[Federal Register Volume 68, Number 22 (Monday, February 3, 2003)]
[Notices]
[Pages 5294-5295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0454]


Agency Information Collection Activities; Submission for OMB 
Review; 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 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 
March 5, 2003.

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: 
Stuart Shapiro, Desk Officer for FDA.

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

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 generally recognized as safe (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.
    In the Federal Register of October 31, 2002 (67 FR 66404), the 
agency requested comments on the proposed collection of information. No 
comments were received that pertained to this collection of 
information.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                     Annual
                                                         No. of    Frequency    Total Annual      Hours    Total
                   21 CFR Section                     Respondents     per     [chyph]Responses     per     Hours
                                                                    Response                    Response
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170.36                                                      50           1            50           150    7,500
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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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                                                          Annual
        21 CFR Section                 No. of          Frequency of   Total Annual        Hours per        Total
                                [chyph]Recordkeepers  Recordkeeping  [chyph]Records  [chyph]Recordkeeper   Hours
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170.36(c)(v)                              50                  1             50                 15           750
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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.


[[Page 5295]]

    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 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: January 28, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-2458 Filed 1-31-03; 8:45 am]
BILLING CODE 4160-01-S