Solicitation of Nominations for Organizations To Serve as Non-Voting Liaison Representatives to the Chronic Fatigue Syndrome Advisory Committee (CFSAC), 13393-13395 [2015-05887]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Ear, Nose, and
Throat Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 30 and May 1, 2015 from
8 a.m. to 6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900.
Contact Person: Patricio Garcia,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 1535, Silver Spring MD 20993–
0002, Patricio.Garcia@fda.hhs.gov, 301–
796–6875, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/Advisory
Committees/default.htm and scroll
down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On April 30, 2015, the
committee will discuss and make
recommendations regarding the
classification of Hearing Protectors,
Circumaural Hearing Protectors, Middle
Ear Inflation Devices, Tactile Hearing
Aid Devices, and Vestibular Analysis
Apparatuses. These devices are
considered preamendments devices
since they were in commercial
distribution prior to May 28, 1976,
when the Medical Devices Amendments
became effective. Hearing Protectors are
currently regulated under the heading,
‘‘Protector, Hearing (Insert),’’ Product
Code EWD, as unclassified under the
510(k) premarket notification authority.
Circumaural Hearing Protectors are
currently regulated under the heading,
‘‘Protector, Hearing (Circumaural),’’
Product Code EWE, as unclassified
under the 510(k) premarket notification
authority. Middle Ear Inflation Devices
are currently regulated under the
heading, ‘‘Device, Inflation, Middle
Ear,’’ Product Code MJV, as unclassified
VerDate Sep<11>2014
19:27 Mar 12, 2015
Jkt 235001
under the 510(k) premarket notification
authority. Tactile Hearing Aid Devices
are currently regulated under the
heading, ‘‘Hearing Aid, Tactile,’’
Product Code LRA, as unclassified
under the 510(k) premarket notification
authority. Vestibular Analysis
Apparatuses are currently regulated
under the heading, ‘‘Apparatus,
Vestibular Analysis,’’ Product Code
LXV, as unclassified under the 510(k)
premarket notification authority. FDA is
seeking committee input on the risks,
safety and effectiveness and the
regulatory classification of Hearing
Protectors, Circumaural Hearing
Protectors, Middle Ear Inflation Devices,
Tactile Hearing Aid Devices, and
Vestibular Analysis Apparatuses.
On May 1, 2015 the committee will
discuss key issues related to a potential
pre- to post-market shift in clinical data
requirements for modifications to
cochlear implants in pediatric patients.
These issues are categorized into three
broad areas for discussion:
1. Cochlear implant changes (e.g.
sound processing features, patient
characteristics) that may be suitable for
this pre- to post-market shift in clinical
data requirements.
2. Appropriate premarket clinical data
requirements to support pre- to postmarket shift (e.g. leveraging clinical data
from adults and/or older children).
3. Clinical study design
considerations (e.g. study endpoints and
test metrics, subject characteristics) for
post market studies to confirm safety
and effectiveness and inform future
labeling.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 22, 2015. Oral
presentations from the public will be
scheduled between approximately 8:45
a.m. and 9:45 a.m. on April 30, 2015
and between approximately 1 p.m. and
2 p.m. on May 1, 2015. Those
individuals interested in making formal
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
13393
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before April 14, 2015. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 16, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact at James
Clark at James.Clark@fda.hhs.gov, or
301–796–5293 at least 7 days in advance
of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05675 Filed 3–12–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Organizations To Serve as Non-Voting
Liaison Representatives to the Chronic
Fatigue Syndrome Advisory
Committee (CFSAC)
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Authority: 42 U.S.C. 217a, Section 222
of the Public Health Service (PHS) Act,
as amended. The committee is governed
E:\FR\FM\13MRN1.SGM
13MRN1
13394
Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices
by the provisions of the Federal
Advisory Committee Act, as amended (5
U.S.C. App 2), which sets forth
standards for the formation and use of
advisory committees.
The Office of the Assistant
Secretary for Health (OASH), within the
Department of Health and Human
Services (HHS), is soliciting
nominations from qualified
organizations to be considered for nonvoting liaison representative positions
on the Chronic Fatigue Syndrome
Advisory Committee (CFSAC). CFSAC
provides advice and recommendations
to the Secretary of HHS, through the
Assistant Secretary for Health (ASH), on
a broad range of issues and topics
related to myalgic encephalomyelitis/
chronic fatigue syndrome (ME/CFS).
