2017-27257. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Evaluation of the SAMHSA Naloxone Education and Distribution Program to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on July 17, 2017 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) 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;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) 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, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone] or send an email to [e-mail]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

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).

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 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. This proposed information collection project will help evaluate this program.

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.

Researchers will use key informant interviews and focus groups with participants in the activities enacted by the twelve state grant recipients. Participants 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. CDC requests a three-year OMB approval to collect the necessary project-related information.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
PDO/Naloxone Advisory Committee Members and Grantees	Focus Group Discussion Guide	140	1	1.5
PDO/Naloxone Grantees	Key Informant Interview Guide for Grantees	36	1	1
PDO/Naloxone Stakeholders and Partners	Key Informant Interview Guide for Partners	84	1	1
PDO/Naloxone Laypersons	Key Informant Interview Guide for Laypersons	24	1	1
All participants (PDO Naloxone grantees, advisory committee, stakeholders and partners, laypersons)	Recruitment contact script	284	1	5/60
PDO/Naloxone Grantees	Key Informant Selection Tool	12	1	15/60

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.