11212 Federal Register / Vol. 62, No. 47 / Tuesday, March 11, 1997 / Notices

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Service, 370 L’Enfant Promenade, S.W.,

Washington, D.C. 20447, Attn: ACF

Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Wendy Taylor.

Dated: March 5, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–6000 Filed 3–10–97; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 93N–0190]

Padam C. Bansal; Grant of Special

Termination; Final Order Terminating

Debarment

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) granting special

termination of the debarment of Dr.

Padam C. Bansal, 9 Powelson Lane,

Bridgewater, NJ 08807. FDA bases this

order on a finding that Dr. Bansal has

provided substantial assistance in the

investigations or prosecutions of

offenses relating to a matter under

FDA’s jurisdiction, and that special

termination of Dr. Bansal’s debarment

serves the interest of justice and does

not threaten the integrity of the drug

approval process.

EFFECTIVE DATE: March 11, 1997.

ADDRESSES: Comments should reference

Docket No. 93N–0190 and be sent to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Diane Sullivan-Ford, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 29, 1993

(58 FR 62674), Dr. Padam C. Bansal, the

former Director of Research and

Development at Par Pharmaceutical, Inc.

(Par), was permanently debarred from

providing services in any capacity to a

person with an approved or pending

drug product application under sections

306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of

the act (21 U.S.C. 335a(c)(1)(B),

(c)(2)(A)(ii), and 321(dd)). The

debarment was based on FDA’s finding

that Dr. Bansal was convicted of a

felony under Federal law for conduct

relating to the development or approval

of any drug product, or otherwise

relating to the regulation of a drug

product (section 306(a)(2) of the act). On

December 29, 1993, Dr. Bansal applied

for special termination of debarment,

under section 306(d)(4) of the act, as

amended by the Generic Drug

Enforcement Act.

Under section 306(d)(4)(C) and (D) of

the act, FDA may limit the period of

debarment of a permanently debarred

individual if the agency finds that: (1)

The debarred individual has provided

substantial assistance in the

investigation or prosecution of offenses

described in subsections (a) or (b) of

section 306 of the act or relating to a

matter under FDA’s jurisdiction; (2)

termination of the debarment serves the

interest of justice; and (3) termination of

the debarment does not threaten the

integrity of the drug approval process.

Special termination of debarment is

discretionary with FDA.

FDA considers a determination by the

Department of Justice concerning the

substantial assistance of a debarred

individual conclusive in most cases. Dr.

Bansal fully cooperated with the

Department of Justice investigations and

prosecutions of others within Par, as

substantiated by two letters received by

FDA from the Maryland U.S. Attorney’s

Office. Accordingly, FDA finds that Dr.

Bansal provided substantial assistance

as required by section 306(d)(4)(C) of

the act.

The additional requisite showings,

i.e., that termination of debarment

serves the interest of justice and poses

no threat to the integrity of the drug

approval process, are difficult standards

to satisfy. In determining whether these

have been met, the agency weighs the

significance of all favorable and

unfavorable factors in light of the

remedial, public health-related purposes

underlying debarment. Termination of

debarment will not be granted unless,

weighing all favorable and unfavorable

information, there is a high level of

assurance that the conduct that formed

the basis for the debarment has not

recurred and will not recur, and that the

individual will not otherwise pose a

threat to the integrity of the drug

approval process.

Based on a thorough analysis of the

available evidence, Dr. Padam C. Bansal

has demonstrated that termination of his

debarment serves the interest of justice

and will not pose a threat to the

integrity of the drug approval process.

Under section 306(d)(4)(D) of the act,

the period of debarment of an

individual who qualifies for special

termination may be limited to less than

permanent but to no less than 1 year. Dr.

Bansal’s period of debarment has lasted

more than 1 year. Accordingly, the

Deputy Commissioner for Operations,

under section 306(d)(4) of the act and

under authority delegated to him (21

CFR 5.20), finds that Dr. Padam C.

Bansal’s application for special

termination of debarment should be

granted, and that the period of

debarment should terminate

immediately, thereby allowing him to

provide services in any capacity to a

person with an approved or pending

drug product application. The Deputy

Commissioner for Operations further

finds that because the agency is granting

Dr. Bansal’s application, an informal

hearing under section 306(d)(4)(C) of the

act is unnecessary.

As a result of the foregoing findings,

Dr. Padam C. Bansal’s debarment is

terminated, effective (insert date of

publication in the Federal Register)

(section 306(d)(4)(C) and (D) of the act).

Dated: February 27, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–5964 Filed 3–10–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93N–0252]

Atul Shah; Grant of Special

Termination; Final Order Terminating

Debarment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

order under the Federal Food, Drug, and

Cosmetic Act (the act) granting special

termination of the debarment of Dr. Atul

Shah, 20 Hampton Hollow Dr.,

Perrineville, NJ 08535. FDA bases this

order on a finding that Dr. Shah has