The issues can include factors affecting
access and care for persons with ME/
CFS; the science and definition of ME/
CFS; and broader public health, clinical,
research, and educational issues related
to ME/CFS. These three non-voting
liaison representative positions will be
occupied by individuals who are
selected by their organizations to serve
as representatives of organizations
concerned with ME/CFS. Organizations
will be designated to occupy the
positions for a two-year term to
commence during the 2015 calendar
year. Nominations of qualified
organizations are being sought for these
three non-voting liaison representative
positions. The organizations chosen for
representation on CFSAC will be
selected by the Designated Federal
Officer (DFO) or designee during the
2015 calendar year. Details of
nomination requirements are provided
below.
SUMMARY:
Nominations must be received
no later than 5 p.m. ET on April 20,
2015, at the address listed below.
ADDRESSES: All nominations should be
sent to Barbara F. James, Designated
Federal Officer, Chronic Fatigue
Syndrome Advisory Committee, Office
on Women’s Health, Department of
Health and Human Services, 200
Independence Avenue SW., Room
728F.3, Washington, DC 20201.
Nomination materials, including
attachments, may be submitted
electronically to cfsac@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Barbara F. James, Designated Federal
Officer, Chronic Fatigue Syndrome
Advisory Committee, Office on
Women’s Health, Department of Health
and Human Services, 200 Independence
Avenue SW., Room 728F.3, Washington,
DC 20201. Inquiries can be sent to
cfsac@hhs.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
19:27 Mar 12, 2015
Jkt 235001
CFSAC
was established on September 5, 2002.
The purpose of the CFSAC is to provide
advice and recommendations to the
Secretary of HHS, through the ASH, on
issues related to ME/CFS. CFSAC
advises and makes recommendations 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 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,
academic, and research communities
about ME/CFS advances; and (4)
partnering to improve the quality of life
of ME/CFS patients. Management and
support services for Committee
activities are provided by staff from the
HHS Office on Women’s Health, within
the OASH. The CFSAC charter is
available at https://www.hhs.gov/
advcomcfs/charter/.
CFSAC meetings are held not less
than two times per year. The CFSAC
membership consists of 11 voting
members, including the Chair. The
voting members are composed of seven
biomedical research scientists with
demonstrated expertise in biomedical
research applicable to ME/CFS and four
individuals with expertise in health care
delivery, private health care services or
insurers, or voluntary organizations
concerned with the problems of
individuals with ME/CFS. CFSAC also
includes seven non-voting ex officio
member representatives from the
Agency for Healthcare Research and
Quality, Centers for Disease Control and
Prevention, Centers for Medicare and
Medicaid Services, Food and Drug
Administration, Health Resources and
Services Administration, National
Institutes of Health, and Social Security
Administration.
In 2012, the CFSAC structure was
expanded to include three non-voting
liaison representative positions.
Continued authorization was given for
the Committee structure to include the
three non-voting liaison representative
positions when the charter was renewed
on September 5, 2014. These positions
will be occupied by individuals who are
selected by their organizations to serve
as the official representative for
organizations that are concerned with
ME/CFS. Organizations will occupy
these positions for a two-year term.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
Nominations
The OASH is requesting nominations
of organizations to fill three non-voting
liaison representative positions for the
CFSAC. The organizations will be
selected by the DFO or designee during
the 2015 calendar year.
Selection of organizations that will
serve as non-voting liaison
representatives will be based on the
organization’s qualifications to
contribute to the accomplishment of the
CFSAC mission, as described in the
Committee charter. In selecting
organizations to be considered for these
positions, the OASH will give close
attention to equitable geographic
distribution and give priority to U.S.chartered 501(c)(3) organizations that
operate within the United States and
have membership with demonstrated
expertise in ME/CFS and related
research, clinical services, or advocacy
and outreach on issues concerning ME/
CFS.
Organizations that currently have
non-voting liaison representatives
serving on CFSAC are also eligible for
nomination or to nominate themselves
for consideration.
The individual designated by the
selected organization to serve as the
official liaison representative will
perform the associated duties without
compensation, and will not receive per
diem or reimbursement for travel
expenses. The organizations that are
selected will cover expenses for their
designated representative to attend, at a
minimum, one in-person CFSAC
meeting per year during the designated
term of appointment.
