[Federal Register Volume 75, Number 41 (Wednesday, March 3, 2010)]
[Notices]
[Page 9605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4340]



[[Page 9605]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
2, 2010.

ADDRESSES:  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: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0601. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

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.

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 
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.
    In the Federal Register of December 2, 2009 (74 FR 63154), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. 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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     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: February 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4340 Filed 3-2-10; 8:45 am]
BILLING CODE 4160-01-S