Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking, 2163-2165 [2018-00568]
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Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
Total/annual
number
of respondents
Instrument
Number of responses
per respondent
2163
Average
burden hours
per response
Annual
burden hours
.333
255
Extension of Previously Approved Information Collection
6-Month Follow-Up Survey ..............................................................................
Estimated Total Annual Burden
Hours: 255.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–00612 Filed 1–12–18; 8:45 am]
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BILLING CODE 4184–09–P
766
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5569]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Device Tracking
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
15, 2018.
ADDRESSES: 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 0910–0442. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
SUMMARY:
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:
Medical Devices; Device Tracking—21
CFR Part 821
OMB Control Number 0910–0442—
Extension
Section 211 of the Food and Drug
Administration Modernization Act of
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1
1997 (FDAMA) (Pub. L. 105–115)
became effective on February 19, 1998.
FDAMA amended the previous medical
device tracking provisions under section
519(e)(1) and (2) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360i(e)(1) and (2)) that were
added by the Safe Medical Devices Act
of 1990 (SMDA) (Pub. L. 101–629).
Unlike the tracking provisions under
SMDA, which required tracking of any
medical device meeting certain criteria,
FDAMA allows FDA discretion in
applying tracking provisions to medical
devices meeting certain criteria and
provides that tracking requirements for
medical devices can be imposed only
after FDA issues an order. In the Federal
Register of February 8, 2002 (67 FR
5943), FDA issued a final rule that
conformed existing tracking regulations
to changes in tracking provisions
effected by FDAMA under part 821 (21
CFR part 821).
Section 519(e)(1) of the FD&C Act, as
amended by FDAMA, provides that
FDA may require by order that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s-l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
patients possessing those devices, to the
extent that patients permit the
collection of identifying information.
Manufacturers and FDA (where
necessary) use the data to: (1) Expedite
the recall of distributed medical devices
that are dangerous or defective and (2)
facilitate the timely notification of
patients or licensed practitioners of the
risks associated with the medical
device.
In addition, the regulations include
provisions for: (1) Exemptions and
variances; (2) system and content
requirements for tracking; (3)
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16JAN1
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Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
obligations of persons other than device
manufacturers, e.g., distributors; (4)
records and inspection requirements; (5)
confidentiality; and (6) record retention
requirements.
Respondents for this collection of
information are medical device
manufacturers, importers, and
distributors of tracked implants or
tracked l/s-l/s devices used outside a
device user facility. Distributors include
multiple and final distributors,
including hospitals.
The annual hourly burden for
respondents involved with medical
device tracking is estimated to be
615,380 hours per year. The burden
estimates cited in tables 1 through 3 are
based on the number of device tracking
orders issued in the last 3 years, an
average of 12 tracking orders annually.
FDA estimates that approximately
22,000 respondents may be subject to
tracking reporting requirements.
Under § 821.25(a), device
manufacturers subject to FDA tracking
orders must adopt a tracking method
that can provide certain device, patient,
and distributor information to FDA
within 3 to 10 working days. Assuming
one occurrence per year, FDA estimates
it would take a firm 20 hours to provide
FDA with location data for all tracked
devices and 56 hours to identify all
patients and/or multiple distributors
possessing tracked devices.
Under § 821.25(d) manufacturers must
notify FDA of distributor
noncompliance with reporting
requirements. Based on the number of
audits manufacturers conduct annually,
FDA estimates it would receive no more
than one notice in any year, and that it
would take 1 hour per incident.
Under § 821.30(c)(2), multiple
distributors must provide data on
current users of tracked devices, current
device locations, and other information,
upon request from a manufacturer or
FDA. FDA has not made such a request
and is not aware of any manufacturer
making a request. Assuming one
multiple distributor receives one request
in a year from either a manufacturer or
FDA, and that lists may be generated
electronically, the Agency estimates a
burden of 1 hour to comply.
Under § 821.30(d) distributors must
verify data or make required records
available for auditing, if a manufacturer
provides a written request. FDA’s
estimate of the burden for distributor
audit responses assumes that
manufacturers audit database entries for
5 percent of tracked devices distributed.
Each audited database entry prompts
one distributor audit response. Because
lists may be generated electronically,
FDA estimates a burden of 1 hour to
comply.
