82 FR 27501 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

Page Range		27501-27504
FR Document		2017-12448

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.

Federal Register, Volume 82 Issue 114 (Thursday, June 15, 2017)

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27501-27504]
From the Federal Register Online [www.thefederalregister.org]
[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.

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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: http://www.thefederalregister.org/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.
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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

27502 Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices

for approval. To comply with this 801(a) of the FD&C Act (21 U.S.C. 371(b) containing cattle material must affirm
requirement, FDA is publishing notice and 381(a)). Section 801(a) of the FD&C that the human food or cosmetics were
of the proposed collection of Act provides requirements with regard manufactured from, processed with, or
information set forth in this document. to imported human food and cosmetics otherwise containing-cattle material and
With respect to the following and provides for refusal of admission of must affirm that the human food or
collection of information, FDA invites human food and cosmetics that appear cosmetics were manufactured in
comments on these topics: (1) Whether to be adulterated into the United States. accordance with the applicable
the proposed collection of information Section 701(b) of the FD&C Act requirements of §§ 189.5 or 700.27. In
is necessary for the proper performance authorizes the Secretaries of Treasury addition, if human food or cosmetics
of FDA’s functions, including whether and Health and Human Services to were manufactured from, processed
the information will have practical jointly prescribe regulations for the with, or otherwise containing-cattle
utility; (2) the accuracy of FDA’s efficient enforcement of section 801 of material, the importer of record must
estimate of the burden of the proposed the FD&C Act. provide within 5 business days records
collection of information, including the These requirements are necessary sufficient to demonstrate that the
validity of the methodology and because once materials are separated human food or cosmetics were not
assumptions used; (3) ways to enhance from an animal it may not be possible, manufactured from, processed with, or
the quality, utility, and clarity of the without records, to know the following: otherwise contains prohibited cattle
information to be collected; and (4) (1) Whether cattle material may contain material, if requested.
ways to minimize the burden of the SRMs (brain, skull, eyes, trigeminal Under FDA’s regulations, FDA may
collection of information on ganglia, spinal cord, vertebral column designate a country from which cattle
respondents, including through the use (excluding the vertebrae of the tail, the materials inspected and passed for
of automated collection techniques, transverse processes of the thoracic and human consumption are not considered
when appropriate, and other forms of lumbar vertebrae and the wings of the prohibited cattle materials, and their use
information technology. sacrum), and dorsal root ganglia from does not render human food or
animals 30 months and older and cosmetics adulterated. Sections 189.5(e)
Recordkeeping and Reporting tonsils and distal ileum of the small and 700.27(e) provide that a country
Requirements for Human Food and intestine from all animals of all ages); seeking to be designated must send a
Cosmetics Manufactured From, (2) whether the source animal for cattle written request to the Director of the
Processed With, or Otherwise material was inspected and passed; (3) Center for Food Safety and Applied
Containing Material From Cattle—21 whether the source animal for cattle Nutrition (CFSAN Director). The
CFR 189.5 and 700.27 material was nonambulatory disabled or information the country is required to
OMB Control Number 0910–0623— MS beef; and (4) whether tallow in submit includes information about a
Extension human food or cosmetics contain less country’s BSE case history, risk factors,
than 0.15 percent insoluble impurities. measures to prevent the introduction
FDA’s regulations in §§ 189.5 and FDA’s regulations in §§ 189.5(c) and and transmission of BSE, and any other
700.27 (21 CFR 189.5 and 700.27) set 700.27(c) require manufacturers and information relevant to determining
forth bovine spongiform processors of human food and cosmetics whether SRMs, the small intestine of
encephalopathy (BSE)-related manufactured from, processed with, or cattle not otherwise excluded from
restrictions applicable to FDA-regulated otherwise containing material from being a prohibited cattle material,
human food and cosmetics. The cattle establish and maintain records material from nonambulatory disabled
regulations designate certain materials sufficient to demonstrate that the cattle, or MS beef from the country
from cattle as ‘‘prohibited cattle human food or cosmetics are not seeking designation should be
materials,’’ including specified risk manufactured from, processed with, or considered prohibited cattle materials.
materials (SRMs), the small intestine of otherwise contains prohibited cattle FDA uses the information to determine
cattle not otherwise excluded from materials. These records must be whether to grant a request for
being a prohibited cattle material, retained for 2 years at the manufacturing designation and to impose conditions if
material from nonambulatory disabled or processing establishment or at a a request is granted.
cattle, and mechanically separated (MS) reasonably accessible location. Sections 189.5 and 700.27 further
beef. Sections 189.5(c) and 700.27(c) set Maintenance of electronic records is state that countries designated under
forth the requirements for recordkeeping acceptable, and electronic records are §§ 189.5(e) and 700.27(e) will be subject
and records access for FDA-regulated considered to be reasonably accessible if to future review by FDA to determine
human food, including dietary they are accessible from an onsite whether their designations remain
supplements, and cosmetics location. Records required by these appropriate. As part of this process,
manufactured from, processed with, or sections and existing records relevant to FDA may ask designated countries to
otherwise containing material derived compliance with these sections must be confirm their BSE situation and the
from cattle. The FDA issued these available to FDA for inspection and information submitted by them, in
recordkeeping regulations under the copying. Existing records may be used support of their original application, has
adulteration provisions in sections if they contain all of the required remained unchanged. FDA may revoke
402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), information and are retained for the a country’s designation if FDA
and 701(a) of the Federal Food, Drug, required time period. determines that it is no longer
and Cosmetic Act (the FD&C Act) (21 Because FDA does not easily have appropriate. Therefore, designated
pmangrum on DSK3GDR082PROD with NOTICES

