Memorandums of Understanding: Division of Select Agents and Toxins Center for Disease Control and Prevention

Federal Register: February 19, 2008 (Volume 73, Number 33)

Notices

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From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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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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