[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Rules and Regulations]
[Pages 84207-84209]
[FR Doc No: 2020-28413]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31346 Amdt. No. 3935]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums
and Obstacle Departure procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective December 28, 2020. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of December 28, 2020.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30. 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

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 73169. Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends 14 CFR part 97 by
establishing, amending, suspending, or removes SIAPS, Takeoff Minimums
and/or ODPS. The complete regulatory description of each SIAP and its
associated Takeoff Minimums or ODP for an identified airport is listed
on FAA form documents which are incorporated by reference in this
amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20.
The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B,
when required by an entry on 8260-15A, and 8260-15C.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers or
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the typed of SIAPS, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPs as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flights safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an

effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C. 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    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.

Lists of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on December 11, 2020.
Wade Terrell,
Aviation Safety, Manager, Flight Procedures & Airspace Group, Flight
Technologies and Procedures Division.

Adoption of The Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CRF part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 28 January 2021

Cullman, AL, KCMD, RNAV (GPS) RWY 20, Amdt 1B
Hope, AR, M18, VOR RWY 4, Orig-A
Killdeer, ND, 9Y1, RNAV (GPS) RWY 13, Orig
Killdeer, ND, 9Y1, RNAV (GPS) RWY 31, Orig
Killdeer, ND, 9Y1, Takeoff Minimums and Obstacle DP, Orig