To qualify for consideration of
selection to the Committee, an
organization should submit the
following items:
(1) A statement of the organization’s
history, mission, and focus, including
information that demonstrates the
organization’s experience and expertise
in ME/CFS and related research, clinical
services, or advocacy and outreach on
issues of ME/CFS, as well as expert
knowledge of the broad issues and
topics pertinent to ME/CFS. This
information should demonstrate the
organization’s proven ability to work
and communicate with the ME/CFS
patient and advocacy community, and
other public/private organizations
concerned with ME/CFS, including
public health agencies at the federal,
state, and local levels.
(2) two to four letters of
recommendation that clearly state why
the organization is qualified to serve on
CFSAC in a non-voting liaison
representative position. These letters
E:\FR\FM\13MRN1.SGM
13MRN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices
should be from individuals who are not
part of the organization.
(3) A statement that the organization
is willing to serve as a non-voting
liaison representative of the Committee
and will cover expenses for their
representative to attend in-person, at a
minimum, one CFSAC meeting per year
in Washington, DC, during the
designated term of appointment.
(4) A current financial disclosure
statement (or annual report)
demonstrating the organization’s ability
to cover expenses for its selected
representative to attend, at a minimum,
one CFSAC meeting per year in
Washington, DC, during the term of
appointment.
Submitted nominations must include
these critical elements in order for the
organization to be considered for one of
the liaison representative positions.
Nomination materials should be
typewritten, using a 12-point font and
double-spaced. All nomination
materials should be submitted
(postmarked or received) by April 20,
2015.
Electronic submissions: Nomination
materials, including attachments, may
be submitted electronically to cfsac@
hhs.gov.
Telephone and facsimile submissions
cannot be accepted.
Regular, Express or Overnight Mail:
Written documents may be submitted to
the following addressee only: Barbara F.
James, Designated Federal Officer,
CFSAC, Office on Women’s Health,
Department of Health and Human
Services, 200 Independence Avenue
SW., Room 728F.3, Washington, DC
20201.
HHS makes every effort to ensure that
the membership of federal advisory
committees is fairly balanced in terms of
points of view represented. Every effort
is made to ensure that a broad
representation of geographic areas, sex,
ethnic and minority groups, and people
with disabilities are given consideration
for membership on federal advisory
committees. Selection of the represented
organizations shall be made without
discrimination against the composition
of an organization’s membership on the
basis of age, sex, race, ethnicity, sexual
orientation, disability, and cultural,
religious, or socioeconomic status.
Dated: February 24, 2015.
Barbara F. James,
Designated Federal Officer, Chronic Fatigue
Syndrome Advisory Committee.
[FR Doc. 2015–05887 Filed 3–12–15; 8:45 am]
BILLING CODE 4150–42–P
VerDate Sep<11>2014
19:27 Mar 12, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0722]
Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Gastroenterology
and Urology Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 14 and 15, 2015, from 8
a.m. to 6 p.m.
Addresses: FDA is opening a docket
for interested persons to submit
electronic or written comments
regarding this meeting. The Docket No.
is FDA–2015–N–0722. Please see the
Procedure section of the notice for
further information.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
Contact Person: Natasha Facey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1552, Silver Spring, MD 20993–0002,
301–796–5290, Natasha.Facey@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://www.fda.
gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate
advisory committee meeting link, or call
the advisory committee information line
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
13395
to learn about possible modifications
before coming to the meeting.
Agenda: On May 14 and 15, 2015, the
committee will discuss recent reports
and epidemiologic investigations of
transmission of infections associated
with the use of duodenoscopes in
endoscopic retrograde
cholangiopancreatography (ERCP)
procedures in hospitals in the United
States.
FDA is convening this committee to
seek expert scientific and clinical
opinion related to reprocessing of
duodenoscopes and other endoscopes,
as well as automated endoscope
reprocessors, based on available
scientific information. The committee
will make recommendations on: (1) The
effectiveness of cleaning, high level
disinfection, and sterilization methods;
(2) the amount and type of premarket
validation data and information needed
to support labeling claims and technical
instructions; (3) the appropriate use of
other risk mitigations, such as
surveillance cultures; (4) best practices
and guidelines for reprocessing
duodenoscopes and endoscopes at user
facilities to minimize the transmission
of infections; and (5) recommended
approaches for ensuring patient safety
during ERCP procedures, including a
discussion of appropriate patient
selection.
