41860 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 / Notices

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 ETOPOPHOS

(etoposide phosphate). ETOPOPHOS

is indicated for the management of the

following neoplasms: Refractory

testicular tumors and small cell lung

cancer. Subsequent to this approval, the

Patent and Trademark Office received a

patent term restoration application for

ETOPOPHOS (U.S. Patent No.

4,904,768) from Bristol-Myers Squibb

Co., and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

July 8, 1997, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the

approval of ETOPOPHOS 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

ETOPOPHOS is 1,719 days. Of this

time, 1,029 days occurred during the

testing phase of the regulatory review

period, 690 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(b) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 355(b)) became effective:

September 4, 1991. FDA has verified the

applicant’s claim that the date the

investigational new drug application

became effective was on September 4,

1991.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the act: June 28, 1994. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

ETOPOPHOS (NDA 20–457) was

initially submitted on June 28, 1994.

3. The date the application was

approved: May 17, 1996. FDA has

verified the applicant’s claim that NDA

20–457 was approved on May 17, 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 1,017 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 5, 1998, 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 February 1, 1999, 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: July 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–20826 Filed 8–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: The Knowledge of

Ryan White Providers About ACTG076

NEW—The HIV/AIDS Bureau (HAB)

intends to conduct a survey of

approximately 305 health care providers

who work in Ryan White IIIb funded

programs and who treat women of

childbearing age. The specific topic area

of this study relates to perinatal

transmission of HIV.

The purpose of this survey is to

determine:

—The specific training and learning

needs of providers in Ryan White

funded programs with regard to HIV/

AIDS issues (especially perinatal

transmission of HIV) and women of

childbearing age.

—The preferred modes of training.

—The level of knowledge of, and

adherence to, Government protocols

for treating women of childbearing

age and reducing the risk of perinatal

transmission of HIV.

—The familiarity of practitioners with

recent advances in HIV/AIDS

treatments such as protease inhibitors

and combined therapies.

Results from this research will be

used to develop specific training

curricula for these providers and to

enhance educational and service

delivery-related support for Bureaufunded providers and clinics.

The study will be a self-administered

mail survey, with phone follow-up if

necessary to improve response rates.

The estimated respondent burden is

as follows:
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 / Notices 41861

Type of respondent Number of respondents

Responses

per respondent

Hours per responseTotal burden

hours

Health care providers ....................................................................................... 305 1 .25 76

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Laura Oliven, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington, DC

20503.

Dated: July 31, 1998.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 98–20877 Filed 8–4–98; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Notice of Meetings

Pursuant to Pub. L. 92–463, notice is

hereby given of the following meetings

of the SAMHSA Special Emphasis Panel

I in August 1998.

A summary of the meetings and

rosters of the members may be obtained

from: Ms. Dee Herman, Committee

Management Liaison, SAMHSA, Office

of Policy and Program Coordination,

Division of Extramural Activities,

Policy, and Review, 5600 Fishers Lane,

Room 17–89, Rockville, Maryland

20857. Telephone: 301–443–7390.

Substantive program information may

be obtained from the individuals named

as Contacts for the meetings listed

below.

The meetings will include the review,

discussion and evaluation of individual

grant applications. These discussions

could reveal personal information

concerning individuals associated with

the applications. Accordingly, these

meetings are concerned with matters

exempt from mandatory disclosure in

Title 5 U.S.C. 552b(c)(6) and 5 U.S.C.

App.2, § 10(d).

Committee Name: SAMHSA Special

Emphasis Panel I (SEP I).

Meeting Dates: August 10–12, 1998.

Place: Hyatt Regency at Crystal City, 2799

Jefferson Davis Highway, Arlington, VA

22202.

Closed: August 10–11, 1998 9:00 a.m.–5:00

p.m. August 12, 1998 9:00 a.m.—

adjournment.

Panel: Center for Mental Health Services

State Indicator Pilot SM 98–010.

Contact: Boris R. Aponte, Room 17–89,

Parklawn Building, Telephone: 301–443–

2290 and FAX: 301–443–3437.

Committee Name: SAMHSA Special

Emphasis Panel I (SEP I).

