[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Notices]
[Pages 17284-17285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-5222]


Agency Information Collection Activities; Submission for OMB 
Review; 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 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 May 
1, 2000.

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: 
Wendy Taylor, Desk Officer for FDA.

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: 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 No. 0910-0342--Extension)

    Section 409 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 348) establishes a premarket approval requirement for ``food 
additives;'' section 201(s) of that act (21 U.S.C. 321(s)) 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

[[Page 17285]]

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 December 17, 1999 (64 FR 70714 at 
70715), the agency requested comments on the proposed collections of 
information. No significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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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 Burden \1\
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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)(1)(v)\2\                     50               1              50              15             750
570.36(c)(1)(v)\2\                     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.
\2\ Due to a clerical error, the CFR cites that appeared in table 2 of the Federal Registerof December 17, 1999
  (64 FR 70714) were incorrect. Table 2 of this document contains the correct CFR cite.

    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: March 24, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-7933 Filed 3-30-00; 8:45 am]
BILLING CODE 4160-01-F