Laboratory Recommendations for Syphilis Testing in the United States, 20169-20170 [2023-07057]
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Federal Register / Vol. 88, No. 65 / Wednesday, April 5, 2023 / Notices
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JoAnne O’Bryant,
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[FR Doc. 2023–07075 Filed 4–4–23; 8:45 am]
BILLING CODE 6730–02–P
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
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), 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 laboratorybased tests, point-of-care tests,
processing of samples, and reporting of
test results. The recommendations are
intended to aid laboratorians and
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SUMMARY:
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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: https://
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 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: John
R. Papp, Centers for Disease Control and
Prevention, 1600 Clifton Road NE,
Mailstop U12–3, Atlanta, GA 30329;
Telephone: 404–639–8000; Email:
jwp6@cdc.gov.
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 https://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.
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20169
• 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
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20170
Federal Register / Vol. 88, No. 65 / Wednesday, April 5, 2023 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–0592]
Human User Safety in New and
Abbreviated New Animal Drug
Applications; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry #278 (GFI #278)
entitled ‘‘Human User Safety in New
and Abbreviated New Animal Drug
Applications.’’ Human User Safety
(HUS) is an integral component of the
overall safety evaluation of proposed
new animal drugs. FDA is issuing this
guidance to clarify the current
approaches and recommendations of
FDA’s Center for Veterinary Medicine
(CVM) for HUS assessment and
submission of HUS information to
support the overall safety of proposed
new animal drugs prior to approval.
DATES: Submit either electronic or
written comments on the draft guidance
by June 5, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
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17:44 Apr 04, 2023
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solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Submit written/paper submissions as
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Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
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• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–D–0592 for ‘‘Human User Safety
in New and Abbreviated New Animal
Drug Applications.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
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• Confidential Submissions—To
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‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
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claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
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contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Karen Sussman, Center for Veterinary
Medicine (HFV–114), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0876,
karen.sussman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
draft GFI #278 entitled ‘‘Human User
Safety in New and Abbreviated New
Animal Drug Applications.’’ This draft
guidance is intended for sponsors
interested in pursuing the approval, or
conditional approval, of new animal
drugs (including new generic animal
drugs). This guidance addresses general
principles of HUS assessment for new
animal drugs, sources of data, mitigation
strategies for proposed new animal
drugs, potential recommendations to
address HUS concerns, and how HUS
information should be submitted to
CVM.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 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: 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 https://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
