Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices 6263

Patent and Trademark Office requested

that FDA determine the products

regulatory review period.

FDA has determined that the

applicable regulatory review period for

DIFFERIN Topical Gel is 2,447 days. Of

this time, 1,401 days occurred during

the testing phase of the regulatory

review period, while 1,046 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 20, 1989.

FDA has verified the applicant’s claim

that the date that the investigational

new drug application became effective

was on September 20, 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: July 21, 1993. The

applicant claims July 15, 1993, as the

date the new drug application (NDA) for

DIFFERIN Topical Gel (NDA 20–380)

was initially submitted. However, FDA

records indicate that NDA 20–380 was

submitted on July 21, 1993.

3. The date the application was

approved: May 31, 1996. FDA has

verified the applicant’s claim that NDA

20–380 was approved on May 31, 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 1,512 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before April 14, 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 August 11, 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: January 31, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–3314 Filed 2–10–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0387]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; DECTOMAX

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

DECTOMAX 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 animal 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.

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 animal drug

products, the testing phase begins on

the earlier date when either a major

environmental effects test was initiated

for the drug or when an exemption

under section 512(j) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C.

360b(j)) became effective and runs until

the approval phase begins. The approval

phase starts with the initial submission

of an application to market the animal

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

an animal drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(4)(B).

FDA recently approved for marketing

the animal drug product DECTOMAX

(doramectin). DECTOMAX is indicated

for cattle treatment and control of

gastrointestinal roundworms,

lungworms, eyeworms, grubs, lice, and

mange mites, and protection against

infection or reinfection with Ostertagla

ostertagia for up to 21 days. Subsequent

to this approval, the Patent and

Trademark Office received a patent term

restoration application for DECTOMAX

(U.S. Patent No. 5,089,480) from Pfizer,

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

October 25, 1996, FDA advised the

Patent and Trademark Office that this

animal drug product had undergone a

regulatory review period and that the

approval of DECTOMAX represented

the first commercial marketing 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

DECTOMAX is 2,836 days. Of this time,

2,695 days occurred during the testing

phase of the regulatory review period,

while 141 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 512(j) of the Federal Food, Drug,

and Cosmetic Act became effective:

October 26, 1988. The applicant claims

December 7, 1988, as the date the

investigational new animal drug

application (INAD) became effective.

However, FDA records indicate that the

date of FDA’s official acknowledgment

letter assigning a number to the INAD

was October 26, 1988, which is

considered to be the effective date for

the INAD.
6264 Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices

2. The date the application was

initially submitted with respect to the

animal drug product under section

512(b) of the Federal Food, Drug, and

Cosmetic Act: March 12, 1996. The

applicant claims March 7, 1996, as the

date the new animal drug application

(NADA) for DECTOMAX (NADA 141–

061) was initially submitted. However,

FDA records indicate that the date of

FDA’s official acknowledgment letter

assigning a number to the NADA was

March 12, 1996, which is considered to

be the NADA initially submitted date.

3. The date the application was

approved: July 30, 1996. FDA has

verified the applicant’s claim that

NADA 141–061 was approved on July

30, 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 527 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before April 14, 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 August 11, 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:January 31, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–3315 Filed 2–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of the Secretary; Glen Canyon

Dam Adaptive Management Work

Group; Notice of Establishment

This notice is published in

accordance with Section 9(a)(2) of the

Federal Advisory Committee Act (Pub.

L. 92–463). Following consultation with

the General Services Administration,

notice is hereby given that the Secretary

of the Interior (Secretary) is establishing

the Glen Canyon Dam Adaptive

Management Work Group. The purpose

of the Adaptive Management Work

Group shall be to advise and provide

recommendations to the Secretary with

respect to his responsibility to comply

with the Grand Canyon Protection Act

of October 30, 1992, embodied in Public

Law 102–575.

Further information regarding the

advisory council may be obtained from

the Bureau of Reclamation, Department

of the Interior, 1849 C Street, NW,

Washington, DC 20240.

The certification of establishment is

published below.

Certification

I hereby certify that establishment of

the Glen Canyon Dam Adaptive

Management Work Group is in the

public interest in connection with the

purpose of duties imposed on the

Department of the Interior by 30 U.S.C.

1–8.

Dated: January 15, 1997.

Bruce Babbitt,

Secretary of the Interior.

[FR Doc. 97–3318 Filed 2–10–97; 8:45 am]

BILLING CODE 4310–94–M

Fish and Wildlife Service

Endangered and Threatened Species

Permit Applications

ACTION: Notice of receipt of applications.

SUMMARY: The following applicants have

applied for a permit to conduct certain

activities with endangered species. This

notice is provided pursuant to section

10(c) of the Endangered Species Act of

1973, as amended (16 U.S.C. 1531, et

seq.).

Permit No. 823110

Applicant: Charles W. Cartwright, Jr.,

Albuquerque, New Mexico

The applicant requests authorization

for research and recovery purposes to

survey for the cactus ferruginous pygmy

owl (Glaucidium brasilianum cactorum)

and the Yuma clapper rail (Rallus

longirostris yumanensis).

Permit No. 813889

Applicant: Larry Benallie, Sr., Window Rock,

Arizona

The applicant requests authorization

for research and recovery purposes to

survey parts of the Navajo Nation for the

possible occurrence of the Kanab

ambersnail (Oxyloma haydeni ssp.

kanabensis).

Permit No. 823253

Applicant: John Lloyd-Reilley, Kingsville,

Texas

The applicant requests authorization

to perfom an intensive study of slender

rush-pea (Hoffmannseggia tenella) for

possible reintroduction to wildland

sites. Applicant was previously granted

permission to collect the seeds of

slender rushpea and propagate plants

for research and recovery purposes.

Permit No. 823293

Applicant: Joseph B. Gebler, Tucson, Arizona

Applicant requests authorization for

research and recovery purposes to

collect up to 10 of the following

endangered fish species from various

locales within Arizona for ecological

and contaminant assessment. Except

when vouchered, endangered and

threatened species will be released

unharmed immediately.

Chub, bonytail (Gila elegans,)

Pupfish, desert (Cyprinodon

macularius)

Minnow, loach (Rhinichthys (=Tiaroga)

cobitis)

Squawfish, Colorado (Ptychocheilus

lucius)

Spikedace (Meda fulgida)

Sucker, razorback (Xyrauchen texanus)

Topminnow, Gila (Poeciliopsis

occidentalis)

Trout, Apache (Oncorhynchus apache)

Trout, Gila (Oncorhynchus gilae)

Woundfin (Plagopterus argentissimus)

Permit No. 823354

Applicant: Dr. Ross Dawkins, San Angelo,

Texas

Applicant requests authorization to

survey, map territory distribution,

capture (using mist nets) band, measure,

and immediately release unharmed no

more than five black-capped vireos

(Vireo atricapillus). Work would be

conducted in Terrell, Brushy Canyon,

and Brewster Counties, Texas.

Permit No. 823431

Applicant: Nancy London, Wickenburg,

Arizona

The applicant requests authorization

to observe, survey, and monitor for

southwestern willow flycatchers

(Empidonax traillii extimus) to

determine habitat preferences of the

species.