Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine), 7743-7745 [2023-02381]
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7743
Federal Register / Vol. 88, No. 24 / Monday, February 6, 2023 / Notices
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN—NONREGISTERED NON-LICENSED COMMERCIAL FEED MILLS 1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section
Total annual
records
Average burden per
recordkeeping
Total hours
225.142 requires procedures for identification, storage, and inventory
control (receipt and use) of Type A medicated articles and Type B
medicated feeds.
225.158 requires records of investigation and corrective action when the
results of laboratory assays of drug components indicate that the medicated feed is not in accord with the permissible assay limits.
225.180 requires identification, storage, and inventory control of labeling
in a manner that prevents label mix-ups and assures that correct labels
are used for medicated feeds.
225.202 requires records of formulation, production, and distribution of
medicated feeds.
4,357
4
17,428
1 ..................................
17,428
4,357
1
4,357
4 ..................................
17,428
4,357
96
418,272
0.12 (7 minutes) .........
50,193
4,357
260
1,132,820
0.65 (39 minutes) .......
736,333
Total ......................................................................................................
........................
........................
........................
.....................................
821,382
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN—NONREGISTERED NON-LICENSED MIXER/FEEDERS 1
Total annual
records
Average burden per
recordkeeper
Total hours
225.142 requires procedures for identification, storage, and inventory
control (receipt and use) of Type A medicated articles and Type B
medicated feeds.
225.158 requires records of investigation and corrective action when the
results of laboratory assays of drug components indicate that the medicated feed is not in accord with the permissible assay limits.
225.180 requires identification, storage, and inventory control of labeling
in a manner that prevents label mix-ups and assures that correct labels
are used for medicated feeds.
225.202 requires records of formulation, production, and distribution of
medicated feeds.
3,400
4
13,600
1 ..................................
13,600
3,400
1
3,400
4 ..................................
13,600
3,400
32
108,800
0.12 (7 minutes) .........
13,056
3,400
260
884,000
0.33 (20 minutes) .......
291,720
Total ......................................................................................................
........................
........................
........................
.....................................
331,976
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall decrease of 10,435 hours and an
increase of 831,545 records since last
OMB approval. We attribute this
adjustment due to an increase in the
number of non-registered, non-licensed
commercial medicated feed mills and
decrease in non-licensed medicated feed
mill recordkeeping the last few years.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Name of Committee: National Center for
Complementary and Integrative Health
Special Emphasis Panel; Research Resource
Center to Build an Open-Access Repository
and Database for Anatomical and
Physiological Correlates of Acupoints (U24,
Clinical Trial Optional).
Date: March 3, 2023.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Center for Complementary
and Integrative Democracy II, 6707
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Shiyong Huang, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, Division of Extramural Activities,
NCCIH/NIH, 6707 Democracy Boulevard,
Suite 401, Bethesda, MD 20817,
shiyong.huang@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
[FR Doc. 2023–02446 Filed 2–3–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DDrumheller on DSK120RN23PROD with NOTICES
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section
National Center for Complementary &
Integrative Health; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
VerDate Sep<11>2014
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in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: February 1, 2023.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–02462 Filed 2–3–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank
(National Library of Medicine)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
SUMMARY:
E:\FR\FM\06FEN1.SGM
06FEN1
7744
Federal Register / Vol. 88, No. 24 / Monday, February 6, 2023 / Notices
Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Christeenna
Iraheta, Office of Administrative and
Management Analysis Services,
National Library of Medicine, Building
38A, Room B2N12A, 8600 Rockville
Pike, Bethesda, MD 20894, or call nontoll-free number (301) 480–7605, or
Email your request, including your
address to: Christeenna.iraheta@
nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on November 15, 2022, pages
68508–9 (87 FR 68508) and allowed 60
DATES:
by title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) and by the Clinical
Trials Registration and Results
Information Submission regulations at
42 CFR part 11. ClinicalTrials.gov
collects registration and results
information for clinical trials and other
types of clinical studies (e.g.,
observational studies and patient
registries) with the objectives of
enhancing patient enrollment and
providing a mechanism for tracking
subsequent progress of clinical studies
to the benefit of public health. It is
widely used by patients, physicians,
and medical researchers; in particular
those involved in clinical research.
