12216 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Notices

B. Smith, Office on Disability and

Health, National Center for

Environmental Health, CDC, 4770

Buford Highway, Building 101, Mailstop

F–29, Atlanta, Georgia 30341, telephone

(770) 488–7082. (Internet address:

jos4@cdc.gov). Epidemiologic and

research-related technical assistance is

available from Donald J. Lollar, Ed.D. at

the same address, telephone (770) 488–

7094. (Internet address: dcl5@cdc.gov).

For Part 2 applications, program

assistance may be obtained from

Douglas R. Browne, National Center for

Injury Prevention and Control, CDC,

4770 Buford Highway, Building 101,

Mailstop F–41, Atlanta, Georgia 30341,

telephone (770) 488–4031. Internet

address: drb7@cdc.gov. Epidemiologic

and research-related technical

assistance is available from Joe Sniezek,

M.D., M.P.H. at the same address and

telephone number. Internet address:

jes6@cdc.gov. A packet of background

information for Part 2 is available by

contacting the above listed CDC staff.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report; Stock number 017–001–00474–

0) or ‘‘Healthy People 2000’’ (Summary

Report; Stock number 017–001–00473–

1) through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: March 7, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–6489 Filed 3–13–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 97N–0036]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information

regarding the Cosmetic Product

Voluntary Reporting Program has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995. This document

announces the OMB approval number.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–80), Food

and Drug Administration, 5600 Fishers

Lane, rm. 16B–19, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 23, 1996

(61 FR 67556), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance. In accordance with the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501–3520), OMB has approved

the information collection and assigned

OMB control number 0910–0030. The

approval expires on January 31, 2000.

Under 5 CFR 1320.5(b), an agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless the collection

displays a valid control number.

Dated: March 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6524 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0497]

I. D. Russell Co. Laboratories;

Withdrawal of Approval of NADA

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of a new animal drug

application (NADA) held by I. D.

Russell Co. Laboratories. The NADA

provides for use of 10 percent

sulfaquinoxaline powder for making

animal feed and 20 percent

sulfaquinoxaline liquid. The sponsor

requested the withdrawal of approval

because the products are no longer

being marketed.

EFFECTIVE DATE: March 24, 1997.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: I. D.

Russell Co. Laboratories, 1301 Iowa

Ave., Longmont, CO 80501, is the

sponsor of NADA 6–776, which

provides for use of 10 percent

sulfaquinoxaline powder for feed and 20

percent sulfaquinoxaline liquid. I. D.

Russell Co. Laboratories requested that

FDA withdraw approval of NADA 6–

776 because the products are no longer

being marketed.

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Center for Veterinary Medicine (21 CFR

5.84), and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADA 6–776 and all

supplements and amendments thereto is

hereby withdrawn, effective March 24,

1997.

Dated: February 3, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–6474 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket Nos. 95P–0061, 95S–0117, 95S–

0126, and 95S–0135]

Expiration Dates for Patents Extended

by the Uruguay Round Agreements

Act; Submission by Applicants of New

Drug and New Animal Drug

Applications; Withdrawal of Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing a

notice published in the Federal Register

of July 21, 1995 (60 FR 37652), which

announced the agency’s position on

patent information submitted by

applicants of new drug applications

(NDA’s) and new animal drug

applications (NADA’s). On April 4,

1996, the U.S. Court of Appeals for the

Federal Circuit issued a decision

establishing the correct method for

calculating patent term expiration dates

for certain patents that are subject to

both the Uruguay Round Agreements

Act (URAA) and the patent term

extension provisions of the U.S. Code.

All NDA and NADA applicants should

calculate patent term expiration dates in

conformance with the court’s decision

and submit corrected patent term

expiration dates to the agency.

DATES: NDA and NADA applicants that

have already submitted patent term

expiration dates should submit patent

term expiration dates calculated in

accordance with this notice by April 14,

1997.

ADDRESSES: Two copies of amended

patent information pertaining to human

drug products regulated under section

505 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 355) by

the Center for Drug Evaluation and

Research (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 the Center for Biologics
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