[Federal Register Volume 65, Number 251 (Friday, December 29, 2000)]
[Notices]
[Pages 83063-83068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33216]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cooperative Arrangement Between the United States Food and Drug 
Administration and Therapeutic Goods Administration, Republic of 
Australia Regarding the Exchange of Information on Current Good 
Manufacturing Practice Inspections of Human Pharmaceutical Facilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
cooperative arrangement between the Food and Drug Administration, 
Department of Health and Human Services, United States of America and 
the Therapeutic Goods Administration, Department of Health and Aged 
Care, Commonwealth of Australia. The purpose of the arrangement is to 
enable each administration to obtain information that will enable it to 
make its own independent facility and/or product regulatory decisions 
in the assessment of current good manufacturing practices compliance, 
public health protection, and approval of new drugs. It also will 
facilitate more efficient use of resources for each organization in 
meeting their statutory requirements without reduction of public safety 
or regulatory responsibilities.

DATES: The arrangement became effective October 11, 2000.

FOR FURTHER INFORMATION CONTACT: Merton V. Smith, Office of 
International Programs, International Agreements Staff (HFG-1), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-0910.

SUPPLEMENTARY INFORMATION: This cooperative arrangement is subject to 
FDA's regulations in 21 CFR 20.108 for cooperative agreements. 
Therefore, in accordance with 21 CFR 20.108(c), which states that all 
written agreements and memoranda of understanding between FDA and 
others shall be published in the Federal Register, the agency is 
publishing notice of this written arrangement.

    Dated: December 20, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.

    The arrangement is set forth in its entirety as follows:

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[FR Doc. 00-33216 Filed 12-28-00; 8:45 am]
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