[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35283-35284]
[FR Doc No: 2013-13904]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0663]

Agency Information Collection Activities; Proposed Collection;
Comment Request: Investigational New Drug Safety Reporting Requirements
for Human Drug and Biological Products and Safety Reporting
Requirements for Bioavailability and Bioequivalence Studies in Humans

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
resulting from investigational new drug (IND) safety reporting
requirements and safety reporting requirements for bioavailability and
bioequivalence studies.

DATES: Submit either electronic or written comments on the collection
of information by August 12, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane., rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies in Humans--(OMB Control
Number 0910-0672)--Extension

    In the Federal Register of September 29, 2010 (75 FR 59935), FDA
published a document entitled ``Investigational New Drug Safety
Reporting Requirements for Human Drug and Biological Products and
Safety Reporting Requirements for Bioavailability and Bioequivalence
Studies in Humans.'' The document clarified the Agency's expectations
for timely review, evaluation, and submission of relevant and useful
safety information and implemented internationally harmonized
definitions and reporting standards for IND safety reports. The
document also required safety reporting for bioavailability and
bioequivalence studies. The document was intended to improve the
utility of IND safety reports, expedite FDA's review of critical safety
information, better protect human subjects enrolled in clinical trials,
and harmonize safety reporting requirements internationally.
    The rulemaking included the following information collection under
the PRA that was not already included in 21 CFR 312.32 and approved
under OMB control number 0910-0014.
    Section 312.32(c)(1)(ii) and (c)(1)(iii) requires reporting to FDA,
in an IND safety report, of potential serious risks from clinical
trials within 15 calendar days for findings from epidemiological
studies, pooled analyses of multiple studies, or other clinical studies
that suggest a significant risk in humans exposed to the drug.
    Section 312.32(c)(1)(iii) specifies the requirements for reporting
to FDA in an IND safety report potential serious risks from clinical
trials within 15 calendar days for findings from in vitro testing that
suggest a significant risk to humans. FDA estimates that approximately
100 sponsors spend a total of approximately 12 hours per report to
prepare and submit approximately 600 reports annually.
    Section 312.32(c)(1)(iv) requires reporting to FDA in an IND safety
report within 15 calendar days of any clinically important increase in
the rate of occurrence of serious suspected adverse reactions over that
listed in the protocol or investigator brochure. FDA estimates that
approximately 10 sponsors spend a total of approximately 12 hours per
report to prepare and submit approximately 10 reports annually.
    The rulemaking also included new information collection under the
PRA by requiring safety reporting for bioavailability and
bioequivalence studies (21 CFR 320.31(d)). FDA estimates that
approximately 10 sponsors spend a total of approximately 14 hours per
report to prepare and submit approximately 200 reports annually.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
320.31(d) Bioavailability and                 10              20             200              14           2,800
 Bioequivalence Safety Reports..
312.32(c)(1)(ii) and (c)(1)(iii)             100               6             600              12           7,200
 IND Safety Reports.............
312.32(c)(1)(iv) IND Safety                   10               1              10              12             120
 Reports........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,120
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13904 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 16, 2010 (Volume 75, Number 50)]
[Notices]
[Page 12533-12534]
[DOCID:fr16mr10-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice Of Filings 1

March 8, 2010.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC10-49-000.
    Applicants: GWF Energy LLC.
    Description: GWF Energy LLC submits an application for disposition
of jurisdictional facilities.
    Filed Date: 03/04/2010.

