National Institute of General Medical Sciences; Notice of Closed Meeting, 73660 [E8-28509]
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73660
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draft guidance describes FDA’s current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This draft guidance is being issued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The draft guidance, when finalized, will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
https://www.regulations.gov.
III. Paperwork Reduction Act of 1995
jlentini on PROD1PC65 with NOTICES
This draft guidance refers to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.
VerDate Aug<31>2005
13:59 Dec 02, 2008
Jkt 217001
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
https://www.fda.gov/cder/guidance/
index.htm or https://
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)
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 73, Number 233 (Wednesday, December 3, 2008)]
[Notices]
[Page 73660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28509]
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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)
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
