[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Rules and Regulations]
[Pages 57734-57737]
[FR Doc No: 2015-24433]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2015-0001; Internal Agency Docket No. FEMA-8401]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Bret Gates, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and

public comment procedures under 5 U.S.C. 553(b), are impracticable and
unnecessary because communities listed in this final rule have been
adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.
    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

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                                              Effective date
                                              authorization/
                                 Community    cancellation of    Current effective map    Date certain  federal
      State and Location            No.        sale of flood             date             assistance  no longer
                                               insurance in                                available  in SFHAs
                                                 community
----------------------------------------------------------------------------------------------------------------
          Region III
Pennsylvania: Aleppo, Township      421667  June 28, 1979,      Oct. 16, 2015.........  Oct. 16, 2015
 of, Greene County.                          Emerg; August 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Carmichaels, Borough of,            420475  July 2, 1975,       ......* do............   Do.
 Greene County.                              Emerg; September
                                             28, 1979, Reg;
                                             October 16, 2015,
                                             Susp.
Center, Township of, Greene         421668  November 18, 1975,  ......do..............   Do.
 County.                                     Emerg; May 1,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Clarksville, Borough of,            420476  December 3, 1975,   ......do..............   Do.
 Greene County.                              Emerg; September
                                             16, 1981, Reg;
                                             October 16, 2015,
                                             Susp.
Cumberland, Township of,            421188  January 27, 1976,   ......do..............   Do.
 Greene County.                              Emerg; July 1,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Dunkard, Township of, Greene        422431  February 22, 1984,  ......do..............   Do.
 County.                                     Emerg; October 5,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Franklin, Township of, Greene       422595  February 7, 1977,   ......do..............   Do.
 County.                                     Emerg; February
                                             17, 1989, Reg;
                                             October 16, 2015,
                                             Susp.
Freeport, Township of, Greene       422432  September 29,       ......do..............   Do.
 County.                                     1980, Emerg;
                                             September 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Gilmore, Township of, Greene        422433  August 8, 1978,     ......do..............   Do.
 County.                                     Emerg; August 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Gray, Township of, Greene           421669  February 4, 1976,   ......do..............   Do.
 County.                                     Emerg; September
                                             24, 1984, Reg;
                                             October 16, 2015,
                                             Susp.
Greene, Township of, Greene         421670  September 7, 1979,  ......do..............   Do.
 County.                                     Emerg; August 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Greensboro, Borough of, Greene      420477  December 2, 1975,   ......do..............   Do.
 County.                                     Emerg; March 2,
                                             1989, Reg;
                                             October 16, 2015,
                                             Susp.
Jackson, Township of, Greene        421671  April 30, 1981,     ......do..............   Do.
 County.                                     Emerg; August 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Jefferson, Township of, Greene      421672  December 2, 1975,   ......do..............   Do.
 County.                                     Emerg; September
                                             16, 1981, Reg;
                                             October 16, 2015,
                                             Susp.
Monongahela, Township of,           421673  July 6, 1979,       ......do..............   Do.
 Greene County.                              Emerg; August 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Morgan, Township of, Greene         421674  January 19, 1977,   ......do..............   Do.
 County.                                     Emerg; July 1,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Morris, Township of, Greene         421675  December 30, 1975,  ......do..............   Do.
 County.                                     Emerg; August 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Perry, Township of, Greene          422434  March 16, 1976,     ......do..............   Do.
 County.                                     Emerg; May 1,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Rices Landing, Borough of,          420479  December 16, 1975,  ......do..............   Do.
 Greene County.                              Emerg; July 16,
                                             1981, Reg;
                                             October 16, 2015,
                                             Susp.
Richhill, Township of, Greene       421676  November 28, 1975,  ......do..............   Do.
 County.                                     Emerg; August 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.

