29236 Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices

Noncompetitive Antagonists of

Dopamine Reuptake Inhibitors’’, based

on U.S. Provisional Patent Application

Serial No. 60/030,248, filed October 31,

1996, to Trillium Neuroscience Inc.,

having a place of business in

Washington, DC. The patent rights in

this invention have been assigned to the

United States of America.

DATES: Only written comments and/or

application for a license which are

received by the NIH Office of

Technology Transfer on or before July

27, 1998 will be considered.

ADDRESSES: Requests for a copy of the

patent applications, inquiries,

comments and other materials relating

to the contemplated license should be

directed to: Leopold J. Luberecki, Jr.,

J.D., Technology Licensing Specialist,

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Box 13, Rockville, MD

20852–3804; Telephone: (301) 496–

7735, ext. 223; Facsimile: (301) 402–

0200.

SUPPLEMENTARY INFORMATION: In an

effort to develop an efficacious

treatment for cocaine addiction, this

invention describes sustained-release

derivatives of hydroxylated analogs of

substituted 1-(2-

[bis(aryl)methoxy]ethyl)-piperazines

and -homopiperazines. These

compounds bind to the dopamine

transporter but do not inhibit dopamine

reuptake, thereby providing a sustained

increase in the level of extracellular

dopamine and providing the drug

abuser with some relief from drug

craving due to dopamine deficiency, yet

they simultaneously inhibit cocaine

from further elevating the level of

extracellular dopamine and increasing

the probability of additional toxic side

effects. The invention provides the

sustained-release derivatives,

pharmaceutical compositions

comprising the same, and a method of

using such sustained released

derivatives as a treatment for cocaine

addiction.

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 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.

The field of use may be limited to the

use of the invention for the

development of pharmaceutical

compounds to treat drug addiction.

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: May 18, 1998.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 98–14139 Filed 5–27–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Institute of Environmental

Health Sciences National Toxicology

Program; Request for Comments on

Chemicals Nominated to the National

Toxicology Program (NTP) for

Toxicology Studies—

Recommendations by the Interagency

Committee for Chemical Evaluation

and Coordination (ICCEC) for Study,

No Studies, or Deferral to Obtain

Additional Information

Background

As part of an effort to earlier inform

the public and obtain input into the

selection of chemicals for evaluation,

the National Toxicology Program (NTP)

routinely seeks public input on (1)

chemicals nominated to the Program for

toxicological studies, and (2) the testing

recommendations made by the ICCEC,

the Federal interagency committee that

serves as the first level of review for

nominations. Summaries of the ICCEC’s

recommendations and public comments

received on the nominated chemicals

are next presented to the NTP Board of

Scientific Counselors (the Program’s

external scientific advisory committee)

for their review and comment in an

open, public session. The ICCEC

recommendation, Board

recommendations, and public

comments are incorporated into the

recommendations that are then

submitted to the NTP Executive

Committee, the Federal interagency

policy oversight body. The Executive

Committee reviews and approves action

to move forward to test, defer, or delete

on each of the nominated chemicals for

the various types of study, and

recommends priorities.

Request for Comment

Interested parties are encouraged to

comment on the recommendations and

provide information on the chemicals

listed below. The Program would

welcome receiving toxicology and

carcinogenesis information from

completed or ongoing studies, and

information on planned studies, as well

as current production data, human

exposure information, use patterns, and

environmental occurrence for any of the

chemicals listed in this announcement.

To provide comments or information,

please contact Dr. William Eastin at the

address given below within 60 days of

the appearance of this announcement.

At their meeting on April 23, 1998,

the ICCEC reviewed 18 agents

nominated to the NTP for consideration

to study and recommended 11

chemicals for absorption, toxicity, or

carcinogenicity studies, recommended

that no studies be performed on 4

chemicals, and deferred 3 substances

pending receipt of test data from other

organizations or from related studies in

progress by the NTP, and information

on production, exposure, and use

patterns. Chemicals with CAS numbers,

nomination source types of studies

under consideration, and other

information are given in the following

tables.

Contact may be made by mail to: Dr.

William Eastin, NIEHS/NTP, P.O. Box

12233, Research Triangle Park, North

Carolina 27709; by telephone at (919)

541–7941; by FAX at (919) 541–3687; or

by email at Eastin@NIEHS.GOV.

Dated: May 18, 1998.

