Submission for OMB Review; 30 Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA), 46589-46591 [2015-19253]
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Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
professionals. In May 2011, FDA
convened a joint meeting of the
Nonprescription Drugs Advisory
Committee and the Pediatric Advisory
Committee to discuss the use of
acetaminophen in children. Shortly
before the meeting, the Consumer
Healthcare Products Association
(CHPA) proposed to voluntarily phase
out all of the existing single-ingredient
concentrated drop formulations of the
OTC, pediatric, oral, liquid
acetaminophen drug products and
market only the 160 mg/5 mL. At the
Advisory Committee meeting, FDA took
note of CHPA’s voluntary transition to
a single concentration of pediatric oral
liquid acetaminophen.
In response to CHPA’s voluntary
transition to a single concentration of
OTC oral liquid acetaminophen
products, FDA published a Drug Safety
Communication on December 22, 2011,
to inform the public of the 160 mg/5 mL
concentration now marketed for
children ages 2 to 3 years and to
recommend that end users of the
product read the Drug Facts label to
identify the concentration of the oral
liquid acetaminophen, dosage, and
directions for use.
FDA issued the draft guidance on
October 8, 2014 (79 FR 60854), to
address ongoing concerns about the
potential for acetaminophen overdose
associated with these products and to
encourage safer use. Comments on the
draft guidance were considered while
finalizing this guidance, which has been
revised and clarified in some respects.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on addressing safety
achieved through drug product design
and labeling to minimize medication
errors. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
VerDate Sep<11>2014
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III. Paperwork Reduction Act of 1995
This guidance refers to a previously
approved collection of information
found in FDA regulations. The
collection of information is subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3520). The collection of
information referenced in this guidance
that pertain to the format and content
requirements for OTC drug product
labeling (§ 201.66) have been approved
under OMB control number 0910–0340.
The labeling requirements in § 201.326
are not subject to review by OMB
because they do not constitute a
‘‘collection of information’’ under the
PRA. Rather, the labeling statements are
a ‘‘public disclosure of information
originally supplied by the Federal
government to the recipient for the
purpose of disclosure to the public’’ (5
CFR 1320.3(c)(2)).
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–19178 Filed 8–4–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Open Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Institute Clinical Trials
and Translational Research Advisory
Committee.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The meeting
will also be videocast and can be
accessed from the NIH Videocasting and
Podcasting Web site (https://videocast.
nih.gov/).
Name of Committee: National Cancer
Institute Clinical Trials and Translational
Research Advisory Committee.
PO 00000
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46589
Date: November 4, 2015.
Time: 8:30 a.m. to 4:00 p.m.
Agenda: Strategic Discussion of NCI’s
Clinical and Translational Research
Programs.
Place: National Institutes of Health,
Building 31, C-Wing, 6th Floor, Room 10, 31
Center Drive, Bethesda, MD 20892.
Contact Person: Sheila A. Prindiville, MD,
MPH, Director, Coordinating Center for
Clinical Trials, National Institutes of Health,
National Cancer Institute, 9609 Medical
Center Drive, Room 6W136, Rockville, MD
20850, 240–276–6173, prindivs@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/ctac/ctac.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: July 31, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–19193 Filed 8–4–15; 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; Post-Award
Reporting Requirements Including
Research Performance Progress
Report Collection (OD/OPERA)
Under the provisions of
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
SUMMARY:
E:\FR\FM\05AUN1.SGM
05AUN1
46590
Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices
listed below. This proposed information
collection was previously published in
the Federal Register on March 16, 2015,
Volume 80, No. 50, pages 13568–13569
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 NIH 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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: Desk Officer for NIH.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
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: Ms. Mikia Currie,
Division of Grants Policy, Office of
Policy for Extramural Research
Administration, NIH, Rockledge 1
Building, Room 3505, 6705 Rockledge
Drive, Bethesda, MD 20892–7974, or
call non-toll-free number (301) 435–
0941, or Email your request, including
your address to:
ProjectClearanceBranch@mail.nih.gov.
Proposed Collection: Public Health
Service (PHS) Post-award Reporting
Requirements. Revision, OMB 0925–
0002, Expiration Date 8/31/2015. Form
numbers: PHS 2590, PHS 416–7, PHS
2271, PHS 3734, PHS 6031–1, and HHS
568.