While many clinical studies are
registered and results information
submitted voluntarily, 42 CFR part 11
requires the registration and submission
of results information for certain
applicable clinical trials of drug,
biological, and device products whether
or not they are approved, licensed, or
cleared by the Food and Drug
Administration.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,219,801.
days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Library of Medicine (NLM),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank, 0925–
0586, Expiration Date 02/28/2023—
EXTENSION, National Library of
Medicine (NLM), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Institutes of
Health operates ClinicalTrials.gov,
which was established as a clinical trial
registry under section 113 of the Food
and Drug Administration Modernization
Act of 1997 (Pub. L. 105–115) and was
expanded to include a results data bank
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Submission type
Number of
responses per
respondent
Average
time per
response
(in hours)
Total
annual
burden
hours
Registration—attachment 2
Initial .................................................................................................................
Updates ............................................................................................................
Triggered, voluntary .........................................................................................
Initial, non-regulated, NIH Policy .....................................................................
Updates, non-regulated, NIH Policy ................................................................
Initial, voluntary and non-regulated .................................................................
Updates, voluntary and non-regulated ............................................................
7,400
7,400
141
940
940
17,860
17,860
1
8
1
1
8
1
8
8
2
8
8
2
8
2
59,200
118,400
1,128
7,520
15,040
142,880
285,760
7,400
7,400
47
940
940
1,400
1,400
1
2
1
1
2
1
2
40
10
45
40
10
40
10
296,000
148,000
2,115
37,600
18,800
56,000
28,000
Certification to delay results—attachment 6 ....................................................
Extension request and Appeal—attachment 7 ................................................
Initial, expanded access—attachment 3 ..........................................................
Updates, expanded access—attachment 3 .....................................................
5,150
125
213
213
1
1
1
2
30/60
2
2
15/60
2,575
250
426
107
Total ..........................................................................................................
77,769
271,122
........................
1,219,801
Results Information Submission—attachment 5
DDrumheller on DSK120RN23PROD with NOTICES
Initial .................................................................................................................
Updates ............................................................................................................
Triggered, voluntary—also attachment 2 ........................................................
Initial, non-regulated, NIH Policy .....................................................................
Updates, non-regulated, NIH Policy ................................................................
Initial, voluntary and non-regulated .................................................................
Updates, voluntary and non-regulated ............................................................
Other
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Federal Register / Vol. 88, No. 24 / Monday, February 6, 2023 / Notices
Dated: January 31, 2023.
Christeenna M. Iraheta,
Project Clearance Liaison, National Library
of Medicine, National Institutes of Health.
[FR Doc. 2023–02381 Filed 2–3–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel; Center Core Grants
for Vision Research (P30) and R13
Conference Grants.
Date: March 9, 2023.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Eye Institute, 6700B
Rockledge Drive, Bethesda, MD 20817
(Virtual Meeting).
Contact Person: Jeanette M Hosseini, Ph.D.,
Scientific Review Officer, National Eye
Institute, National Institutes of Health, 6700
B Rockledge Drive, Bethesda, MD 20892,
301–451–2020, jeanetteh@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.867, Vision Research,
National Institutes of Health, HHS)
Dated: February 1, 2023.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–02461 Filed 2–3–23; 8:45 am]
DDrumheller on DSK120RN23PROD with NOTICES
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
VerDate Sep<11>2014
18:51 Feb 03, 2023
Jkt 259001
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Genes, Genomes, and
Genetics Integrated Review Group;
Therapeutic Approaches to Genetic Diseases
Study Section.
Date: March 1–2, 2023.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
North Bethesda, MD 20852.
Contact Person: Karobi Moitra, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 480–6893, karobi.moitra@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topics: Vision Imaging, Bioengineering and
Low Vision Technology Development.
Date: March 2–3, 2023.
Time: 8:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Susan Gillmor, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (240) 762–3076, susan.gillmor@
nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Oral, Dental and Craniofacial Sciences Study
Section.
Date: March 2–3, 2023.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Yi-Hsin Liu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, (301) 435–
1781, liuyh@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Organization and Delivery of Health Services
Study Section.
Date: March 2–3, 2023.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
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7745
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Catherine Hadeler
Maulsby, MPH, Ph.D., Scientific Review
Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, (301) 435–1266,
maulsbych@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–20–
117: Maximizing Investigators’ Research
Award (MIRA) for Early-Stage Investigators
(R35—Clinical Trial Optional).
Date: March 2–3, 2023.
Time: 9:00 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Anita Szajek, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4187,
Bethesda, MD 20892, 301–827–6276,
anita.szajek@nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Interdisciplinary Clinical Care in Specialty
Care Settings Study Section.
Date: March 2–3, 2023.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Abu Saleh Mohammad
Abdullah, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (301) 827–4043,
abuabdullah.abdullah@nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Neural Oxidative Metabolism
and Death Study Section.
