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Concentrator: means the AirSep DEPARTMENT OF TRANSPORTATION United States Code. This rulemaking is FreeStyle, AirSep LifeStyle, AirSep promulgated under the authority Focus, AirSep Freestyle 5, Delphi RS– Federal Aviation Administration described in 49 U.S.C. 106(f), which 00400, DeVilbiss Healthcare iGo, Inogen establishes the authority of the One, Inogen One G2, Inogen One G3, 14 CFR Parts 121, 125, and 135 Administrator to promulgate regulations and rules and 49 U.S.C. 44701(a)(5), Inova Labs LifeChoice, Inova Labs [Docket No.: FAA–2012–1059; Amdts. No.: LifeChoice Activox, International 121–368, 125–63, 135–128] which requires the Administrator to Biophysics LifeChoice, Invacare XPO2, promulgate regulations and minimum Invacare Solo2, Oxlife Independence RIN 2120–AK11 standards for other practices, methods, and procedures necessary for safety in Oxygen Concentrator, Oxus RS–00400, Minimum Altitudes for Use of air commerce and national security. Precision Medical EasyPulse, Autopilots This amendment to the regulation is Respironics EverGo, Respironics within the scope of that authority AGENCY: Federal Aviation SimplyGo, SeQual Eclipse, SeQual because it prescribes an accepted Administration (FAA), DOT. eQuinox Oxygen System (model 4000), method for ensuring the safe operation SeQual Oxywell Oxygen System (model ACTION: Final rule. of aircraft while using autopilot 4000), SeQual SAROS and VBOX systems. Trooper Oxygen Concentrator medical SUMMARY: This rulemaking amends and device units as long as those medical harmonizes minimum altitudes for use I. Overview of Final Rule device units: (1) Do not contain of autopilots for transport category The FAA amends and harmonizes airplanes; it also enables the operational hazardous materials as determined by minimum altitudes for use of autopilots use of advanced autopilot and the Pipeline and Hazardous Materials for transport category airplanes in order navigation systems by incorporating the Safety Administration; (2) are also to streamline and simplify these capabilities of current and future operational rules. This final rule enables regulated by the Food and Drug autopilots, flight guidance systems, and Administration; and (3) assist a user of the operational use of advanced Global Navigation Satellite System autopilot and navigation systems by medical oxygen under a doctor’s care. (GNSS) guidance systems while These units perform by separating incorporating the capabilities of existing protecting the continued use of legacy and future autopilots, flight guidance oxygen from nitrogen and other gases systems at current autopilot minimum systems, and GNSS guidance systems contained in ambient air and dispensing use altitudes. Additionally, this final while protecting the continued use of it in concentrated form to the user. rule implements a performance-based legacy systems. This allows the FAA to Section 3. Operating Requirements— approach, using the certified enable the benefits of Next Generation capabilities of autopilot systems as (a) No person may use and no aircraft Air Transportation System (NextGen) established by the Airplane Flight operator may allow the use of any technologies and procedures (Optimized Manual (AFM) or as approved by the Profile Descents, Performance Based portable oxygen concentrator device, Administrator. except the AirSep FreeStyle, AirSep Navigation (PBN)) to enhance aviation safety in the National Airspace System LifeStyle, AirSep Focus, AirSep DATES: Effective April 4, 2014. (NAS). This final rule also gives the FreeStyle 5, Delphi RS–00400, DeVilbiss ADDRESSES: For information on where to obtain copies of rulemaking documents FAA Administrator the authorization to Healthcare iGo, Inogen One, Inogen One require an altitude higher than the AFM and other information related to this G2, Inogen One G3, Inova Labs if the Administrator believes it to be in final rule, see ‘‘How To Obtain LifeChoice, Inova Labs LifeChoice the interest of public safety. Activox, International Biophysics Additional Information’’ section of this Currently, operators have a choice LifeChoice, Invacare XPO2, Invacare document. whether or not to update their aircraft Solo2, Oxlife Independence Oxygen FOR FURTHER INFORMATION CONTACT: For with new autopilots as they are Concentrator, Oxus RS–00400, Precision technical questions concerning this developed and certified by equipment Medical EasyPulse, Respironics EverGo, action, contact Kel O. Christianson, manufacturers. This final rule does not Respironics SimplyGo, SeQual Eclipse, FAA, Aviation Safety Inspector, affect this decision-making process and SeQual eQuinox Oxygen System (model Performance Based Flight Systems protects operators to continue operating 4000), SeQual Oxywell Oxygen System Branch (AFS–470), Flight Standards as they do today. As a result, this action (model 4000), SeQual SAROS and Service, Federal Aviation does not impose any additional costs on VBOX Trooper Portable Oxygen Administration, 800 Independence certificate holders that operate under Concentrator units. These units may be Avenue SW., Washington, DC 20591; parts 121, 125, or 135. Also, by setting telephone 202–385–4702; email carried on and used by a passenger on new minimum altitudes for each phase [email protected]. board an aircraft provided the aircraft of flight that approved equipment may For legal questions concerning this operate to, this final rule gives operator ensures that the following action, contact Robert H. Frenzel, conditions are satisfied: manufacturers more certainty that new Manager, Operations Law Branch, Office products can be used as they are * * * * * of the Chief Counsel, Regulations developed. Issued under authority provided by 49 Division (AGC–220), Federal Aviation In response to Executive Order 13563 U.S.C. 106(f) and 44701(a)(5) in Washington, Administration, 800 Independence issued by President Obama on January DC, on December 23, 2013. Avenue SW., Washington, DC 20591; 18, 2011, this rule was identified for Michael P. Huerta, telephone 202–267–3073; email inclusion in the Department of [email protected]. Transportation Retrospective Regulatory Administrator. SUPPLEMENTARY INFORMATION: Review (May 2011), noting that the [FR Doc. 2014–02121 Filed 1–31–14; 8:45 am] current minimum altitudes for use of BILLING CODE 4910–13–P Authority for This Rulemaking autopilots were unduly restrictive and The FAA’s authority to issue rules on would limit the ability to use new aviation safety is found in Title 49 of the technologies. On May 10, 2012,

