[Federal Register: June 18, 1999 (Volume 64, Number 117)]
[Notices]
[Page 32880-32881]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn99-77]
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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 jmcdonal@ora.fda.gov.''
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/<difference>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 Dockets@bangate.fda.gov'' 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
June 8, 1999 Meeting Presentation