Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records, 12735-12737 [2016-05385]
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Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
Guidance for Industry and Food and
Drug Administration Staff on Dear
Health Care Provider Letters:
Improving Communication of
Important Safety Information OMB
Control Number 0910–0754—Extension
This final Guidance for Industry and
FDA staff entitled ‘‘Dear Health Care
Provider Letters: Improving
Communication of Important Safety
Information’’ offers specific guidance to
industry and FDA staff on the content
and format of Dear Health Care Provider
(DHCP) letters. These letters are sent by
manufacturers or distributors to health
care providers to communicate an
important drug warning, a change in
prescribing information, or a correction
of misinformation in prescription drug
promotional labeling or advertising.
This guidance gives specific
instruction on what should and should
not be included in DHCP letters. To
date, some DHCP letters have been too
long, have contained promotional
12735
material, or otherwise have not met the
goals set forth in the applicable
regulation (21 CFR 200.5). In some
cases, health care providers have not
been aware of important new
information, and have been unable to
communicate it to patients, because the
letters’ content and length have made it
difficult to find the relevant
information. In addition, letters have
sometimes been sent for the wrong
reasons.
In addition to content and format
recommendations for each type of DHCP
letter, the guidance also includes advice
on consulting with FDA to develop a
DHCP letter, when to send a letter, what
type of letter to send, and conducting an
assessment of the letter’s impact.
Based on a review of FDA’s Document
Archiving, Reporting, and Regulatory
Tracking System for 2012–2015, we
identified DHCP letters that were sent
and the identity of each sponsor sending
out a DHCP letter for each year. We
estimate that we will receive
approximately 25 DHCP Letters
annually from approximately 18
application holders. FDA professionals
familiar with DHCP letters and with the
recommendations in the guidance
estimate that it should take an
application holder approximately 100
hours to prepare and send DHCP letters
in accordance with the guidance.
FDA estimates the annual reporting
burden of this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Annual Average ....................................................
1 There
18
Total annual
responses
1.4
25
Average burden
per response
100 hours .....................
Total hours
2,500
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05301 Filed 3–9–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0477]
BILLING CODE 4164–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
responses per
respondent
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
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17:55 Mar 09, 2016
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Fax written comments on the
collection of information by April 11,
2016.
DATES:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
Device Exemptions Reports and
Records
AGENCY:
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.
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 0910–0078. Also
ADDRESSES:
E:\FR\FM\10MRN1.SGM
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12736
Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
Investigational Device Exemptions
Reports and Records— OMB Control
Number 0910–0078—Extension
Section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360j(g)) establishes the
statutory authority to collect
information regarding investigational
devices, and establishes rules under
which new medical devices may be
tested using human subjects in a clinical
setting. The Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) added section
520(g)(6) to the FD&C Act and permitted
changes to be made to either the
investigational device or to the clinical
protocol without FDA approval of an
investigational device exemption (IDE)
supplement. An IDE allows a device,
which would otherwise be subject to
provisions of the FD&C Act, such as
premarket notification or premarket
approval, to be used in investigations
involving human subjects in which the
safety and effectiveness of the device is
being studied. The purpose of part 812
(21 CFR part 812) is to encourage, to the
extent consistent with the protection of
public health and safety and with
ethical standards, the discovery and
development of useful devices intended
for human use. The IDE regulation is
designed to encourage the development
of useful medical devices and allow
investigators the maximum freedom
possible, without jeopardizing the
health and safety of the public or
violating ethical standards. To do this,
the regulation provides for different
levels of regulatory control, depending
on the level of potential risk the
investigational device presents to
human subjects.
