[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51438-51439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18276]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-20HR]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Community-Based Organizations' Changes in 
Preparedness and Resources for Support of Biomedical HIV Prevention to 
the Office of Management and Budget (OMB) for review and approval. CDC 
previously published a ``Proposed Data Collection Submitted for Public 
Comment and Recommendations'' notice on March 9, 2020 to obtain 
comments from the public and affected agencies. CDC did not receive 
comments related to the previous notice. This notice serves to allow an 
additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    Community-Based Organizations' Changes in Preparedness and 
Resources for Support of Biomedical HIV Prevention--New--National 
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Antiretroviral (ARV) medications can be effectively used to reduce 
the number

[[Page 51439]]

of new HIV infections. In persons without HIV infection, ARVs can be 
given: (1) For 28 days following a potential HIV exposure through 
sexual or injection behaviors as nPEP, or (2) before potential sexual 
HIV exposures and taken daily for months to years as PrEP. In persons 
with HIV infection, beginning treatment with ARVs early in their 
infection (e.g., with high CD4 cell counts) can greatly lower their 
risk of transmitting infection to uninfected sexual partners; this is 
also called treatment as prevention or TasP. PrEP is 99% effective at 
reducing the risk of HIV through sexual contact when taken daily. PrEP 
is also 74%-84% effective at reducing the risk of HIV infection through 
injection drug use when taken daily. Persons living with HIV who are 
taking ARVs as prescribed, as well as achieving viral suppression, 
effectively have no risk for transmitting the virus to an HIV-negative 
partner through sexual contact. CDC is working with various 
jurisdictions with high HIV prevalence to increase capacity of ARV 
provision, build collaborative efforts between health departments and 
community-based organizations, and engage multi-sector provider systems 
to reach individuals with high risk of HIV infection as part of the End 
the HIV Epidemic Initiative. CBOs will play a crucial role in the End 
the HIV Epidemic Initiative. In a previous survey conducted by CDC's 
Division of HIV/AIDS Prevention, CBOs reported high awareness of nPEP, 
PrEP, and TasP, but their ability to meet client need was low. Although 
clinical CBOs were more prepared to support the expansion of biomedical 
HIV prevention interventions, the likelihood that all CBOs would 
incorporate these interventions if they had additional resources was 
somewhat high.
    Research is needed to better understand the capacity of CBOs to 
incorporate biomedical HIV prevention interventions into their existing 
infrastructure. It is unclear whether the provision of and capacity to 
provide nPEP, PrEP, and TasP has increased among CBOs since the 
original survey was conducted. Furthermore, it is unclear whether non-
clinical CBOs have achieved parity in linking clients to biomedical HIV 
prevention interventions with their clinical counterparts. This new 
survey will assess current capacity and provision of nPEP, PrEP, and 
TasP among CBOs providing HIV services to populations with increased 
risk for HIV acquisition. In addition, the results of this survey will 
be compared to the results of the 2015 survey to assess differences in 
awareness, capacity, and provision of biomedical HIV prevention 
interventions. Respondents will include organizations engaged in HIV 
prevention and outreach. Up to 330 respondents (n=330; 175 funded CBOs 
and 155 CBOs that did not receive funding) will be recruited to 
complete the survey. This project will employ a cross-sectional survey 
design. Executive level staff members of all CBOs within each of the 
two strata (mentioned above) will receive phone calls, using publicly 
available information, to elicit interest in participating in the 
survey. If the executive level staff member is not interested or is 
unable to complete the survey, he or she may nominate a direct client 
service provider and provide this person's email address to study 
staff. Potential respondents will be contacted from a list of CBOs that 
completed the 2015 survey. Potential respondents from CBOs that 
received DHAP funding through PS15-1502 and PS17-1704 will also be 
contacted to determine their interest in participating in the data 
collection effort. Each organization's representative will be sent an 
email with a link to the survey website (created with Survey Monkey). 
One link will be used for CBOs directly funded by CDC and a separate 
link will be used for unfunded CBOs. The email will instruct the 
recipient on how to complete the survey. Three email reminders will be 
sent to organizations for those that do not complete the survey. Email 
reminders will be sent two weeks, one month, and two months after the 
initial email if the potential respondent does not compete the survey. 
The survey should take approximately 30 minutes to complete.
    Where possible, data from the 2015 survey will be combined with 
data from the 2020 survey. Analyses will include completeness (non-
response rates per item) as well as frequency of item responses for 
awareness, intentions, and provision of PrEP, nPEP, and TasP will be 
assessed for all respondents combined. Frequency and differences in 
item responses will be analyzed for relationship to CBO characteristics 
(e.g., clinical CBOs vs non-clinical CBOs). Frequency and differences 
in item responses will be analyzed across survey years. We will perform 
multivariable analysis as needed (to assess interactions between time 
and type of CBO).
    The total annualized burden hours is 165 hours. There are no other 
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
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
                                        Community Based                      330               1           30/60
                                         Organization HIV
                                         Prevention Needs
                                         Assessment Survey.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-18276 Filed 8-19-20; 8:45 am]
BILLING CODE 4163-18-P