Airworthiness Directives; Dassault Aviation Airplanes, 1595-1598 [2016-31871]

Download as PDF Federal Register / Vol. 82, No. 4 / Friday, January 6, 2017 / Rules and Regulations (g) Inspection of Fluid Level and Nitrogen Pressure in HR Within the compliance time defined in table 1 to paragraph (g) of this AD, as applicable, inspect the HR fluid level and nitrogen pressure of each hydraulic circuit, in accordance with the instructions of paragraph 4.2.2.1 of Airbus Alert Operators Transmission (AOT) A29L005–16, Revision 01, dated June 28, 2016. Repeat the inspection thereafter at intervals not to exceed 1,600 flight hours. TABLE 1 TO PARAGRAPH (g) OF THIS AD—INITIAL INSPECTION COMPLIANCE TIME Compliance Time (A or B, whichever occurs later) A ........... B ........... Before accumulating 1,600 flight hours since first flight of the airplane. Within 1,000 flight hours or 3 months, whichever occurs first after the effective date of this AD. (h) Corrective Action If, during any inspection required by paragraph (g) of this AD, any unacceptable pressure or fluid level is identified, before further flight, do the actions in paragraphs (h)(1) and (h)(2) of this AD, as applicable, for each unacceptable pressure or fluid level that is discovered. Accomplishment of these actions on an airplane does not constitute terminating action for the repetitive inspections as required by paragraph (g) of this AD for that airplane. (1) Add or remove hydraulic fluid, as applicable, in accordance with the instructions of paragraph 4.2.2.2 of Airbus Alert Operators Transmission (AOT) A29L005–16, Revision 01, dated June 28, 2016. (2) Add or remove nitrogen gas, as applicable, in accordance with the instructions of paragraph 4.2.2.2 of Airbus AOT A29L005–16, Revision 01, dated June 28, 2016. sradovich on DSK3GMQ082PROD with RULES (i) Servicing Hydraulic Reservoir Concurrent with the initial inspection specified in paragraph (g) of this AD, revise the maintenance or inspection program, as applicable, to incorporate the hydraulic reservoir servicing actions specified in paragraph 4.2.2.2 of Airbus AOT A29L005– 16, Revision 01, dated June 28, 2016. (j) No Alternative Actions and Intervals After accomplishing the revision required by paragraph (i) of this AD, no alternative actions (e.g., inspections) and intervals may be used unless the actions and intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (l)(1) of this AD. (k) Credit for Previous Actions This paragraph provides credit for actions required by paragraphs (g) and (h) of this AD, if those actions were performed before the VerDate Sep<11>2014 17:18 Jan 05, 2017 Jkt 241001 effective date of this AD using Airbus AOTA29L005–16, dated January 28, 2016. (l) Other FAA AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1138; fax 425–227–1149. Information may be emailed to: 9–ANM–116– AMOC–REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM– 116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus’s EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature. (m) Related Information (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2016–0107, dated June 7, 2016, for related information. This MCAI may be found in the AD docket on the Internet at http:// www.regulations.gov by searching for and locating Docket No. FAA–2016–9117. (2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (n)(3) and (n)(4) of this AD. (n) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise. (i) Airbus Alert Operators Transmission (AOT) A29L005–16, Revision 01, dated June 28, 2016. (ii) Reserved. (3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email: airworthiness.A330–A340@airbus.com; Internet: http://www.airbus.com. (4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 1595 information on the availability of this material at the FAA, call 425–227–1221. (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federal-register/cfr/ibrlocations.html. Issued in Renton, Washington, on December 23, 2016. Thomas Groves, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2016–31868 Filed 1–5–17; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA–2016–7420; Directorate Identifier 2015–NM–017–AD; Amendment 39–18774; AD 2017–01–07] RIN 2120–AA64 Airworthiness Directives; Dassault Aviation Airplanes Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. AGENCY: We are adopting a new airworthiness directive (AD) for all Dassault Aviation Model FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; Model MYSTEREFALCON 20–C5, 20–D5, 20–E5, and 20– F5 airplanes; and MYSTERE-FALCON 50 airplanes. This AD was prompted by a report that, during approach for landing, the main entry door detached from an airplane. This AD requires a functional test or check of the main entry door closure and warning system, and applicable door closing inspections, adjustments, operational tests, and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products. DATES: This AD is effective February 10, 2017. The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of February 10, 2017. ADDRESSES: For service information identified in this final rule, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201– 440–6700; Internet http:// SUMMARY: E:\FR\FM\06JAR1.SGM 06JAR1 1596 Federal Register / Vol. 82, No. 4 / Friday, January 6, 2017 / Rules and Regulations www.dassaultfalcon.