
[Federal Register Volume 78, Number 133 (Thursday, July 11, 2013)]
[Notices]
[Pages 41802-41803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16620]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0115]


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 August 
12, 2013.

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 emailed to oira_submission@omb.eop.gov. 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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.

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

    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 (MFRPS).'' These draft program 
standards are the framework that States should use to design and manage 
its manufactured food program. The implementation of the 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. 
Additionally, 26 States may receive up to $300,000 each year for a 
period of 5 years to be in compliance with the 10 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 which includes 
the following: (1) The individual element of 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.
    In the Federal Register of February 19, 2013 (78 FR 11651), 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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                                                                                         Number of
                             Respondent                                 Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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State Departments of Agriculture or Health.........................              44                1               44              303           13,332
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden has been calculated to 303 hours per respondent. This 
burden was determined by capturing the average amount of time for each 
respondent to assess the current state of the program and work toward 
implementation of each of the 10 standards contained in MFRPS. The 
hours per respondent will remain the same as implementation to account 
for continuing improvement and self-sufficiency in the program.

    Dated: July 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16620 Filed 7-10-13; 8:45 am]
BILLING CODE 4160-01-P


