[Federal Register Volume 86, Number 100 (Wednesday, May 26, 2021)]
[Rules and Regulations]
[Pages 28253-28262]
[FR Doc No: 2021-10972]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No. 31372; Amdt. No. 559]

IFR Altitudes; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This amendment adopts miscellaneous amendments to the required
IFR (instrument flight rules) altitudes and changeover points for
certain Federal airways, jet routes, or direct routes for which a
minimum or maximum en route authorized IFR altitude is prescribed. This
regulatory action is needed because of changes occurring in the
National Airspace System. These changes are designed to provide for the
safe and efficient use of the navigable airspace under instrument
conditions in the affected areas.

DATES: Effective 0901 UTC, June 17, 2021.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg 29, Room 104, Oklahoma
City, OK 73125. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal
Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR
altitudes governing the operation of all aircraft in flight over a
specified route or any portion of that route, as well as the changeover
points (COPs) for Federal airways, jet routes, or direct routes as
prescribed in part 95.

The Rule

    The specified IFR altitudes, when used in conjunction with the
prescribed changeover points for those routes, ensure navigation aid
coverage that is adequate for safe flight operations and free of
frequency interference. The reasons and circumstances that create the
need for this amendment involve matters of flight safety and
operational efficiency in the National Airspace System, are related to
published aeronautical charts that are essential to the user, and
provide for the safe and efficient use of the navigable airspace. In
addition, those various reasons or circumstances require making this
amendment effective before the next scheduled charting and publication
date of the flight information to assure its timely availability to the
user. The effective date of this amendment reflects those
considerations. In view of the close and immediate relationship between
these regulatory changes and safety in air commerce, I find that notice
and public procedure before adopting this amendment are impracticable
and contrary to the public interest and that good cause exists for
making the amendment effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(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);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 95 Airspace, Navigation (air).

    Issued in Washington, DC, on May 19, 2021.
Thomas J. Nichols,
Aviation Safety, Manager, Flight Procedures & Airspace Group, Flight
Technologies and Procedures Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, part 95 of the Federal Aviation Regulations (14 CFR part
95) is amended as follows effective at 0901 UTC, June 17, 2021.

0
1. The authority citation for part 95 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44719, 44721.

0
2. Part 95 is amended to read as follows:

                                  Revisions to IFR Altitudes & Changeover Point
                                  [Amendment 559 effective date June 17, 2021]
----------------------------------------------------------------------------------------------------------------
                     From                                         To                        MEA          MAA
----------------------------------------------------------------------------------------------------------------
                                     Sec.   95.3000 Low Altitude RNAV Routes
                               Sec.   95.3295 RNAV Route T295 Is Amended by Adding
----------------------------------------------------------------------------------------------------------------
BANGOR, ME VORTAC.............................  LAUDS, ME WP..........................         2800        17500
LAUDS, ME WP..................................  HULTN, ME WP..........................         2500        17500
HULTN, ME WP..................................  PRESQUE ISLE, ME VOR/DME..............         3000        17500
----------------------------------------------------------------------------------------------------------------
                                           Is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
SASHA, MA FIX.................................  KEYNN, NH WP..........................         4200        17500
KEYNN, NH WP..................................  CONCORD, NH VOR/DME...................         5000        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3312 RNAV Route T312 Is Added to Read
----------------------------------------------------------------------------------------------------------------
HILL CITY, KS VORTAC..........................  MOZEE, KS WP..........................         4400        17500
MOZEE, KS WP..................................  HUTCHINSON, KS VOR/DME................         3800        17500
HUTCHINSON, KS VOR/DME........................  DROOP, MO FIX.........................         3500        17500
DROOP, MO FIX.................................  DOGWOOD, MO VORTAC....................         3300        17500
DOGWOOD, MO VORTAC............................  FARMINGTON, MO VORTAC.................         3400        17500
FARMINGTON, MO VORTAC.........................  JEDPA, IL WP..........................         2900        17500
JEDPA, IL WP..................................  POCKET CITY, IN VORTAC................         2300        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3314 RNAV Route T314 Is Added to Read
----------------------------------------------------------------------------------------------------------------
BARNES, MA VORTAC.............................  FAIDS, MA FIX.........................         2900        17500
FAIDS, MA FIX.................................  PUDGY, MA FIX.........................         2800        17500
PUDGY, MA FIX.................................  GARDNER, MA VOR/DME...................         3000        17500
GARDNER, MA VOR/DME...........................  JOHNZ, NH FIX.........................         3500        17500
JOHNZ, NH FIX.................................  MANCH, NH WP..........................        *2600        17500
    *2100--MOCA
MANCH, NH WP..................................  KHRIS, NH FIX.........................         2300        17500
KHRIS, NH FIX.................................  RAYMY, NH FIX.........................        *2600        17500
    *2100--MOCA
RAYMY, NH FIX.................................  YUKES, NH WP..........................         2300        17500
YUKES, NH WP..................................  KENNEBUNK, ME VOR/DME.................         2600        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3315 RNAV Route T315 Is Added to Read
----------------------------------------------------------------------------------------------------------------
HARTFORD, CT VOR/DME..........................  DVANY, CT FIX.........................         2700        17500
DVANY, CT FIX.................................  DARTH, CT WP..........................         2700        17500
DARTH, CT WP..................................  WITNY, MA FIX.........................        *3000        17500
    *2500--MOCA
WITNY, MA FIX.................................  SPENO, MA FIX.........................         2900        17500
SPENO, MA FIX.................................  GARDNER, MA VOR/DME...................         3000        17500
GARDNER, MA VOR/DME...........................  KEYNN, NH WP..........................        *3600        17500
    *3900--MCA KEYNN, NH WP, N BND
KEYNN, NH WP..................................  JAMMA, VT WP..........................         4400        17500
JAMMA, VT WP..................................  EBERT, VT WP..........................        *5600        17500
    *6100--MCA EBERT, VT WP, N BND
EBERT, VT WP..................................  MUDDI, VT FIX.........................         6400        17500
MUDDI, VT FIX.................................  BURLINGTON, VT VOR/DME................         6000        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3316 RNAV Route T316 Is Added to Read
----------------------------------------------------------------------------------------------------------------
LAMMS, NY WP..................................  ROOMS, NY WP..........................        *3900        17500
    *3900--MCA ROOMS, NY WP, W BND
ROOMS, NY WP..................................  PAYGE, NY WP..........................         3500        17500
PAYGE, NY WP..................................  GALWA, NY FIX.........................         2900        17500
GALWA, NY FIX.................................  ETZUN, NY WP..........................         3000        17500
ETZUN, NY WP..................................  CAMBRIDGE, NY VOR/DME.................        *3300        17500
    *5000--MCA CAMBRIDGE, NY VOR/DME, E BND
CAMBRIDGE, NY VOR/DME.........................  DORIS, VT FIX.........................         6000        17500
DORIS, VT FIX.................................  BRATS, VT WP..........................        *6000        17500
    *4700--MCA BRATS, VT WP, W BND
BRATS, VT WP..................................  STRUM, NH WP..........................         4100        17500
STRUM, NH WP..................................  DUBIN, NH WP..........................        *4800        17500
    *4400--MCA DUBIN, NH WP, W BND
DUBIN, NH WP..................................  *MUGGY, NH FIX........................       **4000        17500
    *3100--MCA MUGGY, NH FIX, W BND
    **3500--MOCA
MUGGY, NH FIX.................................  BASUU, NH FIX.........................        *3000        17500