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425 227–1221. It is also available on the Internet at http:// www.regulations.gov by searching for and locating Docket No. FAA–2016– 7420. Examining the AD Docket You may examine the AD docket on the Internet at http:// www.regulations.gov by searching for and locating Docket No. FAA–2016– 7420; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800–647– 5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1137; fax 425–227–1149. SUPPLEMENTARY INFORMATION: Discussion We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Dassault Aviation Model FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTEREFALCON 200 airplanes; Model MYSTERE-FALCON 20–C5, 20–D5, 20– E5, and 20–F5 airplanes; and MYSTERE–FALCON 50 airplanes. The NPRM published in the Federal Register on July 1, 2016 (81 FR 43120). The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015–0007, dated January 15, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or ‘‘the MCAI’’), to correct an unsafe condition for all Dassault Aviation Model FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; Model MYSTERE-FALCON 20–C5, 20–D5, 20–E5, and 20–F5 airplanes; and MYSTERE-FALCON 50 airplanes. The MCAI states: ` During approach for landing, a MystereFalcon 20–X5 lost the main entrance door [MED] at an altitude of 7,000 feet. The flight crew maintained control of the aeroplane to land uneventfully. The results of the preliminary technical investigations concluded that the cause of this event could be either a broken cable, or an unlocked safety catch, associated with one or two deficient micro switches. This condition, if not detected and corrected, could lead to in-flight opening and/or detachment of the Crew/Passenger door, possibly resulting in loss of control of the aeroplane, and/or injury to persons on the ground. To address this potential unsafe condition, Dassault Aviation issued Service Bulletins (SB) F20–789, F200–133 and MF50–531, providing instructions for inspection/ adjustment, as well as an operational test of the Crew/Passenger door closure. For the reasons described above, this [EASA] AD requires a one-time accomplishment of a functional test/check of the MED closure/warning system. It also requires [a general visual] inspection and operational test of the Crew/Passenger door [including the control and latching mechanisms] and, depending on findings, applicable corrective actions. Corrective actions include adjusting the telescopic rod bolts on the door until the clearance between the lower part of the door and the fuselage is within the specified tolerances. The corrective actions for the control and latching mechanisms include adjusting components and replacing damaged components (including pull latches, microswitches, pulleys, and cables). Signs of damage include cracks, corrosion, wear, and distortion. You may examine the MCAI in the AD docket on the Internet at http:// www.regulations.gov by searching for and locating Docket No. FAA–2016– 7420. Comments We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public. Conclusion We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes: • Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and • Do not add any additional burden upon the public than was already proposed in the NPRM. Related Service Information Under 1 CFR Part 51 Dassault Aviation issued the following service information. • Dassault Service Bulletin F20–789, also referred to as 789, dated December 9, 2014. • Dassault Service Bulletin F50–531, also referred to as 531, dated December 9, 2014. • Dassault Service Bulletin F200–133, also referred to as 133, dated December 9, 2014. The service information describes procedures for inspections, adjustments, and operational tests of certain doors and corrective actions. These documents are distinct since they apply to different airplane models. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section. Costs of Compliance We estimate that this AD affects 392 airplanes of U.S. registry. We estimate the following costs to comply with this AD: ESTIMATED COSTS sradovich on DSK3GMQ082PROD with RULES Action Labor cost 4 work-hours × $85 per hour = $340 ............. Inspections/adjustments/operational tests. We have received no definitive data that will enable us to provide cost VerDate Sep<11>2014 17:18 Jan 05, 2017 Jkt 241001 estimates for the on-condition actions specified in this AD. PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 Cost per product Parts cost $0 Cost on U.S. operators $340 $133,280 Authority for This Rulemaking Title 49 of the United States Code specifies the FAA’s authority to issue E:\FR\FM\06JAR1.SGM 06JAR1 Federal Register / Vol. 82, No. 4 / Friday, January 6, 2017 / Rules and Regulations rules on aviation safety. 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. We are issuing this rulemaking under the authority described in ‘‘Subtitle VII, Part A, Subpart III, Section 44701: General requirements.’’ Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD: 1. Is not a ‘‘significant regulatory action’’ under Executive Order 12866; 2. Is not a ‘‘significant rule’’ under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); 3. Will not affect intrastate aviation in Alaska; and 4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: sradovich on DSK3GMQ082PROD with RULES ■ Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): ■ VerDate Sep<11>2014 17:18 Jan 05, 2017 Jkt 241001 2017–01–07 Dassault Aviation: Amendment 39–18774; Docket No. FAA–2016–7420; Directorate Identifier 2015–NM–017–AD. 1597 (h) Main Entry/Passenger/Crew Door Closing Inspections, Adjustments, and Operational Tests and Corrective Actions Air Transport Association (ATA) of America Code 52, Doors. Within 330 flight hours or 13 months, whichever occurs first after the effective date of this AD, unless already done: Do the applicable door closing inspections, adjustments, and operational tests, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of the applicable service information identified in paragraph (h)(1), (h)(2), or (h)(3) of this AD. Do all applicable corrective actions before further flight. (1) For Model FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F, and G airplanes; and Model MYSTEREFALCON 20–C5, 20–D5, 20–E5, and 20–F5 airplanes: Dassault Service Bulletin F20–789, also referred to as 789, dated December 9, 2014. (2) For Model MYSTERE-FALCON 200 airplanes: Dassault Service Bulletin F200– 133, also referred to as 133, dated December 9, 2014. (3) For Model MYSTERE-FALCON 50 airplanes: Dassault Service Bulletin F50–531, also referred to as 531, dated December 9, 2014. (e) Reason (i) Other FAA AD Provisions This AD was prompted by a report that, during approach for landing, the main entry door detached from an airplane. We