Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38657 

forged, with the intent to create a false 

impression of a state of facts. Dr. 

Hendrick was paid by GlaxoSmithKline 

approximately $116,800 in X-ray fees 

for his participation in the clinical 

research trial. In so doing he caused a 

check to be mailed to him through the 

Postal Service at the direction of 

GlaxoSmithKline as partial payment for 

his participation in the clinical trial for 

the purpose of executing the scheme to 

defraud. 

As a result of this conviction, FDA 

sent Dr. Hendrick by certified mail on 

May 4, 2009, a notice proposing to 

permanently debar him from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. The proposal was 

based on a finding, under section 

306(a)(2)(A) and (a)(2)(B) of the act, that 

Dr. Hendrick was convicted of a felony 

under Federal law for conduct relating 

to the development or approval of a 

drug product, including the process for 

development or approval of a drug 

product, and conduct otherwise relating 

to the regulation of a drug product 

under the act. The proposal also offered 

Dr. Hendrick 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. Dr. Hendrick did not request a 

hearing and has, therefore, waived his 

opportunity for a hearing and any 

contentions concerning his debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Acting Director, Office 

of Enforcement, Office of Regulatory 

Affairs, under section 306(a)(2)(A) and 

(a)(2)(B) of the act, and under authority 

delegated to the Acting Director (Staff 

Manual Guide 1410.35), finds that Dr. 

Hendrick has been convicted of a felony 

under Federal law for conduct relating 

to the development or approval of a 

drug product, including the process for 

development or approval, of a drug 

product, and conduct otherwise relating 

to the regulation of a drug product 

under the act. 

As a result of the foregoing finding, 

Dr. Hendrick 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 (see DATES) 

(see sections 306(c)(1)(B) and 

(c)(2)(A)(ii) and 201(dd) of the act (21 

U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii), 

and 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 Dr. 

Hendrick, in any capacity, during Dr. 

Hendrick’s permanent debarment, will 

be subject to civil money penalties 

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

335b(a)(6))). If Dr. Hendrick, during his 

period of debarment, provides services 

in any capacity to a person with an 

approved or pending drug product 

application, 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 Dr. Hendrick during his 

permanent debarment (section 

306(c)(1)(B) of the act). 

Any application by Dr. Hendrick for 

special termination of debarment under 

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

identified with Docket No. FDA–2008– 

N–0582 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: July 15, 2009. 

Alyson L. Saben, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. E9–18621 Filed 8–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0501] 

Paul H. Kornak: 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 Paul H. Kornak from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on a finding that Paul H. 

Kornak was convicted of three felonies 

under Federal law for conduct relating 

to the development or approval, 

including the process for development 

or approval, of a drug product, and for 

conduct otherwise relating to the 

regulation of a drug product under the 

act. After being given notice of the 

proposed permanent debarment and an 

opportunity to request a hearing within 

the timeframe prescribed by regulation, 

Mr. Kornak failed to request a hearing. 

Mr. Kornak’s failure to request a hearing 

constitutes a waiver of his right to a 

hearing concerning this action. 

DATES: This order is effective August 4, 

2009. 

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: 

Robert L. Hummel, Sr., Division of 

Compliance Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 240–632–6845. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(A) of the act (21 

U.S.C. 335a(a)(2)(A)) requires debarment 

of an individual if FDA finds that the 

individual has been convicted of a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product. 

Section 306(a)(2)(B) of the act requires 

debarment of an individual if FDA finds 

that the individual has been convicted 

of a felony under Federal law for 

conduct otherwise relating to the 

regulation of any drug product under 

the act. 

On January 18, 2005, the U.S. District 

Court for the Northern District of New 

York accepted Mr. Kornak’s plea of 

guilty and entered judgment against Mr. 

Kornak for one count of making and 

using a materially false statement, one 

count of mail fraud, and one count of 

criminally negligent homicide, federal 

felony offenses under 18 U.S.C. 

