[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]


=======================================================================
-----------------------------------------------------------------------

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.

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

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                                       
----------------------------------------------------------------------------------------------------------------
                                                         Annual                                                 
           21 CFR Section                No. of       Frequency per   Total Annual    Hours per     Total Hours 
                                       Respondents      Response        Responses      Response                 
----------------------------------------------------------------------------------------------------------------
170.35(c)(1)                               5               1               5         2614 (avg.)   13,070       
----------------------------------------------------------------------------------------------------------------
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