are issuing this AD to detect and correct defective crew/passenger doors. Such a condition could result in the in-flight opening or detachment of the crew/passenger door, which could result in loss of control of the airplane and injury to persons on the ground. The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1137; fax 425–227–1149. Information may be emailed to: 9-ANM-116AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM– 116, Transport Airplane Directorate, FAA; or the EASA; or Dassault Aviation’s EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature. (a) Effective Date This AD is effective February 10, 2017. (b) Affected ADs None. (c) Applicability This AD applies to the Dassault Aviation airplanes, certificated in any category, identified in paragraphs (c)(1) through (c)(5) of this AD, all airplanes. (1) Model FAN JET FALCON airplanes. (2) Model FAN JET FALCON SERIES C, D, E, F, and G airplanes. (3) Model MYSTERE–FALCON 200 airplanes. (4) Model MYSTERE–FALCON 20–C5, 20– D5, 20–E5, and 20–F5 airplanes. (5) Model MYSTERE–FALCON 50 airplanes. (d) Subject (f) Compliance Comply with this AD within the compliance times specified. (g) Main Entry/Passenger/Crew Door Check or Functional Test Within 65 days after the effective date of this AD, unless done within 6 months before the effective date of this AD, do the applicable functional test or door lock check specified in paragraph (g)(1), (g)(2), or (g)(3) of this AD, and do all applicable corrective actions, using a method approved by the Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Dassault Aviation’s EASA Design Organization Approval (DOA). Do all applicable corrective actions before further flight. (1) For Model FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F, and G airplanes; and Model MYSTEREFALCON 20–C5, 20–D5, 20–E5, and 20–F5 airplanes: A functional test of the passenger/ crew door warning system. (2) For Model MYSTERE-FALCON 200 airplanes: A check of the door locking indicator system. (3) For Model MYSTERE-FALCON 50 airplanes: A check of the door lock indication. PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 (j) Related Information Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015–0007, dated January 15, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA–2016–7420. E:\FR\FM\06JAR1.SGM 06JAR1 1598 Federal Register / Vol. 82, No. 4 / Friday, January 6, 2017 / Rules and Regulations (k) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise. (i) Dassault Service Bulletin F20–789, also referred to as 789, dated December 9, 2014. (ii) Dassault Service Bulletin F50–531, also referred to as 531, dated December 9, 2014. (iii) Dassault Service Bulletin F200–133, also referred to as 133, dated December 9, 2014. (3) For service information identified in this AD, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201–440–6700; Internet http:// www.dassaultfalcon.com. (4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federal-register/cfr/ibrlocations.html. Issued in Renton, Washington, on December 23, 2016. Thomas Groves, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2016–31871 Filed 1–5–17; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA–2014–N–0297] Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as ‘‘specialized surgical instrumentation for use with sradovich on DSK3GMQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 17:18 Jan 05, 2017 Jkt 241001 urogynecologic surgical mesh.’’ FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information. DATES: This order is effective January 6, 2017. See further discussion in section V, ‘‘Implementation Strategy.’’ FOR FURTHER INFORMATION CONTACT: Sharon Andrews, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. G110, Silver Spring, MD 20993, 301–796– 6529, Sharon.Andrews@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.), as amended, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). Devices that were in commercial distribution before the enactment of the 1976 amendments on May 28, 1976, are generally referred to as preamendments devices. Under section 513(d) of the FD&C Act, preamendments devices are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel’s recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures. Devices that were not in commercial distribution prior to May 28, 1976, are generally referred to as postamendments devices. Postamendments devices are automatically classified into class III without any FDA rulemaking process (section 513(f) of the FD&C Act). Postamendments devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807. On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112–144) was enacted. Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device from rulemaking to an administrative order. Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon ‘‘new information.’’ FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify a device. The term ‘‘new information,’’ as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland-Rantos Co. v. United States Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).) Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority (see Bell, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388–391 (D.D.C. 1991)), or in light of changes in ‘‘medical science’’ (Upjohn, 422 F.2d at 951). Whether data before the Agency are old or new data, the ‘‘new information’’ to support reclassification under section 513(e) must be ‘‘valid scientific evidence,’’ as defined in section 513(a)(3) of the FD&C Act and § 860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., Gen. Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).) To be considered in the reclassification process, the ‘‘valid scientific evidence’’ upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending premarket approval application (PMA). (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) The process for issuing a final reclassification order is specified in section 513(e)(1) of the FD&C Act. Prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; E:\FR\FM\06JAR1.SGM 06JAR1

