11672 Federal Register / Vol. 60, No. 41 / Thursday, March 2, 1995 / Notices

approval phase starts with the initial

submission of an application to market

the device and continues until

permission to market the device is

granted. 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 (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 medical device will include

all of the testing phase and approval

phase as specified in 35 U.S.C.

156(g)(3)(B).

FDA recently approved for marketing

the medical device Albunex.

Albunex is indicated as an aid for

ultrasound contrast enhancement of

ventricular chambers and improvement

of endocardial border definition in

patients with suboptimal echoes

undergoing ventricular function and

regional wall motion studies.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

Albunex (U.S. Patent No. 4,844,882)

from Molecular Biosystems, 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

December 19, 1994, FDA advised the

Patent and Trademark Office that this

medical device had undergone a

regulatory review period and that the

approval of Albunex 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

Albunex is 2,397 days. Of this time,

975 days occurred during the testing

phase of the regulatory review period,

while 1,422 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date a clinical investigation

involving this device was begun: January

14, 1988. The applicant claims that the

investigational device exemption (IDE)

required under section 520(g) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360j(g)) for human tests to

begin became effective on August 18,

1987. However, FDA records indicate

that IDE was conditionally approved on

January 14, 1988, which represents the

IDE effective date.

2. The date an application was

initially submitted with respect to the

device under section 515 of the Federal

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

360e): September 14, 1990. The

applicant claims September 11, 1990, as

the date the premarket approval

application (PMA) for Albunex (PMA

P900059) was initially submitted.

However, FDA records indicate that

PMA P900059 was submitted on

September 14, 1990.

3. The date the application was

approved: August 5, 1994. FDA has

verified the applicant’s claim that PMA

P900059 was approved on August 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 763 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before May 1, 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 August 29, 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: February 24, 1995.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 95–5183 Filed 3–1–95; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

Division of Research Grants; Notice of

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following Division

of Research Grants Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Behavioral and

Neurosciences.

Date: March 2, 1995.

Time: 1:00 p.m.

Place: NIH, Westwood Building, Room

309, Telephone Conference.

Contact Person: Dr. Jane Hu, Scientific

Review Administrator, 5333 Westbard Ave.,

Room 309, Bethesda, MD 20892, (301) 594–

7269.

Name of SEP: Behavioral and

Neurosciences.

Date: March 20, 1995.

Time: 1:30 p.m.

Place: NIH, Westwood Building, Room

303, Telephone Conference.

Contact Person: Dr. Teresa Levitin,

Scientific Review Administrator, 5333

Westbard Ave., Room 303, Bethesda, MD

20892, (301) 594–7141.

Name of SEP: Microbiological and

Immunological Sciences.

Date: March 20, 1995.

Time: 12:00 noon.

Place: NIH, Westwood Building, Room

226, Telephone Conference.

Contact Person: Dr. Gerald Liddel,

Scientific Review Admin., 5333 Westbard

Ave., Room 226, Bethesda, MD 20892, (301)

594–7167.

Name of SEP: Biological and Physiological

Sciences.

Date: March 23, 1995.

Time: 1:00 p.m.

Place: NIH, Westwood Building, Room

233A, Telephone Conference.

Contact Person: Dr. Robert Su, Scientific

Review Administrator, 5333 Westbard Ave.,

Room 233A, Bethesda, MD 20892, (301) 594–

7320.

Name of SEP: Microbiological and

Immunological Sciences.

Date: March 31, 1995.

Time: 10:00 a.m.

Place: NIH, Westwood Building, Room

226, Telephone Conference.

Contact Person: Dr. Gerald Liddel,

Scientific Review Admin., 5333 Westbard

Ave., Room 226, Bethesda, MD 20892, (301)

594–7167.

The meetings will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the grant review cycle.

(Catalog of Federal Domestic Assistance

Program Nos. 93.306, 93.333, 93.337, 93.393–

93–396, 93.837–93.844, 93.846–93.878,

93.892, 93.893, National Institutes of Health,

HHS)
Federal Register / Vol. 60, No. 41 / Thursday, March 2, 1995 / Notices 11673

Dated: February 24, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–5230 Filed 3–1–95; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of the Assistant Secretary for

Public and Indian Housing

[Docket No. N–95–3736; FR–3624–N–03]

Announcement of Funding Awards for

the Traditional Indian Housing

Development Program Fiscal Year

1994

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Announcement of funding

awards.

SUMMARY: In accordance with section

102(a)(4)(C) of the Department of

Housing and Urban Development

Reform Act of 1989, this document

notifies the public of funding awards for

Fiscal Year 1994 Indian Housing

Authorities applicants under the

Traditional Indian Housing

Development Program. The purpose of

this document is to announce the names

and addresses of the award winners and

the amount of the awards.

FOR FURTHER INFORMATION CONTACT:

Bruce Knott, Director, Housing

Development Division, Public and

Indian Housing, Department of Housing

and Urban Development, 451 Seventh

Street, SW, Washington, DC 20410;

telephone (202) 755–0068. The TDD

number for hearing impaired is (202)

708–0850. (These are not toll-free

numbers).

SUPPLEMENTARY INFORMATION: The

Traditional Indian Housing

Development program is authorized by

sections 5 and 6 of the U.S. Housing Act

of 1937 (42 U.S.C. 1437c, 1437d); as

amended; U.S. Department of Housing

and Urban Development and

Independent Agencies’ Appropriations

Act for Fiscal Year 1994, Section 23,

U.S. Housing Act of 1937, as added by

sec. 554, Cranston Gonzalez National

Affordable Housing Act; sec. 7(d),

Department of Housing and Urban

Development Act (42 U.S.C. 3535(d)).

