01-10017. Exchange of Letters Between the Food and Drug Administration and Japan Concerning the Exchange of Certain Information on Pharmaceutical Products

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is providing notice of an exchange of letters between FDA, Department of Health and Human Services, United States of America and the Inspection and Guidance Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health and Welfare, Japan. The parties concluded this exchange of letters on December 27, 2000. These letters express the intentions of the United States and Japan to exchange information on matters useful to preserving the safety, quality, and efficacy of pharmaceutical products in the markets of the United States and Japan.

DATES:

Cooperation under the exchange of letters began December 27, 2000.

FOR FURTHER INFORMATION CONTACT:

Joseph Famulare, Division of Manufacturing and Product Quality (HFD-320), Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 301-827-0590.

SUPPLEMENTARY INFORMATION:

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 exchange of letters.

Dated: April 11, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.