Agencies

[Federal Register Volume 82, Number 4 (Friday, January 6, 2017)]
[Rules and Regulations]
[Pages 1595-1598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31871]


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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-7420; Directorate Identifier 2015-NM-017-AD; 
Amendment 39-18774; AD 2017-01-07]
RIN 2120-AA64


Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of 
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all 
Dassault Aviation Model FAN JET FALCON airplanes; Model FAN JET FALCON 
SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; 
Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes; and 
MYSTERE-FALCON 50 airplanes. This AD was prompted by a report that, 
during approach for landing, the main entry door detached from an 
airplane. This AD requires a functional test or check of the main entry 
door closure and warning system, and applicable door closing 
inspections, adjustments, operational tests, and corrective actions if 
necessary. We are issuing this AD to address the unsafe condition on 
these products.

DATES: This AD is effective February 10, 2017.
    The Director of the Federal Register approved the incorporation by 
reference of certain publications listed in this AD as of February 10, 
2017.

ADDRESSES: For service information identified in this final rule, 
contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 
2000, South Hackensack, NJ 07606; telephone 201-440-6700; Internet 
http://

[[Page 1596]]

www.dassaultfalcon.com. You may view this referenced service 
information at the FAA, Transport Airplane Directorate, 1601 Lind 
Avenue SW., Renton, WA. For information on the availability of this 
material at the FAA, call 425 227-1221. It is also available on the 
Internet at http://www.regulations.gov by searching for and locating 
Docket No. FAA-2016-7420.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
7420; or in person at the Docket Management Facility between 9 a.m. and 
5 p.m., Monday through Friday, except Federal holidays. The AD docket 
contains this AD, the regulatory evaluation, any comments received, and 
other information. The street address for the Docket Office (telephone 
800-647-5527) is Docket Management Facility, U.S. Department of 
Transportation, Docket Operations, M-30, West Building Ground Floor, 
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer, 
International Branch, ANM-116, Transport Airplane Directorate, FAA, 
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; 
fax 425-227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR 
part 39 by adding an AD that would apply to all Dassault Aviation Model 
FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F, and G 
airplanes; Model MYSTERE-FALCON 200 airplanes; Model MYSTERE-FALCON 20-
C5, 20-D5, 20-E5, and 20-F5 airplanes; and MYSTERE-FALCON 50 airplanes. 
The NPRM published in the Federal Register on July 1, 2016 (81 FR 
43120).
    The European Aviation Safety Agency (EASA), which is the Technical 
Agent for the Member States of the European Union, has issued EASA 
Airworthiness Directive 2015-0007, dated January 15, 2015 (referred to 
after this as the Mandatory Continuing Airworthiness Information, or 
``the MCAI''), to correct an unsafe condition for all Dassault Aviation 
Model FAN JET FALCON airplanes; Model FAN JET FALCON SERIES C, D, E, F, 
and G airplanes; Model MYSTERE-FALCON 200 airplanes; Model MYSTERE-
FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes; and MYSTERE-FALCON 50 
airplanes. The MCAI states:

    During approach for landing, a Myst[egrave]re-Falcon 20-X5 lost 
the main entrance door [MED] at an altitude of 7,000 feet. The 
flight crew maintained control of the aeroplane to land 
uneventfully. The results of the preliminary technical 
investigations concluded that the cause of this event could be 
either a broken cable, or an unlocked safety catch, associated with 
one or two deficient micro switches.
    This condition, if not detected and corrected, could lead to in-
flight opening and/or detachment of the Crew/Passenger door, 
possibly resulting in loss of control of the aeroplane, and/or 
injury to persons on the ground.
    To address this potential unsafe condition, Dassault Aviation 
issued Service Bulletins (SB) F20-789, F200-133 and MF50-531, 
providing instructions for inspection/adjustment, as well as an 
operational test of the Crew/Passenger door closure.
    For the reasons described above, this [EASA] AD requires a one-
time accomplishment of a functional test/check of the MED closure/
warning system. It also requires [a general visual] inspection and 
operational test of the Crew/Passenger door [including the control 
and latching mechanisms] and, depending on findings, applicable 
corrective actions.

    Corrective actions include adjusting the telescopic rod bolts on 
the door until the clearance between the lower part of the door and the 
fuselage is within the specified tolerances. The corrective actions for 
the control and latching mechanisms include adjusting components and 
replacing damaged components (including pull latches, microswitches, 
pulleys, and cables). Signs of damage include cracks, corrosion, wear, 
and distortion. You may examine the MCAI in the AD docket on the 
Internet at http://www.regulations.gov by searching for and locating 
Docket No. FAA-2016-7420.

Comments

    We gave the public the opportunity to participate in developing 
this AD. We received no comments on the NPRM or on the determination of 
the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and 
the public interest require adopting this AD as proposed except for 
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the 
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was 
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Dassault Aviation issued the following service information.
     Dassault Service Bulletin F20-789, also referred to as 
789, dated December 9, 2014.
     Dassault Service Bulletin F50-531, also referred to as 
531, dated December 9, 2014.
     Dassault Service Bulletin F200-133, also referred to as 
133, dated December 9, 2014.
    The service information describes procedures for inspections, 
adjustments, and operational tests of certain doors and corrective 
actions. These documents are distinct since they apply to different 
airplane models. This service information is reasonably available 
because the interested parties have access to it through their normal 
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 392 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                     Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspections/adjustments/operational     4 work-hours x $85 per                $0            $340        $133,280
 tests.                                  hour = $340.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that will enable us to provide 
cost estimates for the on-condition actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to 
issue

[[Page 1597]]

rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in 
``Subtitle VII, Part A, Subpart III, Section 44701: General 
requirements.'' Under that section, Congress charges the FAA with 
promoting safe flight of civil aircraft in air commerce by prescribing 
regulations for practices, methods, and procedures the Administrator 
finds necessary for safety in air commerce. This regulation is within 
the scope of that authority because it addresses an unsafe condition 
that is likely to exist or develop on products identified in this 
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications 
under Executive Order 13132. This AD will not have a substantial direct 
effect on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order 
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies 
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or 
negative, on a substantial number of small entities under the criteria 
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by 
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the 
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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


Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness 
directive (AD):

2017-01-07 Dassault Aviation: Amendment 39-18774; Docket No. FAA-
2016-7420; Directorate Identifier 2015-NM-017-AD.

(a) Effective Date

    This AD is effective February 10, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Dassault Aviation airplanes, certificated 
in any category, identified in paragraphs (c)(1) through (c)(5) of 
this AD, all airplanes.
    (1) Model FAN JET FALCON airplanes.
    (2) Model FAN JET FALCON SERIES C, D, E, F, and G airplanes.
    (3) Model MYSTERE-FALCON 200 airplanes.
    (4) Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 
airplanes.
    (5) Model MYSTERE-FALCON 50 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Reason

    This AD was prompted by a report that, during approach for 
landing, the main entry door detached from an airplane. We are 
issuing this AD to detect and correct defective crew/passenger 
doors. Such a condition could result in the in-flight opening or 
detachment of the crew/passenger door, which could result in loss of 
control of the airplane and injury to persons on the ground.

(f) Compliance

    Comply with this AD within the compliance times specified.

