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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2011-N-0183]

# 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                           ( print page 50740)                        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