Investigations of significant risk
devices, ones that present a potential for
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serious harm to the rights, safety, or
welfare of human subjects, are subject to
the full requirements of the IDE
regulation. Nonsignificant risk device
investigations, i.e., devices that do not
present a potential for serious harm, are
subject to the reduced burden of the
abbreviated requirements. The
regulation also includes provisions for
treatment IDEs. The purpose of these
provisions is to facilitate the
availability, as early in the device
development process as possible, of
promising new devices to patients with
life-threatening or serious conditions for
which no comparable or satisfactory
alternative therapy is available. Section
812.10 permits the sponsor of the IDE to
request a waiver to all of the
requirements of part 812. This
information is needed for FDA to
determine if waiver of the requirements
of part 812 will impact the public’s
health and safety. Sections 812.20,
812.25, and 812.27 consist of the
information necessary to file an IDE
application with FDA. The submission
of an IDE application to FDA is required
only for significant risk device
investigations.
Section 812.20 lists the data
requirements for the original IDE
application, § 812.25 lists the contents
of the investigational plan; and § 812.27
lists the data relating to previous
investigations or testing. The
information in the original IDE
application is evaluated by the Center
for Devices and Radiological Health to
determine whether the proposed
investigation will reasonably protect the
public health and safety, and for FDA to
make a determination to approve the
IDE.
Upon approval of an IDE application
by FDA, a sponsor must submit certain
requests and reports. Under § 812.35, a
sponsor who wishes to make a change
in the investigation that affects the
scientific soundness of the study or the
rights, safety, or welfare of the subjects,
is required to submit a request for the
change to FDA. Section 812.150 requires
a sponsor to submit reports to FDA.
These requests and reports are
submitted to FDA as supplemental
applications. This information is needed
for FDA to assure protection of human
subjects and to allow review of the
study’s progress. Section 812.36(c)
identifies the information necessary to
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file a treatment IDE application. FDA
uses this information to determine if
wider distribution of the device is in the
interest of the public health. Section
812.36(f) identifies the reports required
to allow FDA to monitor the size and
scope of the treatment IDE, to assess the
sponsor’s due diligence in obtaining
marketing clearance of the device, and
to ensure the integrity of the controlled
clinical trials.
Section 812.140 lists the
recordkeeping requirements for
investigators and sponsors. FDA
requires this information for tracking
and oversight purposes. Investigators
are required to maintain records,
including correspondence and reports
concerning the study, records of receipt,
use or disposition of devices, records of
each subject’s case history and exposure
to the device, informed consent
documentation, study protocol, and
documentation of any deviation from
the protocol. Sponsors are required to
maintain records including
correspondence and reports concerning
the study, records of shipment and
disposition, signed investigator
agreements, adverse device effects
information, and, for a nonsignificant
risk device study, an explanation of the
nonsignificant risk determination,
records of device name and intended
use, study objectives, investigator
information, investigational review
board information, and statement on the
extent that good manufacturing
practices will be followed.
For a nonsignificant risk device
investigation, the investigators’ and
sponsors’ recordkeeping and reporting
burden is reduced. Pertinent records on
the study must be maintained by both
parties, and reports are made to
sponsors and institutional review
boards (IRBs). Reports are made to FDA
only in certain circumstances, e.g.,
recall of the device, the occurrence of
unanticipated adverse effects, and as a
consequence of certain IRB actions. The
estimate of the burden is based on the
number of IDEs received in recent years.
In the Federal Register of October 28,
2015 (80 FR 66009), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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12737
Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Waivers—812.10 ..................................................................
IDE Application—812.20, 812.25, and 812.27 ....................
Supplements—812.35 and 812.150 ....................................
Treatment IDE Applications—812.36(c) ..............................
Treatment IDE Reporting—812.36(f) ...................................
1
219
579
1
1
1
1
6
1
1
1
219
3,474
1
1
1
80
6
120
20
1
17,520
20,844
120
20
Total ..............................................................................
........................
........................
........................
........................
38,505
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
Original—812.140 ..............................................................
Supplemental—812.140 .....................................................
Nonsignificant—812.140 ....................................................
219
579
356
1
6
1
219
3,747
356
10
1
6
2,190
3,474
2,136
Total ............................................................................
........................
..........................
........................
........................
7,800
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Reports for Nonsignificant Risk Studies—812.150 ...........
