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.

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.

The arrangement is set forth in its entirety as follows: