[Federal Register Volume 64, Number 171 (Friday, September 3, 1999)]
[Proposed Rules]
[Page 48336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23008]
[[Page 48336]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 111
[Docket No. 96N-0417]
Dietary Supplements; Center for Food Safety and Applied
Nutrition; Public Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Announcement of public meetings.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing two
public meetings to solicit comments that will assist the Center for
Food Safety and Applied Nutrition (CFSAN) to understand the economic
impact that any proposal to establish current good manufacturing
practices (CGMP) regulations for dietary supplements may have on small
businesses in the dietary supplement industry. These meetings are
intended to give interested persons, including small businesses, an
opportunity to comment on the economic impact that such a proposal may
have on small businesses.
DATES: The public meetings will be held on Tuesday, September 28, 1999,
from 1 p.m. to 5 p.m. and Thursday, October 21, 1999, from 7 p.m. to 10
p.m. You should register at least 5 days prior to the meeting you will
attend. You may submit written comments until November 21, 1999.
ADDRESSES: The public meeting on September 28, 1999, will be held at
the Marriott Hotel, 75 South West Temple, Wasatch Room, Salt Lake City,
UT 84101. The public meeting on October 21, 1999, will be held at the
Holiday Inn-Inner Harbor, 301 West Lombard St., Baltimore, MD 21201.
Submit written comments to the Dockets Management Branch (HFA-305),
Docket No. 96N-0417, Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Two copies of any comments are to be
submitted, except that individuals may submit one copy.
FOR FURTHER INFORMATION CONTACT: Peter J. Vardon, Center for Food
Safety and Applied Nutrition (HFS-726), Food and Drug Administration,
330 C St. SW., Washington, DC 20204, 202-205-5329, FAX 202-260-0794, or
e-mail pvardon@bangate.fda.gov.
SUPPLEMENTARY INFORMATION: These public meetings will provide an
opportunity for an open discussion of the manufacturing practices of
small businesses in the dietary supplement industry. These meetings are
intended to provide interested parties an opportunity to comment on the
economic effects of a possible proposed regulation on CGMP's in the
dietary supplement industry. These public meetings are also intended to
fulfill part of the outreach requirement of the Small Business
Regulatory Enforcement Fairness Act of 1996. The agenda will include
topics regarding the small business entities' manufacturing practices
and standard operating procedures for: (1) Personnel; (2) buildings and
facilities; (3) equipment; (4) laboratory operations; (5) production
and process controls; and (6) warehousing, distribution and post-
distribution of raw, intermediate and final products. The meeting will
also include a discussion about the verification of the identity,
purity, and composition of dietary supplements and dietary supplement
ingredients.
If you would like to attend a public meeting, you should register
at least 5 days prior to the meeting by faxing or e-mailing your name,
title, firm name, address, and telephone number to Peter J. Vardon
(address above). FDA encourages individuals or firms with relevant data
or information to present such information at the meeting or in written
comments to the record. If you would like to request to speak at these
meetings, you may notify Peter J. Vardon (address above) when you
register. There is no registration fee for these public meetings, but
early registration is suggested because space may be limited.
You may request a transcript of the public meeting 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. The transcript of the public meeting and
submitted comments will be available for public examination at the
Dockets Management Branch (address above) between 9 a.m. and 4 p. m.,
Monday through Friday.
Dated: August 27, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-23008 Filed 8-31-99; 11:38 am]
BILLING CODE 4160-01-F