BASUU, NH FIX.................................  MANCH, NH WP..........................        *2600        17500
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                               Sec.   95.3391 RNAV Route T391 Is Amended by Adding
----------------------------------------------------------------------------------------------------------------
HANCOCK, NY VOR/DME...........................  OXFOR, NY WP..........................         4000        17500
OXFOR, NY WP..................................  PITCH, NY WP..........................         3700        17500
PITCH, NY WP..................................  GTOWN, NY WP..........................         3800        17500
GTOWN, NY WP..................................  POMPY, NY WP..........................         3800        17500
POMPY, NY WP..................................  FATUP, NY WP..........................        *3600        17500
    *3100--MCA FATUP, NY WP, SE BND
FATUP, NY WP..................................  SYRACUSE, NY VORTAC...................         2900        17500
----------------------------------------------------------------------------------------------------------------
                                              Is Amended to Delete
----------------------------------------------------------------------------------------------------------------
TUMPS, NY FIX.................................  SYRACUSE, NY VORTAC...................         3400        17500
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                               Sec.   95.3608 RNAV Route T608 Is Amended to Delete
----------------------------------------------------------------------------------------------------------------
WOZEE, NY WP..................................  U.S. CANADIAN BORDER..................        *3000        17500
    *2500--MOCA
U.S. CANADIAN BORDER..........................  HOCKE, MI WP..........................        *3500        17500
    *2900--MOCA
----------------------------------------------------------------------------------------------------------------
                                                Is Added to Read
----------------------------------------------------------------------------------------------------------------
HOCKE, MI WP..................................  U.S. CANADIAN BORDER..................        *3500        17500
    *2500--MOCA
U.S. CANADIAN BORDER..........................  WOZEE, NY WP..........................         2400        17500
WOZEE, NY WP..................................  CLUNG, NY FIX.........................         2700        17500
CLUNG, NY FIX.................................  ROCHESTER, NY VOR/DME.................         2500        17500
ROCHESTER, NY VOR/DME.........................  LORTH, NY FIX.........................         2500        17500
LORTH, NY FIX.................................  SYRACUSE, NY VORTAC...................         2400        17500
SYRACUSE, NY VORTAC...........................  STODA, NY FIX.........................         2300        17500
STODA, NY FIX.................................  VASTS, NY WP..........................         3000        17500
VASTS, NY WP..................................  LAMMS, NY WP..........................         3400        17500
LAMMS, NY WP..................................  NORSE, NY WP..........................         3500        17500
NORSE, NY WP..................................  MARIA, NY FIX.........................         3400        17500
MARIA, NY FIX.................................  ALBANY, NY VORTAC.....................         3000        17500
ALBANY, NY VORTAC.............................  WARUV, NY WP..........................        *3100        17500
    *3700--MCA WARUV, NY WP, E BND
WARUV, NY WP..................................  GRAVE, NY WP..........................        *4100        17500
    *4400--MCA GRAVE, NY WP, SE BND
GRAVE, NY WP..................................  GRISY, MA WP..........................         5300        17500
GRISY, MA WP..................................  WARIC, MA WP..........................         4700        17500
WARIC, MA WP..................................  HURLY, MA WP..........................         3300        17500
HURLY, MA WP..................................  GARDNER, MA VOR/DME...................         3000        17500
GARDNER, MA VOR/DME...........................  GRAYM, MA FIX.........................         3000        17500
GRAYM, MA FIX.................................  BLATT, CT FIX.........................         2800        17500
BLATT, CT FIX.................................  MOGUL, CT FIX.........................         2500        17500
MOGUL, CT FIX.................................  YANTC, CT WP..........................         2300        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3634 RNAV Route T634 Is Added to Read
----------------------------------------------------------------------------------------------------------------
SYRACUSE, NY VORTAC...........................  PAGER, NY FIX.........................         2300        17500
PAGER, NY FIX.................................  BRUIN, NY WP..........................         2600        17500
BRUIN, NY WP..................................  WATERTOWN, NY VORTAC..................         2600        17500
WATERTOWN, NY VORTAC..........................  U.S. CANADIAN BORDER..................         2000        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3662 RNAV Route T662 Is Added to Read
----------------------------------------------------------------------------------------------------------------
U.S. CANADIAN BORDER..........................  KATAH, ME WP..........................        *7000        17500
    *4600--MOCA
KATAH, ME WP..................................  HULTN, ME WP..........................         5800        17500
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.3698 RNAV Route T698 Is Added to Read
----------------------------------------------------------------------------------------------------------------
U.S. CANADIAN BORDER..........................  HULTN, ME WP..........................         7600        17500
HULTN, ME WP..................................  U.S. CANADIAN BORDER..................         2500        17500
----------------------------------------------------------------------------------------------------------------
                               Sec.   95.3705 RNAV Route T705 Is Amended by Adding
----------------------------------------------------------------------------------------------------------------
DANZI, NY WP..................................  CODDI, NY FIX.........................         4400        17500

CODDI, NY FIX.................................  MILID, NY FIX.........................         4000        17500
MILID, NY FIX.................................  LAMMS, NY WP..........................         3800        17500
LAMMS, NY WP..................................  USICI, NY FIX.........................         3400        17500
FOSYU, NY WP..................................  SRNAC, NY WP..........................         5400        17500
SRNAC, NY WP..................................  UUBER, NY WP..........................         5100        17500
UUBER, NY WP..................................  RIGID, NY WP..........................        *5400        17500
    *4800--MCA RIGID, NY WP, W BND
----------------------------------------------------------------------------------------------------------------
                                              Is Amended to Delete
----------------------------------------------------------------------------------------------------------------
UTICA, NY VORTAC..............................  USICI, NY FIX.........................         3900        17500
FOSYU, NY WP..................................  SARANAC LAKE, NY VOR/DME..............         5400        17500
SARANAC LAKE, NY VOR/DME......................  RIGID, NY WP..........................         5400        17500
----------------------------------------------------------------------------------------------------------------
                                           Is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
RIGID, NY WP..................................  PBERG, NY WP..........................         3800        17500
PBERG, NY WP..................................  LATTS, NY WP..........................         3200        17500
LATTS, NY WP..................................  U.S. CANADIAN BORDER..................         2900        17500
----------------------------------------------------------------------------------------------------------------
                               Sec.   95.3781 RNAV Route T781 Is Amended by Adding
----------------------------------------------------------------------------------------------------------------
U.S. CANADIAN BORDER..........................  HULTN, ME WP..........................        *7000        17500
    *4000--MOCA
----------------------------------------------------------------------------------------------------------------
                                    Sec.   95.4000 High Altitude RNAV Routes
                            Sec.   95.4067 RNAV Route Q67 Is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
SMTTH, TN WP..................................  TONIO, KY FIX.........................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
TONIO, KY FIX.................................  HENDERSON, WV VORTAC..................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                              Is Amended to Delete
----------------------------------------------------------------------------------------------------------------
TONIO, KY FIX.................................  DARYN, WV WP..........................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4176 RNAV Route Q176 Is Added to Read
----------------------------------------------------------------------------------------------------------------
CIMARRON, NM VORTAC...........................  KENTO, NM FIX.........................       *22000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
KENTO, NM FIX.................................  LIBERAL, KS VORTAC....................       *22000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
LIBERAL, KS VORTAC............................  WICHITA, KS VORTAC....................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
WICHITA, KS VORTAC............................  BUTLER, MO VORTAC.....................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
BUTLER, MO VORTAC.............................  ST LOUIS, MO VORTAC...................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
ST LOUIS, MO VORTAC...........................  GBEES, IN WP..........................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
GBEES, IN WP..................................  BICKS, KY WP..........................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
BICKS, KY WP..................................  HENDERSON, WV VORTAC..................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
HENDERSON, WV VORTAC..........................  OTTTO, VA WP..........................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------