    Accession Number: 20100305-0213.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 25, 2010.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER99-2948-018; ER00-2918-017; ER01-1654-020; ER01-
556-016; ER02-2567-017; ER04-485-015; ER05-261-010; ER05-728-010; ER07-
244-009; ER07-245-009; ER07-247-009; ER10-346-003.
    Applicants: Baltimore Gas and Electric Company; Constellation Pwr
Source Generation LLC; Nine Mile Point Nuclear Station, LLC; Handsome
Lake Energy, LLC; Constellation NewEnergy, Inc.; R.E. Ginna Nuclear
Power Plant, LLC; Constellation Energy Commodities Group; Constellation
Energy Commodities Group Maine; Raven Three, LLC; Raven Two, LLC; Raven
One, LLC; Calvert Cliffs Nuclear Power Plant LLC.
    Description: Calvert Cliffs Nuclear Power Plant submits Substitute
First Revised Sheet 1 et al. to its Second Revised FERC Electric Tariff
No. 1 et al.
    Filed Date: 03/05/2010.
    Accession Number: 20100308-0202.
    Comment Date: 5 p.m. Eastern Time on Friday, March 26, 2010.

    Docket Numbers: ER01-2217-008; ER02-2263-010; ER06-736-002; ER08-
337-005; ER08-931-004; ER09-712-002.
    Applicants: High Lonesome Mesa, LLC, Midway Sunset Cogeneration
Company, Southern California Edison Company, Sunrise Power Company,
LLC; Walnut Creek Energy, LLC, Watson Cogeneration Company.
    Description: Southwest EIX MBR Affiliates submits supplements and
corrects its 12/22/09 triennial filing.
    Filed Date: 03/08/2010.
    Accession Number: 20100308-0092.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 18, 2010.

    Docket Numbers: ER06-560-007.
    Applicants: Credit Suisse Energy LLC.
    Description: Notice of Non-Material Change in Status of Credit
Suisse Energy LLC.
    Filed Date: 03/05/2010.
    Accession Number: 20100305-5161.
    Comment Date: 5 p.m. Eastern Time on Friday, March 26, 2010.

    Docket Numbers: ER06-1355-006; ER09-1400-002; ER09-1549-002; ER09-
172-006; ER09-173-006; ER09-174-004.
    Applicants: Canandaigua Power Partners I, LLC; Evergreen Wind
Power, LLC, Canandaigua Power Partners, LLC, Evergreen Wind Power V,
LLC, Canandaigua Power Partners II, LLC, Milford Wind Corridor Phase I,
LLC, First Wind Energy Marketing, LLC.
    Description: Canandaigua Power Partners, LLC, et al. Updated
Information.
    Filed Date: 03/05/2010.
    Accession Number: 20100305-5102.
    Comment Date: 5 p.m. Eastern Time on Friday, March 26, 2010.

    Docket Numbers: ER07-1358-015; ER00-2885-029; ER01-2765-028; ER02-
2102-028; ER05-1232-025; ER09-1141-008.
    Applicants: J.P. Morgan Ventures Energy Corporation, BE Louisiana
LLC, Cedar Brakes I, LLC, Utility Contract Funding, LLC, Cedar Brakes
II, LLC, J.P. Morgan Commodities Canada Corporation.
    Description: BE Louisiana LLC, et al. Notice of Change In Status.
    Filed Date: 03/04/2010.
    Accession Number: 20100304-5080.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 25, 2010.

    Docket Numbers: ER10-502-001.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits an errata to the 12/24/09
filing of the Participation Power Agreement with Kansas Power Pool.
    Filed Date: 03/05/2010.
    Accession Number: 20100305-0215.
    Comment Date: 5 p.m. Eastern Time on Friday, March 26, 2010.

    Docket Numbers: ER10-576-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits amendment to its 1/11/2010 filing to amend Schedule 10, et al.
    Filed Date: 03/05/2010.
    Accession Number: 20100308-0205.
    Comment Date: 5 p.m. Eastern Time on Friday, March 26, 2010.

    Docket Numbers: ER10-840-000.
    Applicants: Electric Energy, Inc.
    Description: Electric Energy, Inc submits Interconnection Agreement
with Tennessee Valley Authority et al.
    Filed Date: 03/05/2010.
    Accession Number: 20100305-0225.
    Comment Date: 5 p.m. Eastern Time on Friday, March 26, 2010.

