Memorandum of Understanding Between the Division of Select Agents and Toxins Center for Disease Control and Prevention and the Food and Drug Administration, 9122-9126 [08-686]
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Federal Register / Vol. 73, No. 33 / Tuesday, February 19, 2008 / Notices
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: February 11, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. 08–697 Filed 2–15–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA No. 225–08–8002]
Memorandum of Understanding
Between the Division of Select Agents
and Toxins Center for Disease Control
and Prevention and the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
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HHS.
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ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
the Division of Select Agents and
Toxins (DSAT) of the Centers for
Disease Control and Prevention (CDC).
The purpose of this MOU is to establish
a procedure to allow CDC/DSAT to
confirm that FDA has accepted or
approved, under the authority of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq), an Investigational
New Drug application (IND), a request
to establish an Investigational New
Animal Drug file (INAD), or an
Investigational Device Exemption
application (IDE) for a clinical trial
involving the use of an investigational
product that is, bears, or contains a
select agent or toxin.
FOR FURTHER INFORMATION CONTACT:
Jarilyn Dupont, Director of Regulatory
Policy, Office of Policy and Planning
(HF–11), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–5906.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: February 8, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
The agreement became effective
January 25, 2008.
DATES:
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]]>Agencies
[Federal Register Volume 73, Number 33 (Tuesday, February 19, 2008)]
[Notices]
[Pages 9122-9126]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-686]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA No. 225-08-8002]
Memorandum of Understanding Between the Division of Select Agents
and Toxins Center for Disease Control and Prevention and the Food and
Drug Administration
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 FDA and the Division of
Select Agents and Toxins (DSAT) of the Centers for Disease Control and
Prevention (CDC). The purpose of this MOU is to establish a procedure
to allow CDC/DSAT to confirm that FDA has accepted or approved, under
the authority of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq), an Investigational New Drug application (IND), a request
to establish an Investigational New Animal Drug file (INAD), or an
Investigational Device Exemption application (IDE) for a clinical trial
involving the use of an investigational product that is, bears, or
contains a select agent or toxin.
DATES: The agreement became effective January 25, 2008.
FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Director of Regulatory
Policy, Office of Policy and Planning (HF-11), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5906.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and MOUs between FDA and others
shall be published in the Federal Register, the agency is publishing
notice of this MOU.
Dated: February 8, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 08-686 Filed 2-15-08; 8:45 am]
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