[Federal Register: October 20, 1997 (Volume 62, Number 202)]
[Notices]
[Page 54462]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc97-73]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94N-0227]


Nandlal G. Rana; 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 Mr. Nandlal G. Rana, 184 Parsonage Rd., Edison, NJ 08817,
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 Mr. Rana was convicted of a felony under Federal law for
conduct relating to the regulation of a drug product under the act. Mr.
Rana failed to request a hearing and, therefore, has waived his
opportunity for a hearing concerning this action.

EFFECTIVE DATE: October 20, 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 October 5, 1993, the United States District Court for the
District of Maryland entered judgment against Mr. Nandlal G. Rana for
one count of obstructing an agency proceeding, a Federal felony under
18 U.S.C. 1505.
    As a result of this conviction, FDA served Mr. Rana by certified
mail on February 17, 1995, 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 Mr. Rana was convicted of a felony under Federal
law for conduct relating to the regulation of a drug product. Mr. Rana
was provided 30 days to file objections and request a hearing. Mr. Rana
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, 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 Mr. Nandlal G. Rana 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, Mr. Nandlal G. Rana 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 20, 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 Mr. Rana, in any capacity, during his 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 Mr. Rana, 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
submitted by or with the assistance of Mr. Rana during his period of
debarment.
    Any application by Mr. Rana for termination of debarment under
section 306(d)(4) of the act should be identified with Docket No. 94N-
0227 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. 97-27693 Filed 10-17-97; 8:45 am]
BILLING CODE 4160-01-F