[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Pages 43865-43866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-22HK; Docket No. CDC-2022-0087]


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 information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled Enhanced Surveillance of Persons with Early and Late HIV 
Diagnosis. This project 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 September 20, 
2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0087 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 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 through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology,

[[Page 43866]]

e.g., permitting electronic submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    Enhanced Surveillance of Persons with Early and Late HIV 
Diagnosis--New--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, as well as 
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 initiative ``Ending the HIV Epidemic in the U.S.'' 
(EHE), 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 to prevent new HIV 
infections of the EHE initiative.
    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 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 key 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 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.
    CDC requests OMB approval for an estimated 3167 annual burden 
hours. There are no costs 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       (in hr)
                                                                    respondent          hr)
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Persons screened..............  Recruitment                2,500               1            5/60             208
                                 Screener
                                 English.
Persons screened..............  Recruitment                  500               1            5/60              42
                                 Screener
                                 Spanish.
Enrolled Participant: English   Survey Consent             2,000               1           15/60             500
 Adults.                         English.
Enrolled Participant: Spanish   Survey Consent               500               1           15/60             125
 Adults.                         Spanish.
Enrolled Participant: English   English Survey..           2,000               1           55/60           1,833
 Adults.
Enrolled Participant--Spanish   Spanish Survey..             500               1           55/60             458
 Adults.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,167
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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. 2022-15734 Filed 7-21-22; 8:45 am]
BILLING CODE 4163-18-P