2021-10271. 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.

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: [phone]; email: [e-mail].

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, 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.