Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices 24317

drug product had undergone a

regulatory review period that the

approval of EPIVIRTM 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

EPIVIRTM is 1,582 days. Of this time,

1,448 days occurred during the testing

phase of the regulatory review period,

while 134 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 21, 1991. The

applicant claims July 24, 1991, as the

date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was July 21, 1991,

which was 30 days after FDA receipt of

the IND.

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: July 7, 1995. The

applicant claims June 29, 1995, as the

date the new drug application (NDA’s)

for EPIVIRTM (NDA’s 20–564 and 20–

596) were initially submitted. However,

FDA records indicate that NDA’s 20–

564 and 20–596 were submitted on July

7, 1995 (the date the User Fee checks

were received by the agency). Both

NDA’s were originally received by the

agency on June 30, 1995,

unaccompanied by the appropriate User

Fee checks. Review of a NDA does not

begin until the correct amount of User

Fee money has been received by the

agency from the sponsor of the NDA.

3. The date the application was

approved: November 17, 1995. FDA has

verified the applicants’s claim that

NDA’s 20–564 and 20–596 were

approved on November 17, 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 836 days of patent

term extension..

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 15, 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 November 12, 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: April 26, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 96–12092 Filed 5–13–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0408]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; TRUSOPT

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

TRUSOPT 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 TRUSOPT

(dorzolamide hydrochloride).

TRUSOPT is indicated in the

treatment for elevated intraocular

pressure in patients with ocular

hypertension or open-angle glaucoma.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

TRUSOPT (U.S. Patent No. 4,797,413)

from Merck & Co., 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 January 26, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of TRUSOPT

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

TRUSOPT is 2,101 days. Of this time,

1,736 days occurred during the testing

phase of the regulatory review period,

while 365 days occurred during the

approval phase. These periods of time

were derived from the following dates:
24318 Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices

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: March 11, 1989. FDA

has verified the applicant’s claim that

the date that the investigational new

drug application (IND) became effective

was March 11, 1989.

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: December 10, 1993. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

TRUSOPT (NDA 20–408) was initially

submitted on December 10, 1993.

3. The date the application was

approved: December 9, 1994. FDA has

verified the applicant’s claim that NDA

20–408 was approved on December 9,

1994.

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 1,232 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 15, 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 November 12, 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: April 26, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 96–12093 Filed 5–13–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[ORD–086–N]

New and Pending Demonstration

Project Proposals Submitted Pursuant

to Section 1115(a) of the Social

Security Act: February and March 1996

AGENCY: Health Care Financing

Administration (HCFA).

ACTION: Notice.

SUMMARY: This notice lists new

proposals for Medicaid demonstration

projects submitted to the Department of

Health and Human Services during the

months of February and March 1996

under the authority of section 1115 of

the Social Security Act. This notice also

lists proposals that were approved,

disapproved, pending, or withdrawn

during this time period. (This notice can

be accessed on the Internet at HTTP://

WWW.HCFA.GOV/ORD/

ORDHP1.HTML.)

COMMENTS: We will accept written

comments on these proposals. We will,

if feasible, acknowledge receipt of all

comments, but we will not provide

written responses to comments. We

will, however, neither approve nor

disapprove any new proposal for at least

30 days after the date of this notice to

allow time to receive and consider

comments. Direct comments as

indicated below.

ADDRESSES: Mail correspondence to:

Susan Anderson, Office of Research and

Demonstrations, Health Care Financing

Administration, Mail Stop C3–11–07,

7500 Security Boulevard, Baltimore, MD

21244–1850.

FOR FURTHER INFORMATION CONTACT:

Susan Anderson, (410) 786–3996.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 1115 of the Social

Security Act (the Act), the Department

of Health and Human Services (HHS)

may consider and approve research and

demonstration proposals with a broad

range of policy objectives. These

demonstrations can lead to

improvements in achieving the

purposes of the Act.

In exercising her discretionary

authority, the Secretary has developed a

number of policies and procedures for

reviewing proposals. On September 27,

1994, we published a notice in the

Federal Register (59 FR 49249) that

specified (1) The principles that we

ordinarily will consider when

approving or disapproving

demonstration projects under the

authority in section 1115(a) of the Act;

(2) the procedures we expect States to

use in involving the public in the

development of proposed demonstration

projects under section 1115; and (3) the

procedures we ordinarily will follow in

reviewing demonstration proposals. We

are committed to a thorough and

expeditious review of State requests to

conduct such demonstrations.

As part of our procedures, we publish

a notice in the Federal Register with a

monthly listing of all new submissions,

pending proposals, approvals,

disapprovals, and withdrawn proposals.

Proposals submitted in response to a

grant solicitation or other competitive

process are reported as received during

the month that such grant or bid is

awarded, so as to prevent interference

with the awards process.

II. Listing of New, Pending, Approved,

and Withdrawn Proposals for the

Months of February and March 1996

A. Comprehensive Health Reform

Programs

1. New Proposals: The following

comprehensive health reform proposal

was received during the month of

February.

Demonstration Title/State: Medicaid

Demonstration Project for Los Angeles

County—California.

Description: The State is pursuing a

section 1115 demonstration designed to

stabilize the Los Angeles County health

care system, and to foster a restructuring

process that is responsive to the needs

of the community in the development of

a more cost effective system.

Date Received: February 29, 1996.

State Contact: John Rodriguez, Deputy

Director, Medical Care Services,

Department of Health Services, 714/744

P Street, P.O. Box 942732, Sacramento,

CA 94234–7320, (916) 654–0391.

Federal Project Officer: Gina Clemons,

Health Care Financing Administration,

Office of Research and Demonstrations,

Office of State Health Reform

Demonstrations, Mail Stop C3–18–26,

7500 Security Boulevard, Baltimore, MD

21244–1850.

No new proposals were received

during the month of March.

2. Pending, Approved, and

Withdrawn Proposals: We did not

approve or disapprove any proposals

during February or March nor were any

proposals withdrawn during those

months. The one new pending proposal

added to the month of March is:

Medicaid Demonstration Project for Los

Angeles County—California. See above

II.A.1. for further description. Pending

proposals for the month of November

1995 published in the Federal Register

on January 23, 1996, 61 FR 1769, remain

unchanged with the addition of above

for the months of February and March.