54462 Federal Register / Vol. 62, No. 202 / Monday, October 20, 1997 / Notices

Dated: October 1, 1997.

Barbara M. Williams,

Deputy Standard and Optional Forms

Management Officer.

[FR Doc. 97–27648 Filed 10–17–97; 8:45 am]

BILLING CODE 6820–34–M

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:

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee Meeting;

Amendment of Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

amendment to the notice of meeting of

the Cardiovascular and Renal Drugs

Advisory Committee. This meeting was

announced in the Federal Register of

September 18, 1997. The amendment is

being made to: Remove the second

agenda item scheduled on October 23,

1997; add a closed session to the agenda

scheduled on October 23, 1997; and

provide a new location site for this

closed session. There are no other

changes. This amendment will be

announced at the beginning of the open

portion of the meeting.

FOR FURTHER INFORMATION CONTACT: Joan

C. Standaert, Center for Drug Evaluation

and Research (HFD–110), 419–259–

6211, or Danyiel D’Antonio (HFD–21),

301–443–5455, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12533.

Please call the Information Line for upto-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 18, 1997

(62 FR 49015), FDA announced that a

meeting of the Cardiovascular and Renal

Drugs Advisory Committee would be

held on October 23 and 24, 1997. This

amendment is to provide an update to

the information provided earlier

pertaining to the October 23, 1997,

meeting day. There are no changes for

the October 24, 1997, meeting day. On

page 49015, beginning in column 3,

portions of the notice pertaining to the

October 23, 1997, meeting day are

amended to read as follows:

Location: October 23, 1997, 8:30 a.m.

to 2 p.m., National Institutes of Health,

Clinical Center, Bldg. 10, Jack Masur

Auditorium, 9000 Rockville Pike,

Bethesda, MD.