34200 Federal Register / Vol. 66, No. 124 / Wednesday, June 27, 2001 / Notices

Officer on (202) 690–6207. Written

comments and recommendations for the

proposed information collection should

be sent directly to the OMB desk officer

designated above at the following

address: Human Resources and Housing

Branch, Office of Management and

Budget, New Executive Office Building,

Room 10235, 725 17th Street, NW.,

Washington, DC 20503.

Comments may also be sent to

Cynthia Agens Bauer, OS Reports

Clearance Officer, Room 503H,

Humphrey Building, 200 Independence

Avenue, SW., Washington, DC 20201.

Written comments should be received

within 30 days of this notice.

Dated: June 19, 2001.

Kerry Weems,

Acting Deputy Assistant Secretary, Budget.

[FR Doc. 01–16027 Filed 6–26–01; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: Notice is hereby given that

the Office of Research Integrity (ORI)

and the Assistant Secretary for Health

have taken final action in the following

case:

Kuie-Fu (Tom) Lin, D.V.M., Medical

University of South Carolina (MUSC):

Based on the report of an investigation

conducted by MUSC and additional

analysis conducted by ORI in its

oversight review, the U.S. Public Health

Service (PHS) found that Dr. Lin, a

former graduate student, Department of

Biochemistry and Molecular Biology at

MUSC, engaged in scientific misconduct

in research supported by the National

Heart, Lung, and Blood Institute

(NHLBI), National Institutes of Health

(NIH), grants R01 HL29397, ‘‘Regulation

and Function of Renal Kallikrein,’’ and

R01 HL56686, ‘‘Gene Therapy in

Experimental Hypertension and Renal

Diseases.’’

Specifically, PHS finds that Dr. Lin

engaged in scientific misconduct by:

A. Falsifying research on the

expression and effect of the human

atrial natriuretic peptide (ANP) gene in

rats reported in Hypertension 26:847–

853, 1995. Dr. Lin falsified data in the

text on page 850 that described RT-PCR

results shown in Figure 3 as obtained

from multiple control and experimental

rats, when only one rat was tested for

each group.

B. Falsifying research on the

expression and effect of the human

adrenomelullin gene in rats reported in

Hypertension Research 20:269–277,

1997. Dr. Lin falsified data in: (a) Figure

2 on page 272 by reusing Figure 2 of the

Hypertension paper cited in ‘‘A’’ above,

and falsely relabeling it as being a test

of ADM levels in experimental rats; (b)

Table 1 on page 273 by stating

concentrations of human ADM in

experimental rat tissues without

accounting for the high levels of

endogenous cross-reactive rat ADM; and

(c) Table 1 on page 273 by claiming that

the levels of human ADM seen in rat

tissues were obtained from four animals

when the values were actually obtained

from four serial dilutions of one sample.

The journal published an erratum at

22(3):229, 1999.

C. Falsifying research on the

expression and effect of the human ANP

gene in rats reported in Human Gene

Therapy 9:1429–1438, 1998. Dr. Lin

falsified data in: (a) Figure 3 on page

1431 by reusing Figure 2 of the

Hypertension paper cited in ‘‘A’’ above,

and falsely relabeling it as being based

on the use of an adenovirus vector to

deliver the ANP (gene rather than the

use of ‘‘naked DNA’’ described in the

earlier paper); (b) text on page 1433 that

stated concentrations of human ANP in

experimental rat tissues without

accounting for the high levels of

endogenous cross-reactive rat ANP; and

(c) Table 2 by making an inappropriate

calculation for the renal blood flow

(RFB) of the ‘‘AdCMV-LacZ’’ group by

altering data (from animals that should

not have been included because their

venous flow was greater than their

arterial flow), to falsely produce an

average RBF value that was significantly

different from the group receiving the

ANP vector.

All three of the questioned papers

described gene therapy models in which

the introduced gene lowered blood

pressure in hypertensive or saltsensitive rats. Dr. Lin’s falsifications

greatly enhanced the apparent

expression and effects of the introduced

ANP and ADM genes in the

experimental rats.

Dr. Lin states that he made honest

mistakes and deeply regrets his

unintentional errors in data handling.

Dr. Lin has entered into a Voluntary

Exclusion Agreement (Agreement) with

PHS in which he has voluntarily agreed:

(1) To exclude himself from any

contracting or 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 (Debarment

Regulations) for a period of three (3)

years, beginning on June 12, 2001;

(2) 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 for a period of three

(3) years, beginning on June 12, 2001;

(3) within 30 days of the effective date

of the Agreement to submit letters of

correction or retraction to:

(A) Hypertension 26:847–853, 1995:

Requesting correction of the statement

on page 850 to indicate that results on

RT–PCR of tissue extracts were obtained

with only one control and one

experimental rat, rather than the four

animals for each group claimed in the

paper;

(B) Hypertension Research 20:269–

277, 1997: Requesting retraction of

Table 1; the notice to the journal should

state that the values for human ADM in

Table 1 were incorrect because they did

not account for the high level of

endogenous ADM detected in control

tissues by the RIA, and that only a

single rat was tested rather than the four

animals claimed; and

(C) Human Gene Therapy 9:1429–

1438, 1998: Requesting retraction of

Figure 2 and correction of Table 2 to

indicate that the renal blood flow value

for the ‘‘Ad.CMV-LacZ (4% NaC1)’’ rats

was falsified. The notice to the journal

should state that Figure 2 was falsified

because it was in large part a duplicate

of a previously published figure and

was falsified both because logit values

were deliberately altered and because

the results were obtained from

experimental rats that were treated

differently from those described in the

paper. This statement should also note

that the first paragraph on page 1433

contained misleading concentrations of

human ANP in experimental tissues

because they failed to account for the

high level of cross-reactive endogenous

ANP observed by the RIA used in

control tissues.

These correction and retraction

requirements will remain on the ALERT

System until Dr. Lin sends, and ORI

receives, copies of these letters that are

consistent with the above language.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative

Oversight, Office of Research Integrity,

5515 Security Lane, Suite 700,

Rockville, MD 20852, (301) 443–5330.

Chris Pascal,

Director, Office of Research Integrity.

[FR Doc. 01–16022 Filed 6–26–01; 8:45 am]

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