81_FR_86191 81 FR 85962 - Agency Forms Undergoing Paperwork Reduction Act Review

81 FR 85962 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 229 (November 29, 2016)

Page Range85962-85963
FR Document2016-28588

Federal Register, Volume 81 Issue 229 (Tuesday, November 29, 2016)
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85962-85963]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-16ET]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Comprehensive HIV Prevention and Care for Men Who Have Sex with Men 
of Color (THRIVE)--New--National Center for HIV/AIDS, Viral Hepatitis, 
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    Approximately 40,000 people in the United States are newly infected 
with HIV each year. Gay, bisexual, and other men who have sex with men 
(MSM) remain the population most affected by HIV infection in the 
United States. Among MSM, those who are black and Hispanic comprise 64% 
of all new infections. Goals of the National HIV Prevention Strategy 
include increasing the number of MSM of color living with HIV infection 
who achieve HIV viral suppression with antiretroviral treatment, and 
decreasing the number of new HIV infections among MSM of color at risk 
of acquiring an HIV infection. Achieving these outcomes requires that 
men utilize a broad variety of HIV prevention and care services.
    In 2015, CDC developed a cooperative agreement program to promote 
use and adoption of Targeted Highly-Effective Interventions to Reverse 
the HIV Epidemic (THRIVE). Awardees are seven state and local health 
departments that are developing and implementing demonstration projects 
to provide comprehensive HIV prevention and care services for MSM of 
color. Each THRIVE awardee is creating a collaborative with community-
based organizations, health care, behavioral health, and social 
services providers in its jurisdiction to strengthen referrals and 
coordination of HIV testing, prevention, and treatment services. 
Overall, approximately 80 partner organizations are participating in 
THRIVE collaboratives.
    Each THRIVE collaborative is required to address a total of 24 HIV 
prevention and care services, including 13 HIV prevention services for 
MSM of color at substantial risk for HIV infection and 11 HIV care 
services for MSM of color living with HIV infection. HIV prevention 
services include: 1. HIV testing that uses lab-based 4th generation HIV 
tests; 2. Assessment of indications for pre-exposure prophylaxis (PrEP) 
and non-occupational post-exposure prophylaxis (nPEP); 3. Provision of 
PrEP and nPEP; 4. Adherence interventions for PrEP and nPEP; 5. 
Immediate linkage to care, antiretoriviral treatment, and partner 
services for those diagnosed with acute HIV infection; 6. Expedient 
linkage to care, antiretoriviral treatment, and partner services for 
those diagnosed with established HIV infection; 7. STD screening and 
treatment; 8. Partner services for patients with STDs; 9. Behavioral 
risk-reduction interventions; 10. Screening for behavioral health and 
social services needs; 11. Linkage to behavioral health and social 
services; 12. Navigators to assist utilizing HIV prevention and 
behavioral health and social services; 13. Navigators to assist 
enrollment in a health plan.
    HIV care services include: 1. HIV primary care, including 
antiretroviral treatment; 2. Retention interventions; 3. Re-engagement 
interventions; 4. Adherence interventions; 5. STD screening and 
treatment; 6. Partner services; 7. Behavioral risk reduction 
interventions; 8. Screening patients for behavioral health and social 
services needs; 9. Linkage to behavioral health and social services; 
10. Navigators to assist linking to care and accessing behavioral 
health and social services; 11. Navigators to assist enrollment in a 
health plan.
    CDC requests OMB approval to collect the information needed to 
monitor and assess the demonstration projects. In general, information 
collection will be conducted in 2 steps: THRIVE

