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