41264 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Notices

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

Commissioner 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 GEMZAR

(gemcitabine hydrochloride).

GEMZAR is indicated for use as a

firstline treatment for patients with

locally advanced (nonresectable stage II

or stage III) or metastatic (stage IV)

adenocarcinoma of the pancreas in

patients previously treated with 5–FU.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

GEMZAR (U.S. Patent No. 4,808,614)

from Eli Lilly & Co., and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated March 7, 1997, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of GEMZAR

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

GEMZAR is 3,293 days. Of this time,

2,824 days occurred during the testing

phase of the regulatory review period,

469 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: May 12, 1987.

The applicant claims June 18, 1987, as

the date the investigational new drug

application (IND) for GEMZAR

became effective. However, FDA records

indicate that the IND effective date was

May 12, 1987, 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: February 2, 1995. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

GEMZAR (NDA 20–509) was initially

submitted on February 2, 1995.

3. The date the application was

approved: May 15, 1996. FDA has

verified the applicant’s claim that NDA

20–509 was approved on May 15, 1996.

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 1,537 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 2, 1998, submit to

the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before February 1, 1999, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. 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 Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: July 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–20593 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

District Consumer Forum; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration’s

(FDA’s), Office of Consumer Affairs

(OCA) the Office of Regulatory Affairs

(ORA) offices in Illinois, Michigan, and

Indiana in cooperation with the U.S.

Dept. of Health and Human Services

Office of Minority Health, Office of

Public Health Sciences, Region V,

Illinois Department of Public Health,

Center for Minority Health Services and

Asian Health Coalition of Illinois,

Chicago Department of Health, Chicago

Hispanic Health Coalition, U. S.

Department of Agriculture Food and

Nutrition Service, Regional Office,

Midwest Field Office, Health Resources

and Services Administration, and the

University of Illinois Extension Chicago

Cooperative Extension Center is

announcing a district consumer forum.

The forum will provide an opportunity

for consumers, community-based

organizations, patient advocates, health

professionals, and industry to

participate in open discussions on

health issues and agency regulatory

actions with FDA officials.

Date and Time: The forum will be

held on Tuesday, August 18, 1998, from

10 a.m. to 1 p.m.

Location: The forum will be held at

the Sears Tower, 233 South Wacker Dr.,

Lincoln Ballroom, 33d Fl., Chicago, IL

60606.

Contact: Kimberly Phillips, Chicago

District Office, Office of Regulatory

Affairs, 300 South Riverside Plaza, suite

550–South, Chicago, IL 60606, 312–

353–7126, FAX 312–886–3280.

Registration: Send registration

information (including name, title, firm

name, address, telephone, and fax

number) to the contact person by

August 10, 1998. Every effort will be

made to accommodate all registrants.

However because space is limited,

admittance is on a ‘‘first come, first

serve basis.’’

If you need special accommodations

due to a disability, please contact

Kimberly Phillips (address above) by

August 10, 1998.

Transcripts: Transcripts of the forum

may be requested in writing from the

Freedom of Information Office (HFI–35),

Food and Drug Administration, 5600

Fishers Lane, rm. 12A–16, Rockville,

MD 20857, approximately 15 working

days after the forum, at a cost of 10

cents per page.

Dated: July 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20595 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F