[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