Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee, 19205-19206 [2016-07593]
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Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
19205
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition No.
Title of standard 1
11–304 ...............
Measuring Accuracy after Mechanical Disturbances.
Reference No. and date
ASTM F3107–14.
K. Physical Medicine
16–196 ...............
16–197 ...............
16–198 ...............
Wheelchairs—Part 7: Measurement of seating
and wheel dimensions.
Wheelchairs—Part 8: Requirements and test
methods for static, impact, and fatigue
strengths.
Wheelchairs—Part 22: Set-up procedures ..........
ISO 7176–7 First Edition 1998–05–15.
ISO 7176–8 Second Edition 2014–12–15.
ISO 7176–22 Second Edition 2014–09–01.
L. Software/Informatics
13–81 .................
Health informatics—Personal health device communication—Part 10419: Device Specialization—Insulin Pump.
IEEE Std. 11073–10419: 2015.
M. Sterility
14–479 ...............
Sterilization of health care products—Ethylene
oxide—Requirements for development, validation, and routine control of a sterilization process for medical devices.
ANSI/AAMI/ISO 11135:2014.
N. Tissue Engineering
15–44 .................
1 All
Standard Guide for in vivo Evaluation of
Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) Active
Standard.
standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
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ASTM F2529–13.
FDA maintains the Agency’s current
list of FDA Recognized Consensus
Standards in a searchable database that
may be accessed directly at FDA’s
Internet site at https://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/
cfStandards/search.cfm. FDA will
incorporate the modifications and
revisions described in this notice into
the database and, upon publication in
the Federal Register, this recognition of
consensus standards will be effective.
FDA will announce additional
modifications and revisions to the list of
recognized consensus standards, as
needed, in the Federal Register, once a
year or more often if necessary.
Beginning with Recognition List: 033,
FDA no longer announces minor
revisions to the list of recognized
consensus standards such as technical
contact person, devices affected,
processes affected, Code of Federal
Regulations citations, and product
codes.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
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recommendations, with reasons for the
recommendation, to standards@
cdrh.fda.gov. To be properly considered,
such recommendations should contain,
at a minimum, the following
information: (1) Title of the standard, (2)
any reference number and date, (3)
name and address of the national or
international standards development
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. The Center for Devices and
Radiological Health (CDRH) maintains a
site on the Internet for easy access to
information including text, graphics,
and files that you may download to a
personal computer with access to the
Internet. Updated on a regular basis, the
CDRH home page, https://www.fda.gov/
MedicalDevices, includes a link to
standards-related documents including
the guidance and the current list of
recognized standards. After publication
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in the Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 041’’ will be available at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. You may
access ‘‘Guidance on the Recognition
and Use of Consensus Standards,’’ and
the searchable database for ‘‘FDA
Recognized Consensus Standards,’’ at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards.
Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07467 Filed 4–1–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation for Applications From
Individuals Interested in Being
Appointed to the Chronic Fatigue
Syndrome Advisory Committee
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
E:\FR\FM\04APN1.SGM
04APN1
19206
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
Notice.
Authority: 42 U.S.C. 217a, section 222
of the Public Health Service (PHS) Act,
as amended. The Committee is governed
by the provisions of Public Law 92–463,
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 seeking nominations
of qualified candidates to be considered
for appointment as a member of 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
appointments of several Committee
members are scheduled to end during
the 2016 calendar year. Nominations of
qualified candidates are being sought to
fill the positions that are scheduled to
be vacated.
DATES: Applications for individuals to
be considered for appointment to the
Committee must be received no later
than 5 p.m. ET on April 25, 2016 at the
address listed below.
ADDRESSES: All nominations should be
mailed or delivered to Nancy C. Lee,
Designated Federal Officer, Chronic
Fatigue Syndrome Advisory Committee,
Office on Women’s Health, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, 200 Independence Avenue
SW., Room 712E, Washington, DC
20201. Nomination materials, including
attachments, may be submitted
electronically to cfsac@hhs.gov .