                            Sec.   95.4806 RNAV Route Q806 Is Amended to Read in Part
----------------------------------------------------------------------------------------------------------------
U.S. CANADIAN BORDER..........................  MILLINOCKET, ME VOR/DME...............       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
MILLINOCKET, ME VOR/DME.......................  CANME, ME WP..........................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
CANME, ME WP..................................  U.S. CANADIAN BORDER..................       *18000        45000
    *18000--GNSS MEA
    *DME/DME/IRU MEA
----------------------------------------------------------------------------------------------------------------
                                 Sec.   95.4864 RNAV Route Q864 Is Added to Read
----------------------------------------------------------------------------------------------------------------
U.S. CANADIAN BORDER..........................  U.S. CANADIAN BORDER..................       *18000        45000
    *GNSS REQUIRED
----------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------
               From                           To                 MEA
------------------------------------------------------------------------
                   Sec.   95.6001 VICTOR Routes--U.S.
        Sec.   95.6002 VOR Federal Airway V2 Is Amended to Delete
------------------------------------------------------------------------
BUFFALO, NY VOR/DME..............  ROCHESTER, NY VOR/DME...         2800
ROCHESTER, NY VOR/DME............  MAGEN, NY WP............         2300
MAGEN, NY WP.....................  KONDO, NY WP............         2300
KONDO, NY WP.....................  *WIFFY, NY FIX..........         2300
    *3000--MRA
WIFFY, NY FIX....................  SYRACUSE, NY VORTAC.....         2300
SYRACUSE, NY VORTAC..............  STODA, NY FIX...........         2400
STODA, NY FIX....................  VASTS, NY WP............         3000
VASTS, NY WP.....................  UTICA, NY VORTAC........         3400
UTICA, NY VORTAC.................  MARIA, NY FIX...........         3500
MARIA, NY FIX....................  ALBANY, NY VORTAC.......         3000
ALBANY, NY VORTAC................  WARIC, MA WP............         5000
WARIC, MA WP.....................  GARDNER, MA VOR/DME.....        *4000
    *3500--MOCA
------------------------------------------------------------------------
        Sec.   95.6003 VOR Federal Airway V3 Is Amended to Delete
------------------------------------------------------------------------
BOSTON, MA VOR/DME...............  PEASE, NH VOR/DME.......         3000
PEASE, NH VOR/DME................  YUKES, NH WP............        *3500
    *2400--MOCA
YUKES, NH WP.....................  *PARSO, ME FIX..........       **3500
    *7000--MCA PARSO, ME FIX, N
     BND
    **2800--MOCA
PARSO, ME FIX....................  LABEL, ME WP.
                                   S BND...................         3500
                                   N BND...................         7000
LABEL, ME WP.....................  AUGUSTA, ME VOR/DME.....        *7000
    *3600--MOCA
    *3600--GNSS MEA
AUGUSTA, ME VOR/DME..............  BANGOR, ME VORTAC.......         3000
BANGOR, ME VORTAC................  HOULTON, ME VOR/DME.....        *2800
    *2300--MOCA
HOULTON, ME VOR/DME..............  PRESQUE ISLE, ME VOR/DME        *3400
    *2700--MOCA
------------------------------------------------------------------------
    Sec.   95.6011 VOR Federal Airway V11 Is Amended to Read in Part
------------------------------------------------------------------------
FORT WAYNE, IN VORTAC............  *GRABI, IN FIX..........         3000
    *4500--MRA
GRABI, IN FIX....................  EDGEE, OH FIX...........        *3000
    *2400--MOCA
------------------------------------------------------------------------
       Sec.   95.6014 VOR Federal Airway V14 Is Amended to Delete
------------------------------------------------------------------------
BUFFALO, NY VOR/DME..............  GENESEO, NY VOR/DME.....         4000
GENESEO, NY VOR/DME..............  BEEPS, NY FIX...........        *4000
    *3300--MOCA
BEEPS, NY FIX....................  SCIPO, NY FIX...........        *4000
    *3400--MOCA

SCIPO, NY FIX....................  VESPE, NY FIX...........         4000
VESPE, NY FIX....................  GEORGETOWN, NY VORTAC...         4000
GEORGETOWN, NY VORTAC............  SHERB, NY FIX...........         4000
SHERB, NY FIX....................  COBIA, NY FIX...........         5000
COBIA, NY FIX....................  CASIL, NY WP............        *5000
    *3800--MOCA
CASIL, NY WP.....................  ALBANY, NY VORTAC.......         3600
ALBANY, NY VORTAC................  WARIC, MA WP............         5000
WARIC, MA WP.....................  GARDNER, MA VOR/DME.....        *4000
    *3500--MOCA
GARDNER, MA VOR/DME..............  GRAYM, MA FIX...........         3000
GRAYM, MA FIX....................  NORWICH, CT VOR/DME.....        *3000
    *2200--MOCA
------------------------------------------------------------------------
       Sec.   95.6029 VOR Federal Airway V29 Is Amended to Delete
------------------------------------------------------------------------
SYRACUSE, NY VORTAC..............  PAGER, NY FIX...........        *2400
    *1800--MOCA
PAGER, NY FIX....................  WATERTOWN, NY VORTAC....        *2600
    *2000--MOCA
WATERTOWN, NY VORTAC.............  *LETUS, NY FIX..........       **3000
    *4000--MRA
    **1900--MOCA
LETUS, NY FIX....................  MASSENA, NY VORTAC......        *3000
    *GNSS MEA
------------------------------------------------------------------------
       Sec.   95.6045 VOR Federal Airway V45 Is Amended to Delete
------------------------------------------------------------------------
CHARLESTON, WV VOR/DME...........  HENDERSON, WV VORTAC....         3100
HENDERSON, WV VORTAC.............  *BREMN, OH FIX..........      **10000
    *10000--MCA BREMN, OH FIX, S
     BND
    **3000--GNSS MEA
BREMN, OH FIX....................  APPLETON, OH VORTAC.....         3000
------------------------------------------------------------------------
       Sec.   95.6067 VOR Federal Airway V67 Is Amended to Delete
------------------------------------------------------------------------
CUNNINGHAM, KY VOR/DME...........  MARION, IL VOR/DME......         2600
MARION, IL VOR/DME...............  CENTRALIA, IL VORTAC....         2300
CENTRALIA, IL VORTAC.............  VANDALIA, IL VOR/DME....         2500
------------------------------------------------------------------------
                          Is Amended by Adding
------------------------------------------------------------------------
CORKI, IL FIX....................  VANDALIA, IL VOR/DME....         2500
------------------------------------------------------------------------
    Sec.   95.6072 VOR Federal Airway V72 Is Amended to Read in Part
------------------------------------------------------------------------
FARMINGTON, MO VORTAC............  CENTRALIA, IL VORTAC....        *3000
    *2500--MOCA
------------------------------------------------------------------------
       Sec.   95.6106 VOR Federal Airway V106 Is Amended to Delete
------------------------------------------------------------------------
BARNES, MA VORTAC................  GARDNER, MA VOR/DME.....        *3500
    *3000--MOCA
GARDNER, MA VOR/DME..............  MANCHESTER, NH VOR/DME..         4000
MANCHESTER, NH VOR/DME...........  RAYMY, NH FIX...........        *2600
    *2100--MOCA
RAYMY, NH FIX....................  KENNEBUNK, ME VOR/DME...        *5500
    *2200--MOCA
    *3000--GNSS MEA
------------------------------------------------------------------------
       Sec.   95.6119 VOR Federal Airway V119 Is Amended to Delete
------------------------------------------------------------------------
HENDERSON, WV VORTAC.............  JACEE, WV FIX...........         2700
JACEE, WV FIX....................  PARKERSBURG, WV VOR/DME.         2700
------------------------------------------------------------------------
       Sec.   95.6125 VOR Federal Airway V125 Is Amended to Delete
------------------------------------------------------------------------
NIKEL, IL FIX....................  BURCK, IL WP............         4500
BURCK, IL WP.....................  ST LOUIS, MO VORTAC.....        *3500
    *2600--MOCA
------------------------------------------------------------------------
    Sec.   95.6128 VOR Federal Airway V128 Is Amended to Read in Part
------------------------------------------------------------------------
CROUP, OH FIX....................  RULEY, WV FIX.
                                   NW BND..................         3600