Springhill, Township of,            421677  March 13, 1981,     ......do..............   Do.
 Greene County.                              Emerg; August 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Washington, Township of,            421678  April 4, 1977,      ......do..............   Do.
 Greene County.                              Emerg; August 3,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Wayne, Township of, Greene          421679  April 8, 1981,      ......do..............   Do.
 County.                                     Emerg; August 24,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Waynesburg, Borough of, Greene      420480  April 30, 1975,     ......do..............   Do.
 County.                                     Emerg; June 17,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Whiteley, Township of, Greene       421680  December 21, 1978,  ......do..............   Do.
 County.                                     Emerg; September
                                             10, 1984, Reg;
                                             October 16, 2015,
                                             Susp.
           Region V
Wisconsin: Bell Center,             550068  August 16, 1978,    ......do..............   Do.
 Village of, Crawford County.                Emerg; March 5,
                                             1990, Reg;
                                             October 16, 2015,
                                             Susp.
Crawford County,                    555551  March 19, 1971,     ......do..............   Do.
 Unincorporated Areas.                       Emerg; April 20,
                                             1973, Reg;
                                             October 16, 2015,
                                             Susp.
De Soto, Village of, Crawford       550069  December 15, 1980,  ......do..............   Do.
 and Vernon Counties.                        Emerg; January
                                             16, 1981, Reg;
                                             October 16, 2015,
                                             Susp.
Ferryville, Village of,             555553  April 16, 1971,     ......do..............   Do.
 Crawford County.                            Emerg; May 26,
                                             1972, Reg;
                                             October 16, 2015,
                                             Susp.
Gays Mills, Village of,             550071  April 12, 1973,     ......do..............   Do.
 Crawford County.                            Emerg; June 15,
                                             1978, Reg;
                                             October 16, 2015,
                                             Susp.
Germantown, Village of,             550472  July 15, 1975,      ......do..............   Do.
 Washington County.                          Emerg; May 3,
                                             1982, Reg;
                                             October 16, 2015,
                                             Susp.
Hartford, City of, Dodge and        550473  April 17, 1975,     ......do..............   Do.
 Washington Counties.                        Emerg; December
                                             4, 1984, Reg;
                                             October 16, 2015,
                                             Susp.
Lynxville, Village of,              555563  April 3, 1971,      ......do..............   Do.
 Crawford County.                            Emerg; March 16,
                                             1973, Reg;
                                             October 16, 2015,
                                             Susp.
Prairie du Chien, City of,          555573  May 22, 1970,       ......do..............   Do.
 Crawford County.                            Emerg; May 22,
                                             1970, Reg;
                                             October 16, 2015,
                                             Susp.
Richfield, Village of,              550518  N/A, Emerg;         ......do..............   Do.
 Washington County.                          September 30,
                                             2008, Reg;
                                             October 16, 2015,
                                             Susp.
Slinger, Village of,                550587  October 16, 1986,   ......do..............   Do.
 Washington County.                          Emerg; November
                                             20, 2013, Reg;
                                             October 16, 2015,
                                             Susp.
Soldiers Grove, Village of,         550074  April 9, 1971,      ......do..............   Do.
 Crawford County.                            Emerg; April 3,
                                             1984, Reg;
                                             October 16, 2015,
                                             Susp.
Steuben, Village of, Crawford       555580  May 21, 1971,       ......do..............   Do.
 County.                                     Emerg; April 20,
                                             1973, Reg;
                                             October 16, 2015,
                                             Susp.
Washington County,                  550471  May 28, 1975,       ......do..............   Do.
 Unincorporated Areas..                      Emerg; September
                                             1, 1983, Reg;
                                             October 16, 2015,
                                             Susp.
Wauzeka, Village of, Crawford       555586  April 9, 1971,      ......do..............   Do.
 County.                                     Emerg; April 20,
                                             1973, Reg;
                                             October 16, 2015,
                                             Susp.
          Region VII
Iowa: Burlington, City of, Des      190114  April 15, 1975,     ......do..............   Do.
 Moines County.                              Emerg; July 2,
                                             1981, Reg;
                                             October 16, 2015,
                                             Susp.
Des Moines County,                  190113  N/A, Emerg; July    ......do..............   Do.
 Unincorporated Areas..                      20, 1993, Reg;
                                             October 16, 2015,
                                             Susp.
Letts, City of, Louisa County.      190311  N/A, Emerg;         ......do..............   Do.
                                             September 2,
                                             1993, Reg;
                                             October 16, 2015,
                                             Susp.
          Region VIII
Montana: Columbus, Town of,         300109  April 9, 1997,      ......do..............   Do.
 Stillwater County.                          Emerg; August 2,
                                             1997, Reg;
                                             October 16, 2015,
                                             Susp.
Stillwater County,                  300078  August 26, 1975,    ......do..............   Do.
 Unincorporated Areas.                       Emerg; November
                                             15, 1985, Reg;
                                             October 16, 2015,
                                             Susp.
North Dakota: Belmont,              380653  July 12, 1982,      ......do..............   Do.
 Township of, Traill County.                 Emerg; August 5,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Beulah, City of, Mercer County      380066  March 14, 1975,     ......do..............   Do.
                                             Emerg; January 5,
                                             1978, Reg;
                                             October 16, 2015,
                                             Susp.
Bingham, Township of, Traill        380640  February 8, 1980,   ......do..............   Do.
 County.                                     Emerg; August 5,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Caledonia, Township of, Traill      380638  January 3, 1980,    ......do..............   Do.
 County.                                     Emerg; August 5,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Eldorado, Township of, Traill       380645  April 25, 1980,     ......do..............   Do.
 County.                                     Emerg; August 19,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Elm River, Township of, Traill      380636  September 13,       ......do..............   Do.
 County.                                     1979, Emerg;
                                             August 5, 1986,
                                             Reg; October 16,
                                             2015, Susp.
Hazen, City of, Mercer County.      380067  August 13, 1974,    ......do..............   Do.
                                             Emerg; December
                                             15, 1977, Reg;
                                             October 16, 2015,
                                             Susp.
Hebron, City of, Morton County      380071  April 9, 1974,      ......do..............   Do.
                                             Emerg; September
                                             5, 1979, Reg;
                                             October 16, 2015,
                                             Susp.

Herberg, Township of, Traill        380621  September 25,       ......do..............   Do.
 County.                                     1978, Emerg;
                                             August 5, 1986,
                                             Reg; October 16,
                                             2015, Susp.
Kelso, Township of, Traill          380644  April 11, 1980,     ......do..............   Do.
 County.                                     Emerg; August 5,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Mandan, City of, Morton County      380072  April 4, 1974,      ......do..............   Do.
                                             Emerg; September
                                             30, 1987, Reg;
                                             October 16, 2015,
                                             Susp.
Mercer County, Unincorporated       380294  October 20, 1993,   ......do..............   Do.
 Areas.                                      Emerg; May 4,
                                             1998, Reg;
                                             October 16, 2015,
                                             Susp.
Morton County, Unincorporated       380148  September 13,       ......do..............   Do.
 Areas.                                      1973, Emerg;
                                             September 30,
                                             1987, Reg;
                                             October 16, 2015,
                                             Susp.
Stavanger, Township of, Traill      380642  February 29, 1980,  ......do..............   Do.
 County.                                     Emerg; August 5,
                                             1986, Reg;
                                             October 16, 2015,
                                             Susp.
Three Affiliated Tribes, Dunn,      380721  August 23, 2000,    ......do..............   Do.
 McKenzie, McLean, Mercer and                Emerg; August 19,
 Mountrail Counties..                        2010, Reg;
                                             October 16, 2015,
                                             Susp.
Traill County, Unincorporated       380130  June 30, 1997,      ......do..............   Do.
 Areas.                                      Emerg; May 4,
                                             1998, Reg;
                                             October 16, 2015,
                                             Susp.
Zap, City of, Mercer County...      380068  April 7, 1975,      ......do..............   Do.
                                             Emerg; July 16,
                                             1979, Reg;
                                             October 16, 2015,
                                             Susp.
           Region IX
Arizona: Cottonwood, City of,       040096  May 5, 1975,        ......do..............   Do.
 Yavapai County.                             Emerg; September
                                             16, 1981, Reg;
                                             October 16, 2015,
                                             Susp.
----------------------------------------------------------------------------------------------------------------
......* do = Ditto.
Code for reading third column: Emerg. --Emergency; Reg. --Regular; Susp. --Suspension.

