Draft CDC's Recommendations for HIV Screening in Clinical Settings, 95793-95794 [2024-28294]
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95793
Federal Register / Vol. 89, No. 232 / Tuesday, December 3, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
Form name
Researcher ........................................
Research Data Center proposal ......
110
1
3
330
Total ...........................................
...........................................................
330
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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. 2024–28322 Filed 12–2–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2024–0100]
Draft CDC’s Recommendations for HIV
Screening in Clinical Settings
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention in the
Department of Health and Human
Services announces the opening of a
docket to obtain comment on the draft
Recommendations for HIV Screening in
Clinical Settings, that update portions of
CDC’s ‘‘Revised Recommendations for
HIV Testing of Adults, Adolescents, and
Pregnant Women in Health-Care
Settings,’’ published in 2006.
DATES: Written comments must be
received on or before January 2, 2025.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2024–
0100 by either of the methods listed
below. Do not submit comments by
email. CDC does not accept comments
by email.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Center for HIV, Viral
Hepatitis, STD, and TB Prevention,
CDC, 1600 Clifton Road NE, Mailstop
U.S. 8–6, Atlanta, GA 30329–4027.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to https://regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Type of respondents
VerDate Sep<11>2014
17:09 Dec 02, 2024
Jkt 265001
FOR FURTHER INFORMATION CONTACT:
Cecily Campbell, National Center for
HIV, Viral Hepatitis, STD, and TB
Prevention, CDC, 1600 Clifton Road NE,
Mailstop U.S. 8–6, Atlanta, GA 30329–
4027, Email: nchhstppolicy@cdc.gov.
Office phone: 404–639–0485.
SUPPLEMENTARY INFORMATION: CDC is
requesting public comment on the draft
‘‘Recommendations for HIV Screening
in Clinical Settings,’’ which is available
on regulations.gov in Docket CDC–
2024–0100. These recommendations
modify the ages for HIV screening
including eliminating an upper age
limit, encourage providers to use
clinical decision support tools such as
automated HIV test laboratory orders to
implement HIV screening, provide
considerations for healthcare
populations on which to conduct HIV
screening, recommend anyone who
requests a test should be tested, and
emphasize the use of a general consent
process as used for other routine tests.
CDC describes the methods and
supporting evidence in the
recommendations. The
recommendations’ objectives are to
diagnose and link patients with
undiagnosed infection to clinical care;
relink persons with previously
diagnosed HIV to clinical care; diagnose
HIV infection earlier; and reduce HIV
transmission in the United States.
Public Participation
Interested persons or organizations
are invited to participate by submitting
written views, recommendations, and
data. In addition, CDC invites comments
specifically on the following questions
proposed in this document:
• Does the evidence presented
support the proposed recommendations
for HIV screening in clinical settings,
including the benefits and harms of HIV
screening? If not, please state the reason
why and, if available, provide
additional evidence for consideration.
• Are CDC’s proposed
recommendations for HIV screening in
clinical settings clearly written? If not,
what changes do you propose to make
it clearer?
• If implemented as currently drafted,
do you believe these recommendations
would improve HIV screening in
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
clinical settings, improve diagnoses and
linking patients with undiagnosed
infection to clinical care; relinking
persons with previously diagnosed HIV
to clinical care; diagnosing HIV
infection earlier; and reducing HIV
transmission in the United States? If
not, please provide an explanation and
supporting data or evidence.
• How should CDC disseminate the
final recommendations to effectively
reach end users such as healthcare
providers in clinical settings?
• After the recommendations are
finalized, CDC is planning to publish an
implementation guide for healthcare
providers to supplement the updated
recommendations. What should the
implementation guide include?
Please note that comments received,
including attachments and other
supporting materials, are part of the
public record and are subject to public
disclosure. Comments will be posted on
https://www.regulations.gov. Therefore,
do not include any information in your
comment or supporting materials that
you consider confidential or
inappropriate for public disclosure. If
you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be on
public display. CDC will review all
submissions and may choose to redact,
or withhold, submissions containing
private or proprietary information such
as Social Security numbers, medical
information, inappropriate language, or
duplicate/near duplicate examples of a
mass-mail campaign. Do not submit
comments by email. CDC does not
accept comment by email.
After the comments received on the
draft are considered and addressed, the
final recommendations will be
published on CDC’s website at https://
www.cdc.gov/hiv/guidelines/
testing.html. The final recommendations
will also be posted to docket CDC–
2024–0100 at www.regulations.gov.
