost savings of $108,000 because manufacturers 
will no longer incur the administrative costs of petitioning the FAA 
for each new device. These cost savings easily exceed the labeling 
costs.
    Furthermore, this final rule will result in cost savings because 
POC-using passengers will no longer have to obtain a physician's 
written statement as a prerequisite to bringing POCs on board aircraft 
in parts 121, 125, and 135 operations.
    The largest cost-savings will accrue to airline crews as there will 
no longer be a requirement for the crew to review the contents of the 
physician's statement and to notify the pilot in command about the 
contents of the physician's statement and the intention of the 
passenger to use the POC on board.
    The quantified cost savings of this final rule are summarized in 
table 4.

                              Table 4--Total Estimated Cost Savings From Final Rule
----------------------------------------------------------------------------------------------------------------
                                                                                    7% present      3% present
                                                                   Cost savings    value savings   value savings
----------------------------------------------------------------------------------------------------------------
FAA Savings--No SFAR............................................         $91,644         $68,871         $80,519
Manufacturer Savings--No petition for rulemaking................         108,000          75,853          92,126
Removal of FAA requirement for user to obtain a physician's              569,961         401,645         486,914
 statement for POC use on aircraft..............................
Removal of FAA requirement for crew review of physician's             38,726,085      27,083,677      32,972,652
 statement and PIC notification.................................
                                                                 -----------------------------------------------
    Total Cost Savings..........................................     $39,495,690     $27,630,045     $33,632,212
----------------------------------------------------------------------------------------------------------------

    The FAA also identified another benefit that it did not quantify. 
This benefit comes from the use of a performance-based RF emissions 
acceptance criterion. Currently the manufacturers provide radiated RF 
emissions tests results showing that the device does not exceed 
thresholds established in Section 21 Category M of RTCA DO-160 to the 
FAA which posts these results on its Web site for aircraft operators to 
access. This final rule will include a performance-based RF emissions 
acceptance criterion that allows POC manufacturers to determine how to 
assess whether their POC meets the RF emissions limits for use on 
aircraft before they affix a label to the device confirming that this 
criterion has been satisfied. This might save manufacturers some cost 
if they can demonstrate in a less expensive way that their device meets 
the RF emissions criteria and will not degrade safety as

[[Page 33116]]

the alternative method is an equivalent level of safety to the RTCA 
standard.
Costs of This Rule
    As estimated in the NPRM, the FAA expects that POC manufacturers 
will incur costs of $22,000 to modify labels that they already affix to 
the POC, to contain the language required by this rule.

B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) 
establishes ``as a principle of regulatory issuance that agencies shall 
endeavor, consistent with the objectives of the rule and of applicable 
statutes, to fit regulatory and informational requirements to the scale 
of the businesses, organizations, and governmental jurisdictions 
subject to regulation. To achieve this principle, agencies are required 
to solicit and consider flexible regulatory proposals and to explain 
the rationale for their actions to assure that such proposals are given 
serious consideration.'' The RFA covers a wide-range of small entities, 
including small businesses, not-for-profit organizations, and small 
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will 
have a significant economic impact on a substantial number of small 
entities. If the agency determines that it will, the agency must 
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to 
have a significant economic impact on a substantial number of small 
entities, section 605(b) of the RFA provides that the head of the 
agency may so certify and a regulatory flexibility analysis is not 
required. The certification must include a statement providing the 
factual basis for this determination, and the reasoning should be 
clear.
    This final rule is expected to reduce SFAR No. 106 requirements 
that currently result in a burden on POC manufacturers who produce POC 
devices for use on aircraft. This final rule will also result in small 
costs to manufacturers by requiring POCs intended for use on aircraft 
to bear a label indicating the device meets FAA requirements for use on 
board aircraft. The FAA learned from five of the small POC 
manufacturers that they might incur a one-time cost ranging from $200 
to $1,500 which averages $0.20 to $1 per label.\19\ These costs will be 
offset by cost savings because manufacturers will no longer have to 
petition for rulemaking and lose marketing time awaiting a final 
regulatory action. One manufacturer stated these cost savings are worth 
$4,500 for each petition.
---------------------------------------------------------------------------

    \19\ A sixth manufacturer that was contacted estimated costs of 
$10,200, but this manufacturer is not a small business.
---------------------------------------------------------------------------

    The FAA identified nine companies that produce POCs intended for 
use on board aircraft. The FAA determined that the appropriate North 
American Industry Classification System (NAICS) codes of these 
manufacturers are 339112 and 339113 and the threshold for determining 
whether a company is a small business is 500 employees for those 
industries. Through online research, the FAA found data \20\ indicating 
that six of the nine manufacturers are small entities and concluded 
that a substantial number of manufacturers are small entities. However, 
the FAA does not expect the rule to impose a significant economic 
impact on any of these small entities because the estimated cost 
savings of no longer having to petition the FAA (estimated at $4,500 
per manufacturer) exceed the estimated costs of modifying the label 
(estimated at $2,400 per manufacturer) to comply with this final rule. 
Also, there is a benefit to POC manufacturers, in that the 
manufacturers will receive revenue sooner because they will be able to 
market new portable oxygen concentrators sooner.
---------------------------------------------------------------------------

