Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices, 60207-60209 [2017-27276]
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
person seeking an order under section
911(g)(1) of the FD&C Act must show
that the tobacco product, as it is actually
used by consumers, will significantly
reduce harm and the risk of tobaccorelated disease to individual tobacco
users and will benefit the health of the
population as a whole taking into
account both users of tobacco products
and persons who do not currently use
tobacco products. Section 911(g)(4) of
the FD&C Act describes factors that FDA
must take into account in evaluating
whether a tobacco product benefits the
health of individuals and the population
as a whole.
FDA is issuing this notice to inform
the public that the MRTPAs for the
following products submitted by R.J.
Reynolds Tobacco Co. have been filed
and are being made available for public
comment:
• MR0000068: Camel Snus Frost
• MR0000069: Camel Snus Frost Large
• MR0000070: Camel Snus Mellow
• MR0000071: Camel Snus Mint
• MR0000072: Camel Snus Robust
• MR0000073: Camel Snus Winterchill
In this document, FDA is announcing
the availability of the applications for
public comment. FDA will make any
amendments submitted by the applicant
available for public comment on a
rolling basis. The applications will be
available for public comment for 180
days from the date this notice is
published; however, in the event that
fewer than 30 days remain in the 180day comment period when an
amendment is posted, FDA will extend
or reopen the comment period to allow
for at least 30 days of public comment
on the amendment. FDA believes that
this comment period is appropriate
given the volume and complexity of the
applications being posted. FDA will
notify the public about the availability
of amendments to these applications
and changes to related comment periods
via the Agency’s website and other
means of public communication. To
encourage public participation
consistent with section 911(e) of the
FD&C Act, FDA is making the redacted
MRTPAs that are the subject of this
notice available electronically (see
section II).
II. Electronic Access
Persons with access to the internet
may obtain the documents at: https://
www.fda.gov/TobaccoProducts/
Labeling/MarketingandAdvertising/
UCM564399.htm.
VerDate Sep<11>2014
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Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27246 Filed 12–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0672]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on reprocessed,
single-use device labeling.
DATES: Submit either electronic or
written comments on the collection of
information by February 20, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 20,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 20, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
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
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60207
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0672 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• 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
E:\FR\FM\19DEN1.SGM
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60208
Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices
OMB Control Number 0910–0577—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 352), among other things,
establishes requirements that the label
or labeling of a medical device must
meet so that it is not misbranded and
subject to regulatory action. Section 301
of the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250) amended section 502 of the FD&C
Act to add section 502(u) to require
devices (both new and reprocessed) to
bear prominently and conspicuously the
name of the manufacturer, a generally
recognized abbreviation of such name,
or a unique and generally recognized
symbol identifying the manufacturer.
Section 2(c) of the Medical Device
User Fee Stabilization Act of 2005 (Pub.
L. 109–43) amends section 502(u) of the
FD&C Act by limiting the provision to
reprocessed single-use devices (SUDs)
and the manufacturers who reprocess
them. Under the amended provision, if
the original SUD or an attachment to it
prominently and conspicuously bears
the name of the manufacturer, then the
reprocessor of the SUD is required to
identify itself by name, abbreviation, or
symbol in a prominent and conspicuous
manner on the device or attachment to
the device. If the original SUD does not
prominently and conspicuously bear the
name of the manufacturer, the
manufacturer who reprocesses the SUD
for reuse may identify itself using a
detachable label that is intended to be
affixed to the patient record.
The requirements of section 502(u) of
the FD&C Act impose a minimal burden
on industry. This section of the FD&C
Act only requires the manufacturer,
packer, or distributor of a device to
include their name and address on the
labeling of a device. This information is
readily available to the establishment
and easily supplied. From its
registration and premarket submission
database, FDA estimates that there are
67 establishments that distribute
approximately 427 reprocessed SUDs.
Each response is anticipated to take 0.1
hours (6 minutes) resulting in a total
burden to industry of 43 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Type of respondent
Number of
disclosures
per
respondent
2
Average
burden per
disclosure
Total annual
disclosures
Total hours
Establishments listing fewer than 10 SUDs .................
Establishments listing 10 or more SUDs .....................
58
9
2
34
116
306
0.1 (6 minutes) ......
0.1 (6 minutes) ......
12
31
Total ......................................................................
........................
........................
........................
...............................
43
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded.
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Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
The burden for this information
collection has not changed since the last
OMB approval.
Dated: December 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27276 Filed 12–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: HHS–OS–0990–0281–
30D]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before January 18, 2018.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
SUMMARY:
0990–New–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Prevention
Communication Formative Research—
Revision—OMB No. 0990–0281.
Type of Collection: Revision.
OMB No.: 0990–0281—Office of
Disease Prevention and Health
Promotion.
Abstract: The Office of Disease
Prevention and Health Promotion
(ODPHP) is focused on developing and
disseminating health information to the
public. ODPHP faces an increasingly
urgent interest in finding effective ways
to communicate health information to
America’s diverse population. ODPHP
strives to be responsive to the needs of
America’s diverse audiences while
simultaneously serving all Americans
across a range of channels, from print to
new communication technologies. To
carry out prevention information efforts,
ODPHP is committed to conducting
formative and usability research to
provide guidance on the development
and implementation of their
communication and education efforts.