1
1
1
6
6
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting
burden for this extension has decreased
to 38,505 hours (previously 54,253
hours) as the result of a decrease in the
average number of applications and
supplements submitted. For the same
reason, the recordkeeping burden has
decreased to 7,800 hours (previously
9,968). The previous approved total
burden hours of 64,227, have therefore
decreased by 17,916 to 46,311.
Dated: March 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05385 Filed 3–9–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK4VPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2015–N–0986]
Center for Devices and Radiological
Health: Experiential Learning Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
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17:55 Mar 09, 2016
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The Food and Drug
Administration’s (FDA) Center for
Devices and Radiological Health (CDRH
or Center) is announcing the 2016
Experiential Learning Program (ELP).
This training component is intended to
provide CDRH staff with an opportunity
to understand the policies, laboratory
practices, and challenges faced in
broader disciplines that impact the
device development life cycle. The
purpose of this document is to invite
medical device industry, academia, and
health care facilities to request to
participate in this formal training
program for FDA’s medical device
review staff, or to contact CDRH for
more information regarding the ELP.
DATES: Submit either an electronic or
written request for participation in the
ELP by April 11, 2016.
ADDRESSES: Submit either electronic
requests to https://www.regulations.gov
or written requests to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Identify requests with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Christian Hussong, Center for Devices
SUMMARY:
PO 00000
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and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5261, Silver Spring,
MD 20993–0002, 240–402–2246, FAX:
301–827–3079, Christian.Hussong@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CDRH is responsible for helping to
ensure the safety and effectiveness of
medical devices marketed in the United
States. Furthermore, CDRH assures that
patients and providers have timely and
continued access to high-quality, safe,
and effective medical devices. In
support of this mission, the Center
launched various training and
development initiatives to enhance
performance of its staff involved in
regulatory review and in the premarket
review process. One of these initiatives,
the ELP Pilot, was launched in 2012 and
fully implemented on April 2, 2013 (78
FR 19711).
CDRH is committed to advancing
regulatory science, providing industry
with predictable, consistent,
transparent, and efficient regulatory
pathways, and helping to ensure
consumer confidence in medical
devices marketed in the United States
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]]>Agencies
[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12735-12737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05385]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0477]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational
Device Exemptions Reports and Records
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 April
11, 2016.
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 0910-0078.
Also
[[Page 12736]]
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
Investigational Device Exemptions Reports and Records-- OMB Control
Number 0910-0078--Extension
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360j(g)) establishes the statutory authority to
collect information regarding investigational devices, and establishes
rules under which new medical devices may be tested using human
subjects in a clinical setting. The Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) added section 520(g)(6) to
the FD&C Act and permitted changes to be made to either the
investigational device or to the clinical protocol without FDA approval
of an investigational device exemption (IDE) supplement. An IDE allows
a device, which would otherwise be subject to provisions of the FD&C
Act, such as premarket notification or premarket approval, to be used
in investigations involving human subjects in which the safety and
effectiveness of the device is being studied. The purpose of part 812
(21 CFR part 812) is to encourage, to the extent consistent with the
protection of public health and safety and with ethical standards, the
discovery and development of useful devices intended for human use. The
IDE regulation is designed to encourage the development of useful
medical devices and allow investigators the maximum freedom possible,
without jeopardizing the health and safety of the public or violating
ethical standards. To do this, the regulation provides for different
levels of regulatory control, depending on the level of potential risk
the investigational device presents to human subjects.
Investigations of significant risk devices, ones that present a
potential for serious harm to the rights, safety, or welfare of human
subjects, are subject to the full requirements of the IDE regulation.
Nonsignificant risk device investigations, i.e., devices that do not
present a potential for serious harm, are subject to the reduced burden
of the abbreviated requirements. The regulation also includes
provisions for treatment IDEs. The purpose of these provisions is to
facilitate the availability, as early in the device development process
as possible, of promising new devices to patients with life-threatening
or serious conditions for which no comparable or satisfactory
alternative therapy is available. Section 812.10 permits the sponsor of
the IDE to request a waiver to all of the requirements of part 812.
