[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 [email protected].
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