    \20\ http://www.manta.com/.
---------------------------------------------------------------------------

    Although a substantial number of operators conducting parts 121, 
125 and 135 operations are small entities, all parts 121, 125 and 135 
operators are expected to experience cost savings because the proposal 
will no longer require the PIC to be apprised when a passenger brings 
and intends to use a POC on board the aircraft and be informed on the 
contents of the physician's statement as does SFAR No. 106. The FAA did 
not receive comments on the initial regulatory flexibility analysis 
where we first discussed these cost savings. Therefore, as provided in 
section 605(b), the head of the FAA certifies that this rulemaking will 
not result in a significant economic impact on a substantial number of 
small entities.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the 
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal 
agencies from establishing standards or engaging in related activities 
that create unnecessary obstacles to the foreign commerce of the United 
States. Pursuant to these Acts, the establishment of standards is not 
considered an unnecessary obstacle to the foreign commerce of the 
United States, so long as the standard has a legitimate domestic 
objective, such as the protection of safety, and does not operate in a 
manner that excludes imports that meet this objective. The statute also 
requires consideration of international standards and, where 
appropriate, that they be the basis for U.S. standards. The FAA has 
assessed the potential effect of this final rule and determined that it 
will have only a domestic impact and therefore no effect on 
international trade.

D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement 
assessing the effects of any Federal mandate in a proposed or final 
agency rule that may result in an expenditure of $100 million or more 
(in 1995 dollars) in any one year by State, local, and tribal 
governments, in the aggregate, or by the private sector; such a mandate 
is deemed to be a ``significant regulatory action.'' The FAA currently 
uses an inflation-adjusted value of $155.0 million in lieu of $100 
million. This final rule does not contain such a mandate; therefore, 
the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires 
that the FAA consider the impact of paperwork and other information 
collection burdens imposed on the public. The FAA has determined that 
there is no new requirement for information collection associated with 
this final rule.

F. International Compatibility and Cooperation

    In keeping with U.S. obligations under the Convention on 
International Civil Aviation, it is FAA policy to conform to ICAO 
Standards and Recommended Practices to the maximum extent practicable. 
Annex 18 to the Convention on International Civil Aviation requires 
that dangerous goods are carried in accordance with the ICAO Technical 
Instructions on the Transport of Dangerous Goods by Air. The ICAO 
Technical Instructions do not contain specific provisions for POCs but 
Part 8 of the ICAO Technical Instructions (passenger and crew 
exceptions) allows for their carriage on board aircraft as portable 
medical electronic devices subject to certain conditions. Although the 
format is different, the conditions in

[[Page 33117]]

Part 8 pertaining to batteries used to power POCs are the same as the 
allowances given in 49 CFR 175.10(a)(18).

G. Environmental Analysis

    FAA Order 1050.1F identifies FAA actions that are categorically 
excluded from preparation of an environmental assessment or 
environmental impact statement under the National Environmental Policy 
Act in the absence of extraordinary circumstances. The FAA has 
determined this rulemaking action qualifies for the categorical 
exclusion identified in paragraph 5-6.6 and involves no extraordinary 
circumstances.

VI. Executive Order Determinations

A. Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and 
criteria of Executive Order 13132, Federalism. The agency determined 
that this action will not have a substantial direct effect on the 
States, or the relationship between the Federal Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, and, therefore, does not have Federalism 
implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy 
Supply, Distribution, or Use

    The FAA analyzed this final rule under Executive Order 13211, 
Actions Concerning Regulations that Significantly Affect Energy Supply, 
Distribution, or Use (May 18, 2001). The agency has determined that it 
is not a ``significant energy action'' under the executive order and it 
is not likely to have a significant adverse effect on the supply, 
distribution, or use of energy.

VII. How To Obtain Additional Information

A. Rulemaking Documents

    An electronic copy of a rulemaking document may be obtained by 
using the Internet --
    1. Search the Federal eRulemaking Portal (http://www.regulations.gov);
    2. Visit the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/ or
    3. Access the Government Publishing Office's Web page at http://www.gpo.gov/fdsys/.
    Copies may also be obtained by sending a request (identified by 
notice, amendment, or docket number of this rulemaking) to the Federal 
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence 
Avenue SW., Washington, DC 20591, or by calling (202) 267-9677.

B. Comments Submitted to the Docket

    Comments received may be viewed by going to http://www.regulations.gov and following the online instructions to search the 
docket number for this action. Anyone is able to search the electronic 
form of all comments received into any of the FAA's dockets by the name 
of the individual submitting the comment (or signing the comment, if 
submitted on behalf of an association, business, labor union, etc.).

C. Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 
1996 requires FAA to comply with small entity requests for information 
or advice about compliance with statutes and regulations within its 
jurisdiction. A small entity with questions regarding this document may 
contact its local FAA official, or the person listed under the FOR 
FURTHER INFORMATION CONTACT heading at the beginning of the preamble. 
To find out more about SBREFA on the Internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects

14 CFR Part 1

    Air transportation.

14 CFR Part 11

    Reporting and recordkeeping requirements.

