Agency Forms Undergoing Paperwork Reduction Act Review, 74064-74066 [2011-30832]
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emcdonald on DSK5VPTVN1PROD with NOTICES
74064
Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / Notices
Review Officers (MROs) and HHS
approval of entities that certify MROs.
Subpart M—Medical Review Officer
(MRO), Section 13.1(b), ‘‘Who may serve
as an MRO?’’ states as follows:
‘‘Nationally recognized entities that
certify MROs or subspecialty boards for
physicians performing a review of
Federal employee drug testing results
that seek approval by the Secretary must
submit their qualifications and a sample
examination. Based on an annual
objective review of the qualifications
and content of the examination, the
Secretary shall publish a list in the
Federal Register of those entities and
boards that have been approved.’’
HHS has completed its review of
entities that train and certify MROs, in
accordance with requests submitted by
such entities to HHS.
(1) The HHS Secretary approves the
following MRO certifying entities that
offer both MRO training and
certification through examination:
American Association of Medical
Review Officers (AAMRO), P.O. Box
12873, Research Triangle Park, NC
27709, Phone: (800) 489–1839, Fax:
(919) 490–1010, Email: cferrell@
aamro.com, Web site: https://www.
aamro.com/.
Medical Review Officer Certification
Council (MROCC), 836 Arlington
Heights Road, #327, Elk Grove
Village, IL 60007, Phone: (847) 631–
0599, Fax: (847) 483–1282, Email:
mrocc@mrocc.org, Web site: https://
www.mrocc.org/.
(2) The HHS Secretary lists the
following entities that offer MRO
training as a prerequisite for MRO
certification:
American College of Occupational and
Environmental Medicine (ACOEM),
25 Northwest Point Boulevard, Suite
700, Elk Grove Village, IL 60007–
1030, Phone: (847) 818–1800, Fax:
(847) 818–9266, Contact Form: https://
www.acoem.org/contactacoem.aspx,
Web site: https://www.acoem.org/.
American Society of Addiction
Medicine (ASAM), 4601 N. Park
Avenue, Upper Arcade #101, Chevy
Chase, MD 20815, Phone: (301) 656–
3920, Fax: (301) 656–3815, Email:
email@asam.org, Web site: https://
www.asam.org/.
DATES: HHS approval is effective
November 30, 2011.
FOR FURTHER INFORMATION CONTACT:
Jennifer Fan, Pharm.D., J.D., Division of
Workplace Programs (DWP), Center for
Substance Abuse Prevention (CSAP),
Substance Abuse and Mental Health
Services Administration (SAMHSA), 1
VerDate Mar<15>2010
17:30 Nov 29, 2011
Jkt 226001
Choke Cherry Road, Room 2–1031,
Rockville, MD 20857; Telephone: (240)
276–1759; Email: jennifer.fan@
samhsa.hhs.gov.
Dated: November 21, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011–30846 Filed 11–29–11; 8:45 am]
BILLING CODE ;P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–12–0666]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
National Healthcare Safety Network
(NHSN) (OMB No. 0920–0666 exp.
3/31/2012)—Revision—National Center
for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The National Healthcare Safety
Network (NHSN) is a system designed to
accumulate, exchange, and integrate
relevant information and resources
among private and public stakeholders
to support local and national efforts to
protect patients and to promote
healthcare safety. Specifically, the data
is used to determine the magnitude of
various healthcare-associated adverse
events and trends in the rates of these
events among patients and healthcare
workers with similar risks. Healthcare
institutions that participate in NHSN
voluntarily report their data to CDC
using a web browser based technology
for data entry and data management.
Data are collected by trained
surveillance personnel using written
standardized protocols. The data will be
used to detect changes in the
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
epidemiology of adverse events
resulting from new and current medical
therapies and changing risks.
This revision submission includes an
amended Assurance of Confidentiality,
which required an update of the
Assurance of Confidentiality language
on all forms included in the NHSN
surveillance system. The scope of NHSN
dialysis surveillance is being expanded
to include all outpatient dialysis centers
so that the existing Dialysis Annual
Survey can be used to facilitate
prevention objectives set forth in the
HHS HAI tier 2 Action Plan and to
assess national practices in all
Medicare-certified dialysis centers if
CMS re-establishes this survey method
(as expected). The Patient Safety (PS)
Component is being expanded to
include long term care facilities to
facilitate HAI surveillance in this
setting, for which no standardized
reporting methodology or mechanism
currently exists. Four new forms are
proposed for this purpose. A new form
is proposed to be added to the
Healthcare Personnel Safety (HPS)
Component to facilitate summary
reporting of influenza vaccination in
healthcare workers, which is anticipated
to be required by CMS in the near
future. In addition to this new form, the
scope of the HPS Annual Facility
Survey is being expanded to include all
acute care facilities that would enroll if
CMS does implement this requirement.
