The Systematic Review Report for Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Request for Comment, 26733-26734 [2021-10271]
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Federal Register / Vol. 86, No. 93 / Monday, May 17, 2021 / Notices
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Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2021–10285 Filed 5–14–21; 8:45 am]
BILLING CODE 6750–01–P
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
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
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
SUMMARY:
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26733
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: https://
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 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. 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: cfs@cdc.gov.
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 nonpharmacological 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,
E:\FR\FM\17MYN1.SGM
17MYN1
26734
Federal Register / Vol. 86, No. 93 / Monday, May 17, 2021 / Notices
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.
ACTION:
Notice.
Medicaid and Children’s Health
Insurance Program (CHIP) Generic
Information Collection Activities:
Proposed Collection; Comment
Request
On May 28, 2010, the Office
of Management and Budget (OMB)
issued Paperwork Reduction Act (PRA)
guidance 1 related to the ‘‘generic’’
clearance process. Generally, this is an
expedited process by which agencies
may obtain OMB’s approval of
collection of information requests that
are ‘‘usually voluntary, low-burden, and
uncontroversial collections,’’ do not
raise any substantive or policy issues,
and do not require policy or
methodological review. The process
requires the submission of an
overarching plan that defines the scope
of the individual collections that would
fall under its umbrella. On October 23,
2011, OMB approved our initial request
to use the generic clearance process
under control number 0938–1148
(CMS–10398). It was last approved on
April 26, 2021, via the standard PRA
process which included the publication
of 60- and 30-day Federal Register
notices. The scope of the April 2021
umbrella accounts for Medicaid and
CHIP State plan amendments, waivers,
demonstrations, and reporting. This
Federal Register notice seeks public
comment on one or more of our
collection of information requests that
we believe are generic and fall within
the scope of the umbrella. Interested
persons are invited to submit comments
regarding our burden estimates or any
other aspect of this collection of
information, including: The necessity
and utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments must be received by
June 1, 2021.
ADDRESSES: When commenting, please
reference the applicable form number
(see below) and the OMB control
number (0938–1148). To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
1 https://www.whitehouse.gov/sites/
whitehouse.gov/files/omb/assets/inforeg/PRA_Gen_
ICRs_5-28-2010.pdf.
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]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10398 #71]
AGENCY:
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18:56 May 14, 2021
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SUMMARY:
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document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attention:
CMS–10398 (#71)/OMB control number:
0938–1148, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may access CMS’
website at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
Following
is a summary of the use and burden
associated with the subject information
collection(s). More detailed information
can be found in the collection’s
supporting statement and associated
materials (see ADDRESSES).
SUPPLEMENTARY INFORMATION:
Generic Information Collection
1. Title of Information Collection:
Reporting Requirements for State
Planning Grants for Qualifying
Community-Based Mobile Crisis
Intervention Services During the
COVID–19 Emergency; Type of
Information Collection Request: New
collection; Use: On March 11, 2021,
President Biden signed the American
Rescue Plan Act of 2021 (ARP) (Pub. L.
117–2). Under ARP section 9813,
planning grantees must submit quarterly
progress reports and a final progress
report. The reports should include
narrative updates on planning grant
activities, as well as information on
each recipient’s approved work plan, as
specified in each recipient’s approved
application in accordance with the
‘‘Section 9813 State Planning Grants for
Mobile Crisis Intervention Services
Cooperative Agreement.’’ To ensure
maximum state flexibility and to reduce
the reporting burden on states as much
as possible, states will submit quarterly
and final progress reports in their own
preferred format. CMS will not require
states to use a standardized template or
form. When ready, the Notice of
Funding Opportunity will be posted on
the Grants.gov website; Form Number:
CMS–10398 (#71) (OMB control
number: 0938–1148); Frequency:
Quarterly; Affected Public: State, Local,
or Tribal Governments; Number of
Respondents: 20; Total Annual
Responses: 80; Total Annual Hours:
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 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. 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]
BILLING CODE 4163-18-P