Need and Use of Information
Collection: The RPPR is now required to
be used by all NIH, Food and Drug
Administration, Centers for Disease
Control and Prevention, and Agency for
Healthcare Research and Quality
(AHRQ) grantees. Interim progress
reports are required to continue support
of a PHS grant for each budget year
within a competitive segment. The
phased transition to the RPPR required
the maintenance of dual reporting
processes for a period of time.
Continued use of the PHS Noncompeting Continuation Progress Report
(PHS 2590), exists for a small group of
grantees. This collection also includes
other PHS post-award reporting
requirements: PHS 416–7 NRSA
Termination Notice, PHS 2271
Statement of Appointment, 6031–1
NRSA Annual Payback Activities
Certification, HHS 568 Final Invention
Statement and Certification, Final
Progress Report instructions, iEdison,
and PHS 3734 Statement Relinquishing
Interests and Rights in a PHS Research
Grant. The PHS 416–7, 2271, and 6031–
1 are used by NRSA recipients to
activate, terminate, and provide for
payback of a NRSA. Closeout of an
award requires a Final Invention
Statement (HHS 568) and Final Progress
Report. iEdison allows grantees and
federal agencies to meet statutory
requirements for reporting inventions
and patents. The PHS 3734 serves as the
official record of grantee relinquishment
of a PHS award when an award is
transferred from one grantee institution
to another. The SBIR/STTR Life Cycle
Certifications are completed by small
business grantees once certain
milestones are reached during the
project period. Pre-award reporting
requirements are simultaneously
consolidated under 0925–0001.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
531,802.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Information collection forms
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Total
annual
burden
hours
Reporting
12,580
1,778
11,180
5,697
22,035
243
32,098
2,544
758
2,544
480
32,341
479
11,125
1,330
1
1
1
1
1
1
1
1
1
1
1
3
1
1
1
30/60
20/60
5/60
15/60
15/60
15
15
2
4
1
15/60
5/60
30/60
1
1
6,290
593
932
1,424
5,509
3,645
481,470
5,088
3,032
2,544
120
8,085
240
11,125
1,330
Reporting Burden Total ............................................................................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
PHS 416–7 ......................................................................................................
PHS 6031–1 ....................................................................................................
PHS 568 ..........................................................................................................
iEdison .............................................................................................................
PHS 2271 ........................................................................................................
PHS 2590 ........................................................................................................
RPPR ...............................................................................................................
Biosketch .........................................................................................................
Data Tables .....................................................................................................
PHS Inclusion Enrollment Report ....................................................................
Trainee Diversity Report ..................................................................................
Publication Reporting .......................................................................................
PHS 3734 ........................................................................................................
Final Progress Report ......................................................................................
SBIR/STTR Phase II Final Progress Report ...................................................
........................
........................
........................
531,427
Recordkeeping
SBIR/STTR Life Cycle Certification .................................................................
1,500
1
15/60
375
Grand Total .......................................................................................
........................
........................
........................
531,802
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E:\FR\FM\05AUN1.SGM
05AUN1
Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices
Dated: July 29, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015–19253 Filed 8–4–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary
and Integrative Health; Notice of
Meeting
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council for
Complementary and Integrative Health.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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 Advisory
Council for Complementary and Integrative
Health.
Date: August 26, 2015.
Open: 1:00 p.m. to 1:15 p.m.
Agenda: Concept Review—Mechanistic
Studies of Complementary and Integrative
Mind and Body and Body Interventions
Supported by NCCIH.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Closed: 1:20 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Martin H. Goldrosen,
Ph.D., Director, Division of Extramural
Activities, National Center for
Complementary and Integrative Health, NIH,
6707 Democracy Blvd., Ste. 401, Bethesda,
MD 20892–5475, (301) 594–2014, goldrosm@
mail.nih.gov.
VerDate Sep<11>2014
16:54 Aug 04, 2015
Jkt 235001
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
nccih.nih.gov/about/naccih, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: July 30, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–19174 Filed 8–4–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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 Institute on
Aging Special Emphasis Panel; Albert
Einstein Aging Study.
