Federal Register / Vol. 65, No. 79 / Monday, April 24, 2000 / Notices 21779

Licensing Specialist, Office of

Technology Transfer, National Institutes

of Health, 6011 Executive Boulevard,

Suite 325, Rockville, MD 20852–3804;

Telephone: (301) 496–7735 ext 232;

Facsimile: (301) 402–0220; E-mail:

salatac@OD.NIH.GOV.

SUPPLEMENTARY INFORMATION: The patent

describes a method of determining the

glomerular filtration rate (GFR) of a

subject that comprises comparing the T1

relaxation rate values of serum and

urine samples obtained from a subject

given an NMR detectable paramagnetic

substance that is filtered by the kidney

in accordance with a specified formula.

The prospective exclusive license will

be royalty-bearing and will comply with

the terms and conditions of 35 U.S.C.

209 and 37 CFR 404.7. This prospective

exclusive license may be granted unless,

within 60 days from the date of this

published notice, NIH receives written

evidence and argument that establishes

that the grant of the license would not

be consistent with the requirements of

35 U.S.C. 209 and 37 CFR 404.7.

It is anticipated that this license may

be limited to the use of the method for

determining the glomerular filtration

rate of a patient utilizing a paramagnetic

substance that is filtered by the kidney

which is detectable by NMR.

Properly filed competing applications

for a license filed in response to this

notice will be treated as objections to

the contemplated license. Comments

and objections submitted in response to

this notice will not be made available

for public inspection, and, to the extent

permitted by law, will not be released

under the Freedom of Information Act,

5 U.S.C. 552.

Dated: April 17, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 00–10167 Filed 4–21–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Second Generation

Monoclonal Antibodies, and

Humanized Carcinomas

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(i), that the National

Institutes of Health, Department of

Health and Human Services, is

contemplating the grant of an exclusive

license to practice the inventions

embodied in U.S. Patent Applications S/

N 07/073,685, filed on July 15, 1987,

and S/N 07/547,336 (FWC of 07/

07,3,685), filed on July 20, 1990, both

entitled ‘‘Second Generation

Monoclonal Antibodies Having Binding

Specificity to TAG–72 and Human

Carcinomas and Methods for Employing

the Same’’ and now U.S. Patent

5,512,443 which issued on April 30,

1996; and U.S. Provisional Patent

Applications S/N 60/106,534, filed on

October 31, 1998, and S/N 60/106,757,

filed on November 2, 1998, both entitled

‘‘Variants of Humanized AntiCarcinoma MAb CC49’’, and PCT Patent

Application PCT/US99/25552 (based

upon S/N 60/106,534 and 60/106,757)

filed on October 29, 1999, entitled

‘‘Variants of Humanized AntiCarcinoma Monoclonal Antibody CC49’’

to IDEC Pharmaceutical Corporation of

San Diego, California. The patent rights

in these inventions have been assigned

to the United States of America.

The prospective exclusive license

territory will be worldwide and the field

of use may be limited to anti-TAG–72

monoclonal antibodies, including

fragments, components, constituents

and/or humanized variants thereof, and

excluding bispecific monoclonal

antibodies, which are directly

conjugated to a radioactive isotope, for

use as human anti-cancer therapeutics.

DATES: Only written comments and/or

license applications which are received

by the National Institutes of Health on

or before June 23, 2000 will be

considered.

ADDRESSES: Requests for copies of the

patent, inquiries, comments and other

materials relating to the contemplated

exclusive license should be directed to:

Elaine F. Gese, M.B.A., Technology

Licensing Specialist, Office of

Technology Transfer, National Institutes

of Health, 6011 Executive Boulevard,

Suite 325, Rockville, MD 20852–3804.

Telephone: (301) 496–7056, X282;

Facsimile (301) 402–0220; E-mail

eg46t@nih.gov.

SUPPLEMENTARY INFORMATION: U.S.

Patent 5,512,443 claims various ‘‘second

generation’’ monoclonal antibodies,

including CC49, which have binding

specificity to Tumor Associated

Glycoprotein (TAG–72). PCT Patent

Application PCT/US99/25552 claims

humanized variants of CC49, as well as

methods of generating such variants.

The prospective exclusive license will

be royalty-bearing and will comply with

the terms and conditions of 35 U.S.C.

209 and 37 CFR 404.7. The prospective

exclusive license may be granted unless

within sixty (60) days from the date of

this published notice, the NIH receives

written evidence and argument that

establish that the grant of the license

would not be consistent with the

requirements of 35 U.S.C. 209 and 37

CFR 404.7.

Applications for a license filed in

response to this notice for the noted

field of use will be treated as objections

to the grant of the contemplated

exclusive license. Comments and

objections submitted in response to this

notice will not be made available for

public inspection and, to the extent

permitted by law, will not be released

under the Freedom of Information Act,

5 U.S.C. 552.

Dated: April 17, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 00–10166 Filed 4–21–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 concerning

opportunity for public comment on

proposed collections of information, the

Substance Abuse and Mental Health

Services Administration will publish

periodic summaries of proposed

projects. To request more information

on the proposed projects or to obtain a

copy of the information collection

plans, call the SAMHSA Reports

Clearance Officer on (301) 443–7978.