This information is needed for FDA to determine if waiver of the
requirements of part 812 will impact the public's health and safety.
Sections 812.20, 812.25, and 812.27 consist of the information
necessary to file an IDE application with FDA. The submission of an IDE
application to FDA is required only for significant risk device
investigations.
Section 812.20 lists the data requirements for the original IDE
application, Sec. 812.25 lists the contents of the investigational
plan; and Sec. 812.27 lists the data relating to previous
investigations or testing. The information in the original IDE
application is evaluated by the Center for Devices and Radiological
Health to determine whether the proposed investigation will reasonably
protect the public health and safety, and for FDA to make a
determination to approve the IDE.
Upon approval of an IDE application by FDA, a sponsor must submit
certain requests and reports. Under Sec. 812.35, a sponsor who wishes
to make a change in the investigation that affects the scientific
soundness of the study or the rights, safety, or welfare of the
subjects, is required to submit a request for the change to FDA.
Section 812.150 requires a sponsor to submit reports to FDA. These
requests and reports are submitted to FDA as supplemental applications.
This information is needed for FDA to assure protection of human
subjects and to allow review of the study's progress. Section 812.36(c)
identifies the information necessary to file a treatment IDE
application. FDA uses this information to determine if wider
distribution of the device is in the interest of the public health.
Section 812.36(f) identifies the reports required to allow FDA to
monitor the size and scope of the treatment IDE, to assess the
sponsor's due diligence in obtaining marketing clearance of the device,
and to ensure the integrity of the controlled clinical trials.
Section 812.140 lists the recordkeeping requirements for
investigators and sponsors. FDA requires this information for tracking
and oversight purposes. Investigators are required to maintain records,
including correspondence and reports concerning the study, records of
receipt, use or disposition of devices, records of each subject's case
history and exposure to the device, informed consent documentation,
study protocol, and documentation of any deviation from the protocol.
Sponsors are required to maintain records including correspondence and
reports concerning the study, records of shipment and disposition,
signed investigator agreements, adverse device effects information,
and, for a nonsignificant risk device study, an explanation of the
nonsignificant risk determination, records of device name and intended
use, study objectives, investigator information, investigational review
board information, and statement on the extent that good manufacturing
practices will be followed.
For a nonsignificant risk device investigation, the investigators'
and sponsors' recordkeeping and reporting burden is reduced. Pertinent
records on the study must be maintained by both parties, and reports
are made to sponsors and institutional review boards (IRBs). Reports
are made to FDA only in certain circumstances, e.g., recall of the
device, the occurrence of unanticipated adverse effects, and as a
consequence of certain IRB actions. The estimate of the burden is based
on the number of IDEs received in recent years.
In the Federal Register of October 28, 2015 (80 FR 66009), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 12737]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Waivers--812.10................. 1 1 1 1 1
IDE Application--812.20, 812.25, 219 1 219 80 17,520
and 812.27.....................
Supplements--812.35 and 812.150. 579 6 3,474 6 20,844
Treatment IDE Applications-- 1 1 1 120 120
812.36(c)......................
Treatment IDE Reporting-- 1 1 1 20 20
812.36(f)......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 38,505
----------------------------------------------------------------------------------------------------------------
\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
Activity/21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Original--812.140.............. 219 1 219 10 2,190
Supplemental--812.140.......... 579 6 3,747 1 3,474
Nonsignificant--812.140........ 356 1 356 6 2,136
--------------------------------------------------------------------------------
Total...................... .............. ............... .............. .............. 7,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports for Nonsignificant Risk Studies--812.150.................. 1 1 1 6 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting burden for this extension has
decreased to 38,505 hours (previously 54,253 hours) as the result of a
decrease in the average number of applications and supplements
submitted. For the same reason, the recordkeeping burden has decreased
to 7,800 hours (previously 9,968). The previous approved total burden
hours of 64,227, have therefore decreased by 17,916 to 46,311.
Dated: March 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05385 Filed 3-9-16; 8:45 am]
BILLING CODE 4164-01-P