    Dated: September 8, 2015.
Roy E. Wright
Deputy Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2015-24433 Filed 9-24-15; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register: March 12, 2009 (Volume 74, Number 47)]
[Notices]
[Page 10800-10801]
[DOCID:fr12mr09-116]

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DEPARTMENT OF TRANSPORTATION

ITS Joint Program Office, Intelligent Transportation Systems
Program Advisory Committee; Notice of Meeting

AGENCY: Research and Innovative Technology Administration, U.S.
Department of Transportation.

ACTION: Notice.

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    This notice announces, pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (FACA) (Pub. L. 72-363; 5 U.S.C. app. 2), a
meeting of the Intelligent Transportation Systems (ITS) Program
Advisory Committee (ITSPAC). The meeting will be held on April 6, 2009,
2 p.m. to 4 p.m. The meeting will take place at the U.S. Department of
Transportation (U.S. DOT), 1200 New Jersey Avenue, SE., Washington DC,
in conference room 2 of the U.S DOT Conference Center on the
lobby level of the West Building.
    The ITSPAC, established under Section 5305 of Public Law 109-59,
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users, August 10, 2005, and chartered on February 7, 2008,
was created to advise the Secretary of Transportation on all matters
relating to the study, development and implementation of intelligent
transportation systems. Through its sponsor, the ITS Joint Program
Office, the ITSPAC makes recommendations to the Secretary

regarding ITS Program needs, objectives, plans, approaches, contents,
and progress.
    The following is a summary of the meeting's tentative agenda: (1)
Update on new Administration transition issues and news; (2) Update on
American Recovery and Reinvestment Act issues and news; (3) Report on
IntelliDriveSM Program draft principles; (4) Discussion of
ITSPAC input on transportation legislation reauthorization; (5)
Discussion of ITSPAC input on the Committee's proposed new ITS Program
goal; (6) Update on ITS Program Strategic Plan status; (7) Update on
Intelligent Transportation Society of America 2009 Annual Meeting
activities; (8) Update on U.S. DOT ITS Program governance processes and
status; and (9) Discussion of location, timing, and topics for next
ITSPAC meeting.
    Since access to the U.S. DOT building is controlled, all persons
who plan to attend the meeting must notify Mr. Stephen Glasscock, the
Committee Designated Federal Official, at<PHONE_NUMBER> not later than
April 1, 2009. Individuals attending the meeting must report for
admission at the 1200 New Jersey Avenue entrance of the U.S. DOT
building. Attendance is open to the public, but limited space will be
available on a first come, first served basis. With the approval of Ms.
Shelley Row, Director of the ITS Joint Program Office, members of the
public may present oral statements at the meeting. Non-committee
members wishing to present oral statements or obtain information should
contact Mr. Glasscock.
    Questions about the agenda or written comments may be submitted by
U.S. Mail to: U.S. Department of Transportation, Research and
Innovative Technology Administration, ITS Joint Program Office,
Attention: Stephen Glasscock, 1200 New Jersey Avenue, SE., HOIT,
Washington, DC 20590 or faxed to<PHONE_NUMBER>. The ITS Joint Program
Office requests that written comments be submitted prior to the
meeting.
    Persons with a disability requiring special services, such as an
interpreter for the hearing impaired, should contact Mr. Glasscock at
least seven calendar days prior to the meeting.
    Notice of this meeting is provided in accordance with the FACA and
the General Services
    Administration regulations (41 CFR part 102-3) covering management
of Federal advisory committees.

    Issued in Washington, DC, on the 6th day of March, 2009.
John Augustine,
Managing Director, ITS Joint Program Office.
 [FR Doc. E9-5360 Filed 3-11-09; 8:45 am]

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[Federal Register: December 3, 2009 (Volume 74, Number 231)]
[Notices]
[Page 63405-63406]
[DOCID:fr03de09-30]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0560]

Determination That MESANTOIN (Mephenytoin) Tablets, 100
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its
determination that MESANTOIN (mephenytoin) Tablets, 100 milligrams
(mg), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for mephenytoin tablets, 100 mg, if all
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs.

FDA publishes this list as part of the ``Approved Drug Products With
Therapeutic Equivalence Evaluations,'' which is known generally as the
``Orange Book.'' Under FDA regulations, drugs are removed from the list
if the agency withdraws or suspends approval of the drug's NDA or ANDA
for reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162). Under Sec.  314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must determine whether a listed drug was
withdrawn from sale for reasons of safety or effectiveness before an
ANDA that refers to that listed drug may be approved. FDA may not
approve an ANDA that does not refer to a listed drug.
    Schiff & Co. submitted a citizen petition dated October 16, 2008
(Docket No. FDA-2008-P-0560), under 21 CFR 10.30, requesting that the
agency determine whether MESANTOIN (mephenytoin) Tablets, 100 mg, was
withdrawn from sale for reasons of safety or effectiveness. MESANTOIN
(mephenytoin) Tablets, 100 mg, is the subject of NDA 6-008, held by
Novartis and initially approved on October 23, 1946. MESANTOIN is
indicated to control grand mal, local, Jacksonian, and psychomotor
seizures in patients who have been refractory to less toxic
anticonvulsants. In a letter dated January 13, 2000, Novartis notified
FDA that MESANTOIN (mephenytoin) Tablets, 100 mg, was being
discontinued and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
    FDA has reviewed its records and, under Sec.  314.161, has
determined that MESANTOIN (mephenytoin) Tablets, 100 mg, was not
withdrawn from sale for reasons of safety or effectiveness. The
petitioner identified no data or other information suggesting that
MESANTOIN (mephenytoin) Tablets, 100 mg, was withdrawn for reasons of
safety or effectiveness. FDA has independently evaluated relevant
literature and data for possible postmarketing adverse events and has
found no information that would indicate that this product was
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list MESANTOIN (mephenytoin)
Tablets, 100 mg, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. ANDAs that
refer to MESANTOIN (mephenytoin) Tablets, 100 mg, may be approved by
the agency if all other legal and regulatory requirements for the
approval of ANDAs are met. If FDA determines that labeling for this
drug product should be revised to meet current standards, the agency
will advise ANDA applicants to submit such labeling.

