Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices 8663 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0073] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

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 20, 

2015. 

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 0910–0704. 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. 

Guidance on Consultation Procedures: 

Foods Derived From New Plant 

Varieties—(OMB Control No. 0910– 

0704)—(Extension) 

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 From New Plant Varieties,’’ 

which is available on FDA’s Web site at 

http://www.fda.gov/FoodGuidances. 

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. 

In the Federal Register of December 

11, 2014 (79 FR 73590), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. One comment was 

received; however, it was not responsive 

to the information collection topics 

solicited in the notice and is not, 

therefore, addressed in this document. 

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. 

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 and its Center for 

Food Safety and Applied Nutrition 

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. 


emcdonald on DSK67QTVN1PROD with NOTICES
8664 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices 

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: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03207 Filed 2–17–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1484] 

Hung Yi Lin; Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) debarring Hung Yi Lin for a period 

of 12 years from importing articles of 

food or offering such articles for 

importation into the United States. FDA 

bases this order on a finding that Ms. 

Lin was convicted, as defined in the 

FD&C Act, of three felony counts under 

Federal law for conduct relating to the 

importation into the United States of an 

article of food. Ms. Lin was given notice 

of the proposed debarment and an 

opportunity to request a hearing within 

the timeframe prescribed by regulation. 

As of August 29, 2014 (30 days after 

receipt of the notice), Ms. Lin had not 

responded. Ms. Lin’s failure to respond 

constitutes a waiver of her right to a 

hearing concerning this action. 

DATES: This order is effective February 

18, 2015. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Division Of Enforcement, 

Office of Enforcement and Import 

Operations, Office of Regulatory Affairs, 

Food and Drug Administration, 12420 

Parklawn Dr. (ELEM4144), Rockville, 

MD 20857, 301–796–4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(C) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(C)) permits FDA to 

debar an individual from importing an 

article of food or offering such an article 

for import into the United States if FDA 

finds, as required by section 

306(b)(3)(A) of the FD&C Act, that the 

individual has been convicted of a 

felony for conduct relating to the 

importation into the United States of 

any food. 

On September 30, 2013, Ms. Lin was 

convicted, as defined in section 

306(l)(1)(B) of the FD&C Act, when the 

U.S. District Court for the Northern 

District of Illinois accepted her plea of 

guilty and entered judgment against her 

for the following offense: Three counts 

of entry of goods into the United States 

by means of false statements, in 

violation of 18 U.S.C. 542. 

FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein. The 

factual basis for these convictions is as 

follows: Ms. Lin owned and operated 

KBB Express Inc., a freight forwarding 

company located in South El Monte, CA 

that provided nationwide 

transportation, delivery, and other 

logistical services for imported and 

entered merchandise, including 

Chinese-origin honey. Ms. Lin also 

served as the U.S. agent for at least 12 

importers for which she handled the 

process of importing, and coordinating 

with brokers to enter and bring in, 

Chinese-origin honey into the United 

States. 

On or about December 13, 2009, Ms. 

Lin entered and introduced Chineseorigin honey into the United States by 

means of a false and fraudulent practice, 

false statement, and fraudulent and false 

papers, including Bureau of Customs 

and Border Protection (CBP) forms that 

falsely declared that approximately four 

container loads of Chinese-origin honey 

with a declared value upon entry of 

approximately $92,822 was Chinese 

honey syrup. By so doing, Ms. Lin 

caused losses to the United States of 

approximately $205,141 in uncollected 

anti-dumping duties and honey 

assessment fees, when in fact she knew 

the product was Chinese honey. This 

was in violation of 18 U.S.C. 542. 

On or about December 13, 2009, Ms. 

Lin entered and introduced Chineseorigin honey into the United States by 

means of a false and fraudulent practice, 

false statement, and fraudulent and false 

papers, including CBP forms that falsely 

declared that approximately three 

container loads of Chinese-origin honey 

with a declared value upon entry of 

approximately $69,617 was Chinese 

honey syrup. By so doing, Ms. Lin 

caused losses to the United States of 

approximately $153,855 in uncollected 

anti-dumping duties and honey 

assessment fees, when in fact she knew 

the product was Chinese honey. This 

was in violation of 18 U.S.C. 542. 

On or about December 13, 2009, Ms. 

Lin entered and introduced Chineseorigin honey into the United States by 

means of a false and fraudulent practice, 

false statement, and fraudulent and false 

papers, including CPB forms that falsely 

declared that approximately three 

container loads of Chinese-origin honey 

with a declared value upon entry of 

approximately $69,617 was Chinese 

honey syrup. By so doing, Ms. Lin 

caused losses to the United States of 

approximately $153,855 in uncollected 

anti-dumping duties and honey 

assessment fees, when in fact she knew 

the product was Chinese honey. This 

was in violation of 18 U.S.C. 542. 

Ms. Lin admitted that between 2009 

and 2012, she caused up to 764 

shipping containers of Chinese-origin 

honey valued at approximately 

$11,489,306 to be fraudulently imported 

and entered into the United States, 

thereby causing losses to the United 

States of as much as $39,203,144 

through her fraudulent practices. 

As a result of her conviction, on July 

25, 2014, FDA sent Ms. Lin a notice by 

certified mail proposing to debar her for 


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