Recommendations on these issues
will assist FDA in minimizing patient
exposure to infectious agents that may
result from reprocessed duodenoscopes
and endoscopes.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
CDRH plans to provide a live Webcast
of the May 14 and 15, 2015, meeting of
the Gastroenterology and Urology
Devices Panel. While CDRH is working
to make Webcasts available to the public
for all advisory committee meetings
held at the White Oak campus, there are
instances where the Webcast
transmission is not successful; staff will
work to re-establish the transmission as
soon as possible. The link for the
Webcast is available at: https://
collaboration.fda.gov/gudpm052015/.
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13393-13395]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05887]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Nominations for Organizations To Serve as Non-
Voting Liaison Representatives to the Chronic Fatigue Syndrome Advisory
Committee (CFSAC)
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
Authority: 42 U.S.C. 217a, Section 222 of the Public Health Service
(PHS) Act, as amended. The committee is governed
[[Page 13394]]
by the provisions of the Federal Advisory Committee Act, as amended (5
U.S.C. App 2), which sets forth standards for the formation and use of
advisory committees.
SUMMARY: The Office of the Assistant Secretary for Health (OASH),
within the Department of Health and Human Services (HHS), is soliciting
nominations from qualified organizations to be considered for non-
voting liaison representative positions on the Chronic Fatigue Syndrome
Advisory Committee (CFSAC). CFSAC provides advice and recommendations
to the Secretary of HHS, through the Assistant Secretary for Health
(ASH), on a broad range of issues and topics related to myalgic
encephalomyelitis/chronic fatigue syndrome (ME/CFS). The issues can
include factors affecting access and care for persons with ME/CFS; the
science and definition of ME/CFS; and broader public health, clinical,
research, and educational issues related to ME/CFS. These three non-
voting liaison representative positions will be occupied by individuals
who are selected by their organizations to serve as representatives of
organizations concerned with ME/CFS. Organizations will be designated
to occupy the positions for a two-year term to commence during the 2015
calendar year. Nominations of qualified organizations are being sought
for these three non-voting liaison representative positions. The
organizations chosen for representation on CFSAC will be selected by
the Designated Federal Officer (DFO) or designee during the 2015
calendar year. Details of nomination requirements are provided below.
DATES: Nominations must be received no later than 5 p.m. ET on April
20, 2015, at the address listed below.
ADDRESSES: All nominations should be sent to Barbara F. James,
Designated Federal Officer, Chronic Fatigue Syndrome Advisory
Committee, Office on Women's Health, Department of Health and Human
Services, 200 Independence Avenue SW., Room 728F.3, Washington, DC
20201. Nomination materials, including attachments, may be submitted
electronically to cfsac@hhs.gov.
FOR FURTHER INFORMATION CONTACT: Barbara F. James, Designated Federal
Officer, Chronic Fatigue Syndrome Advisory Committee, Office on Women's
Health, Department of Health and Human Services, 200 Independence
Avenue SW., Room 728F.3, Washington, DC 20201. Inquiries can be sent to
cfsac@hhs.gov.
SUPPLEMENTARY INFORMATION: CFSAC was established on September 5, 2002.
The purpose of the CFSAC is to provide advice and recommendations to
the Secretary of HHS, through the ASH, on issues related to ME/CFS.
CFSAC advises and makes recommendations 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 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, academic,
and research communities about ME/CFS advances; and (4) partnering to
improve the quality of life of ME/CFS patients. Management and support
services for Committee activities are provided by staff from the HHS
Office on Women's Health, within the OASH. The CFSAC charter is
available at https://www.hhs.gov/advcomcfs/charter/.
CFSAC meetings are held not less than two times per year. The CFSAC
membership consists of 11 voting members, including the Chair. The
voting members are composed of seven biomedical research scientists
with demonstrated expertise in biomedical research applicable to ME/CFS
and four individuals with expertise in health care delivery, private
health care services or insurers, or voluntary organizations concerned
with the problems of individuals with ME/CFS. CFSAC also includes seven
non-voting ex officio member representatives from the Agency for
Healthcare Research and Quality, Centers for Disease Control and
Prevention, Centers for Medicare and Medicaid Services, Food and Drug
Administration, Health Resources and Services Administration, National
Institutes of Health, and Social Security Administration.
