[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Notices]
[Pages 41472-41473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16812]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1359]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for reporting and recordkeeping, general and specific 
requirements, and availability of sample electronic product for 
manufacturers and distributors of electronic products.

[[Page 41473]]


DATES: Submit written comments on the collection of information by 
September 5, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: Under 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 set forth in this document.
    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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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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)                        1               1               1         2,614 (average)      2,614
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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: June 27, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-16812 Filed 7-3-00; 8:45 am]
BILLING CODE 4160-01-F