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 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices 8665 

a period of 12 years from importing 

articles of food or offering such articles 

for import into the United States. The 

proposal was based on a finding under 

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

that Ms. Lin’s felony convictions for 

entry of goods by means of false 

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

constitute conduct relating to the 

importation into the United States of an 

article of food because she committed 

an offense related to the importation of 

Chinese honey into the United States. 

The proposal was also based on a 

determination, after consideration of the 

factors set forth in section 306(c)(3) of 

the FD&C Act, that Ms. Lin should be 

subject to a 12-year period of 

debarment. The proposal also offered 

Ms. Lin an opportunity to request a 

hearing, providing her 30 days from the 

date of receipt of the letter in which to 

file the request, and advised her that 

failure to request a hearing constituted 

a waiver of the opportunity for a hearing 

and of any contentions concerning this 

action. Ms. Lin failed to respond within 

the timeframe prescribed by regulation 

and has, therefore, waived her 

opportunity for a hearing and waived 

any contentions concerning her 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement and Import Operations, 

Office of Regulatory Affairs, under 

section 306(b)(1)(C) of the FD&C Act, 

under authority delegated to the 

Director (Staff Manual Guide 1410.35), 

finds that Hung Yi Lin has been 

convicted of three felony counts under 

Federal law for conduct relating to the 

importation into the United States of an 

article of food and that she is subject to 

a 12-year period of debarment. 

As a result of the foregoing finding, 

Hung Yi Lin is debarred for a period of 

12 years from importing articles of food 

or offering such articles for import into 

the United States, effective (see DATES). 

Under section 301(cc) of the FD&C Act 

(21 U.S.C. 331(cc)), the importing or 

offering for import into the United 

States of an article of food by, with the 

assistance of, or at the direction of Hung 

Yi Lin is a prohibited act. 

Any application by Ms. Lin for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2013– 

N–1484 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03210 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–2014–D–2245] 

Immediately in Effect Guidance 

Document: Classification and 

Requirements for Laser Illuminated 

Projectors; Guidance for Industry and 

Food and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Immediately in Effect Guidance 

Document: Classification and 

Requirements for Laser Illuminated 

Projectors (LIPs).’’ This guidance 

describes FDA’s policy with respect to 

certain LIPs that comply with 

International Electrotechnical 

Commission (IEC) standards during 

laser product classification under the 

Electronic Product Radiation Control 

provisions of the Federal Food, Drug 

and Cosmetic Act (the FD&C Act) that 

apply to electronic products. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment, submit either 

electronic or written comments on the 

guidance by April 20, 2015. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Immediately in 

Effect Guidance Document: 

Classification and Requirements for 

Laser Illuminated Projectors’’ to the 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Hintz, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4248, Silver Spring, 

MD 20993–0002, 301–796–6927. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry and FDA staff 

entitled ‘‘Immediately in Effect 

Guidance Document: Classification and 

Requirements for Laser Illuminated 

Projectors.’’ This guidance is being 

issued consistent with FDA’s good 

guidance practices (GGPs) regulation (21 

CFR 10.115). The guidance is being 

implemented without prior public 

comment because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate (21 CFR 10.115(g)(2)). The 

Agency made this determination 

because the guidance presents a less 

burdensome policy consistent with the 

public health. Although this guidance is 

immediately in effect, it remains subject 

to comment in accordance with the 

Agency’s GGPs regulation. This 

guidance describes FDA’s policy with 

respect to certain LIPs that comply with 

IEC standards during laser product 

classification under the Electronic 

Product Radiation Control provisions of 

the FD&C Act that apply to electronic 

products. The regulations for classifying 

laser products are set forth in part 1040 

(21 CFR part 1040). 

For purposes of this guidance, the 

term ‘‘laser illuminated projector’’ refers 

to a type of demonstration laser product 

regulated under § 1040.10(b)(13) that is 

designed to project full-frame digital 

images. The term ‘‘demonstration laser 

product’’ is defined under 

§ 1040.10(b)(13) to mean, ‘‘Any laser 

product manufactured, designed, 

intended, or promoted for purposes of 

demonstration, entertainment, 

advertising display, or artistic 

composition.’’ LIPs may be used in 

locations such as indoor or outdoor 

cinema theaters, laser shows, 

presentations at conventions, as image/ 

data projectors in an office setting, or in 

a home. 

Lasers are being used in LIPs as an 

alternative to conventional lamps in 


emcdonald on DSK67QTVN1PROD with NOTICES