Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 / Notices 32013

c. Obtain informed client consent by

explaining the risks of disclosure and

the recipient’s policies and procedures

for preventing unauthorized disclosure;

d. Provide written assurance to this

effect including copies of relevant

policies; and

e. Obtain assurances of confidentiality

by agencies to which referrals are made.

Assurance of compliance with these

and other processes to protect the

confidentiality of information will be

required of all recipients. A Department

of Health and Human Services (DHHS)

certificate of confidentiality may be

required for some projects.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Addendum I (included in the

application kit).

AR98–1 Human Subjects

Requirements

AR98–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR98–9 Paperwork Reduction Act

Requirements

AR98–10 Smoke-Free Workplace

Requirements

AR98–11 Healthy People 2000

AR98–12 Lobbying Restrictions

AR98–13 Prohibition on Use of CDC

Funds for Certain Gun Control

Activities

Send all reports to: Joanne Wojcik,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–13, Atlanta, GA 30305–

2209.

I. Authority and Catalog of Federal

Domestic Assistance Number

This program announcement is

authorized under Sections 391, 392,

393, and 394 [42 U.S.C. 280b, 280b–1,

280b–1a, and 280b–2] of the Public

Health Service Act, as amended. The

Catalog of Federal Domestic Assistance

number is 93.136.

J. Where to Obtain Additional

Information

The program announcement and

application forms may be downloaded

from the Internet: www.cdc.gov (look

under funding). You may also receive a

complete application kit by calling 1–

888–GRANTS4. You will be asked to

identify the program announcement

number and provide your name and

mailing address. A complete

announcement kit will be mailed to you.

Please refer to Program

Announcement 98072 when you request

information.

If you have questions after reviewing

the forms, for business management

technical assistance, contact: Joanne

Wojcik, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office,

Announcement 98072, Centers for

Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room

300, Mailstop E–13, Atlanta, GA 30305–

2209, telephone (404) 842–6796, E-mail

address jcw6@cdc.gov.

For program technical assistance,

contact Tim Thornton, Division of

Violence Prevention, National Center for

Injury Prevention and Control, Centers

for Disease Control and Prevention

(CDC), 4770 Buford Highway, NE.,

Mailstop K–60, Atlanta, GA 30341–

3724, telephone, (770) 488–4646, E-mail

address, tnt1@cdc.gov.

Dated: June 5, 1998.

John L. Williams,

Director, Procurement and Grants Office

Centers, for Disease Control and Prevention

(CDC)

[FR Doc. 98–15541 Filed 6–10–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0003]

Dulal C. Chatterji; 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.

Dulal C. Chatterji, 308 Dalton Dr.,

Raleigh, NC 27615. FDA bases this order

on a finding that Dr. Chatterji provided

substantial assistance in the

investigations or prosecutions of

offenses relating to a matter under

FDA’s jurisdiction, and that special

termination of Dr. Chatterji’s debarment

serves the interest of justice and does

not threaten the integrity of the drug

approval process.

EFFECTIVE DATE: JUNE 11, 1998.

ADDRESSES: Comments should reference

Docket No. 96N–0003 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:

Leanne Cusumano, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

In a Federal Register notice dated

January 22, 1997 (62 FR 3297), Dr. Dulal

C. Chatterji, cofounder, part owner,

vice-president for scientific affairs, and

head of the research and development

(R&D) division at the generic drug

manufacturer Quad Pharmaceuticals,

Inc. (Quad), 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) and (c)(2)(A)(ii))

and 201(dd) of the act (21 U.S.C.

335a(c)(1)(B) and (c)(2)(A)(ii) and

321(dd)). The effective date of the

debarment was November 1, 1995,

based on Dr. Chatterji’s acquiescence to

debarment. The debarment was based

on FDA’s finding that Dr. Chatterji 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 under section 306 of the

act. On April 7, 1997, Dr. Chatterji

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)(4)(D) of the act, FDA may limit the

period of debarment of a permanently

debarred individual if the agency finds

that the debarred individual has

provided substantial assistance in the

investigation or prosecution of offenses

described in paragraph (a) or (b) of

section 306 of the act or relating to a

matter under FDA’s jurisdiction. If

substantial assistance is found, the

extent to which debarment may be

terminated will depend upon the

agency’s assessment of whether

termination will serve the interest of

justice and 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 that an individual

provided substantial assistance

conclusive in most cases. Dr. Chatterji

fully cooperated with the Department of

Justice investigations and prosecutions

of others within Quad for offenses

related to matters under FDA

jurisdiction, as substantiated by two

letters received by FDA from the U.S.

Attorney’s Office for the District of

Maryland. Accordingly, FDA finds that

Dr. Chatterji provided substantial

assistance as described under section

306(d)(4)(C) of the act.
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]

BILLING CODE 4160–01–F

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]

BILLING CODE 4160–01–F

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]

BILLING CODE 4160–01–F