[Federal Register Volume 81, Number 208 (Thursday, October 27, 2016)]
[Rules and Regulations]
[Pages 74671-74675]
[FR Doc No: 2016-25962]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 91

[Docket No.: FAA-2014-0225; Amdt. No. 91-331D]
RIN 2120-AK92

Extension of the Prohibition Against Certain Flights in the
Simferopol (UKFV) and Dnipropetrovsk (UKDV) Flight Information Regions
(FIRs)

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

ACTION: Final rule.

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SUMMARY: This action extends the prohibition against certain flight
operations in the Simferopol (UKFV) and Dnipropetrovsk (UKDV) flight
information regions (FIRs) by all United States (U.S.) air carriers;
U.S. commercial operators; persons exercising the privileges of a U.S.
airman certificate, except when such persons are operating a U.S.-
registered aircraft for a foreign air carrier; and operators of U.S.-
registered civil aircraft, except when such operators are foreign air
carriers. The FAA finds this action to be necessary to address a
continuing hazard to persons and aircraft engaged in such flight
operations.

DATES: This final rule is effective on October 27, 2016.

FOR FURTHER INFORMATION CONTACT: Michael Filippell, Air Transportation
Division, AFS-220, Flight Standards Service, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

    This action continues the prohibition on flight operations in the
Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs by all U.S. air
carriers; U.S. commercial operators; persons exercising the privileges
of a U.S. airman certificate, except when such persons are operating a
U.S.-registered aircraft for a foreign air carrier; and operators of
U.S.-registered civil aircraft,

except when such operators are foreign air carriers. The FAA finds this
action necessary to address a continuing hazard to persons and aircraft
engaged in such flight operations.

II. Legal Authority and Good Cause

A. Authority for This Rulemaking

    The FAA is responsible for the safety of flight in the U.S. and for
the safety of U.S. civil operators, U.S.-registered civil aircraft, and
U.S.-certificated airmen throughout the world. The FAA's authority to
issue rules on aviation safety is found in title 49, U.S. Code.
Subtitle I, section 106(f), describes the authority of the FAA
Administrator. Section 40101(d)(1) provides that the Administrator
shall consider in the public interest, among other matters, assigning,
maintaining, and enhancing safety and security as the highest
priorities in air commerce. Section 40105(b)(1)(A) requires the
Administrator to exercise his authority consistently with the
obligations of the U.S. Government under international agreements.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, subpart III, section 44701, General requirements.
Under that section, the FAA is charged broadly with promoting safe
flight of civil aircraft in air commerce by prescribing, among other
things, regulations and minimum standards for practices, methods, and
procedures that the Administrator finds necessary for safety in air
commerce and national security. This regulation is within the scope of
that authority because it continues to prohibit the persons subject to
paragraph (a) of Special Federal Aviation Regulation (SFAR) No. 113,
Sec.  91.1607, from conducting flight operations in the Simferopol
(UKFV) and Dnipropetrovsk (UKDV) FIRs due to the hazard to the safety
of such persons' flight operations, as described in the Background
section of this rule.

B. Good Cause for Immediate Adoption

    Section 553(b)(3)(B) of title 5, U.S. Code, authorizes agencies to
dispense with notice and comment procedures for rules when the agency
for ``good cause'' finds that those procedures are ``impracticable,
unnecessary, or contrary to the public interest.'' In this instance,
the FAA finds that notice and public comment to this immediately
adopted final rule, as well as any delay in the effective date of this
rule, are contrary to the public interest due to the immediate need to
address the continuing hazard to civil aviation that exists in the
Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs, as described in the
Background section of this final rule.

