Notice2021-13434
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 24, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33294-33296]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
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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.
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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. 2021-13434 Filed 6-23-21; 8:45 am]
BILLING CODE 4163-18-P
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