Samuel H. Wilson,

Deputy Director, National Toxicology

Program.

Attachment
Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices 29237

CHEMICALS NOMINATED TO THE NTP FOR STUDY, AND TESTING RECOMMENDATIONS MADE BY THE ICCEC ON APRIL 23,

1998

Chemical [CAS No.]

Nominated

by

Recommended for Study rationale; other information

Chemicals Recommended for Testing

Bixin (Annatto) [6973–79–

5 (1393–63–1)].

NCI —Genetic toxicity

—Subchronic toxicity

—Widespread human exposure.

—Natural product.

Diethyl amine [109–89–7] NIEHS —Subchronic toxicity

—Ocular toxicity

—Carcinogenicity

—High production.

—Also present in foods.

—Widespread human exposure.

Dihydroxyacetone [96–

26–4].

NCI —Skin absorption —Widely used as component of tanning compounds.

—Natural product of metabolism.

Fenchone, α-, l-, d-,

[1195–79–5 (α-); 7787–

20–4 (l-); 4695–62–9

(d-)].

NCI —Genetic toxicity

—Defer prechronic studies pending completion and

evaluation of NTP camphor study

—Natural product.

—Used as flavoring.

—Widespread human exposure.

—Production, usage, and exposure data requested.

Isopropylamine [75–31–0] NIEHS —Subchronic toxicity

—Ocular toxicity

—Carcinogenicity (through TSCA–ITC)

—High production.

—Also present in foods.

—Widespread human exposure.

Pulegone [89–82–7]

Menthofuran (494–90–

6].

NIEHS —Toxicologic characterization

—Carcinogenicity study with pulegone

—Natural product.

—Used as flavoring.

—Widespread human exposure.

—Menthofuran is a metabolite of pulegone.

α-Solanine [20562–02–1 (1) —Carcinogenicity —Natural product.

—Widespread human exposure.

—Known human toxicant.

α-Thujone (546–80–5] ..... NCI —Genetic toxicity

—Neurotoxicity

—Subchronic toxicity

—Multigeneration reproductive toxicity

—Natural product.

—Component of food flavoring additives.

—Banned as direct food additive by FDA.

Triethylamine [121–44–8] UAW —Subchronic toxicity

—Ocular toxicity

—Carcinogenicity (through TSCA–ITC)

—High production.

—Known worker exposure.

Trigonelline [535–83–1] ... (1) —Toxicologic characterization

—Metabolic differences between humans and rodents

—Plant hormone.

—Widespread human exposure through diet.

1Private Individual.

Chemical [CAS No.] Nominated by Recommended for Rationale; other information

Chemicals For Which No Testing Is Recommended

β-Caryophyllene [87–

44–5].

NCI ..................................... —Subchronic toxicity; metabolism; cell

transformation; consider for carcinogenicity.

—Insufficient use to warrant testing.

α-Cubebene [17699–

14–8].

NCI ..................................... —metabolism ............................................... —Insufficient use to warrant testing.

Orthanilic acid [88–

21–1].

NIEHS ................................ —Carcinogenicity ......................................... —Low production; little, if any, exposure to

the population.

2-Phenethyl alcohol

(60–12–8].

(1) ........................................ —Carcinogenicity ......................................... —No suspicion for carcinogenicity based on

structure and genetic toxicity tests.

Chemicals Deferred for Additional Information

α-Chaconine [20562–

03–2].

(1) ........................................ —Carcinogenicity ......................................... —Defer testing pending results of α-solanine studies.

St John’s Wort Hypericin [548–04–9].NCI ..................................... —Carnogenicity (St. John’s Wort); genetic

toxicity and carcinogenicity (hypericin).

—Defer pending NTP evaluation of carcinogenicity testing being performed by industry.

—Herbal remedy in widespread use.

—NCI clinical trial in progress.

—Industry has completed subchronic toxicity studies and is completing a rodent

carcinogenicity study using St. John’s

Wort.

1 Private Individual.
29238 Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices

[FR Doc. 98–14138 Filed 5–27–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Fiscal Year (FY) 1998 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 Substance Abuse

Prevention (CSAP) announces the

availability of FY 1998 funds for grants

for the following activity. This activity

is discussed in more detail under

Section 4 of this notice. This notice is

not a complete description of the

activity; potential applicants must

obtain a copy of the Guidance for

Applicants (GFA) before preparing an

application.