                                   SE BND..................         3300
------------------------------------------------------------------------
    Sec.   95.6130 VOR Federal Airway V130 Is Amended to Read in Part
------------------------------------------------------------------------
MINNK, RI FIX....................  MARTHAS VINEYARD, MA VOR/       *3000
                                    DME.
    *1600--MOCA
------------------------------------------------------------------------
       Sec.   95.6145 VOR Federal Airway V145 Is Amended to Delete
------------------------------------------------------------------------
UTICA, NY VORTAC.................  WEEPY, NY WP............         3400
WEEPY, NY WP.....................  FLOOR, NY WP............        *3000
    *2200--MOCA
FLOOR, NY WP.....................  WATERTOWN, NY VORTAC....         3000
WATERTOWN, NY VORTAC.............  U.S. CANADIAN BORDER....        *3000
    *1800--MOCA
------------------------------------------------------------------------
    Sec.   95.6167 VOR Federal Airway V167 Is Amended to Read in Part
------------------------------------------------------------------------
PEAKE, MA FIX....................  MARCONI, MA VOR/DME.....        *3000
    *1600--MOCA
------------------------------------------------------------------------
       Sec.   95.6174 VOR Federal Airway V174 Is Amended to Delete
------------------------------------------------------------------------
YORK, KY VORTAC..................  HENDERSON, WV VORTAC....         3300
HENDERSON, WV VORTAC.............  GAYED, WV WP............        *4000
    *2700--MOCA
GAYED, WV WP.....................  CARLA, WV FIX...........         5500
CARLA, WV FIX....................  ELKINS, WV VORTAC.......         5500
------------------------------------------------------------------------
       Sec.   95.6190 VOR Federal Airway V190 Is Amended to Delete
------------------------------------------------------------------------
FARMINGTON, MO VORTAC............  MARION, IL VOR/DME......         3000
MARION, IL VOR/DME...............  POCKET CITY, IN VORTAC..        *5000
    *2000--MOCA
    *2300--GNSS MEA
------------------------------------------------------------------------
       Sec.   95.6196 VOR Federal Airway V196 Is Amended to Delete
------------------------------------------------------------------------
UTICA, NY VORTAC.................  *SARANAC LAKE, NY VOR/           5400
                                    DME.
    *6500--MCA SARANAC LAKE, NY
     VOR/DME, E BND
SARANAC LAKE, NY VOR/DME.........  RIGID, NY WP.
                                   E BND...................         9000
                                   W BND...................          500
------------------------------------------------------------------------
       Sec.   95.6203 VOR Federal Airway V203 Is Amended to Delete
------------------------------------------------------------------------
STELA, MA FIX....................  ALBANY, NY VORTAC.......        *6000
    *4000--GNSS MEA
ALBANY, NY VORTAC................  OTOLE, NY WP............        *6000
    *2200--MOCA
    *3000--GNSS MEA
OTOLE, NY WP.....................  DINNY, NY WP............       *10000
    *6900--MOCA
    *7000--GNSS MEA
DINNY, NY WP.....................  SARANAC LAKE, NY VOR/DME         7000
SARANAC LAKE, NY VOR/DME.........  MASSENA, NY VORTAC......       *10000
    *5100--MOCA
    *6000--GNSS MEA
------------------------------------------------------------------------
       Sec.   95.6229 VOR Federal Airway V229 Is Amended to Delete
------------------------------------------------------------------------
HARTFORD, CT VOR/DME.............  GARDNER, MA VOR/DME.....         3000
GARDNER, MA VOR/DME..............  KEENE, NH VORTAC........         3600
KEENE, NH VORTAC.................  JAMMA, VT WP............         4500
JAMMA, VT WP.....................  MUDDI, VT FIX...........         6400
MUDDI, VT FIX....................  *BURLINGTON, VT VOR/DME.         6000
    *3100--MCA BURLINGTON, VT VOR/
     DME, SE BND
------------------------------------------------------------------------
       Sec.   95.6249 VOR Federal Airway V249 Is Amended to Delete
------------------------------------------------------------------------
DELANCEY, NY VOR/DME.............  MILID, NY FIX...........         4300
MILID, NY FIX....................  UTICA, NY VORTAC........         3700
------------------------------------------------------------------------
       Sec.   95.6273 VOR Federal Airway V273 Is Amended to Delete
------------------------------------------------------------------------
HANCOCK, NY VOR/DME..............  GEORGETOWN, NY VORTAC...         4000

GEORGETOWN, NY VORTAC............  SYRACUSE, NY VORTAC.....         4000
------------------------------------------------------------------------
       Sec.   95.6282 VOR Federal Airway V282 Is Amended to Delete
------------------------------------------------------------------------
SARANAC LAKE, NY VOR/DME.........  *FAWNS, NY FIX..........         5000
    *5000--MCA FAWNS, NY FIX, S
     BND
FAWNS, NY FIX....................  U.S. CANADIAN BORDER....         5000
------------------------------------------------------------------------
       Sec.   95.6318 VOR Federal Airway V318 Is Amended to Delete
------------------------------------------------------------------------
U.S. CANADIAN BORDER.............  HOULTON, ME VOR/DME.....        *9000
    *3900--MOCA
HOULTON, ME VOR/DME..............  U.S. CANADIAN BORDER....         1900
------------------------------------------------------------------------
       Sec.   95.6322 VOR Federal Airway V322 Is Amended to Delete
------------------------------------------------------------------------
CONCORD, NH VOR/DME..............  GRUMP, NH WP............         4000
GRUMP, NH WP.....................  *NOTTY, NH WP...........         5000
    *6000--MCA NOTTY, NH WP, N
     BND
NOTTY, NH WP.....................  WYLIE, NH WP............        *7000
    *5600--MOCA
------------------------------------------------------------------------
       Sec.   95.6335 VOR Federal Airway V335 Is Amended to Delete
------------------------------------------------------------------------
ST LOUIS, MO VORTAC..............  ARNOL, IL FIX...........         2800
ARNOL, IL FIX....................  *GLASS, MO FIX..........       **3000
    *4500--MRA
    **2100--MOCA
GLASS, MO FIX....................  NIKEL, IL FIX...........        *4500
    *2200--MOCA
    *3500--GNSS MEA
NIKEL, IL FIX....................  MARION, IL VOR/DME......         2400
------------------------------------------------------------------------
       Sec.   95.6352 VOR Federal Airway V352 Is Amended to Delete
------------------------------------------------------------------------
PATTA, ME WP.....................  HOULTON, ME VOR/DME.....         6500
------------------------------------------------------------------------
       Sec.   95.6428 VOR Federal Airway V428 Is Amended to Delete
------------------------------------------------------------------------
GEORGETOWN, NY VORTAC............  EATEN, NY FIX...........         4000
EATEN, NY FIX....................  UTICA, NY VORTAC........         3500
------------------------------------------------------------------------
       Sec.   95.6429 VOR Federal Airway V429 Is Amended to Delete
------------------------------------------------------------------------
MARION, IL VOR/DME...............  BIBLE GROVE, IL VORTAC..        *5000
    *2100--MOCA
    *2300--GNSS MEA
------------------------------------------------------------------------
       Sec.   95.6471 VOR Federal Airway V471 Is Amended to Delete
------------------------------------------------------------------------
MILLINOCKET, ME VOR/DME..........  HOULTON, ME VOR/DME.....        *2600
    *2000--MOCA
HOULTON, ME VOR/DME..............  U.S. CANADIAN BORDER....        *2600
    *2100--MOCA
------------------------------------------------------------------------
       Sec.   95.6490 VOR Federal Airway V490 Is Amended to Delete
------------------------------------------------------------------------
UTICA, NY VORTAC.................  GALWA, NY FIX...........        *4000
    *3300--MOCA
GALWA, NY FIX....................  CAMBRIDGE, NY VOR/DME...        *4000
    *3300--MOCA
CAMBRIDGE, NY VOR/DME............  STRUM, NH WP............        *6000
    *5300--MOCA
STRUM, NH WP.....................  DUBIN, NH WP............         5000
DUBIN, NH WP.....................  LURCH, NH WP............         4000
LURCH, NH WP.....................  *MUGGY, NH FIX..........         4000
    *4000--MCA MUGGY, NH FIX, W
     BND
MUGGY, NH FIX....................  MANCHESTER, NH VOR/DME..         3000
------------------------------------------------------------------------
    Sec.   95.6540 VOR Federal Airway V540 Is Amended to Read in Part
------------------------------------------------------------------------
CUNNINGHAM, KY VOR/DME...........  TAMMS, IL FIX.
                                   NW BND..................         3500
                                   SE BND..................         2800
TAMMS, IL FIX....................  FARMINGTON, MO VORTAC...         3500
------------------------------------------------------------------------