III. Background

    The threat to safety in existence when the FAA first published SFAR
No. 113, Sec.  91.1607 on April 25, 2014 (79 FR 22862) has not abated.
At that time, the FAA viewed the possibility of civil aircraft
receiving confusing and conflicting air traffic control instructions
from both Ukrainian and Russian air traffic service providers when
operating in the portion of the Simferopol (UKFV) FIR covered by SFAR
No. 113, Sec.  91.1607, as an unsafe condition that presented a
potential hazard to U.S. civil flight operations in the disputed
airspace. Because political and military tensions between Ukraine and
the Russian Federation remained high, the FAA was also concerned that
compliance with air traffic control instructions issued by the
authorities of one country could result in a civil aircraft being
misidentified as a threat and intercepted or otherwise engaged by air
defense forces of the other country. The FAA continues to have these
concerns.
    On July 18, 2014, the FAA issued a Notice to Airmen (NOTAM) FDC 4/
2182, expanding the flight prohibition to the entire Simferopol (UKFV)
and Dnipropetrovsk (UKDV) FIRs, primarily as an immediate response to
the shoot down of Malaysia Airlines MH17 on July 17, 2014, while flying
over Ukraine at 33,000 feet just west of the Russian border. Two
hundred ninety eight passengers and crew perished. In addition, there
were other attacks on fixed-wing and rotary-wing Ukrainian military
aircraft flying at lower altitudes, such as the shoot down of a
Ukrainian An-26 flying at 21,000 feet southeast of Luhansk on July 14,
2014. As a result of these events, the FAA determined that the ongoing
conflict in the region posed a significant threat to U.S. civil
aviation operations in these FIRs. The use of weapons capable of
targeting and shooting down aircraft flying on civil air routes at
cruising altitudes posed a significantly dangerous threat to civil
aircraft flying in the Simferopol (UKFV) and Dnipropetrovsk (UKDV)
FIRs. The FAA published a final rule incorporating the expanded flight
prohibition into SFAR No. 113, Sec.  91.1607, on December 29, 2014 (79
FR 77857). The FAA extended this flight prohibition in a final rule
published October 27, 2015 (80 FR 65621).
    The State Aviation Administration of Ukraine conducted and
completed an airspace restructuring that went into effect in the late
2014 timeframe. The new configuration altered both the Simferopol
(UKFV) and Dnipropetrovsk (UKDV) Flight Information Region (FIR)
altitude structures. To address the Ukraine airspace restructuring and
provide additional clarity, on July 22, 2016, the FAA published a
technical amendment to specifically identify the prohibited airspace in
which SFAR No. 113, Sec.  91.1607, applies, with inclusive altitudes
and lateral limitations (latitude and longitude coordinates). 81 FR
47699.
    The FAA has continued to evaluate the situation in the Simferopol
(UKFV) and Dnipropetrovsk (UKDV) FIRs and has determined there is a
continuing significant flight safety hazard to U.S. civil aviation.
Although the European Aviation Safety Agency's (EASA) published a
Safety Information Bulletin (SIB) on February 17, 2016, indicating that
ATS routes L851 and M856 could be considered for planning flights in
the Simferopol (UKFV) FIR, there is continuing concern over the hazard
to U.S. civil aviation from possible conflicting air traffic control
instructions from Ukrainian and Russian air traffic service providers.
Shortly following the EASA bulletin, the Russian Federal Air Transport
Agency responded with a press release in which it again asserted that
it was responsible for air traffic services in a portion of the
Simferopol (UKFV) FIR. The Russian circular (from Feb 21, 2016) further
stated, ``The Russian Federation does not bear the responsibility for
the provision of safety to those flights, which will be operated within
Simferopol FIR under control of ATC unit other than Simferopol Air
Traffic Management Centre.'' Russia contended that EASA's decision was
politically motivated and `pose[d] a threat to aviation safety in the
region.' In addition, there have been reported incidents of purposeful
interference, including GPS jamming, in the Simferopol (UKFV) and
Dnipropetrovsk (UKDV) FIRs. Based on this information, the FAA
continues to assess that there is a significant flight safety hazard to
U.S. civil aviation in the Simferopol (UKFV) FIR.
    In the Dnipropetrovsk (UKDV) FIR, there is an ongoing risk of
skirmishes in the area and a potential for larger-scale fighting in
eastern Ukraine involving combined Russian-separatist forces, which
could result in civil aircraft being misidentified as a threat and then
intercepted or otherwise engaged, as demonstrated by the shoot down of
Malaysia Airlines Flight 17 on July 17, 2014. These combined forces
have access to a variety of anti-aircraft

