Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 8207 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual records 

Average 

burden per 

recordkeeping 

Total hours 

170.36(c)(v) (CFSAN) .......................................................... 40 1 40 15 600 

570.36(c)(v) (CVM) .............................................................. 20 1 20 15 300 

Total .............................................................................. ........................ ........................ ........................ ........................ 900 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

For purposes of this extension 

request, we are retaining our 2012 

estimates. The PRA analysis for the 

GRAS final rule will take into account 

any changes to the GRAS notification 

procedure as set forth in the final rule 

and we will revise the collection 

accordingly. 

Dated: February 12, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–03330 Filed 2–17–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–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) 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 self-nominated 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. 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. 

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 

FDA by March 21, 2016, (see sections I 

and II for further details). Concurrently, 

nomination materials for prospective 

candidates should be sent to FDA by 

March 21, 2016. 

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 may 

be submitted electronically by accessing 

the FDA Advisory Committee 

Membership Nomination Portal: 

https://www.accessdata.fda.gov/scripts/

FACTRSPortal/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 http://www.

fda.gov/AdvisoryCommittees/

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Ames, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5215, Silver Spring, 

MD 20993, 301–796–5960, Fax: 301– 

847–8505, margaret.ames@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency is requesting nominations for 

nonvoting industry representatives to 

certain panels identified in the 

following paragraphs: 

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 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 

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 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 of Food and Drugs 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. 

A. Anesthesiology and Respiratory 

Therapy Devices Panel 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational devices 

for use in anesthesiology and respiratory 

therapy and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. 

B. Ear, Nose and Throat Devices Panel 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational ear, 

nose and throat devices and makes 

appropriate recommendations to the 

Commissioner of Food and Drugs. 

mstockstill on DSK4VPTVN1PROD with NOTICES

8208 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 

C. 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. 

D. General and Plastic Surgery Devices 

Panel 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational general 

and plastic surgery devices and makes 

appropriate recommendations to the 

Commissioner of Food and Drugs. 

E. Hematology and Pathology 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 pathology, 

hematology, histopathology, 

cytotechnology and molecular biology 

and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. 

F. Medical Devices Dispute Resolution 

Provides advice to the Center Director 

on complex or contested scientific 

issues between the FDA and medical 

device sponsors, applicants, or 

manufacturers relating to specific 

products, marketing applications, 

regulatory decisions and actions by 

FDA, and Agency guidance and 

policies. The Panel makes 

recommendations on issues that are 

lacking resolution, are highly complex 

in nature, or result from challenges to 

Agency decisions or actions. 

G. Microbiology 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 microbiology, 

virology, and infectious disease and 

makes appropriate recommendations to 

the Commissioner of Food and Drugs. 

H. Molecular and Clinical Genetics 

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 and 

molecular genetics and makes 

appropriate recommendations to the 

Commissioner of Food and Drugs. 

I. Neurological Devices Panel 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational devices 

for use in the neurological system and 

makes appropriate recommendations to 

the Commissioner of Food and Drugs. 

J. Orthopaedic and Rehabilitation 

Devices Panel 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational 

orthopedic and rehabilitation devices 

and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. 

K. Radiological Devices Panel 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational 

diagnostics or therapeutic radiological 

and nuclear medicine devices 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 Committee of 

interest may be submitted 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 panel. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process). 

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: February 11, 2016. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2016–03283 Filed 2–17–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier OS–4040–0005 60D] 

Agency Information Collection 

Activities; Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Electronic Government Office, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Electronic 

Government Office (EGOV), Department 

of Health and Human Services, has 

submitted an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB) for review and approval. The ICR 

is for a 3-year extension for OMB 

Control Number 4040–0005. The ICR 

will expire on July 31, 2016. The ICR 

also requests categorizing the form as a 

common form, meaning HHS will only 

request approval for its own use of the 

form rather than aggregating the burden 

estimate across all Federal Agencies as 

was done for previous actions on this 

OMB control number. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public on this ICR during the review 

and approval period. 

DATES: Comments on the ICR must be 

received on or before April 18, 2016. 

mstockstill on DSK4VPTVN1PROD with NOTICES