14 CFR Part 121

    Air carriers, Aircraft, Aviation safety, Charter flights, Safety, 
Transportation.

14 CFR Part 125

    Aircraft, Aviation safety.

14 CFR Part 135

    Air taxis, Aircraft, Aviation safety.

14 CFR Part 382

    Air Carriers, Consumer protection, Individuals with disabilities.

The Amendment

    In consideration of the foregoing, the Federal Aviation 
Administration and the Office of the Secretary amend chapters I and II 
of title 14, Code of Federal Regulations as follows:

PART 1--DEFINITIONS AND ABBREVIATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701.


0
2. Amend Sec.  1.1 by adding a definition for ``portable oxygen 
concentrator'' in alphabetical order to read as follows:


Sec.  1.1  General definitions.

* * * * *
    Portable oxygen concentrator means a medical device that separates 
oxygen from other gasses in ambient air and dispenses this concentrated 
oxygen to the user.
* * * * *

0
3. Amend Sec.  1.2 by adding the abbreviation ``POC'' in alphabetical 
order to read as follows:


Sec.  1.2  Abbreviations

* * * * *
    POC means portable oxygen concentrator.
* * * * *

PART 11--GENERAL RULEMAKING PROCEDURES

0
4. The authority citation for part 11 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40101, 40103, 40105, 40109, 
40113, 44110, 44502, 44701-44702, 44711, and 46102.


0
5. In Sec.  11.201, amend the table in paragraph (b) by revising the 
entry for part 121 to read as follows:


Sec.  11.201  Office of Management and Budget (OMB) control numbers 
assigned under the Paperwork Reduction Act.

* * * * *
    (b) * * *

------------------------------------------------------------------------
 14 CFR part or section identified and
               described                     Current OMB control No.
------------------------------------------------------------------------
 
                              * * * * * * *
Part 121...............................  2120-0008, 2120-0028, 2120-
                                          0535, 2120-0571, 2120-0600,
                                          2120-0606, 2120-0614, 2120-
                                          0616, 2120-0631, 2120-0651,
                                          2120-0653, 2120-0691, 2120-
                                          0739, 2120-0760, 2120-0766.
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 33118]]

PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL 
OPERATIONS

0
6. The authority citation for part 121 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40119, 41706, 
42301 preceding note added by Public Law 112-95, sec. 412, 126 Stat. 
89, 44101, 44701-44702, 44705, 44709-44711, 44713, 44716-44717, 
44722, 44729, 44732, 46105; Public Law 111-216, 124 Stat. 2348 (49 
U.S.C. 44701 note); Public Law 112-95, 126 Stat. 62 (49 U.S.C. 44732 
note).

Special Federal Aviation Regulation No. 106 [Removed]

0
7. Remove Special Federal Aviation Regulation No. 106.

0
8. Amend Sec.  121.306 as follows:
0
a. In paragraph (b)(4), remove ``or'' following the semicolon;
0
b. Redesignate paragraph (b)(5) as paragraph (b)(6);
0
c. Add new paragraph (b)(5); and
0
d. In paragraph (c), remove the reference ``(b)(5)'' and add in its 
place ``(b)(6)''.
    The addition reads as follows:


Sec.  121.306  Portable electronic devices.

* * * * *
    (b)* * *
    (5) Portable oxygen concentrators that comply with the requirements 
in Sec.  121.574; or
* * * * *

0
9. Amend Sec.  121.574 as follows:
0
a. Revise the section heading;
0
b. Revise paragraph (a) introductory text;
0
c. In paragraph (a)(3), remove the reference ``49 CFR 173.300(a)'' and 
add in its place ``49 CFR 173.115(b)'';
0
d. Revise paragraph (b); and
0
e. Add paragraph (e).
    The revisions and addition read as follows:


Sec.  121.574  Oxygen and portable oxygen concentrators for medical use 
by passengers.

