[Federal Register Volume 60, Number 59 (Tuesday, March 28, 1995)]
[Notices]
[Pages 15934-15935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7740]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Industry and Consumer Exchange Meeting Concerning FDA and APHIS 
Activities on a Potential Agreement With the European Union Related to 
Human and Animal Drug and Biological Product Information; Notice of 
Public Meeting

AGENCIES: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) and Animal and Plant 
Health Inspection Service (APHIS) are cosponsoring a public meeting 
with all persons interested in a potential agreement with the European 
Union that would facilitate the harmonization of good manufacturing 
practices (GMP's) and quality controls for human and animal drug and 
biological products and associated compliance and enforcement 
activities, and provide for the exchange and use of such information by 
the respective regulatory authorities. Such an agreement would enhance 
the goals of harmonizing the monitoring and enforcement standards of 
the GMP's and would facilitate international trade.

DATES: The industry and consumer exchange meeting will be held on 
Friday, March 31, 1995, 9 a.m. to 12 m.

ADDRESSES: The industry and consumer exchange meeting will be held at 
the Hubert H. Humphrey Bldg., Humphrey Auditorium, 200 Independence 
Ave. SW., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Walter M. Batts, Office of Health 
Affairs (HFY-50), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-4480 (Fax 301-443-0235).
    Those persons interested in attending this meeting should Fax their 
registration, including name, firm, or organization name, address, and 
telephone number to Nathaniel L. Geary, Office of External Affairs, 
Food and Drug Administration (301-443-5153) or telephone 301-443-6776. 
There is no registration fee, but advance registration is requested. 
Additionally, if there are any individuals that wish to make a 
presentation at this meeting, advance notice is required.
SUPPLEMENTARY INFORMATION: The purpose of the public meeting is to 
provide information concerning FDA and APHIS activities with the 
European Union related to human and animal drug and biological product 
GMP's and quality controls, as well as to provide an opportunity to 
hear and address concerns from persons involved in these industries and 
persons representing consumer and other interests. [[Page 15935]] 
    FDA and APHIS have been participating in bilateral Mutual 
Recognition Agreement talks. These talks are being led by the Office of 
the U.S. Trade Representative and the Department of Commerce and by 
representatives of the European Union. FDA and APHIS will meet with 
representatives from the European Union and its Member States from 
April 3 to April 5, 1995, in Brussels, Belgium to exchange information 
on their respective programs. During the Brussels meeting, U.S. 
industry will have the opportunity to present its experience with U.S. 
and European GMP and quality control programs.

    Dated: March 24, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-7740 Filed 3-24-95; 3:14 pm]
BILLING CODE 4160-01-F