9196 Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices

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

EXCENEL Sterile Suspension is 900

days. Of this time, 881 days occurred

during the testing phase of the

regulatory review period, while 19 days

occurred during the approval phase.

These periods of time were derived from

the following dates:

1. The date an exemption under

section 512(j) of the Federal Food, Drug,

and Cosmetic Act became effective:

November 10, 1993. FDA has verified

the applicant’s claim that November 10,

1993, was the date that the

investigational new animal drug

application became effective.

2. The date the application was

initially submitted with respect to the

animal drug product under section

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

Cosmetic Act: April 8, 1996. The

applicant claims April 3, 1996, as the

date the new animal drug application

(NADA) for EXCENEL Sterile

Suspension (NADA 140–890) was

initially submitted. However, a review

of FDA records reveals that FDA’s

official acknowledgment that the NADA

was sufficiently complete to begin

review was a telephone call requesting

that certain additional information be

added to the NADA on April 8, 1996,

which is considered to be the initially

submitted date for the NADA.

3. The date the application was

approved: April 26, 1996. FDA has

verified the applicant’s claim that

NADA 140–890 was approved on April

26, 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 1,151 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 20, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–4954 Filed 2–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94D–0259]

‘‘Points to Consider in the Manufacture

and Testing of Monoclonal Antibody

Products for Human Use (1997);’’

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a points to consider (PTC)

document entitled ‘‘Points to Consider

in the Manufacture and Testing of

Monoclonal Antibody Products for

Human Use (1997).’’ This PTC

document is intended to assist sponsors

and investigators engaged in

monoclonal antibody product

development and it includes

information to submit when filing

investigational new drug applications

and product license applications. The

document revises a 1994 document

entitled ‘‘Draft Points to Consider in the

Manufacture and Testing of Monoclonal

Antibody Products for Human Use.’’

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of the document entitled

‘‘Points to Consider in the Manufacture

and Testing of Monoclonal Antibody

Products for Human Use (1997)’’ to the

Manufacturers Assistance and

Communication Staff (HFM–42), Center

for Biologics Evaluation and Research

(CBER), Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852–1448. Send one self-addressed

adhesive label to assist that office in

processing your requests. The document

may also be obtained by mail or fax by

calling the CBER Fax Information

System at 1–888–CBER–FAX or 301–

827–3844.

Persons with access to the Internet

may obtain the document using the

World Wide Web (WWW) or bounceback e-mail. For WWW access, connect

to CBER at ‘‘http://www.fda.gov/cber/

cberftp.html.’’ For bounce back e-mail

send a message to

‘‘ptclmab@al.cber.fda.gov.’’

Submit written comments on the PTC

document to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

PTC document and received comments

are available for public examination in

the Dockets Management Branch

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

through Friday.

FOR FURTHER INFORMATION CONTACT:

Sharon A. Carayiannis, Center for

Biologics Evaluation and Research

(HFM–630), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–594–

3074.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a PTC

document entitled ‘‘Points to Consider

in the Manufacture and Testing of

Monoclonal Antibody Products for

Human Use (1997).’’ This PTC

document supersedes the document

entitled ‘‘Draft Points to Consider in the

Manufacture and Testing of Monoclonal

Antibody Products for Human Use’’

announced in the Federal Register of

August 3, 1994 (59 FR 39571), and is

designed to assist sponsors and

investigators engaged in monoclonal

antibody product development.

The PTC revision was undertaken for

reasons that include but are not limited

to: (1) Facilitating initial development of

monoclonal antibodies for serious and

immediately life-threatening

indications; (2) updating and

streamlining information from the 1994

PTC document; and (3) assuring

consistency with current CBER policy

and International Conference on

Harmonisation documents dealing with

this category of products. In the revision

of this document, CBER reviewed and

considered all comments submitted to

the docket.

The PTC document details an

approach for sponsors and investigators

to follow in product manufacturing and

testing, preclinical and clinical studies,

and the information to be provided for
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).