Federal Register / Vol. 63, No. 112 / Thursday, June 11, 1998 / Notices 32013
c. Obtain informed client consent by If you have questions after reviewing Evaluation and Research (HFD–7), Food
explaining the risks of disclosure and the forms, for business management and Drug Administration, 5600 Fishers
the recipient’s policies and procedures technical assistance, contact: Joanne Lane, Rockville, MD 20857, 301–594–
for preventing unauthorized disclosure; Wojcik, Grants Management Specialist, 2041.
d. Provide written assurance to this Grants Management Branch, SUPPLEMENTARY INFORMATION:
effect including copies of relevant Procurement and Grants Office, In a Federal Register notice dated
policies; and Announcement 98072, Centers for January 22, 1997 (62 FR 3297), Dr. Dulal
e. Obtain assurances of confidentiality Disease Control and Prevention (CDC), C. Chatterji, cofounder, part owner,
by agencies to which referrals are made. 255 East Paces Ferry Road, NE., Room vice-president for scientific affairs, and
Assurance of compliance with these 300, Mailstop E–13, Atlanta, GA 30305– head of the research and development
and other processes to protect the 2209, telephone (404) 842–6796, E-mail (R&D) division at the generic drug
confidentiality of information will be address email@example.com. manufacturer Quad Pharmaceuticals,
required of all recipients. A Department For program technical assistance, Inc. (Quad), was permanently debarred
of Health and Human Services (DHHS) contact Tim Thornton, Division of from providing services in any capacity
certificate of confidentiality may be Violence Prevention, National Center for to a person with an approved or
required for some projects. Injury Prevention and Control, Centers pending drug product application under
The following additional for Disease Control and Prevention sections 306(c)(1)(B) and (c)(2)(A)(ii))
requirements are applicable to this (CDC), 4770 Buford Highway, NE., and 201(dd) of the act (21 U.S.C.
program. For a complete description of Mailstop K–60, Atlanta, GA 30341–
335a(c)(1)(B) and (c)(2)(A)(ii) and
each, see Addendum I (included in the 3724, telephone, (770) 488–4646, E-mail
321(dd)). The effective date of the
application kit). address, firstname.lastname@example.org.
debarment was November 1, 1995,
AR98–1 Human Subjects Dated: June 5, 1998. based on Dr. Chatterji’s acquiescence to
Requirements John L. Williams, debarment. The debarment was based
AR98–2 Requirements for Inclusion of Director, Procurement and Grants Office on FDA’s finding that Dr. Chatterji was
Women and Racial and Ethnic Centers, for Disease Control and Prevention convicted of a felony under Federal law
Minorities in Research (CDC) for conduct relating to the development
AR98–9 Paperwork Reduction Act [FR Doc. 98–15541 Filed 6–10–98; 8:45 am] or approval of any drug product, or
Requirements BILLING CODE 4163–18–P otherwise relating to the regulation of a
AR98–10 Smoke-Free Workplace drug product under section 306 of the
Requirements act. On April 7, 1997, Dr. Chatterji
AR98–11 Healthy People 2000 DEPARTMENT OF HEALTH AND applied for special termination of
AR98–12 Lobbying Restrictions HUMAN SERVICES
AR98–13 Prohibition on Use of CDC debarment under section 306(d)(4) of
Funds for Certain Gun Control the act, as amended by the Generic Drug
Food and Drug Administration
Activities Enforcement Act.
Send all reports to: Joanne Wojcik, [Docket No. 96N–0003] Under section 306(d)(4)(C) and
Grants Management Specialist, Grants (d)(4)(D) of the act, FDA may limit the
Dulal C. Chatterji; Grant of Special period of debarment of a permanently
Management Branch, Procurement and Termination; Final Order Terminating
Grants Office, Centers for Disease debarred individual if the agency finds
Debarment that the debarred individual has
Control and Prevention (CDC), 255 East
Paces Ferry Road, NE., Room 300, AGENCY: Food and Drug Administration, provided substantial assistance in the
Mailstop E–13, Atlanta, GA 30305– HHS. investigation or prosecution of offenses
2209. ACTION: Notice. described in paragraph (a) or (b) of
section 306 of the act or relating to a
I. Authority and Catalog of Federal SUMMARY: The Food and Drug matter under FDA’s jurisdiction. If
Domestic Assistance Number Administration (FDA) is issuing an substantial assistance is found, the
This program announcement is order under the Federal Food, Drug, and extent to which debarment may be
authorized under Sections 391, 392, Cosmetic Act (the act) granting special terminated will depend upon the
393, and 394 [42 U.S.C. 280b, 280b–1, termination of the debarment of Dr. agency’s assessment of whether
280b–1a, and 280b–2] of the Public Dulal C. Chatterji, 308 Dalton Dr., termination will serve the interest of
Health Service Act, as amended. The Raleigh, NC 27615. FDA bases this order justice and not threaten the integrity of
Catalog of Federal Domestic Assistance on a finding that Dr. Chatterji provided the drug approval process. Special
number is 93.136. substantial assistance in the termination of debarment is
investigations or prosecutions of discretionary with FDA.