    (a) A certificate holder may allow a passenger to carry and operate 
equipment for the storage, generation, or dispensing of oxygen when all 
of the conditions in paragraphs (a) through (d) of this section are 
satisfied. Beginning August 22, 2016, a certificate holder may allow a 
passenger to carry and operate a portable oxygen concentrator when the 
conditions in paragraphs (b) and (e) of this section are satisfied.
* * * * *
    (b) No person may smoke or create an open flame and no certificate 
holder may allow any person to smoke or create an open flame within 10 
feet of oxygen storage and dispensing equipment carried in accordance 
with paragraph (a) of this section or a portable oxygen concentrator 
carried and operated in accordance with paragraph (e) of this section.
* * * * *
    (e) Portable oxygen concentrators--(1) Acceptance criteria. A 
passenger may carry or operate a portable oxygen concentrator for 
personal use on board an aircraft and a certificate holder may allow a 
passenger to carry or operate a portable oxygen concentrator on board 
an aircraft operated under this part during all phases of flight if the 
portable oxygen concentrator satisfies all of the requirements in this 
paragraph (e):
    (i) Is legally marketed in the United States in accordance with 
Food and Drug Administration requirements in title 21 of the CFR;
    (ii) Does not radiate radio frequency emissions that interfere with 
aircraft systems;
    (iii) Generates a maximum oxygen pressure of less than 200 kPa 
gauge (29.0 psig/43.8 psia) at 20 [deg]C (68 [deg]F);
    (iv) Does not contain any hazardous materials subject to the 
Hazardous Materials Regulations (49 CFR parts 171 through 180) except 
as provided in 49 CFR 175.10 for batteries used to power portable 
electronic devices and that do not require aircraft operator approval; 
and
    (v) Bears a label on the exterior of the device applied in a manner 
that ensures the label will remain affixed for the life of the device 
and containing the following certification statement in red lettering: 
``The manufacturer of this POC has determined this device conforms to 
all applicable FAA acceptance criteria for POC carriage and use on 
board aircraft.'' The label requirements in this paragraph (e)(1)(v) do 
not apply to the following portable oxygen concentrators approved by 
the FAA for use on board aircraft prior to May 24, 2016:
    (A) AirSep Focus;
    (B) AirSep FreeStyle;
    (C) AirSep FreeStyle 5;
    (D) AirSep LifeStyle;
    (E) Delphi RS-00400;
    (F) DeVilbiss Healthcare iGo;
    (G) Inogen One;
    (H) Inogen One G2;
    (I) Inogen One G3;
    (J) Inova Labs LifeChoice;
    (K) Inova Labs LifeChoice Activox;
    (L) International Biophysics LifeChoice;
    (M) Invacare Solo2;
    (N) Invacare XPO2;
    (O) Oxlife Independence Oxygen Concentrator;
    (P) Oxus RS-00400;
    (Q) Precision Medical EasyPulse;
    (R) Respironics EverGo;
    (S) Respironics SimplyGo;
    (T) SeQual Eclipse;
    (U) SeQual eQuinox Oxygen System (model 4000);
    (V) SeQual Oxywell Oxygen System (model 4000);
    (W) SeQual SAROS; and
    (X) VBox Trooper Oxygen Concentrator.
    (2) Operating requirements. Portable oxygen concentrators that 
satisfy the acceptance criteria identified in paragraph (e)(1) of this 
section may be carried or operated by a passenger on an aircraft 
provided the aircraft operator ensures that all of the conditions in 
this paragraph (e)(2) are satisfied:
    (i) Exit seats. No person operating a portable oxygen concentrator 
is permitted to occupy an exit seat.
    (ii) Stowage of device. During movement on the surface, takeoff and 
landing, the device must be stowed under the seat in front of the user, 
or in another approved stowage location so that it does not block the 
aisle way or the entryway to the row. If the device is to be operated 
by the user, it must be operated only at a seat location that does not 
restrict any passenger's access to, or use of, any required emergency 
or regular exit, or the aisle(s) in the passenger compartment.

PART 125--CERTIFICATION AND OPERATIONS: AIRPLANES HAVING A SEATING 
CAPACITY OF 20 OR MORE PASSENGERS OR A MAXIMUM PAYLOAD CAPACITY OF 
6,000 POUNDS OR MORE; AND RULES GOVERNING PERSONS ON BOARD SUCH 
AIRCRAFT

0
10. The authority citation for part 125 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701-44702, 44705, 
44710-44711, 44713, 44716-44717, 44722.

Special Federal Aviation Regulation No. 106 [Removed]

0
11. Remove Special Federal Aviation Regulation No. 106.

0
12. Amend Sec.  125.204 as follows:
0
a. In paragraph (b)(4), remove ``or'' following the semicolon;
0
b. Redesignate paragraph (b)(5) as paragraph (b)(6);
0
c. Add new paragraph (b)(5); and
0
d. In paragraph (c), remove the reference ``(b)(5)'' and add in its 
place ``(b)(6)''.
    The addition reads as follows:


Sec.  125.204  Portable electronic devices.

* * * * *
    (b) * * *

[[Page 33119]]

    (5) Portable oxygen concentrators that comply with the requirements 
in Sec.  125.219; or
* * * * *

0
13. Amend Sec.  125.219 as follows:
0
a. Revise the section heading;
0
b. Revise paragraph (a) introductory text;
0
c. In paragraph (a)(1)(iii), after the semicolon, remove ``and'';
0
d. Redesignate paragraph (a)(1)(iv) as paragraph (a)(1)(v);
0
e. Add new paragraph (a)(1)(iv);
0
f. In paragraph (a)(3), remove the reference ``title 49 CFR 
173.300(a)'' and add in its place ``49 CFR 173.115(b)'';
0
g. Revise paragraph (b); and
0
h. Add paragraph (f).
    The revisions and additions read as follows:


Sec.  125.219  Oxygen and portable oxygen concentrators for medical use 
by passengers.

