[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Notices]
[Page 51287-51288]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc09-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0465]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Additive Petitions
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 collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on food additive petitions
regarding animal feed.
DATES: Submit written or electronic comments on the collection of
information by December 7, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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: Denver Presley Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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 collection of information,
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 these topics: (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.
Food Additive Petitions--21 CFR Part 571 (OMB Control Number 0910-
0546)--Extension
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 seek to explain the
requirements and provide a standard format for submission of petitions,
that when implemented, will speed up the time for processing. Labeling
requirements for food additives intended for animal consumption are
also set forth in various regulations contained in 21 CFR parts 573,
582, and 584. 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.
FDA estimates the burden of this collection of information as
follows:
[[Page 51288]]
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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571.1(c) moderate category 1 1 1 3,000 3,000
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571.1(c) complex category 1 1 1 10,000 10,000
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571.6 amendment of petition 2 2 4 1,300 5,200
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Total Hours 18,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA derived the annual reporting burden estimate for the different
categories as follows:
Section 571.1(c)--moderate category: For food additive petition
without complex chemistry, manufacturing, efficacy, or safety issues,
the estimated time requirement per petition is approximately 3,000
hours. An average of 1 (one) petitions of this type is received on an
annual basis, resulting in a burden of 3,000 hours.
Section 571.1(c)--complex category: For a food additive petition
with complex chemistry, manufacturing, efficacy, and/or safety issues,
the estimated time requirement per petition is approximately 10,000
hours. An average of 1 (one) petition of this type is received on an
annual basis, resulting in a burden of 10,000 hours.
Section 571.6: For a food additive petition amendment, the
estimated time requirement per petition is approximately 1,300 hours.
An average of 4 (four) petitions of this type is received on an annual
basis, resulting in a burden of 5,200 hours.
Thus, the estimated total annual burden for this information
collection is 18,200 hours.
Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24047 Filed 10-05-09; 8:45 am]
BILLING CODE 4160-01-S