    Dated: November 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28872 Filed 12-2-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 75, Number 140 (Thursday, July 22, 2010)]
[Notices]
[Pages 42812-42813]
[FR Doc No: 2010-17925]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62503; File No. SR-ISE-2010-71]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to a Market Maker Incentive Plan for Foreign Currency
Options

July 15, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder, \2\ notice is hereby given
that on June 30, 2010, International Securities Exchange, LLC (``ISE''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to extend an incentive plan for market makers
in four foreign currency options (``FX Options''). The text of the
proposed rule change is available on ISE's Web site at http://www.ise.com, on the Commission's Web site at http://www.sec.gov, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this proposed rule change is to extend an incentive
plan for market makers in options on the New Zealand dollar (``NZD''),
the Mexican peso (``PZO''), the Swedish krona (``SKA'') and the
Brazilian real (``BRB'').\3\ On August 3, 2009, the Exchange adopted an
incentive plan applicable to market makers in NZD, PZO and SKA, \4\ and
on January 19, 2010, added BRB to the incentive plan.\5\ The Exchange
subsequently extended the date by which market makers may join the
incentive plan.\6\ The Exchange proposes to again extend the date by
which market makers may join the incentive plan.
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    \3\ The Commission previously approved the trading of options on
NZD, PZO, SKA and BRB. See Exchange Act Release No. 34-55575 (April
3, 2007), 72 FR 17963 (April 10, 2007) (SR-ISE-2006-59).
    \4\ See Exchange Act Release No. 34-60536 (August 19, 2009), 74
FR 43204 (August 26, 2009) (SR-ISE-2009-59).
    \5\ See Exchange Act Release No. 34-61459 (February 1, 2010), 75
FR 6248 (February 8, 2010) (SR-ISE-2010-07).
    \6\ See Exchange Act Release Nos. 34-60810 (October 9, 2009), 74
FR 53527 (October 19, 2009) (SR-ISE-2009-80), 34-61334 (January 12,
2010), 75 FR 2913 (January 19, 2010) (SR-ISE-2009-115), and 61851
(April 6, 2010), 75 FR 18565 (April 12, 2010) (SR-ISE-2010-27).
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    In order to promote trading in these FX Options, the Exchange has
an incentive plan pursuant to which the Exchange waives the transaction
fees for the Early Adopter \7\ FXPMM \8\ and all Early Adopter FXCMMs
\9\ that make a market in NZD, PZO SKA and BRB for as long as the
incentive plan is in effect. Further, pursuant to a revenue sharing
agreement entered into between an Early Adopter Market Maker and ISE,
the Exchange pays the Early Adopter FXPMM forty percent (40%) of the
transaction fees collected on any customer trade in NZD, PZO SKA and
BRB and pays up to ten (10) Early Adopter FXCMMs that participate in
the incentive plan twenty percent (20%) of the transaction fees
collected for trades between a customer and that FXCMM. Market makers
that do not participate in

the incentive plan are charged regular transaction fees for trades in
these products. In order to participate in the incentive plan, market
makers are required to enter into the incentive plan no later than June
30, 2010. The Exchange now proposes to extend the date by which market
makers may enter into the incentive plan to September 30, 2010.
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    \7\ Participants in the incentive plan are known on the
Exchange's Schedule of Fees as Early Adopter Market Makers.
    \8\ A FXPMM is a primary market maker selected by the Exchange
that trades and quotes in FX Options only. See ISE Rule 2213.
    \9\ A FXCMM is a competitive market maker selected by the
Exchange that trades and quotes in FX Options only. See ISE Rule
2213.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\10\ in general, and
furthers the objectives of Section 6(b)(4),\11\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities. The Exchange believes the proposed rule change will
permit additional market makers to join the incentive plan which in
turn will generate additional order flow to the Exchange by creating
incentives to trade these FX Options as well as defray operational
costs for Early Adopter Market Makers.
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    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3) of the Act \12\ and Rule 19b-4(f)(2) \13\ thereunder. At any
time within 60 days of the filing of such proposed rule change, the
Commission may summarily abrogate such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
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    \12\ 15 U.S.C. 78s(b)(3).
    \13\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2010-71 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2010-71. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro/shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing will also be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-ISE-2010-71 and should be
submitted on or before August 12, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-17925 Filed 7-21-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: May 10, 2007 (Volume 72, Number 90)]
[Notices]
[Page 26624]
[DOCID:fr10my07-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2219-020--Utah]

Garkane Energy Cooperative, Inc.; Notice of Availability of Final
Environmental Assessment

May 4, 2007.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR Part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed the application for new license for the
Boulder Creek Hydroelectric Project, located on Boulder Creek in
Garfield County, Utah, and has prepared a final Environmental
Assessment (EA) for the project. The project occupies 29.59 acres of
Federal land, administered by the U.S. Forest Service as part of the
Dixie National Forest.
    The final EA contains the staff's analysis of the potential
environmental impacts of the project and concludes that issuing a new
license for the project, with appropriate environmental protective
measures, would not constitute a major federal action that would
significantly affect the quality of the human environment.
    A copy of the final EA is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,

(202) 502-8659.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    For further information, contact Dianne Rodman at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-8972 Filed 5-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Rules and Regulations]
[Pages 9581-9583]
[FR Doc No: 2013-02895]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1002; Directorate Identifier 2012-NM-052-AD;
Amendment 39-17346; AD 2013-03-11]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and
Model A300 C4-605R Variant F airplanes (collectively called A300-600
series airplanes); and Model A310 series airplanes. This AD was
prompted by reports of cracking through the honeycomb core closed with
phenolic resin. This condition could result in extended debonding and
could adversely affect the structural integrity of the rudder. This AD
requires inspecting to determine the serial number of a certain rudder
and replacing the rudder with a new or serviceable rudder if necessary.
We are issuing this AD to prevent extended de-bonding, which could
result in loss of the rudder and consequent reduced controllability of
the airplane.

