[Federal Register Volume 68, Number 60 (Friday, March 28, 2003)]
[Proposed Rules]
[Pages 15117-15118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7377]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / 
Proposed Rules  

[[Page 15117]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 111

[Docket No. 96N-0417]


Dietary Supplements; Current Good Manufacturing Practice 
Regulations; Public Meetings

AGENCY: Food and Drug Administration, HHS

ACTION: Notification of public meetings.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing two 
public meetings to discuss the proposed rule entitled ``Current Good 
Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 
Ingredients and Dietary Supplements'' that published in the Federal 
Register of March 13, 2003 (68 FR 12157). These meetings are intended 
to provide clarification of the proposed rule and to explain how to 
submit comments on the proposed rule. These meetings will provide 
stakeholders and interested parties, including small businesses, an 
opportunity to ask questions about the proposed rule.

DATES: The public meetings will be held on the East coast on Wednesday, 
April 29, 2003, from 9 a.m. to 12 noon and 1:30 p.m. to 5 p.m. and on 
the West coast on Monday, May 6, 2003, from 9 a.m. to 12 noon and 1:30 
p.m. to 5 p.m. For security and space limitation reasons, you are 
encouraged to register early. You may preregister via the Internet and 
fax until close-of-business 2 business days before the meeting and 
onsite on the day of the meeting, provided that space is available.

ADDRESSES: East coast meeting: The first public meeting will be held at 
the Center for Food Safety and Applied Nutrition, Harvey W. Wiley 
Auditorium, 5100 Paint Branch Pkwy., College Park, MD 20740.
    West coast meeting: The second public meeting will be held at the 
Ronald V. Dellums Federal Bldg., 3d floor auditorium, North Tower, 1301 
Clay St., Oakland, CA 94612-5213.
    A written transcript of the meeting and submitted comments will be 
available for viewing at the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852, and on the FDA Web site (see III. Electronic Access).

FOR FURTHER INFORMATION CONTACT:
    For the East coast meeting: Kenneth Taylor, Center for Food Safety 
and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1439, FAX: 301-436-
2639, or e-mail: [email protected].
    For the West coast meeting: Janet McDonald, FDA/San Francisco 
District, 1431 Harbor Bay Pkwy., Alameda, CA 94502-7070, 510-337-6845, 
FAX: 510-337-6708, or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In 1994, the Dietary Supplement Health and Education Act (DSHEA) 
amended the Federal Food, Drug, and Cosmetic Act. DSHEA, among other 
things, provided FDA with express statutory authority to prescribe 
current good manufacturing practices (CGMPs) for dietary supplements 
(21 U.S.C. 342(g)). In the Federal Register of March 13, 2003 (68 FR 
12157), FDA published a proposed rule entitled ``Current Good 
Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 
Ingredients and Dietary Supplements'' to establish CGMPs that include 
provisions on manufacturing, packaging, labeling, testing, quality 
control, releasing for distribution, and holding of dietary ingredients 
and dietary supplements. The proposed CGMPs are intended to ensure that 
manufacturing practices will not result in an adulterated dietary 
supplement and that dietary supplements are accurately labeled.
    These public meetings will provide an opportunity to brief 
stakeholders on the proposed rule and allow them to ask questions about 
the proposed rule. They are also intended to fulfill part of the 
outreach requirement of the Small Business Regulatory Enforcement 
Fairness Act of 1996.
    Agenda: The daylong meetings will have two sessions: The morning 
session will target interested parties including both small and large 
firms that manufacture, package, or hold dietary ingredients and 
dietary supplements; and the afternoon session will target small firms. 
Small firms are encouraged to attend both sessions.
    The morning agenda will include an overview of the proposed rule 
and the following specific topics: (1) Personnel, (2) physical plant, 
(3) equipment and utensils, (4) production and process controls, (5) 
holding and distributing, (6) consumer complaints, and (7) 
recordkeeping. In addition to explaining the content of the proposed 
rule, we will instruct participants on the process for submitting 
comments. We will also discuss the types of information that we are 
interested in obtaining, i.e., information that would be relevant to 
developing a final rule and to the economic impact of the rule. Lastly, 
we will describe how the Small Business Administration can help small 
firms that might be affected by the proposed rule.
    The afternoon session will provide small businesses an opportunity 
to ask questions about the proposed rule. They can ask about any 
special implications to small businesses and about any items from the 
morning presentations that need more clarification. We will provide 
information on the process for submitting comments and on the types of 
information that we are interested in obtaining from small businesses, 
i.e., information that would be relevant to developing a final rule and 
to the economic impact of the rule. The session will begin with a short 
presentation on the Federal rulemaking process, including how to 
effectively comment on rules in general and how to address particular 
questions that the Government has requested comment on. Following the 
presentation, participants will be asked to break into smaller groups 
to facilitate open discussion.
    Comments: To submit written comments on the proposed rule, please 
follow the instructions in the ``Request for Comments'' section of that 
document (68 FR 12157, March 13, 2003).

II. Registration

    You may preregister for either meeting via the Internet (see III. 
Electronic Access) or by fax (see FOR FURTHER INFORMATION CONTACT) 
until

[[Page 15118]]

close-of-business April 24, 2003, for the East coast meeting and May 1, 
2003, for the West coast meeting, or you may register onsite on the day 
of the meeting. Registrations will be accepted on a space-available 
basis. If you need special accommodations due to a disability, please 
inform the contact person at least 7 days in advance (see FOR FURTHER 
INFORMATION CONTACT). There is no registration fee for these public 
meetings, but early registration is encouraged because space is limited 
and it will expedite entry into the building and parking area. Because 
the meeting will be held in a Federal building, you should also bring a 
photo ID and plan for adequate time to pass through security screening 
systems. For the West coast meeting, please be aware that the building 
management enforces the rule that no food or drink, including water, is 
allowed in the auditorium.
    Registration Form Instructions: You may register for either meeting 
via the Internet (see III. Electronic Access). You may also register by 
faxing the following registration form to the contact person for the 
meeting that you plan to attend (see FOR FURTHER INFORMATION CONTACT).

 
Registration Formï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
Public Meeting to Discuss the Proposed Rule to Establish CGMP Regulations
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III. Electronic Access

    You may register for either meeting or obtain updates to this 
announcement and additional related information on the Dietary 
Supplements home page at http://www.cfsan.fda.gov/[tilde]dms/
supplmnt.html, scroll down the page to ``Recent Announcements.'' 
Transcripts of the public meetings and submitted comments will be 
available at http://www.cfsan.fda.gov/[tilde]dms/ds-ind.html under 
``Good Manufacturing Practices (GMPS).''

IV. Transcripts

    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 at a cost of 10 cents per page. The transcript 
of the public meetings and submitted comments will be available for 
public examination at the Dockets Management Branch (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday, as well as on the FDA 
Web site (see III. Electronic Access).

    Dated: March 24, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-7377 Filed 3-27-03; 8:45 am]
BILLING CODE 4160-01-S