Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Retailer Training Programs, 67043-67045 [2022-24218]
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Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a medical device will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the
medical device ANGELMED
GUARDIAN SYSTEM. ANGELMED
GUARDIAN SYSTEM is indicated for
use in patients who have had prior
acute coronary syndrome (ACS) events
and who remain at high risk for
recurrent ACS events. The ANGELMED
GUARDIAN SYSTEM is indicated as an
adjunct to patient recognized symptoms.
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The ANGELMED GUARDIAN SYSTEM
detects potential ongoing ACS events,
characterized by sustained ST segment
changes, and alerts the patient to seek
medical attention for those potential
ACS events. An ANGELMED
GUARDIAN SYSTEM alert is a more
accurate predictor of ACS events when
compared to patient recognized
symptoms alone and demonstrates a
reduced rate over time of patient
presentations without ACS events (false
positives) when compared to patient
recognized symptoms alone. In the
absence of symptoms, the ANGELMED
GUARDIAN SYSTEM may identify
asymptomatic ACS events and prompt
the patient to seek medical attention.
Subsequent to this approval, the USPTO
received a patent term restoration
application for ANGELMED GUARDIAN
SYSTEM (U.S. Patent No. 6,609,023)
from Angel Medical Systems, Inc., and
the USPTO requested FDA’s assistance
in determining this patent’s eligibility
for patent term restoration. In a letter
dated May 13, 2019, FDA advised the
USPTO that this medical device had
undergone a regulatory review period
and that the approval of ANGELMED
GUARDIAN SYSTEM represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
ANGELMED GUARDIAN SYSTEM is
4,037 days. Of this time, 2,916 days
occurred during the testing phase of the
regulatory review period, while 1,121
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: March 23, 2007. FDA has
verified the applicant’s claim that the
date the investigational device
exemption (IDE) for human tests to
begin, as required under section 520(g)
of the FD&C Act, became effective
March 23, 2007.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): March 16, 2015.
FDA has verified the applicant’s claim
that the premarket approval application
(PMA) for ANGELMED GUARDIAN
SYSTEM (PMA P150009) was initially
submitted March 16, 2015.
3. The date the application was
approved: April 9, 2018. FDA has
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67043
verified the applicant’s claim that PMA
P150009 was approved on April 9, 2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,827 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: November 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24216 Filed 11–4–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0350]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Tobacco Retailer
Training Programs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\07NON1.SGM
Notice.
07NON1
67044
Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
The Food and Drug
Administration (FDA, Agency, or we) 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.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by December
7, 2022.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0745. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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:
Tobacco Retailer Training Programs
OMB Control Number 0910–0745—
Extension
Tobacco products are governed by
chapter IX of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (sections
900 through 920) (21 U.S.C. 387 through
21 U.S.C. 387u). FDA intends to issue
regulations establishing standards for
approved tobacco retailer training
programs under section 906(d) of the
FD&C Act (21 U.S.C. 387f(d)). In the
interim, FDA published a guidance
document entitled ‘‘Tobacco Retailer
Training Programs (Revised)’’ (2018)
that can be downloaded at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
tobacco-retailer-training-programs. The
guidance is intended to assist tobacco
retailers to voluntarily implement
effective training programs for
employees.
The guidance discusses recommended
elements that should be covered in a
training program, such as: (1) Federal
laws restricting the access to, and the
advertising and promotion of, cigarettes,
smokeless, and covered tobacco
products; (2) the health and economic
effects of tobacco use, especially when
the tobacco use begins at a young age;
(3) written company policies against
sales to youth and other restrictions on
the access to, and the advertising and
promotion of, tobacco products; (4)
identification of the tobacco products
sold in the retail establishment that are
subject to the Federal laws and
regulations prohibiting their sale to
underage persons; (5) age verification
methods; (6) practical guidelines for
refusing sales; and (7) testing to ensure
that employees have the required
knowledge. The guidance recommends
that retailers require current and new
employees to take a written test prior to
selling tobacco products and that
refresher training be provided at least
annually and more frequently as
needed. The guidance recommends that
retailers maintain certain written
records documenting that all individual
employees have been trained and that
retailers retain these records for 4 years
in order to be able to provide evidence
of a training program during the 48month time period covered by the civil
money penalty schedules outlined in
the law.
