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The draft guidance also may be obtained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the draft guidance to the Dockets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.
13652 Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices

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

DAUNOXOME (daunorubicin citrate).

DAUNOXOME is indicated as a first

line cytotoxic therapy for advanced

human immunodeficiency virus (HIV)-

associated Kaposi’s sarcoma.

DAUNOXOME is not recommended in

patients with less than advanced HIVrelated Kaposi’s sarcoma. Subsequent to

this approval, the Patent and Trademark

Office received patent term restoration

applications for DAUNOXOME (U.S.

Patent Nos. 5,435,989; 5,441,745; and

5,019,369) from NeXstar

Pharmaceuticals, Inc., and the Patent

and Trademark Office requested FDA’s

assistance in determining these patent’s

eligibilities for patent term restoration.

In letters dated December 2, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of

DAUNOXOME 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

DAUNOXOME is 2,771 days. Of this

time, 1,629 days occurred during the

testing phase of the regulatory review

period, while 1,142 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: September 8, 1988.

The applicant claims September 29,

1988, as the date the investigational new

drug application (IND) for

DAUNOXOME (IND 31,927) became

effective. However, FDA records

indicate that the effective date for IND

31,927 was September 8, 1988, which

was 30 days after FDA received the IND.

2. The date the application was

initially submitted with respect to the

human drug product under section 507

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 357): February 22, 1993.

The applicant claims February 18, 1993,

as the date the new drug application

(NDA) for DAUNOXOME (NDA 50–

704) was initially submitted. However,

FDA records indicate that NDA 50–704

was submitted on February 22, 1993.

3. The date the application was

approved: April 8, 1996. FDA has

verified the applicant’s claim that NDA

50–704 was approved on April 8, 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 258 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before May 20, 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 September 17, 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: March 12, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–7135 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0082]

Behring Diagnostics, Inc.; Premarket

Approval of EMIT 2000 Cyclosporine

Specific Assay

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Behring

Diagnostics, Inc., San Jose, CA, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the EMIT 2000 Cyclosporine

Specific Assay. After reviewing the

recommendation of the Clinical

Chemistry and Toxicology Devices

Panel, FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of October 2, 1996,

of the approval of the application.

DATES: Petitions for administrative

review by April 21, 1997.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Cornelia B. Rooks, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–2436.

SUPPLEMENTARY INFORMATION: On June

29, 1992, Syva Co., San Jose, CA 95161–

9013, submitted to CDRH an application

for premarket approval of the EMIT

2000 Cyclosporine Specific Assay. The

device is a homogeneous enzyme

immunoassay and is indicated for in

vitro diagnostic use on the Roche