[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11651-11652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03707]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0115]
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
[[Page 11652]]
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 ``Manufactured
Food Regulatory Program Standards.''
DATES: Submit either electronic or written comments on the collection
of information by April 22, 2013.
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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850, 301-796-7726, [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
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 need to meet the
program element or documentation requirement of the standard; and (3)
projected completion dates for each task.
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: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03707 Filed 2-15-13; 8:45 am]
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