weapons, to include man-portable air defense systems (MANPADS) and
possibly more advanced surface-to-air-missiles (SAMs) that have the
capability to engage aircraft at higher altitudes. Separatists have
demonstrated their ability to use these anti-aircraft weapons by
successfully shooting down a number of aircraft during the course of
the fighting in eastern Ukraine in 2014. More recently, Organization
for Security and Cooperation in Europe (OSCE) Special Monitoring
Mission to Ukraine (SMM) unmanned aerial systems (UASs) also have been
shot down by surface-to-air missiles and small arms ground fire, and
brought down with GPS jamming in the Dnipropetrovsk (UKDV) FIR.
    Due to the previously described continuing hazards to U.S. civil
aviation operations, the FAA is extending the expiration date of SFAR
No. 113, Sec.  91.1607, to continue the prohibition on flight
operations in the Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs by
all U.S. air carriers; U.S. commercial operators; persons exercising
the privileges of a U.S. airman certificate, except when such persons
are operating a U.S.-registered aircraft for a foreign air carrier; and
operators of U.S.-registered civil aircraft, except when such operators
are foreign air carriers. This rule extends the expiration date of SFAR
No. 113, Sec.  91.1607, from October 27, 2016, to October 27, 2018.
    The FAA will continue to actively evaluate the area to determine to
what extent U.S. civil aviation may be able to safely operate therein.
Adjustments to this SFAR may be appropriate if the risk to aviation
safety and security changes. The FAA may amend or rescind this SFAR as
necessary prior to its expiration date.
    Because the circumstances described herein warrant a continuation
of the flight restrictions imposed by SFAR No. 113, I find that notice
and public comment under 5 U.S.C. 553(b)(3)(B) are impracticable and
contrary to the public interest. I also find that this action is fully
consistent with the obligations under 49 U.S.C. 40105 to ensure that I
exercise my duties consistently with the obligations of the United
States under international agreements.