    (a) Except as provided in paragraphs (d) and (f) of this section, 
no certificate holder may allow the carriage or operation of equipment 
for the storage, generation or dispensing of medical oxygen unless the 
conditions in paragraphs (a) through (c) of this section are satisfied. 
Beginning August 22, 2016, a certificate holder may allow a passenger 
to carry and operate a portable oxygen concentrator when the conditions 
in paragraphs (b) and (f) of this section are satisfied.
    (1) * * *
    (iv) Constructed so that all valves, fittings, and gauges are 
protected from damage during that carriage or operation; and
* * * * *
    (b) No person may smoke or create an open flame and no certificate 
holder may allow any person to smoke or create an open flame within 10 
feet of oxygen storage and dispensing equipment carried under paragraph 
(a) of this section or a portable oxygen concentrator carried and 
operated under paragraph (f) of this section.
* * * * *
    (f) Portable oxygen concentrators--(1) Acceptance criteria. A 
passenger may carry or operate a portable oxygen concentrator for 
personal use on board an aircraft and a certificate holder may allow a 
passenger to carry or operate a portable oxygen concentrator on board 
an aircraft operated under this part during all phases of flight if the 
portable oxygen concentrator satisfies all of the requirements in this 
paragraph (f):
    (i) Is legally marketed in the United States in accordance with 
Food and Drug Administration requirements in title 21 of the CFR;
    (ii) Does not radiate radio frequency emissions that interfere with 
aircraft systems;
    (iii) Generates a maximum oxygen pressure of less than 200 kPa 
gauge (29.0 psig/43.8 psia) at 20 [deg]C (68 [deg]F);
    (iv) Does not contain any hazardous materials subject to the 
Hazardous Materials Regulations (49 CFR parts 171 through 180) except 
as provided in 49 CFR 175.10 for batteries used to power portable 
electronic devices and that do not require aircraft operator approval; 
and
    (v) Bears a label on the exterior of the device applied in a manner 
that ensures the label will remain affixed for the life of the device 
and containing the following certification statement in red lettering: 
``The manufacturer of this POC has determined this device conforms to 
all applicable FAA acceptance criteria for POC carriage and use on 
board aircraft.'' The label requirements in this paragraph (f)(1)(v) do 
not apply to the following portable oxygen concentrators approved by 
the FAA for use on board aircraft prior to May 24, 2016:
    (A) AirSep Focus;
    (B) AirSep FreeStyle;
    (C) AirSep FreeStyle 5;
    (D) AirSep LifeStyle;
    (E) Delphi RS-00400;
    (F) DeVilbiss Healthcare iGo;
    (G) Inogen One;
    (H) Inogen One G2;
    (I) Inogen One G3;
    (J) Inova Labs LifeChoice;
    (K) Inova Labs LifeChoice Activox;
    (L) International Biophysics LifeChoice;
    (M) Invacare Solo2;
    (N) Invacare XPO2;
    (O) Oxlife Independence Oxygen Concentrator;
    (P) Oxus RS-00400;
    (Q) Precision Medical EasyPulse;
    (R) Respironics EverGo;
    (S) Respironics SimplyGo;
    (T) SeQual Eclipse;
    (U) SeQual eQuinox Oxygen System (model 4000);
    (V) SeQual Oxywell Oxygen System (model 4000);
    (W) SeQual SAROS; and
    (X) VBox Trooper Oxygen Concentrator.
    (2) Operating requirements. Portable oxygen concentrators that 
satisfy the acceptance criteria identified in paragraph (f)(1) of this 
section may be carried or used by a passenger on an aircraft provided 
the aircraft operator ensures that all of the conditions in this 
paragraph (f)(2) are satisfied:
    (i) Exit seats. No person operating a portable oxygen concentrator 
is permitted to occupy an exit seat.
    (ii) Stowage of device. During movement on the surface, takeoff and 
landing, the device must be stowed under the seat in front of the user, 
or in another approved stowage location so that it does not block the 
aisle way or the entryway to the row. If the device is to be operated 
by the user, it must be operated only at a seat location that does not 
restrict any passenger's access to, or use of, any required emergency 
or regular exit, or the aisle(s) in the passenger compartment.

PART 135--OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS 
AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT

0
14. The authority citation for part 135 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 41706, 40113, 44701-44702, 
44705, 44709, 44711-44713, 44715-44717, 44722, 44730, 45101-45105; 
Public Law 112-95, 126 Stat. 58 (49 U.S.C. 44730).

Special Federal Aviation Regulation No. 106 [Removed]

0
15. Remove Special Federal Aviation Regulation No. 106.

0
16. Amend Sec.  135.91 as follows:
0
a. Revise the section heading and paragraph (a) introductory text;
0
b. In paragraph (a)(1)(iii), after the semicolon, remove ``and'';
0
c. Redesignate paragraph (a)(1)(iv) as paragraph (a)(1)(v);
0
d. Add new paragraph (a)(1)(iv);
0
e. In paragraph (a)(3), remove the reference ``title 49 CFR 
173.300(a)'' and add in its place ``49 CFR 173.115(b)'';
0
f. Revise paragraph (b); and
0
g. Add paragraph (f).
    The revisions and additions read as follows:


Sec.  135.91  Oxygen and portable oxygen concentrators for medical use 
by passengers.

