10596 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Notices

supersedes the ‘‘Nuclear Pharmacy

Guideline; Criteria for Determining

When to Register as a Drug

Establishment’’ issued by FDA in May

1984.

A. Physiological Research

Facilities using PET

radiopharmaceuticals for purely

physiological research, where the

results of such research are not used to

guide patient management or treatment

decisions, should establish a PET

Regulatory Committee (PRC) in

accordance with §1A361.1 Radioactive

drugs for certain research uses (21 CFR

361.1). The PRC will monitor all

physiological research of the PET

facility. Facilities using PET

radiopharmaceuticals for purely

physiological research are not required

to submit an investigational new drug

application (IND) or NDA as long as this

research is intended to obtain basic

information regarding metabolism or

physiology and is not intended to guide

or be part of therapeutic, diagnostic, or

clinical management plans.

FDA will approve and monitor the

PRC, which should consist of at least

five individuals. In accordance with

§1A361.1(c), each PRC should include:

(1) A physician recognized as a

specialist in nuclear medicine; (2) a

person qualified by training and

experience to manufacture PET

radiopharmaceuticals; and (3) a person

with special competence in radiation

safety and radiation dosimetry. The

remaining PRC members should include

individuals qualified in various

disciplines pertaining to the field of

nuclear medicine, and should be

sufficiently diverse to permit expert

review of the technical and scientific

aspects of proposals submitted to the

committee. In addition to the

requirements in §1A361.1(c) and with

the exception of the member qualified

by training and experience to

manufacture PET radiopharmaceuticals,

PRC membership should include a

representative of a consumer group, and

the members should not have scientific,

clinical, financial, or administrative

conflicts of interest.

The PRC should have three main

responsibilities: (1) To approve research

protocols; (2) to prepare annual reports;

and (3) to determine when purely

physiological research has ended.

In approving protocols, the PRC

should: (1) Determine if the investigator

meets the qualifications specified in the

protocol; (2) review the research

protocol design; (3) review and monitor

the selection of research subjects; (4)

ensure that the research subjects have

signed informed consent documents; (5)

review and monitor the quality of the

PET radiopharmaceuticals

administered; (6) evaluate all reports of

adverse events; and (7) confirm

concurrence of Institutional Review

Board approval.

The annual report should follow the

format and contents prescribed in

§1A361.1(c)(3), summarizing the

conditions of use, doses, route of

administration, protocols, adverse

events reported in the safety

information, and the chemistry,

manufacturing, and control data. The

PRC should submit the completed

annual report to FDA.

The PRC is also responsible for

determining when purely physiological

research becomes investigational

clinical use. This determination should

be based on whether the data obtained

will be used in the diagnostic,

therapeutic, or clinical management of

patients. Once trials are proposed for

investigational clinical use, the facility

must submit an IND before starting to

conduct the trials.

B. Investigational Use

Manufacturers of PET

radiopharmaceuticals intended to be

used in investigational clinical trials

must submit an IND to FDA in

accordance with the regulations in part

312. Institutions or investigators

working together with the same PET

radiopharmaceutical may submit one

IND for that drug product, covering

studies conducted at more than one site

or institution.

C. NDA Approval

Submission of an NDA, in accordance

with FDA regulations in part 314 (21

CFR part 314), is required for PET

radiopharmaceuticals used in clinical

practice. Institutions or investigators

working together with the same PET

radiopharmaceutical may submit one

NDA for that drug product. All sites that

produce the same drug product would

be covered by the submitted NDA. Once

an NDA is approved, other PET facilities

with a radiopharmaceutical that is an

equivalent finished product, but which

did not participate in the NDA or did

not submit manufacturing data, could

submit an abbreviated new drug

application (ANDA) demonstrating that

their drug is bioequivalent to the

innovator drug, in accordance with FDA

regulations in part 314. Alternatively,

the NDA holder could submit a

supplement to add these other facilities

as new manufacturing sites.