U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), access to records maintained at foreign countries may respond to periodic FDA
361(c), and 371(a)). Under section 701(a) establishments, FDA regulations in requests by submitting information to
of the FD&C Act, the FDA is authorized §§ 189.5(c)(6) and 700.27(c)(6), confirm their designations remain
to issue regulations for the FD&C Act’s respectively, require that when filing for appropriate. FDA uses the information
efficient enforcement. With regard to entry with U.S. Customs and Border to ensure their designations remain
records concerning imported human Protection, the importer of record of appropriate.
food and cosmetics, the FDA relied on human food or cosmetics manufactured Description of Respondents:
its authority under sections 701(b) and from, processed with, or otherwise Respondents to this information

VerDate Sep<11>2014 14:10 Jun 14, 2017 Jkt 241001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1

27504 Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices

finished products). Therefore, the total www.fda.gov/AdvisoryCommittees/ U.S.C. app. 2) and 21 CFR part 14,
recordkeeping burden for domestic default.htm. relating to advisory committees.
facilities is estimated to be 9,061 hours FOR FURTHER INFORMATION CONTACT: Dated: June 9, 2017.
(13 hours × 697), and the total Shanika Craig, Office of Device
recordkeeping burden for foreign Anna K. Abram,
Evaluation, Center for Devices and
facilities is estimated to be 11,908 hours Deputy Commissioner for Policy, Planning,
Radiological Health, Food and Drug
(13 hours × 916), as shown in table 2. Administration, 10903 New Hampshire
Legislation, and Analysis.
[FR Doc. 2017–12354 Filed 6–14–17; 8:45 am]
Dated: June 12, 2017. Ave., Bldg. 66, Rm. G644, Silver Spring,
MD 20993–0002, 301–796–6639, email: BILLING CODE 4164–01–P
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Shanika.Craig@fda.hhs.gov.
Legislation, and Analysis. SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting DEPARTMENT OF HEALTH AND
[FR Doc. 2017–12448 Filed 6–14–17; 8:45 am]
members on TEPRSSC that include two HUMAN SERVICES
BILLING CODE 4164–01–P
general public representatives and a
Food and Drug Administration
government representative.
DEPARTMENT OF HEALTH AND I. General Description of the
HUMAN SERVICES [Docket No. FDA–2013–N–1155]
Committee’s Duties
Food and Drug Administration The committee provides advice and Agency Information Collection
consultation to the Commissioner of Activities; Submission for Office of
[Docket No. FDA–2017–N–2495] Food and Drugs (Commissioner) on the Management and Budget Review;
technical feasibility, reasonableness, Comment Request; Food Labeling
Request for Nominations for Voting and practicability of performance Regulations
Members on a Public Advisory standards for electronic products to
Committee; Technical Electronic control the emission of radiation from AGENCY: Food and Drug Administration,
Product Radiation Safety Standards such products, and may recommend HHS.
Committee electronic product radiation safety
standards to the Commissioner for ACTION: Notice.
AGENCY: Food and Drug Administration, consideration.
HHS. SUMMARY: The Food and Drug
II. Criteria for Voting Members Administration (FDA or we) is
ACTION: Notice.
The committee consists of a core of 15 announcing that a proposed collection
SUMMARY: The Food and Drug voting members including the Chair. of information has been submitted to the
Administration (FDA) is requesting Members and the Chair are selected by Office of Management and Budget
nominations for members to serve on the Commissioner or designee from (OMB) for review and clearance under
