[Federal Register: April 21, 2003 (Volume 68, Number 76)]
[Proposed Rules]
[Page 19471-19472]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ap03-29]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 111 and 112
RIN 0910-AB88
[Docket No. 96N-0417]
Dietary Supplements; Current Good Manufacturing Practice Proposed
Regulation; Notice of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; satellite downlink public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting (via satellite downlink) to discuss the proposed rule on
current good manufacturing practice in manufacturing, packing, or
holding dietary ingredients and dietary supplements that published in
the Federal Register of March 13, 2003. This satellite downlink public
meeting is intended to provide clarification of the proposed rule and
to explain how to submit comments on the proposed rule. This meeting
will provide stakeholders, including small business, an opportunity to
ask questions about the proposed rule by telephone, e-mail, or FAX.
Questions also may be submitted in advance of the satellite downlink
public meeting until the day before the downlink (see FOR FURTHER
INFORMATION CONTACT section of this document).
DATES: The public meeting via satellite downlink will be held on May 9,
2003, from 12:30 p.m. to 3:30 p.m. eastern daylight time.
ADDRESSES: Downlink sites for the public meeting will be Food and Drug
Administration District and Regional Offices for FDA employees. Small
businesses wishing to view the satellite downlink should contact their
Regional Small Business Representative. Regional representatives are
listed at the Office of Regulatory Affairs' Web site at:
http://www.fda.gov/ora/fed_state/Small_business/sb_guide/smbusrep.htm
, or
go to
http://www.fda.gov/ora/fed_state/events/default.htm for a list
of public viewing sites.
State and local counterparts who wish to participate may consider
any local viewing location that has access to a C-band steerable dish.
Viewers with access to a steerable dish capable of receiving a C-
band satellite signal may wish to tune this meeting in themselves.
Tuning coordinates and course materials will be
[[Page 19472]]
placed on the Center for Food Safety and Applied Nutrition (CFSAN) Web
site at: http://www.cfsan.fda.gov/ [tilde]dms/supplmnt.html when
available.
FOR FURTHER INFORMATION CONTACT: Bradford W. Williams, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, telephone: 301-436-
1440, FAX: 301-436-2636, e-mail: Brad.Williams@cfsan.fda.gov for
general questions about the downlink and submission of advance
questions.
SUPPLEMENTARY INFORMATION:
I. Background
The Dietary Supplement Health and Education Act of 1994 (DSHEA)
(Public Law 103-417) amended the Federal Food, Drug, and Cosmetic Act
to, among other things, provide FDA with express statutory authority to
prescribe current good manufacturing practice (CGMP) regulations 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 help ensure that manufacturing, packing, and holding
practices will not result in an adulterated or misbranded dietary
supplement.
This downlink meeting will provide an opportunity to brief
stakeholders on the proposed rule and allow them to ask questions about
the proposed rule. It is also intended to fulfill part of the outreach
requirements of the Small Business Regulatory Enforcement Fairness Act
of 1996. The half-day meeting will focus on information for
manufacturers, both large and small, with an emphasis on assistance to
small firms. Small firms are encouraged to view and participate in this
downlink meeting.
II. Agenda
The agenda will include an overview of the proposed rule with the
following specific topics: (1) Personnel, (2) physical plant, (3)
equipment and utensils, (4) production and process controls, (5)
holding and distribution, (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 also will discuss the types of comments and supporting
information that would be most helpful to the agency in developing a
final rule. Lastly, the meeting will describe how the Small Business
Administration (SBA) can help small firms that might be affected by the
proposed rule.
The primary intended audience is dietary ingredient and dietary
supplement manufacturers, packagers, distributors, and holders,
including small businesses, their representatives and consultants;
Federal, State and local representatives; and FDA small business
representatives and other interested FDA staff. Viewers are encouraged
to watch the satellite program and participate in the question and
answer periods. Any interested parties with access to a satellite dish
may view the downlink directly. For specific technical details,
including tuning coordinates, check the CFSAN Web site at: http://www.cfsan.fda.gov/
[tilde]dms/supplmnt.html under ``Recent
Announcements'' before the meeting.
Before the broadcast, we suggest that interested parties read the
section in the March 13, 2003 (68 FR 12157), proposed rule entitled
``Proposal Highlights and Request for Comments,'' as well as the
background document, fact sheet and the guidance for small businesses
that are located at the CFSAN Web site noted above. In addition, a
promotional flyer and specific technical tuning instructions will be
added to the CFSAN Web site in the near future.
Questions may be submitted in advance of the satellite downlink
public meeting until the day before the meeting (see the FOR FURTHER
INFORMATION CONTACT section of this document).
III. Transcripts
A transcript of the program and all questions/answers will be added
to docket 96N-0417 and may be examined at the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday,
as well as on the CFSAN Web site. 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 3 weeks after the meeting at a cost of 10 cents
per page. In addition, a videotape of the satellite downlink public
meeting will be available for viewing after the broadcast at the FDA
Dockets Management Branch.
IV. Comments
To submit written comments on the proposed rule that published in
the Federal Register of March 13, 2003, please follow the instructions
in the ``Request for Comment'' section of that document (68 FR 12157 at
12248), a copy of which may be found at CFSAN's Web site at: http://www.cfsan.fda.gov/
[tilde]dms/supplmnt.html.
Dated: April 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9660 Filed 4-18-03; 8:45 am]
BILLING CODE 4160-01-S
Satellite Broadcast, May 9, 2003 April 15, 2003