Notice2023-07057
Laboratory Recommendations for Syphilis Testing in the United States
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
April 5, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the proposed Laboratory Recommendations for Syphilis Testing in the United States. The proposed recommendations for syphilis testing include laboratory-based tests, point-of-care tests, processing of samples, and reporting of test results. The recommendations are intended to aid laboratorians and clinicians in the diagnosis of syphilis. These proposed recommendations are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available testing methods, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients in the United States.
Full Text
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<title>Federal Register, Volume 88 Issue 65 (Wednesday, April 5, 2023)</title>
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[Federal Register Volume 88, Number 65 (Wednesday, April 5, 2023)]
[Notices]
[Pages 20169-20170]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07057]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2023-0020]
Laboratory Recommendations for Syphilis Testing in the United
States
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), in the
Department of Health and Human Services (HHS), announces the opening of
a docket to obtain comment on the proposed Laboratory Recommendations
for Syphilis Testing in the United States. The proposed recommendations
for syphilis testing include laboratory-based tests, point-of-care
tests, processing of samples, and reporting of test results. The
recommendations are intended to aid laboratorians and clinicians in the
diagnosis of syphilis. These proposed recommendations are intended for
use by clinical laboratory directors, laboratory staff, clinicians, and
disease control personnel who must choose among the multiple available
testing methods, establish standard operating procedures for collecting
and processing specimens, interpret test results for laboratory
reporting, and counsel and treat patients in the United States.
DATES: Written comments must be received on or before June 5, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0020 by either of the methods listed below. Do not submit comments by
email. CDC does not accept comments by email.
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> Mail: Division of STD Prevention, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, Mailstop US12-2, Atlanta,
GA 30329, Attn: Docket No. CDC-2023-0020.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to <a href="http://regulations.gov">http://regulations.gov</a>, including any personal
information provided. For access to the docket to read background
documents or comments received, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: John R. Papp, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, Mailstop U12-3, Atlanta,
GA 30329; Telephone: 404-639-8000; Email: <a href="/cdn-cgi/l/email-protection#69031e195f290a0d0a470e061f"><span class="__cf_email__" data-cfemail="107a676026507374733e777f66">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: CDC's proposed Laboratory Recommendations
for Syphilis Testing in the United States is available under the
Supporting and Related Materials tab in the docket for this notice,
Docket No. CDC-2023-0020, on <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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 Notice:
<bullet> Based on the evidence presented in the full
recommendations document (see the Supporting and Related Materials tab
in the docket), does the evidence support the proposed Laboratory
Recommendations for Syphilis Testing in the United States? If not,
please state the reason why and, if available, provide additional
evidence for consideration.
<bullet> Are CDC's proposed Laboratory Recommendations for Syphilis
Testing in the United States (see Supporting and Related Materials)
clearly written? If not, what changes do you propose to make them
clearer?
<bullet> If implemented as currently drafted, do you believe the
proposed recommendations would result in improved laboratory testing
for syphilis in the United States? If not, please provide an
explanation and supporting data or evidence.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 comments by email.
Background
Syphilis is a notifiable disease, with over 130,000 cases in the
United States reported to the CDC in 2020 (CDC, 2020) and over 6
million new cases reported worldwide (World Health Organization, 2018).
Syphilis is caused by Treponema pallidum subspecies pallidum. The
United States is currently experiencing a syphilis epidemic, with
sustained increases in primary and secondary syphilis. In 2000, 5,979
cases were reported; in 2020 the figure rose to 133,945 cases, a 2,140%
increase (CDC, 2001, 2020). The epidemic is characterized by health
disparities, particularly among sexual and gender minority populations,
intersections with the HIV and substance use epidemics, and increased
morbidity and mortality attributable to congenital syphilis infections
(CDC, 2020). Laboratories play a critical role in the public health
response to the syphilis epidemic. The responsibility of the laboratory
is to test specimens and report results in a timely manner, allowing
clinicians to efficiently make diagnoses and institute patient
management protocols. Public health reporting by laboratories also
allows local health departments and
[[Page 20170]]
CDC to conduct surveillance and monitoring of disease trends. CDC used
current evidence to draft the proposed Laboratory Recommendations for
Syphilis Testing in the United States to improve laboratory testing for
syphilis and aid laboratorians and clinicians in the diagnosis of the
disease.
Dated: March 31, 2023.
Tiffany Brown,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2023-07057 Filed 4-4-23; 8:45 am]
BILLING CODE 4163-18-P
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