[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12613-12614]
[FR Doc No: 2017-04231]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-1725]

Determination That FLONASE (Fluticasone Propionate) Nasal Spray,
0.05 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that prescription FLONASE (fluticasone propionate) Nasal
Spray, 0.05 milligram (mg), was not withdrawn from sale for reasons of
safety or effectiveness. This determination means that FDA will not
begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to this drug product, and this
determination will allow FDA to continue to approve ANDAs for
fluticasone propionate nasal spray, 0.05 mg, if all other legal and
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: David Faranda, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-8767.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    Prescription FLONASE (fluticasone propionate) Nasal Spray, 0.05 mg,
is the subject of NDA 020121, held by GlaxoSmithKline, and initially
approved on October 19, 1994. FLONASE is indicated for the management
of the nasal symptoms of perennial nonallergic rhinitis in adult and
pediatric patients aged 4 years and older.
    In a letter dated May 25, 2016, GlaxoSmithKline notified FDA that
prescription FLONASE (fluticasone propionate) Nasal Spray, 0.05 mg, was
being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc., submitted a citizen petition
dated June 20, 2016 (Docket No. FDA-2016-P-1725), under 21 CFR 10.30,
requesting that the Agency determine whether prescription FLONASE
(fluticasone propionate) Nasal Spray, 0.05 mg, was withdrawn from sale
for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that prescription FLONASE (fluticasone propionate)
Nasal Spray, 0.05 mg, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that this drug product was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, from

sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events. We have found no information
that would indicate that this drug product was withdrawn from sale for
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list prescription FLONASE
(fluticasone propionate) Nasal Spray, 0.05 mg, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to prescription FLONASE (fluticasone
propionate) Nasal Spray, 0.05 mg, may be approved by the Agency as long
as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04231 Filed 3-3-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Rules and Regulations]
[Pages 34938-34940]
[FR Doc No: 2021-13996]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31376; Amdt. No. 3962]

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

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures 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 for the 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 July 1, 2021. 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 July 1, 2021.

ADDRESSES: Availability of matter 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 Information Services, 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 online 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 amending
the referenced SIAPs. The complete

regulatory description of each SIAP is listed on the appropriate FAA
Form 8260, as modified by the National Flight Data Center (NFDC)/
Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference
under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large
number of SIAPs, their complex nature, and the need for a special
format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained on FAA form documents is
unnecessary. This amendment provides the affected CFR sections, and
specifies the SIAPs and 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 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 and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on criteria
contained in the U.S. Standard for Terminal Instrument Procedures
(TERPS). In developing these changes to SIAPs and Takeoff Minimums and
ODPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    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 these
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.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC, on June 11, 2021.
Wade E.K. Terrell,
Aviation Safety, Flight Standards Service, Manager (A), Flight
Technologies and Procedures Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
CFR part 97, (is amended by amending Standard Instrument Approach
Procedures and Takeoff Minimums and ODPs, 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:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC date           State              City                 Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
7/15/2021............  NY             Wurtsboro...........  Wurtsboro-Sullivan         1/1965    4/27/2021  This NOTAM, published in Docket No. 31374,
                                                             County.                                         Amdt No. 3960, TL 21-15, (86 FR 33503; June
                                                                                25, 2021) is hereby rescinded in its
                                                                                entirety.
7/15/2021............  IA             Mason City..........  Mason City Muni.....       1/5288    4/27/2021  This NOTAM, published in Docket No. 31374,
                                                                                Amdt No. 3960, TL 21-15, (86 FR 33503; June
                                                                                25, 2021) is hereby rescinded in its
                                                                                entirety.
7/15/2021............  KS             Hugoton.............  Hugoton Muni........       1/5928    4/23/2021  This NOTAM, published in Docket No. 31374,
                                                                                Amdt No. 3960, TL 21-15, (86 FR 33503; June
                                                                                25, 2021) is hereby rescinded in its
                                                                                entirety.
7/15/2021............  FL             Lake City...........  Lake City Gateway...       1/7904    5/12/2021  This NOTAM, published in Docket No. 31374,
                                                                                Amdt No. 3960, TL 21-15, (86 FR 33503; June
                                                                                25, 2021) is hereby rescinded in its
                                                                                entirety.

