[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21578-21579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08331]



[[Page 21578]]

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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 
(the 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 June 13, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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):Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Animal Feed Regulatory Program Standards.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 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

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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 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 [email protected]. 
Please note that due to editorial revisions and public comments, the 
final standards may differ from the copy you receive.
    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 fully implement the feed standards will vary among States.

    Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08331 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P