82 FR 26931 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 82, Issue 111 (June 12, 2017)

[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26931-26933]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-17BZ]


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

[[Page 26932]]

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

    Project PrIDE (PrEP Implementation, Data to Care & Evaluation)--
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 50,000 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 US population most heavily affected by HIV infection. 
Among MSM, those who are black and Hispanic comprise 58% of all new 
infections. To address the burden of HIV in this population, high 
impact HIV prevention approaches should be implemented by state, local, 
and territorial health departments to reduce new HIV infections among 
MSM of color, and to improve outcomes along the HIV continuum of care 
for MSM of color living with HIV.
    Antiretroviral (ARV) medications for pre-exposure prophylaxis 
(PrEP) can be used for HIV prevention by MSM at substantial risk for 
HIV acquisition or by those with a possible HIV exposure in the past 72 
hours post-exposure prophylaxis (nPEP). The daily use of co-formulated 
tenofovir disoproxil fumarate and emtricitabine (marketed as Truvada) 
for PrEP has been proven to significantly reduce the risk of HIV 
acquisition among sexually active MSM. In July 2012, the US Food and 
Drug Administration approved an HIV prevention indication for Truvada, 
and in May 2014 CDC published clinical practice guidelines for 
provision of PrEP. Given the high incidence of HIV among MSM of color, 
those who are sexually active are considered at risk for HIV 
acquisition and thus could benefit from prevention services such as 
routine and frequent HIV screening with lab-based 4th generation HIV 
tests, routine screening for STDs, assessment of PrEP eligibility, 
provision of PrEP (if at substantial risk for HIV acquisition), 
provision of nPEP (if a possible HIV exposure occurred in the past 72 
hours), and/or other risk reduction interventions.
    Among people living with HIV (PLWH), ARV treatment can suppress HIV 
viral load, which both improves health outcomes of individuals and 
reduces the risk of HIV transmission. Two studies, one that 
demonstrated the effectiveness of ARV treatment in preventing HIV 
transmission, and one that demonstrated improved health outcomes for 
individuals whose ARV treatment was initiated immediately, have led to 
increased public health focus on interventions and strategies designed 
to initiate ARV treatment, link, retain, and re-engage PLWH in HIV 
care, and to provide support for adherence to ARV medications.
    The purpose of the project is to implement PrEP demonstration 
projects. Health departments that are funded under this cooperative 
agreement will be required to prioritize their services to MSM and 
transgender persons at high risk of HIV infection, particularly persons 
of color. PrEP services may also be provided to HIV-negative persons at 
substantial risk for HIV who are not MSM or transgender. Additionally, 
Data to Care services may be provided to persons diagnosed with HIV 
infection and out of care, those who are in care but not virally 
suppressed, or those who have ongoing risk behavior who are not MSM or 
transgender.
    The goals of PrIDE are consistent with the long-term goals of the 
National HIV/AIDS Strategy (NHAS) including reducing HIV incidence, 
increasing access to HIV care and optimizing health outcomes, and 
reducing HIV-related health disparities.
    To evaluate the impact of PrIDE in the 12 jurisdictions, data will 
be collected from both existing CDC data sources and through new data 
collection activities.
    CDC HIV program grantees will collect, enter or upload, and report 
agency-identifying information, budget data, information on the HIV 
prevention and care services, and client demographic characteristics. 
The total annual burden hours are 1,104.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per  response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Clients...............................  Data Elements...........           2,400               1           25/60
Health Departments....................  Data Management Upload..              12               2           20/60
Health Departments....................  Performance Progress                  12               1               8
                                         Report.
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[[Page 26933]]

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. 2017-12060 Filed 6-9-17; 8:45 am]
 BILLING CODE 4163-18-P