Activity Application

deadline

Estimated

funds available

Estimated

No. of

awards

Project period

Faculty Development Program ......................................................................................... 7/28/98 $1.0M 10 3 yrs.

Note: SAMHSA also published notices of

available funding opportunities for FY 1998

in the Federal Register on January 6, 1998,

January 20, 1998, February 26, 1998, March

20, 1998, April 8, 1998, April 16, 1998, April

20, 1998, and on April 22, 1998.

The actual amount available for

awards and their allocation may vary,

depending on unanticipated program

requirements and the volume and

quality of applications. Awards are

usually made for grant periods from one

to three years in duration. FY 1998

funds for activities discussed in this

announcement were appropriated by the

Congress under Public Law No. 105–78.

SAMHSA’s policies and procedures for

peer review and Advisory Council

review of grant and cooperative

agreement applications were published

in the Federal Register (Vol. 58, No.

126) on July 2, 1993.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led national activity for setting

priority areas. The SAMHSA Centers’

substance abuse and mental health

services activities address issues related

to Healthy People 2000 objectives of

Mental Health and Mental Disorders;

Alcohol and Other Drugs; Clinical

Preventive Services; HIV Infection; and

Surveillance and Data Systems.

Potential applicants may obtain a copy

of Healthy People 2000 (Full Report:

Stock No. 017–001–00474–0) or

Summary Report: Stock No. 017–001–

00473–1) through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325

(Telephone: 202–512–1800).

General Instructions: Applicants must

use application form PHS 5161–1 (Rev.

5/96; OMB No. 0937–0189). The

application kit contains the GFA

(complete programmatic guidance and

instructions for preparing and

submitting applications), the PHS 5161–

1 which includes Standard Form 424

(Face Page), and other documentation

and forms. Application kits may be

obtained from the organization specified

for each activity covered by this notice

(see Section 4).

When requesting an application kit,

the applicant must specify the particular

activity for which detailed information

is desired. This is to ensure receipt of

all necessary forms and information,

including any specific program review

and award criteria.

The PHS 5161–1 application form and

the full text of each of the activities (i.e.,

the GFA) described in Section 4 are

available electronically via SAMHSA’s

World Wide Web Home Page (address:

http://www.samhsa.gov).

Application Submission: Unless

otherwise stated in the GFA,

applications must be submitted to:

SAMHSA Programs, Center for

Scientific Review, National Institutes of

Health, Suite 1040, 6701 Rockledge

Drive MSC–7710, Bethesda, Maryland

20892–7710*

(*Applicants who wish to use express mail

or courier service should change the zip code

to 20817.)

Application Deadlines: The deadlines

for receipt of applications are listed in

the table above. Please note that the

deadlines may differ for the individual

activities.

Competing applications must be

received by the indicated receipt date(s)

to be accepted for review. An

application received after the deadline

may be acceptable if it carries a legible

proof-of-mailing date assigned by the

carrier and that date is not later than

one week prior to the deadline date.

Private metered postmarks are not

acceptable as proof of timely mailing.

Applications received after the

deadline date and those sent to an

address other than the address specified

in the GFA will be returned to the

applicant without review.

FOR FURTHER INFORMATION CONTACT:

Requests for activity-specific technical

information should be directed to the

program contact person identified for

each activity covered by this notice (see

Section 4).

Requests for information concerning

business management issues should be

directed to the grants management

contact person identified for each

activity covered by this notice (see

Section 4).

SUPPLEMENTARY INFORMATION: To

facilitate the use of this Notice of

Funding Availability, information has

been organized as outlined in the Table

of Contents below. For each activity, the

following information is provided:

• Application Deadline

• Purpose.

• Priorities.

• Eligible Applicants.

• Grants/Cooperative Agreements/

Amounts.

• Catalog of Federal Domestic

Assistance Number.

• Contacts.

• Application Kits.

Table of Contents

1. Program Background and Objectives

2. Special Concerns

3. Criteria for Review and Funding

3.1 General Review Criteria

3.2 Funding Criteria for Scored

Applications

4. Special FY 1998 Substance Abuse and

Mental Health Services Activities

4.1 Grants

4.1.1 Faculty Development Program—

Faculty Developing People, Programs,

Products and Policies for Integrated

Service Delivery

5. Public Health System Reporting

Requirements