Agency Information Collection Activities: Submission for OMB Review; Comment Request, 28126-28127 [E8-10855]

Download as PDF 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