Notice2025-23602
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
December 22, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 90 Issue 243 (Monday, December 22, 2025)</title>
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[Federal Register Volume 90, Number 243 (Monday, December 22, 2025)]
[Notices]
[Pages 59831-59833]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23602]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-25-1357]
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 Greater Access and Impact with NAT
(GAIN) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention
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 January 8, 2025, to obtain
comments from the public and affected agencies. CDC received no
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 Greater Access and Impact with NAT (GAIN) Study: Improving HIV
Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-
Care Nucleic Acid Tests (NATs) (OMB Control No. 0920-1357)--
Reinstatement--National Center for HIV, Viral Hepatitis, STD, TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The CDC is requesting reapproval for three years of the data
collection titled The Greater Access and Impact with NAT (GAIN) Study:
Improving HIV Diagnosis, Linkage to Care, and Prevention Services with
HIV Point-of-Care Nucleic Acid Tests (NATs). The purpose of this
information collection is to determine the acceptability and
feasibility of HIV point of care nucleic acid tests (POC NAT) for HIV
in clinical and community settings. Current rapid 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 infected. POC NATs can identify early HIV infections, which have
high potential for transmission. POC NATs have the potential to help
address some of the remaining challenges to ending the HIV epidemic in
the United States by assisting with early detection of acute HIV
infection and by providing a more efficient viral load monitoring tool
for people living with HIV. This study is the first of its kind in the
U.S. and is critical to understanding the feasibility and acceptability
of POC NAT use in the U.S.
Data collected during this study will be used to evaluate the
performance of POC NAT and associated clinical outcomes, patient and
provider perspectives regarding acceptability and feasibility, and
implementation science outcomes. The GAIN study will develop,
implement, and evaluate models for use of POC NAT among HIV-negative
persons seeking HIV testing, PEP, and PrEP and HIV-positive persons in
community and clinical settings.
Prior to study expiration in December 2024, the GAIN project was
successful in meeting several information collection goals. GAIN is on
track to reach remaining data collection targets and successfully
conclude this important information collection if the study is
reinstated. A limited number of data collection activities remain to be
completed; therefore, the annual number of respondents needed to
complete the study have been reduced from 3,494 to 150. Accordingly,
the
[[Page 59832]]
annualized burden will also decrease from 880 to 49 hours. GAIN study
stakeholders noted several opportunities to improve the participant
experience and improve data quality by refining existing tools and
collecting additional data; therefore, we propose the addition of three
new study instruments and minor revisions to four study instruments.
The study will be carried out in Seattle, Washington at two
locations: the Gay City community center and the Madison Clinic. Gay
City is the largest community-based testing program in Washington.
Madison Clinic is the largest provider of HIV care in the state. Upon
reinstatement, GAIN will engage four types of participants: (1) persons
living with HIV (PLWH) and receiving care at Madison Clinic; (2)
individuals enrolled in GAIN at the community center prior to study
expiration; (3) health providers at Madison Clinic; and (4) clinic
staff from both study locations. All participants will be at least 18
years of age and able to read and speak English.
In order to complete our evaluation of the impact of POC NAT on
time to virologic suppression among PLWH receiving antiretroviral
therapy (ART), we will enroll 61 PLWH who are receiving ART at Madison
Clinic. Participants will be recruited using a combination of
approaches including in-person outreach, health provider referrals, and
printed media (flyers) displayed in the clinic. Following screening and
enrollment, a computer-assisted quantitative survey will collect
participant demographics and information about substance use, pre-
exposure prophylaxis (PrEP) use, and antiretroviral therapy (ART).
Following the study visit, a web link to the online acceptability
survey will be sent to them via email. The survey will collect
information about participants' knowledge about their POC NAT results,
their perception about the accuracy of those results, and their level
of confidence in the results. The survey will also collect information
about test result sharing, HIV treatment and test result knowledge and
beliefs, ART adherence, and communications with their provider. A
subset of the cohort will be randomly selected by study staff and
invited to participate in a focus group or interview to further explore
their experiences and preferences for HIV testing, and to evaluate
their reactions to the intervention. Interviews and focus groups may be
conducted in person or remotely via a secure, teleconference platform.
A subset of participants who were enrolled at Gay City will be
randomly selected, contacted by study staff via telephone, and invited
to participate in a brief survey. Depending on the group they were
enrolled in, the survey will collect information to determine if the
participant initiated PrEP, engaged in HIV care, or is successfully
taking ART. Study staff may call a participant up to three times to
discuss the outcome of their study visit. The five-minute survey will
provide the information needed to evaluate the impact of POC NAT on the
outcomes of respondents who participated in the GAIN study at the
community center.
Health providers and clinic staff at Madison Clinic who referred
patients to the GAIN study and saw patients enrolled in the study will
be invited by study staff, either in person or via email, to
participate in an interview to describe their experiences with POC NAT
and preferences for HIV testing. Participants will have the option to
attend the interview in-person or remotely via telephone or a
teleconference platform. Providers will be invited to complete up to
three interviews over the course of the study in order to capture the
provider experience over time and in varying clinical scenarios. Clinic
staff with expertise in electronic health record management will be
engaged at each of the study sites to collect medical record data,
including test dates and results.
Data will be collected from a total of 181 individuals over the
three-year data collection period, including 61 PLWH receiving care at
Madison Clinic; 18 health providers at Madison Clinic; 100 participants
at the Gay City center; and two clinic employees. For PLWH
participants, we estimate that we will need to screen 122 individuals
(41 annually) to reach total enrollment. The screening process will
take approximately five minutes to complete. Following enrollment, 61
participants (21 annually) will complete the Release of Information
form which will take five minutes to complete. The study visit survey
will take 15 minutes to complete and will be delivered to 61
participants (21 annually) once. A total of 61 participants (21
annually) will complete the acceptability survey which will take 20
minutes to complete. A subset of participants (12 total, four annually)
will be invited to participate in a focus group or interview which may
take up to one hour to complete. A follow-up telephone survey will be
conducted with participants who were enrolled at Gay City (100 total,
34 annually). The survey will take five minutes to complete, and
participants may be called up to three times. Health providers (18
total, six annually) at Madison Clinic will be invited to participate
in up to three interviews which will take 45 minutes to complete. One
clinic employee at each of the two study sites will be engaged to
collect medical record data. The Madison Clinic will perform an
automated data collection, estimated to take five minutes, once every
two months (six times annually). Gay City center will perform a manual
data pull, estimated to take one hour, once every six months.
CDC is requesting OMB approval for 135 total burden hours across
three years of data collection. The total estimated annualized burden
hours are 49. Participation of respondents is voluntary. There is no
cost to participants other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hr)
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General Public--Adults................ Screen and Link......... 41 1 5/60
General Public--Adults................ Release of Information.. 21 1 5/60
General Public--Adults................ Study Visit Survey...... 21 1 15/60
General Public--Adults................ Acceptability Survey.... 21 1 20/60
General Public--Adults................ Participant Focus Group 4 1 1
and Interview Guide.
General Public--Adults................ Follow Up Phone Call 34 3 5/60
Survey.
Health Practitioners.................. Provider Interview Guide 6 3 45/60
Health Practitioners.................. Madison Clinic Data 1 6 5/60
Collection.
Health Practitioners.................. Gay City Data Collection 1 2 1
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[[Page 59833]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2025-23602 Filed 12-19-25; 8:45 am]
BILLING CODE 4163-18-P
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