8206 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0021] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Substances 

Generally Recognized as Safe: 

Notification Procedure 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 21, 

2016. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0495. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Substances Generally Recognized as 

Safe: Notification Procedure—21 CFR 

170.36 and 570.36 (OMB Control 

Number 0910–0342)—Extension 

Section 409 of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

348) establishes a premarket approval 

requirement for ‘‘food additives’’; 

section 201(s) of the FD&C Act (21 

U.S.C. 321(s)) provides an exclusion to 

the definition of ‘‘food additive’’ and 

thus from the premarket approval 

requirement, for uses of substances that 

are generally recognized as safe (GRAS) 

by qualified experts. In the Federal 

Register of April 17, 1997 (62 FR 18938) 

(the 1997 proposed rule), we published 

a proposed rule that would establish a 

voluntary procedure whereby 

manufacturers would notify us about a 

view of a particular use (or uses) of a 

substance that is not subject to the 

statutory premarket approval 

requirements based on a determination 

that such use is GRAS. Under an interim 

policy announced in the proposed rule, 

we invited manufacturers to submit 

notices of their independent 

determinations for review under the 

framework of the proposed rule during 

the period between issuance of the 

proposal and any final rule based on the 

proposal. The proposed regulations 

(proposed 21 CFR 170.36 and 21 CFR 

570.36) provide a standard format for 

the voluntary submission of a notice. 

To assist respondents in submissions 

to our Center for Food Safety and 

Applied Nutrition (CFSAN), we 

developed Form FDA 3667 entitled 

‘‘Generally Recognized as Safe (GRAS) 

Notice.’’ The form, and elements 

prepared as attachments to the form, 

may be submitted in electronic format 

via the Electronic Submission Gateway 

(ESG), or may be submitted in paper 

format, or as electronic files on physical 

media with paper signature page. While 

we do not expect Form FDA 3667 to 

reduce reporting time for respondents, 

use of the form helps to expedite our 

review of the information being 

submitted. For submissions to our 

Center for Veterinary Medicine (CVM), 

respondents may continue to send 

GRAS notices in letter format to the 

Agency, as instructed in our Federal 

Register notice of June 4, 2010 (75 FR 

31800). 

Presently, we have committed to 

issuing a final rule regarding 

‘‘Substances Generally Recognized as 

Safe’’ in 2016, as part of a settlement 

agreement with the Center for Food 

Safety, which filed a lawsuit in 2014 

seeking to vacate our 1997 proposed 

rule. 

Description of Respondents: The 

respondents to this collection of 

information are manufacturers of 

substances used in food and feed. 

In the Federal Register of September 

17, 2015 (80 FR 55857), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. We received a number of 

comments in support of the information 

collection generally. We also received 

one comment suggesting that the names, 

credentials, and affiliations of ‘‘qualified 

experts’’ associated with GRAS 

determinations be included on the form. 

We received a second comment 

suggesting that information submitted 

by manufacturers be reviewed by 

independent scientists. We appreciate 

this input. As discussed previously, 

rulemaking is underway that will 

necessitate a revision to the information 

collection provisions associated with 

our GRAS program and we continue to 

consider all comments. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Form No.2 Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden 

per response 

Total hours 

170.36 (CFSAN) ........................... 3667 3 ........................ 40 1 40 150 6,000 

570.36 (CVM) ............................... N/A ............................ 20 1 20 150 3,000 

Total ...................................... .................................... ........................ ........................ ........................ ........................ 9,000 

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

2Only CFSAN uses Form FDA 3667. 

3Form FDA 3667 may be submitted electronically via the ESG. 

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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. 

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