Date: March 2–3, 2023.
Time: 9:00 a.m. to 9:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Christine Jean DiDonato,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1014J,
Bethesda, MD 20892, (301) 435–1042,
didonatocj@csr.nih.gov.
Name of Committee: Infectious Diseases
and Immunology B Integrated Review Group;
Bacterial-Host Interactions Study Section
(BHI).
Date: March 2–3, 2023.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Holiday Inn Capitol, 550 C Street
SW, Washington, DC 20024.
Contact Person: Uma Basavanna, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
E:\FR\FM\06FEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7743-7745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02381]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Information
Program on Clinical Trials: Maintaining a Registry and Results Databank
(National Library of Medicine)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below.
[[Page 7744]]
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30-days of the date of
this publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Christeenna Iraheta, Office of Administrative and
Management Analysis Services, National Library of Medicine, Building
38A, Room B2N12A, 8600 Rockville Pike, Bethesda, MD 20894, or call non-
toll-free number (301) 480-7605, or Email your request, including your
address to: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on November 15, 2022,
pages 68508-9 (87 FR 68508) and allowed 60 days for public comment. No
public comments were received. The purpose of this notice is to allow
an additional 30 days for public comment. The National Library of
Medicine (NLM), National Institutes of Health, may not conduct or
sponsor, and the respondent is not required to respond to, an
information collection that has been extended, revised, or implemented
on or after October 1, 1995, unless it displays a currently valid OMB
control number.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, the National Institutes of Health (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below.
Proposed Collection: Information Program on Clinical Trials:
Maintaining a Registry and Results Databank, 0925-0586, Expiration Date
02/28/2023--EXTENSION, National Library of Medicine (NLM), National
Institutes of Health (NIH).
Need and Use of Information Collection: The National Institutes of
Health operates ClinicalTrials.gov, which was established as a clinical
trial registry under section 113 of the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include
a results data bank by title VIII of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) and by the Clinical Trials Registration
and Results Information Submission regulations at 42 CFR part 11.
ClinicalTrials.gov collects registration and results information for
clinical trials and other types of clinical studies (e.g.,
observational studies and patient registries) with the objectives of
enhancing patient enrollment and providing a mechanism for tracking
subsequent progress of clinical studies to the benefit of public
health. It is widely used by patients, physicians, and medical
researchers; in particular those involved in clinical research. While
many clinical studies are registered and results information submitted
voluntarily, 42 CFR part 11 requires the registration and submission of
results information for certain applicable clinical trials of drug,
biological, and device products whether or not they are approved,
licensed, or cleared by the Food and Drug Administration.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 1,219,801.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Submission type Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Registration--attachment 2
----------------------------------------------------------------------------------------------------------------
Initial......................................... 7,400 1 8 59,200
Updates......................................... 7,400 8 2 118,400
Triggered, voluntary............................ 141 1 8 1,128
Initial, non-regulated, NIH Policy.............. 940 1 8 7,520
Updates, non-regulated, NIH Policy.............. 940 8 2 15,040
Initial, voluntary and non-regulated............ 17,860 1 8 142,880
Updates, voluntary and non-regulated............ 17,860 8 2 285,760
----------------------------------------------------------------------------------------------------------------
Results Information Submission--attachment 5
----------------------------------------------------------------------------------------------------------------
Initial......................................... 7,400 1 40 296,000
Updates......................................... 7,400 2 10 148,000
Triggered, voluntary--also attachment 2......... 47 1 45 2,115
Initial, non-regulated, NIH Policy.............. 940 1 40 37,600
Updates, non-regulated, NIH Policy.............. 940 2 10 18,800
Initial, voluntary and non-regulated............ 1,400 1 40 56,000
Updates, voluntary and non-regulated............ 1,400 2 10 28,000
----------------------------------------------------------------------------------------------------------------
Other
----------------------------------------------------------------------------------------------------------------
Certification to delay results--attachment 6.... 5,150 1 30/60 2,575
Extension request and Appeal--attachment 7...... 125 1 2 250
Initial, expanded access--attachment 3.......... 213 1 2 426
Updates, expanded access--attachment 3.......... 213 2 15/60 107
---------------------------------------------------------------
Total....................................... 77,769 271,122 .............. 1,219,801
----------------------------------------------------------------------------------------------------------------
[[Page 7745]]
Dated: January 31, 2023.
Christeenna M. Iraheta,
Project Clearance Liaison, National Library of Medicine, National
Institutes of Health.
[FR Doc. 2023-02381 Filed 2-3-23; 8:45 am]
BILLING CODE 4140-01-P
