82_FR_32839 82 FR 32704 - Proposed Data Collection Submitted for Public Comment and Recommendations

82 FR 32704 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 135 (July 17, 2017)

Page Range32704-32705
FR Document2017-14914

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.

Federal Register, Volume 82 Issue 135 (Monday, July 17, 2017)
[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Notices]
[Pages 32704-32705]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14914]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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



                                                    32704                                    Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices

                                                    There are no costs to the responders
                                                    other than their time.

                                                                                                                          ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                               Avgerage
                                                                                                                                                                                                                Number of
                                                                                                                                                                                                Number of                     burden per
                                                                                 Type of respondents                                                         Form name                                        responses per
                                                                                                                                                                                               respondents                     response
                                                                                                                                                                                                                respondent     (in hours)

                                                    Receptionist ............................................................................   Pre-call ...................................           300                1           5/60
                                                    Occupational health and safety specialists .............................                    Survey ....................................            100                1          20/60
                                                    Industrial Production Managers ..............................................               Survey ....................................             75                1          20/60
                                                    Natural Sciences Managers ....................................................              Survey ....................................             75                1          20/60



                                                    Leroy A. Richardson,                                                    DATES:  Written comments must be                                    previously approved information
                                                    Chief, Information Collection Review Office,                            received on or before September 15,                                 collection before submitting the
                                                    Office of Scientific Integrity, Office of the                           2017.                                                               collection to OMB for approval. To
                                                    Associate Director for Science, Office of the                                                                                               comply with this requirement, we are
                                                                                                                            ADDRESSES: You may submit comments,
                                                    Director, Centers for Disease Control and                                                                                                   publishing this notice of a proposed
                                                    Prevention.                                                             identified by Docket No. CDC–2017–
                                                                                                                            0057 by any of the following methods:                               data collection as described below.
                                                    [FR Doc. 2017–14912 Filed 7–14–17; 8:45 am]
                                                                                                                              • Federal eRulemaking Portal:                                        Comments are invited on: (a) Whether
                                                    BILLING CODE 4163–18–P                                                  Regulations.gov. Follow the instructions                            the proposed collection of information
                                                                                                                            for submitting comments.                                            is necessary for the proper performance
                                                                                                                              • Mail: Leroy A. Richardson,
                                                    DEPARTMENT OF HEALTH AND                                                                                                                    of the functions of the agency, including
                                                                                                                            Information Collection Review Office,
                                                    HUMAN SERVICES                                                          Centers for Disease Control and                                     whether the information shall have
                                                                                                                            Prevention, 1600 Clifton Road NE., MS–                              practical utility; (b) the accuracy of the
                                                    Centers for Disease Control and                                         D74, Atlanta, Georgia 30329.                                        agency’s estimate of the burden of the
                                                    Prevention                                                                                                                                  proposed collection of information; (c)
                                                                                                                              Instructions: All submissions received
                                                                                                                            must include the agency name and                                    ways to enhance the quality, utility, and
                                                    [60Day–17–17AMP; Docket No. CDC–2017–                                   Docket Number. All relevant comments                                clarity of the information to be
                                                    0057]                                                                   received will be posted without change                              collected; (d) ways to minimize the
                                                                                                                            to Regulations.gov, including any                                   burden of the collection of information
                                                    Proposed Data Collection Submitted                                      personal information provided. For                                  on respondents, including through the
                                                    for Public Comment and                                                  access to the docket to read background                             use of automated collection techniques
                                                    Recommendations                                                         documents or comments received, go to                               or other forms of information
                                                                                                                            Regulations.gov.                                                    technology; and (e) estimates of capital
                                                    AGENCY: Centers for Disease Control and                                   Please note: All public comment                                   or start-up costs and costs of operation,
                                                    Prevention (CDC), Department of Health                                  should be submitted through the                                     maintenance, and purchase of services
                                                    and Human Services (HHS).                                               Federal eRulemaking portal                                          to provide information. Burden means
                                                    ACTION:      Notice with comment period.                                (Regulations.gov) or by U.S. mail to the                            the total time, effort, or financial
                                                                                                                            address listed above.                                               resources expended by persons to
                                                    SUMMARY:   The Centers for Disease                                      FOR FURTHER INFORMATION CONTACT: To                                 generate, maintain, retain, disclose or
                                                    Control and Prevention (CDC), as part of                                request more information on the                                     provide information to or for a Federal
                                                    its continuing efforts to reduce public                                 proposed project or to obtain a copy of                             agency. This includes the time needed
                                                    burden and maximize the utility of                                      the information collection plan and                                 to review instructions; to develop,
                                                    government information, invites the                                     instruments, contact LeRoy A.                                       acquire, install and utilize technology
                                                    general public and other Federal                                        Richardson, Information Collection                                  and systems for the purpose of
                                                    agencies to take this opportunity to                                    Review Office, Centers for Disease                                  collecting, validating and verifying
                                                    comment on proposed and/or                                              Control and Prevention, 1600 Clifton                                information, processing and
                                                    continuing information collections, as                                  Road NE., MS–D74, Atlanta, Georgia                                  maintaining information, and disclosing
                                                    required by the Paperwork Reduction                                     30329; phone: 404–639–7570; Email:
                                                                                                                                                                                                and providing information; to train
                                                    Act of 1995. This notice invites                                        omb@cdc.gov.
                                                                                                                                                                                                personnel and to be able to respond to
                                                    comment on a proposed information                                       SUPPLEMENTARY INFORMATION: Under the
                                                                                                                                                                                                a collection of information, to search
                                                    collection entitled ‘‘Evaluation of the                                 Paperwork Reduction Act of 1995 (PRA)
                                                                                                                                                                                                data sources, to complete and review
                                                    SAMHSA Naloxone Education and                                           (44 U.S.C. 3501–3520), Federal agencies
                                                                                                                                                                                                the collection of information; and to
                                                    Distribution Program.’’ CDC will use the                                must obtain approval from the Office of
                                                                                                                                                                                                transmit or otherwise disclose the
                                                    information collected to evaluate the                                   Management and Budget (OMB) for each
                                                                                                                                                                                                information.
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    program ‘‘Substance Abuse and Mental                                    collection of information they conduct
                                                    Health Services Agency (SAMHSA)                                         or sponsor. In addition, the PRA also                               Proposed Project
                                                    Grants to Prevent Prescription Drug/                                    requires Federal agencies to provide a
                                                    Opioid Overdose-Related Deaths.’’ The                                   60-day notice in the Federal Register                                 Evaluation of the SAMHSA Naloxone
                                                    program was recently funded to                                          concerning each proposed collection of                              Education and Distribution Program—
                                                    improve access to treatment for opioid                                  information, including each new                                     New—National Center for Injury
                                                    use disorders, reduce opioid related                                    proposed collection, each proposed                                  Prevention and Control (NCIPC),
                                                    deaths, and strengthen drug misuse                                      extension of existing collection of                                 Centers for Disease Control and
                                                    prevention efforts.                                                     information, and each reinstatement of                              Prevention (CDC).


