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

13396 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 

Further information regarding the 

Webcast, including the Web address for 

the Webcast, will be made available at 

least 2 days in advance of the meeting 

at the following Web site: http://www.

fda.gov/AdvisoryCommittees/

CommitteesMeetingMaterials/Medical

Devices/MedicalDevicesAdvisory

Committee/Gastroenterology-Urology

DevicesPanel/default.htm. Select the 

link for 2015 Meeting Materials. 

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 30, 2015. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. on May 14 and between 

approximately 9 a.m. and 10 a.m. on 

May 15. 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 15, 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 20, 2015. 

FDA is opening a docket for public 

comment on this document. The Docket 

No. is FDA–2015–N–0722. The docket 

will close on May 28, 2015. Interested 

persons are encouraged to use the 

docket to submit electronic or written 

comments regarding this meeting. 

Comments received on or before April 

30, 2015, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by the Agency. Submit 

electronic comments to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Divisions of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday, and will be 

posted to the docket at http://

www.regulations.gov. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

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 AnnMarie 

Williams, at AnnMarie.Williams@

fda.hhs.gov or 301–796–5966 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. 2015–05710 Filed 3–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60 Day Comment 

Request; Assessment of NHLBI’s 

Global Health Initiative Collaborating 

Centers of Excellence (NHLBI) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

To Submit Comments and For Further 

Information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Deshiree Belis, 6705 

Rockledge Drive, Suite 6070, Bethesda, 

MD 20892, or call non-toll-free number 

(301)-435–1032, or Email your request 

to: deshiree.belis@nih.gov. Formal 

requests for additional plans and 

instruments must be requested in 

writing. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Assessment of 

NHLBI’s Global Health Initiative 

Collaborating Centers of Excellence, 

0925-New, National Heart, Lung, and 

Blood Institute (NHLBI), the National 

Institutes of Health (NIH). 

Need and Use of Information 

Collection: This collection proposes to 

conduct a one-time outcome evaluation 

of the NHLBI Global Health Initiative 

Centers of Excellence (GHI COE) 

Program to examine the extent to which 

the program achieved its intended 

objectives in developing sustainable 

research and research training capacity, 

and advancing information about the 

prevention and treatment of chronic 

non-communicable chronic 

cardiovascular and pulmonary diseases 

(CVPD) in low- and middle-income 

country (LMIC) populations. The 

outcome evaluation will utilize a mixedmethods approach to comprehend each 

COE’s processes, short term outcomes, 

and sustainability outcomes/efforts. 

Specifically, the evaluation will involve 

triangulating quantitative data sources 

(e.g., archived systematic reporting 

data), and qualitative data sources (e.g., 

archival data and key informant 

interview data). Data collected will be 

used to develop a Case Study report for 

each COE outlining their experience 

with implementing their program as 

well as a comprehensive cross-site 

Lessons Learned Report describing 

knowledge and experiences from the 

overall program, including similarities 

and differences across a variety of 

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