Notice2023-22274
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
October 6, 2023
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 193 (Friday, October 6, 2023)</title>
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[Federal Register Volume 88, Number 193 (Friday, October 6, 2023)]
[Notices]
[Pages 69640-69641]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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#07686a654764636429606871"><span class="__cf_email__" data-cfemail="d7b8bab597b4b3b4f9b0b8a1">[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 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.
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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]
BILLING CODE 4163-18-P
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