Agency Information Collection Activities; Proposed Collection; Comment Request; Cattle Materials Prohibited From Use in Animal Food or Feed, 70676-70678 [2023-22495]
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70676
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
Advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
website at https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5213, Silver Spring,
MD 20993–0002, 301–796–5960, email:
margaret.ames@fda.hhs.gov.
For questions relating to the Digital
Health Advisory Committee, contact
James Swink, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Room 5211, Silver
Spring, MD 20993–0002, 301–796–6313,
James.swink@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for a pool of
nonvoting industry representatives for
the Digital Health Advisory Committee
(this position may be filled by
representatives of different medical
device areas based on areas of expertise
relevant to the topics being considered
by the Advisory Committee).
Elsewhere in this Federal Register,
FDA is publishing separate documents
regarding:
1. Digital Health Advisory Committee;
Notice of Establishment
2. Request for Nominations for Voting
Members for the Digital Health
Advisory Committee
3. Request for Nominations of
Individuals and Consumer
Organizations for the Digital Health
Advisory Committee
ddrumheller on DSK120RN23PROD with NOTICES1
I. General Description of the
Committee’s Duties
The Committee provides advice on
complex scientific and technical issues
related to Digital Health Technologies
(DHTs). This also may include advice
on the regulation of DHTs, and/or their
use, including use of DHTs in clinical
trials or postmarket studies subject to
FDA regulation. Topics relating to
DHTs, such as artificial intelligence/
machine learning, augmented reality,
virtual reality, digital therapeutics,
wearables, remote patient monitoring,
and software, may be considered by the
Committee. The Committee advises the
Commissioner on issues related to
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DHTs, including, for example, realworld data, real-world evidence,
patient-generated health data,
interoperability, personalized medicine/
genetics, decentralized clinical trials,
use of DHTs in clinical trials for medical
products, cybersecurity, DHT user
experience, and Agency policies and
regulations regarding these
technologies. The Committee provides
relevant expertise and perspective to
improve Agency understanding of the
benefits, risks, and clinical outcomes
associated with use of DHTs. The
Committee performs its duties by
providing advice and recommendations
on new approaches to develop and
evaluate DHTs and to promote
innovation of DHTs, as well as
identifying risks, barriers, or unintended
consequences that could result from
proposed or established Agency policy
or regulation for topics related to DHTs.
II. Qualifications
Persons nominated for the Digital
Health Advisory Committee should be
full-time employees of firms that
manufacture medical device products,
or consulting firms that represent
manufacturers or have similar
appropriate ties to industry.
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interest must send a
letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 45 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes or curriculum
vitae. The letter will also state that it is
the responsibility of the interested
organizations to confer with one another
and to select a candidate or candidates
(to serve in a pool of individuals, with
varying areas of expertise), to represent
industry interest for the committee,
within 60 days after the receipt of the
FDA letter. The interested organizations
are not bound by the list of nominees in
selecting a candidate or candidates.
However, if no individual is selected
within 60 days, the Commissioner will
select temporary nonvoting members (or
pool of individuals) to represent
industry interests.
IV. Nomination Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a
PO 00000
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Sfmt 4703
temporary nonvoting industry
representative. Nominations must
include a cover letter and a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business and/or home address,
telephone number, and email address if
available; and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Committee Membership Nomination
Portal (see ADDRESSES). Nominations
should specify the advisory committee
for which the nominee is recommended
within 30 days of publication of this
document (see DATES). Nominations
should also acknowledge that the
nominee is aware of the nomination,
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. Only interested industry
organizations participate in the
selection process. Persons who
nominate themselves as nonvoting
industry representatives will not
participate in the selection process.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22568 Filed 10–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4181]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Cattle Materials
Prohibited From Use in Animal Food or
Feed
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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
SUMMARY:
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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
response to the notice. This notice
solicits comments on the reporting and
recordkeeping requirements for cattle
materials prohibited from use in animal
food or feed.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
December 11, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
December 11, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
ddrumheller on DSK120RN23PROD with NOTICES1
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.’’
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Instructions: All submissions received
must include the Docket No. FDA–
2023–N–4181 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Cattle
Materials Prohibited From Use in
Animal Food or Feed.’’ 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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
PO 00000
Frm 00040
Fmt 4703
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70677
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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.
