Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Notices 20105

with consumer interests and are

recommended by either a consortium of

consumer-oriented organizations or

other interested persons.

Representatives of industry interests

will serve as liaisons to the regulated

industry. The term of office is up to 4

years.

Nomination Procedures

Interested persons may nominate one

or more qualified persons for

membership on the Committee.

Nominations shall state that the

nominee is willing to serve as a member

of the Committee and appears to have

no conflict of interest that would

preclude Committee membership.

Additionally, the nominee’s mailing

address, telephone number, and

curriculum vitae must accompany the

nominations. Potential candidates will

be asked by FDA to provide detailed

information concerning such matters as

financial holdings, employment,

consultancies, and research grants and/

or contracts to permit evaluation of

possible sources of conflict of interest.

Criteria for Consumer-Nominated

Members

Selection of representatives of

consumer interests will be conducted

through procedures that include use of

a consortium of consumer organizations

which has the responsibility for

screening, interviewing, and

recommending candidates for the

agency’s selection. Candidates from this

group, like all other candidates for

membership on the Committee, should

possess appropriate qualifications to

understand and contribute to the

Committee’s work.

Industry Representatives

Regarding nominations for members

representing industry interests, a letter

will be sent to each person or

organization that has made a

nomination and to other organizations

that have expressed an interest in

participating in the selection process

together with a complete list of all such

organizations and the nominees. The

letter will state that it is the

responsibility of each nominator or

organization that has expressed an

interest in participating in the selection

process to consult with the others and

to provide a consensus slate of possible

members representing industry interests

within 60 days. In the event that a slate

of nominees has not been provided

within 60 days, the agency will select an

industry representative for each such

vacancy from the entire list of industry

nominees to avoid delay or disruption

of the work of the Committee. The

agency is particularly interested in

nominees that possess the essential

scientific credentials needed to

participate fully and knowledgeably in

the Committee’s deliberations. In

addition to this expertise, the agency

believes that it would be an advantage

to the Committee’s work if the

individual(s) had special insight and

direct experience into specific

industrywide issues, practices, and

concerns that might not otherwise be

available to others not similarly

situated.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14,

relating to advisory committees.

Dated: April 17, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–10075 Filed 4–21–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0035]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; LUVOXTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

LUVOXTM 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 LUVOXTM

(fluvoxamine maleate). LUVOXTM is

indicated for the treatment of obsessions

and complusions in patients with

obsessive compulsive disorder.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

LUVOXTM (U.S. Patent No. 4,085,225)

from Duphar International, and the

Patent and Trademark Office requested

FDA’s assistance in determining this

patent’s eligibility for patent term

restoration. In a letter dated March 1,

1995, FDA advised the Patent and

Trademark Office that this human drug

product had undergone a regulatory

review period and that the approval of

LUVOXTM 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

LUVOXTM is 6,958 days. Of this time,

5,886 days occurred during the testing

phase of the regulatory review period,

while 1,072 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 became effective:

November 19, 1975. FDA has verified

the applicant’s claim that the date the

investigational new drug application
20106 Federal Register / Vol. 60, No. 78 / Monday, April 24, 1995 / Notices

(IND) became effective was on

November 19, 1975.

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 30, 1991. The

applicant claims December 24, 1991, as

the date the new drug application

(NDA) for LUVOXTM (NDA 20–243) was

initially submitted. However, FDA

records indicate that NDA 20–243 was

submitted and received on December

30, 1991.

3. The date the applications was

approved: December 5, 1994. FDA has

verified the applicant’s claim that NDA

20–243 was approved on December 5,

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 730 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 23, 1995, 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 October 23, 1995, 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 17, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–10073 Filed 4–21–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0038]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; SERZONE

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

SERZONE 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 SERZONE

(nefazodone hydrochloride).

SERZONE is indicated for treatment of

depression. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for SERZONE (U.S. Patent

No. 4,338,317) from Bristol-Myers

Squibb, and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

March 1, 1995, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the

approval of SERZONE 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

SERZONE is 4,420 days. Of this time,

3,216 days occurred during the testing

phase of the regulatory review period,

while 1,204 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 became effective:

November 17, 1982. FDA has verified

the applicant’s claim that the date that

the investigational new drug application

(IND) became effective was on

November 17, 1982.

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: September 6, 1991. FDA

has verified the applicant’s claim that

the date the new drug application

(NDA) for SERZONE (NDA 20–152)

was initially submitted was on

September 6, 1991.

3. The date the application was

approved: December 22, 1994. FDA has

verified the applicant’s claim that NDA

20–152 was approved on December 22,

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 730 days of patent

term extension.