[Federal Register Volume 74, Number 230 (Wednesday, December 2, 2009)]
[Notices]
[Pages 63154-63155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0554]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Manufactured Food Regulatory Program Standards

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 the Manufactured Food 
Regulatory Program Standards.

DATES: Submit written or electronic comments on the collection of 
information by February 1, 2010.

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: Daniel Gittleson, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-5156, 
[email protected].

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.

Manufactured Food Regulatory Program Standards--(OMB Control Number 
0910-0601--Extension)

I. Background

    In the Federal Register of July 20, 2006 (71 FR 41221), FDA 
announced the availability of a draft document entitled ``Manufactured 
Food Regulatory Program Standards.'' These draft program standards are 
the framework that States should use to design and manage its 
manufactured food program. The implementation of the program standards 
will be negotiated as an option for payment under the State food 
contract. States that are awarded this option will receive up to 
$25,000 over a period of 5 years to fully implement the program 
standards.
    In the first year of implementing the program standards, the State 
program conducts a baseline self-assessment to determine if they meet 
the elements of each standard. The State program should use the 
worksheets and forms contained herein; however it can use alternate 
forms that are equivalent. The State program maintains the documents 
and verifying records required for each standard. The information 
contained in the documents must be current and fit-for-use. If the 
State program fails to meet all program elements and documentation 
requirements of a standard, it develops a strategic plan to fully 
implement the program standards in 5 years. The strategic plan includes 
the following: (1) The individual element or documentation requirement

[[Page 63155]]

of the standard that was not met, (2) improvements needed to meet the 
program element or documentation requirement of the standard, and (3) 
projected completion dates for each task.

II. Electronic Access

    Persons with access to the Internet may obtain the draft program 
standards at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125448.pdf.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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     No. of        Annual Frequency
  Respondents        per Response      Total Annual  Responses    Hours per  Response          Total Hours
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44                                  1                       44                       40                    1,760
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                        Table 2.--Estimated First-Year Baseline Self-Assessment Burden\1\
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     No. of       Five-Year Frequency      Total First-Year
  Respondents        per Response             Responses           Hours  per Response          Total Hours
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17                                  1                       17                      200                    3,400
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: November 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28834 Filed 12-1-09; 8:45 am]
BILLING CODE 4160-01-S