Background
Human immunodeficiency virus
(HIV) is a virus that attacks the body’s
immune system. The only way a person
can know their HIV status is by getting
tested (CDC, 2024a). While there is no
E:\FR\FM\03DEN1.SGM
03DEN1
lotter on DSK11XQN23PROD with NOTICES1
95794
Federal Register / Vol. 89, No. 232 / Tuesday, December 3, 2024 / Notices
cure, people with HIV who get on and
stay on effective HIV treatment can live
long, healthy lives and protect their
partners (CDC, 2024a).
While the number of persons living
with HIV in the United States has
slightly increased from an estimated 1.1
million people at the end of 2006 to 1.2
million people in 2022, the estimated
HIV incidence has decreased from
48,600 in 2006 to 31,800 in 2022
(Campsmith, Rhodes, Hall, & Green,
2008; CDC, 2024b; Prejean et al., 2011).
There are now better HIV assays for
more accurate diagnosis, improved
antiretroviral treatment, pre-exposure
prophylaxis, post-exposure prophylaxis,
and self-testing, which taken together
improve the prevention, diagnosis, and
treatment of HIV infections.
In 2006, the CDC published ‘‘Revised
Recommendations for HIV Testing of
Adults, Adolescents, and Pregnant
Women in Health-Care Settings,’’
(hereafter referred to as 2006 HIV
Testing Recommendations). These
guidelines transformed the HIV testing
paradigm in the United States by
recommending routine, voluntary HIV
screening among all adults and
adolescents between 13–64 years of age
unless prevalence of undiagnosed HIV
infection in their patients has been
documented to be less than 0.1%. In
addition, it was recommended that
repeat screening of persons not likely to
be at high risk for HIV should be
performed based on clinical judgment.
The 2006 HIV Testing
Recommendations aimed to normalize
HIV screening. To update the evidence,
CDC conducted an in-depth systematic
review and analysis of other data
sources using rigorous methods for
guidelines development. CDC obtained
input from the public prior to starting
the update process and from internal
and external experts at different points
in the process. CDC seeks to engage a
diverse range of perspectives to inform
the development of the
recommendations, improve their
credibility, and increase the
transparency of the process.
CDC invites written comments by the
public (any interested persons or
organizations) on the draft HIV
screening guideline. These
recommendations will also undergo
peer review.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2024–28294 Filed 12–2–24; 8:45 am]
BILLING CODE 4163–18–P
VerDate Sep<11>2014
17:09 Dec 02, 2024
Jkt 265001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–25–1365; Docket No. CDC–2024–
0099]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Performance
Monitoring of CDC’s Core State Injury
Prevention Program (SIPP). The goal of
Core SIPP is to strengthen the awardee’s
injury prevention programs and policies
and demonstrate impact in the
reduction of injury-related morbidity
and mortality.
DATES: CDC must receive written
comments on or before February 3,
2025.
SUMMARY:
You may submit comments,
identified by Docket No. CDC–2024–
0099 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;
ADDRESSES:
PO 00000
Frm 00063
Fmt 4703
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Telephone: 404–639–7570; Email: omb@
cdc.gov.
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,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Performance Monitoring of CDC’s
Core State Injury Prevention Program
(SIPP) (OMB Control No. 0920–1365,
Exp. 7/31/2025)—Revision—National
Center for Injury Prevention and Control
(NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
This is a Revision request for the
currently approved Performance
Monitoring of CDC’s Core State Injury
Prevention Program (SIPP) (OMB
Control No. 0920–1369, Exp. Date 7/31/
2025). Approval is requested for an
additional three years to continue
collecting information from awardees
funded under the Core SIPP cooperative
agreement. Data collected up until this
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 89, Number 232 (Tuesday, December 3, 2024)]
[Notices]
[Pages 95793-95794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28294]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2024-0100]
Draft CDC's Recommendations for HIV Screening in Clinical
Settings
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention in the
Department of Health and Human Services announces the opening of a
docket to obtain comment on the draft Recommendations for HIV Screening
in Clinical Settings, that update portions of CDC's ``Revised
Recommendations for HIV Testing of Adults, Adolescents, and Pregnant
Women in Health-Care Settings,'' published in 2006.
DATES: Written comments must be received on or before January 2, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0100 by either of the methods listed below. Do not submit comments by
email. CDC does not accept comments by email.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: National Center for HIV, Viral Hepatitis, STD, and
TB Prevention, CDC, 1600 Clifton Road NE, Mailstop U.S. 8-6, Atlanta,
GA 30329-4027.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to https://regulations.gov, including any personal
information provided. For access to the docket to read background
documents or comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Cecily Campbell, National Center for
HIV, Viral Hepatitis, STD, and TB Prevention, CDC, 1600 Clifton Road
NE, Mailstop U.S. 8-6, Atlanta, GA 30329-4027, Email:
[email protected]. Office phone: 404-639-0485.