Effective 25 February 2021

Toksook Bay, AK, PAOO, RNAV (GPS) RWY 34, Amdt 3B
Grand Canyon, AZ, 40G, RNAV (GPS) RWY 1, Orig-D
Grand Canyon, AZ, 40G, RNAV (GPS) RWY 19, Orig-C
Hollister, CA, KCVH, RNAV (GPS) RWY 31, Amdt 1A
Los Angeles, CA, KLAX, ILS OR LOC RWY 24R, ILS RWY 24R (CAT II), ILS
RWY 24R (CAT III), Amdt 26A
Los Angeles, CA, KLAX, RNAV (GPS) Y RWY 24R, Amdt 3A
Los Angeles, CA, KLAX, RNAV (RNP) Z RWY 24R, Amdt 1B
San Luis Obispo, CA, San Luis County Rgnl, Takeoff Minimums and
Obstacle DP, Amdt 8
Denver, CO, Centennial, Takeoff Minimums and Obstacle DP, Amdt 5A
Lamar, CO, Southeast Colorado Rgnl, RNAV (GPS) RWY 8, Amdt 1D
Lamar, CO, Southeast Colorado Rgnl, RNAV (GPS) RWY 18, Amdt 1E
Lamar, CO, Southeast Colorado Rgnl, RNAV (GPS) RWY 26, Orig-E
Lamar, CO, Southeast Colorado Rgnl, RNAV (GPS) RWY 36, Amdt 1D
Lamar, CO, Southeast Colorado Rgnl, VOR RWY 18, Amdt 10E
Lamar, CO, Southeast Colorado Rgnl, VOR RWY 36, Amdt 1D
Pueblo, CO, Pueblo Memorial, RNAV (GPS) RWY 35, Orig-B
Washington, DC, KDCA, RNAV (GPS) RWY 15, Orig-C
Washington, DC, Ronald Reagan Washington National, RNAV (GPS) RWY
33, Amdt 1B
Arcadia, FL, Arcadia Muni, RNAV (GPS)-A, Orig-A
Arcadia, FL, Arcadia Muni, RNAV (GPS)-B, Orig-A
Jacksonville, FL, KVQQ, RNAV (GPS) RWY 27L, Amdt 1B
Augusta, GA, Augusta Rgnl at Bush Field, ILS OR LOC RWY 17, Amdt 10
Augusta, GA, Augusta Rgnl at Bush Field, RNAV (GPS) RWY 17, Amdt 3
Augusta, GA, Augusta Rgnl at Bush Field, RNAV (GPS) RWY 35, Amdt 2D
Augusta, GA, Augusta Rgnl at Bush Field, RNAV (GPS) Z RWY 8, Amdt 1
Canton, GA, Cherokee County Rgnl, NDB RWY 5, Amdt 4B
Canton, GA, Cherokee County Rgnl, RNAV (GPS) RWY 5, Amdt 1B
Canton, GA, Cherokee County Rgnl, RNAV (GPS) RWY 23, Amdt 1B
Hilo, HI, Hilo Intl, RNAV (GPS) RWY 21, Amdt 1
Honolulu, HI, PHNL, LOC RWY 4R, Amdt 1D
Honolulu, HI, PHNL, LOC RWY 8L, Amdt 1C
Honolulu, HI, PHNL, LDA RWY 26L, Amdt 6A
Honolulu, HI, PHNL, RNAV (GPS) Y RWY 4R, Amdt 3A
Honolulu, HI, PHNL, VOR OR TACAN RWY 4R, Orig-E
Honolulu, HI, PHNL, VOR OR TACAN-A, Amdt 1D
Honolulu, HI, PHNL, VOR OR TACAN-B, Amdt 2D
Mapleton, IA, KMEY, RNAV (GPS) RWY 2, Orig-B
Mapleton, IA, KMEY, RNAV (GPS) RWY 20, Orig-D
Sioux City, IA, Sioux Gateway/Brig Gen Bud Day Field, ILS OR LOC RWY
13, Amdt 3
Sioux City, IA, Sioux Gateway/Brig Gen Bud Day Field, ILS OR LOC RWY
31, Amdt 26
Driggs, ID, Driggs-Reed Memorial, LAMON THREE, Graphic DP
Driggs, ID, Driggs-Reed Memorial, Takeoff Minimums and Obstacle DP,
Amdt 3A
Belleville, IL, KBLV, ILS OR LOC RWY 14R, Orig-G
Belleville, IL, KBLV, RNAV (GPS) RWY 14R, Orig-F
Belleville, IL, KBLV, TACAN RWY 14R, Amdt 1C
Belleville, IL, KBLV, TACAN RWY 32L, Amdt 1C
Parsons, KS, Tri-City, RNAV (GPS) RWY 17, Amdt 1A
Parsons, KS, Tri-City, RNAV (GPS) RWY 35, Amdt 1A
Pittsburg, KS, Atkinson Muni, RNAV (GPS) RWY 4, Amdt 1G
Pittsburg, KS, Atkinson Muni, VOR RWY 4, Amdt 3G
Scott City, KS, Scott City Muni, Takeoff Minimums and Obstacle DP,
Amdt 1
Owensboro, KY, Owensboro-Daviess County Rgnl, Takeoff Minimums and
Obstacle DP, Amdt 5B
Paducah, KY, Barkley Rgnl, ILS OR LOC RWY 5, Amdt 10D
Paducah, KY, Barkley Rgnl, RNAV (GPS) RWY 5, Amdt 2
Paducah, KY, Barkley Rgnl, RNAV (GPS) RWY 14, Amdt 1
Paducah, KY, Barkley Rgnl, RNAV (GPS) RWY 23, Orig-E
Paducah, KY, Barkley Rgnl, RNAV (GPS) RWY 32, Amdt 1
Paducah, KY, Barkley Rgnl, Takeoff Minimums and Obstacle DP, Amdt 4
Paducah, KY, Barkley Rgnl, VOR RWY 5, Amdt 18C
Paducah, KY, Barkley Rgnl, VOR RWY 23, Amdt 6E
Williamsburg, KY, Williamsburg-Whitley County, Takeoff Minimums and
Obstacle DP, Amdt 2A
Jennings, LA, Jennings, Takeoff Minimums and Obstacle DP, Amdt 2B
Opelousas, LA, St Landry Parish-Ahart Field, VOR RWY 36, Amdt 1B
Houlton, ME, Houlton Intl, Takeoff Minimums and Obstacle DP, Amdt 3
Lansing, MI, Capital Region Intl, RNAV (GPS) RWY 6, Amdt 1
Lansing, MI, Capital Region Intl, RNAV (GPS) RWY 10R, Amdt 1

