[Federal Register Volume 67, Number 211 (Thursday, October 31, 2002)]
[Notices]
[Pages 66404-66406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27741]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0454]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Notice of a Claim for Generally Recognized as Safe 
Exemption Based on a Generally Recognized as Safe Determination

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

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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 collection of information, and to allow 60 days for 
public comment in response to the notice. This notice solicits comments 
on the procedures used for submitting a generally recognized as safe 
(GRAS) notice stating that a particular use of a substance is not 
subject to the premarket approval requirements of the Federal Food, 
Drug, and Cosmetic Act (the act).

DATES: Submit written or electronic comments on the collection of 
information by December 30, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
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 Robbins, 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.

 Notice of a Claim for GRAS Exemption Based on a GRAS Determination 
(OMB Control Number 0910-0342)--Extension

    Description: Section 409 of the act (21 U.S.C. 348) establishes a 
premarket approval requirement for ``food additives;'' section 201(s) 
of the act (21 U.S.C. 321) provides an exemption from the definition of 
``food additive'' and thus from the premarket approval requirement, for 
uses of substances that are GRAS by qualified experts. FDA is proposing 
a voluntary procedure whereby members of the food industry who 
determine that use of a substance satisfies the statutory exemption may 
notify FDA of that determination. The notice would include a detailed 
summary of the data and information that support the GRAS 
determination, and the notifier would maintain a record of such data 
and information. FDA would make the information describing the GRAS 
claim, and the agency's response to the notice, available in a publicly 
accessible file; the entire GRAS notice would be publicly available 
consistent with the Freedom of Information Act and other Federal 
disclosure statutes.
    Description of Respondents: Manufacturers of Substances Used in 
Food and Feed.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                               Annual Frequency      Total Annual
                   21 CFR Section                       No. of Respondents      per Response           Responses      Hours per Response    Total Hours
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170.36                                                        50                     1                   50                 150             7,500
570.36                                                        10                     1                   10                 150             1,500
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Total...................................................................................................................................    9,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden \1\
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                                                              No. of         Annual Frequency of      Total Annual         Hours per
                   21 CFR Section                         Recordkeepers         Recordkeeping           Records          Recordkeeper       Total Hours
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170.36(c)(v)                                                  50                     1                   50                  15               750
570.36(c)(v)                                                  10                     1                   10                  15               150
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Total...................................................................................................................................      900
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting requirement is for a proposed rule (62 FR 18937, 
April 17, 1997) that has not yet been issued as a final rule. In 
developing the proposed rule, FDA solicited input from representatives 
of the food industry on the reporting requirements, but could not fully 
discuss with those representatives the details of the proposed 
notification procedure. FDA received no comments on the agency's 
estimate of the hourly reporting requirements, and thus has no basis to 
revise that estimate at this time. During 1998, FDA received 12 notices 
that were

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submitted under the terms of the proposed rule. FDA received 23 notices 
in 1999, 30 notices in 2000, and 28 notices in 2001. To date, the 
number of annual notices is less than FDA's estimate; however, the 
number of annual notices could increase when the proposed rule becomes 
final.

    Dated: October 25, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-27741 Filed 10-30-02; 8:45 am]
BILLING CODE 4160-01-S