IV. Regulatory Notices and Analyses

A. Regulatory Evaluation

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Orders 12866 and 13563 direct that each
Federal agency shall propose or adopt a regulation only upon a reasoned
determination that the benefits of the intended regulation justify its
costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354),
as codified in 5 U.S.C. 603 et seq., requires agencies to analyze the
economic impact of regulatory changes on small entities. Third, the
Trade Agreements Act (Pub. L. 96-39), as amended, 19 U.S.C. Chapter 13,
prohibits agencies from setting standards that create unnecessary
obstacles to the foreign commerce of the United States. In developing
U.S. standards, the Trade Agreements Act requires agencies to consider
international standards and, where appropriate, that they be the basis
of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4), as codified in 2 U.S.C. Chapter 25, requires agencies
to prepare a written assessment of the costs, benefits, and other
effects of proposed or final rules that include a Federal mandate
likely to result in the expenditure by State, local, or tribal
governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this final rule.
    In conducting these analyses, FAA has determined this final rule
has benefits that justify its costs. This rule is a significant
regulatory action as defined in section 3(f) of Executive Order 12866
or as defined in DOT's Regulatory Policies and Procedures, as it raises
novel policy issues. This final rule merely extends an existing flight
prohibition without change. This rule will not have a significant
economic impact on a substantial number of small entities. This rule
will not create unnecessary obstacles to the foreign commerce of the
United States. This rule will not impose an unfunded mandate on State,
local, or tribal governments, or on the private sector by exceeding the
threshold identified above.
    DOT Order 2100.5 prescribes policies and procedures for
simplification, analysis, and review of regulations. If the expected
cost impact is so minimal that a proposed or final rule does not
warrant a full evaluation, this order permits a statement to that
effect and the basis for it to be included in the preamble if a full
regulatory evaluation of the costs and benefits is not prepared. Such a
determination has been made for this final rule. The reasoning for this
determination follows.
    This rule extends the existing prohibition against U.S. civil
flight operations in the Simferopol (UKFV) and Dnipropetrovsk (UKDV)
FIRs. As we noted in the most recent previous amendment to SFAR No.
113, Sec.  91.1607 (80 FR 65621, October 27, 2015), almost all U.S.
operators already had voluntarily ceased their operations in these FIRs
prior to the issuance of the FAA NOTAM on July 18, 2014 (UTC), which
prohibited U.S. civil flight operations in these two FIRS in their
entirety. Prior to the issuance of the July 18, 2014 (UTC) NOTAM, the
FAA had already prohibited U.S. civil flight operations in a portion of
the Simferopol (UKFV) FIR due to a dispute between Ukraine and the
Russian Federation over which country is responsible for providing air
navigation services in the area, first via NOTAM and subsequently when
the FAA initially published SFAR No. 113, Sec.  91.1607, on April 25,
2014. Consequently, no U.S. operators were operating in that portion of
the Simferopol (UKFV) FIR at the time of the December 29, 2014
amendment to the rule.
    Because of the continuing significant hazards to U.S. civil
aviation discussed in the Background section of this final rule, the
FAA believes that few, if any, U.S. operators presently wish to conduct
operations in either of these two FIRS. Moreover, both the amendment
published on December 29, 2014, and this rule, permit a U.S. Government
department, agency, or instrumentality to request FAA approval on
behalf of a person described in paragraph (a) of SFAR No. 113, Sec.
91.1607, to conduct operations under a contract (or subcontract),
grant, or cooperative agreement with that department, agency, or
instrumentality. As no U.S. Government department, agency, or
instrumentality has requested such approval since December 29, 2014,
there is apparently little demand for such approvals. Finally, the
possibility of obtaining an approval, should one be requested, lowers
the expected cost of the extended rule. Accordingly, the FAA believes
the incremental costs of this final rule will be minimal. These minimal
costs will be exceeded by the benefits of avoiding the deaths,
injuries, and/or property damage that would result from a U.S.
operator's aircraft being shot down (or otherwise damaged) while
operating in either or both of the Simferopol (UKFV) and Dnipropetrovsk
(UKDV) FIRs.

B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale

of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis, as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    As described in the Regulatory Evaluation section of this preamble,
the incremental costs of this rule are minimal. Therefore, as provided
in Sec.  605(b), the head of the FAA certifies that this rulemaking
will not result in a significant economic impact on a substantial
number of small entities.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended,
prohibits Federal agencies from establishing standards or engaging in
related activities that create unnecessary obstacles to the foreign
commerce of the United States. Pursuant to this Act, the establishment
of standards is not considered an unnecessary obstacle to the foreign
commerce of the United States, so long as the standard has a legitimate
domestic objective, such as the protection of safety, and does not
operate in a manner that excludes imports that meet this objective. The
statute also requires consideration of international standards and,
where appropriate, that they be the basis for U.S. standards.
    The FAA has assessed the effect of this final rule and determined
that its purpose is to protect the safety of U.S. civil aviation from a
hazard outside the U.S. Therefore, the rule is in compliance with the
Trade Agreements Act.

D. Unfunded Mandates Assessment

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

E. Paperwork Reduction Act

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

F. International Compatibility and Cooperation

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to this regulation.

G. Environmental Analysis

    FAA Order 1050.1F identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act (NEPA) in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 5-6.6f of this order and involves no
extraordinary circumstances.
    The FAA has reviewed the implementation of this SFAR and determined
it is categorically excluded from further environmental review
according to FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.6f. The FAA has examined possible
extraordinary circumstances and determined that no such circumstances
exist. After careful and thorough consideration of the action, the FAA
finds that this Federal action does not require preparation of an
Environmental Assessment or Environmental Impact Statement in
accordance with the requirements of NEPA, Council on Environmental
Quality (CEQ) regulations, and FAA Order 1050.1F.