    (a) Except as provided in paragraphs (d) and (e) of this section, 
no certificate holder may allow the carriage or operation of equipment 
for the storage, generation or dispensing of medical oxygen unless the 
conditions in paragraphs (a) through (c) of this section are satisfied. 
Beginning August 22, 2016, a certificate holder may allow a passenger 
to carry and operate a portable oxygen concentrator when the conditions 
in paragraphs (b) and (f) of this section are satisfied.
    (1) * * *
    (iv) Constructed so that all valves, fittings, and gauges are 
protected from damage during carriage or operation; and
* * * * *
    (b) No person may smoke or create an open flame and no certificate 
holder

[[Page 33120]]

may allow any person to smoke or create an open flame within 10 feet of 
oxygen storage and dispensing equipment carried under paragraph (a) of 
this section or a portable oxygen concentrator carried and operated 
under paragraph (f) of this section.
* * * * *
    (f) Portable oxygen concentrators--(1) Acceptance criteria. A 
passenger may carry or operate a portable oxygen concentrator for 
personal use on board an aircraft and a certificate holder may allow a 
passenger to carry or operate a portable oxygen concentrator on board 
an aircraft operated under this part during all phases of flight if the 
portable oxygen concentrator satisfies all of the requirements of this 
paragraph (f):
    (i) Is legally marketed in the United States in accordance with 
Food and Drug Administration requirements in title 21 of the CFR;
    (ii) Does not radiate radio frequency emissions that interfere with 
aircraft systems;
    (iii) Generates a maximum oxygen pressure of less than 200 kPa 
gauge (29.0 psig/43.8 psia) at 20 [deg]C (68 [deg]F);
    (iv) Does not contain any hazardous materials subject to the 
Hazardous Materials Regulations (49 CFR parts 171 through 180) except 
as provided in 49 CFR 175.10 for batteries used to power portable 
electronic devices and that do not require aircraft operator approval; 
and
    (v) Bears a label on the exterior of the device applied in a manner 
that ensures the label will remain affixed for the life of the device 
and containing the following certification statement in red lettering: 
``The manufacturer of this POC has determined this device conforms to 
all applicable FAA acceptance criteria for POC carriage and use on 
board aircraft.'' The label requirements in this paragraph (f)(1)(v) do 
not apply to the following portable oxygen concentrators approved by 
the FAA for use on board aircraft prior to May 24, 2016:
    (A) AirSep Focus;
    (B) AirSep FreeStyle;
    (C) AirSep FreeStyle 5;
    (D) AirSep LifeStyle;
    (E) Delphi RS-00400;
    (F) DeVilbiss Healthcare iGo;
    (G) Inogen One;
    (H) Inogen One G2;
    (I) Inogen One G3;
    (J) Inova Labs LifeChoice;
    (K) Inova Labs LifeChoice Activox;
    (L) International Biophysics LifeChoice;
    (M) Invacare Solo2;
    (N) Invacare XPO2;
    (O) Oxlife Independence Oxygen Concentrator;
    (P) Oxus RS-00400;
    (Q) Precision Medical EasyPulse;
    (R) Respironics EverGo;
    (S) Respironics SimplyGo;
    (T) SeQual Eclipse;
    (U) SeQual eQuinox Oxygen System (model 4000);
    (V) SeQual Oxywell Oxygen System (model 4000);
    (W) SeQual SAROS; and
    (X) VBox Trooper Oxygen Concentrator.
    (2) Operating requirements. Portable oxygen concentrators that 
satisfy the acceptance criteria identified in paragraph (f)(1) of this 
section may be carried on or operated by a passenger on board an 
aircraft provided the aircraft operator ensures that all of the 
conditions in this paragraph (f)(2) are satisfied:
    (i) Exit seats. No person operating a portable oxygen concentrator 
is permitted to occupy an exit seat.
    (ii) Stowage of device. During movement on the surface, takeoff and 
landing, the device must be stowed under the seat in front of the user, 
or in another approved stowage location so that it does not block the 
aisle way or the entryway to the row. If the device is to be operated 
by the user, it must be operated only at a seat location that does not 
restrict any passenger's access to, or use of, any required emergency 
or regular exit, or the aisle(s) in the passenger compartment.

0
17. Amend Sec.  135.144 as follows:
0
a. In paragraph (a) introductory text, remove ``of the following'';
0
b. In paragraph (b)(4), remove ``or'' following the semicolon;
0
c. Redesignate paragraph (b)(5) as paragraph (b)(6);
0
d. Add new paragraph (b)(5); and
0
e. In paragraph (c), remove the reference ``(b)(5)'' and add in its 
place ``(b)(6)''.
    The addition reads as follows:


Sec.  135.144  Portable electronic devices.

* * * * *
    (b) * * *
    (5) Portable oxygen concentrators that comply with the requirements 
in Sec.  135.91; or
* * * * *

PART 382--NONDISCRIMINATION ON THE BASIS OF DISABILITY IN AIR 
TRAVEL

0
18. The authority citation for part 382 continues to read as follows:

    Authority: 49 U.S.C. 41705.


0
19. In Sec.  382.27, revise paragraph (a) to read as follows:


Sec.  382.27  May a carrier require a passenger with a disability to 
provide advance notice in order to obtain certain specific services in 
connection with a flight?