Comments are invited on: (a) Whether

the proposed collections of information

are necessary for the proper

performance of the functions of the

agency, including whether the

information shall have practical utility;

(b) the accuracy of the agency’s estimate

of the burden of the proposed collection

of information; (c) ways to enhance the

quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

21780 Federal Register / Vol. 65, No. 79 / Monday, April 24, 2000 / Notices

Proposed Project

Administrative Reporting Form (ARF)

for the Cooperative Agreement to Study

Women with Alcohol, Drug Abuse, and

Mental Disorders (ADM) Who Have

Histories of Violence—New—The

Women, ADM Disorders, and Violence

Study is funded by SAMHSA’s Center

for Substance Abuse Treatment (CSAT),

Center for Substance Abuse Prevention

(CSAP), and Center for Mental Health

Services (CMHS) to produce knowledge

on the development and effectiveness of

integrated services for women with cooccurring mental health and substance

abuse disorders who are victims of

violence. Fourteen sites are funded in

Phase I from across the country, and ten

sites are expected to be funded in Phase

II. During Phase I of the study (2 years),

sites are expected to develop integrated

service models. In Phase II, sites that

successfully reapply will test their

interventions in a multi-site outcome

study contrasting comprehensive,

integrated, trauma-specific and

Consumer/Survivor/Recovering Person

(C/S/R) involved services to services as

usual.

A process evaluation occurs through

both phases of the study with the goals

of (1) documenting the development of

integrated service systems across all

sites, (2) feeding information back to

each site to help site staff improve their

project, and (3) describing the service

systems which intervention and control

groups are exposed to at each of the

sites so that meaningful comparisons of

outcomes can be made.

The Administrative Reporting Form

(ARF) is a program monitoring

instrument which is to be completed

jointly by the project director, project

staff members, and directors of

participating organizations at each study

site annually as part of the process

evaluation data collection. The ARF

collects information about the staffing

and governance of each project, project

accomplishments in the previous year,

and specific project components. Like

other periodic progress reports, the ARF

focuses on the reporting of

organizational and institutional

information. No individual information

or opinions are solicited or appropriate

for inclusion in the ARF.

Information collected with the ARF

will be used in three ways,

corresponding to the three goals of the

process evaluation listed above. First,

evaluators will use information from the

ARF to describe the process of project

implementation at each of the study

sites. This information will ultimately

contribute to ‘‘how-to’’ knowledge

products for communities attempting to

integrate services. Second, site visiting

teams will use information from the

ARF in their assessments of the sites

and will make recommendations to each

site of how the site can improve its

project. Third, descriptive information

from the ARF will be used to

characterize each site’s intervention in

terms of the players involved, the

services provided, the manner in which

those services are integrated, and the

manner in which C/S/R persons are

involved. These characterizations will

inform the interpretation of the clientlevel data in the outcome study.

The estimated annualized burden for

these reporting requirements is

summarized below.

Respondent type Number of

respondents

Responses/

respondent

Burden/

response

(hours)

Total burden

hours

Project Directors .............................................................................................. 10 1 10 100

Project Staff Members ..................................................................................... 20 1 10 200

Participating Organization Directors ................................................................ 80 1 .50 40

Total .......................................................................................................... 110 ........................ ........................ 340

Send comments to Nancy Pearce,

SAMHSA Reports Clearance Officer,

Room 16–105, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: April 17, 2000.

Richard Kopanda,

Executive Officer, SAMHSA.

[FR Doc. 00–10084 Filed 4–21–00; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Fiscal Year (FY) 2000 Funding

Opportunities

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Notice of funding availability.

SUMMARY: The Substance Abuse and

Mental Health Services Administration

(SAMHSA) Center for Mental Health

Services (CMHS) announces the

availability of FY 2000 funds for grants

for the following activity. This activity

is discussed in more detail under

Section 3 of this notice. This notice is

not a complete description of the

activity; potential applicants must

obtain a copy of Parts I and II of the

Guidance for Applicants (GFA) before

preparing an application. Part I is

entitled Community Youth Mental

Health Promotion and Violence/

Substance Abuse Prevention

Partnership Grants (GFA No. SM00–

004). Part II is entitled General Policies

and Procedures Applicable to all

SAMHSA Applications for

Discretionary Grants and Cooperative

Agreements.

Activity Application

deadline Estimated funds available, FY 2000 Estimated No.of awards Project period

Coalitions for Prevention Grants ............... 7/12/00 $6.0 million ................................................ *25 2–3 years.*

* Applicants may apply for one of two types of grants under this announcement. It is estimated that there will be 13 awards for the Planning

and Partnership Development Grants ranging from $150,000 to $200,000 in total costs and approximately 12 awards for the Partnership Resource and Infrastructure Support Monies (PRISM) ranging from $300,000 to $350,000. Support may be requested for a period of up to 2 years

for Planning and Partnership Development Grants and up to 3 years for the Partnership Resource and Infrastructure Support Monies (PRISM).