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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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38659 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human biological product 

RECOTHROM (Thrombin, topical 

(Recombinant)). RECOTHROM is 

indicated as an aid to hemostasis 

whenever oozing blood and minor 

bleeding from capillaries and small 

venules is accessible and control of 

bleeding by standard surgical 

techniques is ineffective or impractical. 

Subsequent to this approval, the Patent 

and Trademark Office received patent 

term restoration applications for 

RECOTHROM (U.S. Patent Nos. 

5,476,777, 5,502,034, and 5,527,692) 

from ZymoGenetics, Inc., and the Patent 

and Trademark Office requested FDA’s 

assistance in determining the patents’ 

eligibilities for patent term restoration. 

In a letter dated February 26, 2009, FDA 

advised the Patent and Trademark 

Office that this human biological 

product had undergone a regulatory 

review period and that the approval of 

RECOTHROM represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the Patent 

and Trademark Office requested that 

FDA determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

RECOTHROM is 1,511 days. Of this 

time, 1,115 days occurred during the 

testing phase of the regulatory review 

period, while 396 days occurred during 

the approval phase. These periods of 

time were derived from the following 

dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: November 30, 

2003. FDA has verified the applicant’s 

claims that the date the investigational 

new drug application became effective 

was on November 30, 2003. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): December 18, 2006. FDA 

has verified the applicant’s claims that 

the biologics license application (BLA) 

for RECOTHROM (BLA 125248/0) was 

initially submitted on December 18, 

2006. 

3. The date the application was 

approved: January 17, 2008. FDA has 

verified the applicant’s claims that BLA 

125248/0 was approved on January 17, 

2008. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 952 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by October 5, 2009. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

February 1, 2010. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. 

Comments and petitions may be seen 

in the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: June 8, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–18528 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–0551] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; XIENCE V EECSS 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for XIENCE 

V EECSS and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that medical device. 

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 medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. 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 (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 medical device will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(3)(B). 

FDA recently approved for marketing 

the medical device, XIENCE V EECSS. 

XIENCE V EECSS is indicated for 

improving coronary luminal diameter in 

patients with symptomatic heart disease 

due to de novo native coronary artery 

lesions (length = 28 millimeters (mm)) 

with reference vessel diameters of 2.5 

mm to 4.25 mm. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for XIENCE V EECSS (U.S. 

Patent No. 5,451,233) from Abbott 

Cardiovascular Systems, Inc., and the 

Patent and Trademark Office requested 

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