[Federal Register Volume 64, Number 242 (Friday, December 17, 1999)]
[Notices]
[Pages 70714-70715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-5222]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Notice of a Claim for GRAS Exemption Based on a GRAS 
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 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 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 comments on the collection of information by 
February 15, 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 information collection, 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 No. 0910-0342--Extension)

    Section 409 of the act (21 U.S.C. 348) establishes a premarket 
approval requirement for ``food additives;'' section 201(s) of that act 
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:

[[Page 70715]]



                                  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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170.36                                 50               1              50             150           7,500
570.36                                 10               1              10             150           1,500
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 Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency of    Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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170.36(c)(v)                           50               1              50              15             750
570.36(c)(v)                           10               1              10              15             150
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 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; between January 1, 1999, and November 
30, 1999, FDA received 23 notices. 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: November 10, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-32681 Filed 12-16-99; 8:45 am]
BILLING CODE 4160-01-F