Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Feed Regulatory Program Standards, 49524-49526 [2019-20352]
Download as PDF
<![CDATA[
49524
Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Notices
Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The proposed
information collection will examine
how fatherhood programs include
HMRE and coparenting content, the
types of activities programs use to
promote fathers’ healthy romantic
relationships and coparenting
relationships, barriers to addressing
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Coparenting and Healthy
Relationship and Marriage Education
for Dads (New Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF), Office of
Planning, Research, and Evaluation
(OPRE) proposes to collect information
as part of the Coparenting and Healthy
Relationship and Marriage Education for
Dads (CHaRMED) study. The purpose of
the CHaRMED study is to better
understand the services that fatherhood
programs provide in the areas of
Healthy Marriage and Relationship
Education (HMRE) and coparenting to
learn what strategies hold promise for
promoting active engagement in these
services.
SUMMARY:
healthy romantic relationships and
coparenting in fatherhood programs, the
relevance and success of addressing
healthy romantic relationships and
coparenting with fathers alone versus
with couples or both parents, fathers’
and coparents’ reactions to this
programming, curriculum developers’
perspectives on the curricula used, and
what types of partnerships fatherhood
programs have with other agencies to
promote fathers’ healthy romantic
relationships and coparenting. This
information will be collected through
semi-structured interviews with
fatherhood program staff, community
partners, fathers who are no longer
participating in the programs, and
curriculum developers; and through
focus groups with current program
participants (fathers) and coparents.
This information will inform future
efforts to promote healthy romantic
relationships and coparenting through
fatherhood programming.
Respondents: Federal and non-federal
fatherhood program staff (e.g., program
directors and facilitators), community
partners, fathers, coparents, and
curriculum developers.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
khammond on DSKJM1Z7X2PROD with NOTICES
Screener for selecting fatherhood programs for visits ....................................
Semi-structured interviews with program staff ................................................
Semi-structured interviews with partner organization staff ..............................
Semi-structured interviews with non-participating fathers ...............................
Focus groups with participating fathers ...........................................................
Focus groups with coparents ..........................................................................
Discussions with curriculum developers ..........................................................
Demographic questionnaire—fathers ..............................................................
Demographic questionnaire—coparents .........................................................
Estimated Total Annual Burden
Hours: 676.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
VerDate Sep<11>2014
17:13 Sep 19, 2019
Jkt 247001
28
48
14
20
104
48
7
124
48
to comments and suggestions submitted
within 60 days of this publication.
Authority: Title IV, Part A, Section
403(a)(2) of the Social Security Act [42 U.S.C.
603(a)(2)].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–20384 Filed 9–19–19; 8:45 am]
BILLING CODE 4184–73–P
PO 00000
Number of
responses
per
respondent
Average
burden
hours per
response
1
1
1
1
1
1
1
1
1
Annual
burden hours
6
2
2
1.5
2
2
1
.25
.25
168
96
28
30
208
96
7
31
12
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.
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
SUMMARY:
Frm 00019
Fmt 4703
Sfmt 4703
E:\FR\FM\20SEN1.SGM
20SEN1
Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Notices
(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.
khammond on DSKJM1Z7X2PROD with NOTICES
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.
VerDate Sep<11>2014
17:13 Sep 19, 2019
Jkt 247001
• 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/201523389.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.
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
49525
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.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
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
E:\FR\FM\20SEN1.SGM
20SEN1
49526
Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Notices
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 selfassessment 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 OPPRA@fda.hhs.gov.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Type of respondent
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
State animal feed regulatory Program in the United
States .........................................................................
34
1
34
569
19,346
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
17:13 Sep 19, 2019
Jkt 247001
continual improvement and selfsufficiency 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
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0084]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse Event
Program for Medical Devices (Medical
Product Safety Network)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
Frm 00021
Fmt 4703
Sfmt 4703
E:\FR\FM\20SEN1.SGM
20SEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 49525]]
(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,
[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 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
[[Page 49526]]
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 protected].
We estimate the burden of this collection of information as
follows:
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.
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
