[Federal Register Volume 63, Number 112 (Thursday, June 11, 1998)]
[Notices]
[Page 32102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15483]
[[Page 32101]]
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Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
Guidance for Industry: Notification of a Health Claim or Nutrient
Content Claim Based on an Authoritative Statement of a Scientific Body
and Agency Emergency Processing Request Under OMB Review; Notices
Federal Register / Vol. 63, No. 112 / Thursday, June 11, 1998 /
Notices
[[Page 32102]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0389]
Guidance for Industry: Notification of a Health Claim or Nutrient
Content Claim Based on an Authoritative Statement of a Scientific Body;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry:
Notification of a Health Claim or Nutrient Content Claim Based on an
Authoritative Statement of a Scientific Body.'' The guidance is
intended to provide information regarding the submission of
notifications of health claims or nutrient content claims based on
authoritative statements of scientific bodies. This action is in
response to provisions of the FDA Modernization Act of 1997 (FDAMA).
DATES: Written comments on agency guidance documents may be submitted
at any time.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Guidance for Industry: Notification of a Health Claim or
Nutrient Content Claim Based on an Authoritative Statement of a
Scientific Body'' to the Office of Food Labeling (HFS-150), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C
St. SW., Washington, DC 20204. Send one self-addressed adhesive label
to assist that office in processing your request or include a fax
number to which the guidance may be sent. Alternatively, you may fax
your request to 202-205-5494. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance. Submit written comments on this
guidance to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Constance B. Henry, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance entitled ``Guidance for Industry: Notification of a Health
Claim or Nutrient Content Claim Based on an Authoritative Statement of
a Scientific Body.''
The agency has adopted good guidance practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). The guidance entitled ``Guidance for Industry: Notification of a
Health Claim or Nutrient Content Claim Based on an Authoritative
Statement of a Scientific Body'' is issued as a level 1 guidance
consistent with GGP's. It may be utilized upon issuance because it is
needed to help effect the implementation of the new statutory
provisions of FDAMA.
This guidance document represents the agency's current thinking on
the submission of notifications under sections 303 and 304 of FDAMA
(new section 403(r)(3)(C) and (r)(2)(G) of the Federal Food, Drug, and
Cosmetic Act). It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute, regulations, or both.
Interested persons may, at any time, submit written comments on the
guidance to the Dockets Management Branch (address above). Two copies
of any comments are to be submitted, except that individuals may submit
one copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The guidance and received
comments may be seen in the office above between 9 a.m. and 4 p.m.,
Monday through Friday.
This guidance document contains a collection of information that
requires clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995. In a notice published elsewhere in
this issue of the Federal Register, FDA is announcing that this
collection of information has been submitted to OMB for emergency
processing. The notice also solicits comments on the collection of
information.
An electronic version of the guidance entitled ``Guidance for
Industry: Notification of a Health Claim or Nutrient Content Claim
Based on an Authoritative Statement of a Scientific Body'' is also
available on the Internet at ``http://www.cfsan.fda.gov/
dms/guidance.html''.
Dated: June 5, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15483 Filed 6-10-98; 8:45 am]
BILLING CODE 4160-01-F