Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 / Notices 8081 

TABLE A.12–1 ESTIMATES OF HOUR BURDEN—Continued 

Type of respondents Number of respondents 

Estimated number of responses 

per respondent 

Average burden 

hours per response 

Estimated total 

annual burden 

hours requested 

Accepted Donors ......................................................................... * 12 1 0 .5 6 

Total ...................................................................................... 408 ............................ .............................. 83 .64 

* These respondents are a subgroup of total 408 donors who will be initially contacted to participate in the study. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

For Further Information Contact: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. George Nemo, 

Project Officer, NHLBI, Two Rockledge 

Center, Room 9144, 6701 Rockledge 

Drive, Bethesda, MD 20892–7950, or 

call 301–435–0075, or E-mail your 

request to nemog@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: February 16, 2010. 

George Nemo, 

NHLBI Project Officer, NHLBI, National 

Institutes of Health. 

[FR Doc. 2010–3449 Filed 2–22–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0585] 

Patrick J. Lais: 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 act) permanently 

debarring Patrick J. Lais from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. We base this order 

on a finding that Mr. Lais was convicted 

of a felony under Federal law for 

conduct relating to the regulation of a 

drug product under the act. Mr. Lais has 

notified FDA that he acquiesces to 

debarment, and therefore has waived his 

opportunity for a hearing concerning 

this action. 

DATES: This order is effective February 

23, 2010. 

ADDRESSES: Submit applications for 

special 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, 240–632–6844. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On April 25, 2005, Mr. Patrick J. Lais, 

formerly president of York 

Pharmaceutical, pleaded guilty to 

introducing and delivering, and causing 

to be introduced and delivered into 

interstate commerce, a drug that was 

adulterated within the meaning of 21 

U.S.C. 351(a)(2)(B) of the act, a felony 

under Federal law in violation of 21 

U.S.C. 331(a) and 333(a)(2). Judgment 

was entered against him for this felony 

on August 15, 2005. The basis for this 

conviction was as follows: 

Beginning in 1997 and lasting until 

September 2001, Mr. Lais was the 

president of York Pharmaceutical 

(York). Mr. Lais had responsibility for 

and authority over drug manufacturing 

at York. York manufactured generic 

over-the-counter drugs during the 

period January 1999 through July 2001. 

York distributed in interstate 

commerce human drug products that 

were adulterated within the meaning of 

21 U.S.C. 351(a)(2)(B) of the act, in that 

York manufactured and distributed, 

among other things, subpotent burn 

spray, aspirin that had failed dissolution 

testing, and antacid products 

contaminated with bacteria. 

Mr. Lais knew that York’s 

manufacturing facility lacked basic 

validation processes and controls and 

that York’s drug products were 

adulterated within the meaning of the 

act. Mr. Lais also knew that York: (1) 

Did not use procedures that ensured 

that its drugs had the identity, strength, 

quality, and purity characteristics that 

they were represented to possess; (2) did 

not test raw materials before using them; 

(3) did not perform appropriate 

laboratory determinations of 

conformance with final specifications 

for each of its drug products; (4) 

shipped drug product known not to 

meet established quality control criteria; 

(5) frequently failed to assess the 

stability characteristics of the drugs it 

produced; (6) did not maintain the 

buildings used in the manufacture, 

processing, packing, and holding of its 

drug products in a clean and sanitary 

condition; and (7) did not clean, 

maintain, and sanitize its manufacturing 

equipment and utensils in such a way 

as to prevent contamination of final 

drug products. 

In January 2000, York manufactured 

and compressed a drug product 

identified as ‘‘Uncoated Aspirin.’’ This 

drug failed its final dissolution testing. 

Neither Mr. Lais nor the employees 

under his authority and control 

determined the cause of the dissolution 

failure. Rather, York coated the failed 

aspirin and renumbered the lot. Part of 

this lot then was packaged as ‘‘Coated 

Aspirin.’’ On or about February 21, 

2000, Mr. Lais caused the shipment of 

625 cases of adulterated drug products, 

identified as ‘‘Coated Aspirin,’’ to 

customers in Kansas City, MO. In May 

2000, this ‘‘Coated Aspirin’’ failed 3– 

month stability testing. Mr. Lais and the 

employees under his authority and 

control did not determine the cause of 

the failure and did not inform York’s 

customers that the aspirin was 

adulterated. 

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8082 Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 / Notices 

Mr. Lais is subject to debarment based 

on a finding, under section 306(a)(2)(B) 

of the act (21 U.S.C. 355a(a)(2)(B)), that 

he was convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product. 

In the plea agreement entered on 

April 25, 2005, Mr. Lais expressly 

waived his right, if any, to contest any 

debarment that may be initiated by the 

Secretary of Health and Human Services 

under 21 U.S.C.335a. In accordance 

with section 306(c)(2)(B) of the act, Mr. 

