30-day Federal Register Notice

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Federal Register / Vol. 73, No. 233 / Wednesday, December 3, 2008 / Notices

combination drugs) containing old
antibiotics by December 5, 2008.1 The
draft guidance describes FDA’s current
thinking on the implementation of
section 4(b)(1) of the Q1 Act and
addresses which sponsors of NDAs must
submit patent information to the agency
under section 4(b)(1) of the Q1 Act by
December 5, 2008.
This draft guidance is being issued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The draft guidance, when finalized, will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 agency’s current thinking
on the submission of patent information
under section 4(b)(1) of the Q1 Act. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
http://www.regulations.gov.
III. Paperwork Reduction Act of 1995

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This draft guidance refers to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
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 314.50(h) and
1 Section 4(b)(1) of the Q1 Act requires the
submission of patent information to FDA ‘‘not later
than sixty days after enactment of [the Q1 Act].’’
Sixty days after enactment falls on Sunday,
December 7, 2008. Therefore, to be in compliance
with this provision, sponsors must submit the
patent information on or before the weekday
preceding December 7, 2008, that is, on or before
December 5, 2008.

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314.53 have been approved under OMB
control number 0910–0513.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
http://www.fda.gov/cder/guidance/
index.htm or http://
www.regulations.gov.
Dated: November 26, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–28657 Filed 12–2–08; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences, Special Emphasis
Panel, Large-Scale Collaborative Project
Awards (U54).
Date: December 22, 2008.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892, (Virtual Meeting).
Contact Person: Lisa Dunbar, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12, Bethesda, MD
20892, 301–594–2849, dunbarl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)

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Dated: November 21, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–28509 Filed 12–2–08; 8:45 am]
BILLING CODE 4140–01–M

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice; 30-day notice and
request for comments; Extension,
without change, of a currently approved
collection, OMB Number 1660–0024, No
Form.
AGENCY:

SUMMARY: The Federal Emergency
Management Agency (FEMA) has
submitted the following information
collection to the Office of Management
and Budget (OMB) for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
includes the actual data collection
instruments FEMA will use.

Collection of Information
Title: Federal Assistance for Offsite
Radiological Emergency Planning.
OMB Number: 1660–0024.
Abstract: In accordance with
Executive Order 12657, FEMA will need
certain information from the licensee
(the utility which has applied for or
received a license from the Nuclear
Regulatory Commission (NRC) to
operate a nuclear power plant) in order
to form a decision, based on the advice
of the NRC, as to whether or not a
condition of ‘‘decline or fail’’ exists on
the part of State or local governments
(44 CFR 352.3–4). This information will
be collected by the appropriate FEMA
Regional Office or Headquarters.
Affected Public: Business or other forprofit.
Number of Respondents: 1.
Estimated Time per Respondent: 160
hours.
Estimated Total Annual Burden
Hours: 160 hours.
Frequency of Response: Once.
Comments: Interested persons are
invited to submit written comments on

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Federal Register / Vol. 73, No. 233 / Wednesday, December 3, 2008 / Notices
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to Desk Officer for the Department of
Homeland Security, Federal Emergency
Management Agency, and sent via
electronic mail to
oira.submission@omb.eop.gov or faxed
to (202) 395–6974. Comments must be
submitted on or before January 2, 2009.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Acting Director,
Records Management Division, 500 C
Street, SW., Washington, DC 20472,
Mail Drop Room 301, facsimile number
(202) 646–3347, or e-mail address
FEMA-Information-Collections@dhs.gov.
Lawann Johnson,
Acting Director, Records Management
Division, Office of Management, Federal
Emergency Management Agency, Department
of Homeland Security.
[FR Doc. E8–28688 Filed 12–2–08; 8:45 am]
BILLING CODE 9110–21–P

DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–R5–R–2008–N0204; 50133–1265–
LKUP; S3]

Lake Umbagog National Wildlife
Refuge, Coos County, NH, and Oxford
County, ME
AGENCY:

Fish and Wildlife Service,

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Interior.
ACTION: Notice of availability: Final
comprehensive conservation plan and
environmental impact statement.
SUMMARY: We, the U.S. Fish and
Wildlife Service (Service), announce the
availability for review of our final
comprehensive conservation plan (CCP)
and environmental impact statement
(EIS) for Lake Umbagog National
Wildlife Refuge (NWR). This document
describes how we propose to manage
the refuge for the next 15 years.
DATES: We will sign a record of decision
no sooner than 30 days after the
publication of this notice.
ADDRESSES: You may view or obtain
copies of the final CCP/EIS by any of the
following methods. You may request a
print copy or CD–ROM.
Agency Web Site: Download a copy of
the document(s) at http://
library.fws.gov/ccps.htm.
E-mail: northeastplanning@fws.gov.
Include ‘‘Lake Umbagog Final CCP/EIS’’
in the subject line of your message.

