Federal Register / Vol. 65, No. 122 / Friday, June 23, 2000 / Notices 39149

comments is available as described in

Units I.B.1. and I.B.2.

IV. Policies Not Rules

The policy document discussed in

this notice is intended to provide

guidance to EPA personnel and

decision-makers, and to the public. As

a guidance document and not a rule, the

policy in this guidance is not binding on

either EPA or any outside parties.

Although this guidance provides a

starting point for EPA risk assessments,

EPA will depart from its policy where

the facts or circumstances warrant. In

such cases, EPA will explain why a

different course was taken. Similarly,

outside parties remain free to assert that

a policy is not appropriate for a specific

pesticide or that the circumstances

surrounding a specific risk assessment

demonstrate that a policy should be

abandoned.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests.

Dated: June 15, 2000.

Susan H. Wayland,

Acting Assistant Administrator for

Prevention, Pesticides and Toxic Substances.

[FR Doc. 00–15917 Filed 6–22–00; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL HOUSING FINANCE BOARD

Sunshine Act Meeting: Announcing an

Open Meeting of the Board

TIME AND DATE: 10 a.m., Friday, June 23,

2000.

PLACE: Board Room, Second Floor,

Federal Housing Finance Board, 1777 F

Street, N.W., Washington, D.C. 20006.

STATUS: The entire meeting will be open

to the public.

MATTERS TO BE CONSIDERED DURING

PORTIONS OPEN TO THE PUBLIC: 

• Final Rule: Amendments to

Membership Regulation and Advances

Regulation.

• Final Rule: Election of Federal

Home Loan Bank Directors.

• Resolution Required by Section 608

of the Federal Home Loan Bank

Modernization Act Certifying that

Withdrawal of Bank System Members

will not cause the Bank System to fail

to meet its REFCorp Obligations.

CONTACT PERSON FOR MORE INFORMATION:

Elaine L. Baker, Secretary to the Board,

(202) 408–2837.

William W. Ginsberg,

Managing Director.

[FR Doc. 00–16009 Filed 6–20–00; 4:59 pm]

BILLING CODE 6725–01–P

FEDERAL HOUSING FINANCE BOARD

Sunshine Act Meeting: Announcing an

Open Meeting of the Board

TIME AND DATE: 2 P.M., Thursday, June

29, 2000.

PLACE: Board Room, Second Floor,

Federal Housing Finance Board 1777 F

Street, N.W., Washington, D.C. 20006.

STATUS: The entire meeting will be open

to the public.

MATTERS TO BE CONSIDERED DURING

PORTIONS OPEN TO THE PUBLIC: 

• Final Rule: Federal Home Loan

Bank Acquired Member Assets, Core

Mission Activities, Investments and

Advances.

• Final Rule: Amendments to

Advances and Other Regulations to

Implement Gramm-Leach-Bliley Act

Collateral Provisions and Make Related

Revisions.

CONTACT PERSON FOR MORE INFORMATION:

Elaine L. Baker, Secretary to the Board,

(202) 408–2837.

William W. Ginsberg,

Managing Director.

[FR Doc. 00–16010 Filed 6–20–00; 4:59 pm]

BILLING CODE 6725–01–P

FEDERAL RETIREMENT THRIFT

INVESTMENT BOARD

Employee Thrift Advisory Council;

Amended Meeting

FR.00–14739 appearing on page

36906 in the Federal Register of

Monday, June 12, 2000, change the time

of the meeting from 10 a.m. to 2 p.m. on

Tuesday, June 27, 2000. Everything else

remains the same.

Dated: June 20, 2000.

Elizabeth S. Woodruff,

General Counsel, Federal Retirement Thrift

Investment Board.

[FR Doc. 00–15958 Filed 6–22–00; 8:45 am]

BILLING CODE 6760–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Research Integrity Office Findings;

Lingxun Duan, M.D.

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: Notice is hereby given that

based on oversight by the Office of

Research Integrity (ORI) and decision by

the Assistant Secretary for Health, the

U.S. Public Health Service has taken

final action in the following case:

Lingxun Duan, M.D., Thomas

Jefferson University: The U.S. Public

Health Service (PHS) alleges that Dr.

Duan, former Research Assistant

Professor of Medicine, Division of

Infectious Diseases, Department of

Medicine, Jefferson Medical College,

Thomas Jefferson University, engaged in

scientific misconduct by reporting

research that was inconsistent with

original data or could not be supported

because original data were not retained.

The research in question was supported

by a National Institute of Allergy and

Infectious Diseases (NIAID), National

Institutes of Health (NIH), grant, R01

AI36552, entitled ‘‘Intracellular

antibodies and HIV 1.’’

Specifically, the research in question

was reported in an NIAID, NIH, grant

application; in an FDA-approved phase

I gene therapy investigational new drug

(IND) application entitled ‘‘Intracellular

immunization against HIV—1 infection

using an anti-rev single chain variable

fragment (SFV);’’ and in two

publications: (1) Duan, L., Bagasra, O.,

Laughlin, M.A., Oakes, J.W., &

Pomerantz, R.J., ‘‘Potent inhibition of

human immunodeficiency virus type I

replication by an intracellular anti-Rev

single chain antibody,’’ Proc. Natl.

Acad. Sci. USA 91:5075–5079, 1994;

and (2) Levy-Mintz, P., Duan, L., Zhang,

H., Hu, B., Dornadula, G., Zhu, M.,

Kulkosky, J., Bizub-Bender, D., Skalka,

A.M., and Pomerantz, R.J., ‘‘Intracellular

expression of single-chain variable

fragments to inhibit early stages of the

viral life cycle by targeting human

immunodeficiency virus type 1

integrase,’’ J. Virol. 70:8821–8823, 1996.

Dr. Duan denies all allegations of

scientific misconduct and contends that

some of his original data is missing.

Both Dr. Duan and PHS are desirous of

concluding this matter without further

expense of time and other resources.

Thus, Dr. Duan has entered into a

Voluntary Exclusion Agreement

(Agreement) with PHS, in which Dr.

Duan has voluntarily agreed:

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