    Docket Numbers: ER10-841-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
proposed revisions to its Open Access Transmission Tariff.
    Filed Date: 03/05/2010.
    Accession Number: 20100305-0226.
    Comment Date: 5 p.m. Eastern Time on Friday, March 26, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and Sec.
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-5650 Filed 3-15-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4991-4992]
[FR Doc No: 2011-1772]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Vehicle Theft Prevention
Standard; Suzuki

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition for exemption.

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SUMMARY: This document grants in full the American Suzuki Motor
Corporation's (Suzuki) petition for an exemption of the Kizashi vehicle
line in accordance with 49 CFR part 543, Exemption from the Theft
Prevention Standard. This petition is granted because the agency has
determined that the antitheft device to be placed on the line as
standard equipment is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts-marking
requirements of the 49 CFR part 541, Federal Motor Vehicle Theft
Prevention Standard.

DATES: The exemption granted by this notice is effective beginning with
the 2012 model year.

FOR FURTHER INFORMATION CONTACT: Ms. Deborah Mazyck, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, 400
Seventh Street, SW., Washington, DC 20590. Ms. Mazyck's phone number is
(202) 366-4139. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a petition dated October 22, 2010, Suzuki
requested an exemption from the parts-marking requirements of the Theft
Prevention Standard (49 CFR part 541) for the MY 2012 Suzuki Kizashi
vehicle line. The petition requested an exemption from parts-marking
pursuant to 49 CFR part 543, Exemption from Vehicle Theft Prevention
Standard, based on the installation of an antitheft device as standard
equipment for an entire vehicle line. The agency informed Suzuki by
telephone on November 29, 2010, of the areas of insufficiency with
respect to its October 22, 2010 petition for exemption. On December 10,
2010, Suzuki submitted supplementary information to the agency
addressing its areas of insufficiency.
    Under Sec.  543.5(a), a manufacturer may petition NHTSA to grant
exemptions for one line of its vehicle lines per year. In its petition,
Suzuki provided a detailed description and diagram of the identity,
design, and location of the components of the antitheft device for its
Kazashi vehicle line. Suzuki will install its passive antitheft device
as standard equipment on the line. Key features of the antitheft device
will include an electronically coded key fob, Body Control Module
(BCM), Engine Control Module (ECM) and a passive immobilizer. Suzuki's
submission, along with its supplementary information is considered a
complete petition as required by 49 CFR 543.7, in that it meets the
general requirements contained in Sec.  543.5 and the specific content
requirements of Sec.  543.6. Suzuki stated that the proposed device is
designed to be active at all times without direct intervention by the
vehicle operator and is fully armed immediately after the ignition has
been turned off and the key is removed. The device will provide
protection against unauthorized starting and fueling of the engine.
Suzuki further stated that the device will also incorporate an audible
and visible alarm feature as standard equipment. The lights will flash
and the horn will sound in the event of unauthorized vehicle entry.
    Suzuki stated that the antitheft device will also utilize a special
ignition key and decoder module. Before the vehicle can be operated,
the coded key fob must be confirmed to authorize start and fuel of the
engine. Specifically, Suzuki stated that the BCM sends a signal and an
electronically-coded identification number to the key fob. If the
correct key fob is used, it conducts a calculation and sends the result
to the BCM. The BCM also conducts its own calculation and verifies that
the BCM and key fob calculation result are identical. If the results
are identical, the BCM will send data to the ECM allowing the vehicle
to start. If either the key fob identification number or calculation
result are not an exact match with the BCM information, Suzuki stated
that the ECM will prohibit operation of the vehicle.
    In addressing the specific content requirements of 543.6, Suzuki
provided information on the reliability and durability of the proposed
device. To ensure reliability and durability of the device, Suzuki
conducted tests based on its own specified standards. Suzuki provided a
detailed list of the tests conducted on the components of its
immobilizer device and believes that the device is reliable and durable
since it complied with the specified requirements for each test.
According to the information provided by Suzuki, the components of the
device were tested and the results confirm that the device performed as
designed, meeting compliance in climatic, chemical environments, and
immunity to various electromagnetic radiations.
    Suzuki stated that although there is no theft data available to
show the theft reduction benefits for the Kizashi vehicle line at this
time, it has compared the effectiveness of its antitheft device with
devices which it believes are functionally and operationally similar to
its proposed device. Suzuki stated that data published by the agency,
the Highway Loss data Institute and the National Insurance Crime Bureau
show the effectiveness of passive immobilizer devices at reducing and
deterring theft. Suzuki stated that the agency's theft data show that
the theft rate for the 1999 Nissan Maxima equipped with a standard
passive immobilizer is 2.5 thefts per thousand vehicles, compared to a
theft rate of 5.2 thefts for the 1998 Nissan Maxima without a passive
immobilizer, a reduction of more than 50 percent. Additionally, Suzuki
noted that data from the Highway Loss Data Institute show that overall
theft losses for the 1999 Nissan Maxima (with a passive immobilizer)
were reduced by over 85 percent compared to the overall losses for the
1998 Nissan Maxima (without a passive immobilizer). Suzuki provided
further information showing

