Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices 9197

review and evaluation of clinical testing

and licensing. This document applies to

monoclonal antibodies made by

traditional hybridoma technology as

well as by recombinant technologies.

Some of the major changes in the

revised PTC document include: (1) An

updated definition of a monoclonal

antibody; (2) modification of the quality

control, product testing, and product

comparability sections; and (3)

clarification of the techniques for and

necessity of retrovirus testing. The

section of the draft 1994 PTC document

dealing with changes to be reported

after product approval is not included

in the 1997 PTC document because this

subject is addressed in a separate

rulemaking (61 FR 2739, January 29,

1996).

A new section of the document

discusses abbreviated product testing

for feasibility trials in serious and

immediately life-threatening conditions.

Other important new concepts

contained in the revised PTC document

are those of generic and modular virus

clearance studies and the acceptability

of demonstrating the removal of some

contaminants by means of clearance

studies, as opposed to routine testing.

The concepts of generic and modular

virus clearance studies and of clearance

studies for some contaminants apply not

only to monoclonal antibodies but also

to recombinant products, as appropriate.

CBER intends to update other guidance

documents to reflect these studies. New

concepts on abbreviated product testing

for feasibility trials in serious and

immediately life-threatening conditions

and on generic and modular virus

clearance studies do not apply to

products of entirely human origin or to

products that have the potential to be

contaminated by human pathogens.

As with other guidance documents,

FDA does not intend the PTC document

to be all inclusive and cautions that not

all information may be applicable to all

situations. The document is intended to

provide information and does not set

forth requirements. Manufacturers may

follow the document or may choose to

use alternative procedures that are not

provided in this document. If a

manufacturer chooses to use alternative

procedures, that manufacturer may wish

to discuss the matter further with FDA

to prevent expenditure of resources to

generate data on activities that FDA may

later determine to be unacceptable.

Although this document does not create

or confer any rights for or on any person

and does not operate to bind FDA or the

public, it does represent the agency’s

current thinking on the manufacture

and testing of monoclonal antibody

products for human use.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the PTC document. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Received comments will be

considered in determining whether

further revision of the PTC document in

warranted. Any revised version of the

PTC document will be announced in the

Federal Register.

Dated: February 20, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–5006 Filed 2–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97F–0062]

General Electric Co.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that General Electric Co. has filed a

petition proposing that the food additive

regulations be amended to provide for

the expanded safe use of

triisopropanolamine as a component of

phosphorous acid, cyclic butylethyl

propanediol, 2,4,6-tri-tert-butylphenyl

ester, a stabilizer for olefin polymers

intended for use in contact with food.

DATES: Written comments on the

petitioner’s environmental assessment

by March 31, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7B4535) has been filed by

General Electric Co., 1 Lexan Lane, Mt.

Vernon, IN 47620–9364. The petition

proposes to amend the food additive

regulations in § 178.2010 Antioxidants

and/or stabilizers for polymers (21 CFR

178.2010) to provide for the safe use of

triisopropanolamine as a component of

phosphorous acid, cyclic butylethyl

propanediol, 2,4,6-tri-tert-butylphenyl

ester, a stabilizer for olefin polymers

intended for use in contact with food.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before March 31,

1997, submit to the Dockets

Management Branch (address above)

written comments. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: February 11, 1997.

George H. Pauli,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 97–4962 Filed 2–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0080]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Olean; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of January 6, 1997 (62 FR 763).
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