Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 57939

requested that FDA determine the 

product’s regulatory review period.

FDA has determined that the 

applicable regulatory review period for 

KINERET is 4,101 days. Of this time, 

3,413 days occurred during the testing 

phase of the regulatory review period, 

while 688 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 (21 U.S.C. 355(i)) 

became effective: August 25, 1990. The 

applicant claims August 23, 1990, as the 

date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was August 25, 1990, 

which was 30 days after FDA receipt of 

the IND.

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 28, 1999. The 

applicant claims December 27, 1999, as 

the date the product license application 

(BLA) for KINERET (BLA 103950) was 

initially submitted. However, FDA 

records indicate that BLA 103950 was 

submitted on December 28, 1999.

3. The date the application was 

approved: November 14, 2001. FDA has 

verified the applicant’s claim that BLA 

103950 was approved on November 14, 

2001.

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 1,825 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 November 29, 2004. 

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 

March 28, 2005. 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: August 30, 2004.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug 

Evaluation and Research.

[FR Doc. 04–21675 Filed 9–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001E–0032]

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; VISUDYNE

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

VISUDYNE 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 

that 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.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6699.

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 VISUDYNE 

(verteporfin). VISUDYNE is indicated 

for the treatment of age-related macular 

degeneration in patients with 

predominantly classic subfoveal 

choroidal neovascularization. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

VISUDYNE (U.S. Patent No. 5,095,030) 

from University of British Columbia, 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

May 2, 2001, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of VISUDYNE represented the 

first permitted commercial marketing or 

use of the product. Shortly 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 

VISUDYNE is 3,194 days. Of this time, 

2,953 days occurred during the testing 

phase of the regulatory review period, 

while 241 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: July 17, 1991. 

The applicant claims June 21, 1991, as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

57940 Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 

IND effective date was July 17, 1991, 

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: August 16, 1999. The 

applicant claims August 24, 1999, as the 

date the new drug application (NDA) for 

VISUDYNE (NDA 21–119) was initially 

submitted. However, FDA records 

indicate that NDA 21–119 was 

submitted on August 16, 1999.

3. The date the application was 

approved: April 12, 2000. FDA has 

verified the applicant’s claim that NDA 

21–119 was approved on April 12, 2000.

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 5 years 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 November 29, 2004. 

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 

March 28, 2005. 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: August 30, 2004.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug 

Evaluation and Research.

[FR Doc. 04–21678 Filed 9–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0423]

Second Annual Stakeholder Meeting 

on the Implementation of the Medical 

Device User Fee and Modernization 

Act of 2002 Provisions; Public Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

following public meeting: Second 

Annual Stakeholder Meeting on the 

Implementation of the Medical Device 

User Fee and Modernization Act of 2002 

(MDUFMA). The topic of discussion is 

the agency’s progress in implementing 

the various MDUFMA provisions, 

including the guidances FDA has issued 

on the new law.

DATES: The public meeting will be held 

on November 18, 2004, from 9 a.m. to 

5 p.m. Registration is required by 

Friday, October 22, 2004. All 

individuals wishing to make a 

presentation or to speak on an issue 

should indicate their intent and the 

topic to be addressed and provide an 

abstract of the topic to be presented by 

October 22, 2004. Time for 

presentations will be limited to 10 

minutes.

ADDRESSES: The public meeting will be 

held at the Marriott Gaithersburg 

Washingtonian Center, 9751 

Washingtonian Blvd., Gaithersburg, MD.

Submit written requests to make an 

oral presentation to Cindy Garris, Center 

for Devices and Radiological Health 

(HFZ–220), Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850, 301–443–6597, 

ext. 121, FAX: 301–443–8818, e-mail: 

cxg@cdrh.fda.gov. Include your name, 

title, firm name, address, telephone, and 

fax number with your request. All 

requests and presentation materials 

should include the docket number 

found in brackets in the heading of this 

document. Submit all request for 

suggestions and recommendations to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Cindy Garris, Center for Devices and 

Radiological Health (HFZ–220), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 301–443–

6597, ext. 121, FAX: 301–443–8818, email: cxg@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

On October 26, 2002, MDUFMA 

amended the Federal Food, Drug, and 

Cosmetic Act to include several new 

significant provisions. MDUFMA 

authorizes the following provisions: (1) 

User fees for certain premarket 

applications, (2) establishment of good 

manufacturing practice (GMP) 

inspections by FDA-accredited persons 

(third-parties), and (3) new 

requirements for reprocessed single-use 

devices. In addition, the new law 

contains several provisions that, while 

narrower in scope than the previously 

mentioned provisions, are significant 

changes to the device law. These 

include a modular review program for 

premarket approval applications 

(PMAs), electronic labeling for certain 

prescription devices, several provisions 

concerning devices for pediatric use, 

and a new labeling requirement that 

requires the manufacturer’s name to 

appear on the device itself, with certain 

exceptions.

The agency has been working to 

implement the new law since its 

passage in October 2002. During this 

time, FDA has accomplished the 

following significant milestones: (1) 

Established a user fee program with 

payment, billing, and appeals 

procedures; (2) published accreditation 

criteria for persons conducting thirdparty inspections and accredited 15 

such persons; (3) identified certain 

reprocessed single-use devices that will 

be subject to additional marketing 

requirements; and (4) published 

guidances related to the PMA, 

premarket notification (510(k)), and 

biologics license application (BLA) 

programs, bundling multiple devices in 

a single application, and premarket 

review of pediatric devices. The agency 

is drafting additional documents to be 

issued in the near future.

II. Agenda

On November 18, 2004, FDA is 

providing the opportunity for all 

interested persons to provide 

information and share their views on 

the implementation of MDUFMA. The 

following topics will be discussed:

• User Fees Process—This panel will 

consider the small business 

determination and the user fee payment 

processes.

Premarket Review Performance 

Goals—This panel will discuss the 

agency’s progress in meeting the PMA, 

510(k), and BLA review performance 

goals.

• Qualitative Performance Goals (e.g., 

Modular PMA and GMP and