9198 Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices

The document announced FDA’s

determination of the regulatory review

period for purposes of patent extension

for Olean (olestra). The document was

published with an error. This document

corrects that error.

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.

In FR Doc. 97–138, appearing on page

763 in the Federal Register of Monday,

January 6, 1997, the following

correction is made: On page 763, in the

third column, beginning in line 6,

‘‘Olean (U.S. Patent No. 4,005,196)’’ is

corrected to read ‘‘Olean (U.S. Patent

No. Re. 34,617)’’.

Dated: February 20, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–4960 Filed 2–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0265]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; REDUXTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

REDUXTM 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,

12420 Parklawn Dr., rm. 1–23,

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 REDUXTM

(dexfenfluramine hydrochloride).

REDUXTM is indicated for the

management of obesity including weight

loss and maintenance of weight loss in

patients on a reduced calorie diet.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

REDUXTM (U.S. Patent No. 4,309,445)

from Interneuron Pharmaceuticals, 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

November 21, 1996, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of REDUXTM 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

REDUXTM is 1,613 days. Of this time,

541 days occurred during the testing

phase of the regulatory review period,

while 1,072 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: December 1, 1991. The

applicant claims January 13, 1992, as

the date the investigational new drug

application (IND) for REDUXTM (IND

38,108) became effective. However, FDA

records indicate that the effective date

for IND 38,108 was December 1, 1991,

which was 30 days after FDA receipt of

the IND on November 1, 1991.

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: May 24, 1993. The

applicant claims May 23, 1993, as the

date the new drug application (NDA) for

REDUXTM (NDA 20–344) was initially

submitted. However, FDA records

indicate that NDA 20–344 was

submitted on May 24, 1993.

3. The date the application was

approved: April 29, 1996. FDA has

verified the applicant’s claim that NDA

20–344 was approved on April 29, 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 1,322 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before April 29, 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 August 27, 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: February 18, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–4961 Filed 2–27–97; 8:45 am]

BILLING CODE 4160–01–F