Lansing, MI, Capital Region Intl, RNAV (GPS) RWY 24, Amdt 1
Appleton, MN, KAQP, NDB RWY 13, Amdt 1, CANCELLED
Bemidji, MN, Bemidji Rgnl, ILS OR LOC RWY 25, Amdt 2
Bemidji, MN, Bemidji Rgnl, ILS OR LOC RWY 31, Amdt 7
Benson, MN, KBBB, NDB RWY 14, Amdt 7B, CANCELLED
Cambridge, MN, KCBG, NDB RWY 34, Amdt 7A, CANCELLED
Canby, MN, Myers Field, RNAV (GPS) RWY 30, Amdt 1A
Crookston, MN, KCKN, NDB RWY 13, Amdt 9A, CANCELLED
Glencoe, MN, KGYL, NDB RWY 31, Amdt 1A, CANCELLED
Granite Falls, MN, Granite Falls Muni/Lenzen-Roe-Fagen Memorial
Field, RNAV (GPS) RWY 33, Orig-A
Little Falls, MN, KLXL, NDB RWY 31, Amdt 6E, CANCELLED
Longville, MN, KXVG, NDB RWY 31, Amdt 1A, CANCELLED
Moose Lake, MN, KMZH, NDB RWY 4, Amdt 1B, CANCELLED
Mora, MN, KJMR, NDB RWY 35, Orig-A, CANCELLED
Orr, MN, KORB, NDB RWY 13, Amdt 8C, CANCELLED
Ortonville, MN, KVVV, NDB RWY 34, Amdt 2B, CANCELLED
Park Rapids, MN, KPKD, ILS OR LOC RWY 31, Amdt 2
Pipestone, MN, Pipestone Muni, RNAV (GPS) RWY 36, Amdt 1C
Staples, MN, KSAZ, NDB RWY 14, Amdt 3C, CANCELLED
Thief River Falls, MN, Thief River Falls Rgnl, RNAV (GPS) RWY 4,
Orig-A
Tracy, MN, Tracy Muni, RNAV (GPS) RWY 11, Orig-B
Columbia, MO, Columbia Rgnl, ILS OR LOC RWY 2, Amdt 16B
Columbia, MO, Columbia Rgnl, RNAV (GPS) RWY 2, Amdt 2B
Columbia, MO, Columbia Rgnl, RNAV (GPS) RWY 13, Amdt 1A
Columbia, MO, Columbia Rgnl, RNAV (GPS) RWY 31, Amdt 1A
Columbia, MO, Columbia Rgnl, VOR RWY 13, Amdt 4A
Raleigh/Durham, NC, Raleigh-Durham Intl, RNAV (GPS) Y RWY 5L, Amdt 2
Raleigh/Durham, NC, Raleigh-Durham Intl, RNAV (GPS) Y RWY 5R, Amdt 4
Raleigh/Durham, NC, Raleigh-Durham Intl, RNAV (GPS) Y RWY 23L, Amdt
3
Raleigh/Durham, NC, Raleigh-Durham Intl, RNAV (RNP) Z RWY 5L, Amdt 3
Raleigh/Durham, NC, Raleigh-Durham Intl, RNAV (RNP) Z RWY 5R, Amdt 3
Raleigh/Durham, NC, Raleigh-Durham Intl, RNAV (RNP) Z RWY 23L, Amdt
3
Raleigh/Durham, NC, Raleigh-Durham Intl, VOR RWY 5R, Amdt 13F,
CANCELLED
Raleigh/Durham, NC, Raleigh-Durham Intl, VOR RWY 23L, Amdt 14F,
CANCELLED
Dickinson, ND, KDIK, ILS OR LOC RWY 32, Amdt 1C, CANCELLED
Dickinson, ND, KDIK, RNAV (GPS) RWY 14, Amdt 1A, CANCELLED
Dickinson, ND, KDIK, RNAV (GPS) RWY 32, Amdt 2B, CANCELLED
Dickinson, ND, Dickinson--Theodore Roosevelt Rgnl, Takeoff Minimums
and Obstacle DP, Amdt 2A
Creighton, NE, Creighton Muni, RNAV (GPS) RWY 31, Orig-D
Lexington, NE, Jim Kelly Field, RNAV (GPS) RWY 32, Amdt 2
Jaffrey, NH, KAFN, RNAV (GPS)-C, Amdt 1
Millville, NJ, KMIV, RNAV (GPS) RWY 14, Orig-F