that data from the National Insurance Crime Bureau showed a 70 percent
reduction in theft when comparing MY 1997 Ford Mustang vehicles (with a
standard immobilizer) to MY 1995 Ford Mustang vehicles (without and
immobilizer). Suzuki believes that its antitheft device will be no less
effective than these devices and similar devices for which NHTSA has
already granted exemptions from the parts-marking requirements.
    Based on the supporting evidence submitted by Suzuki on the device,
the agency believes that the antitheft device for the Kizashi vehicle
line is likely to be as effective in reducing and deterring motor
vehicle theft as compliance with the parts-marking requirements of the
Theft Prevention Standard (49 CFR part 541). The agency concludes that
the device will provide the five types of performance listed in Sec.
543.6(a)(3): promoting activation; attracting attention to the efforts
of an unauthorized person to enter or move a vehicle by means other
than a key; preventing defeat or circumvention of the device by
unauthorized persons; preventing operation of the vehicle by
unauthorized entrants; and ensuring the reliability and durability of
the device.
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7 (b), the agency grants
a petition for exemption from the parts-marking requirements of part
541 either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of part 541. The agency
finds that Suzuki has provided adequate reasons for its belief that the
antitheft device for the MBUSA new vehicle line is likely to be as
effective in reducing and deterring motor vehicle theft as compliance
with the parts-marking requirements of the Theft Prevention Standard
(49 CFR part 541). This conclusion is based on the information MBUSA
provided about its device.
    For the foregoing reasons, the agency hereby grants in full
Suzuki's petition for exemption for the Kizashi vehicle line from the
parts-marking requirements of 49 CFR part 541. The agency notes that 49
CFR part 541, appendix A-1, identifies those lines that are exempted
from the Theft Prevention Standard for a given model year. 49 CFR
543.7(f) contains publication requirements incident to the disposition
of all part 543 petitions. Advanced listing, including the release of
future product nameplates, the beginning model year for which the
petition is granted and a general description of the antitheft device
is necessary in order to notify law enforcement agencies of new vehicle
lines exempted from the parts marking requirements of the Theft
Prevention Standard.
    If Suzuki decides not to use the exemption for this line, it should
formally notify the agency. If such a decision is made, the line must
be fully marked as required by 49 CFR 541.5 and 541.6 (marking of major
component parts and replacement parts).
    NHTSA notes that if Suzuki wishes in the future to modify the
device on which this exemption is based, the company may have to submit
a petition to modify the exemption. Part 543.7(d) states that a part
543 exemption applies only to vehicles that belong to a line exempted
under this part and equipped with the antitheft device on which the
line's exemption is based. Further, Sec.  543.9(c)(2) provides for the
submission of petitions ``to modify an exemption to permit the use of
an antitheft device similar to but differing from the one specified in
that exemption.'' The agency wishes to minimize the administrative
burden that part 543.9(c)(2) could place on exempted vehicle
manufacturers and itself. The agency did not intend in drafting Part
543 to require the submission of a modification petition for every
change to the components or design of an antitheft device. The
significance of many such changes could be de minimis. Therefore, NHTSA
suggests that if the manufacturer contemplates making any changes, the
effects of which might be characterized as de minimis, it should
consult the agency before preparing and submitting a petition to
modify.