The NHSN Antimicrobial Use and
Resistance module is transitioning from
manual web entry to electronic data
upload only, which results in a
significant decrease to the reporting
burden for this package. Finally, there
are many updates, clarifications, and
data collection revisions proposed in
this submission.
CDC is requesting to delete four
currently approved forms that are no
longer needed by the NHSN and add
five new forms
The previously-approved NHSN
package included 47 individual data
collection forms. If all proposed
revisions are approved, the reporting
burden will decrease by 1,258,119
hours, for a total estimated burden of
3,914,125 hours and 48 total data
collection tools.
Participating institutions must have a
computer capable of supporting an
Internet service provider (ISP) and
access to an ISP. There is no cost to
respondents other than their time. The
total estimated annual burden hours are
3,914,125.
E:\FR\FM\30NON1.SGM
30NON1
74065
Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Responses
per
respondent
Burden per
response
(hours)
Respondents
Form name
Infection Preventionist ...................
NHSN Registration Form .................................................
Facility Contact Information .............................................
Patient Safety Component—Annual Facility Survey .......
Patient Safety Component—Outpatient Dialysis Center
Practices Survey.
Group Contact Information ...............................................
Patient Safety Monthly Reporting Plan ............................
Primary Bloodstream Infection (BSI) ...............................
Dialysis Event ...................................................................
Pneumonia (PNEU) ..........................................................
Urinary Tract Infection (UTI) ............................................
Denominators for Neonatal Intensive Care Unit (NICU)
6,000 ................................................................................
6,000
6,000
6,000
5,500
1
1
1
1
5/60
10/60
40/60
1
6,000
6,000
6,000
500
6,000
6,000
6,000
9
1
9
36
75
72
27
9
5
5/60
35/60
32/60
15/60
32/60
32/60
4
Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA).
Denominator for Outpatient Dialysis ................................
Surgical Site Infection (SSI) .............................................
Denominator for Procedure ..............................................
Antimicrobial Use and Resistance (AUR)-Microbiology
Data Electronic Upload Specification Tables.
Antimicrobial Use and Resistance (AUR)—Pharmacy
Data Electronic Upload Specification Tables.
Central Line Insertion Practices Adherence Monitoring ..
MDRO or CDI Infection Form ..........................................
MDRO and CDI Prevention Process and Outcome
Measures Monthly Monitoring.
Laboratory-identified MDRO or CDI Event ......................
Vaccination Monthly Monitoring Form–Summary Method
Vaccination Monthly Monitoring Form–Patient-Level
Method.
Patient Vaccination ..........................................................
Patient Safety Component—Annual Facility Survey for
LTCF.
Laboratory-identified MDRO or CDI Event for LTCF .......
MDRO and CDI Prevention Process Measures Monthly
Monitoring for LTCF.
Urinary Tract Infection (UTI) for LTCF .............................
Healthcare Personnel Safety Component Annual Facility
Survey.
Healthcare Worker Survey ...............................................
Healthcare Personnel Safety Monthly Reporting Plan ....
Healthcare Worker Demographic Data ............................
Exposure to Blood/Body Fluids ........................................
Healthcare Worker Prophylaxis/Treatment ......................
Follow-Up Laboratory Testing ..........................................
Healthcare Worker Vaccination History ...........................
Healthcare Worker Influenza Vaccination ........................
Healthcare Worker Prophylaxis/Treatment-Influenza ......
Pre-season Survey on Influenza Vaccination Programs
for Healthcare Personnel.
Post-season Survey on Influenza Vaccination Programs
for Healthcare Personnel.
Healthcare Personnel Influenza Vaccination Monthly
Summary.
Hemovigilance Module Annual Survey ............................
Hemovigilance Module Monthly Reporting Plan ..............
Hemovigilance Module Monthly Incident Summary .........
Hemovigilance Module Monthly Reporting Denominators
Hemovigilance Adverse Reaction ....................................
