39150 Federal Register / Vol. 65, No. 122 / Friday, June 23, 2000 / Notices

(1) To exclude himself from any

contracting of subcontracting with any

agency of the United States government

and from eligibility for, or involvement

in, nonprocurement transactions (e.g.,

grants and cooperative agreements) of

the United States Government as

defined in 45 CFR part 76 for a period

of two (2) years, beginning on June 7,

2000;

(2) That for a period of one (1) year

after the conclusion of the voluntary

exclusion period, any institution that

submits an application for PHS support

for a research project on which his

participation is proposed or that uses

him in any capacity on PHS supported

research, or that submits a report of PHS

funded research in which Dr. Duan is

involved, must concurrently submit a

plan for supervision of his duties to the

funding agency for approval; the

supervisory plan must be designed to

ensure the scientific integrity of Dr.

Duan’s research contribution, and the

institution must also submit a copy of

the supervisory plan to ORI;

(3) To exclude himself from serving in

any advisory capacity to PHS,

including, but not limited to, service on

any PHS advisory committee, board,

and/or peer review committee, or as a

consultant for a period of two (2) years,

beginning on June 7, 2000;

(4) That he will not oppose the

submission to journals of a statement

summarizing the current state of the

science with respect to the scientific

matters at issue relating to grant R01

AI36552, which has been jointly agreed

to by Thomas Jefferson University and

the United States of America.

FOR FURTHER INFORMATION CONTACT:

Acting Director, Division of

Investigative Oversight, Office of

Research Integrity, 5515 Security Lane,

Suite 700, Rockville, MD 20852 (301)

443–5330.

Chris B. Pascal, J.D.,

Acting Director, Office of Research Integrity.

[FR Doc. 00–15900 Filed 6–22–00; 8:45 am]

BILLING CODE 4160–17–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1328]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Extension; Latex

Condoms; User Labeling; Expiration

Dating

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in theFederal Register

concerning each proposed collection of

information, including each proposed

extension of an existing information

collection, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

information collection requirements for

an expiration date on latex condom

labeling based on physical and

mechanical testing performed after

exposing the product to varying

conditions that age latex.

DATES: Submit written comments on the

collection of information by August 22,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520) Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

theFederal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Latex Condoms; User Labeling;

Expiration Dating—21 CFR 801.435

(OMB Control No. 0910–0352)—

Extension

Sections 502(a), 519, 701, and 704 of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 352(a), 360(i),

371, and 374) establish the statutory

authority to collect information under

this regulation. Section 519 of the act

describes recordkeeping, section 502(a)

misbranding, section 704 authority for

inspections, and section 701 general

administrative procedures and

regulations and hearings.

To protect the public health and

minimize the risk of device failure, latex

condoms are required to be labeled with

an expiration date, which must be

supported by data from quality control

tests demonstrating physical and

mechanical integrity of three random

lots of the same product that were

stored under accelerated and real time

conditions (§ 801.435 (21 CFR 801.435)).

The recording of shelf life testing by

condom manufacturers is used to

support the expiration dating on the

labeling of latex condoms. Information

concerning latex shelf life is necessary

to allow lay users to use these products

safely by avoiding use of products that

may have degraded. Degradation of latex

film products like latex condoms occurs

when latex is exposed to various types

of environmental conditions normally

experienced in product use, shipment,

or storage situations. The effectiveness

of latex condoms as a barrier to the

transmission of infectious agents is

dependent upon the integrity of the

latex material. The information and

records generated by condom

manufacturers under this regulation will

be used to establish an expiration date

that will inform consumers when the

product should no longer be used.

Section 510(h) of the act (21 U.S.C.

360(h)) requires that condom

manufacturers as device manufacturers

be inspected at least once in a 2-year

period. During that inspection, FDA

inspectors will review the test records

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