Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 52535 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the act) debarring Su Van 

Ho for a period of 15 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. Ho was convicted of 

three felonies under Federal law for 

conduct relating to the importation into 

the United States of an article of food. 

Mr. Ho was given notice of the proposed 

debarment and an opportunity to 

request a hearing within the timeframe 

prescribed by regulation. As of July 15, 

2010, Mr. Ho failed to respond. Mr. Ho’s 

failure to respond constitutes a waiver 

of his right to a hearing concerning this 

action. 

DATES: This order is effective August 26, 

2010. 

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 Compliance 

Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 240–632–6844. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(C) of the 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 act (21 U.S.C. 

335a(b)(3)(A)), 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, 2009, the United States 

District Court for the Central District of 

California accepted Mr. Ho’s guilty plea 

and entered judgment against him for 

the offenses of: Smuggling, Causing an 

Act to be Done in violation of 18 U.S.C. 

545, Concealing a Material Fact by Trick 

or Device in violation of 18 U.S.C. 

1001(a)(1) and Receipt of an Adulterated 

Food and Delivery Thereof for Pay in 

violation of 21 U.S.C. 331(c), 333(a)(1), 

and 342(a)(3). 

FDA’s finding that debarment is 

appropriate is based on the three felony 

convictions referenced herein for 

conduct relating to the importation into 

the United States of any food. The 

factual basis for those convictions is as 

follows: Between at least January 1, 

2003, through September 16, 2004, Mr. 

Ho owned and operated VincentSeafood 

and Trading, a frozen seafood import 

and distribution business. On or about 

August 20, 2004, in violation of 18 

U.S.C. 545 and 2(b), Mr. Ho knowingly 

and willfully, with the intent to defraud 

the United States, did pass and cause to 

be passed through the customshouse a 

fraudulent commercial invoice that 

falsely described 610 cartons of Frozen 

Silk Worm as ‘‘Frozen Dade’’ fish and 

461 cartons of Pineapple Brand Betel 

Nut as ‘‘Frozen Palmnut.’’ 

On or about September 16, 2004, in 

violation of 18 U.S.C. 1001(a)(1), Mr. Ho 

knowingly and willfully concealed and 

covered up by trick, scheme, or device 

a material fact. Specifically, he was 

ordered by FDA to export or destroy 118 

cartons of frozen Featherback fish from 

import shipment N08–0026008–0 that 

contained Salmonella bacteria, with 

verification of such exportation or 

destruction by FDA. Mr. Ho concealed 

and covered up the material fact that he 

had improperly sold 103 cartons of the 

contaminated Featherback fish from 

import shipment N08–0026008–0 by a 

trick, scheme, or device in which he 

substituted 103 cartons of Featherback 

fish from other, unrelated import 

shipments and presented the substitute 

cartons of fish to FDA for verified 

exportation or destruction as the 

contaminated fish from import 

shipment N08–0026008–0. 

Between on or about January 17, 2004, 

and September 16, 2004, in violation of 

21 U.S.C. 331(c), 333(a)(1), and 

342(a)(3), Mr. Ho received in interstate 

commerce and delivered in exchange for 

payment an adulterated food, namely, 

frozen Featherback fish from import 

shipment N08–0026008–0 that was 

contaminated with Salmonella bacteria. 

As a result of his conviction, on June 

10, 2010, FDA sent Mr. Ho a notice by 

certified mail proposing to debar him 

for a period of 15 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 act that Mr. 

Ho was convicted of three felonies 

under Federal law for conduct relating 

to the importation into the United States 

of an article of food, and a 

determination, after consideration of the 

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

the act (21 U.S.C. 335a(c)(3)), that the 

full periods of debarment shall run 

consecutively as provided by section 

306(c)(2)(A)(iii) of the act (21 U.S.C. 

335a(c)(2)(A)(iii)). The proposal also 

offered Mr. Ho 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. Ho 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 

act, and under authority delegated to the 

Director (Staff Manual Guide 1410.35), 

finds that Mr. Su Van Ho has been 

convicted of three felonies under 

Federal law for conduct relating to the 

importation of an article of food into the 

United States and that the full periods 

of debarment shall run consecutively 

under section 306(c)(2) of the act (21 

U.S.C. 335a(c)(2)). 

As a result of the foregoing finding, 

Mr. Ho is debarred for a period of 15 

years from importing articles of food or 

offering such articles for import into the 

United States, effective (see DATES). 

Pursuant to section 301(cc) of the 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. 

Ho is a prohibited act. 

Any application by Mr. Ho for 

termination of debarment under section 

306(d)(1) of the act should be identified 

with Docket No. FDA–2010–N–0213 

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 12, 2010. 

Howard R. Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2010–21258 Filed 8–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[ATSDR–266] 

Availability of Draft Toxicological 

Profile 

AGENCY: Agency for Toxic Substances 

and Disease Registry (ATSDR), 

mstockstill on DSKH9S0YB1PROD with NOTICES

52536 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 

Department of Health and Human 

Services (DHHS). 

ACTION: Notice of availability. 

