Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Regulatory Program Standards

Federal Register, Volume 85 Issue 5 (Wednesday, January 8, 2020)
[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Pages 907-909]
From the Federal Register Online via the Government Publishing Office []
[FR Doc No: 2020-00073]
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.
SUMMARY: The Food and Drug Administration (FDA) is announcing
[[Page 908]]
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
February 7, 2020.
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 [email protected]. 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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 Control Number 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 (Pub. L. 111-353) 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.
    As set forth in the feed standards, the State program is expected
to review and update its improvement plan on an annual basis. The State
program completes an evaluation of its implementation status at least
every 3 years following the baseline evaluation by reviewing and
updating the self-assessment worksheets and required documentation for
each standard. The evaluation is needed to determine if each standard's
requirements are, or remain, fully met, partially met, or not met. The
State program revises the improvement plan based upon this 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 [email protected].
    In the Federal Register of September 20, 2019 (84 FR 49524), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was submitted but did not
address any of the topics solicited and we therefore do not discuss the
comment here.
    We estimate the burden of this collection of information as
[[Page 909]]
                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
                                                                                         Number of                       Average burden
                         Type of respondent                             Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
State Animal Feed Regulatory Program in the United States..........              34                1               34              569           19,346
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
    Respondents to the information collection are State agencies
seeking to avail themselves of the options described in the document.
State agencies that conduct feed inspections under contract are
interested in implementing the standards. The total estimated annual
recordkeeping burden for implementation is 569 hours per respondent.
The 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 the
AFRPS. The hours per State feed regulatory program will average the
same to account for continual improvement and self-sufficiency in the
program. Our burden estimate reflects a decrease of 100,654 hours as a
result of fewer respondents to the collection and a reevaluation of the
time we ascribe for recordkeeping activities.
    Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00073 Filed 1-7-20; 8:45 am]