[Federal Register Volume 88, Number 65 (Wednesday, April 5, 2023)]
[Notices]
[Pages 20169-20170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     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 http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

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: [email protected].

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 http://www.regulations.gov.

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:
     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.
     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?
     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 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 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