DATES: This AD becomes effective March 18, 2013.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on September 26, 2012
(77 FR 59149). That NPRM proposed to correct an unsafe condition for
the specified products. The Mandatory Continuing Airworthiness
Information (MCAI) states:

    Following in-service findings reported by an operator, rudder
laboratory investigation revealed the existence of a crack through
the honeycomb core closed with phenolic resin. This condition if not
detected and corrected, could result in extended de-bonding, which
would adversely affect the structural integrity of the rudder. The
loss of the rudder could lead to degradation of the handling
qualities and reduces the controllability of the aeroplane.
    Further investigations identified a batch of five affected
rudders.
    For the reasons described above, this [European Aviation Safety
Agency (EASA)] AD [2012-0006, dated January 12, 2012] requires
[inspecting to determine the serial number (S/N) of a certain rudder
and] the replacement of the five affected rudders with [new or]
serviceable ones.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received.

Request To Supersede AD 2010-16-13, Amendment 39-16390 (75 FR 49370,
August 13, 2010)

    UPS requested that the NPRM (77 FR 59149, September 26, 2012)
supersede AD 2010-16-13, Amendment 39-16390 (75 FR 49370, August 13,
2010). UPS stated that three serial numbers in the NPRM are also the
subject of AD 2010-16-13, which could create conflicting actions for
the same component.
    We disagree with the request to supersede AD 2010-16-13, Amendment
39-16390 (75 FR 49370, August 13, 2010). AD 2010-16-13 is a
comprehensive inspection program to verify the integrity of the bonding
between the skin and honeycomb core of many rudders, whereas this AD is
a complete replacement due to in-service findings of a crack through
the honeycomb core. While the actions in AD 2010-16-13 apply to
multiple rudders, the replacement required by this AD is limited to 5
rudders. Since the 5 rudders have to be replaced within 3 months, and
AD 2010-16-13 applies to many rudders with a various repetitive
inspection interval, it is unlikely that the inspection and replacement
requirements would overlap. In addition, depending upon which rudder is
installed by an operator, the inspection program required by AD 2010-
16-13 may or may not apply. No change has been made to this AD in this
regard.

Request for Justification of NPRM (77 FR 59149, September 26, 2012)

    An anonymous commenter requested justification for the actions
required by the NPRM (77 FR 59149, September 26, 2012). The commenter
suggested that we ground the airplanes, inspect, and fix them, in order
to ``stop wasting time and taxpayer money.''
    We disagree with the commenter's suggestion for addressing the
identified unsafe condition. Under part 39 of the Federal Aviation
Regulations (14 CFR part 39), we issue an AD addressing a product when
we find that an unsafe condition exists in the product, and the
condition is likely to exist or develop in other products of the same
type design. In the case of this AD, we determined that the unsafe
condition is de-bonding, which could result in loss of the rudder and
consequent reduced controllability of the airplane.
    Further, under the Administrative Procedure Act (APA) (Pub. L. 79-
404, 5 U.S.C. Sec.  551, et seq.) we are required to provide notice of
our intent to add, change, or remove information in a rule, as well as
to give the public an opportunity to participate in rulemaking actions
unless we find good cause to bypass those requirements. (The APA is a
body of laws that, working together, provides minimum guidelines and
rules that federal agencies are required to follow when issuing a rule
or changing existing rules that, if adopted, would impact the rights of
the regulated public.) We have followed these requirements in issuing
this AD.
    Finally, in ADs, we specify a compliance time to incorporate and
schedule the actions into operators' maintenance programs to prevent
unnecessary grounding of airplanes.
    We find that no change to this AD is necessary in response to the
commenter's request.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 59149, September 26, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 59149, September 26, 2012).

Costs of Compliance

    We estimate that this AD will affect 170 products of U.S. registry.
We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $14,450, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 10 work-hours and require parts costing $714,100, for a cost
of $714,950 per product. We have no way of determining the number of
products that may need these actions.

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 products identified in this
rulemaking action.

Regulatory Findings

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 59149, September 26,
2012), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

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 AD:

2013-03-11 Airbus: Amendment 39-17346. Docket No. FAA-2012-1002;
Directorate Identifier 2012-NM-052-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective March 18,
2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A300 B4-601, B4-603, B4-620, B4-
622, B4-605R, B4-622R, F4-605R, F4-622R, and C4-605R Variant F
airplanes; and Model A310-203, -204, -221, -222, -304, -322, -324,
and -325 airplanes; certificated in any category; all serial
numbers, except those airplanes on which Airbus modification 08827
has been incorporated in production.

(d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

(e) Reason

    This AD was prompted by reports of cracking through the
honeycomb core closed with phenolic resin. This condition could
result in extended debonding and could adversely affect the
structural integrity of the rudder. We are issuing this AD to
prevent extended de-bonding, which could result in loss of the
rudder and consequent reduced controllability of the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspection

    Within 3 months after the effective date of this AD, inspect the
rudder having part number (P/N) A55471500, to determine if the
rudder has serial number (S/N) HF1010, HF1036, HF1059, HF1061, or
HF1064. A review of airplane maintenance records is acceptable in
lieu of this inspection if the serial number of the rudder can be
conclusively determined from that review.

