[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49524-49526]
[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

(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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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

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<EMAIL_ADDRESS>    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


                          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                             National Vehicle and Fuel Emissions Laboratory 2000 Traverwood Drive                                  Ann Arbor, Michigan 48105-2498

July 20, 2016

MEMORANDUM

             SUBJECT:	Methods Utilized in Calculations for GHG Emissions Inventories for Final Aircraft GHG Contribution Finding

             FROM:	Bryan J. Manning, Mechanical Engineer Assessment and Standards Division              Office of Transportation and Air Quality              U.S. Environmental Protection Agency

TO:	The Air and Radiation Docket              Docket No. EPA-HQ-OAR-2014-0828

This memorandum documents the methods utilized in the calculations for the Environmental Protection Agency's (EPA's) historical, current, and projected greenhouse gas (GHG) emissions inventories for the contribution finding in the agency's final aircraft GHG endangerment and contribution findings.  These methods pertain to both United States (U.S.) and global GHG emissions inventories (historical, current, and projected inventories).  This includes calculations for the following types of comparisons of U.S. covered aircraft GHG emissions and total U.S. aircraft GHG emissions:

        As a share of current total U.S. GHG emissions;          As a share of current U.S. transportation GHG emissions;          As a share of current total global GHG emissions; and         As a share of the current global transportation GHG emissions.

Refer to Attachments 1 and 2 of this memorandum for a description of the methods used in the calculations.

Attachments:   Explanation of Calculations for U.S. GHG Emissions in Cause or Contribute Finding (Attachment 1  -  Presentation format)  Methods Utilized in Calculations for U.S. and Global GHG Emissions Inventories for Final Aircraft GHG Contribution Finding (Attachment 2  -  Excel file)