8746 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Notices

Administration, wherein the

participation of the FDA is contingent

on resolution of any apparent conflict of

interest issues, includes the following:

1. Determine the stability, half-life,

and distribution of the Tat peptides

upon delivery into cells.

2. Determine the mechanism of the

Tat peptide inhibition.

3. Determine the inhibitory effect of

peptides on human ‘‘primary’’ Tlymphocytic and monocytic cells

infected with various HIV–1 clades

(subtypes A, G, O, M).

4. Determine the inhibitory effect of

peptide derivatives on Kaposi’s sarcoma

primary cells.

5. Determine the effective dose of Tat

peptide analogs in combination with

other anti-retroviral drugs.

6. Conduct in vivo testing of

appropriate compounds and/or peptide

analogs.

7. Evaluate in vivo test results.

8. Prepare manuscripts for

publication.

The role of the collaborator, includes

the following:

1. Synthesize soluble organic

compounds using peptide mimetics to

mimic the inhibitory activity of the

soluble analogs.

2. Determine the mechanism of the

Tat peptide inhibition.

3. Establish a suitable non-invasive

peptide delivery system for the

preclinical and animal model studies.

4. Determine the effective dose of Tat

peptide analogs in combination with

other anti-retroviral drugs.

5. Determine the stability, half-life,

and distribution of the Tat peptides

upon delivery into cells.

6. Conduct in vivo testing of

appropriate compounds and/or peptide

analogs.

7. Evaluate in vivo test results.

8. Develop vehicle for delivery of

compounds to patients.

9. Conduct pre-clinical and clinical

trials of appropriate candidate

compounds and/or peptide analogs.

10. Prepare manuscripts for

publication.

Criteria for choosing the collaborator

include its demonstrated experience

and commitment to the following:

1. The aggressiveness of the

development plan, including the

appropriateness of milestones and

deadlines for preclinical and clinical

development.

2. Scientific expertise in and

demonstrated commitment to the

development of drug delivery systems.

3. Experience in preclinical and

clinical drug development.

4. Experience and ability to produce,

package, market and distribute

pharmaceutical products.

5. Experience in the monitoring,

evaluation and interpretation of the data

from investigational agent clinical

studies under an IND.

6. A willingness to cooperate with the

NCI and FDA in the collection,

evaluation, publication and maintaining

of data from pre-clinical studies and

clinical trials regarding the subject

compounds.

7. Provision of defined financial and

personnel support for the CRADA to be

mutually agreed upon.

8. An agreement to be bound by the

DHHS rules involving human and

animal subjects.

9. Scientific expertise in and

demonstrated commitment to the

treatment of HIV infection and related

disorders.

10. Provisions for equitable

distribution of patent rights to any

CRADA inventions. Generally the rights

of ownership are retained by the

organization which is the employer of

the inventor, with (1) an irrevocable,

nonexclusive, royalty-free license to the

Government and (2) an option for the

collaborator to elect an exclusive or

nonexclusive license to Government

owned rights under terms that comply

with the appropriate licensing statutes

and regulations.

Dated: February 7, 1997.

Thomas D. Mays,

Director, Office of Technology Development,

OD, NCI.

[FR Doc. 97–4742 Filed 2–25–97; 8:45 am]

BILLING CODE 4140–01–M

National Institutes of Health (NIH)

Notice of a Meeting of the Office of

AIDS Research Advisory Council

Pursuant to Public Law 92–463,

notice is hereby given of the Fourth

meeting of the Office of AIDS Research

Advisory Council (OARAC) on Friday,

March 14, 1997, at the National

Institutes of Health, 9000 Rockville

Pike, Building 31, C Wing, Sixth Floor,

Conference Room 6. The meeting will be

open to the public from 8:30 am to 3:30

pm.

The Office of AIDS Research is

responsible for the planning,

coordination, and evaluation of the NIH

AIDS research program. The OARAC

was established to advise the Director of

the OAR regarding these activities.

The agenda of the open meeting will

include: The FY 1998 budget request for

NIH AIDS research; presentation of the

NIH Implementation Plan in response to

the Report of the NIH AIDS Research

Program Evaluation Task Force; an

update on the NIH Panel to Define

Principles of Therapy of HIV Infection;

an update on the Prevention Science

Working Group; and presentations

regarding the new initiatives in AIDS

vaccine research.

In accordance with the provisions set

forth in section 552b(c)(9)(B), Title 5

U.S.C. and section 10(d) of the Federal

Advisory Committee Act, Public Law

92–463, the meeting will be closed to

the public from 3:45 p.m. until

adjournment for discussions of which

the premature disclosure could impede

implementation of recommendations.

Copies of the meeting agenda and the

roster of council members will be

furnished upon request by Jeannette R.

De Lawter, Program Analyst, Office of

AIDS Research, National Institutes of

Health, Building 31, Room 4B54, 9000

Rockville Pike, Bethesda, MD 20892,

Phone (301) 402–3357, Fax (301) 402–

3360. Any individual who requires

special assistance, such as sign language

interpretation or other reasonable

accommodations, should contact Mrs.

De Lawter no later than March 6.

Dated: February 21, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–4735 Filed 2–25–97; 8:45 am]

BILLING CODE 4140–01–M

National Cancer Institute; Notice of

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 advisory committee

meetings of the National Cancer

Institute.

The meetings will be open to the

public as indicated below, with

attendance by the public limited to

space available. Individuals who plan to

attend and need special assistance, such

as sign language interpretation or other

reasonable accommodations, should

contact Ms. Cynthia Morgan, Committee

Management Specialist, at (301) 496–

5708 in advance of the meetings.

A portion of the meetings will be

closed to the public in accordance with

the provisions set forth in sections

552b(c)(4), 552b(c)(6), and 552(c)(9)(B),

Title 5, U.S.C. and section 10(d) of

Public Law 92–463, for the review,

discussion and evaluation of individual

programs and for discussion of issues

pertaining to programmatic areas and/or

NCI personnel. These discussions could

reveal confidential trade secrets or

commercial property such as patentable

material, and personal information

concerning the individuals associated

with the programs, including

consideration of personnel