Princeton/Rocky Hill, NJ, Princeton, VOR-A, Amdt 7C
Wildwood, NJ, Cape May County, Takeoff Minimums and Obstacle DP,
Amdt 3A
Ruidoso, NM, Sierra Blanca Rgnl, CAPITAN TWO, Graphic DP
Ruidoso, NM, Sierra Blanca Rgnl, Takeoff Minimums and Obstacle DP,
Orig-A
Las Vegas, NV, North Las Vegas, GPS RWY 12R, Orig-E, CANCELLED
Las Vegas, NV, North Las Vegas, GPS RWY 30L, Orig-B, CANCELLED
Las Vegas, NV, North Las Vegas, RNAV (GPS) RWY 12R, Orig
White Plains, NY, Westchester County, ILS OR LOC RWY 16, ILS RWY 16
(SA CAT I), ILS RWY 16 (SA CAT II), Amdt 25C
White Plains, NY, Westchester County, ILS OR LOC RWY 34, Amdt 5C
Ketchum, OK, 1K8, RNAV (GPS) RWY 36, Orig-B
Weatherford, OK, KOJA, RNAV (GPS) RWY 17, Amdt 2A
Mc Minnville, OR, Mc Minnville Muni, Takeoff Minimums and Obstacle
DP, Amdt 5
Chambersburg, PA, Franklin County Rgnl, RNAV (GPS) RWY 6, Orig-C
Chambersburg, PA, Franklin County Rgnl, RNAV (GPS) RWY 24, Orig-C
Doylestown, PA, Doylestown, VOR-A, Orig
Doylestown, PA, Doylestown, VOR/DME RWY 23, Amdt 8B, CANCELLED
Latrobe, PA, Arnold Palmer Rgnl, ILS OR LOC RWY 24, Amdt 17B
Huron, SD, Huron Rgnl, ILS OR LOC RWY 12, Amdt 11
Huron, SD, Huron Rgnl, LOC BC RWY 30, Amdt 14
Huron, SD, Huron Rgnl, RNAV (GPS) RWY 12, Orig-B
Huron, SD, Huron Rgnl, RNAV (GPS) RWY 30, Amdt 1C
Huron, SD, Huron Rgnl, VOR RWY 12, Amdt 22A, CANCELLED
Miller, SD, Miller Muni, RNAV (GPS) RWY 15, Amdt 1B
Miller, SD, Miller Muni, RNAV (GPS) RWY 33, Amdt 1B
Pierre, SD, Pierre Rgnl, RNAV (GPS) RWY 25, Amdt 2A
Pierre, SD, Pierre Rgnl, RNAV (GPS) RWY 31, Amdt 1A
Gallatin, TN, KXNX, RNAV (GPS) RWY 35, Amdt 3B
Jasper, TN, Marion County-Brown Field, Takeoff Minimums and Obstacle
DP, Amdt 2A
Mountain City, TN, Johnson County, Takeoff Minimums and Obstacle DP,
Amdt 1
Austin, TX, KAUS, ILS OR LOC RWY 35R, ILS RWY 35R (SA CAT I), ILS
RWY 35R (SA CAT II), Amdt 4A
Austin, TX, Austin-Bergstrom Intl, RNAV (RNP) Z RWY 17R, Amdt 1A
Austin, TX, KHYI, RNAV (GPS) RWY 8, Orig-C
El Paso, TX, KELP, RADAR-1, Amdt 15C
Harlingen, TX, Valley Intl, VOR RWY 17L, Amdt 1
Marfa, TX, Marfa Muni, Takeoff Minimums and Obstacle DP, Amdt 1A
Midlothian/Waxahachie, TX, Mid-Way Rgnl, RNAV (GPS) RWY 18, Orig-B
Vernal, UT, KVEL, RNAV (GPS) Y RWY 35, Orig-B
Vernal, UT, KVEL, VOR RWY 35, Orig-B
Wise, VA, Lonesome Pine, LOC RWY 24, Amdt 1
Wise, VA, Lonesome Pine, RNAV (GPS) RWY 6, Orig-B
Wise, VA, Lonesome Pine, RNAV (GPS) RWY 24, Amdt 1
Highgate, VT, KFSO, VOR RWY 19, Amdt 5B, CANCELLED