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                                                                                            Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices                                                                                                32705

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

                                                                                                                           ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                      Average
                                                                                                                                                                                                        Number of
                                                                                                                                                                             Number of                                              burden per              Total burden
                                                              Type of respondents                                                Form name                                                            responses per
                                                                                                                                                                            respondents                                              response                (in hours)
                                                                                                                                                                                                        respondent                   (in hours)

                                                    PDO/Naloxone Advisory Committee                          Focus Group Discussion Guide .......                                            140                            1                       1.5              210
                                                     Members and Grantees.
                                                    PDO/Naloxone Grantees ..................                 Individual   Interview    Discussion                                             36                           1                          1               36
                                                                                                               Guide for Grantees.
                                                    PDO/Naloxone Stakeholders and                            Individual   Interview    Discussion                                             84                           1                          1               84
                                                     Partners.                                                 Guide for Partners.
                                                    PDO/Naloxone Laypersons ..............                   Individual   Interview    Discussion                                             24                           1                          1               24
                                                                                                               Guide for Laypersons.
                                                    All participants (PDO Naloxone                           Recruitment contact script ...............                                     284                             1                     5/60                24
                                                       grantees, advisory committee,
                                                       stakeholders   and     partners,
                                                       laypersons).
                                                    PDO/Naloxone Grantees ..................                 Key Informant Selection Tool ...........                                         12                            1                  15/60                   3

                                                         Total ...........................................   ...........................................................   ........................   ........................   ........................            381



                                                    Leroy A. Richardson,                                                    DEPARTMENT OF HEALTH AND                                                      its continuing efforts to reduce public
                                                    Chief, Information Collection Review Office,                            HUMAN SERVICES                                                                burden and maximize the utility of
                                                    Office of Scientific Integrity, Office of the                                                                                                         government information, invites the
                                                    Associate Director for Science, Office of the                           Centers for Disease Control and                                               general public and other Federal
                                                    Director, Centers for Disease Control and                               Prevention                                                                    agencies to take this opportunity to
                                                    Prevention.                                                                                                                                           comment on proposed and/or
                                                                                                                            [60Day–17–1054; Docket No. CDC–2017–
                                                    [FR Doc. 2017–14914 Filed 7–14–17; 8:45 am]                             0055]                                                                         continuing information collections, as
                                                    BILLING CODE 4163–18–P                                                                                                                                required by the Paperwork Reduction
                                                                                                                            Proposed Data Collection Submitted                                            Act of 1995. This notice invites
                                                                                                                            for Public Comment and                                                        comment on a proposed information
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                                                                                            Recommendations                                                               collection entitled ‘‘Drug Overdose
                                                                                                                            AGENCY: Centers for Disease Control and                                       Response Investigation (DORI) Data
                                                                                                                            Prevention (CDC), Department of Health                                        Collections.’’ CDC will use the
                                                                                                                            and Human Services (HHS).                                                     information collected to respond to
                                                                                                                            ACTION: Notice with comment period.                                           urgent requests from state and local
                                                                                                                                                                                                          health authorities to provide
                                                                                                                            SUMMARY:  The Centers for Disease                                             epidemiological information that allows
                                                                                                                            Control and Prevention (CDC), as part of


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Document Created: 2017-07-15 03:45:48
Document Modified: 2017-07-15 03:45:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before September 15, 2017.
ContactTo 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]
FR Citation82 FR 32704 

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