[Federal Register Volume 64, Number 117 (Friday, June 18, 1999)]
[Notices]
[Pages 32880-32881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1174]


Dietary Supplements; Center for Food Safety and Applied Nutrition 
Strategy; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a second 
public meeting to solicit comments that will assist the Center for Food 
Safety and Applied Nutrition (CFSAN) to develop an overall strategy for 
achieving effective regulation of dietary supplements under the Dietary 
Supplement Health and Education Act (DSHEA). This meeting is intended 
to give the public an opportunity to comment on the development of the 
strategy.

DATES: The public meeting will be held on July 20, 1999, from 9 a.m. to 
5 p.m. Submit written comments by August 20, 1999.

ADDRESSES: The public meeting will be held at the Oakland Federal 
Bldg., third fl. auditorium, north tower, 1301 Clay St., Oakland, CA.

FOR FURTHER INFORMATION CONTACT: Janet B. McDonald, Office of 
Regulatory Affairs (HFR-PA-145), Food and Drug Administration, 1431 
Harbor Bay Pkwy., Alameda, CA 94502-7070, 510-337-6845, FAX 510-337-
6708, ``e-mail [email protected].''

SUPPLEMENTARY INFORMATION:

 I. Introduction

     This public meeting is the second of two meetings to seek 
stakeholder comments on the development of an overall strategy for 
achieving effective regulation of dietary supplements under the Federal 
Food, Drug, and Cosmetic Act, as amended by DSHEA. The first meeting 
was held on June 8, 1999, in Washington, DC. These two meetings build 
upon themes that emerged from a broader stakeholder meeting sponsored 
by CFSAN in June 1998. That meeting addressed the nonfood safety 
initiative programs that are managed by CFSAN and identified some basic 
themes including: (1) The need to maintain a credible FDA program, 
including compliance, enforcement, and consumer outreach activities 
that will help ensure consumer confidence in FDA regulated products; 
(2) the need to maintain a solid, science based program staffed with 
highly qualified scientists; and (3) the recognition that FDA's 
assistance to consumers and the regulated industry is important.

 II. Registration and Requests for Oral Presentations

     If you would like to attend the public meeting, you must register 
with the contact person (address above) by July 9, 1999, by providing 
your: Name, title, business affiliation, address, telephone, and fax 
number. To expedite processing, registration information may also be 
faxed to 510-337-6708. If you need special accommodations due to 
disability, please inform the contact person when you register.
     If you wish to make an oral presentation during the meeting, you 
must inform the contact person of that desire when you register to 
attend and submit: (1) A brief written statement of the general nature 
of the evidence or arguments that you wish to present, (2) the names 
and addresses of the persons who will give the presentation, and (3) 
the approximate length of time that you are requesting for your 
presentation. Depending on the number of people who register to make 
presentations, we may have to limit the time allotted for each 
presentation.

[[Page 32881]]

 III. CFSAN's 1999 Program Priorities Document

     The meeting announced in this notice, as well as the meeting that 
took place on June 8, 1999, in Washington, DC, are in response to 
CFSAN's 1999 Program Priorities document that calls for the development 
of an overall dietary supplement strategy in conjunction with other 
agency units and stakeholders. A copy of the priorities document is 
available on the Internet on FDA's Website at ``http://
vm.cfsan.fda.gov/dms/cfsan199.html''.
     The priorities document states that the overall strategy should 
address all elements of the dietary supplement program including: (1) 
Boundaries between dietary supplements and conventional foods, between 
dietary supplements and drugs, and between dietary supplements and 
cosmetic products; (2) claims; (3) good manufacturing practices; (4) 
adverse event reporting; (5) laboratory capability; (6) research needs; 
(7) enforcement; and (8) resource needs. FDA's objective in developing 
this strategy is to ensure consumer access to safe dietary supplements 
that are truthfully and not misleadingly labeled. FDA intends to 
develop this strategy by following a process of openness, flexibility, 
efficiency, and commitment to public health.
     FDA has identified four criteria for priority ranking the tasks 
encompassed in the strategy. These criteria are: (1) Enhancement of 
consumer safety, (2) development of health-related product labeling 
regulation, (3) improvement in efficiency of operation, and (4) closure 
on unresolved regulatory issues.
     This meeting also addresses activity undertaken by the agency to 
solicit comments in accordance with section 406(b) of the Food and Drug 
Administration Modernization Act of 1997 (Pub. L. 105-115) (21 U.S.C. 
393(b)).

 IV. Agenda and Goals

     To help focus comments for the July 20, 1999, meeting, FDA 
requests that oral and written input regarding an overall strategy for 
achieving effective regulation of dietary supplements address the 
following questions:
     1. In addition to ensuring consumer access to safe dietary 
supplements that are truthfully and not misleadingly labeled, are there 
other objectives that an overall dietary supplement strategy should 
include?
     2. Are the criteria for prioritizing the tasks within the 
supplement strategy appropriate? Which specific tasks should FDA 
undertake first?
     3. What factors should FDA consider in determining how best to 
implement a task (i.e., use of regulations, guidance, etc.)?
     4. What tasks should be included under the various dietary 
supplement program elements in the CFSAN 1999 Program Priorities 
document?
     5. Are there current safety, labeling, or other marketplace issues 
that FDA should address quickly through enforcement actions to ensure, 
for example, that consumers have confidence that the products on the 
market are safe, truthfull, and not misleadingly labeled?
     6. Toward what type or area of research on dietary supplements 
should FDA allocate its research resources?
     7. Given FDA's limited resources, what mechanisms are available, 
or should be developed, to leverage FDA's resources to meet effectively 
the objective of the strategy?

 V. Comments

     Interested persons may, on or before August 20, 1999, submit 
written comments to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
You may also send comments to the Dockets Management Branch via e-mail 
to ``FDA D[email protected]'' or via the FDA Website ``http://
www.fda.gov''. You should annotate and organize your comments to 
identify the specific issues to which they refer. You must submit two 
copies of comments, identified with the docket number found in brackets 
in the heading of this document, except that you may submit one copy if 
you are an individual. You may review received comments in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

 VI. Transcripts

     You may request transcripts of the meeting in writing 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. You may 
also examine the transcript of the meeting at the Dockets Management 
Branch (address above) between 9 a.m. and 4 p.m., Monday through 
Friday, as well as on the FDA Website ``http://www.fda.gov''.``http://
vm.cfsan.fda.gov/dms/cfsan199.html''.

    Dated: June 11, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-15476 Filed 6-17-99; 8:45 am]
BILLING CODE 4160-01-F