15-Jul-21............  VI             Charlotte Amalie....  Cyril E King........       1/0192      5/27/21  ILS OR LOC RWY 10, Amdt 1B.
15-Jul-21............  CA             Willits.............  Ells Fld-Willits           1/0906      5/25/21  RNAV (GPS) RWY 34, Amdt 1C.
                                                             Muni.
15-Jul-21............  FL             Lakeland............  Lakeland Linder Intl       1/2541      5/25/21  VOR RWY 9, Amdt 4E.
15-Jul-21............  NY             New York............  John F Kennedy Intl.       1/3949      5/28/21  RNAV (GPS) X RWY 22L, Orig.
15-Jul-21............  NY             Wurtsboro...........  Wurtsboro-Sullivan         1/4012      5/28/21  VOR/DME OR GPS RWY 5, Orig.
                                                             County.
15-Jul-21............  IA             Mason City..........  Mason City Muni.....       1/4035       6/4/21  RNAV (GPS) RWY 30, Amdt 1C.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4714      4/27/21  ILS OR LOC/DME RWY 12, Amdt 9B.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4717      4/27/21  RNAV (GPS) RWY 1L, Orig-C.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4719      4/27/21  RNAV (GPS) RWY 12, Amdt 1C.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4720      4/27/21  RNAV (GPS) RWY 19R, Orig-B.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4723      4/27/21  RNAV (GPS) Y RWY 1C, Amdt 1C.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4724      4/27/21  RNAV (GPS) Y RWY 1R, Amdt 1C.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4726      4/27/21  RNAV (GPS) Y RWY 19C, Amdt 3D.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4727      4/27/21  RNAV (GPS) Y RWY 19L, Amdt 2B.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4728      4/27/21  VOR/DME RWY 12, Amdt 9C.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4960       6/1/21  ILS OR LOC/DME RWY 1C, Amdt 2C.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4961       6/1/21  ILS OR LOC RWY 1R, Amdt 24B.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4962       6/1/21  ILS OR LOC/DME RWY 1L, Amdt 1B.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4963       6/1/21  ILS OR LOC/DME RWY 19C, Amdt 25A.
                                                             Intl.
15-Jul-21............  DC             Washington..........  Washington Dulles          1/4965       6/1/21  ILS OR LOC/DME RWY 19R, Amdt 1A.
                                                             Intl.
15-Jul-21............  VI             Charlotte Amalie....  Cyril E King........       1/5726      5/27/21  VOR-A, Amdt 14C.
15-Jul-21............  NC             Mount Olive.........  Mount Olive Muni....       1/8210      5/27/21  RNAV (GPS) RWY 23, Orig-B.
15-Jul-21............  NC             Mount Olive.........  Mount Olive Muni....       1/8211      5/27/21  RNAV (GPS) RWY 5, Orig-C.
15-Jul-21............  FL             Lakeland............  Lakeland Linder Intl       1/8908      5/25/21  RNAV (GPS) RWY 23, Orig-E.
15-Jul-21............  FL             Lakeland............  Lakeland Linder Intl       1/8909      5/25/21  RNAV (GPS) RWY 27, Amdt 2D.
15-Jul-21............  FL             Lakeland............  Lakeland Linder Intl       1/8910      5/25/21  RNAV (GPS) RWY 9, Amdt 2E.
15-Jul-21............  FL             Lakeland............  Lakeland Linder Intl       1/8911      5/25/21  RNAV (GPS) RWY 5, Orig-G.
15-Jul-21............  FL             Lakeland............  Lakeland Linder Intl       1/8912      5/25/21  VOR RWY 27, Amdt 7H.
15-Jul-21............  ME             Old Town............  Dewitt Fld/Old Town        1/9332      5/25/21  RNAV (GPS) RWY 12, Orig-B.
                                                             Muni.
15-Jul-21............  ME             Old Town............  Dewitt Fld/Old Town        1/9333      5/25/21  RNAV (GPS) RWY 22, Orig-A.
                                                             Muni.
15-Jul-21............  ME             Old Town............  Dewitt Fld/Old Town        1/9334      5/25/21  RNAV (GPS) RWY 30, Orig-B.
                                                             Muni.
15-Jul-21............  ME             Old Town............  Dewitt Fld/Old Town        1/9335      5/25/21  VOR/DME RWY 22, Amdt 5B.
                                                             Muni.
15-Jul-21............  NJ             Millville...........  Millville Muni......       1/9384      5/25/21  ILS OR LOC RWY 10, Amdt 2D.
15-Jul-21............  NJ             Millville...........  Millville Muni......       1/9385      5/25/21  VOR-A, Amdt 1B.
15-Jul-21............  NJ             Millville...........  Millville Muni......       1/9386      5/25/21  RNAV (GPS) RWY 10, Orig-A.
15-Jul-21............  NJ             Millville...........  Millville Muni......       1/9389      5/25/21  RNAV (GPS) RWY 28, Orig-B.
15-Jul-21............  NJ             Millville...........  Millville Muni......       1/9390      5/25/21  RNAV (GPS) RWY 32, Orig-D.
15-Jul-21............  NJ             Millville...........  Millville Muni......       1/9391      5/25/21  RNAV (GPS) RWY 14, Orig-F.
15-Jul-21............  GA             Valdosta............  Valdosta Rgnl.......       1/9557      5/27/21  ILS OR LOC RWY 35, Amdt 7.
15-Jul-21............  GA             Valdosta............  Valdosta Rgnl.......       1/9558      5/27/21  RNAV (GPS) RWY 4, Amdt 1C.
15-Jul-21............  GA             Valdosta............  Valdosta Rgnl.......       1/9562      5/27/21  RNAV (GPS) RWY 17, Amdt 2B.
15-Jul-21............  GA             Valdosta............  Valdosta Rgnl.......       1/9563      5/27/21  RNAV (GPS) RWY 35, Amdt 1.
15-Jul-21............  GA             Valdosta............  Valdosta Rgnl.......       1/9564      5/27/21  VOR RWY 17, Amdt 1A.
15-Jul-21............  GA             Valdosta............  Valdosta Rgnl.......       1/9565      5/27/21  VOR RWY 35, Amdt 1A.
15-Jul-21............  MT             West Yellowstone....  Yellowstone.........       1/9766      5/27/21  ILS OR LOC RWY 1, Amdt 4A.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-13996 Filed 6-30-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 30, 2008 (Volume 73, Number 20)]
[Notices]
[Page 5627-5628]
[DOCID:fr30ja08-136]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Recordkeeping Requirements; Agency Information
Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Request for public comment on proposed collection of
information.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notice with a 60-day comment period was
published on November 15, 2007 [Vol. 72 FR 64275].

