Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle, 27501-27504 [2017-12448]
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
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: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation and Analysis.
[FR Doc. 2017–12352 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0505]
Agency Information Collection
Activities; Proposed Collection;
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 an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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 information collection provisions of
existing FDA regulations concerning
FDA-regulated human food, including
dietary supplements, and cosmetics
manufactured from, processed with, or
otherwise containing material derived
from cattle.
DATES: Submit either electronic or
written comments on the collection of
information by August 14, 2017.
ADDRESSES: You may submit comments
as follows:
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SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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• 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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2009–N–0505 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Recordkeeping and Reporting
Requirements for Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing Material From Cattle.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
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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 Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
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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.
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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. The FDA 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 (the 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, the FDA is authorized
to issue regulations for the FD&C Act’s
efficient enforcement. With regard to
records concerning imported human
food and cosmetics, the FDA relied on
its authority under sections 701(b) and
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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 §§ 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 contains 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 FDA does 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
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containing cattle material must affirm
that the human food or cosmetics were
manufactured from, processed with, or
otherwise containing-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 containing-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, FDA may
designate a country from which cattle
materials inspected and passed for
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 (CFSAN Director). 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.
FDA uses 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,
FDA may ask designated countries to
confirm their BSE situation and the
information submitted by them, in
support of their original application, has
remained unchanged. FDA may revoke
a country’s designation if FDA
determines that it is no longer
appropriate. Therefore, designated
countries may respond to periodic FDA
requests by submitting information to
confirm their designations remain
appropriate. FDA uses the information
to ensure their designations remain
appropriate.
Description of Respondents:
Respondents to this information
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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
§§ 189.5(e) and 700.27(e), foreign
27503
governments seeking designation under
those regulations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
189.5(c)(6) and 700.27(c)(6) ....................................
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
1
1
1
1
54,825
1
1
.033 (2 minutes) ........
80 ..............................
26 ..............................
1,809
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 BURDEN 1
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeper
Total hours
Domestic facilities ....................................................
Foreign facilities .......................................................
697
916
52
52
36,244
47,632
.25 (15 minutes) ........
.25 (15 minutes) ........
9,061
11,908
Total ..................................................................
........................
........................
........................
....................................
20,969
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Except where otherwise noted, this
estimate is based on FDA’s estimate of
the number of facilities affected by the
final rule entitled, ‘‘Recordkeeping
Requirements for Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing Material From Cattle’’
published in the Federal Register of
October 11, 2006 (71 FR 59653).
Reporting: FDA’s regulations in
§§ 189.5(c)(6) and 700.27(c)(6) impose a
reporting burden on importers of human
food and cosmetics manufactured from,
processed with, or otherwise containing
cattle material. Importers of these
products must affirm that the human
food or cosmetics are not manufactured
from, processed with, or otherwise
contain prohibited cattle materials and
must affirm that the human food or
cosmetics were manufactured in
accordance with the applicable
requirements of §§ 189.5 or 700.27. The
affirmation is made by the importer of
record to the FDA through FDA’s
Operational and Administrative System
for Import Support. Affirmation by
importers is expected to take
approximately 2 minutes per entry line.
Table 2 shows 54,825 lines of human
food and cosmetics likely to contain
cattle materials are imported annually.
The reporting burden of affirming
whether import entry lines contain
cattle-derived materials is estimated to
take 1,809 hours annually (54,825 lines
× 2 minutes per line).
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FDA’s estimate of the reporting
burden for designation under §§ 189.5
and 700.27 is based on its experience
and the average number of requests for
designation received in the past 3 years.
In the last 3 years, FDA has not received
any requests for designation. Thus, FDA
estimates that one or fewer will be
received annually in the future. Based
on this experience, FDA estimates the
annual number of new requests for
designation will be one. FDA estimates
that preparing the information required
by §§ 189.5 and 700.27 and submitting
it to FDA in the form of a written
request to the CFSAN Director will
require a burden of approximately 80
hours per request. Thus, the burden for
new requests for designation is
estimated to be 80 hours annually, as
shown in table 1, row 2.
