[Federal Register Volume 64, Number 207 (Wednesday, October 27, 1999)]
[Rules and Regulations]
[Pages 57776-57777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27973]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 26
[Docket No. 98S-1064]
Mutual Recognition of Pharmaceutical Good Manufacturing Practices
Annex; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Announcement of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss the progress of implementing the Mutual Recognition
Agreement (MRA) Pharmaceutical Good Manufacturing Practices (GMP's)
Annex between the United States and the European Community (EC). FDA is
inviting interested persons, including industry, trade, and consumer
groups.
DATES: The meeting will be held on Wednesday, December 8, 1999, from 9
a.m. to 1 p.m. Registration and requests to make an oral presentation
should be received by Monday, November 22, 1999.
ADDRESSES: The meeting will be held in the Center for Drug Evaluation
and Research Advisory Committee Conference Room, 5630 Fishers Lane,
Rockville, MD 20857. To register and request time for an oral
presentation, send or fax written material to the listed contact
person.
FOR FURTHER INFORMATION CONTACT: Charles A. Gaylord, Office of
International and Constituent Relations (HFG-1), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0909,
FAX 301-443-0235.
SUPPLEMENTARY INFORMATION:
I. Background
Regulations implementing the MRA were published as a final rule in
the Federal Register of November 6, 1998 (63 FR 60122). In the preamble
to the final rule, FDA stated that it plans to hold periodic meetings
with interested parties and make public summaries of key meetings held
with its EU counterparts concerning implementation of the MRA (63 FR
60122 and 60127). The regulations were codified in part 26 (21 CFR part
26). FDA established Docket No. 98S-1064 to share public information
concerning the implementation of part 26 (64 FR 11376, March 9, 1999).
FDA has and
[[Page 57777]]
will continue to make information concerning the implementation of the
MRA and part 26 available to the public on FDA's web site at http://
www.fda.gov/oia/homepage.htm (International section).
II. The Public Meeting
The December 8, 1999, meeting is the first public meeting FDA has
held on the Pharmaceutical GMP's Annex to the MRA since the final rule
published. The purpose of the meeting is to provide information
concerning FDA activities related to the implementation of the MRA
Pharmaceutical GMP's Annex (covering human and animal drug and human
biological products) and to provide an opportunity to hear comments and
address concerns from interested members of the public.
The meeting agenda will include: (1) FDA presentations with a
summary of the progress made in the implementation of the
Pharmaceutical GMP's Annex; discussion of the two-way alert system;
public access to information; the process used to determine the
equivalence of the regulatory systems for pharmaceutical GMP's and work
plan, (2) outside presentations, and (3) panel discussion; question and
answer session.
When submitting a request for time for an oral presentation at the
meeting, please indicate your topic, provide a presentation outline,
and identify any presentation needs (an overhead projector, slide
projector, etc.). Time allowed for accepted presenters will depend on
the number of presentation requests. Registration information
(including name, title, firm name, address, telephone, and fax number)
and requests for presentation (including topic and outline) should be
submitted to the listed contact person by November 22, 1999. Space is
limited, therefore, interested parties are encouraged to register
early. Special accommodations due to disability should be submitted at
least 7 days in advance.
Transcripts of the meeting may be requested in writing from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15
working days after the meeting at a cost of 10 cents per page.
Dated: October 19, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-27973 Filed 10-26-99; 8:45 am]
BILLING CODE 4160-01-F
