Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed, 17156-17157 [2021-06706]
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17156
Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices
Dated: March 26, 2021.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2021–06740 Filed 3–31–21; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0520]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by May 3,
2021.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0627. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Ila
S. 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.
jbell on DSKJLSW7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
19:02 Mar 31, 2021
Jkt 253001
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
§ 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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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
(§ 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).
E:\FR\FM\01APN1.SGM
01APN1
17157
Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices
In the Federal Register of December
17, 2020 (85 FR 81930), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
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
Average
burden per
response
Total annual
responses
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
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: March 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06706 Filed 3–31–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–1314]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; IBSRELA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for IBSRELA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
records per
recordkeeper
VerDate Sep<11>2014
19:02 Mar 31, 2021
Jkt 253001
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by June 1, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 28, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
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 June 1, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 1, 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.
DATES:
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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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 d89.pelivery/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.’’
E:\FR\FM\01APN1.SGM
01APN1
]]>Agencies
[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17156-17157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06706]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0520]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by May 3, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0627. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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).
[[Page 17157]]
In the Federal Register of December 17, 2020 (85 FR 81930), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR part Number of responses per Total annual burden per Total hours
respondents respondent responses 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
21 CFR part Number of records per Total annual burden 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: March 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06706 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P
