
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89947-89949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29839]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0764]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Feed 
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 January 
12, 2017.

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:

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202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0760. 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.

Animal Feed Regulatory Program Standards--OMB 0910-0760--Extension

I. Background

    In the United States, Federal and State Government Agencies ensure 
the safety of animal feed. FDA is responsible for ensuring that all 
food and feed moving in interstate commerce, except those under the 
U.S. Department of Agriculture jurisdiction, are safe, wholesome, and 
labeled properly. States are responsible for conducting inspections and 
regulatory activities that help ensure food and feed produced, 
processed, and distributed within their jurisdictions are safe and in 
compliance with State laws and regulations. States primarily perform 
inspections under their own regulatory authority. Some States conduct 
inspections of feed facilities under contract with FDA. Because 
jurisdictions may overlap, FDA and States collaborate and share 
resources to protect animal feed.
    The FDA Food Safety Modernization Act passed on January 4, 2011, 
calls for enhanced partnerships and provides a legal mandate for 
developing an Integrated Food Safety System (IFSS). FDA is committed to 
implementing an IFSS thereby optimizing coordination of food and feed 
safety efforts with Federal, State, local, tribal, and territorial 
regulatory and public health Agencies. Model standards provide a 
consistent, underlying foundation that is critical for uniformity 
across State and Federal Agencies to ensure credibility of food and 
feed programs within the IFSS.

II. Significance of Feed Program Standards

    The Animal Feed Regulatory Program Standards (AFRPS) provide a 
uniform and consistent approach to feed regulation in the United 
States. Implementation of the draft feed program standards is 
voluntary. States implementing the standards will identify and maintain 
program improvements that will strengthen the safety and integrity of 
the U.S. animal feed supply.
    The feed standards are the framework that each State should use to 
design, manage, and improve its feed program. The standards include the 
following: (1) Regulatory foundation; (2) training; (3) inspection 
program; (4) auditing; (5) feed-related illness or death and emergency 
response; (6) enforcement program; (7) outreach activities; (8) budget 
and planning; (9) assessment and improvement; (10) laboratory services; 
and (11) sampling program.
    Each standard has a purpose statement, requirement summary, 
description of program elements, projected outcomes, and a list of 
required documentation. When a State program voluntarily agrees to 
implement the feed standards, it must fully implement and maintain the 
individual program elements and documentation requirements in each 
standard in order to fully implement the standard.
    The feed standards package includes forms, worksheets, and 
templates to help the State program assess and meet the program 
elements in the standard. State programs are not obligated to use the 
forms, worksheets, and templates provided with the feed standards. 
Other manual or automated forms, worksheets, and templates may be used 
as long as the pertinent data elements are present. Records and other 
documents specified in the feed standards must be maintained in good 
order by the State program and must be available to verify the 
implementation of each standard. The feed standards are not intended to 
address the performance appraisal processes that a State Agency may use 
to evaluate individual employee performance.
    In the first year of implementation, the State program uses the 
self-assessment worksheets to determine if the requirements for each 
standard are fully met, partially met, or not met. The self-assessments 
are used to develop an improvement plan for fully implementing the 
requirements of the 11 standards. Second and third-year assessments 
will provide progress evaluation.
    Although FDA plans to provide financial support to State programs 
that implement the feed standards, funding opportunities are contingent 
upon the availability of funds. Funding opportunities may be only 
available to State feed regulatory programs that currently have an FDA 
feed inspection contract. State programs receiving financial support to 
implement the feed standards will be audited by FDA.

III. Electronic Access

    Persons with access to the Internet may submit requests for a 
single copy of the current feed standards from OP-PRA@fda.hhs.gov. 
Please note that due to editorial revisions and public comments, the 
final standards may differ from the copy you receive.
    In the Federal Register of April 12, 2016 (81 FR 21578), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment. However, this 
comment did not address the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                        Type of  respondent                             Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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State Employee.....................................................              40                1               40            3,000          120,000
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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 3,000 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 11 standards contained in AFRPS. FDA 
recognizes that full use and implementation of the feed standards by 
State feed programs will occur over many years and the number of years 
to

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fully implement the feed standards will vary among States.

    Dated: December 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29839 Filed 12-12-16; 8:45 am]
 BILLING CODE 4164-01-P