[[Page 85963]]

collaborative partners will report information to their respective 
health department (THRIVE awardee), and THRIVE awardees will provide 
reports to CDC. The monitoring and evaluation plan is based on semi-
annual reports of Monitoring and Evaluation (M&E) Variables, comprised 
primarily of de-identified or coded client-level data on demographics 
and services received. The M&E files will be transmitted 
electronically. Recognizing that THRIVE awardees and partners vary in 
terms of existing infrastructure, CDC has established guidelines and 
specifications for M&E content, but is permitting a flexible approach 
to electronic reporting. A similar approach will be applied to 
electronic transmission of the annual Funding Allocation Report (FAR). 
The FAR is only required for THRIVE awardees.
    Information collection also includes an Annual Collaborative 
Process and Outcome Evaluation based on semi-structured interviews and 
completion of a questionnaire called the Annual Collaborative 
Assessment Tool. These information collections will allow CDC to assess 
how successful THRIVE awardees have been in creating, engaging, and 
sustaining collaborative partnerships and to understand how these 
partnerships contributed to achieving the goals of the project. Both 
tools will be submitted to CDC electronically on an annual basis.
    CDC will use findings to provide technical assistance to THRIVE 
awardees and to develop recommendations for the coordination of 
comprehensive HIV testing, prevention, and treatment services for MSM 
of color.
    OMB approval is requested for three years. Participation is 
required as a condition of THRIVE funding and there are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 1,543.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
         Type of respondent                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
THRIVE Partners....................  Monitoring and Evaluation                80               2               9
                                      Data Elements on HIV
                                      Prevention and Care
                                      Services.
                                     Qualitative Interview:                   80               1           40/60
                                      Collaborative Process
                                      Evaluation.
                                     Collaborative Assessment                 80               1           20/60
                                      Tool.
THRIVE Awardees....................  Monitoring and Evaluation                 7               2               1
                                      Data Elements on HIV
                                      Prevention and Care
                                      Services.
                                     Qualitative Interview:                    7               1           40/60
                                      Collaborative Process
                                      Evaluation.
                                     Collaborative Assessment                  7               1           20/60
                                      Tool.
                                     Funding Allocation Report..               7               1           20/60
----------------------------------------------------------------------------------------------------------------


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.
[FR Doc. 2016-28588 Filed 11-28-16; 8:45 am]
 BILLING CODE 4163-18-P



                                                    85962                      Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices

                                                    banks and nonbanking companies                          information are encouraged. Your                      adoption of Targeted Highly-Effective
                                                    owned by the bank holding company,                      comments should address any of the                    Interventions to Reverse the HIV
                                                    including the companies listed below.                   following: (a) Evaluate whether the                   Epidemic (THRIVE). Awardees are
                                                      The applications listed below, as well                proposed collection of information is                 seven state and local health departments
                                                    as other related filings required by the                necessary for the proper performance of               that are developing and implementing
                                                    Board, are available for immediate                      the functions of the agency, including                demonstration projects to provide
                                                    inspection at the Federal Reserve Bank                  whether the information will have                     comprehensive HIV prevention and care
                                                    indicated. The applications will also be                practical utility; (b) Evaluate the                   services for MSM of color. Each THRIVE
                                                    available for inspection at the offices of              accuracy of the agencies estimate of the              awardee is creating a collaborative with
                                                    the Board of Governors. Interested                      burden of the proposed collection of                  community-based organizations, health
                                                    persons may express their views in                      information, including the validity of                care, behavioral health, and social
                                                    writing on the standards enumerated in                  the methodology and assumptions used;                 services providers in its jurisdiction to
                                                    the BHC Act (12 U.S.C. 1842(c)). If the                 (c) Enhance the quality, utility, and                 strengthen referrals and coordination of
                                                    proposal also involves the acquisition of               clarity of the information to be                      HIV testing, prevention, and treatment
                                                    a nonbanking company, the review also                   collected; (d) Minimize the burden of                 services. Overall, approximately 80
                                                    includes whether the acquisition of the                 the collection of information on those                partner organizations are participating
                                                    nonbanking company complies with the                    who are to respond, including through                 in THRIVE collaboratives.
                                                    standards in section 4 of the BHC Act                   the use of appropriate automated,                        Each THRIVE collaborative is
                                                    (12 U.S.C. 1843). Unless otherwise                      electronic, mechanical, or other                      required to address a total of 24 HIV
                                                    noted, nonbanking activities will be                    technological collection techniques or                prevention and care services, including
                                                    conducted throughout the United States.                 other forms of information technology,                13 HIV prevention services for MSM of
                                                      Unless otherwise noted, comments                      e.g., permitting electronic submission of             color at substantial risk for HIV
                                                    regarding each of these applications                    responses; and (e) Assess information                 infection and 11 HIV care services for
                                                    must be received at the Reserve Bank                    collection costs.                                     MSM of color living with HIV infection.
                                                    indicated or the offices of the Board of                   To request additional information on               HIV prevention services include: 1. HIV
                                                    Governors not later than December 23,                   the proposed project or to obtain a copy              testing that uses lab-based 4th
                                                    2016.                                                   of the information collection plan and                generation HIV tests; 2. Assessment of
                                                      A. Federal Reserve Bank of San                        instruments, call (404) 639–7570 or                   indications for pre-exposure
                                                    Francisco (Gerald C. Tsai, Director,                    send an email to omb@cdc.gov. Written                 prophylaxis (PrEP) and non-
                                                    Applications and Enforcement) 101                       comments and/or suggestions regarding                 occupational post-exposure prophylaxis
                                                    Market Street, San Francisco, California                the items contained in this notice                    (nPEP); 3. Provision of PrEP and nPEP;
                                                    94105–1579:                                             should be directed to the Attention:                  4. Adherence interventions for PrEP and
                                                      1. BayCom Corp, Walnut Creek,                         CDC Desk Officer, Office of Management                nPEP; 5. Immediate linkage to care,
                                                    California; to become a bank holding                    and Budget, Washington, DC 20503 or                   antiretoriviral treatment, and partner
                                                    company by acquiring 100 percent of                     by fax to (202) 395–5806. Written                     services for those diagnosed with acute
                                                    Bay Commercial Bank, also of Walnut                     comments should be received within 30                 HIV infection; 6. Expedient linkage to
                                                    Creek, California.                                      days of this notice.                                  care, antiretoriviral treatment, and
                                                                                                                                                                  partner services for those diagnosed
                                                      Board of Governors of the Federal Reserve             Proposed Project                                      with established HIV infection; 7. STD
                                                    System, November 23, 2016.                                Comprehensive HIV Prevention and                    screening and treatment; 8. Partner
                                                    Michele Taylor Fennell,                                 Care for Men Who Have Sex with Men                    services for patients with STDs; 9.
                                                    Assistant Secretary of the Board.                       of Color (THRIVE)—New—National                        Behavioral risk-reduction interventions;
                                                    [FR Doc. 2016–28694 Filed 11–28–16; 8:45 am]            Center for HIV/AIDS, Viral Hepatitis,                 10. Screening for behavioral health and
                                                    BILLING CODE 6210–01–P                                  STD, and TB Prevention (NCHHSTP),                     social services needs; 11. Linkage to
                                                                                                            Centers for Disease Control and                       behavioral health and social services;
                                                                                                            Prevention (CDC).                                     12. Navigators to assist utilizing HIV
                                                    DEPARTMENT OF HEALTH AND                                                                                      prevention and behavioral health and
                                                                                                            Background and Brief Description
                                                    HUMAN SERVICES                                                                                                social services; 13. Navigators to assist
                                                                                                               Approximately 40,000 people in the                 enrollment in a health plan.
                                                    Centers for Disease Control and                         United States are newly infected with                    HIV care services include: 1. HIV
                                                    Prevention                                              HIV each year. Gay, bisexual, and other               primary care, including antiretroviral
                                                                                                            men who have sex with men (MSM)                       treatment; 2. Retention interventions; 3.
                                                    [30Day–17–16ET]
                                                                                                            remain the population most affected by                Re-engagement interventions; 4.
                                                    Agency Forms Undergoing Paperwork                       HIV infection in the United States.                   Adherence interventions; 5. STD
                                                    Reduction Act Review                                    Among MSM, those who are black and                    screening and treatment; 6. Partner
                                                                                                            Hispanic comprise 64% of all new                      services; 7. Behavioral risk reduction
                                                       The Centers for Disease Control and                  infections. Goals of the National HIV                 interventions; 8. Screening patients for
                                                    Prevention (CDC) has submitted the                      Prevention Strategy include increasing                behavioral health and social services
                                                    following information collection request                the number of MSM of color living with                needs; 9. Linkage to behavioral health
                                                    to the Office of Management and Budget                  HIV infection who achieve HIV viral                   and social services; 10. Navigators to
                                                    (OMB) for review and approval in                        suppression with antiretroviral                       assist linking to care and accessing
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    accordance with the Paperwork                           treatment, and decreasing the number of               behavioral health and social services;
                                                    Reduction Act of 1995. The notice for                   new HIV infections among MSM of                       11. Navigators to assist enrollment in a
                                                    the proposed information collection is                  color at risk of acquiring an HIV                     health plan.
                                                    published to obtain comments from the                   infection. Achieving these outcomes                      CDC requests OMB approval to collect
                                                    public and affected agencies.                           requires that men utilize a broad variety             the information needed to monitor and
                                                       Written comments and suggestions                     of HIV prevention and care services.                  assess the demonstration projects. In
                                                    from the public and affected agencies                      In 2015, CDC developed a cooperative               general, information collection will be
                                                    concerning the proposed collection of                   agreement program to promote use and                  conducted in 2 steps: THRIVE


