80 FR 44977 - Meeting of the Chronic Fatigue Syndrome Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 144 (July 28, 2015)

Page Range		44977-44978
FR Document		2015-18444

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.

Federal Register, Volume 80 Issue 144 (Tuesday, July 28, 2015)

[Federal Register Volume 80, Number 144 (Tuesday, July 28, 2015)]
[Notices]
[Pages 44977-44978]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Chronic Fatigue Syndrome Advisory Committee

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

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SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. 
Department of Health and Human Services is hereby giving notice that 
the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a 
meeting. The meeting will be open to the public.

[[Page 44978]]


DATES: The meeting will be held on Tuesday, August 18, 2015, from 9:00 
a.m. until 5:00 p.m., ET and Wednesday, August 19, 2015, from 9:00 a.m. 
until 5:00 p.m., ET.

ADDRESSES: Department of Health and Human Services, Hubert H. Humphrey 
Building, 200 Independence Avenue SW., Room 800, Washington, DC 20201. 
For a map and directions to the Hubert H. Humphrey building, please 
refer to http://www.hhs.gov/about/hhh.html.

FOR FURTHER INFORMATION CONTACT: Any questions about meeting 
registration or public comment sign-up should be directed to 
[email protected]. Please direct other inquiries to [email protected].

SUPPLEMENTARY INFORMATION: CFSAC was established on September 5, 2002 
to advise, consult with, and make recommendations to the Secretary, 
through the Assistant Secretary for Health, on a broad range of topics 
including: (1) The current state of knowledge and research and the 
relevant gaps in knowledge and research about the epidemiology, 
etiologies, biomarkers, and risk factors relating to myalgic 
encephalomyelitis/chronic fatigue syndrome (ME/CFS), and identifying 
potential opportunities in these areas; (2) impact and implications of 
current and proposed diagnosis and treatment methods for ME/CFS; (3) 
development and implementation of programs to inform the public, health 
care professionals, and the biomedical research communities about ME/
CFS advances; and (4) strategies to improve the quality of life of ME/
CFS patients.
    The agenda for this meeting is being developed and will be posted 
on the CFSAC Web site, http://www.hhs.gov/advcomcfs/ when finalized. 
The meeting will be live-video streamed at http://www.hhs.gov/live and 
archived through the CFSAC Web site: http://www.hhs.gov/advcomcfs/. 
Listening-only via telephone will be available on both days. Call-in 
information will be posted on the CFSAC Web site.
    Individuals who plan to attend in-person on one or both days will 
need to register in advance so that information can be provided to 
government security officials to facilitate entrance to the building. A 
registration form should be downloaded from the CFSAC Web site (http://www.hhs.gov/advcomcfs/), completed, and emailed to [email protected] to 
facilitate entrance through building security. Registration will be 
open on July 27, 2015. All registration should be completed by August 
13, 2015. Using the same process as above, members of the media will 
need to register at [email protected]. All attendees will be required to 
show valid government-issued picture identification (state or federal) 
for entry into the federal building. Attendees will receive a wrist 
band that must be worn the entire time. Security requires all non-
federal employees to be escorted the entire time they are in the 
building. Upon leaving the building for any reason, persons will be 
required to follow the security steps mentioned above and receive a new 
wrist band.
    Attendance by visitors who are not U.S. citizens is welcome, but 
prior approval is required. A form for non-U.S. citizens can be 
downloaded from the CFSAC Web site (http://www.hhs.gov/advcomcfs/), 
completed, and emailed to [email protected] before August 1, 2015.
    Members of the public will have the opportunity to provide public 
comment at the meeting or via telephone. International calls cannot be 
accommodated. Individuals wishing to provide public comment in-person 
or via phone will be required to request time for public comment by 
Monday, August 10, 2015 at the following link: [email protected]. An 
email will be sent by August 13, 2015 to confirm an individual's time 
for public comment. Each speaker will be limited to three minutes for 
public comment. No exceptions will be made. Priority will be given to 
individuals who have not provided public comment within the previous 
year.
    You are not required to submit a written copy of your testimony 
unless you wish to have it included in the public record. Individuals 
wishing to submit written comment for the public record should send an 
electronic copy of their written testimony to: [email protected] by 
August 13, 2015. The document for public record must not exceed 5 
single-spaced, typed pages, using a 12-point typeface; it is preferred 
that the document be prepared in the MS Word format. Please note that 
PDF files, hand-written notes, charts, and photographs will not be 
posted on the CFSAC Web site.
    Requests to participate in the public comment and provide written 
testimony will not be accepted at [email protected]. Please send all 
questions about public comment requests or inquiries to 
[email protected].
    Only written testimony submitted for public record and received by 
August 13, 2015 are part of the official meeting record; this testimony 
will be posted to the CFSAC Web site within 60 days after the meeting. 
Materials submitted should not include sensitive personal information, 
such as social security number, birthdates, driver's license number, 
state identification or foreign country equivalent, passport number, 
financial account number, credit or debit card number. If you wish to 
remain anonymous the document must specify this.
    Persons who wish to distribute printed materials in person (at 
their own expense) to CFSAC members during the meeting should submit 
one copy for approval to the Designated Federal Officer at 
[email protected], prior to August 13, 2015.

