62866 Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices

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: November 30, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–29768 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0299]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; ZINECARDTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

ZINECARDTM 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

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

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 ZINECARDTM

(dexrazoxane). ZINECARDTM is

indicated for reducing the incidence

and severity of cardomyopathy

associated with doxorubicin

administration in women with

metastatic breast cancer who have

received a cumulative doxorubicin dose

of 300 milligrams per square meter and

who, in their physician’s opinion,

would benefit from continuing therapy

with doxorubicin. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for ZINECARDTM (U.S.

Patent No. 4,275,063) from British

Technology Group Ltd., and the Patent

and Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated October 5, 1995, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of ZINECARDTM

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

ZINECARDTM is 2,748 days. Of this

time, 1,546 days occurred during the

testing phase of the regulatory review

period, while 1,202 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: November 18, 1987.

The applicant claims September 25,

1987, as the date the investigational new

drug application (IND) for ZINECARDTM

(IND 30,617) became effective. However,

FDA records indicate that the agency

received IND 30,617 on September 22,

1987. IND 30,617 was placed on clinical

hold on October 22, 1987, and was

removed from hold on November 18,

1987. The date IND 30,617 was removed

from hold, November 18, 1987, is the

IND effective date.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: February 10, 1992. The

applicant claims February 7, 1992, as

the date the new drug application

(NDA) for ZINECARDTM (NDA 20–212)

was initially submitted. However, FDA

records indicate that FDA received NDA

20–212 on February 10, 1992, making

February 10, 1992, the beginning of the

NDA regulatory review period.

3. The date the application was

approved: May 26, 1995. FDA has

verified the applicant’s claim that NDA

20–212 was approved on May 26, 1995.

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 is incorrect may,

on or before February 5, 1996, 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 June 5, 1996, 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
Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices 62867

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: November 30, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–29769 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0183]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; CPI Ventak P2 AICD

System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for CPI

Ventak P2 AICD System 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

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that medical device.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

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 medical devices,

the testing phase begins with a clinical

investigation of the device and runs

until the approval phase begins. The

approval phase starts with the initial

submission of an application to market

the device and continues until

permission to market the device is

granted. 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 (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 medical device will include

all of the testing phase and approval

phase as specified in 35 U.S.C.

156(g)(3)(B).

FDA recently approved for marketing

the medical device CPI Ventak P2

AICD System. CPI Ventak P2 AICD

System is indicated for the treatment of

patients with ventricular fibrillation

and/or ventricular tachyarrhythmia who

are at high risk of sudden cardiac death.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for CPI

Ventak P2 AICD System (U.S. Patent

No. Re. 34,879) from Cardiac

Pacemakers, Inc., and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated September 25, 1995, FDA

advised the Patent and Trademark

Office that this medical device had

undergone a regulatory review period

and that the approval of CPI Ventak

P2 AICD System represented the first

commercial marketing 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

CPI Ventak P2 AICD System is 1,178

days. Of this time, 620 days occurred

during the testing phase of the

regulatory review period, while 558

days occurred during the approval

phase. These periods of time were

derived from the following dates:

1. The date a clinical investigation

involving this device was begun:

December 20, 1991. FDA has verified

the applicant’s claim that the date the

investigational device exemption (IDE)

required under section 520(g) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360j(g)) for human tests to

begin became effective on December 20,

1991.

2. The date an application was

initially submitted with respect to the

device under section 515 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360e): August 30, 1993. FDA has

verified the applicant’s claim that the

premarket approval application (PMA)

for CPI Ventak P2 AICD Systems

(PMA P930035) was initially submitted

on August 30, 1993.

3. The date the application was

approved: March 10, 1995. FDA has

verified the applicant’s claim that PMA

P930035 was approved on March 10,

1995.

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 363 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before February 5, 1996, 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 June 5, 1996, 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: November 30, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–29766 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–01–F

Grassroots Regulatory Partnership

Meeting; Southeast Region, New

Orleans and Nashville Districts;

Seafood Industry

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of a public meeting.

SUMMARY: The Food and Drug

Administration (FDA) (Office of

External Affairs, Office of Regulatory

Affairs, Office of the Southeast Region,