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President Obama signed Executive Specification (OpSpec), which was E. General Overview of Comments Order 13610, establishing the implemented as a stopgap measure. The The FAA received 3 public Retrospective Regulatory Review as an rule itself was not changed to provide comments. The National Business on-going obligation. The final rule is manufacturers and operators the Aviation Association (NBAA) provided consistent with the requirement in guidance for producing and operating one comment supporting the rule. The Executive Order 13610 to modify or new aircraft capable of attaining lower second commenter focused on the streamline regulations ‘‘in light of autopilot minimum use altitudes. The definitions and terms used in the changed circumstances, including the amendment also failed to address regulatory text and the third commenter rise of new technologies.’’ autopilot minimum use altitudes on requested a clarification of the II. Background instrument approaches or harmonize 14 regulatory text. CFR parts 121, 125 and 135. A. Statement of the Problem III. Discussion of Public Comments and C. ARAC Efforts To Amend Autopilots Final Rule The FAA and Civil Aeronautics Rules Administration (CAA) (the predecessor A. Revise Minimum Altitudes for Use of to the FAA) technical standards for Since 1997, multiple groups have Autopilot (§ 121.579, 125.329 and autopilot systems date back to 1947. been formed to review current 135.93) These standards have been revised eight regulations and autopilot technologies. A commenter suggested that times since 1959, but the operating rules The FAA Transport Airplane Directorate Threshhold Elevation (THRE) be added for autopilot minimum use altitudes in initiated an effort under the ARAC to the definition of TDZE to read, 14 Code of Federal Regulations (14 CFR) Flight Guidance Harmonization ‘‘touchdown zone/threshold elevation’’ §§ 121.579, 125.329, and 135.93 have Working Group to evaluate the status of (TDZE). The suggestion was made based not been amended in any significant current autopilot technologies, rules and on the fact that, at the time of the way since the recodification of the Civil guidance along with the harmonization NPRM, TDZEs were being replaced with Aviation Regulations (CAR) and Civil of U.S. policy and guidance with the THREs on instrument approach plates Aviation Manuals (CAM) on December Joint Aviation Authorities. Later, the (IAPs) in the NAS. This resulted in 31, 1964. Performance-based operations Aviation instrument approach plates published By contrast, autopilot certification Rulemaking Committee, which with either a TDZE or THRE. The standards contained in 14 CFR 25.1329 established the Autopilot Minimum Use comment was suggested so that the rule were updated as recently as April 11, Height (MUH) action team, evaluated would reference both terms, thus 2006. Consequently, operational autopilot minimum use altitudes and allowing both terms to be used by the regulations in parts 121, 125, and 135 made recommendations to the Associate pilots as a reference for adding the do not adequately reflect the capabilities Administrator for Aviation Safety. The applicable altitudes or heights of modern technologies in use today and team was specifically tasked with published in the AFM. thus make it difficult to keep pace with developing recommendations to address The policy to change TDZE to THRE the FAA’s implementation of NextGen. progress in the area of PBN and the has been rescinded. TDZE will now be the standard and will replace THRE on B. History subsets of area navigation (RNAV) and required navigation performance (RNP) IAPs that are currently published with The FAA published an NPRM in the operations. The team’s conclusions THRE. Based on this, the FAA has Federal Register on December 9, 1994 aligned with the previous groups’ decided that TDZE will remain the only (59 FR 63868) based on a acknowledgement that §§ 121.579, term used in this final rule. As a result, recommendation from the Autopilot 125.329 and 135.93 were outdated and this final rule will allow operators to Engagement Working Group of the recommended new rulemaking to take add the applicable altitudes or heights Aviation Rulemaking Advisory advantage of advancements in modern published in the AFM to the airport Committee (ARAC) to change the aircraft technologies and the certified elevation and TDZE published on the existing rules concerning engagement of capabilities of autopilot systems to instrument approach plate. This will autopilots during takeoff. The ARAC create a performance-based structure to provide a standard reference for all determined that the increased use of an aid in the implementation of NextGen operators and manufacturers using and autopilot during takeoff would enhance flight operations. producing Flight Management Systems aviation safety by giving pilots greater (FMS). situational awareness of what was going D. Summary of the NPRM The third commenter suggested on inside and outside of the aircraft. clarifying the regulatory text as it related This benefit would be realized by The FAA published an NPRM in the to the base minimum use altitude for an reducing the task loading required to Federal Register on December 4, 2012 approach and how §§ 91.175 and 91.155 manually fly the aircraft during the (77 FR 71735), proposing to enable the weather conditions are used when critical takeoff phase of flight. The FAA operational use of advanced autopilot applying autopilot minimums. The FAA received seven comments in response to and navigation systems by incorporating agrees with the comment and has the NPRM, and all commenters the capabilities of current and future clarified this particular section. supported an amendment to the rule. autopilots, flight guidance systems, and Specifically, the FAA has realigned the In 1997, the FAA amended GNSS guidance systems while regulatory text and placed into separate §§ 121.579, 125.329, and 135.93 to protecting the continued use of legacy paragraphs the specific conditions that permit certificate holders the use of an systems. The NPRM proposed to must be met in order to apply the approved autopilot system for takeoff, accomplish this through a performance- autopilot minimums. based on the 1994 NPRM and an based approach, using the certified This final rule is a complete rewrite expectation that autopilot technology capabilities of autopilot systems as of §§ 121.579, 125.329 and 135.93. The would continue to advance (62 FR established by the Airplane Flight language in each section of the 27922; May 21, 1997). This Manual (AFM) or as approved by the regulations is identical except for an authorization was given to certificate Administrator. The comment period additional paragraph in § 135.93 holders through an Operations closed on February 4, 2013. exempting rotorcraft. This final rule

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harmonizes these three parts of 14 CFR rule also gives the Administrator the operator has an approved autopilot that because this final rule is based on the authority to use OpSpecs to authorize a can fly a coupled approach, ILS or other performance capabilities of the lower minimum engagement altitude on than the ILS, it may use the AFM equipment being utilized, not the takeoff, which must be specified in the specified ‘‘altitude loss’’ or operating certificate held. Nothing in AFM. Administrator directed height as the this final rule will prevent or adversely This final rule retains the same basis for disconnecting the autopilot on affect the continued safe operation of minimum altitudes for all aircraft to the approach. In instrument flight rules aircraft using legacy navigation systems. protect legacy systems and introduces (IFR) conditions or operations in less Furthermore, this action defines the ability to use a lower engagement than visual flight rules (VFR), the altitude references for the different altitude on takeoff/initial climb based aircraft is below the MDA or DA and phases of flight, whereas the original upon the certified limits of the autopilot pilot has § 91.175 references, the rule defined all altitudes with reference as specified in the AFM. This final rule disengage height remains ‘‘altitude loss to terrain. Altitudes for takeoff/initial also gives the Administrator the plus 50 ft.’’ In VFR conditions, the climb and go-around/missed approach authority to specify an altitude above, operator may use the ‘‘altitude loss’’ as are defined as above the airport but not below, that specified in the the disengage height or 50 ft., whichever elevation. Altitudes for enroute AFM. is higher. This final rule allows the operations are defined as above terrain As a result, this final rule establishes aircraft to be used down to a lower elevation. Altitudes used for approach the AFM as a performance-based minimum use height based on the AFM are defined as being above Touchdown standard by which a certificate holder limitation and the ability of the pilot to Zone Elevation (TDZE). If the altitude is may be authorized for operations immediately recognize a possible in reference to a Decision Altitude/ through its OpSpecs. Once an autopilot deviation by using visual Height (DA(H)) or Minimum Descent autopilot’s capabilities and limitations references outside the aircraft. Altitude (MDA), the altitude will be are certified and reflected in the AFM, No other comments were received on defined in relation to the DA(H) or MDA a certificate holder may request a these three sections and they are itself (e.g. 50 ft. below DA(H)). Upon change to its OpSpecs to authorize use adopted as proposed. Sections further review of the proposed of the new autopilot minimum use 121.579(d), 125.329(d), and 135.93(d) regulatory text, the FAA is removing altitude specified in the AFM. No appear in the final rule with the changes subparagraph (a)(4) from each of these comments were received on these three as described for paragraphs (d)(1). sections. The language ‘‘Altitudes sections and they are adopted as E. Go Around/Missed Approach defined as being above airport elevation, proposed. (§§ 121.579(e), 125.329(e) and 135.93(e)) TDZE or terrain are above ground level (AGL)’’ as proposed in the NPRM is C. Enroute (§§ 121.579(c), 125.329(c) The final rule provides guidance for redundant. The provisions defining the and 135.93(c)) executing a missed approach/go-around altitude references in subparagraphs The enroute paragraph of the current that the current rule lacks. This (a)(1), (a)(2) and (a)(3) are sufficient to rule specifies a minimum use altitude of guidance is first presented in the define the elevations that will be used 500 ft. above terrain, or an altitude that approach paragraph, wherein an aircraft to calculate the autopilot minimum use is no lower than twice the autopilot does not need to comply with the height/altitude for each phase of flight. altitude loss specified in the AFM, autopilot minimum use altitude of that This final rule is formatted to model whichever is higher, for all operations. paragraph provided it is executing a the actual phases of flight: takeoff This final rule maintains the same base coupled missed approach/go-around. A through landing or go-around/missed minimum use altitude as the current new subparagraph provides guidance on approach. Each paragraph in this final rule, while granting the Administrator when the autopilot can be engaged on rule has a base minimum autopilot use the authority to specify a higher altitude the missed approach/go-around when altitude for the intended phase of flight if required by an operational or safety accomplished. that all aircraft may utilize. In order to related need. No comments were received on these protect the use of all legacy systems, the No comments were received on these three sections and they are adopted as base altitudes will remain identical to three sections and they are adopted as proposed. the altitudes in the current rule. Lower proposed. F. Landing (§§ 121.579(f), 125.329(f) and minimum use altitudes are based on D. Approach (§§ 121.579(d), 125.329(d), 135.93(f)) certification of the autopilot system and 135.93(d)) limitations found in the AFM. The The last paragraph in this final rule enroute minimum use altitude will not The base minimum use altitude for an provides guidance for landing. Current change from the current rule. approach in this final rule will remain language authorizes the Administrator, Additionally, the minimum use altitude the same as the current rule. Aircraft through OpSpecs, to allow an aircraft to in each paragraph can be raised by the with a specified height loss may use an touchdown with the autopilot engaged Administrator if warranted by an autopilot no lower than 50 ft. below the using an approved autoland flight operational or safety need. DA (H) or MDA or twice the altitude guidance system. This authorization No other comments were received on loss specified in the AFM, whichever is relies upon an ILS to meet this these three sections and they are greater. The current rule allows for requirement. This final rule states that adopted as proposed. exceptions to this altitude with the use minimum use altitudes do not apply to of a coupled autopilot, instrument autopilot operations when an approved B. Takeoff and Initial Climb (§§ 121.579 landing system (ILS), and specified and authorized landing system mode is (b), 125.329(b) and 135.93(b)) reported weather conditions. being used for landing. This final rule The current rule defines the base This final rule is written to allow will not limit approved landing systems minimum altitude at which all aircraft current operators the ability to operate to ground based systems. This action may engage the autopilot after takeoff as as they do now (thereby protecting will allow new performance based 500 ft. or double the autopilot altitude legacy systems), while also allowing landing systems to be approved and loss (as specified in the AFM) above the operators with updated systems to attain implemented for autoland operations as terrain, whichever is higher. The current lower minimum use heights. If an they become available.

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No comments were received on these will allow operators to more readily defined in DOT’s Regulatory Policies three sections and they are adopted as utilize the capabilities of future and Procedures. proposed. autopilots, flight guidance systems, and B. Regulatory Flexibility Determination GNSS guidance systems as they are G. Rotorcraft Operations (§ 135.93(g)) developed. These new capabilities The Regulatory Flexibility Act of 1980 The current rule expressly excludes accelerate the benefits of NextGen (Pub. L. 96–354) (RFA) establishes ‘‘as a rotorcraft operations from the minimum technologies and procedures that principle of regulatory issuance that altitudes for use of autopilots. This final depend upon auto flight guidance agencies shall endeavor, consistent with rule continues to exclude rotorcraft systems to enhance aviation safety in the objectives of the rule and of operations. the NAS. If operators pursue the lower applicable statutes, to fit regulatory and No comments were received on minimum altitudes based on their informational requirements to the scale § 135.93(g), and it appears as proposed. autopilots’ certification, they will of the businesses, organizations, and realize benefits from increased ability to governmental jurisdictions subject to IV. Regulatory Notices and Analyses operate. regulation. To achieve this principle, A. Regulatory Evaluation agencies are required to solicit and Costs consider flexible regulatory proposals Changes to Federal regulations must This final rule specifies autopilot and to explain the rationale for their undergo several economic analyses. minimum use altitudes for parts 121, actions to assure that such proposals are First, Executive Order 12866 directs that 125 and 135 operators. This final rule is given serious consideration’’. The RFA each Federal agency shall propose or based on the capabilities of the aircraft covers a wide-range of small entities, adopt a regulation only upon a reasoned and the minimum use altitudes or lack including small businesses, not-for- determination that the benefits of the of minimum use altitudes published in profit organizations, and small intended regulation justify its costs. the AFM. This final rule does not affect governmental jurisdictions. Second, the Regulatory Flexibility Act the minimum use altitudes presently Agencies must perform a review to of 1980 (Pub. L. 96–354) requires used by operators in the NAS. Operators determine whether a rule will have a agencies to analyze the economic have the option to operate as they significant economic impact on a impact of regulatory changes on small currently do or pursue the proposed substantial number of small entities. If entities. Third, the Trade Agreements lower minimum use altitudes based on the agency determines that it will, the Act (Pub. L. 96–39) prohibits agencies their aircraft’s autopilot certification. agency must prepare a regulatory from setting standards that create Operators with approved autopilots and flexibility analysis as described in the unnecessary obstacles to the foreign wishing to immediately achieve the RFA. However, if an agency determines commerce of the United States. In lower minimum use altitudes may incur that a rule is not expected to have a developing U.S. standards, this Trade the cost of accelerated training. This significant economic impact on a Act requires agencies to consider voluntary accelerated training cost is a substantial number of small entities, international standards and, where change in present value, but not in total section 605(b) of the RFA provides that appropriate, that they be the basis of cost, because this type of training would the head of the agency may so certify U.S. standards. Fourth, the Unfunded have occurred in the future. and a regulatory flexibility analysis is Mandates Reform Act of 1995 (Pub. L. Additionally, operators will not incur not required. The certification must 104–4) requires agencies to prepare a certification costs for aircraft, avionics include a statement providing the written assessment of the costs, benefits, equipment, autopilot and flight factual basis for this determination, and and other effects of proposed or final management systems that have already the reasoning should be clear. rules that include a Federal mandate been certificated. Also, by setting new In the initial regulatory flexibility likely to result in the expenditure by minimum altitudes for each phase of analysis, the FAA stated the rule would State, local, or tribal governments, in the flight that approved equipment might not impose additional cost, because aggregate, or by the private sector, of operate to, this final rule gives operators could choose to operate as $100 million or more annually (adjusted manufacturers more certainty that new they currently do. The FAA did not for inflation with base year of 1995). products can be used as they are receive any public comments in This portion of the preamble developed. response or contradiction to this summarizes the FAA’s analysis of the The FAA recognizes that autopilots in finding. Therefore, as provided in economic impacts of this final rule. some older airplanes are not approved section 605(b), the head of the FAA Department of Transportation Order to utilize the lower minimum use certifies that this rulemaking will not DOT 2100.5 prescribes policies and altitudes. These operators will not incur result in a significant economic impact procedures for simplification, analysis, any additional costs unless they seek on a substantial number of small and review of regulations. If the new autopilot certifications. However, entities. expected cost impact is so minimal that the FAA does not believe the majority a proposed or final rule does not of operators of older aircraft will seek to C. International Trade Impact warrant a full evaluation, this order modify their aircraft in order to be Assessment permits that a statement to that effect, approved for the lower minimum use The Trade Agreements Act of 1979 and the basis for it, be included in the altitudes. The FAA did not receive any (Pub. L. 96–39), as amended by the preamble if a full regulatory evaluation public comments in response or Uruguay Round Agreements Act (Pub. of the cost and benefits is not prepared. contradiction to these findings. Due to L. 103–465), prohibits Federal agencies A full regulatory evaluation was not the voluntary provisions of the rule, from establishing standards or engaging prepared for this final rule. The there are no quantifiable cost in related activities that create reasoning for this determination reductions. unnecessary obstacles to the foreign follows: The FAA has, therefore, determined commerce of the United States. that this final rule does not qualify as a Pursuant to these Acts, the Benefits ‘‘significant regulatory action’’ as establishment of standards is not This final rule incorporates the defined in section 3(f) of Executive considered an unnecessary obstacle to capabilities of current autopilots and Order 12866, and is not ‘‘significant’’ as the foreign commerce of the United

