73590 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0073] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance on 

Consultation Procedures: Foods 

Derived From New Plant Varieties 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment. This notice solicits 

comments on the information collection 

provisions of FDA’s consultation 

procedures for foods derived from new 

plant varieties, including the 

information collection provisions in the 

guidance entitled, ‘‘Guidance on 

Consultation Procedures: Foods Derived 

From New Plant Varieties,’’ and in Form 

FDA 3665 entitled, ‘‘Final Consultation 

For Food Derived From a New Plant 

Variety (Biotechnology Final 

Consultation),’’ which developers may 

use to prepare the final consultation in 

a standard format. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 9, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, we are publishing notice of 

the proposed collection of information 

set forth in this document. 

With respect to the following 

collection of information, we invite 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of our functions, including whether the 

information will have practical utility; 

(2) the accuracy of our 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 respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance on Consultation Procedures: 

Foods Derived From New Plant 

Varieties 

Since 1992, when FDA issued its 

‘‘Statement of Policy: Foods Derived 

From New Plant Varieties’’ (the 1992 

policy) (57 FR 22984, May 29, 1992), 

FDA has encouraged developers of new 

plant varieties, including those varieties 

that are developed through 

biotechnology, to consult with FDA 

during the plant development process to 

discuss possible scientific and 

regulatory issues that might arise. In the 

1992 policy, FDA explained that, under 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), developers of new 

foods (in this document food refers to 

both human food and animal feed) have 

a responsibility to ensure that the foods 

they offer to consumers are safe and are 

in compliance with all requirements of 

the FD&C Act (57 FR 22984 at 22985). 

FDA recommends that producers who 

use biotechnology in the manufacture or 

development of foods and food 

ingredients work cooperatively with 

FDA to ensure that products derived 

through biotechnology are safe and 

comply with all applicable legal 

requirements and has instituted a 

voluntary consultation process with 

industry. To facilitate this process the 

Agency has issued a guidance entitled, 

‘‘Guidance on Consultation Procedures: 

Foods Derived From New Plant 

Varieties,’’ which is available on FDA’s 

Web site at http://www.fda.gov/Food

Guidances. The guidance describes 

FDA’s consultation process for the 

evaluation of information on new plant 

varieties provided by developers. The 

Agency believes this consultation 

process will help ensure that human 

food and animal feed safety issues or 

other regulatory issues (e.g. labeling) are 

resolved prior to commercial 

distribution. Additionally, such 

communication will help to ensure that 

any potential food safety issues 

regarding a new plant variety are 

resolved during development, and will 

help to ensure that all market entry 

decisions by the industry are made 

consistently and in full compliance with 

the standards of the FD&C Act. 

Description of Respondents: 

Respondents to this collection of 

information include developers of new 

plant varieties intended for food use. 

FDA estimates the burden of this 

collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity FDA form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Initial consultation ............... None ................................... 20 2 40 4 160 

Final consultation ................ FDA 3665 ........................... 12 1 12 150 1,800 

Total ............................. ............................................. ........................ ........................ ........................ ........................ 1,960 

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

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Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73591 

Initial Consultations 

Initial consultations are generally a 

one-time burden, although a developer 

might return more than once to discuss 

additional issues before submitting a 

final consultation. As noted in the 

guidance, FDA encourages developers to 

consult early in the development phase 

of their products, and as often as 

necessary. Historically, firms 

developing a new bioengineered plant 

variety intended for food use have 

generally initiated consultation with 

FDA early in the process of developing 

such a variety, even though there is no 

legal obligation for such consultation. 

These consultations have served to 

make FDA aware of foods and food 

ingredients before these products are 

distributed commercially, and have 

provided FDA with the information 

necessary to address any potential 

questions regarding the safety, labeling, 

or regulatory status of the food or food 

ingredient. As such, these consultations 

have provided assistance to both 

industry and the Agency in exercising 

their mutual responsibilities under the 

FD&C Act. 

FDA estimates that its Center for 

Veterinary Medicine (CVM) and its 

Center for Food Safety and Applied 

Nutrition (CFSAN) jointly received an 

average of 40 initial consultations per 

year in the last 3 years via telephone, 

email or written letter. Based on this 

information, we expect to receive no 

more than 40 annually in the next 3 

years. 

Final Consultations 

Final consultations are a one-time 

burden. At some stage in the process of 

research and development, a developer 

will have accumulated the information 

that the developer believes is adequate 

to ensure that food derived from the 

new plant variety is safe and that it 

demonstrates compliance with the 

relevant provisions of the FD&C Act. 

The developer will then be in a position 

to conclude any ongoing consultation 

with FDA. The developer submits to 

FDA a summary of the safety and 

nutritional assessment that has been 

conducted about the bioengineered food 

that is intended to be introduced into 

commercial distribution. FDA evaluates 

the submission to ensure that all 

potential safety and regulatory questions 

have been addressed. FDA has 

developed a form that prompts a 

developer to include certain elements in 

the final consultation in a standard 

format: Form FDA 3665 entitled, ‘‘Final 

Consultation for Food Derived From a 

New Plant Variety (Biotechnology Final 

Consultation).’’ The form, and elements 

that would be prepared as attachments 

to the form, can be submitted in 

electronic format. 

Upon implementation of the 

collection, FDA contacted five firms that 

had made one or more biotechnology 

consultation submissions. We asked 

each of these firms for an estimate of the 

hourly burden to prepare a submission 

under the voluntary biotechnology 

consultation process. Based on 

information provided by the three firms 

who responded, we estimate the average 

time to prepare a submission for final 

consultation to be 150 hours. 

Dated: December 8, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29046 Filed 12–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1960] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; MedWatch: The 

Food and Drug Administration Medical 

Products Reporting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

revisions to Forms FDA 3500, 3500A, 

and 3500B used in the FDA Medical 

Products Reporting Program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 9, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

MedWatch: The FDA Medical Products 

Reporting Program—(OMB Control 

Number 0910–0291)—Extension 

I. Background 

To ensure the marketing of safe and 

effective products, postmarketing 

adverse outcomes and product problems 

must be reported for all FDA-regulated 

human healthcare products, including 

drugs (prescription, nonprescription, 

and compounded), biologics, medical 

devices, dietary supplements and other 

special nutritional products (e.g. infant 

formula and medical foods), and 

cosmetics. In addition, FDA has 

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