FOR FURTHER INFORMATION CONTACT:
Nancy C. Lee, Designated Federal
Officer, Chronic Fatigue Syndrome
Advisory Committee, Office on
Women’s Health, Office of the Assistant
Secretary for Health, Department of
Health and Human Services, 200
Independence Ave. SW., Room 712E,
Washington, DC 20201. Inquiries may
also be made 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; the relevant gaps in knowledge
and research about the epidemiology,
etiologies, biomarkers, and risk factors
VerDate Sep<11>2014
19:03 Apr 01, 2016
Jkt 238001
relating to ME/CFS; and identifying
potential opportunities in these areas;
(2) impact and implications of current
and proposed diagnostic 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)
strategies to improve the quality of life
of ME/CFS patients. The CFSAC charter
is available at https://www.hhs.gov/
advcomcfs/charter/.
Management and support services for
Committee activities are provided by
staff within the OASH. The ASH
provides directions and guidance for
services performed to support CFSAC
activities and operation.
Nominations: OASH is requesting
nominations to fill CFSAC positions
that are scheduled to be vacated during
2016. The Committee composition
consists of seven scientists with
demonstrated expertise in biomedical
research applicable to ME/CFS, and four
individuals with demonstrated expertise
in health care delivery, private health
care services, or insurance, or voluntary
organizations concerned with the
problems of individuals living with ME/
CFS. The vacant positions are in the
biomedical research, health care
services and delivery categories.
Individuals selected for appointment
to the Committee will serve as voting
members and may be invited to serve
terms of up to four years.
To qualify for consideration of
appointment to the Committee, an
individual must possess demonstrated
experience and knowledge in the
designated fields or disciplines, as well
as expert knowledge of the broad issues
and topics pertinent to ME/CFS.
CFSAC members are authorized to
receive a stipend for attending
Committee meetings. Committee
members also are authorized to receive
per diem and reimbursement for travel
expenses incurred for conducting
Committee business.
Nomination materials should be
typewritten. If mailed, please submit
original documents. The nomination
materials should be submitted
(postmarked or received) no later than
5:00p.m. EDT on the date specified
under DATES. The following information
must be part of the nomination package
submitted for each individual being
nominated: (1) A letter of nomination
that clearly states the name and
affiliation of the nominee, the basis for
the nomination (i.e., specific attributes
which qualify the nominee for service in
this capacity), and a statement that the
nominee is willing to serve as a member
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Fmt 4703
Sfmt 9990
of the Committee; (2) the nominator’s
name, address, and daytime telephone
number; (3) the home and/or work
address, telephone number, and email
address of the individual being
nominated; and (4) a current copy of the
nominee’s curriculum vitae or resume.
An individual may self-nominate.
Federal employees should not be
nominated for consideration of
appointment to this Committee.
Nominations that do not contain all the
above information will not be
considered.
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: Nancy C.
Lee, Designated Federal Officer, CFSAC,
Office on Women’s Health, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, 200 Independence Ave. SW.,
Room 712E, Washington, DC 20201.
Appointment to the Committee is
made by the Secretary of HHS. The
Department 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,
females, ethnic and minority groups,
and people with disabilities are given
consideration for membership on
federal advisory committees.
Appointment to this Committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status. Nominations must state that the
nominee is willing to serve as a member
of CFSAC and appears to have no
conflict of interest that would preclude
membership. Potential candidates are
required to provide detailed information
concerning such matters as financial
holdings, consultancies, and research
grants or contracts for an ethics analysis
to be conducted to identify potential
conflicts of interest.
Dated: March 25, 2016.
Nancy C. Lee,
Designated Federal Officer. Chronic Fatigue
Syndrome Advisory Committee
[FR Doc. 2016–07593 Filed 4–1–16; 8:45 am]
BILLING CODE 4150–42–P
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19205-19206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation for Applications From Individuals Interested in
Being Appointed to the Chronic Fatigue Syndrome Advisory Committee
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
[[Page 19206]]
ACTION: Notice.
-----------------------------------------------------------------------
Authority: 42 U.S.C. 217a, section 222 of the Public Health Service
(PHS) Act, as amended. The Committee is governed by the provisions of
Public Law 92-463, 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 seeking
nominations of qualified candidates to be considered for appointment as
a member of 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 appointments of several Committee members are
scheduled to end during the 2016 calendar year. Nominations of
qualified candidates are being sought to fill the positions that are
scheduled to be vacated.
DATES: Applications for individuals to be considered for appointment to
the Committee must be received no later than 5 p.m. ET on April 25,
2016 at the address listed below.
ADDRESSES: All nominations should be mailed or delivered to Nancy C.
Lee, Designated Federal Officer, Chronic Fatigue Syndrome Advisory
Committee, Office on Women's Health, Office of the Assistant Secretary
for Health, Department of Health and Human Services, 200 Independence
Avenue SW., Room 712E, Washington, DC 20201. Nomination materials,
including attachments, may be submitted electronically to cfsac@hhs.gov
.
FOR FURTHER INFORMATION CONTACT: Nancy C. Lee, Designated Federal
Officer, Chronic Fatigue Syndrome Advisory Committee, Office on Women's
Health, Office of the Assistant Secretary for Health, Department of
Health and Human Services, 200 Independence Ave. SW., Room 712E,
Washington, DC 20201. Inquiries may also be made 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; 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 diagnostic 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) strategies to
improve the quality of life of ME/CFS patients. The CFSAC charter is
available at https://www.hhs.gov/advcomcfs/charter/.
Management and support services for Committee activities are
provided by staff within the OASH. The ASH provides directions and
guidance for services performed to support CFSAC activities and
operation.
Nominations: OASH is requesting nominations to fill CFSAC positions
that are scheduled to be vacated during 2016. The Committee composition
consists of seven scientists with demonstrated expertise in biomedical
research applicable to ME/CFS, and four individuals with demonstrated
expertise in health care delivery, private health care services, or
insurance, or voluntary organizations concerned with the problems of
individuals living with ME/CFS. The vacant positions are in the
biomedical research, health care services and delivery categories.
Individuals selected for appointment to the Committee will serve as
voting members and may be invited to serve terms of up to four years.
To qualify for consideration of appointment to the Committee, an
individual must possess demonstrated experience and knowledge in the
designated fields or disciplines, as well as expert knowledge of the
broad issues and topics pertinent to ME/CFS.
CFSAC members are authorized to receive a stipend for attending
Committee meetings. Committee members also are authorized to receive
per diem and reimbursement for travel expenses incurred for conducting
Committee business.
Nomination materials should be typewritten. If mailed, please
submit original documents. The nomination materials should be submitted
(postmarked or received) no later than 5:00p.m. EDT on the date
specified under DATES. The following information must be part of the
nomination package submitted for each individual being nominated: (1) A
letter of nomination that clearly states the name and affiliation of
the nominee, the basis for the nomination (i.e., specific attributes
which qualify the nominee for service in this capacity), and a
statement that the nominee is willing to serve as a member of the
Committee; (2) the nominator's name, address, and daytime telephone
number; (3) the home and/or work address, telephone number, and email
address of the individual being nominated; and (4) a current copy of
the nominee's curriculum vitae or resume. An individual may self-
nominate. Federal employees should not be nominated for consideration
of appointment to this Committee. Nominations that do not contain all
the above information will not be considered.
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: Nancy C. Lee, Designated
Federal Officer, CFSAC, Office on Women's Health, Office of the
Assistant Secretary for Health, Department of Health and Human
Services, 200 Independence Ave. SW., Room 712E, Washington, DC 20201.
Appointment to the Committee is made by the Secretary of HHS. The
Department 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, females, ethnic and minority groups, and people
with disabilities are given consideration for membership on federal
advisory committees. Appointment to this Committee shall be made
without discrimination on the basis of age, race, ethnicity, gender,
sexual orientation, disability, and cultural, religious, or
socioeconomic status. Nominations must state that the nominee is
willing to serve as a member of CFSAC and appears to have no conflict
of interest that would preclude membership. Potential candidates are
required to provide detailed information concerning such matters as
financial holdings, consultancies, and research grants or contracts for
an ethics analysis to be conducted to identify potential conflicts of
interest.
Dated: March 25, 2016.
Nancy C. Lee,
Designated Federal Officer. Chronic Fatigue Syndrome Advisory Committee
[FR Doc. 2016-07593 Filed 4-1-16; 8:45 am]
BILLING CODE 4150-42-P