Notice2024-02172
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
February 5, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 24 (Monday, February 5, 2024)</title>
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[Federal Register Volume 89, Number 24 (Monday, February 5, 2024)]
[Notices]
[Pages 7711-7712]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02172]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-1402]
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 ``Surveillance of HIV-related service
barriers among Individuals with Early or Late HIV Diagnoses (SHIELD)''
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 October 06, 2023, to
obtain comments from the public and affected agencies. CDC received two
comments 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
Surveillance of HIV-related service barriers among Individuals with
Early or Late HIV Diagnoses (SHIELD) (OMB Control No. 0920-1402, Exp.
05/31/2026)--Revision--National Center for HIV, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
National HIV Surveillance System (NHSS) data indicate that 36,940
adolescents and adults received an HIV diagnosis in the United States
and dependent areas in 2019. During 2015-2019, the overall rate of
annual diagnoses decreased only slightly, from 12.4 to 11.1 per 100,000
persons. Although not every jurisdiction reports complete laboratory
data needed to identify the stage of infection, data from the majority
of jurisdictions show that many of these cases were classified as Stage
0 (6.9%) or Stage 3 (21.5%) infection (i.e., cases diagnosed in early
infection or late infection, respectively). Early and late diagnoses
represent recent failures in prevention and testing systems, and
opportunities to
[[Page 7712]]
understand needed improvements in these systems.
The NHSS would classify HIV infections as Stage 0 if the first
positive HIV test were within six months of a negative HIV test.
Persons who received a diagnosis at Stage 0 (i.e., early diagnosis)
could access HIV testing shortly after infection yet could not benefit
from biomedical and behavioral interventions to prevent HIV infection.
The federal Ending the HIV Epidemic in the U.S. (EHE) initiative
prioritizes the provision of HIV preexposure prophylaxis (PrEP),
syringe services programs, treatment as prevention efforts, and other
proven interventions--as part of the Prevent pillar of the EHE
initiative--to prevent new HIV infections.
HIV infections are classified as Stage 3 (AIDS) by the presence of
an AIDS-defining opportunistic infection or by the lowest CD4
lymphocyte test result. Persons with Stage 3 infection at the time of
their initial HIV diagnosis (i.e., late diagnosis) did not benefit from
timely receipt of testing or HIV prevention interventions. They were
likely unaware of their infection for a substantial length of time.
Nationally, an estimated 13.3% of persons with HIV are unaware of
their infection, contributing to an estimated 40% of all ongoing
transmission. Increasing early diagnosis is a crucial pillar of efforts
to end HIV in the United States. Given the continued occurrence of HIV
infections in the United States, the barriers and gaps associated with
low uptake of HIV testing and prevention services must be addressed to
reduce new infections and facilitate timely diagnosis and treatment.
Individual- and systems-level factors likely contribute to barriers and
gaps in testing and prevention. Therefore, CDC is sponsoring this data
collection to improve understanding of barriers and gaps associated
with new infection and late diagnosis in the era of multiple testing
modalities and prevention options such as PrEP. These enhanced
surveillance activities will identify actionable missed opportunities
for early diagnosis and prevention, thus informing allocation of
resources, development and prioritization of interventions, and
evidence-based local and national decisions to improve HIV testing and
address prevention gaps.
The changes proposed in this request add a new qualitative data
collection activity that encompasses a new consent form and a new data
collection tool (In-depth Interview Guide) to conduct qualitative
interviews to meet prevailing information needs and enhance the value
of SHIELD data and minor edits to the approved SHIELD survey while
remaining within the scope of the currently approved project purpose.
The annualized burden hours of the project increased by 158 hours with
these additions, for a total of 3,074 annualized burden hours. There
are no costs to respondents other than 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 hours)
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Potential Eligible Participant........ Recruitment Script 2,000 1 15/60
English.
Potential Eligible Participant........ Recruitment Script 500 1 15/60
Spanish.
Eligible Participant.................. Consent for quantitative 2,000 1 5/60
survey--English.
Eligible Participant.................. Consent--Spanish........ 500 1 5/60
Eligible Participant.................. Survey--English......... 2,000 1 50/60
Eligible Participant.................. Survey--Spanish......... 500 1 50/60
Eligible Participant.................. Consent for qualitative 50 1 5/60
interview--English.
Eligible Participant.................. Consent for qualitative 50 1 5/60
interview--Spanish.
Eligible Participant.................. In-depth Interview-- 50 1 90/60
English.
Eligible Participant.................. In-depth Interview-- 50 1 90/60
Spanish.
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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. 2024-02172 Filed 2-2-24; 8:45 am]
BILLING CODE 4163-18-P
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