    (a) Except as provided in paragraph (b) of this section and Sec.  
382.133(e)(4) and (5) and (f)(5) and (6), as a carrier you must not 
require a passenger with a disability to provide advance notice in 
order to obtain services or accommodations required by this part.
* * * * *

0
20. Revise Sec.  382.133 to read as follows:


Sec.  382.133  What are the requirements concerning the evaluation and 
use of passenger-supplied electronic devices that assist passengers 
with respiration in the cabin during flight?

    (a) Except for on-demand air taxi operators, as a U.S. carrier 
conducting passenger service you must permit any individual with a 
disability to use in the passenger cabin during air transportation an 
electronic assistive device specified in paragraph (c) of this section 
on all aircraft originally designed to have a maximum passenger 
capacity of more than 19 seats unless:
    (1) The device does not meet applicable FAA requirements for 
medical portable electronic device; or
    (2) The device cannot be stowed and used in the passenger cabin 
consistent with applicable TSA, FAA, and PHMSA regulations.
    (b) Except for foreign carriers conducting operations of a nature 
equivalent to on-demand air taxi operations by a U.S. carrier, as a 
foreign carrier conducting passenger service you must permit any 
individual with a disability to use in the passenger cabin during air 
transportation to, from or within the United States, an electronic 
assistive device specified in paragraph (d) of this section on all 
aircraft originally designed to have a maximum passenger capacity of 
more than 19 seats unless:
    (1) The device does not meet requirements for medical portable 
electronic devices set by the foreign carrier's government if such 
requirements exist;
    (2) The device does not meet requirements for medical portable 
electronic devices set by the FAA for U.S. carriers in circumstances 
where requirements for medical portable electronic devices have not 
been set by the foreign carrier's government and the foreign carrier 
elects to apply FAA requirements for medical portable electronic 
devices; or
    (3) The device cannot be stowed and used in the passenger cabin 
consistent with applicable TSA, FAA and PHMSA

[[Page 33121]]

