Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed, 81930-81932 [2020-27746]
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Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that IMCIVREE (setmelanotide)
injection, manufactured by Rhythm
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher. IMCIVREE
(setmelanotide) injection is indicated for
the treatment of chronic weight
management in adult and pediatric
patients 6 years of age and older with
proopiomelanocortin (POMC),
proprotein convertase subtilisin/kexin
type 1 (PCSK1), or leptin receptor
(LEPR) deficiency obesity confirmed by
genetic testing demonstrating variants in
POMC, PCSK1, or LEPR genes that are
interpreted as pathogenic, likely
pathogenic, or of uncertain significance.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about IMCIVREE
(setmelanotide) injection, go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27760 Filed 12–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0520]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Substances
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
SUMMARY:
VerDate Sep<11>2014
18:52 Dec 16, 2020
Jkt 253001
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 the recordkeeping
requirements for substances prohibited
from use in animal food or feed.
DATES: Submit either electronic or
written comments on the collection of
information by February 16, 2021.
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 February 16,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 16, 2021.
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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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–0520 for ‘‘Substances
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: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
E:\FR\FM\17DEN1.SGM
17DEN1
Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
Substances Prohibited From Use in
Animal Food or Feed—21 CFR Part 589
OMB Control Number 0910–0627—
Extension
This information collection supports
Agency regulations 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. BSE belongs to the
family of diseases known as
VerDate Sep<11>2014
18:52 Dec 16, 2020
Jkt 253001
transmissible spongiform
encephalopathies (TSEs). All TSEs
affect the central nervous system of
infected animals. Our regulation at
§ 589.2001 (21 CFR 589.2001), entitled
‘‘Cattle materials prohibited in animal
food or feed to prevent the transmission
of bovine spongiform encephalopathy,’’
is designed to further strengthen
existing safeguards 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
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 of
specifically defined cattle materials,
including reporting and recordkeeping
requirements. For purposes of the
regulation, we define a renderer as any
firm or individual that processes
slaughter byproducts; animals unfit for
human consumption, including
carcasses of dead cattle; or meat scraps.
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.
Reporting: Under our regulations, we
may designate a country from which
cattle materials are not considered
CMPAF. Section 589.2001(f) provides
that a country seeking to be so
designated must send a written request
to the Director of the Center for
Veterinary Medicine. The country is
required to submit information about its
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). We use the
information to determine whether to
grant a request for designation and to
impose conditions if a request is
granted. Section 589.2001(f) further
states that countries designated under
that section will be subject to our future
review to determine whether their
designations remain appropriate. As
part of this process, we may ask
designated countries from time to time
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81931
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.
Recordkeeping: 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
(§ 589.2001(c)(2)(ii)). Renderers that
receive, manufacture, process, blend, or
distribute CMPAF are required to
establish and maintain records
sufficient to track the CMPAF to ensure
that they are not introduced into animal
feed (§ 589.2001(c)(2)(vi)).
Renderers that receive, manufacture,
process, blend, or distribute any cattle
materials must establish and maintain
records sufficient to demonstrate that
material rendered for use in animal feed
was not manufactured from, processed
with, or does not otherwise contain,
CMPAF (§ 589.2001(c)(3)(i)).
Renderers that receive, manufacture,
process, blend, or distribute any cattle
materials must, if these materials were
obtained from an establishment that
segregates CMPAF from other materials,
establish and maintain records to
demonstrate that the supplier has
adequate procedures in place to
effectively exclude CMPAF from any
materials supplied (§ 589.2001(c)(3)(i)).
Records will meet this requirement if
they include either: (1) Certification or
other documentation from the supplier
that materials supplied do not include
CMPAF (§ 589.2001(c)(3)(i)(A)), or (2)
documentation of another method
acceptable to FDA, such as third-party
certification (§ 589.2001(c)(3)(i)(B)).
Description of Respondents:
Respondents to this information
collection include rendering facilities,
feed manufacturers, livestock feeders,
and foreign governments seeking
designation under § 589.2001(f).
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR part
Total
annual
responses
Average
burden per
response
Total hours
589.2001(f); request for designation ....................................
589.2001(f); response to request for review by FDA ..........
1
1
1
1
1
1
80
26
80
26
Total ..............................................................................
........................
........................
........................
........................
106
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
589.2001(c)(2)(ii); maintain written procedures ...................
589.2001(c)(2)(vi) and (c)(3)(i); maintain records ...............
