80 FR 13393 - Solicitation of Nominations for Organizations To Serve as Non-Voting Liaison Representatives to the Chronic Fatigue Syndrome Advisory Committee (CFSAC)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 80, Issue 49 (March 13, 2015)
Federal Register Volume 80, Issue 49 (March 13, 2015)
| Page Range | 13393-13395 | |
| FR Document | 2015-05887 |
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)] [Notices] [Pages 13393-13395] From the Federal Register Online [www.thefederalregister.org] [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 http://www.hhs.gov/advcomcfs/charter/index.html. 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
![Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 13393
This notice announces a forthcoming under the 510(k) premarket notification oral presentations should notify the
meeting of a public advisory committee authority. Tactile Hearing Aid Devices contact person and submit a brief
of the Food and Drug Administration are currently regulated under the statement of the general nature of the
(FDA). The meeting will be open to the heading, ‘‘Hearing Aid, Tactile,’’ evidence or arguments they wish to
public. Product Code LRA, as unclassified present, the names and addresses of
Name of Committee: Ear, Nose, and under the 510(k) premarket notification proposed participants, and an
Throat Devices Panel of the Medical authority. Vestibular Analysis indication of the approximate time
Devices Advisory Committee. Apparatuses are currently regulated requested to make their presentation on
General Function of the Committee: under the heading, ‘‘Apparatus, or before April 14, 2015. Time allotted
To provide advice and Vestibular Analysis,’’ Product Code for each presentation may be limited. If
recommendations to the Agency on LXV, as unclassified under the 510(k) the number of registrants requesting to
FDA’s regulatory issues. premarket notification authority. FDA is speak is greater than can be reasonably
Date and Time: The meeting will be seeking committee input on the risks, accommodated during the scheduled
held on April 30 and May 1, 2015 from safety and effectiveness and the open public hearing session, FDA may
8 a.m. to 6 p.m. regulatory classification of Hearing conduct a lottery to determine the
Location: Hilton Washington DC Protectors, Circumaural Hearing speakers for the scheduled open public
North/Gaithersburg, Salons A, B, C, and Protectors, Middle Ear Inflation Devices, hearing session. The contact person will
D, 620 Perry Pkwy., Gaithersburg, MD Tactile Hearing Aid Devices, and notify interested persons regarding their
20877. The hotel’s telephone number is Vestibular Analysis Apparatuses. request to speak by April 16, 2015.
301–977–8900. On May 1, 2015 the committee will Persons attending FDA’s advisory
Contact Person: Patricio Garcia, discuss key issues related to a potential committee meetings are advised that the
Center for Devices and Radiological pre- to post-market shift in clinical data Agency is not responsible for providing
Health, Food and Drug Administration, requirements for modifications to access to electrical outlets.
10903 New Hampshire Ave., Bldg. 66, cochlear implants in pediatric patients. FDA welcomes the attendance of the
Rm. 1535, Silver Spring MD 20993– These issues are categorized into three public at its advisory committee
0002, Patricio.Garcia@fda.hhs.gov, 301– broad areas for discussion: meetings and will make every effort to
796–6875, or FDA Advisory Committee 1. Cochlear implant changes (e.g. accommodate persons with physical
Information Line, 1–800–741–8138 sound processing features, patient disabilities or special needs. If you
(301–443–0572 in the Washington, DC characteristics) that may be suitable for require special accommodations due to
area). A notice in the Federal Register this pre- to post-market shift in clinical a disability, please contact at James
about last minute modifications that data requirements. Clark at James.Clark@fda.hhs.gov, or
impact a previously announced 2. Appropriate premarket clinical data 301–796–5293 at least 7 days in advance
advisory committee meeting cannot requirements to support pre- to post- of the meeting.
always be published quickly enough to market shift (e.g. leveraging clinical data FDA is committed to the orderly
provide timely notice. Therefore, you from adults and/or older children). conduct of its advisory committee
should always check the Agency’s Web 3. Clinical study design meetings. Please visit our Web site at
site at http://www.fda.gov/Advisory considerations (e.g. study endpoints and http://www.fda.gov/Advisory
Committees/default.htm and scroll test metrics, subject characteristics) for Committees/AboutAdvisoryCommittees/
down to the appropriate advisory post market studies to confirm safety ucm111462.htm for procedures on
committee meeting link, or call the and effectiveness and inform future public conduct during advisory
advisory committee information line to labeling. committee meetings.
learn about possible modifications FDA intends to make background Notice of this meeting is given under
before coming to the meeting. material available to the public no later the Federal Advisory Committee Act (5
Agenda: On April 30, 2015, the than 2 business days before the meeting. U.S.C. app. 2).
committee will discuss and make If FDA is unable to post the background
recommendations regarding the material on its Web site prior to the Dated: March 9, 2015.
classification of Hearing Protectors, meeting, the background material will Leslie Kux,
Circumaural Hearing Protectors, Middle be made publicly available at the Associate Commissioner for Policy.
Ear Inflation Devices, Tactile Hearing location of the advisory committee [FR Doc. 2015–05675 Filed 3–12–15; 8:45 am]
Aid Devices, and Vestibular Analysis meeting, and the background material BILLING CODE 4164–01–P
Apparatuses. These devices are will be posted on FDA’s Web site after
considered preamendments devices the meeting. Background material is
since they were in commercial available at http://www.fda.gov/ DEPARTMENT OF HEALTH AND
distribution prior to May 28, 1976, AdvisoryCommittees/Calendar/ HUMAN SERVICES
when the Medical Devices Amendments default.htm. Scroll down to the
became effective. Hearing Protectors are appropriate advisory committee meeting Solicitation of Nominations for
currently regulated under the heading, link. Organizations To Serve as Non-Voting
‘‘Protector, Hearing (Insert),’’ Product Procedure: Interested persons may Liaison Representatives to the Chronic
Code EWD, as unclassified under the present data, information, or views, Fatigue Syndrome Advisory
510(k) premarket notification authority. orally or in writing, on issues pending Committee (CFSAC)
Circumaural Hearing Protectors are before the committee. Written AGENCY: Office of the Assistant
mstockstill on DSK4VPTVN1PROD with NOTICES
currently regulated under the heading, submissions may be made to the contact Secretary for Health, Office of the
‘‘Protector, Hearing (Circumaural),’’ person on or before April 22, 2015. Oral Secretary, Department of Health and
Product Code EWE, as unclassified presentations from the public will be Human Services.
under the 510(k) premarket notification scheduled between approximately 8:45 ACTION: Notice.
authority. Middle Ear Inflation Devices a.m. and 9:45 a.m. on April 30, 2015
are currently regulated under the and between approximately 1 p.m. and Authority: 42 U.S.C. 217a, Section 222
heading, ‘‘Device, Inflation, Middle 2 p.m. on May 1, 2015. Those of the Public Health Service (PHS) Act,
Ear,’’ Product Code MJV, as unclassified individuals interested in making formal as amended. The committee is governed
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![Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 13395
should be from individuals who are not DEPARTMENT OF HEALTH AND to learn about possible modifications
part of the organization. HUMAN SERVICES before coming to the meeting.
(3) A statement that the organization Agenda: On May 14 and 15, 2015, the
is willing to serve as a non-voting Food and Drug Administration committee will discuss recent reports
liaison representative of the Committee and epidemiologic investigations of
and will cover expenses for their [Docket No. FDA–2015–N–0722] transmission of infections associated
with the use of duodenoscopes in
representative to attend in-person, at a Gastroenterology and Urology Devices endoscopic retrograde
minimum, one CFSAC meeting per year Panel of the Medical Devices Advisory cholangiopancreatography (ERCP)
in Washington, DC, during the Committee; Notice of Meeting procedures in hospitals in the United
designated term of appointment.
AGENCY: Food and Drug Administration, States.
(4) A current financial disclosure FDA is convening this committee to
statement (or annual report) HHS.
seek expert scientific and clinical
demonstrating the organization’s ability ACTION: Notice. opinion related to reprocessing of
to cover expenses for its selected duodenoscopes and other endoscopes,
representative to attend, at a minimum, This notice announces a forthcoming
as well as automated endoscope
one CFSAC meeting per year in meeting of a public advisory committee
reprocessors, based on available
Washington, DC, during the term of of the Food and Drug Administration
scientific information. The committee
appointment. (FDA). The meeting will be open to the
will make recommendations on: (1) The
public.
Submitted nominations must include effectiveness of cleaning, high level
Name of Committee: Gastroenterology
these critical elements in order for the disinfection, and sterilization methods;
and Urology Devices Panel of the (2) the amount and type of premarket
organization to be considered for one of Medical Devices Advisory Committee.
the liaison representative positions. validation data and information needed
General Function of the Committee: to support labeling claims and technical
Nomination materials should be To provide advice and instructions; (3) the appropriate use of
typewritten, using a 12-point font and recommendations to the Agency on other risk mitigations, such as
double-spaced. All nomination FDA’s regulatory issues. surveillance cultures; (4) best practices
materials should be submitted Date and Time: The meeting will be and guidelines for reprocessing
(postmarked or received) by April 20, held on May 14 and 15, 2015, from 8 duodenoscopes and endoscopes at user
2015. a.m. to 6 p.m. facilities to minimize the transmission
Electronic submissions: Nomination Addresses: FDA is opening a docket of infections; and (5) recommended
materials, including attachments, may for interested persons to submit approaches for ensuring patient safety
be submitted electronically to cfsac@ electronic or written comments during ERCP procedures, including a
hhs.gov. regarding this meeting. The Docket No. discussion of appropriate patient
is FDA–2015–N–0722. Please see the selection.
Telephone and facsimile submissions Procedure section of the notice for Recommendations on these issues
cannot be accepted. further information. will assist FDA in minimizing patient
Regular, Express or Overnight Mail: Location: FDA White Oak Campus, exposure to infectious agents that may
Written documents may be submitted to 10903 New Hampshire Ave., Bldg. 31 result from reprocessed duodenoscopes
the following addressee only: Barbara F. Conference Center, the Great Room (Rm. and endoscopes.
James, Designated Federal Officer, 1503), Silver Spring, MD 20993–0002. FDA intends to make background
CFSAC, Office on Women’s Health, Answers to commonly asked questions material available to the public no later
Department of Health and Human including information regarding special than 2 business days before the meeting.
Services, 200 Independence Avenue accommodations due to a disability, If FDA is unable to post the background
SW., Room 728F.3, Washington, DC visitor parking, and transportation may material on its Web site prior to the
20201. be accessed at: http://www.fda.gov/ meeting, the background material will
HHS makes every effort to ensure that AdvisoryCommittees/AboutAdvisory be made publicly available at the
the membership of federal advisory Committees/ucm408555.htm. location of the advisory committee
committees is fairly balanced in terms of Contact Person: Natasha Facey, Center meeting, and the background material
points of view represented. Every effort for Devices and Radiological Health, will be posted on FDA’s Web site after
is made to ensure that a broad Food and Drug Administration, 10903 the meeting. Background material is
representation of geographic areas, sex, New Hampshire Ave., Bldg. 66, Rm. available at http://www.fda.gov/
ethnic and minority groups, and people 1552, Silver Spring, MD 20993–0002, AdvisoryCommittees/Calendar/
with disabilities are given consideration 301–796–5290, Natasha.Facey@ default.htm. Scroll down to the
for membership on federal advisory fda.hhs.gov, or FDA Advisory appropriate advisory committee meeting
committees. Selection of the represented Committee Information Line, 1–800– link.
organizations shall be made without 741–8138 (301–443–0572 in the CDRH plans to provide a live Webcast
discrimination against the composition Washington, DC area). A notice in the of the May 14 and 15, 2015, meeting of
of an organization’s membership on the Federal Register about last minute the Gastroenterology and Urology
basis of age, sex, race, ethnicity, sexual modifications that impact a previously Devices Panel. While CDRH is working
orientation, disability, and cultural, announced advisory committee meeting to make Webcasts available to the public
mstockstill on DSK4VPTVN1PROD with NOTICES
religious, or socioeconomic status. cannot always be published quickly for all advisory committee meetings
enough to provide timely notice. held at the White Oak campus, there are
Dated: February 24, 2015. Therefore, you should always check the instances where the Webcast
Barbara F. James, Agency’s Web site at http://www.fda. transmission is not successful; staff will
Designated Federal Officer, Chronic Fatigue gov/AdvisoryCommittees/default.htm work to re-establish the transmission as
Syndrome Advisory Committee. and scroll down to the appropriate soon as possible. The link for the
[FR Doc. 2015–05887 Filed 3–12–15; 8:45 am] advisory committee meeting link, or call Webcast is available at: https://
BILLING CODE 4150–42–P the advisory committee information line collaboration.fda.gov/gudpm052015/.
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Document Created: 2015-12-18 11:42:03
Document Modified: 2015-12-18 11:42:03
| 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 | Nominations must be received no later than 5 p.m. ET on April | |
| 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 [email protected] | |
| FR Citation | 80 FR 13393 |
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