Memorandum of Understanding Between the Food and Drug Administration and the National Library of Medicine, 56720-56723 [05-19340]
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56720
Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Notices
BILLING CODE 4160–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA 225–05–3000]
Memorandum of Understanding
Between the Food and Drug
Administration and the National
Library of Medicine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
SUMMARY:
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16:02 Sep 27, 2005
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understanding (MOU) between the Food
and Drug Administration and the
National Library of Medicine (NLM).
The purpose of this MOU is to assign
responsibilities to FDA’s Center for Drug
Evaluation and Research (CDER) and
NLM for the distribution of product
labeling.
DATES: The agreement became effective
July 6, 2005, and supplements the
agreement signed and dated November
21, 2001, and December 3, 2001, by
NLM and CDER representatives,
respectively.
FOR FURTHER INFORMATION CONTACT:
For FDA: Lisa Stockbridge, Food and
Drug Administration (HFD–140),
5600 Fishers Lane, Rockville, MD
20857, 301–827–7761; or Catherine
Miller, Food and Drug
Administration (HFD–140), 5600
PO 00000
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Fishers Lane, Rockville, MD 20857,
301–827–7772.
For NLM: Simon Liu, Bldg. 38A, rm.
2N221, 8600 Rockville Pike,
Bethesda, MD 20894, 301–402–
1698; or Stuart Nelson, Bldg. 38A,
rm. B2E17, 8600 Rockville Pike,
Bethesda, MD 20894, 301–496–
1495.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOU’s between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: September 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
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Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Notices
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Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Notices
BILLING CODE 4160–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders and Genetic Diseases in
Newborns and Children; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Heritable
Disorders and Genetic Diseases in Newborns
and Children (ACHDGDNC).
Dates and Times: October 20, 2005, 9 a.m.
to 5 p.m.; October 21, 2005, 9 a.m. to 3 p.m.
Place: Ronald Reagan Building and
International Trade Center, 1300
Pennsylvania Avenue, NW., Washington, DC
20004.
Status: The meeting will be open to the
public with attendance limited to space
availability.
Purpose: The Advisory Committee
provides advice and recommendations
concerning the grants and projects authorized
under the Heritable Disorders Program and
technical information to develop policies and
priorities for this program. The Heritable
Disorders Program was established to
enhance the ability of State and local health
agencies to provide for newborn and child
screening, counseling and health care
services for newborns and children having or
at risk for heritable disorders. The Committee
was established specifically to advise and
guide the Secretary regarding the most
appropriate application of universal newborn
screening tests, technologies, policies,
guidelines and programs for effectively
reducing morbidity and mortality in
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newborns and children having or at risk for
heritable disorders.
Agenda: The first day will be devoted to
presentations on and a discussion of the
decision-making methodology of the
Committee and an update of the current
status of State specific issues. The second
day will include meetings and reports from
the Committee’s subcommittees on laboratory
standards and procedures, follow-up and
treatment and education and training.
Proposed agenda items are subject to
change.
Public Comments: Time will be provided
each day for public comment. Individuals
who wish to provide public comment or who
plan to attend the meeting and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
ACHDGDNC Executive Secretary, Michele A.
Lloyd-Puryear, M.D., Ph.D. (contact
information provided below).
Contact Person: Anyone interested in
obtaining a roster of members or other
relevant information should write or contact
Michele A. Lloyd-Puryear, M.D., Ph.D.,
Maternal and Child Health Bureau, Health
Resources and Services Administration,
Room 18A–19, Parklawn Building, 5600
Fishers Lane, Rockville, Maryland 20857,
Telephone (301) 443–1080. Information on
the Advisory Committee is available at https://
mchb.hrsa.gov/programs/genetics/committee.
Dated: September 20, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–19295 Filed 9–27–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Director’s Council of Public
Representatives.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Director’s Council of
Public Representatives.
Date: October 25, 2005.
Time: 8:30 a.m. to 3 p.m.
Agenda: Among the topics proposed for
discussion are: (1) NIH Director’s update; (2)
COPR workgroup reports; (3) public
perspective on the NIH Roadmap; (4) updates
on the NIH Re-authorization and the Office
of Portfolio Analysis and Strategic Initiatives;
(5) NIH response to COPR’s Public Trust
Report; and (6) discussion and public
comment.
Place: National Institutes of Health,
Building 31, Conference Room 6, 9000
Rockville Pike, Bethesda, MD 20892.
Contact Person: Jennifer E. Gorman Vetter,
NIH Public Liaison/COPR Coordinator, Office
of Communications and Public Liaison,
Office of the Director, National Institutes of
Health, 9000 Rockville Pike, Building 1,
Room 344, Bethesda, MD 20892. (301) 435–
4448. gormanj@od.nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
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56723
]]>Agencies
[Federal Register Volume 70, Number 187 (Wednesday, September 28, 2005)]
[Notices]
[Pages 56720-56723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19340]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA 225-05-3000]
Memorandum of Understanding Between the Food and Drug
Administration and the National Library of Medicine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between the Food and Drug
Administration and the National Library of Medicine (NLM). The purpose
of this MOU is to assign responsibilities to FDA's Center for Drug
Evaluation and Research (CDER) and NLM for the distribution of product
labeling.
DATES: The agreement became effective July 6, 2005, and supplements the
agreement signed and dated November 21, 2001, and December 3, 2001, by
NLM and CDER representatives, respectively.
FOR FURTHER INFORMATION CONTACT:
For FDA: Lisa Stockbridge, Food and Drug Administration (HFD-140),
5600 Fishers Lane, Rockville, MD 20857, 301-827-7761; or Catherine
Miller, Food and Drug Administration (HFD-140), 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7772.
For NLM: Simon Liu, Bldg. 38A, rm. 2N221, 8600 Rockville Pike,
Bethesda, MD 20894, 301-402-1698; or Stuart Nelson, Bldg. 38A, rm.
B2E17, 8600 Rockville Pike, Bethesda, MD 20894, 301-496-1495.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and MOU's between FDA and others
shall be published in the Federal Register, the agency is publishing
notice of this MOU.
Dated: September 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 05-19340 Filed 9-27-05; 8:45 am]
BILLING CODE 4160-01-C