[FR Doc. 2020-28413 Filed 12-23-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61820-61822]
[FR Doc No: 2015-26055]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3419]

General Considerations for Animal Studies for Medical Devices;
Draft Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``General
Considerations for Animal Studies for Medical Devices.'' FDA has
developed this guidance document to assist industry in designing
evaluation strategies for, and reporting the results of, animal studies
for medical devices. The intent of this draft guidance is to provide a
reference of best practices for the approach to, and conduct of, animal
studies, and the presentation of animal study data intended to
demonstrate that the device under study is sufficiently safe for early
human experience (e.g., to support an investigational device exemption
(IDE) application) or to demonstrate device safety in support of a
marketing application, while incorporating modern animal care and use
strategies. This draft guidance is not final nor is it in effect at
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 12, 2016.

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 No.
FDA-2015-D-3419 for ``General Considerations for Animal Studies for
Medical Devices.'' 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.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``General Considerations for Animal Studies for Medical Devices'' to
the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this guidance document to assist industry in
designing evaluation strategies for, and reporting the results of,
animal studies for medical devices. The animal studies utilized for the
assessment of these devices typically provide initial evidence of
device safety, their potential performance when used in a living
system, and the biologic response that a living system may mount
towards the device. The intent of this guidance is to provide a
reference of best practices for the approach to, and conduct of, animal
studies, and the presentation of animal study data intended to
demonstrate that the device under study is sufficiently safe for early
human experience (e.g., to support an investigational device exemption
application) or to demonstrate device safety in support of a marketing
application, while incorporating modern animal care and use strategies.
We encourage sponsors to consult with us if it they wish to use a non-
animal testing method they believe is suitable, adequate, validated,
and feasible. We will consider if such an alternative method could be
assessed for equivalency to an animal test method.
    This draft guidance, when finalized, will supersede the July 2010
guidance entitled ``Guidance for Industry and FDA Staff: General
Considerations for Animal Studies for Cardiovascular Devices.''

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on General
Considerations for Animal Studies for Medical Devices. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``General Considerations for
Animal Studies for Medical Devices,'' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1802 to identify the guidance
you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 58 have been approved
under OMB control number 0910-0119; the collections of information in
21 CFR part 807, subpart E, have been approved under OMB control number
0910-0120; the collections of information in 21 CFR part 812 have been
approved under OMB control number 0910-0078; the collections of
information in 21 CFR part 814, subparts A through E, have been
approved under OMB control numbers 0910-0231; and the collections of
information in 21 CFR part 814, subpart H have been approved under OMB
control number 0910-0332.
    This draft guidance also refers to proposed collections of
information described in FDA's August 14, 2014, draft guidance
entitled, ``De Novo Classification Process (Evaluation of Automatic
Class III Designations)'' (de novo draft guidance) (79 FR 47651). The
proposed collections of information described in the de novo draft
guidance are subject to review by OMB under the PRA. As required by the
PRA, FDA has published an analysis of the proposed information
collection described in the de novo draft guidance (79 FR 47651 at
47653) and has submitted them for OMB approval.

    Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26055 Filed 10-13-15; 8:45 am]
BILLING CODE 4164-01-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

                                   	  Issued by the Department of
Transportation on December 10, 2004

		       NOTICE OF ACTION TAKEN -- DOCKET OST-2002-14036

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of     Northwest Airlines, Inc.        filed    11/24/04
to:

XX  Renew for two years exemption under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between Newark, New Jersey, and Santiago, Dominican Republic, and to
integrate this authority with its existing certificate and exemption
authority.  Northwest operates this service pursuant to a code-share
arrangement with Continental Airlines whereby Northwest displays its
designator code on flights operated by Continental.

