Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle, 75330-75331 [2020-26059]
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75330
Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
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: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26066 Filed 11–24–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1677]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recordkeeping
and Reporting Requirements for
Human Food and Cosmetics
Manufactured From, Processed With,
or Otherwise Containing Material From
Cattle
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.
DATES: Submit written comments
(including recommendations) on the
collection of information by December
28, 2020.
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 0910–0623. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:27 Nov 24, 2020
Jkt 253001
collection of information to OMB for
review and clearance.
Recordkeeping and Reporting
Requirements for Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing Material From Cattle—21
CFR 189.5 and 700.27
OMB Control Number 0910–0623—
Extension
FDA’s regulations in §§ 189.5 and
700.27 (21 CFR 189.5 and 700.27) set
forth bovine spongiform
encephalopathy (BSE)-related
restrictions applicable to FDA-regulated
human food and cosmetics. The
regulations designate certain materials
from cattle as ‘‘prohibited cattle
materials,’’ including specified risk
materials (SRMs), the small intestine of
cattle not otherwise excluded from
being a prohibited cattle material,
material from nonambulatory disabled
cattle, and mechanically separated (MS)
beef.
Sections 189.5(c) and 700.27(c) set
forth the requirements for recordkeeping
and records access for FDA-regulated
human food, including dietary
supplements, and cosmetics
manufactured from, processed with, or
otherwise containing material derived
from cattle. We issued these
recordkeeping regulations under the
adulteration provisions in sections
402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c),
and 701(a) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c),
and 371(a)). Under section 701(a) of the
FD&C Act, we are authorized to issue
regulations for the FD&C Act’s efficient
enforcement. With regard to records
concerning imported human food and
cosmetics, we relied on our authority
under sections 701(b) and 801(a) of the
FD&C Act (21 U.S.C. 371(b) and 381(a)).
Section 801(a) of the FD&C Act provides
requirements with regard to imported
human food and cosmetics and provides
for refusal of admission of human food
and cosmetics that appear to be
adulterated into the United States.
Section 701(b) of the FD&C Act
authorizes the Secretaries of Treasury
and Health and Human Services to
jointly prescribe regulations for the
efficient enforcement of section 801 of
the FD&C Act.
These requirements are necessary
because once materials are separated
from an animal it may not be possible,
without records, to know the following:
(1) Whether cattle material may contain
SRMs (brain, skull, eyes, trigeminal
ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
transverse processes of the thoracic and
lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia from
animals 30 months and older and
tonsils and distal ileum of the small
intestine from all animals of all ages);
(2) whether the source animal for cattle
material was inspected and passed; (3)
whether the source animal for cattle
material was nonambulatory disabled,
or MS beef; and (4) whether tallow in
human food or cosmetics contain less
than 0.15 percent insoluble impurities.
FDA’s regulations in §§ 189.5(c) and
700.27(c) require manufacturers and
processors of human food and cosmetics
manufactured from, processed with, or
otherwise containing material from
cattle establish and maintain records
sufficient to demonstrate that the
human food or cosmetics are not
manufactured from, processed with, or
otherwise contain prohibited cattle
materials. These records must be
retained for 2 years at the manufacturing
or processing establishment or at a
reasonably accessible location.
Maintenance of electronic records is
acceptable, and electronic records are
considered to be reasonably accessible if
they are accessible from an onsite
location. Records required by these
sections and existing records relevant to
compliance with these sections must be
available to FDA for inspection and
copying. Existing records may be used
if they contain all of the required
information and are retained for the
required time period.
Because we do not easily have access
to records maintained at foreign
establishments, FDA regulations in
§§ 189.5(c)(6) and 700.27(c)(6),
respectively, require that when filing for
entry with U.S. Customs and Border
Protection, the importer of record of
human food or cosmetics manufactured
from, processed with, or otherwise
containing, cattle material must affirm
that the human food or cosmetics were
manufactured from, processed with, or
otherwise contains, cattle material and
must affirm that the human food or
cosmetics were manufactured in
accordance with the applicable
requirements of §§ 189.5 or 700.27. In
addition, if human food or cosmetics
were manufactured from, processed
with, or otherwise contains cattle
material, the importer of record must
provide within 5 business days records
sufficient to demonstrate that the
human food or cosmetics were not
manufactured from, processed with, or
otherwise contains prohibited cattle
material, if requested.
Under FDA’s regulations, we may
designate a country from which cattle
materials inspected and passed for
E:\FR\FM\25NON1.SGM
25NON1
Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
human consumption are not considered
prohibited cattle materials, and their use
does not render human food or
cosmetics adulterated. Sections 189.5(e)
and 700.27(e) provide that a country
seeking to be designated must send a
written request to the Director of the
Center for Food Safety and Applied
Nutrition. The information the country
is required to submit includes
information about a country’s BSE case
history, risk factors, measures to prevent
the introduction and transmission of
BSE, and any other information relevant
to determining whether SRMs, the small
intestine of cattle not otherwise
excluded from being a prohibited cattle
material, material from nonambulatory
disabled cattle, or MS beef from the
country seeking designation should be
considered prohibited cattle materials.