The guidance also recommends that
retailers implement certain hiring and
management practices as part of an
effective retailer training program. The
guidance suggests that applicants and
current employees be notified both
verbally and in writing of the
importance of complying with laws
prohibiting the sales of tobacco products
to underage persons. In addition, FDA
recommends that retailers implement an
internal compliance check program and
document the procedures and corrective
actions for the program.
In the Federal Register of May 5, 2022
(87 FR 26766), 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity; guidance section IV
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Develop training program ....................................................
Develop written policy against sales to youth and employee acknowledgement .................................................
Develop internal compliance check program ......................
79,700
1
79,700
16
1,275,200
79,700
79,700
1
1
79,700
79,700
1
8
79,700
637,600
Total ..............................................................................
........................
........................
........................
........................
1,992,500
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
khammond on DSKJM1Z7X2PROD with NOTICES
Activity; guidance section IV
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Training program ................................................
Written policy against sales to youth and employee acknowledgement.
Internal compliance check program ...................
79,700
79,700
4
4
318,800
318,800
0.25 (15 minutes) ...........
0.10 (6 minutes) .............
79,700
31,880
79,700
2
159,400
0.5 (30 minutes) .............
79,700
Total .............................................................
........................
........................
........................
.........................................
191,280
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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67045
Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
FDA’s estimate of the number of
respondents in tables 1 and 2 is based
on data from the deeming rule Final
Regulatory Impact Analysis,1 which
showed there are an estimated 362,273
retail establishments that currently sell
tobacco products. The Agency reviewed
these numbers again for this notice, and
believe they are an accurate estimation.
We assume that 75 percent of tobacco
retailers already have some sort of age
and identification verification training
program in place. We expect that some
of those retailer training programs
already meet the elements in the
guidance, some retailers would update
their training program to meet the
elements in the guidance, and other
retailers would develop a training
program for the first time. Thus, we
estimate that two-thirds of tobacco
retailers would develop a training
program that meets the elements in the
guidance (66 percent of 362,273 =
239,100; then annualized to 79,700).
We have adjusted our burden estimate
and the number of respondents, which
has resulted in a decrease to the
currently approved burden and
respondent count. This adjustment is
based on available data estimating the
number of retail establishments that sell
tobacco products in the United States.
Additionally, the burden chart was
updated to reflect a change from an
estimation over the course of 3 years to
annualized burden.
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24218 Filed 11–4–22; 8:45 am]
BILLING CODE 4164–01–P
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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:
[Docket No. FDA–2013–N–0557]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarket
Surveillance of Medical Devices
AGENCY:
Postmarket Surveillance of Medical
Devices—21 CFR Part 822
OMB Control Number 0910–0449—
Extension
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: Submit written comments
(including recommendations) on the
collection of information by December
7, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0449. 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
SUMMARY:
Section 522 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360l)
authorizes FDA to require a
manufacturer to conduct postmarket
surveillance (PS) of any device that
meets the criteria set forth in the statute.
The PS regulation establishes
procedures that FDA uses to approve
and disapprove PS plans. The regulation
provides instructions to manufacturers,
so they know what information is
required in a PS plan submission. FDA
reviews PS plan submissions in
accordance with 21 CFR 822.15 through
822.19 of the regulation, which describe
the grounds for approving or
disapproving a PS plan. In addition, the
PS regulation provides instructions to
manufacturers to submit interim and
final reports in accordance with 21 CFR
822.38. Respondents to this collection of
information are those manufacturers
that require PS of their products.
In the Federal Register of May 27,
2022 (87 FR 32169), 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR part/activity
Average
burden per
response
Total annual
responses
Total hours
§§ 822.9 and 822.10; PS submission ..................................
§ 822.21; Changes to PS plan after approval .....................
§ 822.28; Changes to PS plan for a device that is no
longer marketed ...............................................................
§ 822.29; Waiver ..................................................................
§ 822.30; Exemption request ...............................................
§ 822.38; Periodic reports ....................................................
5
9
1
1
5
9
120
40
600
360
1
0
0
17
1
0
0
3
1
0
0
51
8
40
40
40
8
0
0
2,040
Total ..............................................................................
........................
........................
........................
........................
3,008
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Reporting Burden
Estimate: The burden captured in table
1 is based on the data from FDA’s
internal tracking system. 21 CFR 822.26,
822.27, and 822.34 do not constitute
information collection subject to review
1 Deeming Tobacco Products to be Subject to the
[Federal] Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking Prevention and
Tobacco Control Act: Final Regulatory Impact
Analysis, 2016 https://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/Reports/
EconomicAnalyses/UCM500254.pdf.
