[Federal Register: June 4, 2004 (Volume 69, Number 108)]
[Notices]
[Page 31617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04jn04-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0481]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Additive
Petitions
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 (the PRA).
DATES: Fax written comments on the collection of information by July 6,
2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
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.
Food Additive Petitions--21 CFR Part 571
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 348 (a)), provides that a food additive shall be deemed
to be unsafe unless its use is permitted by a regulation which
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by regulation for investigational use. Section
409(b) of the act specifies the information that must be submitted by a
petition in order to establish the safety of a food additive and to
secure the issuance of a regulation permitting its use.
To implement the provision of section 409 of the act, procedural
regulations have been issued under part 571 (21 CFR part 571). These
procedural regulations are designed to specify more thoroughly the
information that must be submitted to meet the requirement set down in
broader terms by the law. The regulations add no substantive
requirements to those indicated in the law, but attempt to explain the
requirements and provide a standard format for submission to speed the
processing of the petition. Labeling requirements for food additives
intended for animal consumption are also set forth in various
regulations contained in 21 CFR parts 572, 573, and 580. The labeling
regulations are considered by FDA to be cross referenced to Sec.
571.1, which is the subject of this same OMB clearance for food
additive petitions.
In the Federal Register of November 12, 2003 (68 FR 64110), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No 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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Number of Total Annual Hours per Total
21 CFR Section Respondents Annual Frequency Per Response Responses Response Hours
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571.1(c) moderate 1 1 1 1,800 1,800
category
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571.1(c) complex 1 1 1 6,000 6,000
category
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571.6 2 2 4 1,300 5,200
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Total 4 4 6 9,100 13,000
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\1\ There are no capital costs or operating and maintenence costs associated with this collection of
information.
Dated: May 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12686 Filed 6-3-04; 8:45 am]
BILLING CODE 4160-01-S