Under §§ 189.5(e) and 700.27(e),
designated countries are subject to
future review by FDA and may respond
to periodic FDA requests by submitting
information to confirm their
designations remain appropriate. In the
last 3 years, FDA has not requested any
reviews. Thus, FDA estimates that one
or fewer will occur annually in the
future. FDA estimates that the
designated country undergoing a review
in the future will need one-third of the
time it took preparing its request for
designation to respond to FDA’s request
for review, or 26 hours (80 hours × 0.33
= 26.4 hours, rounded to 26). The
annual burden for reviews is estimated
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to be 26 hours, as shown in table 1, row
3. The total reporting burden for this
information collection is estimated to be
1,915 hours annually.
Recordkeeping: FDA estimates that
there are 697 domestic facility
relationships and 916 foreign facility
relationships consisting of the following
facilities: An input supplier of cattlederived materials that requires records
(the upstream facility) and a purchaser
of cattle-derived materials requiring
documentation (this may be a human
food or cosmetics manufacturer or
processor). The recordkeeping burden of
FDA’s regulations in §§ 189.5(c) and
700.27(c) is the burden of sending,
verifying, and storing documents
regarding shipments of cattle material
that is to be used in human food and
cosmetics.
In this estimate of the recordkeeping
burden, FDA treats these recordkeeping
activities as shared activities between
the upstream and downstream facilities.
It is in the best interests of both facilities
in the relationship to share the burden
necessary to comply with the
regulations; therefore, FDA estimates
the time burden of developing these
records as a joint task between the two
facilities. Thus, FDA estimates that this
recordkeeping burden will be about 15
minutes per week, or 13 hours per year,
and FDA assumes that the
recordkeeping burden will be shared
between 2 entities (i.e., the ingredient
supplier and the manufacturer of
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finished products). Therefore, the total
recordkeeping burden for domestic
facilities is estimated to be 9,061 hours
(13 hours × 697), and the total
recordkeeping burden for foreign
facilities is estimated to be 11,908 hours
(13 hours × 916), as shown in table 2.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12448 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2495]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Technical Electronic
Product Radiation Safety Standards
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for members to serve on
the Technical Electronic Product
Radiation Safety Standards Committee
(TEPRSSC) in the Center for Devices
and Radiological Health.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Nominations received on or
before August 14, 2017 will be given
first consideration for membership on
TEPRSSC. Nominations received after
August 14, 2017 will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by accessing FDA’s
Advisory Committee Membership
Nomination Portal at 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 Web site at https://
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SUMMARY:
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www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Shanika Craig, Office of Device
Evaluation, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G644, Silver Spring,
MD 20993–0002, 301–796–6639, email:
Shanika.Craig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on TEPRSSC that include two
general public representatives and a
government representative.
I. General Description of the
Committee’s Duties
The committee provides advice and
consultation to the Commissioner of
Food and Drugs (Commissioner) on the
technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products, and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
II. Criteria for Voting Members
The committee consists of a core of 15
voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of science or engineering,
applicable to electronic product
radiation safety. Members will be
invited to serve for overlapping terms of
up to 4 years. Terms of more than 2
years are contingent upon the renewal
of the committee by appropriate action
prior to its expiration.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the committee. Selfnominations are also accepted.
Nominations must include a current and
´
´
complete resume or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available. Nominations must also
specify the advisory committee for
which the nominee is recommended.
Nominations must also acknowledge
that the nominee is aware of the
nomination unless self-nominated. FDA
will ask potential candidates to provide
detailed information concerning such
matters related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
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U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12354 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1155]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling
Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by July 17,
2017.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0381. 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, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726.
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:
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]]>Agencies
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27501-27504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12448]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0505]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 information collection
provisions of existing FDA regulations concerning FDA-regulated human
food, including dietary supplements, and cosmetics manufactured from,
processed with, or otherwise containing material derived from cattle.
DATES: Submit either electronic or written comments on the collection
of information by August 14, 2017.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2009-N-0505 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping and Reporting
Requirements for Human Food and Cosmetics Manufactured From, Processed
With, or Otherwise Containing Material From Cattle.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB
[[Page 27502]]
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.
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. The FDA 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 (the 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, the FDA is authorized to issue regulations for the FD&C Act's
efficient enforcement. With regard to records concerning imported human
food and cosmetics, the FDA relied on its 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 contains 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 FDA does 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 containing-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 containing-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, FDA may designate a country from which
cattle materials inspected and passed for 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 (CFSAN Director). 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. FDA uses 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, FDA may ask designated countries
to confirm their BSE situation and the information submitted by them,
in support of their original application, has remained unchanged. FDA
may revoke a country's designation if FDA determines that it is no
longer appropriate. Therefore, designated countries may respond to
periodic FDA requests by submitting information to confirm their
designations remain appropriate. FDA uses the information to ensure
their designations remain appropriate.