We use the information to determine
whether to grant a request for
designation and to impose conditions if
a request is granted.
Sections 189.5 and 700.27 further
state that countries designated under
§§ 189.5(e) and 700.27(e) will be subject
to future review by FDA to determine
whether their designations remain
appropriate. As part of this process, we
may ask designated countries to confirm
that their BSE situation and the
information submitted by them, in
support of their original application, has
remained unchanged. We may revoke a
country’s designation if we determine
that it is no longer appropriate.
Therefore, designated countries may
respond to periodic FDA requests by
submitting information to confirm their
designations remain appropriate. We
use the information to ensure their
designations remain appropriate.
Description of Respondents:
Respondents to this information
collection include manufacturers,
processors, and importers of FDA-
75331
regulated human food, including dietary
supplements, and cosmetics
manufactured from, processed with, or
otherwise containing material derived
from cattle, as well as, with regard to
§§ 189.5(e) and 700.27(e), foreign
governments seeking designation under
those regulations.
In the Federal Register of August 14,
2020 (85 FR 49657), we published a 60day notice requesting public comment
on the proposed collection of
information. Although some comments
were received, only one pertained to the
information collection. The comment
suggested requiring greater than a 2-year
retention period for records; however,
we believe that additional retention
requirements may impose undue burden
on respondents to the information
collection without providing greater
utility to the Agency.
We estimate 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 section; activity
Total annual
responses
Average burden per
response
Total hours
189.5(c)(6) and 700.27(c)(6); affirmation of compliance.
189.5(e) and 700.27(e); request for designation .....
189.5(e) and 700.27(e); response to request for review by FDA.
54,825
1
54,825
0.033 (2 minutes) ......
1,809
1
1
1
1
1
1
80 ..............................
26 ..............................
80
26
Total ..................................................................
........................
........................
........................
....................................
1,915
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
Type of respondent
Total annual
records
Average burden per
recordkeeper
Total hours
Domestic facilities ....................................................
Foreign facilities .......................................................
697
916
52
52
36,244
47,632
0.25 (15 minutes) ......
0.25 (15 minutes) ......
9,061
11,908
Total ..................................................................
........................
........................
........................
....................................
20,969
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Termination of the Food and Drug
Administration’s Unapproved Drugs
Initiative; Request for Information
Regarding Drugs Potentially Generally
Recognized as Safe and Effective
[FR Doc. 2020–26059 Filed 11–24–20; 8:45 am]
jbell on DSKJLSW7X2PROD with NOTICES
Number of
records per
recordkeeper
Food and Drug Administration
BILLING CODE 4164–01–P
Food and Drug Administration
(FDA), Department of Health and
Human Services (HHS).
AGENCY:
ACTION:
VerDate Sep<11>2014
16:27 Nov 24, 2020
Jkt 253001
PO 00000
Notice; request for information.
Frm 00049
Fmt 4703
Sfmt 4703
The Department of Health and
Human Services is issuing this Notice to
withdraw FDA’s Marketed Unapproved
Drugs—Compliance Policy Guide, Sec.
440.100, Marketed New Drugs Without
Approved NDAs or ANDAs, and to
request information from the public
regarding drugs that may be
grandfathered or generally recognized as
safe and effective.
SUMMARY:
Part I of this Notice shall be
effective thirty days from the date of
publication in the Federal Register. To
be considered, responses and comments
related to Part II of this Notice must be
received electronically at the email
DATES:
E:\FR\FM\25NON1.SGM
25NON1
]]>Agencies
[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75330-75331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1677]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recordkeeping and
Reporting Requirements for Human Food and Cosmetics Manufactured From,
Processed With, or Otherwise Containing Material From Cattle
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 December 28, 2020.
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 0910-0623. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Recordkeeping and Reporting Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle--21 CFR 189.5 and 700.27
OMB Control Number 0910-0623--Extension
FDA's regulations in Sec. Sec. 189.5 and 700.27 (21 CFR 189.5 and
700.27) set forth bovine spongiform encephalopathy (BSE)-related
restrictions applicable to FDA-regulated human food and cosmetics. The
regulations designate certain materials from cattle as ``prohibited
cattle materials,'' including specified risk materials (SRMs), the
small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, and mechanically separated (MS) beef.
Sections 189.5(c) and 700.27(c) set forth the requirements for
recordkeeping and records access for FDA-regulated human food,
including dietary supplements, and cosmetics manufactured from,
processed with, or otherwise containing material derived from cattle.
We issued these recordkeeping regulations under the adulteration
provisions in sections 402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c),
and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c), and 371(a)). Under
section 701(a) of the FD&C Act, we are authorized to issue regulations
for the FD&C Act's efficient enforcement. With regard to records
concerning imported human food and cosmetics, we relied on our
authority under sections 701(b) and 801(a) of the FD&C Act (21 U.S.C.
