Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices 12217

Evaluation and Research (CBER) should

be submitted to the Document Control

Center, Center for Biologics Evaluation

and Research (HFM–99), Food and Drug

Administration, 1401 Rockville Pike,

suite 200N, Rockville, MD 20852.

A third copy of the amended patent

information pertaining to human drug

products regulated under section 505 of

the act by either CDER or CBER should

be sent to the Division of Database

Management, Drug Information Services

Branch (HFD–85), Center for Drug

Evaluation and Research, Food and

Drug Administration, 1901 Chapman

Ave., rm. 218, Rockville, MD 20852.

Two copies of amended patent

information pertaining to animal drug

products should be sent to the

Document Control Unit, Center for

Veterinary Medicine (HFV–199), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1049.

SUPPLEMENTARY INFORMATION: FDA is

withdrawing the July 21, 1995, notice,

which announced the agency’s position

on patent information submitted by

applicants of NDA’s and NADA’s. In

that notice, FDA stated that patent term

expiration dates for certain patents that

are subject to both the URAA and the

patent term extension provisions of

Title II of the Drug Price Competition

and Patent Term Restoration Act and

Title II of the Generic Animal Drug and

Patent Term Restoration Act, both

codified at 35 U.S.C. 156, should be

calculated in accordance with the Patent

and Trademark Office’s determination

(PTO determination) published in the

Federal Register of June 7, 1995 (60 FR

30069). FDA also announced that it

would not publish dates in ‘‘Approved

Drug Products with Therapeutic

Equivalence Evaluations’’ (the Orange

Book) or the ‘‘FDA Approved Animal

Drug Products’’ (the Green Book) that

the NDA or NADA applicant stated were

not in accordance with the PTO

determination.

The PTO determination and the July

21, 1995, notice were challenged in

Federal court by a number of

pharmaceutical companies that hold

NDA’s or NADA’s. On April 4, 1996, the

U.S. Court of Appeals for the Federal

Circuit issued a decision in Merck & Co.

v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996)

establishing the correct method for

calculating patent expiration dates for

patents subject to both patent extension

under the URAA and the patent term

extension provisions of 35 U.S.C. 156.

The Federal Circuit remanded the case

to the U.S. District Court for the Eastern

District of Virginia, which issued orders

that, among other things, established the

patent expiration dates for the patents at

issue in the litigation. (Merck & Co. v.

Kessler, Civ. No. 95–1005–A (E.D. Va.

Sept. 5, 1996); and Organon, Inc. v.

Kessler, Civ. No. 95–1380–A (E.D. Va.

Sept. 13, 1996).)

In conformance with the district court

order, FDA is publishing the patent

expiration dates determined in the order

for the patents directly at issue in the

litigation in the monthly supplement to

the Orange Book. FDA advises that NDA

and NADA applicants should submit to

FDA within 30 days, new patent

expiration dates calculated in

accordance with the courts’ orders for

any patents that have already been

submitted to FDA. Patent expiration

dates already submitted to the agency

that were calculated by the method

described in the court’s order need not

be resubmitted. Expiration dates for

patents first submitted to FDA after the

date of this notice must be calculated in

accordance with the method described

in Merck & Co. v. Kessler.

Two copies of amended patent

information pertaining to human drug

products regulated under section 505 of

the act by CDER should be submitted to

the assigned reviewing division. The

submission should bear the pertinent

NDA number.

Two copies of amended patent

information pertaining to human drug

products regulated under section 505 of

the act by CBER should be submitted to

the Document Control Center, Center for

Biologics Evaluation and Research

(HFM–99), Food and Drug

Administration, 1401 Rockville Pike,

suite 200N, Rockville, MD 20852.

To expedite the availability to the

public of the updated patent

information, a third copy of the

amended patent information pertaining

to human drug products regulated under

section 505 of the act by either CDER or

CBER should be sent to the Division of

Database Management, Drug

Information Services Branch (HFD–85),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 1901 Chapman Ave.,

rm. 218, Rockville, MD 20852.

Two copies of amended patent

information pertaining to animal drug

products should be sent to the

Document Control Unit, Center for

Veterinary Medicine (HFV–199), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855.

Dated: March 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6413 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0051]

Eurexpan Labo; Premarket Approval of

ContaClair Multi-Purpose Solution

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by the law firm of Akin, Gump, Strauss,

Hauer and Field, as the United States

Representative on behalf of Eurexpan

Labo, 41120 Cellettes, France, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of ContaClair Multi-Purpose Solution.

