Federal Register / Vol. 65, No. 238 / Monday, December 11, 2000 / Notices 77383

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:

Michael K. Hartzer, Ph.D., Oakland

University: Based on the report of an

investigation conducted by Oakland

University and additional analysis

conducted by ORI during its oversight

review, PHS found that Dr. Hartzer,

former Associate Professor of

Biomedical Sciences, Eye Institute,

Oakland University, engaged in

scientific misconduct by falsifying the

status of support materials in eight

National Eye Institute (NEI), National

Institutes of Health (NIH), grant

applications.

Specifically, Dr. Hartzer falsified the

status of 11 manuscripts in eight grant

applications by listing them as

‘‘accepted’’ or ‘‘in press’’ when the

papers had either not been subsequently

published or had been rejected. The

repetition of these actions over several

years indicates a pattern of knowingly

misrepresenting the research record.

Dr. Hartzer has accepted the PHS

finding and has entered into a Voluntary

Exclusion Agreement with PHS in

which he has voluntarily agreed for a

period of three (3) years, beginning on

November 20, 2000:

(1) That he must submit with each

PHS research application, continuing

application, or report a statement of

certification, endorsed by an

institutional official, that all

manuscripts or publications are

properly and accurately cited in the

application; the institution must also

submit a copy of the certification to ORI;

(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, or as a consultant.

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. 00–31361 Filed 12–8–00; 8:45 am]

BILLING CODE 4155–31–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1506]

Agency Information Collection

Activities; Announcement of OMB

Approval; Guidance for Industry on

How to Use E-Mail to Submit a Notice

of Final Disposition of Animals Not

Intended for Immediate Slaughter

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Guidance for Industry on How to Use

E-Mail to Submit a Notice of Final

Disposition of Animals Not Intended

For Immediate Slaughter’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 21, 2000

(65 FR 57193), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0453. The

approval expires on November 30, 2003.

A copy of the supporting statement for

this information collection is available

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: December 5, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–31480 Filed 12–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1467]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Shipment

of a Blood Product Prior to Completion

of Testing for Hepatitis B Surface

Antigen (HbsAg); and Shipment of

Blood Products Known Reactive for

HBsAg

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by January 10,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Shipment of a Blood Product Prior to

Completion of Testing for Hepatitis B

Surface Antigen (HBsAg)—(21 CFR

610.40(b)); and Shipment of Blood

Products Known Reactive for HBsAg—

(21 CFR 610.40(d)) (OMB Control

Number 0910–0168)—Extension

Under sections 351 and 361 of the

Public Health Service Act (42 U.S.C. 262

and 264), FDA prescribes standards

designed to ensure the safety, purity,

potency, and effectiveness of biological

products including blood and blood

components and to prevent the

transmission of communicable diseases.

To accomplish this, FDA requires,

among other things, that each unit of

Whole Blood or Source Plasma be tested

by a licensed serologic test for hepatitis