       Sec.   95.6542 VOR Federal Airway V542 Is Amended to Delete
------------------------------------------------------------------------
ELMIRA, NY VOR/DME...............  BINGHAMTON, NY VOR/DME..         3500
BINGHAMTON, NY VOR/DME...........  OXFOR, NY WP............         3500
OXFOR, NY WP.....................  ROCKDALE, NY VOR/DME....         4000
------------------------------------------------------------------------
Sec.   95.6480 ALASKA VOR Federal Airway V480 Is Amended to Read in Part
------------------------------------------------------------------------
ZESKA, AK FIX....................  BETHEL, AK VORTAC.
                                   NE BND..................        *2000
                                   SW BND..................       *10000
    *1500--MOCA
BETHEL, AK VORTAC................  CABOT, AK FIX.
                                   NE BND..................        *8000
                                   SW BND..................        *2000
    *1400--MOCA
CABOT, AK FIX....................  ANIAK, AK FIX.
                                   NE BND..................        *9000
                                   SW BND..................        *8000
    *2400--MOCA
ANIAK, AK FIX....................  JOANY, AK FIX...........       #*9000
    *5600--MOCA
#MEA IS ESTABLISHED WITH A GAP IN
 NAVIGATION SIGNAL COVERAGE.
JOANY, AK FIX....................  MC GRATH, AK VORTAC.
                                   NE BND..................        *6000
                                   SW BND..................        *9000
    *4700--MOCA
NENANA, AK VORTAC................  FAIRBANKS, AK VORTAC....        *4000
    *3000--MOCA
------------------------------------------------------------------------

                     From                                         To                        MEA          MAA
----------------------------------------------------------------------------------------------------------------
                                            Sec.   95.7001 Jet Routes
                                Sec.   95.7091 Jet Route J91 Is Amended to Delete
----------------------------------------------------------------------------------------------------------------
VOLUNTEER, TN VORTAC..........................  HENDERSON, WV VORTAC..................        18000        45000
----------------------------------------------------------------------------------------------------------------
                               Sec.   95.7134 Jet Route J134 Is Amended to Delete
----------------------------------------------------------------------------------------------------------------
FALMOUTH, KY VOR/DME..........................  HENDERSON, WV VORTAC..................        18000        45000
HENDERSON, WV VORTAC..........................  LINDEN, VA VORTAC.....................        18000        45000
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                          Airway segment                                          Changeover points
----------------------------------------------------------------------------------------------------------------
                From                               To                 Distance                 From
----------------------------------------------------------------------------------------------------------------
                               Sec.   95.8003 VOR Federal Airway Changeover Point
                                Alaska V480 Is Amended to Modify Changeover Point
----------------------------------------------------------------------------------------------------------------
BETHEL, AK VORTAC...................  MC GRATH, AK VORTAC.........          117  BETHEL.
----------------------------------------------------------------------------------------------------------------
                                    V2 Is Amended to Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
BUFFALO, NY VOR/DME.................  ROCHESTER, NY VOR/DME.......           45  BUFFALO.
----------------------------------------------------------------------------------------------------------------
                                    V45 Is Amended to Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
HENDERSON, WV VORTAC................  APPLETON, OH VORTAC.........           59  HENDERSON.
----------------------------------------------------------------------------------------------------------------
                                   V203 Is Amended to Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
ALBANY, NY VORTAC...................  SARANAC LAKE, NY VOR/DME....           60  ALBANY.
----------------------------------------------------------------------------------------------------------------
                                   V273 Is Amended to Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
HANCOCK, NY VOR/DME.................  GEORGETOWN, NY VORTAC.......           31  HANCOCK.
----------------------------------------------------------------------------------------------------------------
                                   V282 Is Amended to Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
SARANAC LAKE, NY VOR/DME............  MONTREAL, CA VOR/DME........           37  SARANAC LAKE.
----------------------------------------------------------------------------------------------------------------

                                   V490 Is Amended to Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
CAMBRIDGE, NY VOR/DME...............  MANCHESTER, NH VOR/DME......           37  CAMBRIDGE.
----------------------------------------------------------------------------------------------------------------
                                    J91 Is Amended to Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
VOLUNTEER, TN VORTAC................  HENDERSON, WV VORTAC........          135  VOLUNTEER.
----------------------------------------------------------------------------------------------------------------
                                   J134 Is Amended to Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
HENDERSON, WV VORTAC................  LINDEN, VA VORTAC...........          133  HENDERSON.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-10972 Filed 5-25-21; 8:45 a.m.]
BILLING CODE 4910-13-P


[Federal Register: October 18, 2010 (Volume 75, Number 200)]
[Notices]
[Page 63889-63892]
[DOCID:fr18oc10-123]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2010-0005-N-19]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking approval of the following
information collection activities. Before submitting these information
collection requirements for clearance by the Office of Management and
Budget (OMB), FRA is soliciting public comment on specific aspects of
the activities identified below.

DATES: Comments must be received no later than December 17, 2010.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC
20590, or Ms. Kimberly Toone, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop
35, Washington, DC 20590. Commenters requesting FRA to acknowledge
receipt of their respective comments must include a self-addressed
stamped postcard stating, ``Comments on OMB control number 2130-----
--.'' Alternatively, comments may be transmitted via facsimile to (202)
493-6216 or<PHONE_NUMBER>, or via e-mail to Mr. Brogan at
<EMAIL_ADDRESS>or to Ms. Toone at<EMAIL_ADDRESS>
Please refer to the assigned OMB control number or collection title in
any correspondence submitted. FRA will summarize comments received in
response to this notice in a subsequent notice and include them in its
information collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Planning
and Evaluation Division, RRS-21, Federal Railroad Administration, 1200
New Jersey Ave., SE., Mail Stop 17, Washington, DC 20590 (telephone:
(202) 493-6292) or Ms. Kimberly Toone, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave., SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-
6132). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, section 2, 109 Stat. 163 (1995) (codified as revised
at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part
1320, require Federal agencies to provide 60 days' notice to the public
for comment on information collection activities before seeking
approval by OMB. 44 U.S.C. 3506(c)(2)(A); 5 CFR 1320.8(d)(1),
1320.10(e)(1), 1320.12(a). Specifically, FRA invites interested
respondents to comment on the following summary of proposed information
collection activities regarding (i) whether the information collection
activities are necessary for FRA to properly execute its functions,
including whether the activities will have practical utility; (ii) the
accuracy of FRA's estimates of the burden of the information collection
activities, including the validity of the methodology and assumptions
used to determine the estimates; (iii) ways for FRA to enhance the
quality, utility, and clarity of the information being collected; and
(iv) ways for FRA to minimize the burden of information collection
activities on the public by automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology (e.g., permitting electronic submission of responses). See
44 U.S.C. 3506(c)(2)(A)(i)-(iv); 5 CFR 1320.8(d)(1)(i)-(iv). FRA
believes that soliciting public comment will promote its efforts to
reduce the administrative