PET radiopharmaceuticals are also

subject to the adulteration and

misbranding provisions of the act.

Facilities where PET

radiopharmaceuticals are manufactured

are subject to inspection by FDA for

compliance with CGMP requirements

and other drug-related requirements.

Dated: February 17, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–4691 Filed 2–24–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of the Assistant Secretary for

Public and Indian Housing

[Docket No. N–55–3710; FR–3636–-03]

Announcement of Funding Awards

Public Housing Drug Elimination

Technical Assistance Program, FY

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 announcement

notifies the public of funding decisions

made by the Department in a

competition for funding under the

Notice of Funding Availability (NOFA)

for Public Housing Drug EliminationTechnical Assistance Program. This

announcement contains the names and

addresses of the award winners and the

amount of the awards.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Cocke, Drug Free

Neighborhoods Division, Department of

Housing and Urban Development, 451

Seventh Street, SW., Room 4116,

Washington, DC 20410, telephone (202)

708–1197. A telecommunications device

for hearing or speech impaired persons

(TDD) is available at (202) 708–0850.

(These are not toll-free numbers.)

SUPPLEMENTARY INFORMATION: The

Public Housing Drug EliminationTechnical Assistance Program is

authorized by the Departments of

Veterans Affairs and Housing and Urban

Development, and Independent

Agencies Appropriations Act, 1994

(approved October 28, 1993, Pub. L.

103–124).

The NOFA published in the Federal

Register on March 10, 1994 (59 FR

11418) announced the FY 1994

availability of $1,255,175 to fund

qualified applicants selected under the

FY 1993 NOFA and invited additional

applicants for FY 1994. The purpose of
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Notices 10597

the program is to provide short-term

technical assistance to public housing

agencies, Indian housing authorities,

resident management corporations, and

incorporated resident councils that are

combating abuse of controlled

substances in public and Indian housing

communities. These funds reimburse

consultants who provide expert advice

and work with housing authorities or

resident councils to assist them in

gaining skills and training to eliminate

drug abuse and related problems from

public housing communities.

Applications were scored and selected

for funding for the third and fourth

quarter based on criteria contained in

the Notice.

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 21, 1995.

Joseph Shuldiner,

Assistant Secretary for Public and Indian

Housing.

APPENDIX A.—FISCAL YEAR 1994 PUBLIC AND INDIAN HOUSING RECIPIENTS OF THIRD AND FOURTH QUARTER FUNDING

DECISIONS

Name and address Amount

awarded

PROGRAM NAME: Public Housing Drug Elimination Technical Assistance Program

STATUTE: Public Law 103–124, October 28, 1993.

MIDTOWN TERRACE RESIDENT COUNCIL, WV, LILLIAN YOUNG, 1447 Peachtree Street, #522, Atlanta, GA 30309 .............. $8,937.00

COLLEGE PARK HOUSING AUTHORITY, GA, ANTHONY RANDOLPH, 1050 Topeka Street Pasadena, CA 91104 .................. 9,807.00

MONTICELLO HOUSING AUTHORITY, NY, ROBERT BORGHESE, 21 S. 12th St. Suite 902, Philadelphia, PA 19107 .............. 8,686.00

APACHE MANOR RESIDENT COUNCIL, OK, IAN HORNCASTLE, 830 South Woodlawn Ave., Okmulgee, OK 74447 ............... 10,000.00

SANDY PARK RESIDENT ASSOCIATION, OK, GLENN MCCURDY, 7942 Park Avenue, Elkins Park, PA 19117 ........................ 5,741.00

MAKAH INDIAN HOUSING AUTHORITY, WA, GARY LIMING, 19707–44th Ave., W. Suite 212, Lynwood, WA 98036 ................ 6,654.00

PONTIAC HOUSING COMMISSION, MI, RONALD SIMPKINS, Commitment To Character, P.O. BOX 157151, Cincinnati, OH

