[Federal Register Volume 64, Number 117 (Friday, June 18, 1999)]
[Proposed Rules]
[Pages 32830-32831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15475]
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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 Meeting
Agency: Food and Drug Administration, HHS.
Action: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting 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's)
regulations for dietary supplements may have on small businesses in the
dietary supplement industry. This meeting is 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 meeting will be held on Monday, July 12, 1999, from 7
p.m. to 9 p.m. You must register by July 7, 1999. You may submit
written comments until August 12, 1999.
ADDRESSES: The public meeting will be held at the Flamingo Hotel, The
Carson City II Room, 3555 Las Vegas Blvd., Las Vegas, NV. 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.
If you would like to attend the public meeting, you should register
by July 7, 1999, by faxing or e-mailing your name, title, firm name,
address, and telephone number to Peter Vardon (address above).
There is no registration fee for this public meeting, but early
registration is suggested because space may be limited.
SUPPLEMENTARY INFORMATION: This public meeting will provide an
opportunity for an open discussion of the manufacturing practices of
small businesses in the dietary supplement industry. The meeting is
intended to be one of a series intended to give all interested parties
an opportunity to comment on the economic effects of a possible
proposed regulation on CGMP's in the dietary supplement industry. This
public meeting is also intended to fulfill part of the outreach
requirement of 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)
lab 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.
[[Page 32831]]
FDA encourages individuals or firms with relevant data or
information to present such information at the meeting or in written
comments to the record.
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: June 11, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-15475 Filed 6-17-99; 8:45 am]
BILLING CODE 4160-01-F
