38656 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

faculty at the DISL are actively involved 

in both basic and applied research in 

coastal waters of the northern Gulf of 

Mexico. The DISL operates marine 

research vessels (boats) crewed by 

faculty and students for field studies 

and sample collections. DISL possesses 

extensive laboratory and wet-laboratory 

resources relevant to the mission of the 

FDA/GCSL. The DISL is located within 

1 mile of the FDA/GCSL which will 

engage the proposed program of 

collaboration and internships. This 

unique circumstance of capability, 

capacity and proximity is irreplaceable 

without extended and costly 

concessions. 

II. Award Information/Funds Available 

A. Award Amount 

The estimated amount of support in 

FY09 will be up to $250,000 total costs 

(direct plus indirect costs). 

B. Length of Support 

The award will provide 12 months of 

support contingent upon satisfactory 

performance in the achievement of 

project and program reporting. 

III. Paper Application, Registration, 

and Submission Information 

To submit a paper application in 

response to this FOA, applicants should 

first review the full announcement 

located at http://www.cfsan.fda.gov/ 

list.html. Persons interested in applying 

for a grant may obtain an application 

from the PHS 398 application 

instructions available at http:// 

grants.nih.gov/grants/forms.htm. The 

following steps are required for paper 

submission: 

• Step 1: Obtain a Dun and Bradstreet 

Number (DUNS) 

Applicants are now required to have 

a DUNS number to apply for a grant or 

cooperative agreement from the Federal 

Government. The DUNS number is a 9- 

digit identification number that 

uniquely identifies business entities. To 

obtain a DUNS number, call DUN and 

Bradstreet at 1–866–705–5711. Be 

certain that you identify yourself as a 

Federal grant applicant when you 

contact Dun and Bradstreet. For foreign 

entities the Web site https:// 

eupdate.DNB.com. 

• Step 2: Register With Central 

Contractor Registration (CCR) 

Applicants must register with the CCR 

database. You must have a DUNS 

number to begin your registration. This 

database is a government-wide 

warehouse of commercial and financial 

information for all organizations 

conducting business with the Federal 

Government. The preferred method for 

completing a registration is through the 

Web site at https://www.ccr.gov. This 

Web site provides a CCR handbook with 

detailed information on data you will 

need prior to beginning the online preregistration, as well as steps to walk you 

through the registration process. 

• Step 3: Register With Electronic 

Research Administration (eRA) 

Commons 

Steps 1 and 2, in detail, can be found 

at http://www07.grants.gov/applicants/ 

organization_registration.jsp. Step 3, in 

detail, can be found at https:// 

commons.era.nih.gov/commons/ 

registration/registrationInstructions.jsp. 

After you have followed these steps, 

submit paper applications to: Camille 

Peake, Division of Acquisition Support 

and Grants, Food and Drug 

Administration (HFA 500), 5630 Fishers 

Lane, rm. 2139, Rockville, MD 20857, 

301–827–7175, FAX: 301–827–7101, email: Camille.Peake@fda.hhs.gov. 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18533Filed 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–N–0582] 

Kim C. Hendrick: 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 Kim C. Hendrick, M.D., 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 Dr. Hendrick was 

convicted of a felony 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, Dr. Hendrick 

failed to request a hearing. Dr. 

Hendrick’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 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 September 11, 2007, the U.S. 

District Court for the Eastern District of 

Michigan accepted Dr. Hendrick’s guilty 

plea and entered judgment against him 

for one count of mail fraud, a federal 

felony offense under 18 U.S.C. 1341. 

This offense was committed when Dr. 

Hendrick was a licensed physician 

practicing medicine in the State of 

Michigan. Dr. Hendrick agreed to 

participate in the clinical research trial 

for Augmentin XR, including its use in 

the treatment of adults with Acute 

Bacterial Sinusitis (ABS). As part of his 

participation in the clinical study, he 

agreed to conduct the study in 

conformity with the protocol 

established by GlaxoSmithKline and to 

comply with FDA regulations. He also 

agreed to take X-rays, before and after 

treatment, of persons he diagnosed with 

ABS, and to have an independent 

radiologist analyze these and issue 

reports regarding the X-rays. 

Dr. Hendrick admitted that instead of 

having an independent radiologist 

review the X-rays and issue reports, he 

allowed certain X-rays to be sent in 

batch form, which was a direct violation 

of the protocol. Further, he did not 

verify the purported signatures of the 

independent radiologist reports and, 

instead, failed to disclose to 

GlaxoSmithKline and/or FDA that the 

signatures were unverified and possibly 

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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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