[Federal Register: December 17, 1999 (Volume 64, Number 242)]
[Notices]
[Page 70714-70715]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de99-78]
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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