[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Notices]
[Pages 32704-32705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14914]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17AMP; Docket No. CDC-2017-0057]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection entitled ``Evaluation of the SAMHSA Naloxone 
Education and Distribution Program.'' CDC will use the information 
collected to evaluate the program ``Substance Abuse and Mental Health 
Services Agency (SAMHSA) Grants to Prevent Prescription Drug/Opioid 
Overdose-Related Deaths.'' The program was recently funded to improve 
access to treatment for opioid use disorders, reduce opioid related 
deaths, and strengthen drug misuse prevention efforts.

DATES: Written comments must be received on or before September 15, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0057 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact LeRoy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Evaluation of the SAMHSA Naloxone Education and Distribution 
Program--New--National Center for Injury Prevention and Control 
(NCIPC), Centers for Disease Control and Prevention (CDC).

[[Page 32705]]

Background and Brief Description

    Overdose deaths involving prescription opioids and heroin have 
reached epidemic levels in the U.S. and continue to rise. To address 
the prescription drug/opioid overdose crisis, the federal government 
has recently allocated funding to improve access to treatment for 
opioid use disorders, reduce opioid related deaths, and strengthen drug 
misuse prevention efforts. One program resulting from the federal 
government's efforts to address the opioid crisis is, the Substance 
Abuse and Mental Health Services Agency (SAMHSA) Grants to Prevent 
Prescription Drug/Opioid Overdose-Related Deaths (PDO/naloxone grant). 
This collection will be to evaluate the Substance Abuse and Mental 
Health Services Agency (SAMHSA) Grants to Prevent Prescription Drug/
Opioid Overdose-Related Deaths.
    This evaluation will seek to describe and understand the scope and 
impact of the program on overdose. To address the prescription drug/
opioid overdose crisis, the federal government has recently allocated 
funding to improve access to treatment for opioid use disorders, reduce 
opioid related deaths, and strengthen drug misuse prevention efforts. 
One program resulting from the federal government's efforts to address 
the opioid crisis is, the Substance Abuse and Mental Health Services 
Agency (SAMHSA) Grants to Prevent Prescription Drug/Opioid Overdose-
Related Deaths (PDO/naloxone grant). Through this program, SAMHSA 
awarded funding to 12 states. The funding is aimed at reducing the 
number of prescription drug/opioid overdose-related deaths and adverse 
events among individuals 18 years of age and older through educating 
and training first responders and other key community sectors on the 
prevention of prescription drug/opioid overdose-related deaths, 
including the purchase and distribution of naloxone. SAMHSA is funding 
the grant and CDC is responsible for conducting the grantee evaluation.
    The intended use of the resulting data is to increase CDC and 
SAMHSA understanding of the scope and impact of the program on overdose 
fatalities and how program effectiveness may vary among different sub-
populations and settings, and to increase knowledge of barriers and 
facilitators to program implementation. Key informant interviews and 
focus groups with participants in the activities enacted by the twelve 
state grant recipients will be methodology used. This will include 
state administrators of the grant and other PDO/Naloxone stakeholders 
including advisory council members, first responders, social service 
providers, laypersons including end users and their family and friend. 
All focus groups and interviews will be analyzed through qualitative 
content analysis, including utilization of a systematic coding scheme.
    Total burden in hours for this collection is 381. There are no 
costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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PDO/Naloxone Advisory           Focus Group                  140               1             1.5             210
 Committee Members and           Discussion
 Grantees.                       Guide.
PDO/Naloxone Grantees.........  Individual                    36               1               1              36
                                 Interview
                                 Discussion
                                 Guide for
                                 Grantees.
PDO/Naloxone Stakeholders and   Individual                    84               1               1              84
 Partners.                       Interview
                                 Discussion
                                 Guide for
                                 Partners.
PDO/Naloxone Laypersons.......  Individual                    24               1               1              24
                                 Interview
                                 Discussion
                                 Guide for
                                 Laypersons.
All participants (PDO Naloxone  Recruitment                  284               1            5/60              24
 grantees, advisory committee,   contact script.
 stakeholders and partners,
 laypersons).
PDO/Naloxone Grantees.........  Key Informant                 12               1           15/60               3
                                 Selection Tool.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             381
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-14914 Filed 7-14-17; 8:45 am]
 BILLING CODE 4163-18-P