52534 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 

Proposed Project: Sickle Cell Disease 

and Other Hemoglobinopathies 

Program Evaluation—[NEW] 

Background: In response to the 

growing need for resources devoted to 

sickle cell disease and other 

hemoglobinopathies, Congress, under 

Section 501(a)2 of the Social Security 

Act (2000), authorized the appropriation 

of funds for enabling the Secretary to 

provide for special projects of regional 

and national significance, research and 

training with respect to maternal and 

child health and children with special 

health care needs the following: Genetic 

disease testing, counseling and 

information development and 

dissemination programs, for grants 

relating to hemophilia without regard to 

age, and for the screening of newborns 

for sickle cell anemia and other genetic 

disorders, and follow-up services. As 

stated in House Report No. 107–229 

regarding the Department of Labor, 

Health and Human Services, and 

Education, and Related Agencies 

Appropriation Bill 2002, the purpose of 

the Sickle Cell Disease and Newborn 

Screening Program (SCDNBSP) is ‘‘to 

enhance the sickle cell disease newborn 

screening program and its locally based 

outreach and counseling efforts.’’ In 

addition, the American Jobs Creation 

Act of 2004, Public Law 108–357, states 

that ‘‘* * * the Bureau of Primary 

Health Care and the Maternal and Child 

Health Bureau, shall conduct a 

demonstration program by making 

grants for up to 40 eligible entities, for 

each fiscal year in which the program is 

conducted under this section, for the 

purpose of developing and establishing 

systemic mechanisms to improve the 

prevention and treatment of Sickle Cell 

Disease.’’ (See 42 U.S.C. 300b–1). 

Purpose: HRSA’s activities under the 

legislative authorities relative to the 

Sickle Cell Disease and Newborn 

Screening Program (SCDNBSP) have 

been delegated to the Maternal and 

Child Health Bureau (MCHB), Genetic 

Services Branch (GSB). The MCHB’s 

GSB supports seventeen community 

based organizations and the National 

Coordinating and Evaluation Center for 

the Sickle Cell Disease and Newborn 

Screening Program (SCDNBS) in 

addition to nine cooperative agreements 

and a National Coordinating Center for 

the Sickle Cell Disease Treatment 

Demonstration Program (SCDTDP). An 

evaluation will be conducted to assess 

the service delivery processes and 

quality of the system of care delivered 

by grantees under the Newborn 

Screening Program to individuals 

affected by Sickle Cell disease who 

present at their sites for care. The 

Centers for Disease Control and 

Prevention defines Hemoglobinopathies 

as ‘‘a group of disorders affecting red 

blood cells. SCD and Thalassemia are 

included in this group.’’ (See http:// 

www.cdc.gov/ncbddd/sicklecell/ 

RuSH_FAQs.html). The information 

from the evaluation will be used to 

evaluate the grantees’ performance in 

achieving the objectives of the 

hemoglobinopathies program during the 

grant period, assess the breadth of 

grantees’ outreach to emerging 

populations affected by 

hemoglobinopathies and the needs of 

those populations attempting to access 

services. Data collection tools for which 

OMB approval is being requested are as 

follows: (1) The Minimum Database 

Project Sickle Cell Disease (MDP SCD) 

Questionnaire, (2) the Minimum 

Database Project Sickle Cell Trait/ 

Carrier (MDP SCT) Questionnaire, and 

(3) the MDP Hemoglobinopathies 

Emerging Populations Questionnaire. 

Respondents: The MDP SCD and the 

MDP SCT Questionnaires will be 

administered by grantees to clients or 

caregivers when they present for 

services. At the time of enrollment, 

SCDNBSP participants will be informed 

about the data collection and clients 

will be asked to participate in either the 

SCD questionnaire or the SCT 

questionnaire depending on their 

disease or carrier status. The program 

will enroll participants on a rolling 

basis such that new patients will be 

added to the program as they present for 

services and provide consent. Data will 

be collected at two points annually for 

the SCD Questionnaire, the first, when 

clients and caregivers are enrolled into 

the SCDNBS Program and the second, at 

follow-up after enrollment. Data will be 

collected once annually for the SCT 

Questionnaire. The Hemoglobinopathies 

Emerging Populations Form serves as a 

stand alone form for the other HRSA 

hemoglobinopathies programs, with its 

content. These questions are also 

embedded in the MDT SCD and MDP 

SCT questionnaires. The HRSA 

hemoglobinopathies programs also plan 

to use this questionnaire in developing 

educational materials, prioritizing 

outreach activities and informing 

decisions for future funding requests. 

The annual estimate of burden is as 

follows: 

Questionnaires Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average hours 

per response 

Total hour 

burden Wage rate Total hour cost 

MDP SCD Questionnaire ......... 140 2 280 .45 126 $20.90 $2,633.40 

MDP SCT Questionnaire ......... 1,400 1 1,400 .30 420 20.90 8,778.00 

Hemoglobinopathies Emerging 

Populations Form ................. *1,125 2 *2,250 .20 450 20.90 9,405.00 

Total .................................. 2,665 ........................ 3,930 ........................ 996 .................... 20,816.40 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: August 19, 2010. 

Sahira Rafiullah, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–21220 Filed 8–25–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0213] 

Su Van Ho: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

mstockstill on DSKH9S0YB1PROD with NOTICES

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