SUMMARY: This notice announces, for 

review and comment, the availability of 

one new draft toxicological profile on 

unregulated hazardous substances that 

was prepared for the Department of 

Defense (DOD). All toxicological 

profiles issued as ‘‘Drafts for Public 

Comment’’ represent ATSDR’s best 

efforts to provide important 

toxicological information on priority 

hazardous substances. We are seeking 

public comments and additional 

information or reports on studies about 

the health effects of royal demolition 

explosive (RDX), chemical name 

hexahydro-1,3,5-trinitro-1,3,5-triazine, 

also known as cyclonite, for review and 

potential inclusion in the profile. 

ATSDR remains committed to providing 

a public comment period for these 

documents as a means to best serve 

public health and our stakeholders. 

DATES: To be considered, comments on 

this draft toxicological profile must be 

received not later than November 19th, 

2010. Comments received after the close 

of the public comment period will be 

considered at the discretion of ATSDR, 

based upon what is deemed to be in the 

best interest of the general public. 

ADDRESSES: Requests for printed copies 

of the draft toxicological profile should 

be sent via e-mail to cdcinfo@cdc.gov, or 

to Ms. Olga Dawkins, Division of 

Toxicology and Environmental 

Medicine, Agency for Toxic Substances 

and Disease Registry, Mailstop F–62, 

1600 Clifton Road, NE., Atlanta, Georgia 

30333. Electronic access to this 

document is also available at the 

ATSDR Web site: http:// 

www.atsdr.cdc.gov/toxpro2.html. 

Written comments and other data 

submitted in response to this notice and 

to the draft RDX toxicological profile 

should bear the docket control number 

ATSDR–XXX. Send one copy of all 

comments and three copies of all 

supporting documents to the attention 

of Ms. Nickolette Roney, Division of 

Toxicology and Environmental 

Medicine, Agency for Toxic Substances 

and Disease Registry, Mailstop F–62, 

1600 Clifton Road, NE., Atlanta, Georgia 

30333, by the end of the comment 

period. Electronic comments may be 

sent via e-mail to: 

tppubliccomments@cdc.gov. Please 

include RDX in the subject line of the 

e-mail. Because all public comments 

regarding ATSDR toxicological profiles 

are available for public inspection, no 

confidential business information or 

other confidential information should 

be submitted in response to this notice. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Olga Dawkins, Division of Toxicology 

and Environmental Medicine, Agency 

for Toxic Substances and Disease 

Registry, Mailstop F–62, 1600 Clifton 

Road, NE., Atlanta, Georgia 30333, 

telephone (770) 488–3315. Electronic 

access to this document is also available 

at the ATSDR Web site: http:// 

www.atsdr.cdc.gov/toxpro2.html. 

Comments and other data submitted in 

response to this notice and the draft 

toxicological profile should bear the 

docket control number ATSDR–266. 

SUPPLEMENTARY INFORMATION: The 

Superfund Amendments and 

Reauthorization Act (SARA) of 1986 

(Pub. L. 99–499) amended the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA or Superfund). Section 

211 of SARA also amended Title 10 of 

the U.S. Code, creating the Defense 

Environmental Restoration Program. 

Section 2704(a) of Title 10 of the U.S. 

Code directs the Secretary of Defense to 

notify the Secretary of DHHS of not less 

than 25 of the most commonly found 

unregulated hazardous substances at 

defense facilities. The Secretary of 

DHHS is to prepare toxicological 

profiles of these substances. Each profile 

is to include an examination, summary, 

and interpretation of available 

toxicological information and 

epidemiologic evaluations. This 

information is used to ascertain the 

level of significant human exposure for 

the substance and the associated health 

effects. The toxicological profile 

includes a determination of whether 

adequate information on the health 

effects of each substance is available or 

is in the process of being developed. 

When adequate information is not 

available, ATSDR, in cooperation with 

the National Toxicology Program (NTP), 

may plan a program of research 

designed to determine these health 

effects. 

Although a number of key studies for 

this substance were identified and 

evaluated during the draft profile 

development process, this Federal 

Register notice seeks to solicit any 

additional studies, particularly 

unpublished data and ongoing studies. 

These studies will be evaluated for 

possible addition to the profile now or 

in the future. 

The draft toxicological profile will be 

made available to the public on or about 

August 20, 2010. 

Hazardous substance CAS No. 

RDX .......................................... 121–82–4 

Dated: August 20, 2010. 

Kenneth Rose, 

Director, Office of Policy, Planning, and 

Evaluation, National Center for 

Environmental Health/Agency for Toxic 

Substances and Disease Registry. 

[FR Doc. 2010–21298 Filed 8–25–10; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Research 

Resources; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Research Resources Initial Review Group, 

Comparative Medicine Review Committee 

CMRC. 

Date: October 14, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Bonnie B. Dunn, PhD, 

Scientific Review Officer, National Center for 

Research Resources, or National Institutes of 

Health, 6701 Democracy Blvd., 1 Democracy 

Plaza, Room 1074, MSC 4874, Bethesda, MD 

20892–4874. 301–435–0824. 

dunnbo@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research; 93.371, Biomedical 

Technology; 93.389, Research Infrastructure, 

93.306, 93.333; 93.702, ARRA Related 

Construction Awards., National Institutes of 

Health, HHS) 

Dated: August 20, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–21312 Filed 8–25–10; 8:45 am] 

BILLING CODE 4140–01–P 

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