[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.
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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