[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Notices]
[Page 54117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27586]



[[Page 54117]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95N-0070]


Hedviga Herman; 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 Ms. Hedviga Herman, 1326 42d St., Brooklyn, NY 11219, 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. Herman was convicted of a felony under Federal law for conduct 
relating to the regulation of a drug product under the act. Ms. Herman 
has failed to request a hearing and, therefore, has waived her 
opportunity for a hearing concerning this action.

EFFECTIVE DATE: October 17, 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:  Christine F. Rogers, 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 September 23, 1994, the United States District Court for the 
District of Maryland entered judgment against Ms. Hedviga Herman for, 
among other counts: (1) One count of introducing adulterated drugs into 
interstate commerce, a Federal felony offense under 21 U.S.C. 331(a) 
and 333(a)(2); (2) one count of introducing unapproved new drugs into 
interstate commerce, a Federal felony offense under 21 U.S.C. 331(d) 
and 333(a)(2); and (3) one count of obstruction of an agency 
proceeding, a Federal felony offense under 18 U.S.C. 1505.
    As a result of these convictions, FDA served Ms. Herman by 
certified mail on February 20, 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 she was convicted of a felony under Federal law 
for conduct relating to the regulation of a drug product. Ms. Herman 
was provided 30 days to file objections and request a hearing. Ms. 
Herman 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)(2)(B) of the act, and under authority delegated to 
her (21 CFR 5.99), finds that Ms. Hedviga Herman 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. Hedviga Herman 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 October 17, 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. Herman, 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. Herman, 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 
submitted by or with the assistance of Ms. Herman during her period of 
debarment.
    Any application by Ms. Herman for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 95N-
0070 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: October 1, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-27586 Filed 10-16-97; 8:45 am]
BILLING CODE 4160-01-F