Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Notices 8745

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

1. Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Medicare

Provider/Supplier Enrollment

Application; Form No.: HCFA–855; Use:

This information is needed to enroll

providers/suppliers by identifying them,

verifying their qualifications and

eligibility to participate in Medicare,

and to price and pay their claims;

Frequency: Other (Initial Application/

recertification); Affected Public:

Business or other for profit, not for

profit institutions, and federal

government; Number of Respondents:

165,000; Total Annual Responses:

165,000; Total Annual Hours: 370,000.

To obtain copies of the supporting

statement and any related forms, E-mail

your request, including your address

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections should be sent

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC 20503.

Dated: February 21, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–4759 Filed 2–25–97; 8:45 am]

BILLING CODE 4126–03–P

National Institutes of Health

National Cancer Institute and the Food

and Drug Administration: Opportunity

for a Cooperative Research and

Development Agreement (CRADA) for

the Scientific and Commercial

Development of Soluble Tat Peptide

Analogs for the Inhibition of HIV

Transcription and Viral Replication

AGENCY: National Institutes of Health

and the Food and Drug Administration,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The National Cancer Institute

(NCI) and the Food and Drug

Administration (FDA), wherein the

participation of the FDA is contingent

on resolution of any apparent conflict of

interest issues, seek a company that can

collaboratively pursue the pre-clinical

and clinical development of Soluble Tat

Peptide Analogs for the Inhibition of

HIV Transcription and Viral

Replication. The National Cancer

Institute, Laboratory of Molecular

Virology (LMV) and the Food and Drug

Administration, Center for Biologics,

Laboratory of Immunochemistry, have

established that particular Soluble Tat

Peptide Analogs can inhibit the

transcription and replication of the

Human Immunodeficiency Virus in

vitro. The selected sponsor will be

selected as a CRADA partner for the codevelopment of this agent with the

National Cancer Institute and the Food

and Drug Administration for the codevelopment of this agent with the NCI

and with the FDA, wherein the

participation of the FDA is contingent

on resolution of any apparent conflict of

interest issues.

ADDRESSES: Questions about this

opportunity may be addressed to Jeremy

A. Cubert, M.S., J.D., Office of

Technology Development, NCI, 6120

Executive Blvd. MSC 7182, Bethesda,

MD 20892–7182, Phone: (301) 496–

0477, Facsimile: (301) 402–2117, from

whom further information may be

obtained. The Government has filed a

patent application related to this

CRADA opportunity. For further

information on licensing this patent

application (DHHS ref. no. E–059–96/0)

contact Cindy Fuchs, J.D., NIH Office of

Technology Transfer, 6011 Executive

Blvd., Suite 325, Rockville, MD 20852,

Phone: (301) 496–7735 (ext. 232);

Facsimile: (301) 402–0220.

DATES: In view of the important priority

of developing new agents for the

treatment of infectious disease and

related malignancies, interested parties

should notify this office in writing no

later than April 28, 1997. Respondents

will then be provided an additional 30

days for the filing of formal proposals.

SUPPLEMENTARY INFORMATION:

‘‘Cooperative Research and

Development Agreement’’ or ‘‘CRADA’’

means the anticipated joint agreement to

be entered into by NCI pursuant to the

Federal Technology Transfer Act of

1986 and amendments (including 104

P.L. 133) and Executive Order 12591 of

October 10, 1987 to collaborate on the

specific research project described

below.

The Government is seeking a

pharmaceutical company which, in

accordance with the requirements of the

regulations governing the transfer of

agents in which the Government has

taken an active role in developing (37

CFR 404.8), can further develop the

subject compounds through Federal

Food and Drug Administration approval

and to a commercially available status

to meet the needs of the public and with

the best terms for the Government. The

government has applied for a patent

application directed to Inhibition of HIV

Transcription and Viral Replication

Using Soluble Tat Peptide Analogs.

Licenses to intellectual property rights

related to this opportunity are available

from the National Institutes of Health,

Office of Technology Transfer and may

be necessary to continue development

of the technology.

The tat gene encodes an 86 amino

acid protein with a number of identified

domains including an N-terminus, a

cysteine rich, a core domain and a basic

domain. Tat, through the core region,

has been shown to interact with and

stabilize the TFIID basal transcription

factor and TFIIA preinitiation complex.

Mutations within the core domain of Tat

significantly decrease both gene

expression and viral replication.

National Cancer Institute (‘‘NCI’’) and

Food and Drug Administration (‘‘FDA’’)

studies have been directed at synthesis

of Tat peptide analogs to compete with

wild-type Tat in vivo. The NCI and FDA

synthesized soluble peptide analogs of

the HIV–1 Tat protein. These peptide

analogs inhibit transactivation of HIV,

viral replication and formation of viral

particles. The peptide analogs compete

with Tat in down-regulating Tat

transactivation and induce a ninety

percent reduction of viral particles from

infected cells in vitro. The inhibitory

peptide analogs are not toxic in vitro.

The Laboratory of Molecular Virology,

Division of Basic Sciences, NCI and the

Laboratory of Immunochemistry,

Division of Transfusion and

Transmitted Diseases, FDA are

interested in establishing a CRADA with

a company to assist in the continuing

development of these peptide analogs,

wherein the participation of the FDA is

contingent on resolution of any

apparent conflict of interest issues. The

Government will provide all available

expertise and information to date and

will jointly pursue pre-clinical and

clinical studies as required, giving the

company full access to existing data and

data developed pursuant to CRADA.

The successful company will provide

the necessary scientific, financial and

organizational support to establish

clinical efficacy and possible

commercial status of the subject

compounds.

The expected duration of the CRADA

will be two (2) to five (5) years.

The role of the National Cancer

Institute and Food and Drug
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