[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Pages 45667-45668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22856]


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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