[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83087-83089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21AC; Docket No. CDC-2020-0110]


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 The GAIN (Greater Access and 
Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and 
Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs). 
GAIN is an implementation study to compare a point-of-care nucleic acid 
HIV test (HIV RNA POC NAT) to standard lab-based HIV testing.

DATES: CDC must receive written comments on or before February 19, 
2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0110 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

[[Page 83088]]

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: 404-639-7118; 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

    The GAIN (Greater Access and Impact with NAT) Study: Improving HIV 
Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-
Care Nucleic Acid Tests (NATs)--NEW--National Center for HIV/AIDS, STD, 
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Current rapid point-of-care (POC) HIV testing technologies do not 
reliably detect the earliest HIV infections and lab-based testing can 
introduce delays while patients wait for test results. During this 
time, patients can drop out of care and remain at high-risk to acquire 
HIV. Direct molecular detection of HIV through nucleic acid tests 
(NATs) can identify early HIV infections, which have high potential for 
transmission. NATs that are used at the point-of-care (POC NAT) can 
provide results in 60 to 90 minutes. Obtaining timely molecular test 
results from a POC NAT in clinics or community settings can expand 
prevention as well as HIV treatment services, improve our reach into 
disproportionately affected populations, and provide opportunities to 
approach the goal of no new HIV infections. The purpose of this 
research is to develop feasible and effective models for using HIV POC 
NATs to: (1) Improve PrEP initiation, and duration of PrEP use, among 
persons at high-risk for acquiring HIV infection; and (2) reduce the 
time between testing in community-based and clinical-based settings and 
linkage to HIV care, ART initiation, and viral suppression.
    GAIN is an implementation study to compare a point-of-care nucleic 
acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing. 
Study activities include: 1. Retrospective baseline data collection 
from clinical site electronic medical records. This will establish 
baseline PrEP and HIV care metrics for comparison after study 
implementation; 2. A longitudinal, prospective study of HIV-negative 
patients seeking HIV testing and/or PrEP services; 3. A longitudinal, 
prospective study of HIV-positive patients seeking STI testing; 4. An 
RCT of POC NAT or Standard of Care for HIV-positive patients; 5. A 
survey, interviews, and focus groups examining POC NAT acceptability 
among HIV-negative and HIV-positive patients; 6. A cross-sectional 
comparison of several point-of-care NATs among HIV-positive patients; 
7. Acceptability/feasibility assessment among clinical and community 
providers and costing analyses. These data will be analyzed and 
disseminated to describe the real-world performance and clinical 
effects of HIV RNA POC NAT testing technology. This study will develop 
functional models to integrate HIV RNA POC NAT testing technology into 
HIV prevention and treatment services. There are no 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 respondent            Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
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Participants in prospective     Consent form....            1150               1           30/60             575
 study of HIV-negative          HIPPA form......            1150               1           10/60             192
 patients seeking HIV testing
 and/or PrEP services.
                                Release of                  1150               1           10/60             192
                                 information
                                 form.
                                Study visit                 1150               1           15/60             288
                                 survey.
Participants in prospective     Consent form....             125               1           30/60              63
 study of HIV-positive          HIPPA form......             125               1           10/60              21
 patients seeking STI testing.
                                Release of                   125               1           10/60              21
                                 information
                                 form.
                                Study visit                  125               1           15/60              31
                                 survey.
Participants in RCT of POC NAT  Consent form....             250               1           30/60             125
 or Standard of Care for HIV-   HIPPA form......             250               1           10/60              42
 positive patients.

[[Page 83089]]

 
                                Release of                   250               1           10/60              42
                                 information
                                 form.
                                Study visit                  250               1           15/60              63
                                 survey.
Participants in survey group    POC NAT                       87               1           20/60              29
 examining POC NAT               acceptability
 acceptability.                  survey.
Participants in cross-          Consent.........             250               1           30/60             125
 sectional comparison of        Release of                   250               1           10/60              42
 several point-of-care NATs.     information
                                 form.
                                Study visit                  250               1           15/60              63
                                 survey.
Acceptability/feasibility       POC NAT                       25               1               1              25
 assessment among clinical and   acceptability
 community providers.            survey, focus
                                 group, or
                                 interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,667
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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. 2020-28113 Filed 12-18-20; 8:45 am]
BILLING CODE 4163-18-P