371(b) and 381(a)). Section 801(a) of the FD&C Act provides
requirements with regard to imported human food and cosmetics and
provides for refusal of admission of human food and cosmetics that
appear to be adulterated into the United States. Section 701(b) of the
FD&C Act authorizes the Secretaries of Treasury and Health and Human
Services to jointly prescribe regulations for the efficient enforcement
of section 801 of the FD&C Act.
These requirements are necessary because once materials are
separated from an animal it may not be possible, without records, to
know the following: (1) Whether cattle material may contain SRMs
(brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the
thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal
root ganglia from animals 30 months and older and tonsils and distal
ileum of the small intestine from all animals of all ages); (2) whether
the source animal for cattle material was inspected and passed; (3)
whether the source animal for cattle material was nonambulatory
disabled, or MS beef; and (4) whether tallow in human food or cosmetics
contain less than 0.15 percent insoluble impurities.
FDA's regulations in Sec. Sec. 189.5(c) and 700.27(c) require
manufacturers and processors of human food and cosmetics manufactured
from, processed with, or otherwise containing material from cattle
establish and maintain records sufficient to demonstrate that the human
food or cosmetics are not manufactured from, processed with, or
otherwise contain prohibited cattle materials. These records must be
retained for 2 years at the manufacturing or processing establishment
or at a reasonably accessible location. Maintenance of electronic
records is acceptable, and electronic records are considered to be
reasonably accessible if they are accessible from an onsite location.
Records required by these sections and existing records relevant to
compliance with these sections must be available to FDA for inspection
and copying. Existing records may be used if they contain all of the
required information and are retained for the required time period.
Because we do not easily have access to records maintained at
foreign establishments, FDA regulations in Sec. Sec. 189.5(c)(6) and
700.27(c)(6), respectively, require that when filing for entry with
U.S. Customs and Border Protection, the importer of record of human
food or cosmetics manufactured from, processed with, or otherwise
containing, cattle material must affirm that the human food or
cosmetics were manufactured from, processed with, or otherwise
contains, cattle material and must affirm that the human food or
cosmetics were manufactured in accordance with the applicable
requirements of Sec. Sec. 189.5 or 700.27. In addition, if human food
or cosmetics were manufactured from, processed with, or otherwise
contains cattle material, the importer of record must provide within 5
business days records sufficient to demonstrate that the human food or
cosmetics were not manufactured from, processed with, or otherwise
contains prohibited cattle material, if requested.
Under FDA's regulations, we may designate a country from which
cattle materials inspected and passed for
[[Page 75331]]
human consumption are not considered prohibited cattle materials, and
their use does not render human food or cosmetics adulterated. Sections
189.5(e) and 700.27(e) provide that a country seeking to be designated
must send a written request to the Director of the Center for Food
Safety and Applied Nutrition. The information the country is required
to submit includes information about a country's BSE case history, risk
factors, measures to prevent the introduction and transmission of BSE,
and any other information relevant to determining whether SRMs, the
small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, or MS beef from the country seeking designation should be
considered prohibited cattle materials. We use the information to
determine whether to grant a request for designation and to impose
conditions if a request is granted.
Sections 189.5 and 700.27 further state that countries designated
under Sec. Sec. 189.5(e) and 700.27(e) will be subject to future
review by FDA to determine whether their designations remain
appropriate. As part of this process, we may ask designated countries
to confirm that their BSE situation and the information submitted by
them, in support of their original application, has remained unchanged.
We may revoke a country's designation if we determine that it is no
longer appropriate. Therefore, designated countries may respond to
periodic FDA requests by submitting information to confirm their
designations remain appropriate. We use the information to ensure their
designations remain appropriate.
Description of Respondents: Respondents to this information
collection include manufacturers, processors, and importers of FDA-
regulated human food, including dietary supplements, and cosmetics
manufactured from, processed with, or otherwise containing material
derived from cattle, as well as, with regard to Sec. Sec. 189.5(e) and
700.27(e), foreign governments seeking designation under those
regulations.
In the Federal Register of August 14, 2020 (85 FR 49657), we
published a 60-day notice requesting public comment on the proposed
collection of information. Although some comments were received, only
one pertained to the information collection. The comment suggested
requiring greater than a 2-year retention period for records; however,
we believe that additional retention requirements may impose undue
burden on respondents to the information collection without providing
greater utility to the Agency.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
189.5(c)(6) and 700.27(c)(6); affirmation of 54,825 1 54,825 0.033 (2 minutes)......................... 1,809
compliance.
189.5(e) and 700.27(e); request for 1 1 1 80........................................ 80
designation.
189.5(e) and 700.27(e); response to request 1 1 1 26........................................ 26
for review by FDA.
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 1,915
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic facilities......................... 697 52 36,244 0.25 (15 minutes)......................... 9,061
Foreign facilities.......................... 916 52 47,632 0.25 (15 minutes)......................... 11,908
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 20,969
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: November 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26059 Filed 11-24-20; 8:45 am]
BILLING CODE 4164-01-P