45215 ............................................................................................................................................................................................... 5,444.00

CRESTVIEW HOUSING AUTHORITY, FL, PAUL TANNER, 5618 Shorewood Road, Jacksonville, FL 32210 ............................... 8,776.00

HOUSING AUTHORITY OF TOWN, OF SOUTH KINGSTOWN, RI, SUSAN BARRY, SYMPATICO INC., 57 Columbia Street,

Wakefield, RI 02879 ........................................................................................................................................................................ 8,425.00

HOUSING AUTHORITY OF THE CITY OF ASHEVILLE, NC, RICHARD MARTIN, P.O. Box 12311, Raleigh, NC 27605 ............. 8,737.00

NORTH WILKESBORO DEPT. OF HOUSING, NC, JOHN T. PHILLIPS, 302 North Lee Street, Ayden, NC 28513 ....................... 5,840.00

TACOMA HOUSING AUTHORITY, WA, EDWIN C. GOODWIN, National Facility Consultants, 1579–F Monroe Dr., NE, Suite

168, Atlanta, GA 30324 ................................................................................................................................................................... 9,682.00

MESCALERO APACHE INDIAN HOUSING, AUTHORITY, NM, SUSAN GUYETTE, 97 Moya Rd., Santa Fe, NM 87505 ............ 8,618.00

GREENSBORO HOUSING AUTHORITY, AL, JOSEPH ALEX, P.O. BOX 210546, 4604 Virginia Loop Road, Montgomery, AL,

36121 ............................................................................................................................................................................................... 8,510.00

STAMFORD HOUSING AUTHORITY, CT, SEVERIN SORENSEN, PO Box 34469, Bethesda, MD 20813–1072 .......................... 9,930.00

ERNIE CRAGIN TERRACE RESIDENT COUNCIL, NV, PAUL TURNER, 410 Castello Road, Lafayette, CA 94549 ..................... 9,915.00

NAVAJO HOUSING AUTHORITY, AZ, THOMAS WICKENDEN AND LAURENCE GISHEY, BOX 4132 Northern Arizona University, Flagstaff, AZ 86011–4132 ................................................................................................................................................... 7,424.00

OPELIKA HOUSING AUTHORITY, AL, JOSEPH ALEX, P.O. BOX 210546, 4604 Virginia Loop Road, Montgomery, AL 36121 .. 9,116.00

HOUSING AUTHORITY OF THE TOWN OF LAURINBURG, NC, SEVERIN SORENSEN, PO Box 34469, Bethesda, MD

20813–1072 ..................................................................................................................................................................................... 7,407.00

KEY WEST HOUSING AUTHORITY, FL, JOHN DOYLE BANYAN PRODUCTIONS, 3134 Northside Drive, Key West, FL 33040 9,955.00

LITTLE ROCK HOUSING AUTHORITY, AR, SEVERIN SORENSEN, PO Box 34469, Bethesda, MD 20813–1072 ...................... 9,758.00

SPOKANE HOUSING AUTHORITY, WA, JEFFREY OSHINS, 271 Rosario Park Road, Santa Barbara, CA 93105 ...................... 9,143.00

LUMBERTON HOUSING AUTHORITY, MS, ROBERT TAYLOR, 425 Beasley Road, #B7, Jackson, MS 39286 ........................... 8,073.00

UNIONTOWN HOUSING AUTHORITY, AL, JOSEPH ALEX, P.O. BOX 210546, 4604 Virginia Loop Road, Montgomery, AL

36121 ............................................................................................................................................................................................... 5,864.00

CUMBERLAND PLATEAU REGIONAL HOUSING AUTHORITY, VA, GENEVA O’QUINN, Route 1, Box 601–A, Clintwood, VA

24228 ............................................................................................................................................................................................... 4,725.00