and paperwork burdens associated with the collection of information
mandated by Federal regulations. In summary, FRA reasons that comments
received will advance three objectives: (i) Reduce reporting burdens;
(ii) ensure that it organizes information collection requirements in a
``user friendly'' format to improve the use of such information; and
(iii) accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below is a brief summary of current information collection
activities that FRA will submit for clearance by OMB as required under
the PRA:
    Title: Safety Integration Plans.
    OMB Control Number: 2130-0557.
    Abstract: The Federal Railroad Administration (FRA) and the Surface
Transportation Board (STB), working in conjunction with each other,
have issued joint final rules establishing procedures for the
development and implementation of safety integration plans (``SIPs'' or
``plans'') by a Class I railroad proposing to engage in certain
specified merger, consolidation, or acquisition of control transactions
with another Class I railroad, or a Class II railroad with which it
proposes to amalgamate operations. The scope of the transactions
covered under the two rules is the same. FRA uses the information
collected, notably the required SIPs, to maintain and promote a safe
rail environment by ensuring that affected railroads (Class Is and some
Class IIs) address critical safety issues unique to the amalgamation of
large, complex railroad operations.
    Form Number(s): N/A.
    Affected Public: Railroads.
    Respondent Universe: Class I Railroads.
    Frequency of Submission: On occasion.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average time per       Total annual    Total annual
                CFR Section                   Respondent  universe     Total annual  responses          response           burden hours     burden cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
244.13--Safety Integration Plans:           8 railroads               1 plan                    340 hours                            340         $24,016
 Amalgamation of Operations
--SIP Development & Quarterly Meetings
--------------------------------------------------------------------------------------------------------------------------------------------------------
244.17--Procedures                          8 railroads               25 reports                40 hours/2 hours                      88           5,632
--Responses to FRA Inquiries Re: SIP data   8 railroads               6 responses               8 hours                               48           3,072
--Coordination in Implementing Approved     8 railroads               25 phone calls            10 minutes                             4             256
 SIP                                        8 railroads               1 request                 16 hours                              16           2,512
--Request for Confidential Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
244.19--Disposition                         8 railroads               2 reports                 16 hours                              32           2,048
--Comments on Proposed SIP Amendments
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Responses: 60.
    Estimated Total Annual Burden: 528 hours.
    Status: Extension of a currently approved collection.
    Title: Locomotive Crashworthiness.
    OMB Control Number: 2130-0564.
    Abstract: In a final rule published June 28, 2006, the Federal
Railroad Administration (FRA) issued comprehensive standards for
locomotive crashworthiness. These crashworthiness standards are
intended to help protect locomotive cab occupants in the event of a
locomotive collision. The collection of information is used by FRA to
ensure that locomotive manufacturers and railroads meet minimum
performance standards and design load requirements for newly
manufactured and re-manufactured locomotives in order to help protect
locomotive cab occupants in the event that one of these covered
locomotives collides with another locomotive, the rear of another
train, a piece of on-track equipment, a shifted load on a freight car
on an adjacent parallel track, or a highway vehicle at a rail-highway
grade crossing.
    Form Number(s): N/A.
    Affected Public: Railroads.
    Respondent Universe: 685 railroads/ 4 locomotive manufacturers.
    Frequency of Submission: On occasion.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average time per       Total annual
                CFR Section                    Respondent universe     Total annual  responses          response           burden hours
-----------------------------------------------------------------------------------------------------------------------------------------
229.207--Petition for FRA Approval of New   685 Railroads + 4 Loco.   2 petitions               1,050 hours                        2,100
 Locomotive Crashworthiness Standards        Manufacturers            1 petition                1,050 hours                        1,050
--Petition for FRA Approval of Substantive  685 Railroads + 4 Loco.   1 petitions               400 hours                            400
 Change to FRA-Approved Crashworthiness      Manufacturers
 Design Standard                            685 Railroads + 4 Loco.
--Petition for FRA Approval of Non-          Manufacturers
 Substantive Change to FRA-Approved
 Crashworthiness Design Standard
--------------------------------------------------------------------------------------------------------------------------------------------------------
229.209--Petition for FRA Approval of       685 Railroads + 4 Loco.   1 petition                2,550 hours                        2,550
 Alternative Locomotive Crashworthiness      Manufacturers
 Design Standard
--------------------------------------------------------------------------------------------------------------------------------------------------------

229.211--Comments on FRA Notice of          4 Loco. Manuf./RR         10 comments               16 hours                             160
 Petitions Received by Agency                Association/Labor        4 hearings (16 comments)  24 hours                              96
--Agency Request for Additional              Organizations/Public
 Information Concerning Petitions:          685 Railroads/4 Loco.
 Hearings                                    Manuf./Other Interested
                                             Parties/Public
--------------------------------------------------------------------------------------------------------------------------------------------------------
229.213--Locomotive Manufacturing           685 Railroads             1,000 records or          6 minutes                            100
 Information: Retention of Required Info.                              stickers or badge
                                                                       plates
--------------------------------------------------------------------------------------------------------------------------------------------------------
229.215--Retention of Records--Original     4 Loco. Manuf.            24 loco. rcds.            8 hours                              192
 Designs                                    685 Railroads             6 records                 4 hours                               24
--Retention of Records--Repairs and         6 Loco. Manuf./           10 records                2 minutes                            .33
 Modifications                               Rebuilders
--Inspection of Records
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Responses: 1,059.
    Estimated Total Annual Burden: 6,672 hours.
    Status: Extension of a currently approved collection.
    Title: Safety Appliance Concern Recommendation Report; Guidance
Checklist Forms.
    OMB Control Number: 2130-0565.
    Abstract: In an ongoing effort to conduct more thorough and more
effective inspections of railroad freight equipment and to further
enhance safe rail operations, FRA has developed a safety concern
recommendation report form, and a group of guidance checklist forms
that facilitate railroad, rail car owner, and rail equipment
manufacturer compliance with agency Railroad Safety Appliance Standards
regulations. In lieu of completing an official inspection report (Form
FRA F 6180.96), which takes subject railroad equipment out of service
and disrupts rail operations, Form FRA F 6180.4a enables Federal and
State safety inspectors to report to agency headquarters systemic or
other safety concerns. FRA headquarters safety specialists can then
contact railroads, car owners, and equipment manufacturers to address
the reported issue(s) and institute necessary corrective action(s) in a
timely fashion without unnecessarily having to take affected rail
equipment out of service, unless deemed defective. Forms FRA F
6180.4(b)-(m) are used in conjunction with the Special Inspection of
Safety Appliance Equipment form (Form FRA F 6180.4) to assist Federal
Motive, Power, and Equipment (MP&E) field inspectors in ensuring that
critical sections of 49 CFR part 231 (Railroad Safety Appliance
Standards), pertaining to various types of freight equipment, are
complied with through use of a check-off list. By simplifying their
demanding work, check-off lists for 12 essential sections of Part 231
ensure that FRA MP&E field personnel completely and thoroughly inspect
each type of freight car for compliance with its corresponding section
in Part 231. The Guidance Checklist forms may later be used by state
field inspectors as well. FRA believes that this collection of
information will result in improved construction of newly designed
freight cars and improved field inspections of all freight cars
currently in use. This, in turn, will serve to reduce the number of
accidents/incidents and corresponding injuries and fatalities that
occur every year due to unsafe or defective equipment that was not
promptly repaired/replaced.
    Form Number(s): FRA F 6180.4(a)-(m).
    Affected Public: Businesses.
    Reporting Burden:

