Federal Register / Vol. 61, No. 1 / Tuesday, January 2, 1996 / Notices 73

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 PREVACID

(lansoprazole). PREVACID is indicated

for short-term treatment (up to 4 weeks)

for healing and symptom relief of active

duodenal ulcer. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for PREVACID (U.S. Patent

No. 4,628,098) from Hiroshi Akimoto,

and the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

September 25, 1995, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of PREVACID 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

PREVACID is 2,870 days. Of this time,

2,328 days occurred during the testing

phase of the regulatory review period,

while 542 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: July 3, 1987. FDA has

verified the applicants’s claim that the

date that the investigational new drug

application (IND) became effective was

July 3, 1987.

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: November 15, 1993. The

applicant claims November 12, 1993, as

the date the new drug application

(NDA) for PREVACID (NDA 20–406)

was initially submitted. However, FDA

records indicate that the applicant

submitted NDA 20–406 on November

12, 1993, and FDA received the NDA on

November 15, 1993, which is

considered to be the NDA initially

submitted date.

3. The date the application was

approved: May 10, 1995. FDA has

verified the applicant’s claim that NDA

20–406 was approved on May 10, 1995.

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 1,706 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before March 4, 1996, 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 July 1, 1996, 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: December 21, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–31557 Filed 12–29–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0303]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; ADENOSCAN

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

ADENOSCAN 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,

rm. 1–23, 12420 Parklawn Dr.,

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

ADENOSCAN (adenosine).

ADENOSCAN is indicated as an

adjunct to thallium-201 myocardial

perfusion scintigraphy in patients

unable to exercise adequately.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

ADENOSCAN (U.S. Patent No.

5,070,877) from Medco Research, 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

September 25, 1995, FDA advised the

Patent and Trademark Office that this
74 Federal Register / Vol. 61, No. 1 / Tuesday, January 2, 1996 / Notices

human drug product had undergone a

regulatory review period and that the

approval of ADENOSCAN 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

ADENOSCAN is 2,688 days. Of this

time, 768 days occurred during the

testing phase of the regulatory review

period, while 1,920 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: January 9, 1988. The

applicant claims December 10, 1987, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was January 9, 1988,

which was 30 days after FDA receipt of

the IND on December 10, 1987.

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: February 14, 1990. The

applicant claims February 9, 1990, as

the date the new drug application

(NDA) for ADENOSCAN (NDA 20–

059) was initially submitted. However,

while FDA records indicate that the

applicant submitted NDA 20–059 on

February 9, 1990, FDA received the

NDA on February 14, 1990, which is

considered to be the date the NDA was

initially submitted.

3. The date the human drug was

approved: May 18, 1995. FDA has

verified the applicant’s claim that NDA–

059 was approved on May 18, 1995.

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 159 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before March 4, 1996, 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 July 1, 1996, 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: December 21, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–31555 Filed 12–29–95; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Immunology Devices Panel of the

Medical Devices Advisory Committee

Date, time, and place. January 22,

1996, 9:30 a.m., Gaithersburg Hilton

Hotel, Salons D & E, 620 Perry Pkwy.,

Gaithersburg, MD. A limited number of

overnight accommodations have been

reserved at the hotel. Attendees

requiring overnight accommodations

may contact the hotel at 301–977–8900

and reference FDA Panel meeting block.

Reservations will be confirmed at the

group rate based on availability.

Type of meeting and contact person.

Open public hearing, 9:30 a.m. to 10:30

a.m., unless participation does not last

that long; open committee discussion,

10:30 a.m. to 4 p.m. For information

regarding the analyte specific reagents

classification—Kaiser J. Aziz, Center for

Devices and Radiological Health (HFZ–

440), Food and Drug Administration,

2098 Gaither Rd., Rockville, MD 20850,

301–594–3084. For information

regarding the conduct of the meeting—

Peter E. Maxim, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1293, or FDA Advisory Committee

Information Hotline, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), Immunology Devices Panel, code

12516.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational devices

and makes recommendations for their

regulation.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before January 8, 1996,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time required to make their

comments.

Open committee discussion. The

committee will consider the

classification of analyte specific

reagents as in vitro diagnostic devices.

FDA intends to develop a regulatory

scheme to handle products currently

being used by clinical laboratories as

materials for in-house (‘‘home brew’’)

assays. Analyte specific reagents are

chemical, poly or monoclonal

antibodies, proteins, nucleic acid

sequences, which, by their physiochemical reaction with substances in a

specimen, allow a test procedure to

distinguish or quantify an individual

chemical substance or ligand in a

biological specimen. These are used in

the production of in-house tests which

are of high complexity under the

Clinical Laboratory Improvement Act of