CANTON HOUSING AUTHORITY, MS, ROBERT TAYLOR, 425 Beasley Road, #B7 Jackson, MS 39286 .................................... 5,967.00

HOUSING AUTHORITY OF BAYTOWN, TX, ROBIN MITCHELL, FREEDOM COMMUNICATIONS, 512 East 11th, Suite 206,

Austin, TX 78702 ............................................................................................................................................................................. 9,545.00

MANAHAN VILLAGE RESIDENT COUNCIL, NJ, WANDA W. STANSBURY, 206 Renfrew Ave., Trenton, NJ 08618 ................... 9,981.00

SMITHFIELD HOUSING AUTHORITY, NC, SEVERIN SORENSEN, PO Box 34469, Bethesda, MD 20813–1072 ........................ 7,063.00

MASSENA HOUSING AUTHORITY, NY, ROBERT BORGHESE, 21 S. 12th St., Suite 902, Philadelphia, PA 19107 ................... 9,155.00

MONTGOMERY COUNTY HOUSING AUTHORITY, PA, WANDA W. STANSBURY, 206 Renfrew Ave., Trenton, NJ 08618 ....... 9,960.00

SOUTH HILLS TERRACE TENANTS ORGANIZATION, PA, DAVID BUCHES, RD 1 Box 735A, Dover, DE 19901 ...................... 6,306.00

HOUSING AUTHORITY OF LAUREL, MS, ROBERT TAYLOR, 425 Beasley Road, #B7, Jackson, MS 39286 .............................. 6,525.00

FORT WALTON BEACH HOUSING AUTHORITY, FL, JIM L. MUNRO, 7335 No. Shores Dr., Navarre, FL 32566 ....................... 5,129.00

INKSTER HOUSING COMMISSION, MI, CURTIS JONES, 6 Lindsey Street, Dorchester, MA 02124 ............................................ 9,307.00

BLACKFEET INDIAN HOUSING AUTHORITY, MT, JEFFREY OSHINS, 271 Rosario Park Road, Santa Barbars, CA 93105 ...... 8,502.00

TURTLE MOUNTAIN INDIAN HOUSING AUTHORITY, SD, ANNE FALLIS, Rural Route 1, BOX 1845, Rapid City, SD 57702 ... 8,324.00

CHOCTAW NATION INDIAN HOUSING AUTHORITY, OK, RICARDO JASSO, P.O. Box 11615, Casa Grande, AZ 85230 ......... 8,624.00

HALL COUNTY HOUSING AUTHORITY, NE, GARY DAVIS, 620 Alum Creek Drive, Columbus, OH 43205 ................................. 5,629.00

HOUSING AUTHORITY OF THE CITY OF PASCO AND FRANKLIN COUNTY, GWENDOLYN SHEPHERD, GMSS LEARNING

SERVICES, 7060 McCormick Woods Dr. SW, Port Orchard, WA 98366–7645 ............................................................................ 8,900.00

TEMPLE HOUSING AUTHORITY, TX, KAI MARTENSEN, 706 Bridgeman Terrace, Towson, MD 21204 ...................................... 9,786.00

NORTHERN CHEYENNE INDIAN HOUSING AUTHORITY, MT, DEBRA WILLIAMS-HOUSE, Stone Mountain, GA .................... 9,985.00

HOUSING AUTHORITY OF RICHMOND, CA, ROBERT REYNOLDS, 2131–2nd Ave., Los Angeles, CA 90018 .......................... 9,436.00
10598 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Notices

APPENDIX A.—FISCAL YEAR 1994 PUBLIC AND INDIAN HOUSING RECIPIENTS OF THIRD AND FOURTH QUARTER FUNDING

DECISIONS—Continued

Name and address Amount

awarded

DISTRICT OF COLUMBIA DEPARTMENT OF PUBLIC AND ASSISTED HOUSING, DC, ROBERT BORGHESE, 21 S. 12th

St., Suite 902, Philadelphia, PA 19107 ........................................................................................................................................... 7,805.00