The information collected will be used
to improve communication, products,
and services that support key office
activities including: Healthy People,
Dietary Guidelines for Americans,
Physical Activity Guidelines for
Americans, healthfinder.gov, and
increasing health care quality and
patient safety. ODPHP communicates
through its websites
(www.healthfinder.gov,
www.HealthyPeople.gov,
www.health.gov) and through other
channels including social media, print
materials, interactive training modules,
and reports. This request builds on
previous formative research approaches
to place more emphasis on web-based
data collection to allow greater
geographical diversity among
respondents, to decrease respondent
burden, and to save government costs.
Data collection will be qualitative and
quantitative and may include in-depth
interviews, focus groups, web-based
surveys, omnibus surveys, card sorting,
and various forms of usability testing of
materials and interactive tools to assess
the public’s understanding of disease
prevention and health promotion
content, responses to prototype
materials, and barriers to effective use.
The program is requesting a 3-year
clearance.
Likely Respondents: Respondents are
likely to be either consumers or health
professionals.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden/
response
(in hours)
Number
responses/
respondent
Total response
burden
(in hours)
Data collection task
Instrument/form name
In-depth interviews ............................
Screener ...........................................
Interview ...........................................
Screener ...........................................
Focus Group ....................................
Interview ...........................................
Screener ...........................................
Cognitive Test ..................................
Screener ...........................................
Survey ..............................................
Survey ..............................................
Review ..............................................
Screener ...........................................
Card Sort ..........................................
Screener ...........................................
1,500
500
2,925
975
5,250
150
50
30,000
10,000
2,100
325
600
200
1,800
1
1
1
1
1
1
1
1
1
1
1
1
1
1
10/60
1.00
10/60
1.50
5/60
10/60
2.00
5/60
15/60
10/60
30/60
10/60
1.00
10/60
250
500
487.5
1,462.5
437.50
25
100
2,500
2,500
350
162.5
100
200
300
Usability Test ....................................
600
1
1.00
600
...........................................................
........................
........................
........................
9,975.00
Focus groups ....................................
Intercept interviews ...........................
Cognitive testing of instruments .......
Web-based surveys ..........................
sradovich on DSK3GMQ082PROD with NOTICES
Omnibus surveys ..............................
Gatekeeper reviews ..........................
Card sorting ......................................
Usability and prototype testing of
materials (print and web).
Total ...........................................
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]]>Agencies
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60207-60209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27276]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0672]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prominent and Conspicuous Mark of Manufacturers on
Single-Use Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on reprocessed, single-use device labeling.
DATES: Submit either electronic or written comments on the collection
of information by February 20, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 20, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 20, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0672 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
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
[[Page 60208]]
for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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 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.
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
OMB Control Number 0910-0577--Extension
Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 352), among other things, establishes requirements that
the label or labeling of a medical device must meet so that it is not
misbranded and subject to regulatory action. Section 301 of the Medical
Device User Fee and Modernization Act of 2002 (Pub. L. 107-250) amended
section 502 of the FD&C Act to add section 502(u) to require devices
(both new and reprocessed) to bear prominently and conspicuously the
name of the manufacturer, a generally recognized abbreviation of such
name, or a unique and generally recognized symbol identifying the
manufacturer.
Section 2(c) of the Medical Device User Fee Stabilization Act of
2005 (Pub. L. 109-43) amends section 502(u) of the FD&C Act by limiting
the provision to reprocessed single-use devices (SUDs) and the
manufacturers who reprocess them. Under the amended provision, if the
original SUD or an attachment to it prominently and conspicuously bears
the name of the manufacturer, then the reprocessor of the SUD is
required to identify itself by name, abbreviation, or symbol in a
prominent and conspicuous manner on the device or attachment to the
device. If the original SUD does not prominently and conspicuously bear
the name of the manufacturer, the manufacturer who reprocesses the SUD
for reuse may identify itself using a detachable label that is intended
to be affixed to the patient record.
The requirements of section 502(u) of the FD&C Act impose a minimal
burden on industry. This section of the FD&C Act only requires the
manufacturer, packer, or distributor of a device to include their name
and address on the labeling of a device. This information is readily
available to the establishment and easily supplied. From its
registration and premarket submission database, FDA estimates that
there are 67 establishments that distribute approximately 427
reprocessed SUDs. Each response is anticipated to take 0.1 hours (6
minutes) resulting in a total burden to industry of 43 hours.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishments listing fewer than 10 SUDs..... 58 2 116 0.1 (6 minutes)......................... 12
Establishments listing 10 or more SUDs........ 9 34 306 0.1 (6 minutes)......................... 31
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 43
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
[[Page 60209]]
The burden for this information collection has not changed since
the last OMB approval.
Dated: December 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27276 Filed 12-18-17; 8:45 am]
BILLING CODE 4164-01-P