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States, so long as the standard has a this action would have no effect on B. Comments Submitted to the Docket legitimate domestic objective, such as international regulatory cooperation. Comments received may be viewed by the protection of safety, and does not G. Environmental Analysis going to http://www.regulations.gov and operate in a manner that excludes following the online instructions to FAA Order 1050.1E identifies FAA imports that meet this objective. The search the docket number for this actions that are categorically excluded statute also requires consideration of action. Anyone is able to search the from preparation of an environmental international standards and, where electronic form of all comments assessment or environmental impact appropriate, that they be the basis for received into any of the FAA’s dockets statement under the National U.S. standards. The FAA has assessed by the name of the individual Environmental Policy Act in the the potential effect of this final rule and submitting the comment (or signing the absence of extraordinary circumstances. determined that it is relieving, thus will comment, if submitted on behalf of an not create unnecessary obstacles to the The FAA has determined this association, business, labor union, etc.). foreign commerce of the United States. rulemaking action qualifies for the categorical exclusion identified in C. Small Business Regulatory D. Unfunded Mandates Assessment paragraph 312f and involves no Enforcement Fairness Act Title II of the Unfunded Mandates extraordinary circumstances. The Small Business Regulatory Reform Act of 1995 (Pub. L. 104–4) V. Executive Order Determinations Enforcement Fairness Act (SBREFA) of requires each Federal agency to prepare 1996 requires FAA to comply with a written statement assessing the effects A. Executive Order 13132, Federalism small entity requests for information or of any Federal mandate in a proposed or The FAA has analyzed this final rule advice about compliance with statutes final agency rule that may result in an under the principles and criteria of and regulations within its jurisdiction. expenditure of $100 million or more (in Executive Order 13132, Federalism. The A small entity with questions regarding 1995 dollars) in any one year by State, agency determined that this action will this document, may contact its local local, and tribal governments, in the not have a substantial direct effect on FAA official, or the person listed under aggregate, or by the private sector; such the States, or the relationship between the FOR FURTHER INFORMATION CONTACT a mandate is deemed to be a ‘‘significant the Federal Government and the States, heading at the beginning of the regulatory action.’’ The FAA currently or on the distribution of power and preamble. To find out more about uses an inflation-adjusted value of responsibilities among the various SBREFA on the Internet, visit http:// $143.1 million in lieu of $100 million. levels of government, and, therefore, www.faa.gov/regulations_policies/ This final rule does not contain such a does not have Federalism implications. rulemaking/sbre_act/. mandate; therefore, the requirements of Title II of the Act do not apply. B. Executive Order 13211, Regulations List of Subjects That Significantly Affect Energy Supply, E. Paperwork Reduction Act 14 CFR Part 121 Distribution, or Use The Paperwork Reduction Act of 1995 Air carriers, Aircraft, Airmen, The FAA analyzed this final rule Aviation safety, Safety, Transportation. (44 U.S.C. 3507(d)) requires that the under Executive Order 13211, Actions FAA consider the impact of paperwork Concerning Regulations that 14 CFR Part 125 and other information collection Significantly Affect Energy Supply, Aircraft, Airmen, Aviation safety. burdens imposed on the public. The Distribution, or Use (May 18, 2001). The FAA has determined that there is no agency has determined that it is not a 14 CFR Part 135 new requirement for information ‘‘significant energy action’’ under the collection associated with this final Air taxis, Aircraft, Airmen, Aviation executive order and it is not likely to safety. rule. have a significant adverse effect on the F. International Compatibility supply, distribution, or use of energy. The Amendment In consideration of the foregoing, the In keeping with U.S. obligations VI. How To Obtain Additional Federal Aviation Administration under the Convention on International Information amends chapter I of title 14, Code of Civil Aviation, it is FAA policy to A. Rulemaking Documents Federal Regulations as follows: conform to International Civil Aviation Organization (ICAO) Standards and An electronic copy of a rulemaking PART 121—OPERATING Recommended Practices to the document may be obtained by using the REQUIREMENTS: DOMESTIC, FLAG, maximum extent practicable. The FAA Internet— AND SUPPLEMENTAL OPERATIONS has determined that there are no ICAO 1. Search the Federal eRulemaking Standards and Recommended Practices Portal (http://www.regulations.gov); ■ 1. The authority citation for part 121 that correspond to these proposed 2. Visit the FAA’s Regulations and continues to read as follows: regulations. Policies Web page at http:// _ Authority: 49 U.S.C. 106(f), 106(g), 40113, Executive Order 13609, Promoting www.faa.gov/regulations policies/or 40119, 41706, 44101, 44701–44702, 44705, International Regulatory Cooperation, 3. Access the Government Printing 44709–44711, 44713, 44716–44717, 44722, promotes international regulatory Office’s Web page at http:// 46105. cooperation to meet shared challenges www.gpo.gov/fdsys/. ■ 2. Revise § 121.579 to read as follows: involving health, safety, labor, security, Copies may also be obtained by environmental, and other issues and to sending a request (identified by notice, § 121.579 Minimum altitudes for use of reduce, eliminate, or prevent amendment, or docket number of this autopilot. unnecessary differences in regulatory rulemaking) to the Federal Aviation (a) Definitions. For purpose of this requirements. The FAA has analyzed Administration, Office of Rulemaking, section— this action under the policies and ARM–1, 800 Independence Avenue (1) Altitudes for takeoff/initial climb agency responsibilities of Executive SW., Washington, DC 20591, or by and go-around/missed approach are Order 13609, and has determined that calling (202) 267–9680. defined as above the airport elevation.

