Federal Register / Vol. 65, No. 122 / Friday, June 23, 2000 / Notices 39151

used to support the expiration date in

order to ensure that the expiration date

is accurate.

The respondents to this collection of

information are domestic and foreign

condom manufacturers.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Hours per Response Total Hours

801.435 45 1 45 96 4,320

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The number of domestic

establishments was estimated by

reviewing the FDA data base of

registered medical device manufacturers

to arrive at 5 domestic and 40 foreign

condom manufacturers. Based upon

conversations with condom

manufacturers, FDA field personnel,

and comments received from the public

during this collections initial approval,

FDA determined the number hours to

complete labeling and testing of

condoms to be 96 hours per respondent.

Dated: June 15, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–15865 Filed 6–22–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Children’s Hospitals Graduate Medical

Education (CHGME) Program

Conference

On June 19, 2000, the Health

Resources and Services Administration

(HRSA) published a notice in the

Federal Register announcing the

Children’s Hospitals Graduate Medical

Education (CHGME) Program (65 FR

37985). Interested parties are invited to

attend a briefing conference on July 7,

2000, from 1 p.m. to 3 p.m. EDT in

conference room D in the Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland 20857. Parties may also

participate in the conference by

telephone. To do so, dial: 800–545–4387

or 700–991–1738 (for Federal

Government employees), then enter the

access code ID# 28353. Telephone

participants should call by 12:45 p.m.

The conference is to provide

information on the topics contained in

the CHGME notice: proposed eligibility

criteria, funding factors and

methodology, and performance

measures. It will include a question and

answer period.

For additional information call or

write to: F. Lawrence Clare, telephone:

(301) 443–7334; Division of Medicine

and Dentistry, Bureau of Health

Professions, Room 9–A–27, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland 20857; lclare@hrsa.gov.

Dated: June 19, 2000.

Claude Earl Fox,

Administrator.

[FR Doc. 00–15901 Filed 6–22–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute: Development

of Innovative Idiotype Tumor Vaccines

Multiple opportunities are available

for collaboration with the National

Cancer Institute (NCI), Division of

Clinical Sciences, for the pre-clinical

and clinical development of protein

and/or DNA-based idiotypic vaccines

using novel formulations, adjuvants or

delivery systems and directed against

low-grade and intermediate B-cell

lymphomas, mantle cell lymphomas or

chronic lymphocytic leukemias (CLL). It

is anticipated that because of the

magnitude and diversity of these

projects the collaboration(s) will take

the form of multiple Cooperative

Research and Development Agreements

(CRADAs). The collaboration(s) may

involve any aspect of the therapeutic

development of these tumor vaccines

from basic scientific inquiry to late stage

clinical trials.

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice of opportunities for

Cooperative Research and Development

Agreements.

SUMMARY: Pursuant to the Federal

Technology Transfer Act of 1986 (FTTA,

15 U.S.C. 3710; Executive Order 12591

of April 10, 1987 as amended by the

National Technology Transfer and

Advancement Act of 1995), the National

Cancer Institute (NCI) of the National

Institutes of Health (NIH) of the Public

Health Service (PHS) of the Department

of Health and Human Services (DHHS)

is seeking pharmaceutical or

biotechnology companies which can

effectively collaborate on the scientific

and commercial development of

idiotypic tumor vaccines for treatment

of low-grade and intermediate B-cell

lymphomas, mantle cell lymphoma or

chronic lymphocytic leukemia (CLL).

The goal of the collaboration(s) will be

the development of novel vaccine

strategies to elicit an immune response

directed against autologous idiotypic

surface immunoglobulin derived from

these tumors. Any CRADA for further

development of this technology that

focuses on preclinical or clinical studies

of idiotypic vaccines for treatment of the

indicated diseases will be considered.

The CRADA would have an expected

duration of three (3) to five (5) years.

The goals of the CRADA will include

the rapid publication of research results

and timely commercialization of

products, diagnostics, and treatments

that result from the research. The

CRADA Collaborators will have an

option to negotiate the terms of an

exclusive or nonexclusive

commercialization license to subject

inventions arising under the CRADA.

ADDRESSES: Proposals and questions

about this CRADA opportunity may be

addressed to Dr. Thomas M. Stackhouse,

Technology Development &

Commercialization Branch, National

Cancer Institute—Frederick Cancer

Research and Development Center,

Fairview Center, 1003 West Seventh

Street, Room 502, Frederick, MD 20852,

Telephone: (301) 846–5222; Facsimile:

(301) 846–6820. Scientific Inquiries may

be directed to Dr. Larry Kwak, M.D.,

Ph.D., Senior Investigator, Division of

Clinical Sciences, National Cancer

Institute, Bldg. 567, Room 205,

Frederick, MD 21702–1201, Telephone:

(301) 846–1607; Facsimile: (301) 846–

6107.

EFFECTIVE DATE: Organizations must

submit a proposal summary preferably

two pages or less, to NCI within 90 days

from date of this publication. Guidelines