Inspections, Compliance, Enforcement, and Criminal Investigations

10/20/1997

[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]


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.


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:

  1. 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.

  2. 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

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