[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Page 38994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16937]



[[Page 38994]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0414]


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 9, 2019.

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 Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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 document entitled ``Manufactured Food 
Regulatory Program Standards.'' These program standards are the 
framework that States should use to design and manage their 
manufactured food programs. There are 43 State programs enrolled, which 
receive an average of $230,000 (maximum of $300,000) each year for a 
period of 5 years from the year they first enroll, provided there is 
significant conformance with and/or maintenance of 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. FDA suggests that the State program 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 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 April 17, 2019 (84 FR 16020), 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.........................              43                1               43              569           24,467
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                             Respondent                                 Number of       records per      Total annual          per         Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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State Departments of Agriculture or Health.........................              43               10              430               40           17,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    One additional State has enrolled in the program since 2016. The 
total estimated burden of this collection has increased to 41,667 hours 
among 43 respondents, from a previous total of 15,792 hours among 42 
respondents. This increase is due to a change in the self-reported 
response times provided by the respondents. Because this is a long-term 
program, we believe this change is the result of more precise 
documentation by participating agencies as they have grown more 
experienced over time.

    Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16937 Filed 8-7-19; 8:45 am]
 BILLING CODE 4164-01-P


