[Federal Register Volume 86, Number 93 (Monday, May 17, 2021)]
[Notices]
[Pages 26733-26734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2021-0053]


The Systematic Review Report for Diagnosis and Treatment of 
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Request 
for Comment

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 systematic review draft report for 
Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue 
Syndrome (ME/CFS). The draft report describes inclusion and exclusion 
criteria to identify relevant literature, outlines the approach for 
evaluating study quality, and summarizes the systematic review results. 
The report, once finalized, is intended to support the anticipated 
development of future clinical practice guidelines, which would guide 
physicians in managing and providing care for patients with ME/CFS. 
Currently there are no federal guidelines for management of ME/CFS. CDC 
has commissioned the Pacific Northwest Evidence-Based Practice Center 
at Oregon Health & Science University to conduct a systematic review of 
the publicly available scientific literature and now seeks public 
comment to inform the final report. In particular, CDC seeks data and 
information, including reports and manuscripts that are pending 
publications or are not available through indexed bibliographic 
databases. Access to pertinent scientific information from research and 
evidence-based clinical practice may be used to inform the final 
report. The anticipated CDC guideline would assist clinicians by 
outlining management practices for patients with ME/CFS.

DATES: Written comments must be received on or before August 16, 
2021.May 17, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0053 by either of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Anindita Issa, MD, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE, Mailstop H24-12, Atlanta, Georgia 
30329.
    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. Do 
not submit comments by email. CDC does not accept comments by email.

FOR FURTHER INFORMATION CONTACT: For technical information on the 
systematic review report for ME/CFS, contact Anindita Issa, MD, Centers 
for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H24-
12, Atlanta, Georgia 30329. Telephone: 404-718-3959; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Public Participation

    Interested persons or organizations are invited to participate by 
submitting written views, recommendations, and data related to the 
draft report, including perspectives on and experiences with diagnosis 
and management of ME/CFS illness. In addition, CDC invites comments 
specifically on topics for pharmacological or non-pharmacological 
treatments.
    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,

[[Page 26734]]

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. CDC will carefully consider all comments submitted in 
preparation of the final systematic review report and may revise it as 
appropriate. Do not submit comments by email. CDC does not accept 
comments by email.

Background

    CDC has commissioned the Pacific Northwest Evidence-Based Practice 
Center at Oregon Health and Science University to conduct a systematic 
review of the publicly available scientific literature for ME/CFS 
(systematic review). Once finalized, the systematic review report is 
intended to support the anticipated development of future agency 
clinical practice guidelines. The anticipated CDC guideline would 
assist physicians and other clinicians by outlining management 
practices for caring for patients with ME/CFS.
    Public comment may inform the final systematic review report and 
may be used to inform development of a clinical guideline and related 
materials, which would help clinicians diagnose and treat patients with 
ME/CFS.

    Dated: May 11, 2021.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2021-10271 Filed 5-14-21; 8:45 am]
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