[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]]

_______________________________________________________________________

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.

-----------------------------------------------------------------------

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/
<difference>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