XX  Waiver from 14 CFR 377.10(c)

Applicant rep.:   Megan Rae Rosia,<PHONE_NUMBER>    DOT analyst:
Sylvia Moore,<PHONE_NUMBER>

DISPOSITION

XX  Exemption granted (subject to conditions, see below)

The above action was effective when taken:    December 10, 2004,
through  December 10, 2006

XX  Waiver granted (see remarks below)

Action taken by:  Paul L. Gretch, Director

		  Office of International Aviation

XX  The authority granted is consistent with the overall state of
aviation relations between the United States and the Dominican Republic.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, limitations indicated:  XX  Holder’s
certificates of public convenience and necessity

	   XX  Standard exemption conditions (attached)

________________________

Conditions:  (1) The code-share operations conducted under this
authority must comply with 14 CFR 257 and with any amendments to the
Department's regulations concerning code-share arrangements that may be
adopted.  Notwithstanding any provisions in the contract between the
carriers, our approval here is expressly conditioned upon the
requirements that the subject foreign air transportation be sold in the
name of the carrier holding out such service in computer reservation
systems and elsewhere; that the carrier selling such transportation
(i.e., the carrier shown on the ticket) accept responsibility for the
entirety of the code-share journey for all obligations established in
its contract of carriage with the passenger; and that the

2

passenger liability of the operating carrier be unaffected, and (2) the
authority granted here is specifically conditioned so that neither
Northwest nor Continental shall give any force and effect to any
contractual provisions between themselves that are contrary to these
conditions.

The route integration authority granted is subject to the condition that
any service provided

under this exemption shall be consistent with all applicable agreements
between the United States and the foreign countries involved.
Furthermore, (a) nothing in the award of the route integration authority
requested should be construed as conferring upon Northwest rights
(including fifth-freedom intermediate and/or beyond rights) to serve
markets where U.S. carrier entry is limited unless Northwest notifies
the Department of its intent to serve such a market and unless and until
the Department has completed any necessary carrier selection procedures
to determine which carrier(s) should be authorized to exercise such
rights; and (b) should there be a request by any carrier to use the
limited-entry route rights that are included in Northwest’s authority
by virtue of the route integration exemption granted here, but that are
not then being used by Northwest, the holding of such authority by route
integration will not be considered as providing any preference for
Northwest in a competitive carrier selection proceeding to determine
which carrier(s) should be entitled to use the authority at issue.

Remarks:  Northwest requested a waiver from the 60-day advance filing
requirements of 14 CFR 377 to ensure that its authority would continue
in effect beyond the expiration date (January 3, 2005), pending action
on its renewal application.  On December 7, 2004, we orally granted the
request.  We confirm that action here.

________________________________________________________________________
______________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

																	  05/2004


[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73916-73919]
[FR Doc No: 2012-30005]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-1125]
RIN 1625-AA11

Regulated Navigation Area; S99 Alford Street Bridge
Rehabilitation Project, Mystic River, MA

AGENCY: Coast Guard, DHS.

ACTION: Temporary interim rule with request for comments.

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

SUMMARY: The Coast Guard is reinstating a regulated navigation area
(RNA) that was promulgated to protect the public against hazardous
conditions created by repair work on the S99 Alford Street Bridge
across the Mystic River between Boston and Chelsea, Massachusetts. The
original RNA terminates on November 30, 2012 and must be reinstated
because repair work is continuing beyond that date. This rule promotes
the Coast Guard's maritime safety and stewardship missions.

