[Federal Register Volume 66, Number 79 (Tuesday, April 24, 2001)]
[Notices]
[Pages 20665-20670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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.

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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.

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[FR Doc. 01-10017 Filed 4-23-01; 8:45 am]
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