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Mail: P.O. Box 240, Errol, NH 03579–
0240.
In-Person Viewing or Pickup: Call
603–482–3415, ext. 20, to make an
appointment during regular business
hours at Route 16 North, Errol, NH.
FOR FURTHER INFORMATION CONTACT: For
answers to questions about the refuge,
contact Paul Casey, Refuge Manager,
603–482–3415, ext. 20, e-mail:
paul_casey@fws.gov or, for questions
about the planning process, contact
Nancy McGarigal, Natural Resource
Planner, 413–253–8562, e-mail:
northeastplanning@fws.gov. Please
remember to put ‘‘Lake Umbagog NWR
Final CCP/EIS’’ in the subject line of
your message.
SUPPLEMENTARY INFORMATION:
Introduction
Our publishing this notice of
availability facilitates the CCP process
for Lake Umbagog NWR that we started
by publishing a notice of intent in the
Federal Register (67 FR 136; July 16,
2002). For more about the process, see
that notice. We released the draft CCP/
EIS to the public and requested your
comments in a notice of availability in
the Federal Register (72 FR 129; July 6,
2007).
We are announcing the availability of
the final CCP/EIS for Lake Umbagog
NWR, and our preferred actions for
managing it, in accordance with the
National Environmental Policy Act
(NEPA) (40 CFR 1506.6(b)). The
document contains a thorough analysis
of impacts on the human environment.
Our next planning step will be to
complete a Record of Decision no
sooner than 30 days after publication of
this notice (40 CFR 1506.10(b)(2)).
The CCP will guide us in managing
and administering the refuge for the
next 15 years. We propose that
alternative B, the Service-preferred
alternative, serve as the foundation for
the final, stand-alone CCP. We highlight
the modifications we made to
alternative B between the draft and final
CCP/EIS in ‘‘Comments,’’ below.
Our first purchase of land for the
refuge established it in 1992. Its
purposes are to provide long-term
protection for unique wetlands, federaland state-listed threatened or
endangered species, migratory birds of
conservation concern, and regionally
significant concentrations of wildlife.
This 21,650-acre refuge lies in Coos
County, New Hampshire, and Oxford
County, Maine. It contains widely
diverse types of upland and wetland
habitats around the 8,500-acre Umbagog
Lake. Since establishing the refuge, we
have focused primarily on conserving

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land within its approved boundary,
monitoring the occupancy and
productivity of its common loon, bald
eagle, and osprey nesting sites and
protecting them from human
disturbance, conducting baseline
biological inventories, and providing
public opportunities for wildlifedependent recreation.
Background
The CCP Process
The National Wildlife Refuge System
Improvement Act of 1997 (16 U.S.C.
668dd–668ee; Improvement Act), which
amends the National Wildlife Refuge
System Administration Act of 1966,
requires us to develop a CCP for each
national wildlife refuge. The purpose for
developing CCPs is to provide refuge
managers with 15-year plans for
achieving refuge purposes, contributing
toward the mission of the National
Wildlife Refuge System (NWRS), and
conforming to sound principles of fish
and wildlife management, conservation,
legal mandates, and our policies. In
addition to outlining broad management
direction on conserving wildlife and
their habitats, CCPs identify wildlifedependent recreational opportunities
available to the public: Hunting, fishing,
wildlife observation and photography,
and environmental education and
interpretation. We will review and
update the CCP at least once every 15
years, also in accordance with the
Improvement Act.
CCP Alternatives
Our draft CCP/EIS (72 FR 129) and
this final CCP/EIS fully analyze three
alternatives for the future management
of the refuge. During the planning
process, we identified and addressed 18
major issues generated by several
sources: the public, state or federal
agencies, other Service programs, and
our planning team. Both the draft and
final plans identify alternative B as the
Service-preferred alternative.
Comments
We solicited comments on the draft
CCP/EIS for Lake Umbagog refuge for a
45-day period starting on July 6, 2007
(72 FR 129). In response to requests for
additional time, we extended that
comment period another 32 days, until
September 21, 2007. We held five public
hearings and two information sessions
during that time, and received 14,269
responses, both oral and written. We
evaluated all of the written and
electronic correspondence and oral
testimony we received, and responded
to them in final CCP/EIS appendix O,
‘‘Summary of, and the Service’s

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