regulations, and the safety or security regulations of the foreign 
carrier's government.
    (c) Except as provided in paragraph (a) of this section, as a 
covered U.S. air carrier, you must accept the passenger supplied 
electronic assistive device in this paragraph (c):
    (1) A portable oxygen concentrator (POC), a ventilator, a 
respirator or a continuous positive airway pressure machine that 
displays a manufacturer's label that indicates the device meets FAA 
requirements; and
    (2) The following POC models whether or not they are labeled:
    (i) AirSep Focus;
    (ii) AirSep FreeStyle;
    (iii) AirSep FreeStyle 5;
    (iv) AirSep LifeStyle;
    (v) Delphi RS-00400;
    (vi) DeVilbiss Healthcare iGo;
    (vii) Inogen One;
    (viii) Inogen One G2;
    (ix) Inogen One G3;
    (x) Inova Labs LifeChoice;
    (xi) Inova Labs LifeChoice Activox;
    (xii) International Biophysics LifeChoice;
    (xiii) Invacare Solo2;
    (xiv) Invacare XPO2;
    (xv) Oxlife Independence Oxygen Concentrator;
    (xvi) Oxus RS-00400;
    (xvii) Precision Medical EasyPulse;
    (xviii) Respironics EverGo;
    (xix) Respironics SimplyGo;
    (xx) SeQual Eclipse;
    (xxi) SeQual eQuinox Oxygen System (model 4000);
    (xxii) SeQual Oxywell Oxygen System (model 4000);
    (xxiii) SeQual SAROS; and
    (xxiv) VBox Trooper Oxygen Concentrator.
    (d) Except as provided in paragraph (b) of this section, as a 
covered foreign air carrier, you must accept the supplied electronic 
assistive devices in this paragraph (d):
    (1) A POC, a ventilator, a respirator or a continuous positive 
airway pressure machine that displays a manufacturer's label according 
to FAA requirements in circumstances where requirements for labeling 
these devices have not been set by the foreign carrier's government; 
and
    (2) The following POC models whether or not they are labeled:
    (i) AirSep Focus;
    (ii) AirSep FreeStyle;
    (iii) AirSep FreeStyle 5;
    (iv) AirSep LifeStyle;
    (v) Delphi RS-00400;
    (vi) DeVilbiss Healthcare iGo;
    (vii) Inogen One;
    (viii) Inogen One G2;
    (ix) Inogen One G3;
    (x) Inova Labs LifeChoice;
    (xi) Inova Labs LifeChoice Activox;
    (xii) International Biophysics LifeChoice;
    (xiii) Invacare Solo2;
    (xiv) Invacare XPO2;
    (xv) Oxlife Independence Oxygen Concentrator;
    (xvi) Oxus RS-00400;
    (xvii) Precision Medical EasyPulse;
    (xviii) Respironics EverGo;
    (xix) Respironics SimplyGo;
    (xx) SeQual Eclipse;
    (xxi) SeQual eQuinox Oxygen System (model 4000);
    (xxii) SeQual Oxywell Oxygen System (model 4000);
    (xxiii) SeQual SAROS; and
    (xxiv) VBox Trooper Oxygen Concentrator.
    (e) As a U.S. carrier, you must provide information during the 
reservation process as indicated in paragraphs (e)(1) through (6) of 
this section upon inquiry from an individual concerning the use in the 
cabin during air transportation of a ventilator, respirator, continuous 
positive airway machine, or a POC. The information in this paragraph 
(e) must be provided:
    (1) Any applicable requirement for a manufacturer-affixed label to 
reflect that the device has been tested to meet applicable FAA 
requirements for medical portable electronic devices;
    (2) The maximum weight and dimensions (length, width, height) of 
the device to be used by an individual that can be accommodated in the 
aircraft cabin consistent with FAA safety requirements;
    (3) The requirement to bring an adequate number of batteries as 
outlined in paragraph (h)(2) of this section and to ensure that extra 
batteries carried onboard to power the device are packaged and 
protected from short circuit and physical damage in accordance with 
applicable PHMSA regulations regarding spare batteries carried by 
passengers in an aircraft cabin;
    (4) Any requirement, if applicable, that an individual contact the 
carrier operating the flight 48 hours before scheduled departure to 
learn the expected maximum duration of his/her flight in order to 
determine the required number of batteries for his/her particular 
ventilator, respirator, continuous positive airway pressure machine, or 
POC;
    (5) Any requirement, if applicable, of the carrier operating the 
flight for an individual planning to use such a device to check-in up 
to one hour before that carrier's general check-in deadline; and
    (6) For POCs, the requirement of Sec.  382.23(b)(1)(ii) to present 
to the operating carrier at the airport a physician's statement 
(medical certificate).
    (f) As a foreign carrier operating flights to, from or within the 
United States, you must provide the information during the reservation 
process as indicated in paragraphs (f)(1) through (7) of this section 
upon inquiry from an individual concerning the use in the cabin during 
air transportation on such a flight of a ventilator, respirator, 
continuous positive airway machine, or POC. The information in this 
paragraph (f) must be provided:
    (1) Any applicable requirement for a manufacturer-affixed label to 
reflect that the device has been tested to meet requirements for 
medical portable electronic devices set by the foreign carrier's 
government if such requirements exist;
    (2) Any applicable requirement for a manufacturer-affixed label to 
reflect that the device has been tested to meet requirements for 
medical portable electronic devices set by the FAA for U.S. carriers if 
requirements for medical portable electronic devices have not been set 
by the foreign carrier's government and the foreign carrier elects to 
apply FAA requirements for medical portable electronic devices;
    (3) The maximum weight and dimensions (length, width, height) of 
the device to be used by an individual that can be accommodated in the 
aircraft cabin consistent with the safety regulations of the foreign 
carrier's government;
    (4) The requirement to bring an adequate number of batteries as 
outlined in paragraph (h)(2) of this section and to ensure that extra 
batteries carried onboard to power the device are packaged in 
accordance with applicable government safety regulations;
    (5) Any requirement, if applicable, that an individual contact the 
carrier operating the flight 48 hours before scheduled departure to 
learn the expected maximum duration of his/her flight in order to 
determine the required number of batteries for his/her particular 
ventilator, respirator, continuous positive airway pressure machine, or 
POC;
    (6) Any requirement, if applicable, of the carrier operating the 
flight for an individual planning to use such a device to check-in up 
to one hour before that carrier's general check-in deadline; and
    (7) Any requirement, if applicable, that an individual who wishes 
to use a POC onboard an aircraft present to the operating carrier at 
the airport a physician's statement (medical certificate).

[[Page 33122]]

    (g) In the case of a codeshare itinerary, the carrier whose code is 
used on the flight must either inform the individual inquiring about 
using a ventilator, respirator, CPAP machine or POC onboard an aircraft 
to contact the carrier operating the flight for information about its 
requirements for use of such devices in the cabin, or provide such 
information on behalf of the codeshare carrier operating the flight.
    (h)(1) As a U.S. or foreign carrier subject to paragraph (a) or (b) 
of this section, you must inform any individual who has advised you 
that he or she plans to operate his/her device in the aircraft cabin, 
within 48 hours of his/her making a reservation or 24 hours before the 
scheduled departure date of his/her flight, whichever date is earlier, 
of the expected maximum flight duration of each segment of his/her 
flight itinerary.
    (2) You may require an individual to bring an adequate number of 
fully charged batteries onboard, based on the battery manufacturer's 
estimate of the hours of battery life while the device is in use and 
the information provided in the physician's statement, to power the 
device for not less than 150% of the expected maximum flight duration.
    (3) If an individual does not comply with the conditions for 
acceptance of a medical portable electronic device as outlined in this 
section, you may deny boarding to the individual in accordance with 
Sec.  382.19(c) and in that event you must provide a written 
explanation to the individual in accordance with Sec.  382.19(d).

    Issued under authority provided by 49 U.S.C. 106(f) and 
44701(a), and authority provided by 49 U.S.C. 41705, delegated at 49 
CFR 1.27, in Washington, DC, on May 11, 2016.
Kathryn B. Thomson,
General Counsel, Department of Transportation.

Michael P. Huerta,
Administrator, Federal Aviation Administration.
[FR Doc. 2016-11918 Filed 5-23-16; 8:45 am]
 BILLING CODE 4910-13-P