[Federal Register Volume 62, Number 90 (Friday, May 9, 1997)]
[Notices]
[Pages 25632-25633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12256]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0158]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 25633]]

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by June 
9, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Petitions for Affirmation of Generally Recognized As Safe (GRAS) 
Status--21 CFR 170.35(c)(1)--(OMB Control Number 0910-0132--
Reinstatement)

    Under authority of sections 201, 402, 409, and 701 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321, 342, 348, and 
371), FDA reviews petitions for affirmation as GRAS which are submitted 
on a voluntary basis by the food industry and other interested parties. 
Under section 409 of the act, the agency has the authority to regulate 
food additives. Section 201(s) of the act defines ``food additive'' and 
expressly excludes from the definitions substances GRAS for use in 
food.
    Specifically under section 201(s) of the act, a substance is GRAS 
if it is generally recognized among experts qualified by scientific 
training and experience to evaluate its safety, to be safe either 
through scientific procedures or through common use in food before 
1958. The act has historically been interpreted to permit food 
manufacturers to make their own determination that use of a substance 
in food is GRAS. To implement the GRAS provisions of the act, FDA has 
issued procedural regulations under Sec. 170.35(c)(1) (21 CFR 
170.35(c)(1)). These regulations establish a process by which a person 
may obtain FDA concurrence with a GRAS determination; this concurrence 
is referred to as ``GRAS affirmation.'' These regulation set forth the 
information to be submitted to FDA to obtain agency concurrence that a 
substance is GRAS (Sec. 170.35(c)(1)).
    GRAS petitions are reviewed by FDA to ascertain whether the 
available data establish that the intended use of the substance is GRAS 
based upon either a history of the safe use of the substance before 
1958, or upon widely available safety data (scientific procedures). The 
GRAS affirmation process is a voluntary one, and there is some risk 
that FDA may not agree with the petitioner's GRAS determination. The 
GRAS petition process does provide a public procedure for coordinating 
GRAS determinations. The process reduces the potential for public 
health problems when substances are marketed based upon unwarranted 
safety determinations and allows a food manufacturer to rely on the 
lawful status of a substance that has been affirmed by FDA as GRAS.
    FDA estimates the burden of this collection of information as 
follows:

                                        Estimated Annual Reporting Burden                                       
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                           No. of       Annual Frequency    Total Annual                                        
   21 CFR Section        Respondents      per Response        Responses      Hours per Response    Total Hours  
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170.35(c)(1)........         5                 1                 5             2,614 (average)     13,070       
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There are no capital costs or operating and maintenance costs associated with this collection.                  


    Dated: May 2, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-12256 Filed 5-8-97; 8:45 am]
BILLING CODE 4160-01-F