08/11/1997

[Federal Register: August 11, 1997 (Volume 62, Number 154)]

[Notices]              

[Page 42998]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr11au97-71]

 

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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.

 

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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]

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