[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 [email protected].

    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