DISTRICT OF COLUMBIA DEPARTMENT OF PUBLIC AND ASSISTED HOUSING, DC, SEVERIN SORENSEN, PO Box

34469, Bethesda, MD 20813–1072 ................................................................................................................................................. 10,000.00

MUCKLESHOOT INDIAN HOUSING AUTHORITY, WA, SEVERIN SORENSEN, PO Box 34469, Bethesda, MD 20813–1072 .... 10,000.00

HOUSING AUTHORITY OF BALTIMORE CITY, MD, DAVID ROUEN, TSAILE, INC. (PATH) Box 1827, Carolina Beach, NC

28428 ............................................................................................................................................................................................... 5,496.00

DANBURY HOUSING AUTHORITY, CT, PATRICIA SURPRENANT, 418 Robin Ct., Cheshire, CT 06410 .................................... 4,836.00

HOUSING AUTHORITY OF WINONA, MS, PAUL TANNER, 5618 Shorewood Rd., Jacksonville, FL 32210 ................................. 9,018.00

FORT BERTHOLD INDIAN HOUSING AUTHORITY, ND, ANNE FALLIS, Rural Route 1, Box 1845, Rapid City, SD 57702 ........ 9,204.00

HATTIESBURG HOUSING AUTHORITY, MS, C. JEAN BENNETT, 207 Valley North Blvd., Jackson, MS 39206 ......................... 8,084.00

FOREST HOUSING AUTHORITY, MS, C. JEAN BENNETT, 207 Valley North Blvd., Jackson, MS 39206 .................................... 8,718.00

HOUSING AUTHORITY OF THE CITY OF NEW BERN, NC, LEXIE WILLIAMS, 1177 Dominion Court, Port Orange, FL 32119 . 7,240.00

HOUSING AUTHORITY OF GRANT COUNTY, WA, ROXANNA NANTO, CC CONSULTING ASSOCIATES, 704 NE Larch

Court, Wenatchee, WA 98802 ......................................................................................................................................................... 6,613.00

TAYLOR HOUSING AUTHORITY, TX, JAMES GODFREY, GODFREY & ASSOCIATES, P.O. Box 2470, Hot Springs, AR

71914 ............................................................................................................................................................................................... 9,512.00

COLORADO RIVER INDIAN HOUSING AUTHORITY, AZ, SUSAN GUYETTE, 97 Moya Rd., Santa Fe, NM 87505 .................... 8,953.00

HOUSING AUTHORITY OF WOONSOCKET, RI, ROBERT BORGHESE, 21 S. 12th St., Suite 902, Philadelphia, PA 19107 ..... 9,132.00

ROME HOUSING AUTHORITY, GA, JAMES GODFREY, GODFREY & ASSOCIATES, P.O. Box 2470, Hot Springs, AR 71914 9,787.00

PROVIDENCE HOUSING AUTHORITY, RI, SEVERIN SORENSEN, PO Box 34469, Bethesda, MD 20813–1072 ....................... 10,000.00

CANTON HOUSING AUTHORITY, NY, LYNN BORRELL, Lynne Borrell & Associates, Suite 402, 1165 North Clarke, Chicago,

IL 60610 ........................................................................................................................................................................................... 10,000.00

THE HOUSING AUTHORITIES OF FAIRBURN/UNION CITY, GA, SAUNDRA D. WILLIAMS, D & J CONSULTANTS, 4300 Flat

Shoals Road #2606, Union City, GA 30291 .................................................................................................................................... 9,440.00

MARIANNA HOUSING AUTHORITY, FL, PAUL TANNER, 5618 Shorewood Road, Jacksonville, FL 32210 ................................. 8,858.00

SCHWARTZ-ROBESON TENANTS ASSOCIATION, NJ, ALEXANDER SUTTON, 1133 Kensington Ave., Plainfield, NJ 07060 .. 10,000.00

