[Federal Register: February 3, 2003 (Volume 68, Number 22)]
[Notices]
[Page 5294-5295]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe03-56]
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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