----------------------------------------------------------------------------------------------------------------
                                                                                Average time
             Form No.                 Respondent universe        Total annual      per response    Total annual
                                                                  responses            (min)       burden hours
----------------------------------------------------------------------------------------------------------------
FRA F 6180.4a--MP& E Safety        130 Fed'l & State         30 Forms...........              60              30
 Concern and Recommendation         Inspectors.
 Report.
FRA F 6180.4b--Check List Sec.     130 Fed'l & State         10 Forms...........              60              10
 231.1.                             Inspectors.
FRA F 6180.4c--Check List Sec.     130 Fed'l & State         30 Forms...........              60              30
 231.2.                             Inspectors.
FRA F 6180.4d--Check List Sec.     130 Fed'l & State         3 Forms............              60               3
 231.3.                             Inspectors.
FRA F 6180.4e--Check List Sec.     130 Fed'l & State         15 Forms...........              60              15
 231.4.                             Inspectors.
FRA F 6180.4f--Check List Sec.     130 Fed'l & State         5 Forms............              60               5
 231.5.                             Inspectors.
FRA F 6180.4g--Check List Sec.     130 Fed'l & State         30 Forms...........              60              30
 231.6.                             Inspectors.
FRA F 6180.4h--Check List 231.7..  130 Fed'l & State         3 Forms............              60               3
                                    Inspectors.
FRA F 6180.4i--Check List Sec.     130 Fed'l & State         5 Forms............              60               5
 231.8.                             Inspectors.
FRA F 6180.4j--Check List Sec.     130 Fed'l & State         5 Forms............              60               5
 231.9.                             Inspectors.
FRA F 6180.4k--Check List Sec.     130 Fed'l & State         10 Forms...........              60              10
 231.21.                            Inspectors.
FRA F 6180.4l--Check List Sec.     130 Fed'l & State         10 Forms...........              60              10
 231.27.                            Inspectors.
FRA F 6180.4m--Check List Sec.     130 Fed'l & State         10 Forms...........              60              10
 231.28.                            Inspectors.
FRA F 6180.4n--Check List Sec.     130 Fed'l & State         5 Forms............              30               3
 231.138.                           Inspectors.
FRA F 6180.4o--Check List Sec.     130 Fed'l & State         5 Forms............              30               3
 231.14.                            Inspectors.
FRA F 6180.4p--Check List Sec.     130 Fed'l & State         5 Forms............              60               5
 231.29.                            Inspectors.
FRA F 6180.4q--Check List Sec.     130 Fed'l & State         5 Forms............              60               5
 231.29.                            Inspectors.
----------------------------------------------------------------------------------------------------------------

    Respondent Universe: Federal and State Safety Inspectors.
    Frequency of Submission: On occasion.
    Total Responses: 186 forms.
    Estimated Total Annual Burden: 182 hours.
    Status: Extension of a currently approved collection.
    Title: Passenger Train Emergency Systems.
    OMB Control Number: 2130-0576.
    Abstract: The collection of information is due to passenger train
emergency regulations set forth in 49 CFR 238 to further the safety of
passenger train occupants through both enhancements and additions to
FRA's existing requirements. The collection of information is used by
FRA, railroad employees, rescue workers, and the public. Emergency
responders use the information collected to be able to quickly find and
understand how to operate passenger cars' emergency windows, doors, and
roof hatches so that they can successfully perform their jobs and save
lives. The information collected is used by train passengers to: (1)
Recognize and immediately report potential emergencies to train crew
members; (2) recognize hazards; (3) recognize and know how and when to
operate appropriate emergency-related features and equipment, such as
fire extinguishers, train doors, and emergency exits; and (4) recognize
the potential special needs of fellow passengers, such as children, the
elderly, and disabled, during an emergency; and (5) know how to quickly
and safely evacuate the train in the event of an emergency, such as a
collision, derailment, explosion, fire, or some other unanticipated
occurrence. Luminescent or lighted emergency exit markings are used by
train passengers and emergency responders to determine where the
closest and most accessible emergency exit is located as well as how to
operate the emergency exit mechanisms. Records of the inspection,
maintenance, and repairs of emergency window and door exits and
operational efficiency tests are used by FRA inspectors to monitor
railroads' regulatory compliance with this Part.
    Form Number(s): N/A.
    Affected Public: Businesses.
    Reporting Burden:

----------------------------------------------------------------------------------------------------------------
                                          Respondent         Total annual      Average time per    Total annual
             49 CFR 238                    universe            responses           response        burden hours
----------------------------------------------------------------------------------------------------------------
238.113--Emergency Window Exits--     22 railroads        662 window          60 minutes/90                  964
 Markings                                                  markings            minutes/120
                                                                               minutes
----------------------------------------------------------------------------------------------------------------
238.114-Rescue Access Windows         22 railroads        1,092 access        45 minutes                     819
                                                           window markings
----------------------------------------------------------------------------------------------------------------
238.121--Emergency Communications--   22 railroads        116 marked          5 minutes                       10
 Marked Intercom Locations                                 intercom
                                                           locations
----------------------------------------------------------------------------------------------------------------
238.123--Emergency Road Access--      22 railroads        232 marked roof     30 minutes                     116
 Markings and Instructions                                 access locations
----------------------------------------------------------------------------------------------------------------
238.303--Exterior Calendar Day        22 railroads        150 required        20 minutes                      50
 Mechanical Inspection of Equip                            replacement
                                                           markings
    --Rescue Access Exterior          22 railroads        150 records         2 minutes                        5
     Markings/Signage/Instructions
    --Records of Non-Compliance
----------------------------------------------------------------------------------------------------------------
238.305--Interior Calendar Day
 Mechanical Inspection of Cars.
    --Written Notification to Train   22 railroads        260 notifications   1 minute                         9
     Crew of Non-compliant Car +                           + 260 notices
     Notice on Door
    --Inoperative PA system and       22 railroads        300 notifications   1 minute                         5
     Notification to Crew
    --Records of Non-complying        22 railroads        300 records         2 minutes                       10
     Condition
----------------------------------------------------------------------------------------------------------------
238.307--Periodic Mechanical          22 railroads        32 replacement      20 minutes                      11
 Inspection of Pass. Cars--                                markings
 Replacement Roof Access Markings
----------------------------------------------------------------------------------------------------------------

    Respondent Universe: Businesses (railroads).
    Frequency of Submission: On occasion.
    Total Responses: 3,554.
    Estimated Total Annual Burden: 1,999 hours.
    Status: Extension of a currently approved collection.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on October 13, 2010.
Kimberly Coronel,
Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. 2010-26158 Filed 10-15-10; 8:45 am]
BILLING CODE 4910-06-P


Comment Info: =================

General Comment:Hello my name is Nathan, I started vaping about one year ago after smoking tobacco for over 4 years. Since I started vaping I have completely stopped smoking tobacco. I feel alot better knowing what I am putting in my body rather than smoking tobacco which has over 4000 chemicals that I do not know. It would be mean alot to me and alot of people I know who vape to not regulate it because then the liquids will be changed and it will be on the same page as tobacco.  Thank you, Nathan Humphrey

A 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days.


[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Notices]
[Pages 69323-69324]
[FR Doc No: 2011-28893]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2011-0157, Notice 1]

Notice of Receipt of Petition for Decision that Nonconforming
1987-1994 ALPINA Burkard Bovensiepen GmbH B11 Sedan Model Passenger
Cars Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice.

