[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)]
[Notices]
[Pages 76592-76594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26500]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17BZ]; Docket No. CDC-2016-0104]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

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

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project entitled ``Project Pride.'' This project 
is funded by CDC at 12 health departments in the United States. The 
health departments will report standardized program monitoring and 
evaluation (M&E) data to CDC. CDC is requesting approval to collect 
standardized HIV prevention program evaluation data from funded health 
departments.

DATES: Written comments must be received on or before January 3, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0104 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 the 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

[[Page 76593]]

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

    Project PrIDE--New--National Center for HIV/AIDS, Viral Hepatitis, 
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    State, local and territorial health departments in the U.S. are 
implementing high impact HIV prevention programs to reduce new HIV 
infections among populations of gay, bisexual, and other men who have 
sex with men (MSM) and transgender persons. Additional effort is needed 
to realize the benefits of new prevention strategies that have the 
potential to significantly reduce new HIV infections and increase viral 
suppression among MSM and transgender persons.
    Pre-exposure prophylaxis (PrEP) is a potent new prevention tool for 
MSM without HIV but who are at substantial risk of acquiring HIV 
infection. The daily use of oral, antiretroviral medication (PrEP) with 
co-formulated tenofovir disoproxil fumarate and emtricitabine (marketed 
as Truvada[supreg]) is proven to significantly reduce the risk of HIV 
acquisition among sexually active adults. In July 2012, the US Food and 
Drug Administration approved an HIV prevention indication for Truvada, 
and in May 2014 CDC published Public Health Service clinical practice 
guidelines for provision of PrEP to persons at substantial risk of HIV 
acquisition through sexual or injection routes of transmission as part 
of a package of HIV prevention clinical services. It is critical for 
health departments to address barriers to and facilitate broader 
awareness, support and capacity for the scale-up of PrEP services for 
MSM and transgender persons at high risk for HIV infection, 
particularly persons of color, recognizing that the population with the 
highest incidence of HIV in the U.S. is young African American MSM.
    Another potent prevention tool involves antiretroviral medication 
to suppress HIV-1 viral load, improve health outcomes and reduce 
transmission risk among people living with HIV (PLWH). The importance 
of antiretroviral treatment has increased focus on interventions and 
public health strategies designed to link, engage and re-engage persons 
living with HIV in health care, with the ultimate outcome of 
suppressing HIV viral load, decreasing morbidity and increasing 
survival. To increase viral suppression, more people who are diagnosed 
with HIV will need to be retained in HIV medical care and receive 
antiretroviral treatment. There is a need for health departments to 
implement public health strategies for improving linkage, engagement 
and re-engagement of MSM and transgender persons who are not in care.
    Data to Care is a public health strategy for identifying these 
individuals. Data to Care is based on the use of surveillance data to 
intervene directly in disease control. Data to Care programs use 
laboratory reports received by a health department's HIV surveillance 
program, and a range of other data sources as markers of HIV care, and 
analyze these reports to confidentially identify HIV-diagnosed 
individuals who are not engaged in HIV medical care or have not 
achieved viral suppression. Several state health departments have taken 
steps toward initiating a Data to Care program, and a few have reported 
successful implementation of Data to Care activities. It is important 
that these efforts be expanded and that other state, local and 
territorial health departments scale up and implement this promising 
public health strategy to improve outcomes along the HIV continuum of 
care and prevent new HIV infections.
    The purpose of this project is to support 12 health departments in 
the United States to implement PrEP and Data to Care demonstration 
projects for 200 clients annually, prioritizing MSM and transgender 
persons at high risk of HIV infection, particularly persons of color.
    Health departments that are involved in this project will be 
required to prioritize their services to these populations. Services 
may also be provided for persons at substantial risk for HIV (for PrEP) 
or persons who have HIV and are not virally suppressed or have ongoing 
risk behavior (for Data to Care) who are not MSM or transgender.
    CDC HIV program grantees will collect, enter or upload, and report 
budget data, information on the HIV prevention and care services, and 
client demographic characteristics with an estimated of 1,104 burden 
hours.

                                                            Estimated Annualized Burden Hours
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                                                                                                          Number of      Average burden
               Type of respondents                             Form name                 Number of      responses per     per response     Total burden
                                                                                        respondents       respondent       (in hours)         hours
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Clients.........................................  Data Elements.....................            2,400                1            25/60            1,000
Health Departments..............................  Data Management...................               12                2            20/60                8
Health Departments..............................  Performance Progress Report.......               12                1                8               96
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    Total.......................................  ..................................  ...............  ...............  ...............            1,104
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[[Page 76594]]

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. 2016-26500 Filed 11-2-16; 8:45 am]
 BILLING CODE 4163-18-P