SUPPLEMENTARY INFORMATION: CDC is requesting public comment on the
draft ``Recommendations for HIV Screening in Clinical Settings,'' which
is available on regulations.gov in Docket CDC-2024-0100. These
recommendations modify the ages for HIV screening including eliminating
an upper age limit, encourage providers to use clinical decision
support tools such as automated HIV test laboratory orders to implement
HIV screening, provide considerations for healthcare populations on
which to conduct HIV screening, recommend anyone who requests a test
should be tested, and emphasize the use of a general consent process as
used for other routine tests. CDC describes the methods and supporting
evidence in the recommendations. The recommendations' objectives are to
diagnose and link patients with undiagnosed infection to clinical care;
relink persons with previously diagnosed HIV to clinical care; diagnose
HIV infection earlier; and reduce HIV transmission in the United
States.
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data. In addition, CDC
invites comments specifically on the following questions proposed in
this document:
Does the evidence presented support the proposed
recommendations for HIV screening in clinical settings, including the
benefits and harms of HIV screening? If not, please state the reason
why and, if available, provide additional evidence for consideration.
Are CDC's proposed recommendations for HIV screening in
clinical settings clearly written? If not, what changes do you propose
to make it clearer?
If implemented as currently drafted, do you believe these
recommendations would improve HIV screening in clinical settings,
improve diagnoses and linking patients with undiagnosed infection to
clinical care; relinking persons with previously diagnosed HIV to
clinical care; diagnosing HIV infection earlier; and reducing HIV
transmission in the United States? If not, please provide an
explanation and supporting data or evidence.
How should CDC disseminate the final recommendations to
effectively reach end users such as healthcare providers in clinical
settings?
After the recommendations are finalized, CDC is planning
to publish an implementation guide for healthcare providers to
supplement the updated recommendations. What should the implementation
guide include?
Please note that comments received, including attachments and other
supporting materials, are part of the public record and are subject to
public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your
comment or supporting materials that you consider confidential or
inappropriate for public disclosure. If you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be on public display. CDC will
review all submissions and may choose to redact, or withhold,
submissions containing private or proprietary information such as
Social Security numbers, medical information, inappropriate language,
or duplicate/near duplicate examples of a mass-mail campaign. Do not
submit comments by email. CDC does not accept comment by email.
After the comments received on the draft are considered and
addressed, the final recommendations will be published on CDC's website
at https://www.cdc.gov/hiv/guidelines/testing.html. The final
recommendations will also be posted to docket CDC-2024-0100 at
www.regulations.gov.
Background
Human immunodeficiency virus (HIV) is a virus that attacks the
body's immune system. The only way a person can know their HIV status
is by getting tested (CDC, 2024a). While there is no
[[Page 95794]]
cure, people with HIV who get on and stay on effective HIV treatment
can live long, healthy lives and protect their partners (CDC, 2024a).
While the number of persons living with HIV in the United States
has slightly increased from an estimated 1.1 million people at the end
of 2006 to 1.2 million people in 2022, the estimated HIV incidence has
decreased from 48,600 in 2006 to 31,800 in 2022 (Campsmith, Rhodes,
Hall, & Green, 2008; CDC, 2024b; Prejean et al., 2011). There are now
better HIV assays for more accurate diagnosis, improved antiretroviral
treatment, pre-exposure prophylaxis, post-exposure prophylaxis, and
self-testing, which taken together improve the prevention, diagnosis,
and treatment of HIV infections.
In 2006, the CDC published ``Revised Recommendations for HIV
Testing of Adults, Adolescents, and Pregnant Women in Health-Care
Settings,'' (hereafter referred to as 2006 HIV Testing
Recommendations). These guidelines transformed the HIV testing paradigm
in the United States by recommending routine, voluntary HIV screening
among all adults and adolescents between 13-64 years of age unless
prevalence of undiagnosed HIV infection in their patients has been
documented to be less than 0.1%. In addition, it was recommended that
repeat screening of persons not likely to be at high risk for HIV
should be performed based on clinical judgment.
The 2006 HIV Testing Recommendations aimed to normalize HIV
screening. To update the evidence, CDC conducted an in-depth systematic
review and analysis of other data sources using rigorous methods for
guidelines development. CDC obtained input from the public prior to
starting the update process and from internal and external experts at
different points in the process. CDC seeks to engage a diverse range of
perspectives to inform the development of the recommendations, improve
their credibility, and increase the transparency of the process.
CDC invites written comments by the public (any interested persons
or organizations) on the draft HIV screening guideline. These
recommendations will also undergo peer review.
Noah Aleshire,
Chief Regulatory Officer, Centers for Disease Control and Prevention.
[FR Doc. 2024-28294 Filed 12-2-24; 8:45 am]
BILLING CODE 4163-18-P