the Technical Electronic Product among authorities knowledgeable in the the Paperwork Reduction Act of 1995
Radiation Safety Standards Committee fields of science or engineering, (PRA).
(TEPRSSC) in the Center for Devices applicable to electronic product
and Radiological Health. radiation safety. Members will be DATES: Fax written comments on the
FDA seeks to include the views of invited to serve for overlapping terms of collection of information by July 17,
women and men, members of all racial up to 4 years. Terms of more than 2 2017.
and ethnic groups, and individuals with years are contingent upon the renewal
and without disabilities on its advisory of the committee by appropriate action ADDRESSES: To ensure that comments on
committees and, therefore, encourages prior to its expiration. the information collection are received,
nominations of appropriately qualified OMB recommends that written
III. Nomination Procedures
candidates from these groups. comments be faxed to the Office of
Any interested person may nominate Information and Regulatory Affairs,
DATES: Nominations received on or
one or more qualified individuals for OMB, Attn: FDA Desk Officer, FAX:
before August 14, 2017 will be given
membership on the committee. Self- 202–395–7285, or emailed to oira_
first consideration for membership on
nominations are also accepted. submission@omb.eop.gov. All
TEPRSSC. Nominations received after
Nominations must include a current and comments should be identified with the
August 14, 2017 will be considered for complete résumé or curriculum vitae for
nomination to the committee as later OMB control number 0910–0381. Also
each nominee, including current
vacancies occur. include the FDA docket number found
business address and/or home address,
ADDRESSES: All nominations for telephone number, and email address if in brackets in the heading of this
membership should be sent available. Nominations must also document.
electronically by accessing FDA’s specify the advisory committee for FOR FURTHER INFORMATION CONTACT: Ila
Advisory Committee Membership which the nominee is recommended.
Nomination Portal at https:// S. Mizrachi, Office of Operations, Food
Nominations must also acknowledge and Drug Administration, Three White
www.accessdata.fda.gov/scripts/ that the nominee is aware of the
FACTRSPortal/FACTRS/index.cfm or by Flint North, 10A63, 11601 Landsdown
nomination unless self-nominated. FDA
St., North Bethesda, MD 20852, 301–
pmangrum on DSK3GDR082PROD with NOTICES

mail to Advisory Committee Oversight will ask potential candidates to provide
and Management Staff, Food and Drug detailed information concerning such 796–7726.
Administration, 10903 New Hampshire matters related to financial holdings, SUPPLEMENTARY INFORMATION: In
Ave., Bldg. 32, Rm. 5103, Silver Spring, employment, and research grants and/or compliance with 44 U.S.C. 3507, FDA
MD 20993–0002. Information about contracts to permit evaluation of has submitted the following proposed
becoming a member on an FDA advisory possible sources of conflicts of interest. collection of information to OMB for
committee can also be obtained by This notice is issued under the review and clearance.
visiting FDA’s Web site at https:// Federal Advisory Committee Act (5

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Document Created: 2017-06-15 01:03:32
Document Modified: 2017-06-15 01:03:32

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 14, 2017.
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.
FR Citation		82 FR 27501

82 FR 27501 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration