Agency Information Collection Activities: Submission for OMB Review; Comment Request, 28126-28127 [E8-10855]
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mstockstill on PROD1PC66 with NOTICES
28126
Federal Register / Vol. 73, No. 95 / Thursday, May 15, 2008 / Notices
the health care community and, through
the Office of Health Technology
Assessment, National Center for Health
Services Research and Health Care
Technology Assessment (NCHSRHCTA),
to those agencies requiring this
information; (4) provides a link between
technology assessment activities of the
research institutes of the NIH and the
NCHSRHCTA; and (5) monitors the
effectiveness and progress of the
assessment and transfer activities of the
NIH.
Office of Portfolio Analysis and
Strategic Initiatives (NA W6, formerly
HNA W6). Supports regular trans-NIH
scientific planning and initiatives and
the successful and adaptive priority
setting process for identifying areas of
scientific and health improvement
opportunities.
Division of Resource Development
and Analysis (NA W62, formerly HNA
W62). (1) Uses resources (databases,
analytic tools, and methodologies) and
develops specifications for new
resources, when needed, to conduct
assessments based on NIH and other
databases in support of portfolio
analyses and priority setting in
scientific areas of interest across NIH;
(2) serves as a resource for portfolio
management at the programmatic level;
and (3) ensures that NIH addresses
important areas of emerging scientific
opportunities and public health
challenges effectively.
Division of Strategic Coordination
(NA W63, formerly HNA W63). (1)
Integrates information and develops
recommendations to inform NIH’s
priority-setting and decision making
processes with respect to strategic
initiatives; (2) addresses exceptional
scientific opportunities and emerging
public health needs; (3) provides the
NIH Director with the information
needed to allocate resources effectively
for trans-NIH efforts; and (4) identifies
trans-NIH initiatives for consideration
and evaluation by both outside advisors
and NIH leadership.
Division of Evaluation and Systematic
Assessments (NA W64, formerly HNA
W64). Plans, conducts, coordinates, and
supports program evaluations,
including, but not limited to, IC specific
program and project evaluations; transNIH evaluations, including Roadmap
initiatives; and systematic assessments
required by the Government
Performance and Results Act and the
OMB Program Assessment Rating Tool.
II. Under the heading ‘‘Office of the
Director (NA, formerly HNA)’’ delete in
their entirety the following headed
paragraphs: ‘‘Office of Research on
Women’s Health (NAG, formerly
HNAG)’’; the ‘‘Office of AIDS Research
VerDate Aug<31>2005
16:18 May 14, 2008
Jkt 214001
(NA5, formerly HNA5)’’; the ‘‘Office of
Behavioral and Social Sciences
Research (NAH, formerly HNAH)’’; the
‘‘Office of Disease Prevention (NA2,
formerly HNA2)’’; the ‘‘Office of
Medical Applications of Research
(NA23, formerly HNA23)’’; the ‘‘Office
of Dietary Supplements (NA25, formerly
HNA25)’’; the ‘‘Office of Rare Diseases
(NA26, formerly HNA26)’’; the ‘‘Office
of Portfolio Analysis and Strategic
Initiatives (NAU, formerly HNAU)’’; the
‘‘Division of Resource Development and
Analysis (NA, formerly HNAU2)’’; the
‘‘Division of Strategic Coordination
(NAU3, formerly HNAU3)’’; and the
‘‘Division of Evaluation and Systematic
Assessments (NAU4, formerly
HNAU4).’’
III. Delegations of Authority: All
delegations and redelegations of
authority to officers and employees of
NIH which were in effect immediately
prior to the effective date of this
reorganization and are consistent with
this reorganization shall continue in
effect in them or their successors,
pending further redelegation.
Dated: May 6, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8–10637 Filed 5–14–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Opioid Treatment Programs
(OTPs) Mortality Reporting Form—
NEW
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center for Substance Abuse
Treatment (CSAT), has developed a
voluntary reporting form for Opioid
Treatment Programs (OTPs) to report
mortality data on patients who at the
time of death, were enrolled in the
Programs that were certified to operate
by SAMHSA.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Methadone is a Schedule II controlled
substance approved by the Food and
Drug Administration for the treatment of
opioid dependence and pain. Although
it has been proven safe and effective, it
must be carefully administered and for
that reason, treatment of opioid
dependence with methadone is
provided only through specialized and
Federally regulated and accredited
clinics, the OTPs. Buprenorphine, a
Schedule III controlled substance, is
also used in the treatment of opioid
addiction by OTPs and office-based
physicians.
In recent years, methadone has been
associated with an increasing number of
deaths around the country.
Simultaneously, the use of methadone
for pain has increased significantly over
the last 5 to 10 years. While the Food
and Drug Administration (FDA)
maintains oversight of methadone for
use in pain, SAMHSA provides
oversight of methadone for use in opioid
addiction treatment. Currently, there is
no national database that tracks
mortality among patients receiving
methadone in OTPs and as a result, it
is not clear whether and to what extent
the increase in methadone-associated
deaths may be related to treatment in
OTPs. MedWatch, a voluntary reporting
system maintained by FDA, provides
information relevant to its role in its
more general oversight of medication
and device safety. A similar system is
needed within SAMHSA to gather
information directly relevant to the
agency’s mission of overseeing and
ensuring safe and effective treatment for
patients with opioid dependence.
In order to more accurately
understand potential methadoneassociated deaths at the OTP level, it is
necessary to examine all patient deaths,
including those related to
buprenorphine. Understanding the
actual cause of death of patients
enrolled in OTPs can be a challenging
task for many reasons, including
inconsistencies in methods of reporting
causes of deaths across different
localities and officials; patients’ use of
other drugs, including illicit, over-thecounter, and prescription products; and
other aspects of the patient’s physical
and mental condition. The standardized
terminology to be used for reporting in
the proposed system will contribute to
a more precise and relevant analysis of
individual cases and higher-level
trends. The data will be used by
SAMHSA to increase understanding of
the factors contributing to these deaths,
identify preventable causes of deaths,
and ultimately, take appropriate action
to minimize risk and help improve the
quality of care. Importantly, better data
E:\FR\FM\15MYN1.SGM
15MYN1
28127
Federal Register / Vol. 73, No. 95 / Thursday, May 15, 2008 / Notices
will enable the agency to more
proactively manage the oversight of
treatment.
The information requested from OTPs
should be readily available to any OTP
that has met accreditation standards.
The OTP should not find any need to
otherwise analyze or synthesize new
data in order to complete this form.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS
Form
Number of
facilities
(OTPs)
Responses
per facility
Burden/responses
(hours)
Annual burden
(hours)
SAMHSA OTP Mortality Report .......................................................................
1,150
2
0.5
1,150
Written comments and
recommendations concerning the
proposed information collection should
be sent by June 16, 2008 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: 202–395–6974.
Dated: May 6, 2008.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. E8–10855 Filed 5–14–08; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
National Protection and Programs
Directorate; Submission for Review:
Critical Infrastructure/Key Resources
Private Sector Clearance Program
(CIKR PSCP) 1670—NEW
National Protection and
Programs Directorate, Office of
Infrastructure Protection, Partnership
and Outreach Division, Partnership
Programs and Information Sharing
Office, DHS.
ACTION: 30-Day Notice and request for
comments.
mstockstill on PROD1PC66 with NOTICES
AGENCY:
SUMMARY: The Department of Homeland
Security (DHS) invites the general
public and other federal agencies the
opportunity to comment on new
information collection request 1670—
NEW, Critical Infrastructure/Key
Resources Private Sector Clearance
Program (CIKR PSCP) Clearance
Request. As required by the Paperwork
Reduction Act of 1995, (Pub. L. 104–13,
44 U.S.C. chapter 35) as amended by the
Clinger-Cohen Act (Pub. L. 104–106),
DHS is soliciting comments for this
collection. The information collection
was previously published in the Federal
Register on November 23, 2007, at 72
FR 65757 allowing for a 60-day public
comment period. No comments were
VerDate Aug<31>2005
16:18 May 14, 2008
Jkt 214001
received on this existing information
collection. The purpose of this notice is
to allow an additional 30 days for public
comments.
DATES: Comments are encouraged and
will be accepted until June 16, 2008.
This process is conducted in accordance
with 5 CFR 1320.1.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget, 725 17th Street, NW.,
Washington, DC 20503, Attention: Desk
Officer for National Protection and
Programs Directorate, DHS, or sent via
electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–6974.
FOR FURTHER INFORMATION CONTACT: A
copy of this ICR, with applicable
supporting documentation, may be
obtained by contacting the Office of
Information and Regulatory Affairs,
Office of Management and Budget, 725
17th Street, NW., Washington, DC
20503, Attention: Desk Officer for
National Protection and Programs
Directorate, DHS, or via electronic mail
to oira_submission@omb.eop.gov.
SUPPLEMENTARY INFORMATION: The Office
of Management and Budget is
particularly interested in comments
that:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
e.g., permitting electronic submissions
of responses.
Analysis
Agency: Department of Homeland
Security, National Protection and
Programs Directorate, Partnership and
Outreach Division.
Title: CIKR PSCP Clearance Request
Form.
OMB Number: 1670—NEW.
Frequency: Once.
Affected Public: Private sector.
Number of Respondents: 250
responses per year.
Estimated Time per Respondent: 10
minutes.
Total Burden Hours: 42 hours.
Total Burden Cost (capital/startup):
None.
Total Burden Cost (operating/
maintaining): None.
Description: The Critical
Infrastructure/Key Resources Private
Sector Clearance Program (CIKR PSCP)
is designed to provide private sector
individuals clearances so that they can
be partners with DHS. These partners
are subject matter experts within
specific industries and sectors. DHS has
created this program to facilitate
granting clearances to appropriate
individuals. The CIKR PSCP requires
individuals to complete a clearance
request form that initiates the clearance
process. Individuals are selected and
then invited to become partners with
DHS for a specific project or task. DHS
Sector Specialists or Protective Security
Advisors e-mail the form to the
individual who e-mails back the
completed form. The data from these
forms make up the Master Roster. The
Name, Social Security Number, Date of
Birth and Place of Birth are entered into
e-QIP—Office of Personnel
Management’s secure portal for
investigation processing. Once the data
is entered in e-QIP by the DHS Office of
Security, Personnel Security Division,
then the applicant can complete the rest
of the e-QIP security questionnaire. The
CIKR PSCP Master Roster contains all
the information found on the clearance
request form in addition to their
clearance info (date granted, level, date
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 73, Number 95 (Thursday, May 15, 2008)]
[Notices]
[Pages 28126-28127]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10855]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Project: Opioid Treatment Programs (OTPs) Mortality Reporting Form--NEW
The Substance Abuse and Mental Health Services Administration
(SAMHSA), Center for Substance Abuse Treatment (CSAT), has developed a
voluntary reporting form for Opioid Treatment Programs (OTPs) to report
mortality data on patients who at the time of death, were enrolled in
the Programs that were certified to operate by SAMHSA.
Methadone is a Schedule II controlled substance approved by the
Food and Drug Administration for the treatment of opioid dependence and
pain. Although it has been proven safe and effective, it must be
carefully administered and for that reason, treatment of opioid
dependence with methadone is provided only through specialized and
Federally regulated and accredited clinics, the OTPs. Buprenorphine, a
Schedule III controlled substance, is also used in the treatment of
opioid addiction by OTPs and office-based physicians.
In recent years, methadone has been associated with an increasing
number of deaths around the country. Simultaneously, the use of
methadone for pain has increased significantly over the last 5 to 10
years. While the Food and Drug Administration (FDA) maintains oversight
of methadone for use in pain, SAMHSA provides oversight of methadone
for use in opioid addiction treatment. Currently, there is no national
database that tracks mortality among patients receiving methadone in
OTPs and as a result, it is not clear whether and to what extent the
increase in methadone-associated deaths may be related to treatment in
OTPs. MedWatch, a voluntary reporting system maintained by FDA,
provides information relevant to its role in its more general oversight
of medication and device safety. A similar system is needed within
SAMHSA to gather information directly relevant to the agency's mission
of overseeing and ensuring safe and effective treatment for patients
with opioid dependence.
In order to more accurately understand potential methadone-
associated deaths at the OTP level, it is necessary to examine all
patient deaths, including those related to buprenorphine. Understanding
the actual cause of death of patients enrolled in OTPs can be a
challenging task for many reasons, including inconsistencies in methods
of reporting causes of deaths across different localities and
officials; patients' use of other drugs, including illicit, over-the-
counter, and prescription products; and other aspects of the patient's
physical and mental condition. The standardized terminology to be used
for reporting in the proposed system will contribute to a more precise
and relevant analysis of individual cases and higher-level trends. The
data will be used by SAMHSA to increase understanding of the factors
contributing to these deaths, identify preventable causes of deaths,
and ultimately, take appropriate action to minimize risk and help
improve the quality of care. Importantly, better data
[[Page 28127]]
will enable the agency to more proactively manage the oversight of
treatment.
The information requested from OTPs should be readily available to
any OTP that has met accreditation standards. The OTP should not find
any need to otherwise analyze or synthesize new data in order to
complete this form.
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
Number of Burden/
Form facilities Responses per responses Annual burden
(OTPs) facility (hours) (hours)
----------------------------------------------------------------------------------------------------------------
SAMHSA OTP Mortality Report................. 1,150 2 0.5 1,150
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent by June 16, 2008 to: SAMHSA Desk
Officer, Human Resources and Housing Branch, Office of Management and
Budget, New Executive Office Building, Room 10235, Washington, DC
20503; due to potential delays in OMB's receipt and processing of mail
sent through the U.S. Postal Service, respondents are encouraged to
submit comments by fax to: 202-395-6974.
Dated: May 6, 2008.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. E8-10855 Filed 5-14-08; 8:45 am]
BILLING CODE 4162-20-P
