32014 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 / Notices

In determining whether termination

of debarment serves the interest of

justice and poses no threat to the

integrity of the drug approval process,

the agency weighs the significance of all

favorable and unfavorable factors in

light of the remedial, public healthrelated 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.

The evidence presented to FDA in

support of termination shows that,

despite the seriousness of the offense for

which Dr. Chatterji was debarred, his

conduct may have been an aberration,

his character and scientific ability

remain highly regarded by his

professional peers, and that he may

serve as a strong advocate for

compliance with current good

manufacturing practice regulations. For

these reasons, the agency finds that

termination of Dr. Chatterji’s 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.

Chatterji’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. Dulal C. Chatterji’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. Chatterji’s

application, an informal hearing under

section 306(d)(4)(C) of the act is

unnecessary.

As a result of the foregoing findings,

Dr. Dulal C. Chatterji’s debarment is

terminated effective June 11, 1998

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

act).

Dated: June 5, 1998.

Michael A. Friedman,

Acting Commissioner of Food and Drugs.

[FR Doc. 98–15555 Filed 6–10–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Circulatory

System Devices Panel of the Medical

Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on June 29 and 30, 1998, 8 a.m. to

5 p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: John E. Stuhlmuller,

Center for Devices and Radiological

Health (HFZ–450), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–443–8243,

ext. 157, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12625. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: On June 29, 1998, the

committee will discuss, make

recommendations, and vote on a

premarket approval application for an

external compression device used in

cardiopulmonary resuscitation. On June

30, 1998, the committee will discuss

and make recommendations on

permanent cardiovascular implants

such as heart valves and vascular grafts.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by June 18, 1998. Oral

presentations from the public will be

scheduled between approximately 8

a.m. and 8:30 a.m. on June 29 and 30,

1998. Near the end of committee

deliberations on both days, a 30-minute

open public session will be conducted

to address issues specific to the

submission or topic before the

committee. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before June 18, 1998, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 4, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–15556 Filed 6–10–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0489]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘(Petition for) Administrative

Reconsideration of Action’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 26, 1998 (63

FR 14717), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0192. The

approval expires on May 31, 2001.

Dated: June 5, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15602 Filed 6–10–98; 8:45 am]

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