In the Federal Register of October 18,
2017 (82 FR 48516), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited and therefore will not be
discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR section
Average
burden per
response
Total annual
responses
Total hours
Discontinuation of business—821.1(d) ................................
Exemption or variance—821.2 and 821.30(e) .....................
Notification of failure to comply—821.25(d) ........................
Multiple distributor data—821.30(c)(2) ................................
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
4
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/21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Tracking information—821.25(a) .........................................
Record of tracking data—821.25(b) ....................................
Standard operating procedures—821.25(c) 2 ......................
Manufacturer data audit—821.25(c)(3) ................................
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
12
12
12
12
1
46,260
1
1,124
12
555,120
12
13,488
76
1
63
1
912
555,120
756
13,488
22,000
1
22,000
1
22,000
Total ..............................................................................
........................
........................
........................
........................
592,276
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
2 One-time
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TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity/21 CFR section
Acquisition of tracked devices and final distributor data—
821.30(a) and (b) .............................................................
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
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22:48 Jan 12, 2018
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Frm 00034
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
22,000
1
22,000
1
22,000
1,100
1
1,100
1
1,100
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16JAN1
Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
2165
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Activity/21 CFR section
Total ..............................................................................
1 There
Dated: January 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00568 Filed 1–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6877]
Accreditation Scheme for Conformity
Assessment of Medical Devices to
Food and Drug AdministrationRecognized Standards; Public
Workshop; Request for Comments
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Accreditation
Scheme for Conformity Assessment of
Medical Devices to FDA-Recognized
Standards.’’ The purpose of the
workshop is to present a draft design of
the Accreditation Scheme for
Conformity Assessment (ASCA) pilot
program. The workshop is intended to
discuss and obtain input and
recommendations from stakeholders on
the draft accreditation scheme,
including its goals and scope, a suitable
framework and procedures, and
requirements to facilitate
implementation of an eventual pilot
program. The overarching objectives of
the ASCA pilot program are to
streamline the standards conformity
SUMMARY:
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Total annual
disclosures
Average
burden per
disclosure
........................
........................
........................
........................
Total hours
23,100
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this
information collection has not changed
since the last OMB approval.
This document also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by OMB under the
PRA (44 U.S.C. 3501–3520). The
collections of information found in
§§ 821.2(b), 821.25(e), and 821.30(e)
have been approved under OMB control
number 0910–0191.
AGENCY:
Number of
disclosures
per
respondent
VerDate Sep<11>2014
22:48 Jan 12, 2018
Jkt 244001
assessment of medical devices and to
improve consistency and predictability
in the premarket review process where
certain FDA recognized standards are
used.
DATES: The public workshop will be
held on May 22 and 23, 2018, from 9
a.m. to 5 p.m. Submit either electronic
or written comments on this public
workshop by June 29, 2018. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before June 29, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
June 29, 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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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–
2017–N–6877 for ‘‘Accreditation
Scheme for Conformity Assessment of
Medical Devices to FDA-Recognized
Standards; Public Workshop; Request
for Comments.’’ 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
E:\FR\FM\16JAN1.SGM
16JAN1
]]>Agencies
[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2163-2165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00568]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5569]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Device Tracking
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 15, 2018.
ADDRESSES: 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 [email protected]. All
comments should be identified with the OMB control number 0910-0442.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Devices; Device Tracking--21 CFR Part 821
OMB Control Number 0910-0442--Extension
Section 211 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) became effective on February 19,
1998. FDAMA amended the previous medical device tracking provisions
under section 519(e)(1) and (2) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360i(e)(1) and (2)) that were added by the
Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629). Unlike the
tracking provisions under SMDA, which required tracking of any medical
device meeting certain criteria, FDAMA allows FDA discretion in
applying tracking provisions to medical devices meeting certain
criteria and provides that tracking requirements for medical devices
can be imposed only after FDA issues an order. In the Federal Register
of February 8, 2002 (67 FR 5943), FDA issued a final rule that
conformed existing tracking regulations to changes in tracking
provisions effected by FDAMA under part 821 (21 CFR part 821).
Section 519(e)(1) of the FD&C Act, as amended by FDAMA, provides
that FDA may require by order that a manufacturer adopt a method for
tracking a class II or III medical device, if the device meets one of
the three following criteria: (1) The failure of the device would be
reasonably likely to have serious adverse health consequences, (2) the
device is intended to be implanted in the human body for more than 1
year (referred to as a ``tracked implant''), or (3) the device is life-
sustaining or life-supporting (referred to as a ``tracked l/s-l/s
device'') and is used outside a device user facility.
