Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 50739 

5There are no capital costs or operating and 

maintenance costs associated with this collection of 

information. 

The preliminary design is included as 

follows: 

TABLE 1—STUDY DESIGN

Medical condition Disease outcome 

information 

Format of disease information Control 

(no disease information) Integrated Separated 

Condition A ........................ No Outcomes 

Outcomes 

Condition B ........................ No Outcomes 

Outcomes 

Condition C ........................ No Outcomes 

Outcomes 

FDA estimates the burden of this 

collection of information as follows: We 

estimate the response burden to be 20 

minutes in the pretests and the study, 

for a burden of 1,985 hours. This will 

be a one time (rather than annual) 

collection of information. The 

questionnaire is available upon request. 

The response burden chart is listed as 

follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN5

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

respondents 

Average burden 

per response Total hours 

Screener ............................................................ 6,750 1 6,750 0.03 (2 min.) ..... 203 

Pretests ............................................................. 900 1 900 0.33 (20 min.) ... 297 

Study ................................................................. 4,500 1 4,500 0.33 (20 min.) ... 1,485 

Total ........................................................... ............................ ............................ ............................ ........................... 1,985 

Dated: August 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20814 Filed 8–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0183] 

Hung Ta Fan: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Hung Ta Fan for a period of 5 years from 

importing articles of food or offering 

such articles for importation into the 

United States. FDA bases this order on 

a finding that Mr. Fan was convicted of 

a felony under Federal law for conduct 

relating to the importation into the 

United States of an article of food. Mr. 

Fan was given notice of the proposed 

debarment and an opportunity to 

request a hearing within the timeframe 

prescribed by regulation. As of July 13, 

2011 (30 days after receipt of the 

notice), Mr. Fan had not responded. 

Mr. Fan’s failure to respond constitutes 

a waiver of his right to a hearing 

concerning this action. 

DATES: This order is effective August 16, 

2011. 

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, Office of Regulatory 

Affairs (HFC–230), Food and Drug 

Administration, 5600 Fishers Lane, 

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 August 4, 2010, the United States 

District Court for the Northern District 

of Illinois accepted Mr. Fan’s guilty plea 

and entered judgment against him for 

the offense of conspiracy, in violation of 

18 U.S.C. 371 and 2, for conspiring to 

defraud the United States and to violate 

18 U.S.C. 542 (entry of Goods into the 

United States by means of false 

statements) and 18 U.S.C. 545 

(importation contrary to law). 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein for 

conduct relating to the importation into 

the United States of any food. The 

factual basis for this conviction is as 

follows: In or around March 2005 and 

continuing until in or around November 

2006, in violation of 18 U.S.C. 371 and 

2, Mr. Fan agreed and conspired with 

others to defraud the United States and 


emcdonald on DSK2BSOYB1PROD with NOTICES
50740 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 

to commit offenses against the United 

States, to wit: Entry of Goods into the 

United States by means of False 

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

and Smuggled Goods into the United 

States in violation of 18 U.S.C. 545. 

Specifically, Mr. Fan owned and 

operated Blue Action Enterprise, Inc., 7 

Tiger Enterprise, Inc., Honey World 

Enterprise, Inc., Kazak Food Corp., and 

Kashaka USA, Inc., through which he 

imported honey into the United States. 

Mr. Fan conspired to cause these 

companies to import, enter, and sell 

Chinese-origin honey into the United 

States and avoid payment of 

antidumping duties by falsely declaring 

to the U.S. Department of Homeland 

Security, Bureau of Customs and Border 

Protection that the imported honey 

originated from countries other than 

China, including India, South Korea, 

Taiwan, and Thailand, when in fact he 

knew that the honey originated in 

China. Mr. Fan’s actions allowed him to 

avoid paying approximately $5,378,370 

in antidumping duties to the United 

States. 

Further, in or around January 2009, in 

violation of 18 U.S.C. 371 and 2, Mr. 

Fan agreed and conspired with others to 

enter into the commerce of the United 

States honey diluted and blended with 

approximately 20 to 30 percent artificial 

sugar, by means of false and fraudulent 

declarations and practices in violation 

of 18 U.S.C. 542, for the purpose of 

increasing his profits. 

As a result of his conviction, on June 

8, 2011, FDA sent Mr. Fan a notice by 

certified mail proposing to debar him 

for a period of 5 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 Mr. Fan was convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 

of an article of food because he 

conspired to commit offenses related to 

the importation of Chinese honey into 

the United States, and a determination, 

after consideration of the factors set 

forth in section 306(c)(3) of the FD&C 

Act that Mr. Fan should be subject to 

the maximum possible period of 

debarment. The proposal also offered 

Mr. Fan an opportunity to request a 

hearing, providing him 30 days from the 

date of receipt of the letter in which to 

file the request, and advised him that 

failure to request a hearing constituted 

a waiver of the opportunity for a hearing 

and of any contentions concerning this 

action. Mr. Fan failed to respond within 

the timeframe prescribed by regulation 

and has, therefore, waived his 

opportunity for a hearing and waived 

any contentions concerning his 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under section 306(b)(1)(C) of the 

FD&C Act, and under authority 

delegated to the Director (Staff Manual 

Guide 1410.35), finds that Mr. Hung Ta 

Fan has been convicted of a felony 

under Federal law for conduct relating 

to the importation of an article of food 

into the United States and that he is 

subject to the full period of debarment. 

As a result of the foregoing finding, 

Mr. Fan is debarred for a period of 5 

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 Mr. 

Fan is a prohibited act. 

Any application by Mr. Fan for 

termination of debarment under section 

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

identified with Docket No. FDA–2011– 

N–0183 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: August 8, 2011. 

Armando Zamora, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2011–20780 Filed 8–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0514] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Procedures for Handling Section 522 

Postmarket Surveillance Studies; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Procedures for Handling 

Section 522 Postmarket Surveillance 

Studies.’’ This guidance document is 

intended to assist device manufacturers 

subject to a section 522 postmarket 

surveillance order imposed by FDA by 

providing an overview of section 522 of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), procedural 

information on how to fulfill section 

522 obligations, and recommendations 

on the format, content, and review of 

postmarket surveillance study 

submissions. This draft guidance is not 

final nor is it in effect at this time. 

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 on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by November 14, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Procedures for 

Handling Section 522 Postmarket 

Surveillance Studies’’ to the Division of 

Small Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

draft 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: 

Mary Beth Ritchey, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4115, Silver Spring, 

MD 20993–0002, 301– 96–6638. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Postmarket surveillance under section 

522 of the FD&C Act (21 U.S.C. 306l) is 

one means by which FDA can obtain 

additional information when it is 

necessary to protect the public health or 

provide safety and/or effectiveness data 

for a device after it has been cleared or 

approved. The Food and Drug 

Administration Amendments Act of 

2007 amended section 522 of the FD&C 


emcdonald on DSK2BSOYB1PROD with NOTICES