NOTICES: Government-Owned Inventions; Availability for Licensing,
Published: 2008-09-08
The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies
NOTICES: American Health Information Community,
Published: 2008-09-08
This notice announces the meeting date for the 24th meeting of
the American Health Information Community in accordance with the
Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.) The
American Health Information Community will advise the Secretary and
recommend specific actions to achieve a common interoperability
framework for health
NOTICES: National Institute of Child Health and Human Development,
Published: 2008-09-08
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
NOTICES: National Institute of Child Health and Human Development,
Published: 2008-09-08
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
NOTICES: National Institute of Child Health and Human Development,
Published: 2008-09-08
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 contract proposals and the discussions
NOTICES: National Institute on Deafness and Other Communication Disorders,
Published: 2008-09-08
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
NOTICES: Live, Attenuated Virus Vaccines Against RSV, PIV, and hMPV,
Published: 2008-09-08
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH),
Department of Health and Human Services, is contemplating the grant of
worldwide exclusive license to practice the invention embodied in: RSV Technologies
(1) U.S. Patents 5,993,824 (issued November 30, 1999) and
NOTICES: RoC Expert Panels Recommendation on Listing Status for Styrene in the 12th RoC and the Scientific Justification for the Recommendation,
Published: 2008-09-08
The RoC Office invites public comment on the recommendation
from an expert panel on the listing status for styrene in the 12th RoC
and the scientific justification for the recommendation. The
recommendation and scientific justification for styrene is available
electronically in Part B of the Expert Panel Report (
RULES: Amendments to Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals,
Published: 2008-09-08
The Food and Drug Administration (FDA) is amending certain of
its regulations on current good manufacturing practice (CGMP)
requirements for finished pharmaceuticals as the culmination of the
first phase of an incremental approach to modifying the CGMP
regulations for these products. This rule revises CGMP requirements
primarily concerning aseptic
RULES: Restrictions on African Rodents, Pairie Dogs, and Certain Other Animals,
Published: 2008-09-08
The Food and Drug Administration (FDA) is removing its
regulation that established restrictions on the capture, transport,
sale, barter, exchange, distribution, and release of African rodents,
prairie dogs, and certain other animals. We are removing the
restrictions because we believe they are no longer needed to prevent
the further introduction,
NOTICES: FDA Clinical Trial Requirements Regulations, Compliance, and Good Clinical Practice Conference; Public Workshop,
Published: 2008-09-08
The Food and Drug Administration (FDA) Dallas District, in
cooperation with the Society of Clinical Research Associates(SoCRA), is
announcing a workshop on FDA Clinical Trial statutory and regulatory
requirements. This 2day workshop for the clinical research community
targets sponsors, monitors, clinical investigators, institutional
review boards,
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-09-08
In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), the National
Institutes of Health (NIH) will publish periodic summaries of proposed
projects to be
NOTICES: Simulations for Drug Related Science Education,
Published: 2008-09-08
Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below. This proposed information
collection was
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-09-05
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-09-05
NOTICES: National Center for Complementary & Alternative Medicine,
Published: 2008-09-05
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 meetings.
The meetings 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
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-09-05
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Gamma-hydroxybutyric acid; Ketamine; Dextromethorphan; N-benzylpiperazine; 1-(3-trifluoromethylphenyl)piperazine; etc.,
Published: 2008-09-05
The Food and Drug Administration (FDA) is requesting comments
concerning abuse potential, actual abuse, medical usefulness,
trafficking, and impact of scheduling changes on availability for
medical use of 10 drug substances. These comments will be considered in
preparing the United States' response to the World Health Organization
(WHO) regarding
NOTICES: Peripheral and Central Nervous System Drugs Advisory Committee,
Published: 2008-09-05
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Peripheral and Central Nervous System Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's
NOTICES: Product-Specific Bioequivalence Recommendations; Publication of Guidances for Industry,
Published: 2008-09-05
The Food and Drug Administration (FDA) is announcing the
availability of additional draft and revised draft productspecific
bioequivalence (BE) recommendations. The recommendations provide
productspecific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
May 31, 2007 (72 FR
NOTICES: Science Board to the Food and Drug Administration; Request for Nominations,
Published: 2008-09-05
The Food and Drug Administration (FDA) is requesting nominations to serve on the Science Board to the FDA (Science Board).
[[Page 51831]]
FDA has special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees and, therefore, encourages nominations qualified
NOTICES: National Institute of Dental and Craniofacial Research,
Published: 2008-09-04
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
NOTICES: National Institute on Alcohol Abuse and Alcoholism,
Published: 2008-09-04
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
NOTICES: Center for Scientific Review,
Published: 2008-09-04
Notice is hereby given of a change in the meeting of the Social
Psychology, Personality and Interpersonal Processes Study Section,
October 6, 2008, 8 a.m. to October 6, 2008, 5 p.m., Admiral Fell Inn,
888 South Broadway, Baltimore, MD, 21231 which was published in the Federal Register on August 21, 2008, 73 FR 4946549467.
The meeting will
NOTICES: Center for Scientific Review,
Published: 2008-09-04
Notice is hereby given of a change in the meeting of the
Macromolecular Structure and Function B Study Section, October 6, 2008,
8 a.m. to October 7, 2008, 6 p.m., Melrose Hotel, 2430 Pennsylvania
Avenue, NW., Washington, DC, 20037 which was published in the Federal Register on August 21, 2008, 73 FR 4946549467.
The meeting will be held one