DATES: This rule is effective in the CFR on December 12, 2012. This
rule is effective with actual notice for purposes of enforcement from
11:59 p.m. on November 30, 2012, through December 31, 2014. Public
comments will be accepted and reviewed by the Coast Guard through
December 31, 2014.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2011-1125. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' Box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with the rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation, West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Mr. Mark Cutter, Coast Guard Sector
Boston Waterways Management Division, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>or Lieutenant Isaac Slavitt, Coast Guard First
District Waterways Management Branch, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call

Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-
9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
COTP Captain of the Port

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.
    As this temporary interim rule will be in effect before the end of
the comment period, the Coast Guard will evaluate and revise this rule
as necessary to address significant public comments.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-1125), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via www.regulations.gov, it will be considered received
by the Coast Guard when you successfully transmit the comment. If you
fax, hand deliver, or mail your comment, it will be considered as
having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an email address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number (USCG-2012-1125) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change this rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number ``USCG-2012-1125'' in the ``SEARCH'' box and
click ``Search.'' Click and Open Docket Folder on the line associated
with this rulemaking. You may also visit the Docket Management Facility
in Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. We have an agreement with the Department of Transportation to
use the Docket Management Facility.

3. Privacy Act

    Anyone can search the electronic form of 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 a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    The Coast Guard does not currently plan to hold public meetings.
However, a public meeting may be requested by using one of the methods
specified under ADDRESSES. Please explain why you believe such a public
meeting would be beneficial. If we determine that one would aid this
rulemaking, we will hold one at a time and place announced by a later
notice in the Federal Register.

B. Regulatory Information

    This is the second temporary interim rule with request for comments
issued by the Coast Guard to establish a regulated navigation area in
connection with the S99 Alford Street Bridge rehabilitation over the
main channel of the Mystic River between Boston and Chelsea,
Massachusetts. The first rule was published in the Federal Register on
January 9, 2012 (77 FR 1020). We received no public comments on the
first rule.
    The Coast Guard is issuing this second rule without prior Federal
Register notice pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA), 5 U.S.C. 553(b). This provision
authorizes an agency to issue a rule without prior notice when the
agency for good cause finds that those procedures are ``impracticable,
unnecessary, or contrary to the public interest.'' Under 5 U.S.C.
553(b)(B), the Coast Guard has good cause to find that publishing a
notice of proposed rulemaking (NPRM) for this second rule, and taking
public comment on that NPRM, would be both impracticable and contrary
to the public interest. The repair work that necessitated the first
rule has not been completed on schedule and therefore the hazardous
conditions that gave rise to the need for RNA protective measures
continue. Expiration of the first RNA on November 30, 2012 leaves no
time for notice and comment procedures if both the repair work and RNA
protective measures are to remain in place after that date. Temporarily
stopping necessary repair work would impracticably delay the resumption
of normal traffic patterns and raise construction costs, contrary to
the public interest. To some extent, it is also unnecessary to follow
normal notice and comment practice with respect to this RNA, because
the affected public can clearly see that the bridge repair work and
that work's associated hazards continue, and anyone who wishes to
comment on the need for or the terms of the RNA may at any time submit
comments to the Coast Guard, and the Coast Guard will respond to those
comments.
    For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule effective less than
30 days after publication in the Federal Register.

C. Basis and Purpose

    Under the Ports and Waterways Safety Act, the Coast Guard has the
authority to establish RNAs in defined water areas that are determined
to have hazardous conditions and in which vessel traffic can be
regulated in the interest of safety. See 33 U.S.C. 1231 and Department
of Homeland Security Delegation No. 0170.1.
    The purpose of this temporary interim rule and request for comments
is to keep in place and extend the regulated navigation area that was
the subject of the Coast Guard temporary interim rule and request for
comments published in the Federal Register on January 9, 2012 in order
to ensure the safe transit of vessels in the area and to protect all
persons, vessels, and the marine environment during the rehabilitation
project of the S99 Alford Street Bridge.

D. Discussion of Rule

    This rule reinstates a regulated navigation area that was
promulgated to protect the public against hazardous conditions created
by repair work on the S99 Alford Street Bridge across the Mystic River
between Boston and Chelsea, Massachusetts. The original RNA took effect
with actual notice on December 27, 2011, was the subject of a temporary
interim rule and request for comments published in the Federal Register
on January 9, 2012, and expires by its own terms at 11:59 p.m. on
November 30, 2012. However, the repair work is continuing beyond that
date and therefore the RNA must be reinstated to extend the RNA's
protective measures for the duration of that work. This new temporary
interim rule and request for comments makes no substantive changes in
the RNA.

E. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) Executive Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under that Order. We expect the economic impact of
this rule to be minimal because the amount of traffic in this waterway
is extremely limited. Furthermore, the Captain of the Port has the
ability to suspend the provisions of this regulation when necessary.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended requires federal agencies to consider the potential impact of
regulations on small entitles during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule would not have a
significant economic impact on a substantial number of small entities.
    This rule will affect the following entities some of which may be
small entities: The owners or operators of marinas, businesses (such as
waterside restaurants), and vessels who intend to transit in the Mystic
River beneath the S99 Alford Street Bridge during the effective period.
    This regulation may have some impact on the public, but the
potential impact will be minimized for the following reasons: this
action only serves to reinstate an RNA that is already in place and for
which no public comments were received. Many parties that have the
potential to be affected have been involved in the discussions and have
made plans to work around the closure times. We will use appropriate
means to inform the public before, during, and at the conclusion of any
RNA enforcement period.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.

4. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``Significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one

of a category of actions that do not individually or cumulatively have
a significant effect on the human environment. This rule involves the
modification of an existing regulated navigation area. This rule is
categorically excluded from further review under, paragraph 34(g) of
figure 2-1 of the Commandant Instruction. An environmental analysis
checklist and a categorical exclusion determination are available in
the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for Part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T01-1130 to read as follows:

Sec.  165.T01-1130  Regulated Navigation Area; S99 Alford Street Bridge
rehabilitation project, Mystic River, MA

    (a) Location. The following area is a Regulated Navigation Area
(RNA): All navigable waters of the Mystic River between Boston and
Chelsea, MA, from surface to bottom, within 100 yards of any point on
the S99 Alford Street Bridge.
    (b) Regulations. (1) The general regulations contained in 33 CFR
165.10, 165.11, and 165.13 apply in addition to those provisions
outlined below.
    (2) In accordance with the general regulations, entry into or
movement within this zone, during periods of enforcement, is prohibited
unless authorized by Captain of the Port (COTP) Sector Boston.
    (3) All persons and vessels must comply with all directions given
to them by the COTP Sector Boston or the on-scene representative. The
``on-scene representative'' of the COTP is any Coast Guard
commissioned, warrant or petty officer who has been designated by the
COTP to act on the COTP's behalf. The on-scene representative may be on
a Coast Guard vessel or other designated craft, or may be on shore and
will communicate with vessels via VHF-FM radio or loudhailer. Members
of the Coast Guard Auxiliary may be present to inform vessel operators
of this regulation.
    (4) Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of the vessel must proceed
as directed.
    (5) Notwithstanding any other provisions in this regulation, the
movement of official, emergency vessels within the regulated area is
permitted provided that the contractor is notified in order to remove
potential hazards or obstructions.
    (6) All other relevant regulations, including but not limited to
the Rules of the Road (33 CFR subchapter E, Inland Navigational Rules)
remain in effect within the regulated area and must be strictly
followed at all times.
    (c) Enforcement period. (1) This regulated navigation area is
enforceable 24 hours a day from 11:59 p.m. on November 30, 2012 through
December 31, 2014.
    (2) The COTP Sector Boston will cause notice of enforcement,
suspension of enforcement, or closure of the waterway to be made by all
appropriate means to achieve the widest distribution among the affected
segments of the public. Such means of notification may include but are
not limited to Broadcast Notice to Mariners, Local Notice to Mariners
and Marine Safety Information Bulletins. Such notification will include
the date and time that enforcement is suspended as well as the date and
time that enforcement will resume.
    (3) Report violations of this regulated navigation area to the COTP
Sector Boston, at<PHONE_NUMBER> or on VHF-Channel 16.

    Dated: November 29, 2012.
D.B. Abel,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2012-30005 Filed 12-11-12; 8:45 am]
BILLING CODE 9110-04-P