13650 Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled,

‘‘Guidance for Industry: FDA Approval

of New Cancer Treatment Uses for

Marketed Drug and Biological

Products.’’ The draft guidance considers

the quality and quantity of data that

may be adequate to add a new use to the

prescribing information for a product

used in the treatment of cancer. The

draft guidance is part of the agency’s

‘‘New Use Initiative—Evidence for

Primary and Supplemental Approvals,’’

which is exploring ways to expedite the

development of new and supplemental

uses for drug and biological products.

Elsewhere in this issue of the Federal

Register, FDA is publishing a notice of

availability of a draft guidance that

discusses what clinical evidence of

efficacy should be provided in new drug

and biological product license

applications as well as in supplemental

applications. The agency is seeking

public comment on the draft guidance.

DATES: Written comments on the draft

guidance by May 20, 1997. General

comments on agency guidance

documents may be submitted at any

time.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Guidance for Industry: FDA

Approval of New Cancer Treatment

Uses for Marketed Drug and Biological

Products’’ to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857; or the Office

of Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send two

self-addressed adhesive labels to assist

the offices in processing your requests.

The draft guidance also may be obtained

by mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by facsimile by

calling the FAX Information System at

1–800–835–4709 or 301–827–1800. See

the SUPPLEMENTARY INFORMATION

section for electronic access to the draft

guidance. Submit written comments on

the draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Robert J. Delap, Center for Drug

Evaluation and Research (HFD–150),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–2473.

SUPPLEMENTARY INFORMATION:

I. Background

When drugs approved for one use

prove safe and effective for treating

other conditions, information on the

new use should be added to the product

labeling as soon as possible. FDA has

launched the ‘‘New Use Initiative—

Evidence for Primary and Supplemental

Approvals’’ to explore ways the agency

can improve the supplemental

application process. FDA believes it can

expedite the development of new and

supplemental uses of drug and

biological products by doing the

following: (1) Clarifying what evidence

should be provided in primary as well

as supplemental applications and (2)

working with industry to reduce barriers

to submitting applications for new uses

for their products.

Some of the information submitted in

a supplemental application may be

available from the primary application.

As a result, the agency decided that its

first step would be to clarify what

information sponsors should provide in

applications in general. Elsewhere in

this issue of the Federal Register, FDA

is announcing the availability of a draft

guidance entitled ‘‘Guidance for

Industry: Providing Clinical Evidence of

Effectiveness for Human Drug and

Biological Products,’’ The draft

guidance addresses the information that

should be provided in new drug and

biological product license applications

as well as supplemental applications.

The draft guidance entitled

‘‘Guidance for Industry: FDA Approval

of New Cancer Treatment Uses for

Marketed Drug and Biological Products’’

focuses on the particular information to

be provided when submitting an

application for the approval of a

supplemental new use for a drug

product to treat cancer. Cancer

treatments often yield potential new

uses for already marketed drugs.

Although this draft guidance does not

create or confer any rights on any

person, and does not operate to bind

FDA in any way, it does represent the

agency’s current thinking on new cancer

treatment uses for marketed drug and

biological products.

II. Request for Comments

Interested parties may submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). 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. The draft guidance and

received comments may be seen in the

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

Monday through Friday.

III. Electronic Access

An electronic version of the draft

guidance also is available via Internet

using the World Wide Web (WWW)

(connect to the CDER home page at

attp://www.fda.gov/cder and go to the

‘‘Regulatory Guidance’’ section, or to the

CBER home page at http://www.fda.gov/

cber/cberfp.html).

Dated: March 14, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7132 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97D–0100]

Draft Guidance for Industry: Providing

Clinical Evidence of Effectiveness for

Human Drug and Biological Products;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled,

‘‘Guidance for Industry: Providing

Clinical Evidence of Effectiveness for

Human Drug and Biological Products.’’

The purpose of the draft guidance is to

clarify what clinical evidence of

effectiveness should be provided in new

drug applications, biological product

license applications, and supplemental

applications. The draft guidance is part

of the agency’s ‘‘New Use Initiative—

Evidence for Primary and Supplemental

Approvals,’’ which is exploring ways to

expedite the development of new and

supplemental uses for drug and

biological products. Elsewhere in this

issue of the Federal Register, FDA is

announcing the availability of a draft

guidance that discusses the quality and

quantity of data that may be adequate to

add a new use to the prescribing

information for a product used in the

treatment of cancer. The agency is

seeking public comment on the draft

guidance.