1001(a)(3), 1341 and 1346, and 13, 

respectively. The actions underlying 

these convictions were committed while 

Mr. Kornak was employed by the 

Department of Veterans Affairs as the 

coordinator of several clinical studies of 

drug products. Mr. Kornak participated 

in a scheme to defraud the sponsors of 

these studies by repeatedly submitting 

false documentation and enrolling and 

causing to be enrolled persons as study 

subjects who did not qualify under 

particular study protocols. Mr. Kornak 

admitted to submitting a case report 

form with regard to a study subject 

knowing the document contained 

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38658 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

materially false laboratory entries and 

altered information from a radiology 

display report, which were critical 

factors in determining whether the 

individual was eligible to participate in 

the clinical study. He also admitted to 

knowingly and willfully 

misrepresenting the results of a blood 

chemistry analysis related to the 

participation of a study subject who 

would not otherwise have met the 

criteria for that study. The subject was 

administered chemotherapeutic drugs in 

connection with the clinical study and 

died as a result thereof. Mr. Kornak’s 

failure to perceive a substantial and 

unjustifiable risk that death would 

occur when he knowingly and willingly 

made and used such false documents 

constituted a gross deviation from the 

standard of care that a reasonable 

person would observe in the situation. 

Mr. Kornak further admitted to 

knowingly and willfully using interstate 

mail for the purpose of executing the 

aforesaid scheme and artifice to defraud, 

deprive, and obtain money and 

property. 

As a result of these convictions, FDA 

sent Mr. Kornak by certified mail on 

May 4, 2009, a notice proposing to 

permanently debar him from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. The proposal was 

based on a finding, under section 

306(a)(2)(A) and (a)(2)(B) of the act, that 

Mr. Kornak was convicted of felonies 

under Federal law for conduct relating 

to the development or approval of a 

drug product, and for conduct otherwise 

relating to the regulation of a drug 

product under the act. The proposal also 

offered Mr. Kornak 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. Kornak did 

not request a hearing and has, therefore, 

waived his opportunity for a hearing 

and any contentions concerning his 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Acting Director, Office 

of Enforcement, Office of Regulatory 

Affairs, under section 306(a)(2)(A) and 

(a)(2)(B) of the act, and under authority 

delegated to the Acting Director (Staff 

Manual Guide 1410.35), finds that Mr. 

Kornak has been convicted of felonies 

under Federal law for conduct relating 

to the development of approval of a 

drug product and conduct otherwise 

relating to the regulation of a drug 

product under the act. 

As a result of the foregoing finding, 

Mr. Kornak 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 (see DATES) 

(see sections 306(c)(1)(B) and 

(c)(2)(A)(ii) and 201(dd) of the act (21 

U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii), 

and 321(dd)). Any person with an 

approved or pending drug product 

application who knowingly employs or 

retains Mr. Kornak as a consultant or 

contractor, or otherwise uses in any 

capacity the services of Mr. Kornak 

during Mr. Kornak’s permanent 

debarment, will be subject to civil 

money penalties (section 307(a)(6) of the 

act (21 U.S.C. 335b(a)(6))). If Mr. 

Kornak, during his period of debarment, 

provides services in any capacity to a 

person with an approved or pending 

drug product application, 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. Kornak during his period of 

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

act). 

Any application by Mr. Kornak for 

special termination of debarment under 

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

identified with Docket No. 2007–N– 

0501 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: July 20, 2009. 

Alyson L. Saben, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. E9–18619 Filed 8–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–E–0258; FDA–2008– 

E–0260; and FDA–2008–E–0261] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; RECOTHROM 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

RECOTHROM and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of three applications to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of patents which claim that 

human biological product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the human 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the human 

biological product. Although only a 

portion of a regulatory review period 

may count toward the actual amount of 

extension that the Director of Patents 

and Trademarks may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human biological product will include 

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