42998 Federal Register / Vol. 62, No. 154 / Monday, August 11, 1997 / Notices

modification of the standards to

accommodate the technological advances.

Matters To Be Discussed: Agenda items

include Genetics Testing; Proficiency Testing

(PT) Implementation; Data measuring the

effectiveness of CLIA in improving laboratory

performance.

Agenda items are subject to change.

Contact Person: John Ridderhof, Dr.P.H.,

Division of Laboratory Systems, Public

Health Practice Program Office, CDC, 4770

Buford Highway, NE, MS G25, Atlanta,

Georgia 30341–3724, telephone 770/488–

4674.

Dated: August 5, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–21100 Filed 8–8–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 94N–0193]

Robert E. Sacher; Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

order under the Federal Food, Drug, and

Cosmetic Act (the act) permanently

debarring Dr. Robert E. Sacher, 117 Deer

Path Lane, Weston, MA 02193, from

providing services in any capacity to a

person that has an approved or pending

drug product application. FDA bases

this order on a finding that Dr. Sacher

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product under the

act. Dr. Sacher has failed to request a

hearing and, therefore, has waived his

opportunity for a hearing concerning

this action.

EFFECTIVE DATE: August 11, 1997.

ADDRESSES: Application for termination

of debarment to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Leanne Cusumano, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

On June 1, 1992, the U.S. district

court for the District of Massachusetts

entered judgment against Dr. Robert E.

Sacher for one count of corruptly

influencing, obstructing, and impeding

the due administration of justice in an

administrative proceeding of FDA, a

Federal felony under 18 U.S.C. 1505.

As a result of this conviction, FDA

served Dr. Sacher by certified mail on

November 25, 1994, a notice proposing

to permanently debar him from

providing services in any capacity to a

person that has an approved or pending

drug product application, and offered

him an opportunity for a hearing on the

proposal. The proposal was based on a

finding, under section 306(a)(2)(B) of

the act (21 U.S.C. 335a(a)(2)(B)), that Dr.

Sacher was convicted of a felony under

Federal law for conduct relating to the

regulation of a drug product. Dr. Sacher

did not request a hearing. His failure to

request a hearing constitutes a waiver of

his opportunity for a hearing and a

waiver of any contentions concerning

his debarment.

II. Findings and Order

Therefore, the Director of the Center

for Drug Evaluation and Research, under

section 306(a) of the act, and under

authority delegated to her (21 CFR

5.99(b)), finds that Dr. Robert E. Sacher

has been convicted of a felony under

Federal law for conduct relating to the

regulation of a drug product.

As a result of the foregoing finding,

Dr. Robert E. Sacher is permanently

debarred from providing services in any

capacity to a person with an approved

or pending drug product application

under sections 505, 507, 512, or 802 of

the act (21 U.S.C. 355, 357, 360b, or

382), or under section 351 of the Public

Health Service Act (42 U.S.C. 262),

effective August 11, 1997 (sections

306a(c)(1)(B) and (c)(2)(A)(ii) and

201(dd) of the act (21 U.S.C. 321(d))).

Any person with an approved or

pending drug product application who

knowingly uses the services of Dr.

Sacher, in any capacity, during his

period of debarment, will be subject to

civil money penalties (section 307(a)(6)

of the act). If Dr. Sacher, during his

period of debarment, provides services

in any capacity to a person with an

approved or pending drug product

application, he will be subject to civil

money penalties (section 307(a)(7) of the

act). In addition, FDA will not accept or

review any abbreviated new drug

applications or abbreviated antibiotic

drug applications from Dr. Sacher

during his period of debarment.

Any application by Dr. Sacher for

termination of debarment under section

306(d)(4) of the act should be identified

with Docket No. 94N–0193 and sent to

the Dockets Management Branch

(address above). All such submissions

are to be filed in four copies. The public

availability of information in these

submissions is governed by 21 CFR

10.20(j). Publicly available submissions

may be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: July 18, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–21085 Filed 8–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Notice of CRADA Opportunities

National Cancer Institute: Nitric

Oxide Technology: Opportunities for

Cooperative Research and Development

Agreements (CRADAs) for the

development of medicinal agents useful

for treating a variety of disorders arising

from localized physiologic deficiencies

of the multifaceted bioregulatory

molecule, nitric oxide. The NCI is

looking for multiple CRADA

Collaborators to develop independently

different aspects of their nitric oxide

technology.

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice for CRADA

opportunities.

SUMMARY: Pursuant to the Federal

Technology Transfer Act of 1986 (FTTA,

15 U.S.C. § 3710, and 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)

seeks Cooperative Research and

Development Agreements (CRADAs)

with pharmaceutical or biotechnology

companies to develop applications of

nitric oxide technology. Any CRADA for

the biomedical use of this technology

will be considered. The CRADAs would

have an expected duration of one (1) to

five (5) years. The goals of the CRADAs

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