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 https://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 https://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., https:// 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 https://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 https:// 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 https://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 (https://www.regulations.gov); 2. Visit the FAA’s Regulations and Policies Web page at https:// www.faa.gov/regulations_policies/ or 3. Access the Government Publishing Office’s Web page at https:// 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 https://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 https:// 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.
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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\
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\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
https://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 https://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., https://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 https://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
https://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\ https://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 (https://www.regulations.gov);
2. Visit the FAA's Regulations and Policies Web page at https://www.faa.gov/regulations_policies/ or
3. Access the Government Publishing Office's Web page at https://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 https://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 https://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

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