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(2) Altitudes for enroute operations (2) For autopilots with AFM specified (3) Altitudes for approach are defined are defined as above terrain elevation. approach altitude limitations, the as above the touchdown zone elevation (3) Altitudes for approach are defined greater of— (TDZE), unless the altitude is as above the touchdown zone elevation (i) The minimum use altitude specifically in reference to DA (H) or (TDZE), unless the altitude is specified for the coupled approach MDA, in which case the altitude is specifically in reference to DA (H) or mode selected; defined by reference to the DA(H) or MDA, in which case the altitude is (ii) 50 feet; or MDA itself. defined by reference to the DA(H) or (iii) An altitude specified by (b) Takeoff and initial climb. No MDA itself. Administrator. person may use an autopilot for takeoff (b) Takeoff and initial climb. No (3) For autopilots with an AFM or initial climb below the higher of 500 person may use an autopilot for takeoff specified negligible or zero altitude loss feet or an altitude that is no lower than or initial climb below the higher of 500 for an autopilot approach mode twice the altitude loss specified in the feet or an altitude that is no lower than malfunction, the greater of— Airplane Flight Manual (AFM), except twice the altitude loss specified in the (i) 50 feet; or as follows— Airplane Flight Manual (AFM), except (ii) An altitude specified by (1) At a minimum engagement as follows— Administrator. altitude specified in the AFM; or (1) At a minimum engagement (4) If executing an autopilot coupled (2) At an altitude specified by the altitude specified in the AFM; or go-around or missed approach using a Administrator, whichever is greater. (2) At an altitude specified by the certificated and functioning autopilot in (c) Enroute. No person may use an Administrator, whichever is greater. accordance with paragraph (e) in this autopilot enroute, including climb and (c) Enroute. No person may use an section. descent, below the following— autopilot enroute, including climb and (e) Go-Around/Missed Approach. No (1) 500 feet; descent, below the following— person may engage an autopilot during (2) At an altitude that is no lower than (1) 500 feet; a go-around or missed approach below twice the altitude loss specified in the (2) At an altitude that is no lower than the minimum engagement altitude AFM for an autopilot malfunction in twice the altitude loss specified in the specified for takeoff and initial climb in cruise conditions; or (3) At an altitude specified by the AFM for an autopilot malfunction in paragraph (b) in this section. An cruise conditions; or Administrator, whichever is greater. autopilot minimum use altitude does (d) Approach. No person may use an (3) At an altitude specified by the not apply to a go-around/missed autopilot at an altitude lower than 50 Administrator, whichever is greater. approach initiated with an engaged feet below the DA(H) or MDA for the (d) Approach. No person may use an autopilot. Performing a go-around or instrument procedure being flown, autopilot at an altitude lower than 50 missed approach with an engaged except as follows— feet below the DA(H) or MDA for the autopilot must not adversely affect safe (1) For autopilots with an AFM instrument procedure being flown, obstacle clearance. specified altitude loss for approach except as follows— (f) Landing. Notwithstanding operations— (1) For autopilots with an AFM paragraph (d) of this section, autopilot (i) An altitude no lower than twice the specified altitude loss for approach minimum use altitudes do not apply to specified altitude loss if higher than 50 operations— autopilot operations when an approved feet below the MDA or DA(H); (i) An altitude no lower than twice the automatic landing system mode is being (ii) An altitude no lower than 50 feet specified altitude loss if higher than 50 used for landing. Automatic landing higher than the altitude loss specified in feet below the MDA or DA(H); systems must be authorized in an the AFM, when the following (ii) An altitude no lower than 50 feet operations specification issued to the conditions are met— higher than the altitude loss specified in operator. (A) Reported weather conditions are the AFM, when the following less than the basic VFR weather conditions are met— PART 125—CERTIFICATION AND conditions in § 91.155 of this chapter; (A) Reported weather conditions are OPERATIONS: AIRPLANES HAVING A (B) Suitable visual references less than the basic VFR weather SEATING CAPACITY OF 20 OR MORE specified in § 91.175 of this chapter conditions in § 91.155 of this chapter; PASSENGERS OR A MAXIMUM have been established on the instrument (B) Suitable visual references PAYLOAD CAPACITY OF 6,000 approach procedure; and specified in § 91.175 of this chapter POUNDS OR MORE; AND RULES (C) The autopilot is coupled and have been established on the instrument GOVERNING PERSONS ON BOARD receiving both lateral and vertical path approach procedure; and SUCH AIRCRAFT references; (C) The autopilot is coupled and (iii) An altitude no lower than the receiving both lateral and vertical path ■ 3. The authority citation for part 125 higher of the altitude loss specified in references; is revised to read as follows: the AFM or 50 feet above the TDZE, (iii) An altitude no lower than the Authority: 49 U.S.C. 106(f), 106(g), 40113, when the following conditions are higher of the altitude loss specified in 44701–44702, 44705, 44710–44711, 44713, met— the AFM or 50 feet above the TDZE, 44716–44717, 44722. (A) Reported weather conditions are when the following conditions are ■ 4. Revise § 125.329 to read as follows: equal to or better than the basic VFR met— weather conditions in § 91.155 of this (A) Reported weather conditions are § 125.329 Minimum altitudes for use of chapter; and equal to or better than the basic VFR autopilot. (B) The autopilot is coupled and weather conditions in § 91.155 of this (a) Definitions. For purpose of this receiving both lateral and vertical path chapter; and section— references; or (B) The autopilot is coupled and (1) Altitudes for takeoff/initial climb (iv) A greater altitude specified by the receiving both lateral and vertical path and go-around/missed approach are Administrator. references; or defined as above the airport elevation. (2) For autopilots with AFM specified (iv) A greater altitude specified by the (2) Altitudes for enroute operations approach altitude limitations, the Administrator. are defined as above terrain elevation. greater of—

