[Federal Register Volume 89, Number 24 (Monday, February 5, 2024)]
[Notices]
[Pages 7711-7712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

    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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


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]
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