Hemovigilance Incident ....................................................
6,000
18
5
500
6,000
6,000
6,000
12
27
540
12
5/60
32/60
10/60
5/60
6,000
12
5/60
6,000
6,000
6,000
100
72
24
5/60
32/60
10/60
6,000
6,000
2,000
240
5
5
25/60
14
2
2,000
250
250
1
10/60
25/60
250
250
8
3
30/60
7/60
250
6,000
9
1
30/60
8
600
600
600
600
600
600
600
600
600
600
100
9
200
50
10
100
300
500
50
1
10/60
10/60
20/60
1
15/60
15/60
10/60
10/60
10/60
10/60
600
1
10/60
6,000
6
2
500
500
500
500
500
500
1
12
12
12
120
72
2
2/60
2
30/60
10/60
10/60
Staff RN ........................................
Denominators for Specialty Care
Area (SCA).
Staff RN ........................................
Infection Preventionist ...................
Staff RN ........................................
Laboratory Technician ..................
Pharmacy Technician ...................
Infection Preventionist ...................
Occ Health RN ..............................
Laboratory Technician ..................
Occ Health RN ..............................
Occ Health RN ..............................
emcdonald on DSK5VPTVN1PROD with NOTICES
Clinical Laboratory Technologist ...
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E:\FR\FM\30NON1.SGM
30NON1
74066
Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / Notices
Dated: November 22, 2011
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–30832 Filed 11–29–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–12–11IR]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Evaluation of Core Violence and
Injury Prevention Program (Core
VIPP)—New—National Center for Injury
Prevention and Control, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Injuries and their consequences,
including unintentional and violencerelated injuries, are the leading cause of
death for the first four decades of life,
regardless of gender, race, or
socioeconomic status. More than
179,000 individuals in the United States
die each year as a result of unintentional
injuries and violence, more than 29
million others suffer non-fatal injuries
and over one-third of all emergency
department (ED) visits each year are due
to injuries. In 2000, injuries and
violence ultimately cost the United
States $406 billion, with over $80
billion in medical costs and the
remainder lost in productivity.1 Most
events that result in injury and/or death
from injury could be prevented if
evidence-based public health strategies,
practices, and policies were used
throughout the nation.
CDC’s National Center for Injury
Prevention and Control (NCIPC) is
committed to working with their
partners to promote action that reduces
injuries, violence, and disabilities by
providing leadership in identifying
priorities, promoting tools, and
monitoring effectiveness of injury and
violence prevention and to promote
effective strategies for the prevention of
injury and violence, and their
consequences. One tool NCIPC will use
to accomplish this is the Core Violence
and Injury Prevention Program (VIPP).
This program funds state health
departments to build effective delivery
systems for dissemination,
implementation and evaluation of
evidence based/best practice programs
and policies.
Core VIPP also focuses on the
integration of unintentional injury and
violence prevention. Unintentional
injury and violence prevention have
many common risk and protective
factors for children. In an endeavor to
promote efforts to prevent child
maltreatment, a NCIPC priority, CDC is
collaborating with the Health Resources
and Services Administration (HRSA)
regarding the new Affordable Care Act
(ACA) Maternal, Infant, and Early
Childhood Home Visiting Program. The
state health departments funded by the
Core VIPP will be required to partner
with the state agency responsible for
administration of the State Home
Visiting program.
CDC requests OMB approval to collect
program evaluation data for Core VIPP
over a three-year period. Specifically,
CDC will use the Safe States Alliance
State of the States (SOTS) survey as the
template for annual evaluation surveys
and an annual follow-up telephone
interview. Both the SOTS and the
telephone interviews will be conducted
with state Violence and Injury
Prevention programs directors and staff.
This approach provides a means to
collect standardized, systematic data
from the Core VIPP grantees for program
evaluation and improvement. Topics for
data collection include: Program
evaluation, state injury and violence
prevention program (IVP) infrastructure,
IVP strategies and partners, policy
strategies, injury surveillance, quality of
surveillance, and regional network
leaders. Part of the requirement for
receiving Core VIPP funding is for State
Injury and Violence Programs (SIVPs) to
develop and maintain their own
evaluation capacity and data systems;
thus, this data collection is not expected
to entail significant burdens to
respondents.
