[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 907-909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00073]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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: 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, 
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 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 OP-PRA@fda.hhs.gov.
    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 
follows:

[[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]
 BILLING CODE 4164-01-P