V. Executive Order Determinations

A. Executive Order 13132, Federalism

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

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

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

C. Executive Order 13609, Promoting International Regulatory
Cooperation

    Executive Order 13609, Promoting International Regulatory
Cooperation, (77 FR 26413, May 4, 2012) promotes international
regulatory cooperation to meet shared challenges involving health,
safety, labor, security, environmental, and other issues and to reduce,
eliminate, or prevent unnecessary differences in regulatory
requirements. The FAA has analyzed this action under the policies and
agency responsibilities of Executive Order 13609, and has determined
that this action would have no effect on international regulatory
cooperation.

VI. Additional Information

A. Availability of Rulemaking Documents

    An electronic copy of rulemaking documents may be obtained from the
Internet by--

 Searching the Federal eRulemaking Portal (http://www.regulations.gov);

 Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or
 Accessing the Government Publishing Office's Web page at
http://www.fdsys.gov

    Copies may also be obtained by sending a request (identified by
docket or amendment number of the rule) to the Federal Aviation
Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue
SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
    Except for classified material, all documents the FAA considered in
developing this rule, including economic analyses and technical
reports, may be accessed from the Internet through the Federal
eRulemaking Portal referenced above.

B. Small Business Regulatory Enforcement Fairness Act

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

List of Subjects in 14 CFR Part 91

    Air traffic control, Aircraft, Airmen, Airports, Aviation safety,
Freight, Ukraine.

    In consideration of the foregoing, the Federal Aviation
Administration amends chapter I of title 14, Code of Federal
Regulations, as follows:

PART 91--GENERAL OPERATING AND FLIGHT RULES

0
1. The authority citation for part 91 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 1155, 40101, 40103, 40105,
40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712,
44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507,
47122, 47508, 47528-47531, 47534, articles 12 and 29 of the
Convention on International Civil Aviation (61 Stat. 1180), (126
Stat. 11).

0
2. Amend Sec.  91.1607 by revising paragraph (e) to read as follows:

Sec.  91.1607  Special Federal Aviation Regulation No. 113--Prohibition
Against Certain Flights in the Simferopol (UKFV) and Dnipropetrovsk
(UKDV) Flight Information Regions (FIRs).

* * * * *
    (e) Expiration. This SFAR will remain in effect until October 27,
2018. The FAA may amend, rescind, or extend this SFAR as necessary.

    Issued in Washington, DC, under the authority of 49 U.S.C.
106(f), 40101(d)(1), 40105(b)(1)(A), and 44701(a)(5), on October 21,
2016.
Victoria B. Wassmer,
Acting Deputy Administrator.
[FR Doc. 2016-25962 Filed 10-24-16; 4:20 pm]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20688-20689]
[FR Doc No: 2011-8886]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1998-D-0281]

Guidance for Industry and Food and Drug Administration Staff; 30-
Day Notices, 135-Day Premarket Approval Supplements and 75-Day
Humanitarian Device Exemption Supplements for Manufacturing Method or
Process Changes; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``30-Day Notices, 135-Day
Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device
Exemption (HDE) Supplements for Manufacturing Method or Process
Changes.'' This document provides guidance on the type of changes to an
approved application that FDA believes may qualify for submission as
30-day notices, the type of information to submit in a 30-day notice,
and the user fees associated with these submissions. The guidance
document is immediately in effect, but it remains subject to comment in
accordance with the Agency's good guidance practices (GGP).