Description of Respondents: Respondents to this information
[[Page 27503]]
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
189.5(c)(6) and 700.27(c)(6)................ 54,825 1 54,825 .033 (2 minutes).......................... 1,809
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 Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic facilities......................... 697 52 36,244 .25 (15 minutes).......................... 9,061
Foreign facilities.......................... 916 52 47,632 .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.
Except where otherwise noted, this estimate is based on FDA's
estimate of the number of facilities affected by the final rule
entitled, ``Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle'' published in the Federal Register of October 11, 2006 (71
FR 59653).
Reporting: FDA's regulations in Sec. Sec. 189.5(c)(6) and
700.27(c)(6) impose a reporting burden on importers of human food and
cosmetics manufactured from, processed with, or otherwise containing
cattle material. Importers of these products must affirm that the human
food or cosmetics are not manufactured from, processed with, or
otherwise contain prohibited cattle materials 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. The affirmation
is made by the importer of record to the FDA through FDA's Operational
and Administrative System for Import Support. Affirmation by importers
is expected to take approximately 2 minutes per entry line. Table 2
shows 54,825 lines of human food and cosmetics likely to contain cattle
materials are imported annually. The reporting burden of affirming
whether import entry lines contain cattle-derived materials is
estimated to take 1,809 hours annually (54,825 lines x 2 minutes per
line).
FDA's estimate of the reporting burden for designation under
Sec. Sec. 189.5 and 700.27 is based on its experience and the average
number of requests for designation received in the past 3 years. In the
last 3 years, FDA has not received any requests for designation. Thus,
FDA estimates that one or fewer will be received annually in the
future. Based on this experience, FDA estimates the annual number of
new requests for designation will be one. FDA estimates that preparing
the information required by Sec. Sec. 189.5 and 700.27 and submitting
it to FDA in the form of a written request to the CFSAN Director will
require a burden of approximately 80 hours per request. Thus, the
burden for new requests for designation is estimated to be 80 hours
annually, as shown in table 1, row 2.
Under Sec. Sec. 189.5(e) and 700.27(e), designated countries are
subject to future review by FDA and may respond to periodic FDA
requests by submitting information to confirm their designations remain
appropriate. In the last 3 years, FDA has not requested any reviews.
Thus, FDA estimates that one or fewer will occur annually in the
future. FDA estimates that the designated country undergoing a review
in the future will need one-third of the time it took preparing its
request for designation to respond to FDA's request for review, or 26
hours (80 hours x 0.33 = 26.4 hours, rounded to 26). The annual burden
for reviews is estimated to be 26 hours, as shown in table 1, row 3.
The total reporting burden for this information collection is estimated
to be 1,915 hours annually.
Recordkeeping: FDA estimates that there are 697 domestic facility
relationships and 916 foreign facility relationships consisting of the
following facilities: An input supplier of cattle-derived materials
that requires records (the upstream facility) and a purchaser of
cattle-derived materials requiring documentation (this may be a human
food or cosmetics manufacturer or processor). The recordkeeping burden
of FDA's regulations in Sec. Sec. 189.5(c) and 700.27(c) is the burden
of sending, verifying, and storing documents regarding shipments of
cattle material that is to be used in human food and cosmetics.
In this estimate of the recordkeeping burden, FDA treats these
recordkeeping activities as shared activities between the upstream and
downstream facilities. It is in the best interests of both facilities
in the relationship to share the burden necessary to comply with the
regulations; therefore, FDA estimates the time burden of developing
these records as a joint task between the two facilities. Thus, FDA
estimates that this recordkeeping burden will be about 15 minutes per
week, or 13 hours per year, and FDA assumes that the recordkeeping
burden will be shared between 2 entities (i.e., the ingredient supplier
and the manufacturer of
[[Page 27504]]
finished products). Therefore, the total recordkeeping burden for
domestic facilities is estimated to be 9,061 hours (13 hours x 697),
and the total recordkeeping burden for foreign facilities is estimated
to be 11,908 hours (13 hours x 916), as shown in table 2.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12448 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P