    Dated: July 17, 2015.
Nancy C. Lee,
Designated Federal Officer, Chronic Fatigue Syndrome Advisory 
Committee.
[FR Doc. 2015-18444 Filed 7-27-15; 8:45 am]
BILLING CODE 4150-42-P

Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices 44977

V. Attendance and/or Participation at seating. Attendance will be free and on Management (see ADDRESSES). A
the Public Meeting a first-come, first-served basis. If you transcript will also be available in either
wish to attend (either in person or by hard copy or on CD–ROM, after
A. Purpose and Scope of the Meeting
Web cast (see Streaming Web Cast of the submission of a Freedom of Information
The purpose of this meeting and Public Meeting)) and/or present at the request. Send written requests to the
public docket is for CDER and CBER to meeting, please register for the meeting Division of Freedom of Information
hear from stakeholders any questions, and/or make a request for oral (ELEM–1029), Food and Drug
concerns, and suggestions regarding the presentations or comments by visiting Administration, 12420 Parklawn Dr.,
proposed plans for the scope and https://qualitymetrics-public- Element Bldg., Rockville, MD 20857.
implementation of the quality metrics meeting.eventbrite.com on or before Streaming Web Cast of the Public
reporting program proposed in this August 7, 2015. The registration request Meeting: For those unable to attend in
guidance. should contain complete contact person, FDA will provide a live Web
information for each attendee (i.e., cast of the meeting. To join the meeting
B. Questions to Stakeholders
name, title, affiliation, address, email via the Web cast, please go to https://
FDA seeks input from stakeholders address, telephone number, and priority collaboration.fda.gov/qmpm2015/. An
and other members of the public on the number(s)). Those without email access agenda will be posted on the FDA Web
following meeting questions: can register by contacting Althea Cuff by site at http://www.fda.gov/Drugs/News
1. Are there other objective metrics August 7, 2015 (see FOR FURTHER Events/ucm451529.htm prior to the
that FDA should request in advance of INFORMATION CONTACT). meeting.
or in lieu of an inspection that FDA FDA will try to accommodate all Docket Comments: Regardless of
should collect to improve our persons who wish to make a attendance at the public meeting,
understanding of products and presentation. Individuals wishing to interested persons may submit either
establishments for purposes of more present should identify the number of electronic or written comments
informed, risk-based inspection the topic, or topics, they wish to address
regarding this document to the public
scheduling and identification of (see section V.B.). This will help FDA
docket (see ADDRESSES) by (see DATES).
potential product shortages? organize the presentations. FDA will
Given that time will be limited at the
2. Are the definitions of the metrics notify registered presenters of their
public meeting, FDA encourages all
and associated data requests selected scheduled presentation times. The time
interested persons to comment in
adequate and clear? allotted for each presentation will
3. Are the metrics requested from writing to ensure that their comments
depend on the number of individuals
each business segment/type clear and are considered.
who wish to speak. Once FDA notifies
appropriate? registered presenters of their scheduled VI. Electronic Access
4. Should the Agency explore times, they are encouraged to submit an
collecting metrics from high-risk Persons with access to the Internet
electronic copy of their presentation to
excipient producers, and if so, which may obtain the document at either
Althea Cuff at Althea.Cuff@fda.hhs.gov
