[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49524-49526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995

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(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of 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 FDA's Animal Feed Regulatory Program 
Standards (AFRPS).

DATES: Submit either electronic or written comments on the collection 
of information by November 19, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 19, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0764 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Animal Feed Regulatory Program 
Standard.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila 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: 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.

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

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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 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.
    We estimate 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 animal feed regulatory Program in the United States.......               34                 1               34               569           19,346
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\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. 
States 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 eleven 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: September 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20352 Filed 9-19-19; 8:45 am]
BILLING CODE 4164-01-P