Date: September 17, 2015.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Carmen Moten, MPH,
Ph.D., Scientific Review Officer, National
PO 00000
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46591
Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–402–7703, cmoten@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: July 31, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–19192 Filed 8–4–15; 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; PHS Applications
and Pre-Award Reporting
Requirements (OD/OPERA)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act (PRA) of 1995, the Office
of the Director (OD), Office of
Extramural Research (OER), 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. This proposed
information collection was previously
published in the Federal Register on
March 16, 2015, Volume 80, No. 50,
pages 13567–13568 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 NIH
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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time should be sent via email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
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 Ms. Mikia Currie,
SUMMARY:
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Pages 46589-46591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19253]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30 Day Comment Request; Post-Award
Reporting Requirements Including Research Performance Progress Report
Collection (OD/OPERA)
SUMMARY: Under the provisions of 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
[[Page 46590]]
listed below. This proposed information collection was previously
published in the Federal Register on March 16, 2015, Volume 80, No. 50,
pages 13568-13569 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 NIH 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
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: Ms. Mikia Currie, Division of Grants Policy,
Office of Policy for Extramural Research Administration, NIH, Rockledge
1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974,
or call non-toll-free number (301) 435-0941, or Email your request,
including your address to: ProjectClearanceBranch@mail.nih.gov.
Proposed Collection: Public Health Service (PHS) Post-award
Reporting Requirements. Revision, OMB 0925-0002, Expiration Date 8/31/
2015. Form numbers: PHS 2590, PHS 416-7, PHS 2271, PHS 3734, PHS 6031-
1, and HHS 568.
Need and Use of Information Collection: The RPPR is now required to
be used by all NIH, Food and Drug Administration, Centers for Disease
Control and Prevention, and Agency for Healthcare Research and Quality
(AHRQ) grantees. Interim progress reports are required to continue
support of a PHS grant for each budget year within a competitive
segment. The phased transition to the RPPR required the maintenance of
dual reporting processes for a period of time. Continued use of the PHS
Non-competing Continuation Progress Report (PHS 2590), exists for a
small group of grantees. This collection also includes other PHS post-
award reporting requirements: PHS 416-7 NRSA Termination Notice, PHS
2271 Statement of Appointment, 6031-1 NRSA Annual Payback Activities
Certification, HHS 568 Final Invention Statement and Certification,
Final Progress Report instructions, iEdison, and PHS 3734 Statement
Relinquishing Interests and Rights in a PHS Research Grant. The PHS
416-7, 2271, and 6031-1 are used by NRSA recipients to activate,
terminate, and provide for payback of a NRSA. Closeout of an award
requires a Final Invention Statement (HHS 568) and Final Progress
Report. iEdison allows grantees and federal agencies to meet statutory
requirements for reporting inventions and patents. The PHS 3734 serves
as the official record of grantee relinquishment of a PHS award when an
award is transferred from one grantee institution to another. The SBIR/
STTR Life Cycle Certifications are completed by small business grantees
once certain milestones are reached during the project period. Pre-
award reporting requirements are simultaneously consolidated under
0925-0001.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 531,802.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total annual
Information collection forms respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Reporting
----------------------------------------------------------------------------------------------------------------
PHS 416-7....................................... 12,580 1 30/60 6,290
PHS 6031-1...................................... 1,778 1 20/60 593
PHS 568......................................... 11,180 1 5/60 932
iEdison......................................... 5,697 1 15/60 1,424
PHS 2271........................................ 22,035 1 15/60 5,509
PHS 2590........................................ 243 1 15 3,645
RPPR............................................ 32,098 1 15 481,470
Biosketch....................................... 2,544 1 2 5,088
Data Tables..................................... 758 1 4 3,032
PHS Inclusion Enrollment Report................. 2,544 1 1 2,544
Trainee Diversity Report........................ 480 1 15/60 120
Publication Reporting........................... 32,341 3 5/60 8,085
PHS 3734........................................ 479 1 30/60 240
Final Progress Report........................... 11,125 1 1 11,125
SBIR/STTR Phase II Final Progress Report........ 1,330 1 1 1,330
---------------------------------------------------------------
Reporting Burden Total...................... .............. .............. .............. 531,427
----------------------------------------------------------------------------------------------------------------
Recordkeeping
----------------------------------------------------------------------------------------------------------------
SBIR/STTR Life Cycle Certification.............. 1,500 1 15/60 375
---------------------------------------------------------------
Grand Total............................. .............. .............. .............. 531,802
----------------------------------------------------------------------------------------------------------------
[[Page 46591]]
Dated: July 29, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-19253 Filed 8-4-15; 8:45 am]
BILLING CODE 4140-01-P
