[Federal Register Volume 68, Number 76 (Monday, April 21, 2003)]
[Proposed Rules]
[Pages 19471-19472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9660]


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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: [email protected] 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