[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Notices]
[Pages 67835-67836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32551]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0458]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Extension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995,
Federal agencies are required to publish notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on requirements relating to the affirmation of
generally recognized as safe (GRAS) substances.
DATES: Submit written comments on the collection of information by
February 24, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
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: Under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval
from the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information
listed below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Affirmation of Generally Recognized As Safe (GRAS) Status (21 CFR
170.35(c)(1))--(OMB Control Number 0910-0132)--Extension
Under authority of sections 201, 402, 409, and 701 of 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 (21 U.S.C.
348), the agency has the authority to regulate food additives. Section
201(s) of the act (21 U.S.C. 321(s)), defines ``food additive'' and
expressly excludes from the definition substances generally recognized
as safe 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). 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
[[Page 67836]]
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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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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170.35(c)(1) 5 1 5 2614 (avg.) 13,070
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There are no capital costs or operating and maintenance costs associated with this collection.
This estimate is based on the number of GRAS affirmation petitions
received in 1995. Although the burden varies with the type, size, and
complexity of the petition submitted, GRAS petitions may involve
analytical work and analysis of appropriate toxicological studies, as
well as 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: December 13, 1996.
William K. Hubbard.
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32551 Filed 12-23-96; 8:45 am]
BILLING CODE 4160-01-F