Estimates of burden for the survey are
based on previous experience with
evaluation data collections conducted
by the evaluation staff. The State of the
States (SOTS) web-based survey
assessment will be completed by 28
Core Funded State Health Departments
(SHDs) and 22 Non-Funded SHDs,
taking 3 hours to complete. The SOTS
Financial Module will also be
completed by the 28 Core Funded and
22 Non-Funded SHD, taking 1 hour to
complete. The telephone interviews will
take 1.5 hours to conclude and will be
completed by the 28 Core Funded
States. We expect that each of the 28
Core Funded states will complete three
web-based surveys and three telephone
interviews during the first three years of
Core funding. It is anticipated that up to
22 unfunded states will complete three
web-based surveys during the first three
years of Core funding.
There are no costs to respondents
other than their time.
The total estimated annual burden
hours are 242.
ESTIMATED ANNUALIZED BURDEN HOURS
emcdonald on DSK5VPTVN1PROD with NOTICES
Type of respondent
Core VIPP funded
Core VIPP funded
Core VIPP funded
Non-funded SHD
ment and staff.
Non-funded SHD
ment and staff.
VerDate Mar<15>2010
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden
per response
(in hours)
SVIP directors and staff ...
SVIP directors and staff ...
VIP directors and staff ......
Injury Program manage-
State of the States Survey (SOTS) ...............
SOTS Financial Module .................................
Telephone interview .......................................
SOTS ..............................................................
28
28
28
22
1
1
1
1
3
1
1.5
3
Injury Program manage-
SOTS Financial Module .................................
22
1
1
17:30 Nov 29, 2011
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E:\FR\FM\30NON1.SGM
30NON1
Agencies
[Federal Register Volume 76, Number 230 (Wednesday, November 30, 2011)]
[Notices]
[Pages 74064-74066]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30832]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-12-0666]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an email to
omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-5806.
Written comments should be received within 30 days of this notice.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB No. 0920-0666 exp.
3/31/2012)--Revision--National Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The National Healthcare Safety Network (NHSN) is a system designed
to accumulate, exchange, and integrate relevant information and
resources among private and public stakeholders to support local and
national efforts to protect patients and to promote healthcare safety.
Specifically, the data is used to determine the magnitude of various
healthcare-associated adverse events and trends in the rates of these
events among patients and healthcare workers with similar risks.
Healthcare institutions that participate in NHSN voluntarily report
their data to CDC using a web browser based technology for data entry
and data management. Data are collected by trained surveillance
personnel using written standardized protocols. The data will be used
to detect changes in the epidemiology of adverse events resulting from
new and current medical therapies and changing risks.
This revision submission includes an amended Assurance of
Confidentiality, which required an update of the Assurance of
Confidentiality language on all forms included in the NHSN surveillance
system. The scope of NHSN dialysis surveillance is being expanded to
include all outpatient dialysis centers so that the existing Dialysis
Annual Survey can be used to facilitate prevention objectives set forth
in the HHS HAI tier 2 Action Plan and to assess national practices in
all Medicare-certified dialysis centers if CMS re-establishes this
survey method (as expected). The Patient Safety (PS) Component is being
expanded to include long term care facilities to facilitate HAI
surveillance in this setting, for which no standardized reporting
methodology or mechanism currently exists. Four new forms are proposed
for this purpose. A new form is proposed to be added to the Healthcare
Personnel Safety (HPS) Component to facilitate summary reporting of
influenza vaccination in healthcare workers, which is anticipated to be
required by CMS in the near future. In addition to this new form, the
scope of the HPS Annual Facility Survey is being expanded to include
all acute care facilities that would enroll if CMS does implement this
requirement. The NHSN Antimicrobial Use and Resistance module is
transitioning from manual web entry to electronic data upload only,
which results in a significant decrease to the reporting burden for
this package. Finally, there are many updates, clarifications, and data
collection revisions proposed in this submission.
CDC is requesting to delete four currently approved forms that are
no longer needed by the NHSN and add five new forms
The previously-approved NHSN package included 47 individual data
collection forms. If all proposed revisions are approved, the reporting
burden will decrease by 1,258,119 hours, for a total estimated burden
of 3,914,125 hours and 48 total data collection tools.
Participating institutions must have a computer capable of
supporting an Internet service provider (ISP) and access to an ISP.
There is no cost to respondents other than their time. The total
estimated annual burden hours are 3,914,125.