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(i) The minimum use altitude (b) Takeoff and initial climb. No (3) For autopilots with an AFM specified for the coupled approach person may use an autopilot for takeoff specified negligible or zero altitude loss mode selected; or initial climb below the higher of 500 for an autopilot approach mode (ii) 50 feet; or feet or an altitude that is no lower than malfunction, the greater of— (iii) An altitude specified by twice the altitude loss specified in the (i) 50 feet; or Administrator. Airplane Flight Manual (AFM), except (ii) An altitude specified by (3) For autopilots with an AFM as follows— Administrator. specified negligible or zero altitude loss (1) At a minimum engagement (4) If executing an autopilot coupled for an autopilot approach mode altitude specified in the AFM; or go-around or missed approach using a malfunction, the greater of— (2) At an altitude specified by the certificated and functioning autopilot in (i) 50 feet; or Administrator, whichever is greater. accordance with paragraph (e) in this (ii) An altitude specified by (c) Enroute. No person may use an section. Administrator. autopilot enroute, including climb and (e) Go-Around/Missed Approach. No (4) If executing an autopilot coupled descent, below the following— go-around or missed approach using a person may engage an autopilot during (1) 500 feet; a go-around or missed approach below certificated and functioning autopilot in (2) At an altitude that is no lower than accordance with paragraph (e) in this the minimum engagement altitude twice the altitude loss specified in the specified for takeoff and initial climb in section. AFM for an autopilot malfunction in (e) Go-Around/Missed Approach. No paragraph (b) in this section. An cruise conditions; or person may engage an autopilot during autopilot minimum use altitude does (3) At an altitude specified by the not apply to a go-around/missed a go-around or missed approach below Administrator, whichever is greater. the minimum engagement altitude approach initiated with an engaged (d) Approach. No person may use an autopilot. Performing a go-around or specified for takeoff and initial climb in autopilot at an altitude lower than 50 paragraph (b) in this section. An missed approach with an engaged feet below the DA(H) or MDA for the autopilot must not adversely affect safe autopilot minimum use altitude does instrument procedure being flown, not apply to a go-around/missed obstacle clearance. except as follows— (f) Landing. Notwithstanding approach initiated with an engaged (1) For autopilots with an AFM autopilot. Performing a go-around or paragraph (d) of this section, autopilot specified altitude loss for approach minimum use altitudes do not apply to missed approach with an engaged operations— autopilot must not adversely affect safe autopilot operations when an approved (i) An altitude no lower than twice the automatic landing system mode is being obstacle clearance. specified altitude loss if higher than 50 (f) Landing. Notwithstanding used for landing. Automatic landing feet below the MDA or DA(H); systems must be authorized in an paragraph (d) of this section, autopilot (ii) An altitude no lower than 50 feet minimum use altitudes do not apply to operations specification issued to the higher than the altitude loss specified in operator. autopilot operations when an approved the AFM, when the following automatic landing system mode is being (g) This section does not apply to conditions are met— operations conducted in rotorcraft. used for landing. Automatic landing (A) Reported weather conditions are systems must be authorized in an less than the basic VFR weather Issued under authority provided by 49 operations specification issued to the conditions in § 91.155 of this chapter; U.S.C. 106(f) and 44701(a)(5) in Washington, operator. (B) Suitable visual references DC, on December 24, 2013. specified in § 91.175 of this chapter Michael P. Huerta, PART 135—OPERATING Administrator. REQUIREMENTS: COMMUTER AND have been established on the instrument [FR Doc. 2014–02123 Filed 1–31–14; 8:45 am] ON DEMAND OPERATIONS AND RULE approach procedure; and GOVERNING PERSONS ON BOARD (C) The autopilot is coupled and BILLING CODE 4910–13–P SUCH AIRCRAFT receiving both lateral and vertical path references; ■ 5. The authority citation for part 135 (iii) An altitude no lower than the DEPARTMENT OF HEALTH AND continues to read as follows: higher of the altitude loss specified in HUMAN SERVICES the AFM or 50 feet above the TDZE, Authority: 49 U.S.C. 106(f), 106(g), 41706, Food and Drug Administration 40113, 44701–44702, 44705, 44709, 44711– when the following conditions are 44713, 44715–44717, 44722, 45101–45105. met— 21 CFR Part 17 ■ 6. Revise § 135.93 to read as follows: (A) Reported weather conditions are equal to or better than the basic VFR [Docket No. FDA–2014–N–0113] § 135.93 Minimum altitudes for use of weather conditions in § 91.155 of this autopilot. chapter; and Maximum Civil Money Penalty (a) Definitions. For purpose of this (B) The autopilot is coupled and Amounts; Civil Money Penalty section— receiving both lateral and vertical path Complaints (1) Altitudes for takeoff/initial climb references; or and go-around/missed approach are (iv) A greater altitude specified by the AGENCY: Food and Drug Administration, defined as above the airport elevation. Administrator. HHS. (2) Altitudes for enroute operations (2) For autopilots with AFM specified ACTION: Direct final rule. are defined as above terrain elevation. approach altitude limitations, the (3) Altitudes for approach are defined greater of— SUMMARY: The Food and Drug as above the touchdown zone elevation (i) The minimum use altitude Administration (FDA) is issuing a new (TDZE), unless the altitude is specified for the coupled approach regulation to adjust for inflation the specifically in reference to DA (H) or mode selected; maximum civil money penalty (CMP) MDA, in which case the altitude is (ii) 50 feet; or amounts for the various CMP authorities defined by reference to the DA(H) or (iii) An altitude specified by within our jurisdiction and to amend MDA itself. Administrator. the process for initiating certain CMP

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