excipients should be considered high- http://www.fda.gov/Drugs/Guidance
on or before August 7, 2015. If time
risk and what metrics should apply? permits, individuals or organizations ComplianceRegulatoryInformation/
5. Should the Agency explore that did not register in advance may be Guidances/default.htm, http://www.fda.
collecting metrics from the medical gas granted the opportunity to make a gov/BiologicsBloodVaccines/Guidance
manufacturing industry? presentation. ComplianceRegulatoryInformation/
6. Should the Agency add the ‘‘Right Persons registered to make an oral default.htm or http://
First Time’’ metric (see section I.), and presentation are encouraged to arrive at www.regulations.gov.
if so, should the definition be a rework/ the meeting room early and check in at Dated: July 23, 2015.
reprocessing rate or a measure of lots the onsite registration table to confirm Leslie Kux,
manufactured without processing their designated presentation time. An Associate Commissioner for Policy.
deviations? agenda for the meeting and other [FR Doc. 2015–18448 Filed 7–27–15; 8:45 am]
7. What data standards/mechanisms background materials will be made BILLING CODE 4164–01–P
would be useful to aid reporting and available 3 days before the meeting at
how should the submissions be http://www.fda.gov/Drugs/NewsEvents/
structured? ucm451529.htm. If you need special DEPARTMENT OF HEALTH AND
8. Are there reporting hurdles to accommodations because of a disability, HUMAN SERVICES
collecting metrics by reporting please contact Althea Cuff (see FOR
establishment/product (segmented by FURTHER INFORMATION CONTACT) at least 7 Meeting of the Chronic Fatigue
site) versus by site (segmented by days before the meeting. Syndrome Advisory Committee
product), and how can they be Meeting Registration and Request to
overcome? Present: The meeting is free and seating AGENCY: Office of the Assistant
9. FDA may consider whether to will be on a first-come, first-served Secretary for Health, Office of the
require the submission of quality basis. If you wish to attend or make an Secretary, Department of Health and
metrics on a recurring basis. How oral presentation, see section V.C. for Human Services.
frequently should metrics be reported information on how to register and the ACTION: Notice.
deadline for registration. If you cannot
asabaliauskas on DSK5VPTVN1PROD with NOTICES

and/or segmented within the reporting
period (e.g., annually, semiannually, or attend in person, information about how SUMMARY: As stipulated by the Federal
quarterly)? you can access a live Web cast will be Advisory Committee Act, the U.S.
located at http://www.fda.gov/Drugs/ Department of Health and Human
C. Meeting Participation and Request To NewsEvents/ucm451529.htm. Services is hereby giving notice that the
Present Transcripts: As soon as a transcript is Chronic Fatigue Syndrome Advisory
The FDA Conference Center at the available, it will be accessible at Committee (CFSAC) will hold a
White Oak location is a Federal facility http://www.regulations.gov. It may also meeting. The meeting will be open to
with security procedures and limited be viewed at the Division of Dockets the public.

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Document Created: 2018-02-23 09:28:15
Document Modified: 2018-02-23 09:28:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The meeting will be held on Tuesday, August 18, 2015, from 9:00 a.m. until 5:00 p.m., ET and Wednesday, August 19, 2015, from 9:00 a.m. until 5:00 p.m., ET.
Contact		Any questions about meeting registration or public comment sign-up should be directed to [email protected] Please direct other inquiries to [email protected]
FR Citation		80 FR 44977