(h) Rudder Replacement

    If, during the inspection required by paragraph (g) of this AD,
any rudder having S/N HF1010, HF1036, HF1059, HF1061, or HF1064 is
found, before further flight, replace the rudder with a new or
serviceable rudder, using a method approved by either the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA) (or its delegated
agent).

    Note 1 to Paragraph (h) of this AD:  Rudders having S/N HF1010,
HF1036, HF1059, HF1061, and HF1064 were installed on airplanes
having S/N 0295, 0297, 0321, 0355, and 0500; however, each rudder
may have been moved to another airplane.

(i) Parts Installation Prohibition

    As of the effective date of this AD, no person may install a
rudder P/N A55471500, having S/N HF1010, HF1036, HF1059, HF1061, or
HF1064, on any airplane.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(k) Related Information

    Refer to MCAI EASA Airworthiness Directive 2012-0006, dated
January 12, 2012, for related information.

(l) Material Incorporated by Reference

    None.

    Issued in Renton, Washington, on January 30, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-02895 Filed 2-8-13; 8:45 am]
BILLING CODE 4910-13-P


AME may defer an applicant to the FAA for further review (which may
include further examination and testing by a specialist physician) when
there is information indicating the existence or potential of an
adverse medical finding that may warrant further FAA medical evaluation
and oversight. Second-class medical certificates held for any
operations requiring a commercial pilot certificate (including the
second-class medical certificates that is required for balloon
operations under this final rule) expire at the end of the last day of
the 12th month after the month of the date of examination shown on the
medical certificate.
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    \34\ https://medxpress.faa.gov/.
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Alternatives Considered To Minimize Any Significant Economic Impact on
Small Entities
    The FAA has not identified any significant alternative that would
minimize any significant economic impact on small entities which do not
conflict with the statutory mandate. During the comment period, the FAA
solicited comment on potential alternative approaches that could
minimize the burden on small entities while still accomplishing the
objectives of the proposal and did not receive any suggestions.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing standards or engaging in related activities
that create unnecessary obstacles to the foreign commerce of the United
States. Pursuant to these Acts, the establishment of standards is not
considered an unnecessary obstacle to the foreign commerce of the
United States, so long as the standard has a legitimate domestic
objective, such as the protection of safety, and does not operate in a
manner that excludes imports that meet this objective. The statute also
requires consideration of international standards and, where
appropriate, that they be the basis for U.S. standards. The FAA has
assessed the potential effect of this final rule and determined that it
will not create unnecessary obstacles to the foreign commerce of the
United States.
    The FAA has assessed the potential effect of this rule and
determined that it ensures the safety of the American public and does
not exclude imports that meet this objective. As a result, the

FAA does not consider this rule as creating an unnecessary obstacle to
foreign commerce.

D. Unfunded Mandates Assessment

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
governs the issuance of Federal regulations that require unfunded
mandates. An unfunded mandate is a regulation that requires a State,
local, or tribal government or the private sector to incur direct costs
without the Federal government having first provided the funds to pay
those costs. The FAA determined that the final rule will not result in
the expenditure of $165,000,000 or more by State, local, or tribal
governments, in the aggregate, or the private sector, in any one year.

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.
    According to the 1995 amendments to the Paperwork Reduction Act (5
CFR 1320.8(b)(2)(vi)), an agency may not collect or sponsor the
collection of information, nor may it impose an information collection
requirement unless it displays a currently valid Office of Management
and Budget (OMB) control number.
    This final rule contains the following amendments to the existing
information collection requirements previously approved under OMB
Control No. 2120-0034. In the analysis below, the FAA describes the
incremental changes in the number of respondents, annual burden, and
monetized costs of the existing information collection requirement
previously approved under OMB Control No. 2120-0034. As required by the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the FAA has
submitted the information collection requirements to OMB for its
review.
Requirements To Hold a Second-Class Medical Certificate
    The final rule requires airmen to hold a valid second-class medical
certificate when exercising the privileges of a commercial pilot
certificate in a balloon for compensation or hire. To obtain a medical
certificate, an airman has to complete an online application (FAA form
8500-8, Application for Medical Certificate) using the FAA's medical
certificate application tool, MedXPress and undergo a physical
examination with an FAA-designated Aviation Medical Examiner (AME).
    In Table 12 below, the FAA shows the incremental burden of this
rule to the approved information collection under OMB Control No. 2120-
0034. Additional details on assumptions and calculations used in this
section are presented elsewhere in the Regulatory Evaluation section of
this document.
Estimates of the Hour Burden of the Collection of Information
    The mid estimate of the number of applicants in the first year is
2,277.

      Table 12--Burden Hours Associated With MedXPress Form 8500-8
------------------------------------------------------------------------
                       Number of          Hours per
     Form No.          applicants         applicant        Total hours
------------------------------------------------------------------------
         8500-8              2,277                1.5             3,416
------------------------------------------------------------------------

Estimate of the Total Annual Cost Burden to Respondents or Record
Keepers Resulting From the Collection of Information
    Once the information on FAA Form 8500-8 is collected, respondents
must receive a medical examination in order to be certificated to
exercise commercial balloon pilot privileges. The average fee for a
basic medical examination is estimated at $150. The total cost for
medical exams in the first year is as follows:

$150 x 2,277 submissions of Form 8500-8 = $ 341,550
Estimates of Annualized Costs to the Federal Government
    The estimated annualized cost to the Federal Government to
implement the final rule is between $133,339 and $540,118, with a mid-
estimate of $285,910 at a 7 percent discount rate. The FAA would incur
costs associated with reviewing and processing applications submitted
through MedXPress. It costs about $30 per medical certification review
using the primary estimate for the number of applications in the first
year, the FAA estimates a total cost of $67,399 (= $29.60 per
application x 2,277) in the first year.
    Currently, a MedXPress application that requires a special issuance
medical certificate is deferred to the AMCD of Oklahoma City for
further consideration. The FAA assumes that 10 percent of the
applicants do not initially qualify for second-class medical
certification and, therefore, would require special issuance. The
average cost to FAA for each medical certificate special issuance
review is approximately $126.
    The total annualized costs for the FAA to review, including NDR and
process MedXPress applications from commercial balloon applicants and
costs for the FAA to conduct Special Issuance Review for commercial
balloon applicants is between $98,855 and $400,430, with a mid-estimate
of $211,967 at a 7 percent discount rate over ten years.

