[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33294-33296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13434]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-21-21AC]


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 The GAIN (Greater Access and Impact with NAT) 
Study: Improving HIV Diagnosis, Linkage to Care, and Prevention

[[Page 33295]]

Services with HIV Point-of-Care Nucleic Acid Tests (NATs) 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 December 21, 2020 to obtain comments from 
the public and affected agencies. CDC received two 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

    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, 
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Pre-exposure prophylaxis (PrEP) can prevent HIV acquisition among 
persons at risk. To prevent the emergence of drug-resistant HIV 
strains, prior to initiating PrEP, persons must be tested for HIV to 
ensure that they are not infected. Current rapid point-of-care (POC) 
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 are still 
at high-risk to become HIV infected. 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.
    CDC requests OMB approval to conduct the GAIN (Greater Access and 
Impact with NAT) study at two clinics in Seattle, Washington. 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. 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.
    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.
    OMB approval is requested for three years. Participation is 
voluntary and there are no costs to respondents other than their time. 
The total estimated annualized burden is 1,067 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondent                    Form name           respondents    responses per   response (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Participating clinic..................  Baseline data collection               2               1               2
                                         variables list.
                                        Monthly study report                   2              12           15/60
                                         form.
Participants in prospective study of    Release of information              1530               1           10/60
 HIV-negative patients seeking HIV       form.
 testing and/or PrEP services.
                                        Study visit survey......            1530               1           15/60
Participants in prospective study of    Release of information               165               1           10/60
 HIV-positive patients seeking STI       form.
 testing.
                                        Study visit survey......             165               1           15/60
Participants in RCT of POC NAT or       Release of information               333               1           10/60
 Standard of Care for HIV-positive       form.
 patients.
                                        Study visit survey......             333               1           15/60

[[Page 33296]]

 
Participants in survey group examining  POC NAT acceptability                117               1           20/60
 POC NAT acceptability.                  survey.
Participants in cross-sectional         Release of information               333               1           10/60
 comparison of several point-of-care     form.
 NATs.
                                        Study visit survey......             333               1           15/60
Acceptability/feasibility assessment    POC NAT acceptability                 33               1               1
 among clinical and community            survey, focus group, or
 providers.                              interview.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-13434 Filed 6-23-21; 8:45 am]
BILLING CODE 4163-18-P