13652 Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 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

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

DAUNOXOME (daunorubicin citrate).

DAUNOXOME is indicated as a first

line cytotoxic therapy for advanced

human immunodeficiency virus (HIV)-

associated Kaposi’s sarcoma.

DAUNOXOME is not recommended in

patients with less than advanced HIVrelated Kaposi’s sarcoma. Subsequent to

this approval, the Patent and Trademark

Office received patent term restoration

applications for DAUNOXOME (U.S.

Patent Nos. 5,435,989; 5,441,745; and

5,019,369) from NeXstar

Pharmaceuticals, Inc., and the Patent

and Trademark Office requested FDA’s

assistance in determining these patent’s

eligibilities for patent term restoration.

In letters dated December 2, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of

DAUNOXOME 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

DAUNOXOME is 2,771 days. Of this

time, 1,629 days occurred during the

testing phase of the regulatory review

period, while 1,142 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: September 8, 1988.

The applicant claims September 29,

1988, as the date the investigational new

drug application (IND) for

DAUNOXOME (IND 31,927) became

effective. However, FDA records

indicate that the effective date for IND

31,927 was September 8, 1988, which

was 30 days after FDA received the IND.

2. The date the application was

initially submitted with respect to the

human drug product under section 507

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 357): February 22, 1993.

The applicant claims February 18, 1993,

as the date the new drug application

(NDA) for DAUNOXOME (NDA 50–

704) was initially submitted. However,

FDA records indicate that NDA 50–704

was submitted on February 22, 1993.

3. The date the application was

approved: April 8, 1996. FDA has

verified the applicant’s claim that NDA

50–704 was approved on April 8, 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 258 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before May 20, 1997, 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 September 17, 1997, 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: March 12, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–7135 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0082]

Behring Diagnostics, Inc.; Premarket

Approval of EMIT 2000 Cyclosporine

Specific Assay

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Behring

Diagnostics, Inc., San Jose, CA, for

premarket approval, under the Federal

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

of the EMIT 2000 Cyclosporine

Specific Assay. After reviewing the

recommendation of the Clinical

Chemistry and Toxicology Devices

Panel, FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of October 2, 1996,

of the approval of the application.

DATES: Petitions for administrative

review by April 21, 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:

Cornelia B. Rooks, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–2436.

SUPPLEMENTARY INFORMATION: On June

29, 1992, Syva Co., San Jose, CA 95161–

9013, submitted to CDRH an application

for premarket approval of the EMIT

2000 Cyclosporine Specific Assay. The

device is a homogeneous enzyme

immunoassay and is indicated for in

vitro diagnostic use on the Roche
Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices 13653

Diagnostic Systems chemistry systems

(i.e., COBAS MIRA , COBAS MIRA

S, and COBAS MIRA Plus) for the

quantitative analysis of cyclosporine

(CsA) in human whole blood as an aid

in the management of cyclosporine

therapy in kidney, heart, and liver

transplant patients.

On November 16, 1992, the Clinical

Chemistry and Toxicology Devices

Panel of the Medical Devices Advisory

Committee, an FDA advisory committee,

reviewed and recommended approval of

the application. On October 2, 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 (21 U.S.C.

360e(d)(3)) 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 21, 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: February 20, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–7134 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETINGS: The following advisory

committee meetings are announced:

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee

Date, time, and place. April 7, 1997,

8:30 a.m., Corporate Bldg., conference

rm. 020B, 9200 Corporate Blvd.,

Rockville, MD. A limited number of

overnight accommodations have been

reserved at the Gaithersburg Marriott

Washingtonian Center, 9751

Washingtonian Blvd., Gaithersburg, MD.

Attendees requiring overnight

accommodations may contact the hotel

at 1–800–228–9290 or 301–590–0044

and reference the FDA Panel meeting

block. Reservations will be confirmed at

the group rate based on availability.

Attendees with a disability requiring

special accommodations should contact

Christie Wyatt, KRA Corp., 301–495–

1591, ext. 267.

Type of meeting and contact person.

Closed committee deliberations, 8:30

a.m. to 9:30 a.m.; open public hearing,

9:30 a.m. to 10:30 a.m., unless public

participation does not last that long;

open committee discussion, 10:30 a.m.

to 1:30 p.m.; closed presentation of data,

1:30 p.m. to 2:30 p.m.; open committee

discussion, 2:30 p.m. to 3:30 p.m.; John

E. Stuhlmuller, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8243, ext. 157, or FDA

Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Circulatory System Devices Panel, code

12625. Please call the hotline for

information concerning any possible

changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational devices

and makes recommendations for their

regulation.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before April 1, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

required to make their comments.

Open committee discussion. The

committee will discuss a new premarket

notification (510(k)) for a

transtelephonic cardiac event monitor

for over-the-counter use

(nonprescription). This device has

previously been cleared by the agency

for prescription use.

Closed presentation of data. The

sponsor may present trade secret and/or

confidential commercial information

regarding the cardiac monitor. This

portion of the meeting will be closed to

permit discussion of this information (5

U.S.C. 552b(c)(4)).