Meeting Dates: August 17–18, 1998.

Place: Hyatt Regency At Crystal City, 2799

Jefferson Davis Highway, Arlington, VA

22202.

Closed: August 17, 1998 9:00 a.m.–5:00

p.m.–August 18, 1998 9:00 a.m.,

adjournment.

Panel: Center for Substance Abuse

Treatment Grants for Identification of

Exemplary Treatment Models for

Adolescents TI 98–007.

Contact: C. Danielle Johnson, Room 17–89,

Parklawn Building, Telephone: 301–443–

2683 and FAX: 301–443–3437.

Committee Name: Special Emphasis Panel

I.

Meeting Date(s): August 17–20, 1998.

Place: Hyatt Regency—Crystal City, 2799

Jefferson Davis Highway, Arlington, Virginia

22202.

Closed: August 17–19, 1998 8:00 a.m.–4:00

p.m., August 20, 1998 8:00 a.m.–

adjournment.

Panel: Center for Substance Abuse

Treatment State, Regional, and Local

Recovery Network Development TI 98–08.

Contact: Boris Aponte, Room 17–89,

Parklawn Building, Telephone: 301–443–

2290; and FAX: 301–443–3437.

This notice is being published less than 15

days prior to the August 10–12 meeting due

to the urgent need to meet timing limitations

imposed by the review and funding cycle.

Dated: July 30, 1998.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 98–20827 Filed 8–4–98; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Issuance of Permit for Marine

Mammals

On March 11, 1998, the Service

received an application from Harald

Mueller for a permit (PRT–840852) to

import two sport-hunted polar bear

trophies, taken prior to April 30, 1994,

from the Lancaster Sound population,

Northwest Territories, Canada, for

personal use. On April 9, 1998, a notice

was published in the Federal Register,

Vol. 63, No. 68, Page 17463, which

incorrectly noted import of only one

trophy.

Notice is hereby given that on June 4,

1998, as authorized by the provisions of

the Marine Mammal Protection Act of

1972, as amended (16 U.S.C. 1361 et

seq.) the Fish and Wildlife Service

authorized the requested permit subject

to certain conditions set forth therein.

On July 3, 1997, a notice was

published in the Federal Register, Vol.

62, No. 128, Page 36070, that an

application had been filed with the Fish

and Wildlife Service by Gary Dumdei,

Grand Rapids, MN, for a permit (PRT–

829908) to import a sport-hunted polar

bear (Ursus maritimus) trophy, taken

prior to April 30, 1994, from the

Southern Beaufort Sea population,

Northwest Territories, Canada, for

personal use.

Notice is hereby given that on July 1,

1998, as authorized by the provisions of

the Marine Mammal Protection Act of

1972, as amended (16 U.S.C. 1361 et

seq.) the Fish and Wildlife Service

authorized the requested permit subject

to certain conditions set forth therein.

On May 20, 1998, a notice was

published in the Federal Register, Vol.

63, No. 97, Page 27744, that an

application had been filed with the Fish

and Wildlife Service by Kenneth J.

Semelsberger, Strongsville, OH for a

permit (PRT–842191) to import a sporthunted polar bear (Ursus maritimus)

trophy, taken from the Western Hudson

Bay population, Canada, for personal

use.

Notice is hereby given that on July 2,

1998, as authorized by the provisions of

the Marine Mammal Protection Act of

1972, as amended (16 U.S.C. 1361 et

seq.) the Fish and Wildlife Service

authorized the requested permit subject

to certain conditions set forth therein.

On May 20, 1998, a notice was

published in the Federal Register, Vol.

63, No. 97, Page 27744, that an

application had been filed with the Fish

and Wildlife Service by Ken D.

Semelsberger, Strongsville, OH for a

permit (PRT–842192) to import a sporthunted polar bear (Ursus maritimus)

trophy, taken from the Western Hudson

Bay population, Canada, for personal

use.

Notice is hereby given that on July 2,

1998, as authorized by the provisions of

the Marine Mammal Protection Act of

1972, as amended (16 U.S.C. 1361 et

seq.) the Fish and Wildlife Service

authorized the requested permit subject

to certain conditions set forth therein.