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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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]

 

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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