F. International Compatibility

    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
reviewed the corresponding ICAO Standards and Recommended Practices and
has determined that this rule will require a minor modification to the
existing differences filed in regard to medical certification for
commercial balloon pilots. Currently, the U.S. has filed a difference
stating that balloon pilots are not required to hold a medical
certificate but are prohibited from operating during periods of medical
deficiency. This statement will be updated to reflect the medical
certificate requirement described in this rule.

G. Environmental Analysis

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

VI. Executive Order Determination

A. Executive Order 13132, Federalism

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

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

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

C. Executive Order 13609, International Cooperation

    Executive Order 13609, Promoting International Regulatory
Cooperation, 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 reduces
differences between U.S. aviation standards and those of other civil
aviation authorities by bringing U.S. regulatory requirements partially
into compliance with International Civil Aviation Organization (ICAO)
standards for medical certification.\35\
---------------------------------------------------------------------------

    \35\ The 12th edition of the Annex 1 to the Convention on
International Civil Aviation, Personnel Licensing, (July 2018),
specifies that a person exercising the privileges of a Free Balloon
Pilot License must hold a Class 2 medical. See <IP_ADDRESS>.
---------------------------------------------------------------------------

VII. Privacy

    The information collected from FAA Form 8500-8 becomes part of the
Privacy Act System of Records DOT/FAA 847, ``Aviation Records on
Individuals,'' [DOT/FAA 847] and is provided the protection outlined in
the description of the system as published in the Federal Register.

VIII. Additional Information

A. Electronic Access and Filing

    A copy of the NPRM, all comments received, this final rule, and all
background material may be viewed online at https://www.regulations.gov
using the docket number listed above. Electronic retrieval help and
guidelines are available on the website. It is available 24 hours each
day, 365 days each year. An electronic copy of this document may also
be downloaded from the Office of the Federal Register's website at
https://www.federalregister.gov and the Government Publishing Office's
website at https://www.govinfo.gov. A copy may also be found on the
FAA's Regulations and Policies website at https://www.faa.gov/regulations_policies.
    Copies may also be obtained by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW, Washington, DC 20591, or by calling<PHONE_NUMBER>.
Commenters must identify the docket or amendment number of this
rulemaking.
    All documents the FAA considered in developing this final rule,
including economic analyses and technical reports, may be accessed in
the electronic docket for this rulemaking.

B. Small Business Regulatory Enforcement Fairness Act

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

List of Subjects

14 CFR Part 61

    Aircraft, Airmen, Alcohol abuse, Aviation safety, Drug abuse,
Flight instruction, Medical certification, Recreation and recreation
areas, Reporting and recordkeeping requirements, Security measures,
Teachers.

14 CFR Part 68

    Aircraft, Airmen, Health, Reporting and Recordkeeping requirements.

The Amendment

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

PART 61--CERTIFICATION: PILOTS, FLIGHT INSTRUCTORS, AND GROUND
INSTRUCTORS

0
1. The authority citation for part 61 is revised to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701-44703, 44707,
44709-44711, 44729, 44903, 45102-45103, 45301-45302.

0
2. Amend Sec.  61.3 by revising paragraphs (c)(2)(xiii) and
(c)(2)(xiv), and adding paragraph (c)(2)(xv) to read as follows:

Sec.  61.3  Requirement for certificates, ratings, and authorizations.

* * * * *
    (c) * * *
    (2) * * *
    (xiii) Is exercising the privileges of a student, recreational or
private pilot certificate for operations conducted under the conditions
and limitations set forth in Sec.  61.113(i) and holds a U.S. driver's
license;
    (xiv) Is exercising the privileges of a flight instructor
certificate and acting as pilot in command or a required flightcrew
member for operations conducted under the conditions and limitations
set forth in Sec.  61.113(i) and holds a U.S. driver's license; or
    (xv) Is exercising the privileges of a student pilot certificate or
higher while acting as pilot in command on a special medical flight
test authorized under part 67 of this chapter.
* * * * *

0
3. Effective May 22, 2023, amend Sec.  61.3 by revising paragraph
(c)(2)(vi) to read as follows:

Sec.  61.3  Requirement for certificates, ratings, and authorizations.

* * * * *
    (c) * * *
    (2) * * *
    (vi) Is holding a pilot certificate with a balloon class rating and
that person--
    (A) Is exercising the privileges of a private pilot certificate in
a balloon; or
    (B) Is providing flight training in a balloon in accordance with
Sec.  61.133(a)(2)(ii);
* * * * *

0
4. Amend Sec.  61.23 by:
0
a. Revising paragraphs (b)(8) and (b)(9)(ii);
0
b. Adding paragraph (b)(10); and
0
c. Revising paragraphs (c)(3)(i)(C), (c)(3)(i)(D), and (c)(3)(i)(E).
    The revisions and additions read as follows:

Sec.  61.23  Medical certificates: Requirement and duration.