    Authority:  49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

    Issued on: January 21, 2011.
Joseph S. Carra,
Acting, Associate Administrator for Rulemaking.
[FR Doc. 2011-1772 Filed 1-26-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: March 25, 2008 (Volume 73, Number 58)]
[Notices]
[Page 15834-15835]
[DOCID:fr25mr08-120]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2008-0052]

Decision that Certain Nonconforming Motor Vehicles are Eligible
for Importation

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Notice of decision by NHTSA that certain nonconforming motor
vehicles are eligible for importation.

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SUMMARY: This document announces decisions by NHTSA that certain motor
vehicles not originally manufactured to comply with all applicable
Federal motor vehicle safety standards (FMVSS) are eligible for
importation into the United States because they are substantially
similar to vehicles originally manufactured for importation into and/or
sale in the United States and certified by their manufacturers as
complying with the safety standards, and they are capable of being
readily altered to conform to the standards or because they have safety
features that comply with, or are capable of being altered to comply
with, all applicable FMVSS.

DATES: These decisions became effective on the dates specified in Annex
A.

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

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and/or sale in the United
States, certified under 49 U.S.C. 30115, and of the same model year as
the model of the motor vehicle to be compared, and is capable of being
readily altered to conform to all applicable FMVSS.
    Where there is no substantially similar U.S.-certified motor
vehicle, 49 U.S.C. 30141(a)(1)(B) permits a nonconforming motor vehicle
to be admitted into the United States if its safety features 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.
    NHTSA received petitions from registered importers to decide
whether the vehicles listed in Annex A to this notice are eligible for
importation into the United States. To afford an opportunity for public
comment, NHTSA published notice of these petitions as specified in
Annex A. The reader is referred to those notices for a thorough
description of the petitions. No substantive comments were received in
response to these notices. Based on its review of the information
submitted by the petitioners, NHTSA has decided to grant the petitions.

Vehicle Eligibility Number for Subject Vehicles

    The importer of a vehicle admissible under any final decision must
indicate on the form HS-7 accompanying entry the appropriate vehicle
eligibility number indicating that the vehicle is eligible for entry.
Vehicle eligibility numbers assigned to vehicles admissible

under this decision are specified in Annex A.

Final Decision

    Accordingly, on the basis of the foregoing, NHTSA hereby decides
that each motor vehicle listed in Annex A to this notice, which was not
originally manufactured to comply with all applicable FMVSS, is either
(1) substantially similar to a motor vehicle manufactured for
importation into and/or sale in the United States, and certified under
49 U.S.C. 30115, as specified in Annex A, and is capable of being
readily altered to conform to all applicable FMVSS or (2) has safety
features that comply with, or are capable of being altered to comply
with, all applicable Federal motor vehicle safety standards.

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

    Issued on: March 19, 2008.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.

Annex A

Nonconforming Motor Vehicles Decided to be Eligible for Importation

1. Docket No. NHTSA-2007-28262

    Nonconforming Vehicles: 2005 Honda CR-V Multipurpose Passenger
Vehicle.
    Substantially Similar U.S. Certified Vehicles: 2005 Honda CR-V
Multipurpose Passenger Vehicle.
    Notice of Petition Published at: 72 FR 30428 (May 31, 2007).
    Vehicle Eligibility Number: VSP-489 (effective date July 11, 2007).

2. Docket No. NHTSA-2007-28261

    Nonconforming Vehicles: 1986-1987 Volkswagen Transporter
Multipurpose Passenger Vehicle.
    Substantially Similar U.S. Certified Vehicles: 1986-1987 Volkswagen
Vanagon Multipurpose Passenger Vehicle.
    Notice of Petition Published at: 72 FR 30424 (May 31, 2007).
    Vehicle Eligibility Number: VSP-490 (effective date July 11, 2007).

3. Docket No. NHTSA-2007-28263

    Nonconforming Vehicles: 2006 Harley Davidson FX, FL, & XL
Motorcycle
    Substantially Similar U.S. Certified Vehicles: 2006 Harley Davidson
FX, FL, & XL Motorcycle.
    Notice of Petition Published at: 72 FR 30425 (May 31, 2007).
    Vehicle Eligibility Number: VSP-491 (effective date July 11, 2007).

4. Docket No. NHTSA-2007-28264

    Nonconforming Vehicles: 2003 Kawasaki VN1500-P1/P2 Motorcycle.
    Substantially Similar U.S. Certified Vehicles: 2003 Kawasaki
VN1500-P1/P2 Motorcycle.
    Notice of Petition Published at: 72 FR 30429 (May 31, 2007).
    Vehicle Eligibility Number: VSP-492 (effective date July 11, 2007).

5. Docket No. NHTSA-2007-28531

    Nonconforming Vehicles: 2004 Hyundai XG350 Passenger Car.
    Substantially Similar U.S. Certified Vehicles: 2004 Hyundai XG350
Passenger Car.
    Notice of Petition Published at: 72 FR 35541 (June 28, 2007).
    Vehicle Eligibility Number: VSP-494 (effective date August 14,
2007).

6. Docket No. NHTSA-2007-0006

    Nonconforming Vehicles: 2000-2001 Moto Guzzi California
Motorcycles.
    Substantially Similar U.S. Certified Vehicles: 2000-2001 Moto Guzzi
California Motorcycles.
    Notice of Petition Published at: 72 FR 59591 (October 22, 2007).
    Vehicle Eligibility Number: VSP-495 (effective date November 28,
2007).

7. Docket No. NHTSA-2007-0005

    Nonconforming Vehicles: 2004-2005 Vespa LX and PX Model
Motorcycles.
    Substantially Similar U.S. Certified Vehicles: 2004-2005 Vespa LX
and PX Model Motorcycles.
    Notice of Petition Published at: 72 FR 59588 (October 22, 2007).
    Vehicle Eligibility Number: VSP-496 (effective date November 28,
2007).

8. Docket No. NHTSA-2007-0004

    Nonconforming Vehicles: 1999-2007 Yamaha Drag Star 1100
Motorcycles.
    Substantially Similar U.S. Certified Vehicles: 1999-2007 Yamaha V
Star 1100 Motorcycles.
    Notice of Petition Published at: 72 FR 59586 (October 22, 2007).
    Vehicle Eligibility Number: VSP-497 (effective date November 28,
2007).

9. Docket No. NHTSA-2007-0007

    Nonconforming Vehicles: 1988 Ducati 851 Motorcycles.
    Substantially Similar U.S. Certified Vehicles: 1988 Ducati 851
Motorcycles.
    Notice of Petition Published at: 72 FR 59584 (October 22, 2007).
    Vehicle Eligibility Number: VSP-498 (effective date November 28,
2007).

10. Docket No. NHTSA-2007-0009

    Nonconforming Vehicles: 2007 Harley Davidson FXSTC Soft Tail Custom
Motorcycles.
    Substantially Similar U.S. Certified Vehicles: 2007 Harley Davidson
FXSTC Soft Tail Custom Motorcycles.
    Notice of Petition Published at: 72 FR 59590 (October 22, 2007).
    Vehicle Eligibility Number: VSP-499 (effective date November 28,
2007).

