Document ID: FDA-2008-N-0043-0003
Agency: fda
Document Type: Notice
Title: Memorandum of Understanding Between the Division of Select Agents and Toxins Center for Disease Control and Prevention and the Food and Drug Administration
Posted Date: 2008-02-19T05:00Z

[Federal Register: February 19, 2008 (Volume 73, Number 33)]
[Notices]               
[Page 9122-9126]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe08-59]                         

-----------------------------------------------------------------------

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.
BILLING CODE 4160-01-S

[[Page 9123]]

[GRAPHIC] [TIFF OMITTED] TN19FE08.000

[[Page 9124]]

[GRAPHIC] [TIFF OMITTED] TN19FE08.001

[[Page 9125]]

[GRAPHIC] [TIFF OMITTED] TN19FE08.002

[[Page 9126]]

[GRAPHIC] [TIFF OMITTED] TN19FE08.003

[FR Doc. 08-686 Filed 2-15-08; 8:45 am]

BILLING CODE 4160-01-C