[Federal Register Volume 65, Number 186 (Monday, September 25, 2000)]
[Notices]
[Pages 57616-57617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1359]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Affirmation of Generally Recognized as Safe 
(GRAS) Status

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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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.

DATES:  Submit written comments on the collection of information by 
October 25, 2000.

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: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:  Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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

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

    Under the 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 that 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 definition 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 through 
either scientific procedures or common use in food. 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 regulations 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, 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.
    In the Federal Register of July 5, 2000 (65 FR 41472), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 57617]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         Number of       Annual frequency      Total annual       Hours per
  21 CFR section        respondents        per response          responses        response        Total hours
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      170.35(c)(1)          1                   1                   1           2,614            2,614
                                                                                 (average)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that it may receive one GRAS petition annually. 
Although the burden varies with the type, size, and complexity of the 
petition submitted, GRAS petitions may involve analytical work, 
analysis of appropriate toxicological studies, and the work of drafting 
the petition itself. Since 1980, FDA has not received any petitions for 
affirmation of GRAS status under 21 CFR part 186--Indirect Food 
Substances Affirmed As Generally Recognized As Safe. Section 184.1(a) 
(21 CFR 184.1(a)) affirms the use of those substances affirmed as GRAS 
in 21 CFR part 184--Direct Food Substances Affirmed As Generally 
Recognized As Safe, for use as indirect food ingredients.

    Dated: September 19, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24479 Filed 9-22-00; 8:45 am]
BILLING CODE 4160-01-F