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health (CDRH), Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993-0002; or to the Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    For devices regulated by CDRH: Anastacia Bilek, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3656, Silver Spring, MD 20993-0002, 301-
796-5588.
    For devices regulated by CBER: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``30-Day Notices, 135-Day Premarket Approval (PMA) Supplements
and 75-Day Humanitarian Device Exemption (HDE) Supplements for
Manufacturing Method or Process Changes.'' This guidance is being
issued consistent with FDA's GGP regulation (Sec.  10.115 (21 CFR
10.115). This guidance is being implemented without prior public
comment because the Agency has determined that prior public
participation is not feasible or appropriate (Sec.  10.115(g)(2)). The
Agency made this determination because statutory provisions regarding
medical device user fees under the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) are in effect and being
implemented, and guidance is needed to help effect such implementation.
Although this guidance is immediately in effect, it remains subject to
comment in accordance with the Agency's GGP regulation.
    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Pub. L. 107-250) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. et seq.) to authorize FDA to collect user fees for
the review of certain premarket submissions (See section 708 of the
FD&C Act (21 U.S.C. 379j).) FDAAA further amended the FD&C Act to
extend FDA's authority to collect medical device user fees through
September 30, 2012, and added 30-day notices to the types of premarket
submissions subject to user fees (21 U.S.C. 379j(a)(2)(A)(vi)). For
additional information on the MDUFMA, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.
    This guidance supersedes the previous guidance document entitled
``30-Day Notices and 135-Day PMA Supplements for Manufacturing Method
or Process Changes, Guidance for Industry and CDRH,'' that published in
the Federal Register of February 25, 1998 (63 FR 9570). This guidance
describes the user fees authorized, updates the previous guidance to
clarify the process for submitting a 30-day notice, and provides
additional information on the types of changes that may be submitted.
The previous guidance did not include information on HDEs even though
certain modifications to a manufacturing procedure or method of
manufacture for HDEs are subject to the 30-day notice provisions. The
current guidance includes this information.
    The guidance represents the Agency's current thinking on 30-day
notices, 135-day PMA supplements and 75-Day HDE supplements for
manufacturing method or process changes. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-

3520). The collections of information 21 CFR part 814, subparts B and
E, have been approved under OMB control number 0910-0231; the
collections of information 21 CFR part 814, subpart H, have been
approved under OMB control number 0910-0332; the collections of
information 21 CFR part 820 have been approved under OMB control number
0910-0073; the collections of information in FDA form 3601 have been
approved under OMB control number 0910-0511; and the collections of
information in FDA form 3602a have been approved under OMB control
number 0910-0508.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or http://www.regulations.gov. Always access an FDA guidance document
by using FDA's Web site listed previously to find the most current
version of the guidance.

    Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8886 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Notices]
[Pages 77995-77996]
[FR Doc No: 2011-32148]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-569-000]

Blackwell Wind, LLC; Supplemental Notice that Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Blackwell Wind, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 28, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by

clicking on the appropriate link in the above list. They are also
available for review in the Commission's Public Reference Room in
Washington, DC. There is an eSubscription link on the web site that
enables subscribers to receive email notification when a document is
added to a subscribed docket(s). For assistance with any FERC Online
service, please email<EMAIL_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 8, 2011.
Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2011-32148 Filed 12-14-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Rules and Regulations]
[Pages 8743-8745]
[FR Doc No: 2018-03928]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-5019; Product Identifier 2015-SW-079-AD; Amendment
39-19210; AD 2018-05-01]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Airbus
Helicopters Model AS332C, AS332C1, AS332L, AS332L1, AS332L2, and
EC225LP helicopters. This AD requires inspecting the sliding cabin plug
door (sliding door). This AD was prompted by the failure of the sliding
door's jettison mechanism due to corrosion. The actions of this AD are
intended to address an unsafe condition in these products.

DATES: This AD is effective April 5, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of April 5, 2018.

ADDRESSES: For service information identified in this final rule,
contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html. You may review the referenced service information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177. It is also available
on the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2016-5019.