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                                                                                Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices                                                          85963

                                                    collaborative partners will report                          electronic reporting. A similar approach                       achieving the goals of the project. Both
                                                    information to their respective health                      will be applied to electronic                                  tools will be submitted to CDC
                                                    department (THRIVE awardee), and                            transmission of the annual Funding                             electronically on an annual basis.
                                                    THRIVE awardees will provide reports                        Allocation Report (FAR). The FAR is                              CDC will use findings to provide
                                                    to CDC. The monitoring and evaluation                       only required for THRIVE awardees.                             technical assistance to THRIVE
                                                    plan is based on semi-annual reports of                        Information collection also includes
                                                                                                                                                                               awardees and to develop
                                                    Monitoring and Evaluation (M&E)                             an Annual Collaborative Process and
                                                                                                                                                                               recommendations for the coordination
                                                    Variables, comprised primarily of de-                       Outcome Evaluation based on semi-
                                                                                                                                                                               of comprehensive HIV testing,
                                                    identified or coded client-level data on                    structured interviews and completion of
                                                    demographics and services received.                         a questionnaire called the Annual                              prevention, and treatment services for
                                                    The M&E files will be transmitted                           Collaborative Assessment Tool. These                           MSM of color.
                                                    electronically. Recognizing that THRIVE                     information collections will allow CDC                           OMB approval is requested for three
                                                    awardees and partners vary in terms of                      to assess how successful THRIVE                                years. Participation is required as a
                                                    existing infrastructure, CDC has                            awardees have been in creating,                                condition of THRIVE funding and there
                                                    established guidelines and                                  engaging, and sustaining collaborative                         are no costs to respondents other than
                                                    specifications for M&E content, but is                      partnerships and to understand how                             their time. The total estimated
                                                    permitting a flexible approach to                           these partnerships contributed to                              annualized burden hours are 1,543.

