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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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08/28/1997

[Federal Register: August 28, 1997 (Volume 62, Number 167)]

[Notices]              

[Page 45667-45668]

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

[DOCID:fr28au97-82]

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N-0256]

 

Norma D. Banks; 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 Norma D. Banks, 3688 West Minarets Ave., Fresno, CA 91331,

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 Ms. Banks was convicted of a felony under Federal law for

conduct relating to the regulation of a drug product under the act. Ms.

Banks has failed to request a hearing and, therefore, has waived her

opportunity for a hearing concerning this action.

 

EFFECTIVE DATE: August 28, 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

    

Ms. Banks was employed by H. R. Cenci Laboratories, Inc. (Cenci),

as Director of Quality Assurance and Regulatory Affairs. In that

capacity, on November 17, 1993, she knowingly and willfully made false,

fictitious, and fraudulent representations in a matter within the

jurisdiction of FDA. Specifically, she misrepresented to FDA's Office

of Generic Drugs information contained in an annual report that

stability tests for three drug products manufactured by H. R. Cenci

Laboratories, Inc. (i.e., promethazine syrup with phenylephrine,

promethazine syrup with codeine, and promethazine syrup with

phenylephrine and codeine), were uniformly passing, when, in fact,

several stability test results were failing.

 

On January 25, 1996, the United States District Court for the

District of Maryland entered judgment against Ms.

 

[[Page 45668]]

 

Banks for one count of knowingly and willfully making false,

fictitious, and fraudulent statements and representations to a Federal

agency as to material facts, a Federal felony under 18 U.S.C. 1001.

 

As a result of this conviction, FDA served Ms. Banks by certified

mail on September 26, 1996, a notice proposing to permanently debar her

from providing services in any capacity to a person that has an

approved or pending drug product application, and offered her 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 Ms. Banks was convicted of a felony under Federal

law for conduct relating to the regulation of a drug product. Ms. Banks

did not request a hearing. Her failure to request a hearing constitutes

a waiver of her opportunity for a hearing and a waiver of any

contentions concerning her debarment.

 

II. Findings and Order

    

Therefore, the Director, 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 Ms. Norma D. Banks 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, Ms. Norma D. Banks is

permanently debarred from providing services in any capacity to a

person with an approved or pending drug product application under

section 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 28, 1997 (sections 306(c)(1)(B) and

(c)(2)(A)(ii) and 201(dd) of the act (21 U.S.C. 321(dd)). Any person

with an approved or pending drug product application who knowingly uses

the services of Ms. Banks in any capacity, during her period of

debarment, will be subject to civil money penalties (section 307(a)(6)

of the act (21 U.S.C. 335b(a)(6))). If Ms. Banks, during her period of

debarment, provides services in any capacity to a person with an

approved or pending drug product application, she 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 submitted by or with the

assistance of Ms. Banks during her period of debarment.

 

Any application by Ms. Banks for termination of debarment under

section 306(d)(4) of the act should be identified with Docket No. 96N-

0256 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: August 12, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

[FR Doc. 97-22856 Filed 8-27-97; 8:45 am]

BILLING CODE 4160-01-F