
[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)]
[Notices]
[Pages 53148-53149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19165]


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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 
September 12, 2016.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@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 program standards 
have since been finalized and updated multiple times. The current 
standards are the framework that States should use to design and manage 
their manufactured food programs. The current version expires on 
September 30, 2016, and FDA is proposing to update and submit for 
issuance with a new expiration date. The current and proposed versions 
of the standards are available at the docket number identified in 
brackets at the heading of this document. Persons with access to the 
Internet may submit email requests for a single copy of the draft 
manufactured food standards to OP-ORA@fda.hhs.gov. There are 42 State 
programs enrolled, in which each State may receive up to $300,000 each 
year for a period of 5 years provided there is significant conformance 
with the 10 standards.
    In the first year of implementing the program standards, the State 
program conducts a baseline self-assessment to determine if it meets 
the elements of each standard. The State program should use the 
worksheets and forms contained in the draft program standards; however, 
it can use alternate forms that are equivalent. The State program 
maintains the documents and verifies 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 improvement plan that includes the following: (1) The 
individual program 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.
    In the Federal Register of February 12, 2016 (81 FR 7544), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received two comments. However, these 
comments did not address the information collection.
    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.........................              42                1               42              376           15,792
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 53149]]

    The burden has been calculated as 376 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 change as accounted for in the continuing 
improvement and self-sufficiency of the program.

    Dated: August 8, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation and Analysis.
[FR Doc. 2016-19165 Filed 8-10-16; 8:45 am]
 BILLING CODE 4164-01-P