In 2012, the CFSAC structure was expanded to include three non-
voting liaison representative positions. Continued authorization was
given for the Committee structure to include the three non-voting
liaison representative positions when the charter was renewed on
September 5, 2014. These positions will be occupied by individuals who
are selected by their organizations to serve as the official
representative for organizations that are concerned with ME/CFS.
Organizations will occupy these positions for a two-year term.
Nominations
The OASH is requesting nominations of organizations to fill three
non-voting liaison representative positions for the CFSAC. The
organizations will be selected by the DFO or designee during the 2015
calendar year.
Selection of organizations that will serve as non-voting liaison
representatives will be based on the organization's qualifications to
contribute to the accomplishment of the CFSAC mission, as described in
the Committee charter. In selecting organizations to be considered for
these positions, the OASH will give close attention to equitable
geographic distribution and give priority to U.S.-chartered 501(c)(3)
organizations that operate within the United States and have membership
with demonstrated expertise in ME/CFS and related research, clinical
services, or advocacy and outreach on issues concerning ME/CFS.
Organizations that currently have non-voting liaison
representatives serving on CFSAC are also eligible for nomination or to
nominate themselves for consideration.
The individual designated by the selected organization to serve as
the official liaison representative will perform the associated duties
without compensation, and will not receive per diem or reimbursement
for travel expenses. The organizations that are selected will cover
expenses for their designated representative to attend, at a minimum,
one in-person CFSAC meeting per year during the designated term of
appointment.
To qualify for consideration of selection to the Committee, an
organization should submit the following items:
(1) A statement of the organization's history, mission, and focus,
including information that demonstrates the organization's experience
and expertise in ME/CFS and related research, clinical services, or
advocacy and outreach on issues of ME/CFS, as well as expert knowledge
of the broad issues and topics pertinent to ME/CFS. This information
should demonstrate the organization's proven ability to work and
communicate with the ME/CFS patient and advocacy community, and other
public/private organizations concerned with ME/CFS, including public
health agencies at the federal, state, and local levels.
(2) two to four letters of recommendation that clearly state why
the organization is qualified to serve on CFSAC in a non-voting liaison
representative position. These letters
[[Page 13395]]
should be from individuals who are not part of the organization.
(3) A statement that the organization is willing to serve as a non-
voting liaison representative of the Committee and will cover expenses
for their representative to attend in-person, at a minimum, one CFSAC
meeting per year in Washington, DC, during the designated term of
appointment.
(4) A current financial disclosure statement (or annual report)
demonstrating the organization's ability to cover expenses for its
selected representative to attend, at a minimum, one CFSAC meeting per
year in Washington, DC, during the term of appointment.
Submitted nominations must include these critical elements in order
for the organization to be considered for one of the liaison
representative positions.
Nomination materials should be typewritten, using a 12-point font
and double-spaced. All nomination materials should be submitted
(postmarked or received) by April 20, 2015.
Electronic submissions: Nomination materials, including
attachments, may be submitted electronically to cfsac@hhs.gov.
Telephone and facsimile submissions cannot be accepted.
Regular, Express or Overnight Mail: Written documents may be
submitted to the following addressee only: Barbara F. James, Designated
Federal Officer, CFSAC, Office on Women's Health, Department of Health
and Human Services, 200 Independence Avenue SW., Room 728F.3,
Washington, DC 20201.
HHS makes every effort to ensure that the membership of federal
advisory committees is fairly balanced in terms of points of view
represented. Every effort is made to ensure that a broad representation
of geographic areas, sex, ethnic and minority groups, and people with
disabilities are given consideration for membership on federal advisory
committees. Selection of the represented organizations shall be made
without discrimination against the composition of an organization's
membership on the basis of age, sex, race, ethnicity, sexual
orientation, disability, and cultural, religious, or socioeconomic
status.
Dated: February 24, 2015.
Barbara F. James,
Designated Federal Officer, Chronic Fatigue Syndrome Advisory
Committee.
[FR Doc. 2015-05887 Filed 3-12-15; 8:45 am]
BILLING CODE 4150-42-P