DATES: Comments must be submitted on or before February 22, 2008.

FOR FURTHER INFORMATION CONTACT: Mr. Paul Simmons at the National
Highway Traffic Safety Administration, Office of Defects Investigation,
NHTSA, 1200 New Jersey Avenue SE., Washington, DC 20590. Mr. Simmons
can be contacted at<PHONE_NUMBER>. Please identify the relevant
collection of information by referring to its OMB Control Number.

ADDRESSES:  Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725-17th
Street, NW., Washington, DC 20503, Attention NHTSA Desk Officer.

SUPPLEMENTARY INFORMATION: Before a Federal agency can collect certain
information from the public, it must receive approval from the Office
of Management and Budget (OMB). Under procedures established by the
Paperwork Reduction Act of 1995, before seeking OMB approval, Federal
agencies must solicit public comment on proposed collections of
information, including extensions and reinstatement of previously
approved collections.
    Agency: National Highway Traffic Safety Administration.
    Title: Reporting of Information and Documents About Potential
Defects. OMB Number: 2127-0616.
    OMB Number: 2127-0616.
    Type of Request: Extension of currently approved collection.
    Abstract: Under Chapter 301 of Title 49 of the United States Code,
manufacturers of motor vehicles and items of motor vehicle equipment
are periodically required to submit certain information to NHTSA,
including information about claims and notices about deaths and serious
injury, property damage data, communications to customers and others,
and information on incidents resulting in fatalities or serious
injuries from possible defects in vehicles or equipment in the United
States or in identical or substantially similar vehicles or equipment
in foreign countries. The statute also authorizes NHTSA to require the
submission of other data that may assist in the identification of
safety-related defects in vehicles and equipment. Information and
documents submitted are intended to provide NHTSA with ``early
warning'' of potential safety related defects in motor vehicles and
motor vehicle equipment. NHTSA relies on the information provided (as
well as other relevant information) in deciding whether to open safety
defect investigations. Please note that the currently approved ICR,
``Reporting of Information About Foreign Safety Recalls and Campaigns
Related to Potential Defects'' (OMB Control Number 2127-0620) is
incorporated with this request for collections.
    Affected Public: Manufacturers of motor vehicles and motor vehicle
equipment sold in the U.S.
    Estimated Total Annual Burden: The annual burden is estimated to be
82,381 hours. The estimated annual cost is $8,916,602.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725-17th
Street, NW., Washington, DC 20503. Attention NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. A comment to OMB is most effective if OMB
receives it within 30 days of publication.

    Issued in Washington, DC, on January 24, 2008.
Kathleen C. DeMeter,
Director, Office of Defects Investigation.
[FR Doc. 08-377 Filed 1-29-08; 8:45 am]

BILLING CODE 4910-59-P