38660 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated February 

18, 2009, FDA advised the Patent and 

Trademark Office that this medical 

device had undergone a regulatory 

review period and that the approval of 

XIENCE V EECSS 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 

XIENCE V EECSS is 1,157 days. Of this 

time, 759 days occurred during the 

testing phase of the regulatory review 

period, while 398 days occurred during 

the approval phase. These periods of 

time were derived from the following 

dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

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

360j(g)) involving this device became 

effective: May 4, 2005. FDA has verified 

the applicant’s claim that the date the 

investigational device exemption (IDE) 

required under section 520(g) of the act 

for human tests to begin became 

effective on May 4, 2005. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the act (21 

U.S.C. 360e): June 1, 2007. The 

applicant claims the premarket approval 

application (PMA) XIENCE V EECSS 

(PMA 70015) was submitted in three 

modules and that Module 1 was initially 

submitted on July 14, 2006. The 

applicant claims July 14, 2006, as the 

date PMA 70015 was initially 

submitted. It is FDA’s position that the 

approval phase begins when the 

marketing application is complete. A 

review of FDA records indicates that 

PMA 70015 was submitted as a 

complete application on June 1, 2007, 

which is considered to be the initially 

submitted date for PMA 70015. 

3. The date the application was 

approved: July 2, 2008. FDA has verified 

the applicant’s claim that PMA 70015 

was approved on July 2, 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 937 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. E9–18530 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–2009–E–0020] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EOVIST 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for EOVIST 

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 

human drug 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 drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug 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 drug product will 

include 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 drug product EOVIST 

(gadoxetate disodium). EOVIST is 

indicated for intravenous use in T1– 

weighted magnetic resonance imaging of 

the liver to detect and characterize 

lesions in adults with known or 

suspected focal liver disease. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for EOVIST 

(U.S. Patent No. 6,039,931) from Bayer 

Schering Pharma Aktiengesellschaft, 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

February 26, 2009, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of EOVIST represented the 

first permitted commercial marketing or 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38661 

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 

EOVIST is 3,818 days. Of this time, 

3,450 days occurred during the testing 

phase of the regulatory review period, 

while 368 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

subsection 505(i) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 355(i)) became effective: January 

21, 1998. The applicant claims January 

19, 1998, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

January 21, 1998, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: July 2, 2007. The 

applicant claims June 29, 2007, as the 

date the new drug application (NDA) for 

EOVIST (NDA 22–090) was initially 

submitted. However, FDA records 

indicate that NDA 22–090 was 

submitted on July 2, 2007. 

3. The date the application was 

approved: July 3, 2008. FDA has verified 

the applicant’s claim that NDA 22–090 

was approved on July 3, 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 1,699 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. E9–18527 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–2001–D–0129 (formerly 

Docket No. 2001D–0064)] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Dental Amalgam, Mercury, and 

Amalgam Alloy; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Dental Amalgam, Mercury, 

and Amalgam Alloy.’’ This guidance 

document describes a means by which 

manufacturers of dental amalgam, 

mercury, and amalgam alloy may 

comply with special controls that apply 

to these class II devices. Elsewhere in 

this issue of the Federal Register, FDA 

is publishing a final rule to classify 

dental amalgam into class II (special 

controls), reclassify dental mercury from 

class I (general controls) to class II 

(special controls), and designate a 

special controls guidance document to 

support the class II classification of 

these two devices, as well as the current 

class II classification of amalgam alloy. 

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Dental Amalgam, 

Mercury, and Amalgam Alloy’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 4613, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request, or fax your request to 301– 

847–8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this guidance 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Michael Adjodha, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 2606, Silver Spring, 

MD 20993–0002, 301–796–6276. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 

20, 2002 (67 FR 7620), FDA issued a 

proposed rule to issue a separate 

regulation classifying encapsulated 

dental amalgam into class II (special 

controls); amending the class II 

classification of amalgam alloy by 

designating special controls; and 

reclassifying dental mercury from class 

I (general controls) to class II (special 

controls). Also, in the Federal Register 

of February 20, 2002 (67 FR 7703), FDA 

announced the availability of the draft 

guidance entitled ‘‘Special Control 

Guidance Document on Encapsulated 

Amalgam, Amalgam Alloy, and Dental 

Mercury Labeling,’’ which would serve 

as a special control for all three devices. 

The comment period on the proposed 

rule closed on May 21, 2002. FDA 

reopened the comment period in July 

2002 (67 FR 46991) and again in April 

2008 (73 FR 22877) to provide the 

public with additional opportunities to 

comment and to submit data and 

information that may have become 

available since publication of the 

proposed rule. The comment period 

closed on July 28, 2008. 

FDA received more than 1,400 

comments on the proposed rule and the 

draft special controls guidance 

document. Because of the intertwined 

nature of the proposed rule and the draft 

guidance, and because of the significant 

overlap in comments, FDA considered 

all comments in preparing both the final 

rule and the special controls guidance 

document. The analysis of comments is 

contained in the preamble to the final 

rule. 

mstockstill on DSKH9S0YB1PROD with NOTICES