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-
5019; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the European Aviation Safety Agency (EASA) AD, any
incorporated-by-reference service information, the economic evaluation,
any comments received, and other information. The street address for
Docket Operations (phone:<PHONE_NUMBER>) is 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: David Hatfield, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    On March 3, 2017, at 82 FR 12424, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 by adding an AD that would apply to Airbus Helicopters
Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2 helicopters with a
date of manufacture on or before July 14, 2014, and with a sliding door
with Airbus Helicopters modification AL25612 or 0725870 installed; and
Model EC225LP helicopters with a date of manufacture on or before July
14, 2014.
    The NPRM proposed to require visually inspecting for and removing
any sealing compound from the sliding doors and any corrosion from all
visible bracket surfaces, measuring corrosion depth and performing a
jettisoning test if there is corrosion, and measuring the clearance
between the bracket and stainless steel pipe to ensure a minimum
clearance. For Model EC225LP helicopters and Model AS332-series
helicopters with modification AL25612, the NPRM also proposed
inspecting for drain obstruction. The proposed requirements were
intended to prevent corrosion damage, which can hinder jettisoning the
door during an emergency, jeopardizing the safe evacuation of
occupants.
    The NPRM was prompted by AD No. 2015-0156, dated July 29, 2015, and
corrected July 30, 2015, issued by EASA, which is the Technical Agent
for the Member States of the European Union, to correct an unsafe
condition for the Airbus Helicopters Model AS332C, AS332C1, AS332L,
AS332L1, and AS332L2 helicopters manufactured before July 14, 2014, and
equipped with sliding doors modified in accordance with Airbus
Helicopters modification (MOD) AL25612 or 0725870. EASA AD No. 2015-
0156 also applies to Airbus Helicopters Model EC225LP helicopters
manufactured before July 14, 2014, and equipped with sliding doors.
    EASA advises that the sliding door's emergency jettisoning
mechanism failed during a scheduled inspection because of significant
corrosion damage caused by water accumulation from a plastic-rubber
compound that obstructed the water drain of the jettison mechanism
system. According to EASA, this condition, if not detected and
corrected, could lead to jamming of the jettisoning mechanism, possibly
preventing the jettisoning of the door during an emergency and
jeopardizing the safe evacuation of occupants. To address this unsafe
condition, EASA AD No. 2015-0156 requires a one-time inspection of the
left hand and right hand sliding doors for corrosion.
    Since the NPRM was issued, the FAA's Aircraft Certification Service
has changed its organization structure. The new structure replaces
product directorates with functional divisions. We have revised some of
the office titles and nomenclature throughout this Final rule to
reflect the new organizational changes. Additional information about
the new structure can be found in the Notice published on July 25, 2017
(82 FR 34564).

Comments

    After our NPRM was published, we received comments from two
commenters.

Request

    Both commenters requested that we require replacement of the entire
door jettisoning system. In support of this request, the commenters
stated that only replacing corroded parts and not the entire system
does not eliminate the danger of the parts corroding again.

    We disagree. The AD does not only require the replacement of
corroded parts. It also requires removing any sealing compound,
measuring any corrosion and testing the door jettisoning mechanism,
ensuring the clearance between the bracket and stainless steel pipe,
and ensuring there is no obstruction of the drain on the roller well
bracket. We determined that the combination of these actions reduces
the risk of the corrosion recurring to an acceptable level and is
therefore sufficient to correct the unsafe condition.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA, reviewed the relevant information,
considered the comments received, and determined the unsafe condition
exists and is likely to exist or develop on other helicopters of these
same type designs and that air safety and the public interest require
adopting the AD requirements as proposed.

Differences Between This AD and the EASA AD

    The EASA AD requires compliance within various times, depending on
the helicopter model and modifications. This AD requires compliance
within 30 days.

Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Helicopters Alert Service Bulletin No. AS332-
53.01.86, Revision 1, dated June 29, 2015 (ASB AS332-53.01.86), for
Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2 helicopters and
military model AS332B, B1, F1, M, and M1 helicopters; and Alert Service
Bulletin No. EC225-53A048, Revision 0, dated August 18, 2014 (ASB
EC225-53A048), for Model EC225LP helicopters. ASB AS332-53.01.86 and
ASB EC225-53A048 specify checking areas of the emergency jettisoning
system of the sliding doors for the absence of sealing compound, for
corrosion on the visible surfaces of the bracket, for the absence of
interference between the stainless steel pipe and the aluminum bracket,
and for non-obstruction of the drain.
    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 24 helicopters of U.S. Registry
and that labor costs average $85 per work-hour. Based on these
estimates, we expect that visually inspecting for corrosion requires 1
work-hour and no parts for a total cost of $85 per helicopter, and
$2,040 for the U.S. fleet. Replacing corroded parts requires 8 work-
hours and parts cost $500 for a total cost of $1,180 per helicopter.
Replacing the door jettisoning system requires 16 work-hours and parts
cost $4,500 for a total cost of $5,860 per helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue 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 helicopters identified in this
rulemaking action.

