[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