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of June 20, 1996, of

the approval of the application.

DATES: Petitions for administrative

review by April 14, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

James F. Saviola, Center for Devices and

Radiological Health (HFZ–460), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1744.

SUPPLEMENTARY INFORMATION: On

December 19, 1991, the law firm of

Akin, Gump, Strauss, Hauer and Field,

as the United States Representative on

behalf of Eurexpan Labo, 41120

Cellettes, France, submitted to CDRH an

application for premarket approval of

ContaClair Multi-Purpose Solution.

The device is a cleaning, rinsing,

disinfecting, and storing solution and is

indicated for cleaning, rinsing,

disinfecting, and storing daily and

extended wear clear and tinted soft

(hydrophilic) contact lenses.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory
12218 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices

committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel.

On June 20, 1996, CDRH approved the

application by a letter to the applicant

from the Director of the Office of Device

Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act authorizes

any interested person to petition, under

section 515(g) of the act, for

administrative review of CDRH’s

decision to approve this application. A

petitioner may request either a formal

hearing under 21 CFR part 12 of FDA’s

administrative practices and procedures

regulations or a review of the

application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

21 CFR 10.33(b). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of the review

to be used, the persons who may

participate in the review, the time and

place where the review will occur, and

other details.

Petitioners may, at any time on or

before April 14, 1997, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: January 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–6409 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97N–0083]

Abbreviated New Drug Applications;

Positron Emission Tomography

Radiopharmaceuticals; Notice of a

Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public workshop to provide information

to the positron emission tomography

(PET) radiopharmaceutical industry on

submitting abbreviated new drug

applications (ANDA’s) and other

regulatory issues affecting PET

radiopharmaceutical drug products. The

workshop will provide guidance on

topics such as ANDA regulatory

requirements, registration and listing

requirements, chemistry and

manufacturing controls, sterility

assurance, bioequivalence requirements,

and labeling. An agenda and materials

to be discussed at the workshop will be

available before the workshop.

DATES: The workshop will be held on

Monday, April 28, 1997, from 8 a.m. to

5 p.m. Because space is limited,

interested persons are encouraged to

register as soon as possible.

Preregistration will be accepted through

April 18, 1997. There is no registration

fee for the workshop. The

administrative docket will remain open

until June 27, 1997, to receive written

comments, data, information, or views

on the workshop and materials

distributed at the workshop.

ADDRESSES: The workshop will be held

at the Parklawn Bldg., 5600 Fishers

Lane, conference rm. D, Rockville, MD

20857. Persons interested in attending

should pre-register by faxing their name,

title, organization name if any, address,

telephone and fax numbers to the

contact person. Registrants’ fax numbers

should be provided, so that registration

can be confirmed by return fax.

Before the workshop, the agenda and

materials to be discussed at the

workshop will be available via the

Internet using the World Wide Web

(WWW). To connect to the Center for

Drug Evaluation and Research (CDER)

Home Page, type http://www.fda.gov/

cder and go to the ‘‘What’s Happening’’

section. A transcript of the workshop

will be available from the Freedom of

Information Office (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857,

approximately 15 business days after

the workshop at a cost of 10 cents per

page.

Written comments on the workshop

or materials discussed at the workshop

can be submitted until June 27, 1997, to

the Dockets Management Branch (HFA–

305), 12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of

comments 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 notice. Received

comments may be viewed at the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Susan C. Lange, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–160),

5600 Fishers Lane, Rockville, MD

20857, 301–443–0260, FAX 301–594–

0746.

SUPPLEMENTARY INFORMATION:

I. Background

PET is a diagnostic imaging modality

consisting of onsite production of

radionuclides that are usually

intravenously injected into patients for

diagnostic purposes. The potential

usefulness of a PET

radiopharmaceutical is based upon the

product’s interaction with a biochemical

process in the body.

Over the last 20 years, there has been

increasingly widespread commercial

use of a growing number of PET

radiopharmaceuticals. Having

considered the available information,

including that presented to the agency

at a March 1993 hearing and in written

materials, in the Federal Register of

February 27, 1995 (60 FR 10593), FDA

provided additional notice and

guidance to the industry stating how the

agency would apply its regulatory

authority to PET drug products.

Since the approval of one new drug

application for F–18 FDG, PET drug

product manufacturers have sought

information on the submission of

ANDA’s. Details of the ANDA

submission process will be discussed at

the workshop. Other topics to be

addressed include registration and

listing requirements, chemistry and

manufacturing controls, sterility

assurance, bioequivalence requirements,

labeling, and compliance with current