Tracked device information is collected to facilitate identifying
the current location of medical devices and patients possessing those
devices, to the extent that patients permit the collection of
identifying information. Manufacturers and FDA (where necessary) use
the data to: (1) Expedite the recall of distributed medical devices
that are dangerous or defective and (2) facilitate the timely
notification of patients or licensed practitioners of the risks
associated with the medical device.
In addition, the regulations include provisions for: (1) Exemptions
and variances; (2) system and content requirements for tracking; (3)
[[Page 2164]]
obligations of persons other than device manufacturers, e.g.,
distributors; (4) records and inspection requirements; (5)
confidentiality; and (6) record retention requirements.
Respondents for this collection of information are medical device
manufacturers, importers, and distributors of tracked implants or
tracked l/s-l/s devices used outside a device user facility.
Distributors include multiple and final distributors, including
hospitals.
The annual hourly burden for respondents involved with medical
device tracking is estimated to be 615,380 hours per year. The burden
estimates cited in tables 1 through 3 are based on the number of device
tracking orders issued in the last 3 years, an average of 12 tracking
orders annually. FDA estimates that approximately 22,000 respondents
may be subject to tracking reporting requirements.
Under Sec. 821.25(a), device manufacturers subject to FDA tracking
orders must adopt a tracking method that can provide certain device,
patient, and distributor information to FDA within 3 to 10 working
days. Assuming one occurrence per year, FDA estimates it would take a
firm 20 hours to provide FDA with location data for all tracked devices
and 56 hours to identify all patients and/or multiple distributors
possessing tracked devices.
Under Sec. 821.25(d) manufacturers must notify FDA of distributor
noncompliance with reporting requirements. Based on the number of
audits manufacturers conduct annually, FDA estimates it would receive
no more than one notice in any year, and that it would take 1 hour per
incident.
Under Sec. 821.30(c)(2), multiple distributors must provide data
on current users of tracked devices, current device locations, and
other information, upon request from a manufacturer or FDA. FDA has not
made such a request and is not aware of any manufacturer making a
request. Assuming one multiple distributor receives one request in a
year from either a manufacturer or FDA, and that lists may be generated
electronically, the Agency estimates a burden of 1 hour to comply.
Under Sec. 821.30(d) distributors must verify data or make
required records available for auditing, if a manufacturer provides a
written request. FDA's estimate of the burden for distributor audit
responses assumes that manufacturers audit database entries for 5
percent of tracked devices distributed. Each audited database entry
prompts one distributor audit response. Because lists may be generated
electronically, FDA estimates a burden of 1 hour to comply.
In the Federal Register of October 18, 2017 (82 FR 48516), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Discontinuation of business-- 1 1 1 1 1
821.1(d).......................
Exemption or variance--821.2 and 1 1 1 1 1
821.30(e)......................
Notification of failure to 1 1 1 1 1
comply--821.25(d)..............
Multiple distributor data-- 1 1 1 1 1
821.30(c)(2)...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Tracking information--821.25(a). 12 1 12 76 912
Record of tracking data-- 12 46,260 555,120 1 555,120
821.25(b)......................
Standard operating procedures-- 12 1 12 63 756
821.25(c) \2\..................
Manufacturer data audit-- 12 1,124 13,488 1 13,488
821.25(c)(3)...................
Multiple distributor data and 22,000 1 22,000 1 22,000
distributor tracking records--
821.30(c)(2) and (d)...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 592,276
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One-time burden.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Acquisition of tracked devices 22,000 1 22,000 1 22,000
and final distributor data--
821.30(a) and (b)..............
Multiple distributor data and 1,100 1 1,100 1 1,100
distributor tracking records--
821.30(c)(2) and (d)...........
-------------------------------------------------------------------------------
[[Page 2165]]
Total....................... .............. .............. .............. .............. 23,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimate for this information collection has not changed
since the last OMB approval.
This document also refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). The
collections of information found in Sec. Sec. 821.2(b), 821.25(e), and
821.30(e) have been approved under OMB control number 0910-0191.
Dated: January 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00568 Filed 1-12-18; 8:45 am]
BILLING CODE 4164-01-P
