Federal Register / Vol. 65, No. 25 / Monday, February 7, 2000 / Notices 5875

1A review of the scientific literature on stress,

drugs of abuse, and relapse to drug use is available

upon request.

further study of the modulation of stress

responses by CRF antagonists in drug

dependent and formerly dependent

subjects and the possible relationship to

reduction of drug use or prevention of

relapse is a high priority for NIDA.1

NIDA does not currently own or have

access to a CRF antagonist with which

to undertake this line of research and

development. To this end, NIDA is

seeking collaborations with

pharmaceutical partners to evaluate CRF

antagonists in drug dependent and

formerly drug dependent subjects. NIDA

is seeking to enter into a Cooperative

Research and Development Agreement

(CRADA) with a pharmaceutical

company or its license, the purpose of

which would be to assess the effects of

CRF antagonists in drug dependent

populations. NIDA is willing to provide

both intellectual expertise and

preclinical and clinical support in a

collaboration. While NIDA would prefer

to enter into a CRADA with a company

or licensee that is already in clinical

testing phase with a CRF antagonist, it

would also entertain collaborations

involving drug candidates in the

preclinical stage of testing. NIDA’s

Medications Development Program

possesses the capacity to perform

pharmacological and toxicological

testing, pharmacokinetics, dosage form

development and clinical testing from

Phase I through Phase III testing and is

willing to apply these capacities in the

assessment of a CRF antagonist.

Selection factors of importance of

NIDA include:

(1) It is mandatory that the

collaborator have proprietary rights to

the CRF antagonist sufficient to permit

research and commercial development

for the intended field of use, i.e.,

treatment of cocaine dependence. In the

event the collaborator does not own the

CRF antagonist, collaborator must

provide appropriate documentation of a

commercialization license to the field of

use sufficient to permit the CRADA to

proceed. Collaborator must be able to

supply dosage forms of a CRF antagonist

made to FDA Good Manufacturing

Practices (GMP) standards sufficient to

permit each stage of research and

development to proceed.

(2) NIDA will consider the amount of

research and development

documentation and experience already

in the collaborator’s possession. NIDA

will sign appropriate confidential

disclosure agreements in order to review

proprietary and unpublished data.

While NIDA will consider all proposals,

it will give a higher priority to proposals

that can document a more advanced

level of development with the proposed

CRF antagonist.

(3) NIDA will consider the amount

and type of research and development

resources the collaborator proposes to

undertake as part of a proposed CRADA.

(4) NIDA will consider the

background, experience, and expertise

in medications development of the

proposed collaborator.

Dated: February 1, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 00–2628 Filed 2–4–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; Notice of Closed Meeting

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

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Center for

Research Resources Special Emphasis Panel

Comparative Medicine.

Date: February 10, 2000.

Time: 2:00 PM to 3 PM.

Agenda: To review and evaluate grant

applications.

Place: Office of Review, National Center for

Research Resources, 6705 Rockledge Drive,

Bethesda, MD 20892, (Telephone Conference

Call)

Contact Person: Sybil A. Wellstood, PHD,

Scientific Review Administrator, Office of

Review, National Center for Research

Resources, 6705 Rockledge Drive, MSC 7965,

Room 6018, Bethesda, MD 20892–7965, 301–

435–0814.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic

Assistance Program Nos. 93.306,

Comparative Medicine, 93.306; 93.333,

Clinical Research, 93.333; 93.371,

Biomedical Technology; 93.389,

Research Infrastructure, National

Institutes of Health, HHS)

Dated: January 28, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–2625 Filed 2–4–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Human Genome Research

Institute; Notice of Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of a meeting of the

National Advisory Council for Human

Genome Research.

The meeting will be open to the

public as indicated below, with

attendance limited to space available.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

notify the Contact Person listed below

in advance of the meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications

and/or contract proposals and the

discussions could disclose confidential

trade secrets or commrcial property

such as patentable material, and

personal information concerning

individuals associated with the grant

applications and/or contract proposals,

the disclosure of which would

constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Advisory

Council for Human Genome Research.

Date: February 28–29, 2000.

Open: February 28, 2000, 8:30 AM to 3:00

PM.

Agenda: Discussion of matters of program

relevance.

Place: National Institutes of Health,

Natcher Building, Conference Rooms E1 &

E2, 45 Center Drive, Bethesda, MD 20892.

Closed: February 28, 2000, 3:00 PM to

Adjournment on Tuesday, February 29, 2000.

Agenda: to review and evaluate grant

applications and/or proposals.

Place: National Institutes of Health,

Natcher Building, Conference Rooms E1&E2,

45 Center Drive, Bethesda, MD 20892.

Contact Person: Elke Jordan, Deputy

Director, National Human Genome Research

Institute, National Institutes of Health, PHS,