589.2001(c)(3)(i)(A) and (B); certification or documentation
from the supplier ..............................................................
50
175
1
1
50
175
20
20
1,000
3,500
175
1
175
26
4,550
Total ..............................................................................
........................
........................
........................
........................
9,050
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: December 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27746 Filed 12–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0074]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; State Enforcement
Notifications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we, or Agency) 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 reporting
requirements contained in existing FDA
SUMMARY:
VerDate Sep<11>2014
18:52 Dec 16, 2020
Jkt 253001
regulations governing State enforcement
notifications.
DATES: Submit either electronic or
written comments on the collection of
information by February 16, 2021.
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 February 16,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 16, 2021.
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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–
2018–N–0074 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; State
Enforcement Notifications.’’ 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, 202–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 81930-81932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27746]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0520]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Substances 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 response to the
notice. This notice solicits comments on the recordkeeping requirements
for substances prohibited from use in animal food or feed.
DATES: Submit either electronic or written comments on the collection
of information by February 16, 2021.
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 February 16, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 16, 2021. 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-0520 for ``Substances 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White
[[Page 81931]]
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. 3501-3521), 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.
Substances Prohibited From Use in Animal Food or Feed--21 CFR Part 589
OMB Control Number 0910-0627--Extension
This information collection supports Agency regulations 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. BSE belongs to the family of diseases known as transmissible
spongiform encephalopathies (TSEs). All TSEs affect the central nervous
system of infected animals. Our regulation at Sec. 589.2001 (21 CFR
589.2001), entitled ``Cattle materials prohibited in animal food or
feed to prevent the transmission of bovine spongiform encephalopathy,''
is designed to further strengthen existing safeguards 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 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 of specifically
defined cattle materials, including reporting and recordkeeping
requirements. For purposes of the regulation, we define a renderer as
any firm or individual that processes slaughter byproducts; animals
unfit for human consumption, including carcasses of dead cattle; or
meat scraps. 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.
Reporting: Under our regulations, we may designate a country from
which cattle materials are not considered CMPAF. Section 589.2001(f)
provides that a country seeking to be so designated must send a written
request to the Director of the Center for Veterinary Medicine. The
country is required to submit information about its 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). We use the information
to determine whether to grant a request for designation and to impose
conditions if a request is granted. Section 589.2001(f) further states
that countries designated under that section will be subject to our
future review to determine whether their designations remain
appropriate. As part of this process, we may ask designated countries
from time to 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.
Recordkeeping: 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 (Sec.
589.2001(c)(2)(ii)). Renderers that receive, manufacture, process,
blend, or distribute CMPAF are required to establish and maintain
records sufficient to track the CMPAF to ensure that they are not
introduced into animal feed (Sec. 589.2001(c)(2)(vi)).
Renderers that receive, manufacture, process, blend, or distribute
any cattle materials must establish and maintain records sufficient to
demonstrate that material rendered for use in animal feed was not
manufactured from, processed with, or does not otherwise contain, CMPAF
(Sec. 589.2001(c)(3)(i)).
Renderers that receive, manufacture, process, blend, or distribute
any cattle materials must, if these materials were obtained from an
establishment that segregates CMPAF from other materials, establish and
maintain records to demonstrate that the supplier has adequate
procedures in place to effectively exclude CMPAF from any materials
supplied (Sec. 589.2001(c)(3)(i)). Records will meet this requirement
if they include either: (1) Certification or other documentation from
the supplier that materials supplied do not include CMPAF (Sec.
589.2001(c)(3)(i)(A)), or (2) documentation of another method
acceptable to FDA, such as third-party certification (Sec.
589.2001(c)(3)(i)(B)).
Description of Respondents: Respondents to this information
collection include rendering facilities, feed manufacturers, livestock
feeders, and foreign governments seeking designation under Sec.
589.2001(f).
FDA estimates the burden of this collection of information as
follows:
[[Page 81932]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
589.2001(f); request for 1 1 1 80 80
designation....................
589.2001(f); response to request 1 1 1 26 26
for review by FDA..............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 106
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
589.2001(c)(2)(ii); maintain 50 1 50 20 1,000
written procedures.............
589.2001(c)(2)(vi) and 175 1 175 20 3,500
(c)(3)(i); maintain records....
589.2001(c)(3)(i)(A) and (B); 175 1 175 26 4,550
certification or documentation
from the supplier..............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 9,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: December 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27746 Filed 12-16-20; 8:45 am]
BILLING CODE 4164-01-P
