
[Federal Register Volume 78, Number 132 (Wednesday, July 10, 2013)]
[Notices]
[Pages 41401-41403]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16517]


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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; Draft Animal Feed Regulatory Program Standards; 
Availability

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection associated with 
the draft Animal Feed Regulatory Program Standards (AFRPS). The draft 
feed standards are neither final nor intended for implementation at 
this time.

DATES: Submit either electronic or written comments on the collection 
of information by September 9, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document. Submit 
written requests for single copies of the draft feed standards to the 
U.S. Food and Drug Administration, Office of Regulatory Affairs, Office 
of Partnerships, 12420 Parklawn Dr., ELEM-3033, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist the office in 
processing your request, or fax your request to 301-827-3588. See the 
SUPPLEMENTARY INFORMATION section for an electronic copy of the draft 
feed standards.

FOR FURTHER INFORMATION CONTACT: With regard to the information 
collection:

Ila S. Mizrachi, Office of Information Management, Food and Drug 
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,

[[Page 41402]]

301-796-7726, Ila.Mizachi@fda.hhs.gov.
    With regard to the draft feed program standards:
Beverly Kent, Office of Partnerships, Food and Drug Administration, 
716-714-9503, Beverly.kent@fda.hhs.gov; or
Jenny Murphy, Center for Veterinary Medicine, Food and Drug 
Administration, 240-453-6845, Jenny.murphy@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 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.

Draft Animal Feed Regulatory Program Standards--(OMB Control Number 
0910-New)

I. Background

    In the United States, Federal and State government Agencies ensure 
the safety of animal feed. FDA is responsible for ensuring that all 
foods and feeds 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.
    At this time, model regulatory program standards exist for human 
food, but do not exist for animal feed. The draft feed standards are a 
major step in a long-term process of collaboration to achieve 
uniformity and consistency in feed safety across the nation while 
acknowledging State responsibilities and authorities.

II. Significance of Feed Program Standards

    The AFRPS provide a uniform and consistent approach to feed 
regulation in the United States. Implementation of the feed program 
standards would be 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.
    Description: These draft feed standards are the framework that each 
State should use to design, manage, and improve its feed program. 
Eleven standards describing regulatory foundation, training, inspection 
program, auditing, feed-related illness or death and emergency 
response, enforcement program, outreach activities, budget and 
planning, laboratory services, sampling program, and assessment and 
improvement of standard implementation are the basis for the draft feed 
standards.
    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 draft 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 State 
program must fully implement the 11 standards to achieve full 
implementation of the AFRPS. These program standards are not intended 
to address the performance appraisal processes that a State agency may 
use to evaluate individual employee performance.
    The standards have 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 draft 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 standards must be maintained in good order by the 
State program and must be available to verify the implementation of 
each standard.
    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.
    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 email requests for a 
single copy of the draft feed standards to OP-ORA@fda.hhs.gov.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 41403]]



                                                    Table 1--Estimated Annual Recordkeeping Burden\1\
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                                                                                         Number of                      Average  burden
                             Respondent                                 Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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State Feed Regulatory Programs in the United States................              50                1               50            3,000          150,000
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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. The 
estimate includes time for reviewing the standards, gathering and 
maintaining the data and documents for each standard, and completing 
and reviewing the data and documents that would be spent to fully 
implement the 11 standards. 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. This burden was determined by 
averaging the burden estimates received from five respondents. The five 
respondents are representative of the State feed programs in the United 
States.

    Dated: July 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16517 Filed 7-9-13; 8:45 am]
BILLING CODE 4160-01-P


