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
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 50741 

Act to expand the situations in which 

FDA may order postmarket surveillance 

and allow longer surveillance periods in 

certain circumstances. This guidance 

document is intended to assist device 

manufacturers subject to a section 522 

postmarket surveillance order by 

providing an overview of section 522 of 

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. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on ‘‘Procedures for Handling Section 

522 Postmarket Surveillance Studies.’’ It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Procedures for Handling 

Section 522 Postmarket Surveillance 

Studies’’ you may either send an e-mail 

request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number 1754 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 822 have 

been approved under OMB control 

number 0910–0449. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: August 10, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20727 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–0002] 

2011 Parenteral Drug Association/Food 

and Drug Administration Joint Public 

Conference; Quality and Compliance in 

Today’s Regulatory Enforcement 

Environment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

The Food and Drug Administration 

(FDA), in cosponsorship with Parenteral 

Drug Association (PDA), is announcing 

a public conference entitled ‘‘Quality 

and Compliance in Today’s Regulatory 

Enforcement Environment.’’ The 

conference will span 21⁄2 days and cover 

current issues affecting the industry as 

well as explore strategies and 

approaches for ensuring conformance 

with regulations to facilitate the 

development and continuous 

improvement of safe and effective 

medical products. The conference 

establishes a unique forum to discuss 

the foundations, emerging technologies 

and innovations in regulatory science, 

as well as the current quality and 

compliance areas of concerns. Meeting 

participants will hear from FDA and 

industry speakers about the 

requirements and best practices to 

consider while implementing robust 

quality systems in order to deliver the 

best quality product. 

Date and Time: The public conference 

will be held on September 19, 2011, 

from 7 a.m. to 6 p.m.; September 20, 

2011, from 7:30 a.m. to 6:15 p.m.; and 

September 21, 2011, from 7:30 a.m. to 

12:15 p.m. 

Location: The public conference will 

be held at the Renaissance Hotel, 999 

Ninth St., NW., Washington, DC 20001, 

202–898–9000, FAX: 202–289–0947. 

Contact: Wanda Neal, Parenteral Drug 

Association, PDA Global Headquarters, 

Bethesda Towers, 4350 East West Hwy., 

suite 200, Bethesda, MD 20814, 301– 

656–5900, FAX: 301–986–1093, e-mail: 

info@pda.org. 

Accommodations: Attendees are 

responsible for their own 

accommodations. To make reservations 

at the Renaissance Hotel at the reduced 

conference rate, contact the Renaissance 

Hotel (see Location)—cite the meeting 

code ‘‘PDA.’’ Room rates are: Single: 

$288, plus 14.5% state and local taxes 

and Double: $288, plus 14.5 percent 

state and local taxes. Reservations can 

be made on a space and rate availability 

basis. 

Registration: Attendees are 

encouraged to register at their earliest 

convenience. The PDA registration fees 

cover the cost of facilities, materials, 

and refreshments. Seats are limited; 

please submit your registration as soon 

as possible. Conference space will be 

filled in order of receipt of registration. 

Those accepted for the conference will 

receive confirmation. Registration will 

close after the conference is filled. 

Onsite registration will be available on 

a space available basis on each day of 

the public conference beginning at 7 

a.m. on September 19, 2011. The cost of 

registration is as follows: 

COST OF REGISTRATION

Affiliation Fee 

PDA Members .............................. $1,895 

NonMembers ................................ 2,144 

PDA Member Government/Health 

Authority .................................... 700 

NonMember Government/Health 

Authority .................................... 800 

PDA Member Academic ............... 700 

NonMember Academic ................. 780 

PDA Member Students ................. 280 

NonMember Students ................... 310 

Please visit PDA’s Web site: http:// 

www.pda.org/pdafda2011 to confirm 

the prevailing registration fees. (FDA 

has verified the Web site address, but 

FDA is not responsible for any 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 

If you need special accommodations 

due to a disability, please contact 

Wanda Neal (see Contact), at least 7 

days in advance of the conference. 

Registration Instructions: To register, 

please submit your name, affiliation, 

mailing address, telephone, fax number, 

and e-mail address, along with a check 

or money order payable to ‘‘PDA.’’ Mail 

to: PDA, Global Headquarters, Bethesda 

Towers, 4350 East West Hwy., suite 200, 

Bethesda, MD 20814. To register via the 


emcdonald on DSK2BSOYB1PROD with NOTICES