* * * * *
    (b) * * *
    (8) When taking a practical test or a proficiency check for a
certificate, rating, authorization or operating privilege conducted in
a glider, balloon, flight simulator, or flight training device;
    (9) * * *
    (ii) The flight conducted is a domestic flight operation within
U.S. airspace; or
    (10) When exercising the privileges of a student pilot certificate
or higher while acting as pilot in command on a special medical flight
test authorized under part 67 of this chapter.
    (c) * * *
    (3) * * *
    (i) * * *
    (C) Complete the medical education course set forth in Sec.  68.3
of this chapter during the 24 calendar months before acting as pilot in
command or serving as a required flightcrew member in an operation
conducted under Sec.  61.113(i) and retain a certification of course
completion in accordance with Sec.  68.3(b)(1) of this chapter;
    (D) Receive a comprehensive medical examination from a State-
licensed physician during the 48 months before acting as pilot in
command or serving as a required flightcrew member of an operation
conducted under Sec.  61.113(i) and that medical examination is
conducted in accordance with the requirements in part 68 of this
chapter; and
    (E) If the individual has been diagnosed with any medical condition
that may impact the ability of the individual to fly, be under the care
and treatment of a State-licensed physician when acting as pilot in
command or serving as a required flightcrew member of an operation
conducted under Sec.  61.113(i).
* * * * *

0
5. Effective May 22, 2023, amend Sec.  61.23 by:
0
a. Revising paragraphs (a)(2)(i) and (a)(2)(ii);
0
b. Adding paragraph (a)(2)(iii);
0
c. Revising paragraph (b)(3);
0
d. Redesignating paragraphs (b)(4) through (b)(10) as paragraphs (b)(6)
through (b)(12); and
0
e. Adding new paragraphs (b)(4) and (b)(5);
0
f. Revising paragraphs (d)(1)(iii) and (d)(2)(i).
    The revisions and additions read as follows:

Sec.  61.23  Medical certificates: Requirement and duration.

    (a) * * *
    (2) * * *
    (i) Second-in-command privileges of an airline transport pilot
certificate in part 121 of this chapter (other than operations
specified in paragraph (a)(1)(ii) of this section);
    (ii) Privileges of a commercial pilot certificate in an aircraft
other than a balloon or glider; or
    (iii) Except as provided in paragraph (b)(5) of this section,
privileges of a commercial pilot certificate with a balloon class
rating for compensation or hire; or
    (b) * * *
    (3) When exercising the privileges of a pilot certificate with a
glider category rating in a glider;
    (4) When exercising the privileges of a private pilot certificate
with a balloon class rating in a balloon;
    (5) When exercising the privileges of a commercial pilot
certificate with a balloon class rating in a balloon if the person is
providing flight training in accordance with Sec.  61.133(a)(2)(ii);
* * * * *
    (d) * * *

----------------------------------------------------------------------------------------------------------------
                                                                                Then your medical
                                       And on the date of                                  certificate expires,
            If you hold               examination for your    And you are conducting an   for that operation, at
                                       most recent medical       operation requiring        the end of the last
                                      certificate you were                                      day of the
----------------------------------------------------------------------------------------------------------------
(1) * * *
----------------------------------------------------------------------------------------------------------------
                                     (iii) Any age.........  a commercial pilot           12th month after the
                                                              certificate (other than a    month of the date of
                                                              commercial pilot             examination shown on
                                                              certificate with a balloon   the medical
                                                              rating when conducting       certificate.
                                                              flight training), a flight
                                                              engineer certificate, or
                                                              an air traffic control
                                                              tower operator certificate.
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(2) * * *
----------------------------------------------------------------------------------------------------------------
                                     (i) Any age...........  an airline transport pilot   12th month after the
                                                              certificate for second-in-   month of the date of
                                                              command privileges (other    examination shown on
                                                              than the operations          the medical
                                                              specified in paragraph       certificate.
                                                              (d)(1) of this section), a
                                                              commercial pilot
                                                              certificate (other than a
                                                              commercial pilot
                                                              certificate with a balloon
                                                              rating when conducting
                                                              flight training), a flight
                                                              engineer certificate, or
                                                              an air traffic control
                                                              tower operator certificate.
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
6. Amend Sec.  61.113 by revising the introductory text of paragraph
(i) to read as follows:

Sec.  61.113  Private pilot privileges and limitations: Pilot in
command.

* * * * *
    (i) A private pilot may act as pilot in command or serve as a
required flightcrew member of an aircraft without holding a medical
certificate issued under part 67 of this chapter provided the pilot
holds a valid U.S. driver's license, meets the requirements of Sec.
61.23(c)(3), and complies with this section and all of the following
conditions and limitations:
* * * * *

PART 68--REQUIREMENTS FOR OPERATING CERTAIN SMALL AIRCRAFT WITHOUT
A MEDICAL CERTIFICATE

0
7. The authority citation for part 68 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 44701-44703.

0
8. Amend Sec.  68.3 by revising the introductory text of paragraph (a)
and the introductory text of paragraph (b) to read as follows:

Sec.  68.3  Medical education course requirements.

    (a) The medical education course required to act as pilot in
command or serve as a required flightcrew member in an operation under
Sec.  61.113(i) of this chapter must--
* * * * *
    (b) Upon successful completion of the medical education course, the
following items must be electronically provided to the individual
seeking to act as pilot in command or serve as a required flightcrew
member under the conditions and limitations of Sec.  61.113(i) of this
chapter and transmitted to the FAA--
* * * * *

0
9. Amend Sec.  68.9 by revising the introductory text of paragraph (a)
to read as follows:

Sec.  68.9  Special Issuance process.

    (a) General. An individual who has met the qualifications to
operate an aircraft under Sec.  61.113(i) of this chapter and is
seeking to act as a pilot in command or serve as a required flightcrew
member under that section must have completed the process for obtaining
an Authorization for Special Issuance of a Medical Certificate for each
of the following:
* * * * *

    Issued in Washington, DC, under authority provided by 49 U.S.C.
106(f), 44701, 44702, and 44703 on or about November 16, 2022.
Billy Nolen,
Acting Administrator.
[FR Doc. 2022-25288 Filed 11-21-22; 8:45 am]
BILLING CODE 4910-13-P