DATES: Written comments on the draft

guidance by May 20, 1997. General

comments on agency guidance

documents may be submitted at any

time.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Guidance for Industry:
Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices 13651

Providing Clinical Evidence of

Effectiveness for Human Drug and

Biological Products’’ to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857; or the Office

of Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send two

self-addressed adhesive labels to assist

the offices in processing your requests.

The draft guidance also may be obtained

by mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by facsimile by

calling the FAX Information System at

1–800–835–4709 or 301–827–1800. See

the SUPPLEMENTARY INFORMATION

section for electronic access to the draft

guidance. Submit written comments on

the draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Joseph P. Griffin, Center for Drug

Evaluation and Research (HFD–5), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5400.

SUPPLEMENTARY INFORMATION:

I. Background

When drugs approved for one use

prove safe and effective for treating

other conditions, information on the

new use should be added to the product

labeling as soon as possible. FDA is

exploring ways to expedite the

development of new and supplemental

uses of drug and biological products.

The agency believes it can improve the

approval process and increase the

number of safe and effective new uses

being added to drug labeling by doing

the following: (1) Clarifying what

evidence should be provided in primary

and supplemental applications and (2)

working with industry to reduce barriers

to submitting applications for new uses

for their products.

Because some of the information

submitted in a supplemental application

may be available from the primary

application, the agency decided that its

first step would be to clarify what

information sponsors should provide in

applications in general. The draft

guidance entitled, ‘‘Guidance for

Industry: Providing Clinical Evidence of

Effectiveness for Human Drug and

Biological Products’’ discusses the

clinical evidence that should be

provided when submitting a new drug

or biological product license application

or a supplemental application for a new

use of a drug or biological product.

Elsewhere in this issue of the Federal

Register, FDA is announcing the

availability of a second draft guidance

entitled, ‘‘Guidance for Industry: FDA

Approval of New Cancer Treatment

Uses for Marketed Drug and Biological

Products.’’ The draft guidance focuses

on the quality and quantity of data that

may be adequate to add a new use to the

prescribing information for a product

used in the treatment of cancer. Cancer

treatments often yield potential new

uses for marketed drug products.

Although this guidance does not

create or confer any right on any person

, and does not operate to bind FDA in

any way, it does represent the agency’s

current thinking on clinical evidence of

effectiveness for human drug and

biological products.

II. Request for Comments

Interested parties may submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). 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. The draft guidance and

received comments may be seen in the

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

Monday through Friday.

III. Electronic Access

An electronic version of this draft

guidance also is available via Internet

using the World Wide Web (WWW)

(connect to the CDER home page at

http://www.fda.gov/cder and go to the

‘‘Regulatory Guidance’’ section, or to the

CBER home page at http://www.fda.gov/

cber/cberftp.html).

Dated: March 14, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7133 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0095]

Hoffmann-La Roche, Inc., et al.;

Withdrawal of Approval of 49 New

Drug Applications, 9 Abbreviated

Antibiotic Applications, and 36

Abbreviated New Drug Applications;

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 March 27, 1996 (61 FR

13506). The document announced the

withdrawal of approval of 49 new drug

applications (NDA’s), 9 abbreviated

antibiotic applications (AADA’s), and

36 abbreviated new drug applications

(ANDA’s). The document inadvertently

withdrew approval of NDA 18–962 for

Manganese Chloride Injection held by

Abbott Laboratories, D–389, Bldg. AP30,

200 Abbott Park Rd., Abbott Park, IL

60064–3537. This document confirms

that approval of NDA 18–962 is still in

effect, and that the withdrawal of

approval of the NDA was in error.

EFFECTIVE DATE: March 27, 1996.

FOR FURTHER INFORMATION CONTACT:

Olivia A. Vieira, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1046.

In FR Doc. 96–7309, appearing on

page 13506 in the Federal Register of

Wednesday, March 27, 1996, the

following correction is made: On page

13507, in the table, the entry for NDA

18–962 is removed.

Dated: March 14, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7187 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket Nos. 96E–0289, 96E–0286, and 96E–

0288]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; DAUNOXOME

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

DAUNOXOME 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.