20106 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Notices

(IND) became effective was on

November 19, 1975.

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: December 30, 1991. The

applicant claims December 24, 1991, as

the date the new drug application

(NDA) for LUVOXTM (NDA 20–243) was

initially submitted. However, FDA

records indicate that NDA 20–243 was

submitted and received on December

30, 1991.

3. The date the applications was

approved: December 5, 1994. FDA has

verified the applicant’s claim that NDA

20–243 was approved on December 5,

1994.

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 730 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 23, 1995, 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 October 23, 1995, 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: April 17, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–10073 Filed 4–21–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0038]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; SERZONE

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

SERZONE 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 SERZONE

(nefazodone hydrochloride).

SERZONE is indicated for treatment of

depression. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for SERZONE (U.S. Patent

No. 4,338,317) from Bristol-Myers

Squibb, 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 1, 1995, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the

approval of SERZONE 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

SERZONE is 4,420 days. Of this time,

3,216 days occurred during the testing

phase of the regulatory review period,

while 1,204 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 became effective:

November 17, 1982. FDA has verified

the applicant’s claim that the date that

the investigational new drug application

(IND) became effective was on

November 17, 1982.

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: September 6, 1991. FDA

has verified the applicant’s claim that

the date the new drug application

(NDA) for SERZONE (NDA 20–152)

was initially submitted was on

September 6, 1991.

3. The date the application was

approved: December 22, 1994. FDA has

verified the applicant’s claim that NDA

20–152 was approved on December 22,

1994.

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 730 days of patent

term extension.
Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Notices 20107

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 23, 1995, 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 October 23, 1995, 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: April 17, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–10077 Filed 4–21–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94E–0071]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Zosyn; Correction

AGENCY: Food and Drug Administration.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting the

notice that appeared in the Federal

Register of August 30, 1994. The

document announced FDA’s

determination of the regulatory review

period for purposes of patent extension

for Zosyn (tazobactam sodium and

piperacillin sodium). The document

was published with some errors. The

document incorrectly stated:

FDA has determined that the applicable

regulatory review period for Zosyn is 1,819

days. Of this time, 1,038 days occurred

during the testing phase of the regulatory

review period, while 781 days occurred

during the approval phase.

1. The date an exemption under 505(i) of

the Federal Food, Drug, and Cosmetic Act

became effective: October 31, 1988. The

applicant claims July 10, 1988, as the date

the investigational new drug application

(IND) for Zosyn (IND 31,705) became

effective. However, IND 31,705 was received

on June 14, 1988, and it was placed on

clinical hold on July 1, 1988. It was removed

from clinical hold on October 31, 1988,

making the IND effective date October 31,

1988.

It should have stated:

FDA has determined that the

applicable regulatory review period for

Zosyn is 1,906 days. Of this time,

1,125 days occurred during the testing

phase of the regulatory review period,

while 781 days occurred during the

approval phase.

1. The date an exemption under 505(i)

of the Federal Food, Drug, and Cosmetic

Act became effective: August 5, 1988.

The applicant claims July 10, 1988, as

the date the investigational new drug

application (IND) for Zosyn (IND

31,705) became effective. However, IND

31,705 was received on June 14, 1988,

and it was placed on clinical hold on

July 1, 1988. It was removed from

clinical hold on August 5, 1988, making

the IND effective date August 5, 1988.

This document corrects those errors.

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: In FR Doc.

94–21286, appearing on page 44738 in

the Federal Register of August 30, 1994,

the following corrections are made:

On page 44739, in the first column, in

the third full paragraph, in the third

line, ‘‘1,819’’ is corrected to read

‘‘1,906’’ and in the fourth line, ‘‘1,038’’

is corrected to read ‘‘1,125’’; in the same

column, in the fourth line from the

bottom, ‘‘October 31, 1988’’ is corrected

to read ‘‘August 5, 1988’’; and in the

second column, in the fifth and sixth

lines, ‘‘October 31, 1988’’ is corrected to

read ‘‘August 5, 1988’’.

Dated: April 17, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–10074 Filed 4–21–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0012]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Sonic Accelerated Fracture

Healing System (SAFHS)

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

SAFHS 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 SAFHS. SAFHS

is indicated for the acceleration of the

time to a healed fracture for fresh,

closed, distal radius (Colle’s) fractures

and fresh, closed or Grade I open tibial

diaphysis fractures in skeletally mature

individuals when these fractures are

orthopedically managed by closed

reduction and cast immobilization.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

SAFHS (U.S Patent No. 4,530,360)

from Exogen, Inc., and the Patent and