HOUSING AUTHORITY OF GALLATIN, TN, KARRIEM SHABAZZ, 3150 Borge Street, Oakton, VA 22124 .................................. 6,630.00

TRIANA HOUSING AUTHORITY, AL, JOSEPH ALEX, P.O. BOX 210546, 4604 Virginia Loop Road, Montgomery, AL 36121 .... 8,355.00

PENNINGTON COURT TENANTS ASSOCIATION, NJ, GERARD LEE, 810 Belvidere Ave., Plainfield, NJ 07060 ....................... 10,000.00

HOUSING AUTHORITY OF MERCED, CA, JEFFREY OSHINS, 271 Rosario Park Road, Santa Barbara, CA 93105 .................. 7,504.00

WILMINGTON HOUSING AUTHORITY, DE, NANCY LOWE-CONNO, 3406 Wild Cherry Road, Baltimore, MD 21207 ................ 9,959.00

SOUTHERN PUGET SOUND INDIAN HOUSING AUTHORITY, WALINDA RINALDI, Seattle, WA ................................................ 9,786.00

HOUSING AUTHORITY OF JACKSON COUNTY OR ROXANNA NANTO, CC CONSULTING ASSOCIATES, 704 NE Larch

Court, Wenatchee, WA 98802 ......................................................................................................................................................... 9,441.00

OLNEY HOUSING AUTHORITY, TX, JEFFREY OSHINS, 271 Rosario Park Road, Santa Barbara, CA 93105 ............................ 7,911.00

Total .......................................................................................................................................................................................... 595,673.00

[FR Doc. 95–4658 Filed 2–24–95; 8:45 am]

BILLING CODE 4210–33–P

Office of the Secretary

[Docket No. N–95–3892; FR–3864–N–01]

Notice of Regulatory Waiver Requests

Granted

AGENCY: Office of the Secretary, HUD.

ACTION: Public notice of the granting of

regulatory waivers. Request: July 1, 1994

through September 30, 1994.

SUMMARY: Under the Department of

Housing and Urban Development

Reform Act of 1989 (Reform Act), the

Department (HUD) is required to make

public all approval actions taken on

waivers of regulations. This notice is the

fifteenth in a series, being published on

a quarterly basis, providing notification

of waivers granted during the preceding

reporting period. The purpose of this

notice is to comply with the

requirements of section 106 of the

Reform Act.

FOR FURTHER INFORMATION CONTACT:

For general information about this

Notice, contact Camille E. Acevedo,

Assistant General Counsel for

Regulations, Room 10276, Department

of Housing and Urban Development,

451 Seventh Street, SW, Washington,

DC 20410; (telephone 202–708–3055);

TDD: (202) 708–3259. These are not tollfree numbers.) For information

concerning a particular waiver action,

about which public notice is provided

in this document, contact the person

whose name and address is set out, for

the particular item, in the

accompanying list of waiver-grant

action.

SUPPLEMENTARY INFORMATION: As part of

the Housing and Urban Development

Reform Act of 1989, the Congress

adopted, at HUD’s request, legislation to

limit and control the granting of

regulatory waivers by the Department.

Section 106 of the Act (Section 7(q)(3)

of the Department of Housing and Urban

Development Act, 42 U.S.C. 3535 (q)(3),

provides that:

1. Any waiver of a regulation must be

in writing and must specify the grounds

for approving the waiver;

2. Authority to approve a waiver of a

regulation may be delegated by the

Secretary only to an individual of

Assistant Secretary rank or equivalent

rank, and the person to whom authority

to waive is delegated must also have

authority to issue the particular

regulation to be waived;

3. Not less than quarterly, the

Secretary must notify the public of all

waivers of regulations that the

Department has approved, by

publishing a Notice in the Federal

Register. These Notices (each covering

the period since the most recent

previous notification) shall:

a. Identify the project, activity, or

undertaking involved;