Notice2022-15734
Proposed Data Collection Submitted for Public Comment and Recommendations
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
July 22, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 140 (Friday, July 22, 2022)</title>
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[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Pages 43865-43866]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#ed82808fad8e898ec38a829b"><span class="__cf_email__" data-cfemail="d8b7b5ba98bbbcbbf6bfb7ae">[email protected]</span></a>.
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.
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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
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