Lais notified FDA of his acquiescence to 

debarment in a letter signed on October 

3, 2006. A person subject to debarment 

is entitled to an opportunity for an 

agency hearing on disputed issues of 

material fact under section 306(i) of the 

act, but by acquiescing to debarment Mr. 

Lais waived his opportunity for a 

hearing and to raise any contentions 

concerning his debarment. 

II. Findings and Order 

Therefore, the Acting Director, Office 

of Enforcement, Office of Regulatory 

Affairs, under section 306(a)(2)(B) of the 

act, under authority delegated to the 

Acting Director (Staff Manual Guide 

1410.35), finds that Patrick J. Lais has 

been convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product under the 

act. 

As a result of the foregoing finding 

and based on his notification of 

acquiescence, Mr. Lais is permanently 

debarred from providing services in any 

capacity to a person with an approved 

or pending drug product application 

under sections 505, 512, or 802 of the 

act (21 U.S.C. 355, 360b, or 382), or 

under section 351 of the Public Health 

Service Act (42 U.S.C. 262), effective 

October 3, 2006, the date of notification 

of acquiescence (see sections 

306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of 

the act (21 U.S.C. 321(dd))). Any person 

with an approved or pending drug 

product application who knowingly 

employs or retains as a consultant or 

contractor, or otherwise uses the 

services of Patrick J. Lais, in any 

capacity during Mr. Lais’s debarment, 

will be subject to civil money penalties 

(section 307(a)(6) of the act (21 U.S.C. 

335b(a)(6))). If Mr. Lais provides 

services in any capacity to a person with 

an approved or pending drug product 

application during his period of 

debarment he will be subject to civil 

money penalties (section 307(a)(7) of the 

act). In addition, FDA will not accept or 

review any abbreviated new drug 

applications submitted by or with the 

assistance of Mr. Lais during his period 

of debarment (section 306(c)(1)(B) of the 

act). 

Any application by Mr. Lais for 

special termination of debarment under 

section 306(d)(4) of the act should be 

identified with Docket No. FDA–2009– 

N–0585 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: January 26, 2010. 

Brenda Holman, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2010–3552 Filed 2–22–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Automated Computer-Aided Polyp 

Detection for Computed Tomography 

Colonography (Virtual Colonoscopy) 

Description of Invention: This 

invention describes an automated 

method for colon registration from 

supine and prone scans that combines 

the use of Computed Tomographic 

Colonography (CTC) and Computer 

Aided Detection (CAD) software. 

Currently, in order to detect colonic 

polyps, patients are scanned twice— 

once in the supine, and again in the 

prone positions. This approach 

improves CTC sensitivity by reducing 

the extent of non-interpretable collapsed 

or fluid-filled segments. In order to 

assist radiologists in interpreting CTC 

data or evaluating colonic polyp 

candidates detected by CAD in both 

scans, it is important to provide not 

only the locations of suspicious polyps, 

but also the possible matched pairs 

(correspondences) of polyps in these 

scans. To achieve this, the two scans 

need to be aligned. In this invention, the 

colon registration problem is formulated 

as time series matching along the 

centerline of the colon. Anatomically 

salient points on the colon are initially 

distinguished as they can be viewed as 

landmarks along the central path of the 

colon. Correlation optimized warping is 

then applied to the segments defined by 

the anatomical landmarks to find better 

global registration based on the local 

correlation of segments. 

When CTC is performed in 

conjunction with CAD software, 

screening may become easier on 

patients, less time-consuming, and more 

accurate. The effectiveness of the 

method was verified in experiments in 

which the polyp location was used as a 

measure for the registration error. The 

algorithm was tested on a CTC dataset 

of 12 patients with 14 polyps. 

Experimental results showed that by 

using this method, the estimation error 

of polyp location could be reduced 

60.4% (from 47.2mm to18.7mm on 

average) compared to a traditional 

method based on dynamic time 

warping. 

Colon cancer is the second leading 

cause of cancer-related deaths in the 

United States, and the method used in 

this invention will aid in effective early 

detection of the disease, which will 

have a significant impact on its 

prognosis. 

Applications: Efficient and robust 

detection of colon cancer. 

Development Status: Early stage. 

Inventors: Ronald M. Summers et al. 

(NIHCC). 

Related Publication: Huang A, Roy D, 

Franaszek M, Summers RM. Teniae coli 

guided navigation and registration for 

virtual colonoscopy. Visualization, 

2005. VIS 05. IEEE, pp. 279–285, 23–28 

Oct 2005; doi 10.1109/ 

VISUAL.2005.1532806. 

Patent Status: U.S. Patent Application 

No. 61/220,481 filed June 25, 2009 (HHS 

Reference No. E–135–2009/0–US–01). 

Licensing Status: Available for 

licensing. 

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