[[Page 74065]]
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Burden per
Respondents Form name Number of Responses per response
respondents respondent (hours)
----------------------------------------------------------------------------------------------------------------
Infection Preventionist............ NHSN Registration Form..... 6,000 1 5/60
Facility Contact 6,000 1 10/60
Information.
Patient Safety Component-- 6,000 1 40/60
Annual Facility Survey.
Patient Safety Component-- 5,500 1 1
Outpatient Dialysis Center
Practices Survey.
Group Contact Information.. 6,000 1 5/60
Patient Safety Monthly 6,000 9 35/60
Reporting Plan.
Primary Bloodstream 6,000 36 32/60
Infection (BSI).
Dialysis Event............. 500 75 15/60
Pneumonia (PNEU)........... 6,000 72 32/60
Urinary Tract Infection 6,000 27 32/60
(UTI).
Staff RN........................... Denominators for Neonatal 6,000 9 4
Intensive Care Unit (NICU).
Denominators for Specialty Care 6,000...................... 9 5
Area (SCA).
Denominators for Intensive 6,000 18 5
Care Unit (ICU)/Other
locations (not NICU or
SCA).
Staff RN........................... Denominator for Outpatient 500 12 5/60
Dialysis.
Infection Preventionist............ Surgical Site Infection 6,000 27 32/60
(SSI).
Staff RN........................... Denominator for Procedure.. 6,000 540 10/60
Laboratory Technician.............. Antimicrobial Use and 6,000 12 5/60
Resistance (AUR)-
Microbiology Data
Electronic Upload
Specification Tables.
Pharmacy Technician................ Antimicrobial Use and 6,000 12 5/60
Resistance (AUR)--Pharmacy
Data Electronic Upload
Specification Tables.
Infection Preventionist............ Central Line Insertion 6,000 100 5/60
Practices Adherence
Monitoring.
MDRO or CDI Infection Form. 6,000 72 32/60
MDRO and CDI Prevention 6,000 24 10/60
Process and Outcome
Measures Monthly
Monitoring.
Laboratory-identified MDRO 6,000 240 25/60
or CDI Event.
Vaccination Monthly 6,000 5 14
Monitoring Form-Summary
Method.
Vaccination Monthly 2,000 5 2
Monitoring Form-Patient-
Level Method.
Patient Vaccination........ 2,000 250 10/60
Patient Safety Component-- 250 1 25/60
Annual Facility Survey for
LTCF.
Laboratory-identified MDRO 250 8 30/60
or CDI Event for LTCF.
MDRO and CDI Prevention 250 3 7/60
Process Measures Monthly
Monitoring for LTCF.
Urinary Tract Infection 250 9 30/60
(UTI) for LTCF.
Occ Health RN...................... Healthcare Personnel Safety 6,000 1 8
Component Annual Facility
Survey.
Healthcare Worker Survey... 600 100 10/60
Healthcare Personnel Safety 600 9 10/60
Monthly Reporting Plan.
Healthcare Worker 600 200 20/60
Demographic Data.
Exposure to Blood/Body 600 50 1
Fluids.
Healthcare Worker 600 10 15/60
Prophylaxis/Treatment.
Laboratory Technician.............. Follow-Up Laboratory 600 100 15/60
Testing.
Occ Health RN...................... Healthcare Worker 600 300 10/60
Vaccination History.
Occ Health RN...................... Healthcare Worker Influenza 600 500 10/60
Vaccination.
Healthcare Worker 600 50 10/60
Prophylaxis/Treatment-
Influenza.
Pre-season Survey on 600 1 10/60
Influenza Vaccination
Programs for Healthcare
Personnel.
Post-season Survey on 600 1 10/60
Influenza Vaccination
Programs for Healthcare
Personnel.
Healthcare Personnel 6,000 6 2
Influenza Vaccination
Monthly Summary.
Clinical Laboratory Technologist... Hemovigilance Module Annual 500 1 2
Survey.
Hemovigilance Module 500 12 2/60
Monthly Reporting Plan.
Hemovigilance Module 500 12 2
Monthly Incident Summary.
Hemovigilance Module 500 12 30/60
Monthly Reporting
Denominators.
Hemovigilance Adverse 500 120 10/60
Reaction.
Hemovigilance Incident..... 500 72 10/60
----------------------------------------------------------------------------------------------------------------
[[Page 74066]]
Dated: November 22, 2011
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-30832 Filed 11-29-11; 8:45 am]
BILLING CODE 4163-18-P