11. Docket No. NHTSA-2007-0008

    Nonconforming Vehicles: 1993 Ducati 888 Motorcycles.
    Substantially Similar U.S. Certified Vehicles: 1993 Ducati 888
Motorcycles.
    Notice of Petition Published at: 72 FR 59589 (October 22, 2007).
    Vehicle Eligibility Number: VSP-500 (effective date November 28,
2007).

12. Docket No. NHTSA-2007-0036

    Nonconforming Vehicles: 1992 Alfa Romeo Spyder Passenger Cars.
    Substantially Similar U.S. Certified Vehicles: 1992 Alfa Romeo
Spyder Passenger Cars.
    Notice of Petition Published at: 72 FR 65833 (November 23, 2007).
    Vehicle Eligibility Number: VSP-503 (effective date January 16,
2008).

13. Docket No. NHTSA-2007-0021

    Nonconforming Vehicles: 2000-2003 BMW C1 Motorcycles. Because there
are no substantially similar U.S.-certified version 2000-2003 BMW C1
Motorcycles, the petitioner sought import eligibility under 49 U.S.C.
30141(a)(1)(B).
    Notice of Petition Published at: 72 FR 63652 (November 9, 2007).
    Vehicle Eligibility Number: VCP-40 (effective date January 16,
2008).

[FR Doc. E8-6074 Filed 3-24-08; 8:45 am]

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[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Page 60484]
[FR Doc No: 2012-24340]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Form 11-K.
    OMB Control No. 3235-0082, SEC File No. 270-101.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    Form 11-K (17 CFR 249.311) is the annual report designed for use by
employee stock purchase, savings and similar plans to comply with the
reporting requirements under Section 15(d) of the Securities and
Exchange Act of 1934 (the ``Exchange Act'') (15 U.S.C. 78o(d)). Section
15(d) establishes a periodic reporting obligation for every issuer of a
class of securities registered under the Securities Act of 1933 (the
``Securities Act'')(15 U.S.C. 77a et seq.). Form 11-K provides
employees of an issuer with financial information so that they can
assess the performance of the investment vehicle or stock plan. Form
11-K is filed on occasion. The information collected must be filed with
the Commission and is publicly available. Form 11-K takes approximately
30 burden hours per response and is filed by 2,000 respondents for
total of 60,000 burden hours.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, VA 22312 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: September 28, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-24340 Filed 10-2-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 75, Number 250 (Thursday, December 30, 2010)]
[Notices]
[Pages 82381-82382]
[FR Doc No: 2010-32837]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-2436-000]

Oracle Energy Services, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

December 22, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Oracle Energy Services, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR

part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 11, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-32837 Filed 12-29-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74113-74114]
[FR Doc No: 2015-30121]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
    Name of Committee: Vaccines and Related Biological Products
Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 14, 2016, from 1
p.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    For those unable to attend in person, the meeting will also be
webcast and will be available at the following link https://collaboration.fda.gov/vrbpacsem1/.
    Contact Person: Sujata Vijh or Denise Royster, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, at
240-402-7107 and<PHONE_NUMBER> respectively, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously

announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate advisory committee meeting link, or
call the advisory committee information line to learn about possible
modifications before coming to the meeting.
    Agenda: On January 14, 2016, the committee will meet by
teleconference. In open session, the committee will hear updates of the
research program in the Laboratory of Method Development, Division of
Viral Products, Center for Biologics Evaluation and Research, FDA.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: On January 14, 2016, from 1 p.m. to 3:35 p.m., the
meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Written submissions may be made to the contact person on
or before January 7, 2016. Oral presentations from the public will be
scheduled between approximately 2:35 p.m. and 3:35 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
December 29, 2015. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by December 30,
2015.
    Closed Committee Deliberations: On January 14, 2016, from 3:35 p.m.
to 5 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The Committee will discuss the report of
the intramural research program and make recommendations regarding
personnel staffing decisions.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Sujata Vijh at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 20, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-30121 Filed 11-25-15; 8:45 am]
BILLING CODE 4164-01-P