[Federal Register Volume 88, Number 193 (Friday, October 6, 2023)]
[Notices]
[Pages 69640-69641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-1402; Docket No. CDC-2023-0081]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed or continuing 
information collection, as required by the Paperwork Reduction Act of 
1995. This notice invites comments on a proposed information collection 
titled Surveillance of HIV-related service barriers among Individuals 
with Early or Late HIV Diagnoses (SHIELD), which collects information 
from people who were recently diagnosed with HIV at early (Stage 0) or 
late diagnosis (Stage 3) to understand barriers to HIV prevention and 
testing services to contributing to transmission.

DATES: CDC must receive written comments on or before December 5, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0081 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) or by U.S. mail to the address listed 
above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road, NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118; 
Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of the existing collection 
of information, and each reinstatement of previously approved 
information collection before submitting the collection to the OMB for 
approval. To comply with this requirement, we are publishing this 
notice of a proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. Minimize the burden of the collection of information on those 
who are to respond, including using appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology, e.g., permitting electronic submissions of 
responses; and
    5. Assess information collection costs.

Proposed Project

    Surveillance of HIV-related service barriers among Individuals with 
Early or Late HIV Diagnoses (SHIELD) (OMB Control No. 0920-1402, Exp. 
5/31/2026)--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 37,968 
adolescents and adults received an HIV diagnosis in the United States 
and dependent areas in 2018. During 2015-2019, the overall rate of 
annual diagnoses decreased only slightly, from 12.4 to 11.1 per 
100,000. Although not every jurisdiction reports complete laboratory 
data needed to identify stage of infection, data from most 
jurisdictions show that many of these cases were classified as Stage 0 
(7.9%) or Stage 3 (20.2%) infection (i.e., cases diagnosed in early 
infection or late infection, respectively). Early and late diagnoses 
represent recent failures in prevention and testing systems, 
respectively, and opportunities to understand needed improvements in 
these systems.
    The NHSS classifies HIV infections as Stage 0 if the first positive 
HIV test was within six months of a negative HIV test. Persons who 
received a diagnosis at Stage 0 (i.e., early diagnosis) were able to 
access HIV testing shortly after infection yet were unable to 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 and were 
likely unaware of their infection for a substantial 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. 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

[[Page 69641]]

modalities and prevention options such as PrEP. These enhanced 
surveillance activities will identify actionable missed opportunities 
for early diagnosis and prevention, thus informing the 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 Revision 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 is 
no cost to respondents other than their time to participate.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response (in        hours
                                                                    respondent        hours)
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Potential Eligible Participant  Recruitment                2,000               1           15/60             500
                                 Script English.
Potential Eligible Participant  Recruitment                  500               1           15/60             125
                                 Script Spanish.
Eligible Participant..........  Consent for                2,000               1            5/60             167
                                 quantitative
                                 survey--English.
Eligible Participant..........  Consent for                  500               1            5/60              42
                                 quantitative
                                 survey--Spanish.
Eligible Participant..........  Survey--English.           2,000               1           50/60           1,666
Eligible Participant..........  Survey--Spanish.             500               1           50/60             416
Eligible Participant..........  Consent for in-               50               1            5/60               4
                                 depth
                                 interview--Engl
                                 ish.
Eligible Participant..........  Consent for in-               50               1            5/60               4
                                 depth
                                 interview--Span
                                 ish.
Eligible Participant..........  In-depth                      50               1           90/60              75
                                 Interview--Engl
                                 ish.
Eligible Participant..........  In-depth                      50               1           90/60              75
                                 Interview--Span
                                 ish.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,074
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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. 2023-22274 Filed 10-5-23; 8:45 am]
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