(g) Main Entry/Passenger/Crew Door Check or Functional Test

    Within 65 days after the effective date of this AD, unless done 
within 6 months before the effective date of this AD, do the 
applicable functional test or door lock check specified in paragraph 
(g)(1), (g)(2), or (g)(3) of this AD, and do all applicable 
corrective actions, using a method approved by the Manager, 
International Branch, ANM-116, Transport Airplane Directorate, FAA; 
or the European Aviation Safety Agency (EASA); or Dassault 
Aviation's EASA Design Organization Approval (DOA). Do all 
applicable corrective actions before further flight.
    (1) For Model FAN JET FALCON airplanes; Model FAN JET FALCON 
SERIES C, D, E, F, and G airplanes; and Model MYSTERE-FALCON 20-C5, 
20-D5, 20-E5, and 20-F5 airplanes: A functional test of the 
passenger/crew door warning system.
    (2) For Model MYSTERE-FALCON 200 airplanes: A check of the door 
locking indicator system.
    (3) For Model MYSTERE-FALCON 50 airplanes: A check of the door 
lock indication.

(h) Main Entry/Passenger/Crew Door Closing Inspections, Adjustments, 
and Operational Tests and Corrective Actions

    Within 330 flight hours or 13 months, whichever occurs first 
after the effective date of this AD, unless already done: Do the 
applicable door closing inspections, adjustments, and operational 
tests, and do all applicable corrective actions, in accordance with 
the Accomplishment Instructions of the applicable service 
information identified in paragraph (h)(1), (h)(2), or (h)(3) of 
this AD. Do all applicable corrective actions before further flight.
    (1) For Model FAN JET FALCON airplanes; Model FAN JET FALCON 
SERIES C, D, E, F, and G airplanes; and Model MYSTERE-FALCON 20-C5, 
20-D5, 20-E5, and 20-F5 airplanes: Dassault Service Bulletin F20-
789, also referred to as 789, dated December 9, 2014.
    (2) For Model MYSTERE-FALCON 200 airplanes: Dassault Service 
Bulletin F200-133, also referred to as 133, dated December 9, 2014.
    (3) For Model MYSTERE-FALCON 50 airplanes: Dassault Service 
Bulletin F50-531, also referred to as 531, dated December 9, 2014.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, 
International Branch, ANM-116, Transport Airplane Directorate, FAA, 
has the authority to approve AMOCs for this AD, if requested using 
the procedures found in 14 CFR 39.19. In accordance with 14 CFR 
39.19, send your request to your principal inspector or local Flight 
Standards District Office, as appropriate. If sending information 
directly to the International Branch, send it to ATTN: Tom 
Rodriguez, Aerospace Engineer, International Branch, ANM-116, 
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, 
WA 98057-3356; telephone 425-227-1137; fax 425-227-1149. Information 
may be emailed to: 9-ANM-116-AMOC-REQUESTS@faa.gov. Before using any 
approved AMOC, notify your appropriate principal inspector, or 
lacking a principal inspector, the manager of the local flight 
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD 
to obtain corrective actions from a manufacturer, the action must be 
accomplished using a method approved by the Manager, International 
Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; 
or Dassault Aviation's EASA DOA. If approved by the DOA, the 
approval must include the DOA-authorized signature.

(j) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI) 
EASA Airworthiness Directive 2015-0007, dated January 15, 2015, for 
related information. This MCAI may be found in the AD docket on the 
Internet at http://www.regulations.gov by searching for and locating 
Docket No. FAA-2016-7420.

[[Page 1598]]

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the 
incorporation by reference (IBR) of the service information listed 
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do 
the actions required by this AD, unless this AD specifies otherwise.
    (i) Dassault Service Bulletin F20-789, also referred to as 789, 
dated December 9, 2014.
    (ii) Dassault Service Bulletin F50-531, also referred to as 531, 
dated December 9, 2014.
    (iii) Dassault Service Bulletin F200-133, also referred to as 
133, dated December 9, 2014.
    (3) For service information identified in this AD, contact 
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, 
South Hackensack, NJ 07606; telephone 201-440-6700; Internet http://www.dassaultfalcon.com.
    (4) You may view this service information at the FAA, Transport 
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For 
information on the availability of this material at the FAA, call 
425-227-1221.
    (5) You may view this service information that is incorporated 
by reference at the National Archives and Records Administration 
(NARA). For information on the availability of this material at 
NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on December 23, 2016.
Thomas Groves,
Acting Manager, Transport Airplane Directorate, Aircraft Certification 
Service.
[FR Doc. 2016-31871 Filed 1-5-17; 8:45 am]
 BILLING CODE 4910-13-P