[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Pages 13656-13657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20HR; Docket No. CDC-2020-0019]


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 effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Community-Based Organizations' 
Changes in Preparedness and Resources for Support of Biomedical HIV 
Prevention. The information collection project will be used to assess 
community-based organizations' (CBOs) awareness of, intentions to 
provide, and provision of Treatment as Prevention (TasP), non-
occupational post-exposure prophylaxis (nPEP), or pre-exposure 
prophylaxis (PrEP) among clinical and non-clinical CBOs that have 
received funding from CDC's Division of HIV/AIDS Prevention (DHAP) and 
those that applied but did not receive funding.

DATES: CDC must receive written comments on or before May 8, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0019 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments 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 Jeffrey M. Zirger, 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 the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Community-Based Organizations' Changes in Preparedness and 
Resources for Support of Biomedical HIV Prevention--New--Division of 
HIV/AIDS Prevention (DHAP), 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 of new HIV infections. In persons without HIV infection, 
ARVs can be given as either: (1) For 28 days following a potential HIV 
exposure through sexual or injection behaviors as nPEP or (2) begun 
before potential sexual HIV exposures and taken daily for months to 
years as PrEP. In persons with HIV infection, beginning treating with 
ARVs early in their infection (e.g., with high CD4 cell counts) can 
greatly lower their risk of transmitting infection

[[Page 13657]]

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. All CBOs within each of the two strata (1. Clinical and non-
clinical CBOs directly funded by CDC, and 2. Clinical and non-clinical 
CBOs that did not receive CDC funding) will receive phone calls to 
elicit interest in participating in the survey and to receive the 
contact information of an organization's representative to complete the 
survey on behalf of the organization. Potential respondents will be 
contacted from a list of CBOs that completed the 2015 survey. In 
addition, 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 and to nominate a staff 
member to complete the survey. Each organization's representative will 
receive an email with a link to the survey website (created with Survey 
Monkey). The email will instruct the representative on how to complete 
the survey. Three email reminders will be sent to organizations for 
those that do not complete the survey. 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
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Community Based Organization..  Community Based              330               1           30/60             165
                                 Organization
                                 HIV Prevention
                                 Needs
                                 Assessment
                                 Survey.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             165
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-04721 Filed 3-6-20; 8:45 am]
 BILLING CODE 4163-18-P