The purpose of the competition was

to make funding available for the

development of new Indian housing

units and to replace units approved for

demolition/disposition. These Indian

Housing Development grants will enable

Indian Housing authorities to assist in

the development and operation of lowincome housing projects in Indian areas.

Recipients were chosen in a competition

under selection criteria announced a

Notice of Funding Availability (NOFA)

published in the Federal Register on

April 20, 1994 (59 FR 18846).

In accordance with section

102(a)(4)(C) of the Department of

Housing and Urban Development

Reform Act of 1989 (Pub. L. 101–235,

approved December 15, 1989), the

Department is publishing the names and

addresses of the recipients which

received funding under this NOFA, and

the amount of funds awarded to each.

This information is provided in

Appendix A to this document.

Dated: February 27, 1995.

Joseph Shuldiner,

Assistant Secretary for Public and Indian

Housing.

APPENDIX A.—FISCAL YEAR 1994 PUBLIC AND INDIAN HOUSING RECIPIENTS OF FINAL FUNDING DECISIONS

Funding recipient (Name and address) Amount

approved

Program name: New Indian Housing Development

Statute: U.S. Housing Act of 1937; as added by the Indian Housing Act of 1988

Metlakatla HA, P.O. Box 59, Metlakatla, AK 99926 ............................................................................................................................ $2,258,704

Metlakatla HA, P.O. Box 59, Metlakatla, AK 99926 ............................................................................................................................ 3,060,695

Tlingit-Haida Reg HA, Route 1 Box 376, Ketchikan, AK 99901 ......................................................................................................... 2,663,667

ASRC HA, Box 677, Barrow, AK 99723 ............................................................................................................................................. 3,482,243

ASRC HA, Box 677, Barrow, AK 99723 ............................................................................................................................................. 3,262,943

Northwest Inupiat HA, P.O. Box 29, Kiana, AK 99749 ....................................................................................................................... 3,753,000

Interior Reg HA, General Delivery, Ft Yukon, AK 99740 .................................................................................................................... 1,867,642

Interior Reg HA, General Delivery, Ft Yukon, AK 99740 .................................................................................................................... 1,307,355

Interior Reg HA, General Delivery, Ft Yukon, AK 99740 .................................................................................................................... 933,826

Bering Straits Reg HA, P.O. Box 995, Nome, AK 99762 ................................................................................................................... 3,264,438

Bering Straits Reg HA, P.O. Box 995, Nome, AK 99762 ................................................................................................................... 3,264,438

Bering Straits Reg HA, P.O. Box 995, Nome, AK 99762 ................................................................................................................... 3,264,438

Bering Straits Reg HA, P.O. Box 995, Nome, AK 99762 ................................................................................................................... 3,264,438

AVCP Reg HA, General Delivery, Kipnuk, AK 99557 ......................................................................................................................... 3,756,264

Bristol Bay HA, P.O. Box 750, Dillingham, AK 99576 ........................................................................................................................ 697,133

Bristol Bay HA, P.O. Box 750, Dillingham, AK 99576 ........................................................................................................................ 1,568,549

Bristol Bay HA, P.O. Box 750, Dillingham, AK 99576 ........................................................................................................................ 697,133

North Pacific Rim HA, P.O. Box 171, Tatitlek, AK 99677 ................................................................................................................... 2,136,645

North Pacific Rim HA, P.O. Box 171, Tatitlek, AK 99677 ................................................................................................................... 879,795

Aleutian HA, General Delivery, St. Paul, AK 99660 ........................................................................................................................... 572,019

Baranof Island HA, P.O. Box 517, Sitka, AK 99835 ........................................................................................................................... 2,849,637

MOWA Band of Choctaw Indians, Route 1, Box 1080, Mt. Vernon, AL 36560 ................................................................................. 720,848

MOWA Band of Choctaw Indians, Route 1, Box 1080, Mt. Vernon, AL 36560 ................................................................................. 1,123,060

Navajo Housing Authority, P.O. Box 387, Window Rock, AZ 86515 .................................................................................................. 1,132,143

Navajo Housing Authority, P.O. Box 387, Window Rock, AZ 86515 .................................................................................................. 2,875,417

Navajo Housing Authority, P.O. Box 387, Window Rock, AZ 86515 .................................................................................................. 10,286,309

Navajo Housing Authority, P.O. Box 387, Window Rock, AZ 86515 .................................................................................................. 5,221,645

Navajo Housing Authority, P.O. Box 387, Window Rock, AZ 86515 .................................................................................................. 8,193,320

Cocopah Housing Authority, P.O. Box AF, Somerton, AZ 85350 ...................................................................................................... 3,557,408

Kaibab Paiute Housing Authority, HC 65, Box 122, Fredonia, AZ 86022 .......................................................................................... 1,664,576

Quechan Tribal Housing Authority, 1860 W. Sapphire Lane, Winterhaven, CA 92283 ..................................................................... 2,924,710

Modoc-Lassen Indian Housing Authority, P.O. Box 2028, Susanville, CA 96130 .............................................................................. 1,540,331

Modoc-Lassen Indian Housing Authority, P.O. Box 2028, Susanville, CA 96130 .............................................................................. 1,499,135