Regulatory Findings

    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 DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; 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.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

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):

2018-05-01 Airbus Helicopters: Amendment 39-19210; Docket No. FAA-
2016-5019; Product Identifier 2015-SW-079-AD.

(a) Applicability

    This AD applies to the following Airbus Helicopters,
certificated in any category:
    (1) Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2
helicopters with a date of manufacture on or before July 14, 2014,
and with a sliding cabin plug door (sliding door) with Airbus
Helicopters modification AL25612 or 0725870 installed; and
    (2) Model EC225LP helicopters with a date of manufacture on or
before July 14, 2014.

(b) Unsafe Condition

    This AD defines the unsafe condition as corrosion of a
jettisoning mechanism which, if not detected and corrected, could
result in failure of a sliding door to jettison, preventing
occupants from exiting the helicopter during an emergency.

(c) Effective Date

    This AD becomes effective April 5, 2018.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 30 days:
    (1) Visually inspect the left-hand and right-hand sliding doors
for sealing compound as shown in Figure 1 of Airbus Helicopters
Alert Service Bulletin No. AS332-53.01.86, Revision 1, dated June
29, 2015 (ASB AS332-53.01.86), or Airbus Helicopters Alert Service
Bulletin No. EC225-53A048, Revision 0, dated August 18, 2014 (ASB
EC225-53A048), as applicable for your model helicopter. Remove any
sealing compound.

    (2) Inspect all visible bracket surfaces for corrosion. If there
is any corrosion, remove the corrosion and measure the corrosion
depth.
    (i) If the measured corrosion depth is less than 0.5 mm, perform
a jettisoning test. If the door passes the test, apply corrosion
protectant. If the door does not pass the test, replace the
jettisoning system before further flight.
    (ii) If the measured corrosion depth is 0.5 mm or more, perform
a jettisoning test. If the door passes the test, apply corrosion
protectant, perform a jettisoning test at intervals not to exceed
two months for not more than six months, and replace the jettisoning
system within six months. If the door does not pass the test,
replace the jettisoning system before further flight.
    (3) Measure the clearance between the bracket and stainless
steel pipe. If the clearance is less than 3 mm, remove the lockwire
from the union and loosen the unions of the air vent pipe. Position
the support and the air vent pipe to ensure a minimum clearance of 3
mm. Tighten the support and unions of the pipe and safety the union
using lockwire.
    (4) For Model EC225LP helicopters and Model AS332-series
helicopters with modification AL25612, inspect for drain obstruction
by compressing the middle rail roller well piston and injecting
distilled water through the roller well to determine if the water
drains. If the drain is obstructed, remove the sealing compound and
adhesive from the gutter in the bracket area. Remove the drain from
the gutter and unclog the drain and gutter using a spatula or brush.
Clean the gutter on the bracket side and the drain. Apply adhesive
to the gutter and then slide in the drain. Allow the adhesive to
dry, and then apply sealing compound.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
David Hatfield, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy, Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2015-0156, dated July 29, 2015, and corrected
July 30, 2015. You may view the EASA AD on the internet at http://www.regulations.gov in Docket No. FAA-2016-5019.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 5220, Emergency
Exits.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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 the AD specifies otherwise.
    (i) Airbus Helicopters Alert Service Bulletin No. AS332-
53.01.86, Revision 1, dated June 29, 2015.
    (ii) Airbus Helicopters Alert Service Bulletin No. EC225-53A048,
Revision 0, dated August 18, 2014.
    (3) For Airbus Helicopters service information identified in
this AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand
Prairie, TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(972) 641-3775; or at http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-
321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (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<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on February 21, 2018.
Scott A. Horn,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2018-03928 Filed 2-28-18; 8:45 am]
 BILLING CODE 4910-13-P