Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 13393 

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 http://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 

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 http://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 

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 

http://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) 

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 

mstockstill on DSK4VPTVN1PROD with NOTICES

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. 

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 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. 

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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 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 

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: http://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 http://www.fda.

gov/AdvisoryCommittees/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 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 http://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/. 

mstockstill on DSK4VPTVN1PROD with NOTICES