Cattle Materials Prohibited From Use in
Animal Food or Feed—21 CFR
589.2001
OMB Control Number 0910–0627—
Extension
This information collection supports
implementation of Agency statutory and
regulatory requirements regarding
substances prohibited from use in
animal food or feed. Bovine spongiform
encephalopathy (BSE) is a progressive
and fatal neurological disorder of cattle
that results from an unconventional
transmissible agent. Our regulation at
§ 589.2001 (21 CFR 589.2001) is
designed to safeguard against the
establishment and amplification of BSE
in the United States through animal
feed. The regulation prohibits the use of
certain cattle origin materials in the
food or feed of all animals. These
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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
materials are referred to as ‘‘cattle
materials prohibited in animal feed’’ or
CMPAF. Under § 589.2001, no animal
feed or feed ingredient can contain
CMPAF. As a result, we impose
requirements on renderers that process
cattle materials, including reporting and
recordkeeping requirements. The
reporting and recordkeeping
requirements are necessary because
once materials are separated from an
animal it may not be possible, without
records, to know whether the cattle
material meets the requirements of our
regulation.
Under our regulations, we may
designate a country from which cattle
materials are not considered CMPAF. A
country seeking to be so designated
must send a written request to the
Director of the Center for Veterinary
Medicine, including certain required
information. We use the information
provided to determine whether to grant
a request for designation and to impose
conditions if a request is granted.
Additionally, designated countries will
be subject to our future review to
determine whether their designations
remain appropriate. As part of this
process, we may ask designated
countries at any time to confirm that
their BSE situation and the information
submitted by them in support of their
original application remains unchanged.
We may revoke a country’s designation
if we determine that it is no longer
appropriate. Therefore, designated
countries may respond to our periodic
requests by submitting information to
confirm their designations remain
appropriate. We use the information to
ensure their designations remain
appropriate.
Renderers that receive, manufacture,
process, blend, or distribute CMPAF, or
products that contain or may contain
CMPAF, must take measures to ensure
that the materials are not introduced
into animal feed, including maintaining
adequate written procedures specifying
how such processes are to be carried
out.
Description of Respondents:
Respondents to this information
collection are foreign governments
seeking designation under § 589.2001(f)
and rendering facilities that process
cattle materials.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR part; activity
Average
burden per
response
Total annual
responses
Total hours
589.2001(f); Process for designating countries to request
exemption from the requirements of this regulation ........
589.2001(f); response to request for review by FDA ..........
1
1
1
1
1
1
40
26
40
26
Total ..............................................................................
........................
........................
........................
........................
66
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The information the country is
required to submit includes information
about that country’s BSE case history,
risk factors, measures to prevent the
introduction and transmission of BSE,
and any other information relevant to
determining whether the cattle materials
from the requesting country do or do not
meet the definitions set forth in
§ 589.2001(b)(1).
Since the last renewal, we have
reduced the request for designation
burden from 80 hours to 40 hours. This
reduction is because respondents are
required to provide this information to
other entities in order to comply with
international standards and therefore
will have already compiled the
necessary information.
Our estimate of the reporting burden
for designation under § 589.2001(f) is
based on estimates found in our final
rule. Since the rule’s effective date in
2009, only two requests for designation
have been received; however, we retain
our current estimate of one to permit
such requests for designation by
respondents and to permit related
responses to FDA.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part; activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
589.2001(c)(2)(ii), 589.2001(c)(2)(vi) and (c)(3)(i), and
589.2001(c)(3)(i)(A) and (B); Rendering facilities maintain written procedures and records, and certification or
documentation from the supplier ......................................
145
1
145
45
6,525
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden we attribute to
recordkeeping activities is assumed to
be distributed among the individual
elements and averaged among
respondents. The total number of
recordkeepers contains a subset of 50
recordkeepers who maintain written
procedures and records specifically
required by 21 CFR 589.2001(c).
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17:34 Oct 11, 2023
Jkt 262001
We have adjusted our recordkeeping
burden estimate in Table 2, which
results in a decrease of 2,525 hours.
This is based primarily on consolidation
within the industry and a decrease in
the estimated number of respondents
subject to recordkeeping requirements.
Based on our review since the last
OMB approval, there is an overall
adjustment decrease of 2,565 burden
PO 00000
Frm 00041
Fmt 4703
Sfmt 9990
hours. The adjustment is attributable to
decreases in the average reporting
burden time and in respondent subject
to recordkeeping requirements.
Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22495 Filed 10–11–23; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70676-70678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22495]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4181]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Cattle Materials Prohibited From Use in Animal Food or
Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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
[[Page 70677]]
response to the notice. This notice solicits comments on the reporting
and recordkeeping requirements for cattle materials prohibited from use
in animal food or feed.
DATES: Either electronic or written comments on the collection of
information must be submitted by December 11, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 11, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2023-N-4181 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Cattle Materials Prohibited From
Use in Animal Food or Feed.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Cattle Materials Prohibited From Use in Animal Food or Feed--21 CFR
589.2001
OMB Control Number 0910-0627--Extension
This information collection supports implementation of Agency
statutory and regulatory requirements regarding substances prohibited
from use in animal food or feed. Bovine spongiform encephalopathy (BSE)
is a progressive and fatal neurological disorder of cattle that results
from an unconventional transmissible agent. Our regulation at Sec.
589.2001 (21 CFR 589.2001) is designed to safeguard against the
establishment and amplification of BSE in the United States through
animal feed. The regulation prohibits the use of certain cattle origin
materials in the food or feed of all animals. These
[[Page 70678]]
materials are referred to as ``cattle materials prohibited in animal
feed'' or CMPAF. Under Sec. 589.2001, no animal feed or feed
ingredient can contain CMPAF. As a result, we impose requirements on
renderers that process cattle materials, including reporting and
recordkeeping requirements. The reporting and recordkeeping
requirements are necessary because once materials are separated from an
animal it may not be possible, without records, to know whether the
cattle material meets the requirements of our regulation.
Under our regulations, we may designate a country from which cattle
materials are not considered CMPAF. A country seeking to be so
designated must send a written request to the Director of the Center
for Veterinary Medicine, including certain required information. We use
the information provided to determine whether to grant a request for
designation and to impose conditions if a request is granted.
Additionally, designated countries will be subject to our future review
to determine whether their designations remain appropriate. As part of
this process, we may ask designated countries at any time to confirm
that their BSE situation and the information submitted by them in
support of their original application remains unchanged. We may revoke
a country's designation if we determine that it is no longer
appropriate. Therefore, designated countries may respond to our
periodic requests by submitting information to confirm their
designations remain appropriate. We use the information to ensure their
designations remain appropriate.
Renderers that receive, manufacture, process, blend, or distribute
CMPAF, or products that contain or may contain CMPAF, must take
measures to ensure that the materials are not introduced into animal
feed, including maintaining adequate written procedures specifying how
such processes are to be carried out.
Description of Respondents: Respondents to this information
collection are foreign governments seeking designation under Sec.
589.2001(f) and rendering facilities that process cattle materials.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR part; activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
589.2001(f); Process for 1 1 1 40 40
designating countries to
request exemption from the
requirements of this regulation
589.2001(f); response to request 1 1 1 26 26
for review by FDA..............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 66
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The information the country is required to submit includes
information about that country's BSE case history, risk factors,
measures to prevent the introduction and transmission of BSE, and any
other information relevant to determining whether the cattle materials
from the requesting country do or do not meet the definitions set forth
in Sec. 589.2001(b)(1).
Since the last renewal, we have reduced the request for designation
burden from 80 hours to 40 hours. This reduction is because respondents
are required to provide this information to other entities in order to
comply with international standards and therefore will have already
compiled the necessary information.
Our estimate of the reporting burden for designation under Sec.
589.2001(f) is based on estimates found in our final rule. Since the
rule's effective date in 2009, only two requests for designation have
been received; however, we retain our current estimate of one to permit
such requests for designation by respondents and to permit related
responses to FDA.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR part; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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589.2001(c)(2)(ii), 589.2001(c)(2)(vi) and (c)(3)(i), and 145 1 145 45 6,525
589.2001(c)(3)(i)(A) and (B); Rendering facilities maintain
written procedures and records, and certification or documentation
from the supplier.................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden we attribute to recordkeeping activities is assumed to
be distributed among the individual elements and averaged among
respondents. The total number of recordkeepers contains a subset of 50
recordkeepers who maintain written procedures and records specifically
required by 21 CFR 589.2001(c).
We have adjusted our recordkeeping burden estimate in Table 2,
which results in a decrease of 2,525 hours. This is based primarily on
consolidation within the industry and a decrease in the estimated
number of respondents subject to recordkeeping requirements.
Based on our review since the last OMB approval, there is an
overall adjustment decrease of 2,565 burden hours. The adjustment is
attributable to decreases in the average reporting burden time and in
respondent subject to recordkeeping requirements.
Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22495 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P
