Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records, 31022-31024 [2012-12590]
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31022
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices
Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–12591 Filed 5–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0477]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Investigational
Device Exemptions Reports and
Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
investigational device exemptions
reports and records.
DATES: Submit either electronic or
written comments on the collection of
information by July 23, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@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
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
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Jkt 226001
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.
Investigational Device Exemptions
Reports and Records—21 CFR Part 812
(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
PO 00000
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Fmt 4703
Sfmt 4703
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; § 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.
E:\FR\FM\24MYN1.SGM
24MYN1
31023
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices
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.
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
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
356
356
1
1
1
1
12
1
1
1
356
4,272
1
1
1
80
6
120
20
1
28,480
25,632
120
20
Total ..............................................................................
........................
........................
........................
........................
54,253
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
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 .........................................................
356
356
356
1
12
1
356
4,272
356
10
1
6
3,560
4,272
2,136
Totals ............................................................................
........................
........................
........................
........................
9,968
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
For a nonsignificant risk device
investigation, the investigator’s and
sponsor’s 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.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of respondents
Activity/21 CFR section
Reports for Nonsignificant Risk Studies/812.150 ................
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
Number of
disclosures
per respondent
1
Average
burden per
disclosure
Total annual
disclosures
1
1
are no capital costs or operating and maintenance costs associated with this collection of information.
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24MYN1
Total hours
6
6
31024
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Notices
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 0910–0636. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@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.
The estimate of the burden is based
on the number of IDEs received in the
last 3 years.
Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–12590 Filed 5–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0915]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Postmarketing Adverse
Event Reporting for Nonprescription
Human Drug Products Marketed
Without an Approved Application
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 June 25,
2012.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
Guidance for Industry on
Postmarketing Adverse Event Reporting
for Nonprescription
Human Drug Products Marketed
Without an Approved Application
(OMB Control Number 0910–0636)—
Extension.
Respondents to this collection of
information are manufacturers, packers,
and distributors whose name (under
section 502(b)(1) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act))
appears on the label of a
nonprescription drug marketed in the
United States.
FDA is requesting public comment on
estimates of annual submissions from
these respondents, as required by Public
Law 109–462 and described in the
guidance. This guidance document
discusses what should be included in a
serious adverse drug event report
submitted under section 760(b)(1) of the
FD&C Act, including follow-up reports
under 760(c)(2) of the FD&C Act, and
how to submit these reports. The
estimates for annual reporting burden
and recordkeeping are based on FDA’s
knowledge of adverse drug experience
reports historically submitted per year
for prescription drug products and for
nonprescription drug products marketed
under an approved application,
including knowledge about the time
needed to prepare the reports and to
maintain records.
FDA receives approximately 2,500
serious adverse event reports for
nonprescription drug products marketed
under approved applications, which
comprise approximately 20 percent of
the overall nonprescription drug market.
Based on this experience, we estimate
between 10,000 and 15,000 (i.e., 12,500)
total annual responses for
nonprescription drugs marketed without
an approved application.
In the Federal Register of December
27, 2011 (76 FR 80946), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments on the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................
50
250
12,500
2
25,000
Total ..............................................................................
........................
........................
........................
........................
25,000
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) of the FD&C Act also
requires that responsible persons
maintain records of nonprescription
adverse event reports, whether or not
the event is serious, for a period of 6
years. The guidance recommends that
responsible persons maintain records of
efforts to obtain the minimum data
elements for a report of a serious
adverse drug event and any followup
VerDate Mar<15>2010
16:31 May 23, 2012
Jkt 226001
reports. Although the guidance does not
provide recommendations on
recordkeeping activities generally under
section 760(e) of the FD&C Act, FDA is
providing an estimate for the burden of
this collection. Historically, serious
adverse event reports comprise
approximately two-thirds and
nonserious adverse event reports
comprise approximately one-third of the
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
total number of postmarketing adverse
event reports associated with drugs and
biologic therapeutics (except vaccines)
received by FDA. Based on this
generalization, FDA estimates the total
annual records to be approximately
20,000 records per year. FDA estimates
that it takes 5 hours to maintain each
record and the recordkeeping burden as
follows:
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31022-31024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12590]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0477]
Agency Information Collection Activities; Proposed Collection;
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 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 investigational device
exemptions reports and records.
DATES: Submit either electronic or written comments on the collection
of information by July 23, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@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.
Investigational Device Exemptions Reports and Records--21 CFR Part 812
(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.
[[Page 31023]]
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.
FDA estimates the burden of this collection of information as
follows:
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, 356 1 356 80 28,480
and 812.27.....................
Supplements/812.35 and 812.150.. 356 12 4,272 6 25,632
Treatment IDE applications/ 1 1 1 120 120
812.36(c)......................
Treatment IDE reporting/ 1 1 1 20 20
812.36(f)......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 54,253
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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.
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................ 356 1 356 10 3,560
Supplemental/812.140............ 356 12 4,272 1 4,272
Nonsignificant/812.140.......... 356 1 356 6 2,136
-------------------------------------------------------------------------------
Totals...................... .............. .............. .............. .............. 9,968
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
For a nonsignificant risk device investigation, the investigator's
and sponsor's 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.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Reports for Nonsignificant Risk 1 1 1 6 6
Studies/812.150................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 31024]]
The estimate of the burden is based on the number of IDEs received
in the last 3 years.
Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12590 Filed 5-23-12; 8:45 am]
BILLING CODE 4160-01-P
