[Federal Register: March 28, 2003 (Volume 68, Number 60)]
[Proposed Rules]
[Page 15117-15118]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr03-20]
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Proposed Rules
Federal Register
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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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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.
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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: Kenneth.Taylor@cfsan.fda.gov. 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: Janet.McDonald@fda.gov.
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 Form¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
Public Meeting to Discuss the Proposed Rule to Establish CGMP Regulations
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Name: .................................... ....................................
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Title: .................................... ....................................
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Company: .................................... ....................................
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Address: .................................... ....................................
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Telephone: .................................... ....................................
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Fax: .................................... ....................................
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E-mail: .................................... ....................................
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Please indicate the type of organization that you represent.
------ Industry ------ Government ------ Consumer Organization
------ Media ------ Healthcare Professional ------ Law Firm
------ Education Organization ------ Other (specify) -------------- ....................................
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.................................... ....................................
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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