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SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
1987-1994 ALPINA B11 sedan model passenger cars that were not
originally manufactured to comply with all applicable Federal Motor
Vehicle Safety Standards (FMVSS) are eligible for importation into the
United States because they have safety features that comply with, or
are capable of being altered to comply with, all such standards.

DATE: The closing date for comments on the petition is December 8,
2011.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: George Stevens, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(B), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS, and has no
substantially similar U.S.-certified counterpart, shall be refused
admission into the United States unless NHTSA has decided that the
motor vehicle has safety features that comply with, or are capable of
being altered to comply with, all applicable FMVSS based on destructive
test data or such other evidence as NHTSA decides to be adequate.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the

petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    101 Innovations, LLC, of Ferndale, Washington (101 Innovations)
(Registered Importer 07-350) has petitioned NHTSA to decide whether
nonconforming 1987-1994 ALPINA B11 sedan model passenger cars are
eligible for importation into the United States. 101 Innovations
believes that these vehicles are capable of being modified to meet all
applicable FMVSS.
    In its petition, 101 Innovations described the 1987-1994 ALPINA B11
sedan as a modified version of the 1987-1994 BMW 7-series (e32) sedan
that was manufactured for sale in the United States and certified by
BMW as complying with all applicable FMVSS. The petitioner noted,
however, that these vehicles were altered by ALPINA and, as altered,
were assigned vehicle identification numbers (VINs) by ALPINA that
differ from those assigned to the base vehicles manufactured by BMW. In
view of these circumstances, the petitioner acknowledged that it could
not base its petition on the substantial similarity of the 1987-1994
ALPINA B11 sedan to the U.S.-certified 1987-1994 BMW 7-series (e32)
sedan, but would instead need to establish import eligibility on the
basis that the vehicles have safety features that comply with, or are
capable of being modified to comply with, the FMVSS based on
destructive test data or such other evidence that NHTSA decides to be
adequate. The petitioner did note, however, that the 1987-1994 ALPINA
B11 sedan utilizes the same components as the U.S.-certified 1987-1994
BMW 7-series (e32) sedan in virtually all of the systems subject to the
FMVSS.
    101 Innovations submitted information with its petition intended to
demonstrate that non-U.S. certified 1987-1994 ALPINA B11 sedans conform
to many FMVSS and are capable of being altered to comply with all other
standards to which they were not originally manufactured to conform.
    Specifically, the petitioner claims that non-U.S. certified 1987-
1994 ALPINA B11 sedans, as originally manufactured, conform to:
Standard Nos. 102 Transmission Shift Lever Sequence, Starter Interlock,
and Transmission Braking Effect, 103 Windshield Defrosting and
Defogging Systems, 104 Windshield Wiping and Washing Systems, 105
Hydraulic Brake Systems, 106 Brake Hoses, 107 Reflecting Surfaces, 109
New Pneumatic Tires, 113 Hood Latch System, 116 Motor Vehicle Brake
Fluids, 124 Accelerator Control Systems, 201 Occupant Protection in
Interior Impact, 202 Head Restraints, 204 Steering Control Rearward
Displacement, 205 Glazing Materials, 206 Door Locks and Door Retention
Components, 207 Seating Systems, 210 Seat Belt Assembly Anchorages, 211
Wheel Nuts, Wheel Discs and Hub Caps, 212 Windshield Mounting, 214 Side
Impact Protection, 216 Roof Crush Resistance, 219 Windshield Zone
Intrusion, 301 Fuel System Integrity, and 302 Flammability of Interior
Materials.
    In addition, the petitioner claims that the vehicles comply with
the Bumper Standard found in 49 CFR Part 581.
    The petitioner also contends that the vehicles are capable of being
altered to meet the following standards, in the manner indicated:
    Standard No. 101 Controls and Displays: installation of U.S.-model
instrument cluster and U.S.-version software.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: installation of U.S.-model: (a) headlamps; (b) front and
rear side marker lamps; and (c) rear high mounted stop lamp and
associated wiring.
    Standard No. 110 Tire Selection and Rims: installation on the
vehicle of a tire information placard.
    Standard No. 111 Rearview Mirrors: installation of a U.S.-model
passenger side rearview mirror, or inscription of the required warning
statement on the face of that mirror.
    Standard No. 114 Theft Protection: installation of U.S.-version
software and a U.S.-model ignition switch to meet the requirements of
this standard.
    Standard No. 115 Vehicle Identification: installation of a vehicle
identification plate near the left windshield post to meet the
requirements of this standard.
    Standard No. 118 Power-Operated Window, Partition, and Roof Panel
Systems: inspection of all vehicles and modification or deactivation of
any remote activation features that cause the system not to conform to
the standard.
    Standard No. 208 Occupant Crash Protection: (a) Installation of
U.S.-model knee bolsters; and (b) inspection of all vehicles and
replacement of any non U.S.-model air bag system components, including
all warning systems, warning labels and telltales, with U.S.-model
components on vehicles not already so equipped.
    Standard No. 209 Seat Belt Assemblies: inspection of all vehicles
and replacement of any non U.S.-model seat belt components on vehicles
not already so equipped.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: November 2, 2011.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2011-28893 Filed 11-7-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Notices]
[Pages 88245-88246]
[FR Doc No: 2016-29303]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA 2016-E-0630 and FDA-2016-E-1102]

Determination of Regulatory Review Period for Purposes of Patent
Extension; GARDASIL 9

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for GARDASIL 9 and is publishing this notice
of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 6, 2017. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 5, 2017.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA 2016-E-0630 and FDA-2016-E-1102 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; GARDASIL 9.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product GARDASIL
9

(Human papillomavirus 9-valent Vaccine, Recombinant). GARDASIL 9 is
indicated in girls and women 9 through 26 years of age for the
prevention of the following diseases:
     Cervical, vulvar, vaginal, and anal cancer caused by Human
Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.
     Genital warts caused by HPV types 6 and 11.

And the following precancerous or dysplastic lesions caused by HPV
types 6, 11, 16, 18, 31, 33, 45, 52, and 58:

     Cervical intraepithelial neoplasia (CIN) grade 2/3 and
cervical adenocarcinoma in situ.
     CIN grade 1.
     Vulvar intraepithelial neoplasia (VIN) grade 2 and grade
3.
     Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade
1.
     Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.

Gardasil 9 is also indicated in boys and men 9 through 26 years for the
prevention of the following diseases;

     Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and
58.
     Genital warts caused by HPV types 6 and 11.

And the following precancerous or dysplastic lesions caused by HPV
types 6, 11, 16, 18, 31, 33, 45, 52, and 58:

     AIN grades 1, 2, and 3.
    Subsequent to this approval, the USPTO received patent term
restoration applications for GARDASIL 9 (U.S. Patent Nos. 7,476,389 and
7,482,015) from Merck Sharp & Dohme Corp. for CSL Limited and The
University of Queensland; the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated April 26, 2016, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of GARDASIL 9 represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
GARDASIL 9 is 2,662 days. Of this time, 2,296 days occurred during the
testing phase of the regulatory review period, while 366 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 29,
2007. The applicant claims September 2, 2007, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 29, 2007,
which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 10, 2013. FDA has verified the
applicant's claim that the biologics license application (BLA) for
GARDASIL 9 (BLA 125508/0) was initially submitted on December 10, 2013.
    3. The date the application was approved: December 10, 2014. FDA
has verified the applicant's claim that BLA 125508/0 was approved on
December 10, 2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,062 days or 1,254 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket Nos. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29303 Filed 12-6-16; 8:45 am]
 BILLING CODE 4164-01-P