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

                                                    THRIVE Partners ....................   Monitoring and Evaluation Data Elements on HIV Preven-                                       80                  2                 9
                                                                                             tion and Care Services.
                                                                                           Qualitative Interview: Collaborative Process Evaluation ........                             80                  1          40/60
                                                                                           Collaborative Assessment Tool ..............................................                 80                  1          20/60
                                                    THRIVE Awardees ..................     Monitoring and Evaluation Data Elements on HIV Preven-                                        7                  2              1
                                                                                             tion and Care Services.
                                                                                           Qualitative Interview: Collaborative Process Evaluation ........                                 7               1          40/60
                                                                                           Collaborative Assessment Tool ..............................................                     7               1          20/60
                                                                                           Funding Allocation Report ......................................................                 7               1          20/60



                                                    Leroy A. Richardson,                                        following: (a) Evaluate whether the                            Proposed Project
                                                    Chief, Information Collection Review Office,                proposed collection of information is                            National Health Interview Survey
                                                    Office of Scientific Integrity, Office of the               necessary for the proper performance of                        (NHIS) (OMB No. 0920–0214, expires
                                                    Associate Director for Science, Office of the               the functions of the agency, including
                                                    Director, Centers for Disease Control and                                                                                  01/31/2019)—Revision—National
                                                                                                                whether the information will have                              Center for Health Statistics (NCHS),
                                                    Prevention.
                                                                                                                practical utility; (b) Evaluate the                            Centers for Disease Control and
                                                    [FR Doc. 2016–28588 Filed 11–28–16; 8:45 am]                accuracy of the agencies estimate of the                       Prevention (CDC).
                                                    BILLING CODE 4163–18–P                                      burden of the proposed collection of
                                                                                                                information, including the validity of                         Background and Brief Description
                                                                                                                the methodology and assumptions used;                             Section 306 of the Public Health
                                                    DEPARTMENT OF HEALTH AND                                    (c) Enhance the quality, utility, and
                                                    HUMAN SERVICES                                                                                                             Service (PHS) Act (42 U.S.C. 242k), as
                                                                                                                clarity of the information to be                               amended, authorizes that the Secretary
                                                    Centers for Disease Control and                             collected; (d) Minimize the burden of                          of Health and Human Services (DHHS),
                                                    Prevention                                                  the collection of information on those                         acting through NCHS, shall collect data
                                                                                                                who are to respond, including through                          on the extent and nature of illness and
                                                    [30Day–17–0214]                                             the use of appropriate automated,                              disability of the population of the
                                                                                                                electronic, mechanical, or other                               United States.
                                                    Agency Forms Undergoing Paperwork                           technological collection techniques or                            The annual National Health Interview
                                                    Reduction Act Review                                        other forms of information technology,                         Survey is a major source of general
                                                       The Centers for Disease Control and                      e.g., permitting electronic submission of                      statistics on the health of the U.S.
                                                    Prevention (CDC) has submitted the                          responses; and (e) Assess information                          population and has been in the field
                                                    following information collection request                    collection costs. To request additional                        continuously since 1957. Clearance is
                                                    to the Office of Management and Budget                      information on the proposed project or                         sought for three years, to collect data
                                                    (OMB) for review and approval in                            to obtain a copy of the information                            from 2017 to 2019.
                                                    accordance with the Paperwork                               collection plan and instruments, call                             This voluntary and confidential
                                                    Reduction Act of 1995. The notice for                       (404) 639–7570 or send an email to                             household-based survey collects
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    the proposed information collection is                      omb@cdc.gov. Direct written comments                           demographic and health-related
                                                    published to obtain comments from the                       and/or suggestions regarding the items                         information from a nationally
                                                    public and affected agencies.                               contained in this notice to the                                representative sample of
                                                       Written comments and suggestions                         Attention: CDC Desk Officer, Office of                         noninstitutionalized, civilian persons
                                                    from the public and affected agencies                       Management and Budget, Washington,                             and households throughout the country.
                                                    concerning the proposed collection of                       DC 20503 or by fax to (202) 395–5806.                          Personal identification information is
                                                    information are encouraged. Your                            Written comments should be received                            requested from survey respondents to
                                                    comments should address any of the                          within 30 days of this notice.                                 facilitate linkage of survey data with


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Document Created: 2016-11-29 00:32:50
Document Modified: 2016-11-29 00:32:50
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
FR Citation81 FR 85962 

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