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07NON1
]]>Agencies
[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67043-67045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24218]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0350]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Tobacco Retailer
Training Programs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 67044]]
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by December 7, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0745. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
Tobacco Retailer Training Programs
OMB Control Number 0910-0745--Extension
Tobacco products are governed by chapter IX of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (sections 900 through 920) (21 U.S.C.
387 through 21 U.S.C. 387u). FDA intends to issue regulations
establishing standards for approved tobacco retailer training programs
under section 906(d) of the FD&C Act (21 U.S.C. 387f(d)). In the
interim, FDA published a guidance document entitled ``Tobacco Retailer
Training Programs (Revised)'' (2018) that can be downloaded at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-retailer-training-programs. The guidance is intended to assist
tobacco retailers to voluntarily implement effective training programs
for employees.
The guidance discusses recommended elements that should be covered
in a training program, such as: (1) Federal laws restricting the access
to, and the advertising and promotion of, cigarettes, smokeless, and
covered tobacco products; (2) the health and economic effects of
tobacco use, especially when the tobacco use begins at a young age; (3)
written company policies against sales to youth and other restrictions
on the access to, and the advertising and promotion of, tobacco
products; (4) identification of the tobacco products sold in the retail
establishment that are subject to the Federal laws and regulations
prohibiting their sale to underage persons; (5) age verification
methods; (6) practical guidelines for refusing sales; and (7) testing
to ensure that employees have the required knowledge. The guidance
recommends that retailers require current and new employees to take a
written test prior to selling tobacco products and that refresher
training be provided at least annually and more frequently as needed.
The guidance recommends that retailers maintain certain written records
documenting that all individual employees have been trained and that
retailers retain these records for 4 years in order to be able to
provide evidence of a training program during the 48-month time period
covered by the civil money penalty schedules outlined in the law.
The guidance also recommends that retailers implement certain
hiring and management practices as part of an effective retailer
training program. The guidance suggests that applicants and current
employees be notified both verbally and in writing of the importance of
complying with laws prohibiting the sales of tobacco products to
underage persons. In addition, FDA recommends that retailers implement
an internal compliance check program and document the procedures and
corrective actions for the program.
In the Federal Register of May 5, 2022 (87 FR 26766), 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:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; guidance section IV Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Develop training program........ 79,700 1 79,700 16 1,275,200
Develop written policy against 79,700 1 79,700 1 79,700
sales to youth and employee
acknowledgement................
Develop internal compliance 79,700 1 79,700 8 637,600
check program..................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,992,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; guidance section IV Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Training program.......................... 79,700 4 318,800 0.25 (15 minutes)........................... 79,700
Written policy against sales to youth and 79,700 4 318,800 0.10 (6 minutes)............................ 31,880
employee acknowledgement.
Internal compliance check program......... 79,700 2 159,400 0.5 (30 minutes)............................ 79,700
-------------------------------------------------------------------------------------------------------------
Total................................. .............. .............. .............. ............................................ 191,280
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 67045]]
FDA's estimate of the number of respondents in tables 1 and 2 is
based on data from the deeming rule Final Regulatory Impact
Analysis,\1\ which showed there are an estimated 362,273 retail
establishments that currently sell tobacco products. The Agency
reviewed these numbers again for this notice, and believe they are an
accurate estimation. We assume that 75 percent of tobacco retailers
already have some sort of age and identification verification training
program in place. We expect that some of those retailer training
programs already meet the elements in the guidance, some retailers
would update their training program to meet the elements in the
guidance, and other retailers would develop a training program for the
first time. Thus, we estimate that two-thirds of tobacco retailers
would develop a training program that meets the elements in the
guidance (66 percent of 362,273 = 239,100; then annualized to 79,700).
---------------------------------------------------------------------------
\1\ Deeming Tobacco Products to be Subject to the [Federal]
Food, Drug, and Cosmetic Act, as Amended by the Family Smoking
Prevention and Tobacco Control Act: Final Regulatory Impact
Analysis, 2016 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf.
---------------------------------------------------------------------------
We have adjusted our burden estimate and the number of respondents,
which has resulted in a decrease to the currently approved burden and
respondent count. This adjustment is based on available data estimating
the number of retail establishments that sell tobacco products in the
United States. Additionally, the burden chart was updated to reflect a
change from an estimation over the course of 3 years to annualized
burden.
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24218 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P
