45298 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852, and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday. 

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, 

‘‘Developing Drugs for Developing 

Countries,’’ Health Affairs, vol. 25, no. 2, 

pp. 313–324, 2006. 

Dated: September 22, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20799 Filed 9–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0001] 

Request for Nominations on Public 

Advisory Panels of the Medical 

Devices Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of 

nonvoting industry representatives to 

serve on certain panels of the Medical 

Devices Advisory Committee (MDAC or 

Committee) in the Center for Devices 

and Radiological Health (CDRH) notify 

FDA in writing. FDA is also requesting 

nominations for nonvoting industry 

representatives to serve on certain 

device panels of the MDAC in the 

CDRH. A nominee may either be selfnominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

will be accepted for current and 

upcoming vacancies effective with this 

notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

the FDA by October 30, 2017 (see 

sections I and II of this document for 

further details). Concurrently, 

nomination materials for prospective 

candidates should be sent to FDA by 

October 30, 2017. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nomination should be sent to Margaret 

Ames (see FOR FURTHER INFORMATION

CONTACT). All nominations for 

nonvoting industry representatives 

should be submitted electronically by 

accessing the FDA Advisory Committee 

Membership Nomination Portal: https:// 

www.accessdata.fda.gov/scripts/FACT

RSPortal/FACTRS/index.cfm or by mail 

to Advisory Committee Oversight and 

Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s Web site at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Ames, Division of Workforce 

Management, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5264, Silver Spring, 

MD 20993, 301–796–5960, Fax: 301– 

847–8505, email: margaret.ames@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency is requesting nominations for 

nonvoting industry representatives to 

the panels listed in the table in this 

document. 

I. Medical Devices Advisory Committee 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational devices 

and makes recommendations for their 

regulation. The panels engage in a 

number of activities to fulfill the 

functions the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) envisions 

for device advisory panels. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, advises 

the Commissioner of Food and Drugs 

(the Commissioner) regarding 

recommended classification or 

reclassification of devices into one of 

three regulatory categories; advises on 

any possible risks to health associated 

with the use of devices; advises on 

formulation of product development 

protocols; reviews premarket approval 

applications for medical devices; 

reviews guidelines and guidance 

documents; recommends exemption of 

certain devices from the application of 

portions of the FD&C Act; advises on the 

necessity to ban a device; and responds 

to requests from the agency to review 

and make recommendations on specific 

issues or problems concerning the safety 

and effectiveness of devices. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, may also 

make appropriate recommendations to 

the Commissioner on issues relating to 

the design of clinical studies regarding 

the safety and effectiveness of marketed 

and investigational devices. The 

Committee also provides 

recommendations to the Commissioner 

or designee on complexity 

categorization of in vitro diagnostics 

under the Clinical Laboratory 

Improvement Amendments of 1988. 

Panels Function 

Circulatory System Devices Panel Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the circulatory and vascular systems and makes appropriate recommendations to the 

Commissioner of Food and Drugs. 

Clinical Chemistry and Clinical 

Toxicology Devices Panel.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in 

vitro devices for use in clinical laboratory medicine including clinical toxicology, clinical chemistry, endocrinology, and oncology and makes appropriate recommendations to the Commissioner of Food and 

Drugs. 

Gastroenterology and Urology Devices Panel.Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gastroenterology, urology, and nephrology devices and makes appropriate recommendations to the Commissioner of Food and Drugs. 

General Hospital and Personal Use 

Devices Panel.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational general hospital, infection control, and personal use devices and makes appropriate recommendations to the 

Commissioner of Food and Drugs. 

Obstetrics and Gynecology Devices 

Panel.

Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in obstetrics and gynecology and makes appropriate recommendations to the Commissioner of Food and Drugs. 

Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45299 

Panels Function 

Ophthalmic Devices Panel .............. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the eye and makes appropriate recommendations to the Commissioner of Food and 

Drugs. 

II. Qualifications 

Persons nominated for the device 

panels should be full-time employees of 

firms that manufacture products that 

would come before the panel, or 

consulting firms that represent 

manufacturers, or have similar 

appropriate ties to industry. 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for a particular device panel. 

The interested organizations are not 

bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within 60 days, 

the Commissioner will select the 

nonvoting member to represent industry 

interests. 

IV. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Contact 

information, a current curriculum vitae, 

and the name of the panel of interest 

should be sent to the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES) within 30 days of 

publication of this document (see 

DATES). FDA will forward all 

nominations to the organizations 

expressing interest in participating in 

the selection process for the particular 

device panels listed in the table. 

(Persons who nominate themselves as 

nonvoting industry representatives will 

not participate in the selection process). 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 22, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20778 Filed 9–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0330] 

Agency Information Collection 

Request. 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before November 27, 

2017. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202)795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0330–60D 

and project title for reference, to 

Sherrette.funn@hhs.gov, the Reports 

Clearance Officer Sherrette Funn, call 

202–795–7714. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title: Appellant Climate Survey, 

Revision. 

Abstract: The Office of Medicare 

Hearings and Appeals (OMHA) requests 

revision to a previously approved 

information collection request from the 

Office of Management and Budget 

(OMB). The annual OMHA Appellant 

Climate Survey is a survey of Medicare 

beneficiaries, providers, suppliers, or 

their representatives who participated 

in a hearing before an Administrative 

Law Judge (ALJ) from OMHA. 

Appellants dissatisfied with the 

outcome of their Level 2 Medicare 

appeal may request a hearing before an 

OMHA ALJ. The Appellant Climate 

Survey will be used to measure 

appellant satisfaction with their OMHA 

appeals experience, as opposed to their 

satisfaction with a specific ruling. 

OMHA was established by the Medicare 

Prescription Drug, Improvement, and 

Modernization Act (MMA) of 2003 (Pub. 

L. 108–173) and became operational on 

July 1, 2005. The MMA legislation and 

implementing regulations issued on 

March 8, 2007 instituted a number of 

changes in the appeals process. The 

MMA legislation also directed HHS to 

consider the feasibility of conducting 

hearings using telephone or videoteleconference (VTC) technologies. In 

carrying out this mandate, OMHA 

makes use of both teleconferencing and 

VTC to provide appellants with a vast 

nationwide network of access points for 

hearings close to their homes. The first 

3-year administration cycle of the 

OMHA survey began in fiscal year (FY) 

2008, a second 3-year cycle began in 

FY2011, and third 3-year cycle began in 

FY2014. The survey will continue to be 

conducted annually over a 3-year period 

with the next data collection cycle 

beginning in FY2018. Data collection 

instruments and recruitment materials 

will be offered in English and Spanish. 

Total burden for survey respondents is 

100.00 hours each year. 

Affected Public: Survey respondents 

will consist of Medicare beneficiaries 

and non-beneficiaries (i.e., providers, 

suppliers), who participated in a 

hearing before an OMHA ALJ. OMHA 

will draw a representative, nonredundant sample of appellants whose