J. Where to Obtain Additional offenses relating to a matter under FDA considers a determination by the
Information FDA’s jurisdiction, and that special Department of Justice that an individual
The program announcement and termination of Dr. Chatterji’s debarment provided substantial assistance
application forms may be downloaded serves the interest of justice and does conclusive in most cases. Dr. Chatterji
from the Internet: www.cdc.gov (look not threaten the integrity of the drug fully cooperated with the Department of
under funding). You may also receive a approval process. Justice investigations and prosecutions
complete application kit by calling 1– EFFECTIVE DATE: JUNE 11, 1998. of others within Quad for offenses
888–GRANTS4. You will be asked to ADDRESSES: Comments should reference related to matters under FDA
identify the program announcement Docket No. 96N–0003 and be sent to the jurisdiction, as substantiated by two
number and provide your name and Dockets Management Branch (HFA– letters received by FDA from the U.S.
mailing address. A complete 305), Food and Drug Administration, Attorney’s Office for the District of
announcement kit will be mailed to you. 12420 Parklawn Dr., rm. 1–23, Maryland. Accordingly, FDA finds that
Please refer to Program Rockville, MD 20857. Dr. Chatterji provided substantial
Announcement 98072 when you request FOR FURTHER INFORMATION CONTACT: assistance as described under section
information. Leanne Cusumano, Center for Drug 306(d)(4)(C) of the act.
32014 Federal Register / Vol. 63, No. 112 / Thursday, June 11, 1998 / Notices
In determining whether termination DEPARTMENT OF HEALTH AND presentations should notify the contact
of debarment serves the interest of HUMAN SERVICES person before June 18, 1998, and submit
justice and poses no threat to the a brief statement of the general nature of
integrity of the drug approval process, Food and Drug Administration the evidence or arguments they wish to
the agency weighs the significance of all present, the names and addresses of
favorable and unfavorable factors in Circulatory System Devices Panel of proposed participants, and an
light of the remedial, public health- the Medical Devices Advisory indication of the approximate time
related purposes underlying debarment. Committee; Notice of Meeting requested to make their presentation.
Termination of debarment will not be AGENCY: Food and Drug Administration, Notice of this meeting is given under
granted unless, weighing all favorable HHS. the Federal Advisory Committee Act (5
and unfavorable information, there is a U.S.C. app. 2).
high level of assurance that the conduct ACTION: Notice.
Dated: June 4, 1998.
that formed the basis for the debarment This notice announces a forthcoming Michael A. Friedman,
has not recurred and will not recur, and meeting of a public advisory committee
that the individual will not otherwise Deputy Commissioner for Operations.
of the Food and Drug Administration [FR Doc. 98–15556 Filed 6–10–98; 8:45 am]
pose a threat to the integrity of the drug (FDA). The meeting will be open to the
approval process. public.
BILLING CODE 4160–01–F
The evidence presented to FDA in Name of Committee: Circulatory
support of termination shows that, System Devices Panel of the Medical
despite the seriousness of the offense for DEPARTMENT OF HEALTH AND
Devices Advisory Committee. HUMAN SERVICES
which Dr. Chatterji was debarred, his General Function of the Committee:
conduct may have been an aberration, To provide advice and Food and Drug Administration
his character and scientific ability recommendations to the agency on
remain highly regarded by his FDA’s regulatory issues. [Docket No. 97N–0489]
professional peers, and that he may Date and Time: The meeting will be
serve as a strong advocate for Agency Information Collection
held on June 29 and 30, 1998, 8 a.m. to
compliance with current good Activities; Announcement of OMB
manufacturing practice regulations. For Approval
Location: Corporate Bldg., conference
these reasons, the agency finds that room 020B, 9200 Corporate Blvd., AGENCY: Food and Drug Administration,
termination of Dr. Chatterji’s debarment Rockville, MD. HHS.
serves the interest of justice and will not Contact Person: John E. Stuhlmuller,
pose a threat to the integrity of the drug ACTION: Notice.
Center for Devices and Radiological
approval process. Health (HFZ–450), Food and Drug SUMMARY: The Food and Drug
Under section 306(d)(4)(D) of the act,
Administration, 9200 Corporate Blvd., Administration (FDA) is announcing
the period of debarment of an
Rockville, MD 20850, 301–443–8243, that a collection of information entitled
individual who qualifies for special
ext. 157, or FDA Advisory Committee ‘‘(Petition for) Administrative
termination may be limited to less than
Information Line, 1–800–741–8138 Reconsideration of Action’’ has been
permanent but to no less than 1 year. Dr.
(301–443–0572 in the Washington, DC approved by the Office of Management
Chatterji’s period of debarment has
area), code 12625. Please call the and Budget (OMB) under the Paperwork
lasted more than 1 year.
Information Line for up-to-date Reduction Act of 1995 (the PRA).
Accordingly, the Deputy
information on this meeting. FOR FURTHER INFORMATION CONTACT:
Commissioner for Operations, under
Agenda: On June 29, 1998, the JonnaLynn P. Capezzuto, Office of
section 306(d)(4) of the act and under
committee will discuss, make Information Resources Management
authority delegated to him (21 CFR
recommendations, and vote on a (HFA–250), Food and Drug
5.20), finds that Dr. Dulal C. Chatterji’s
premarket approval application for an Administration, 5600 Fishers Lane,
application for special termination of
external compression device used in Rockville, MD 20857, 301–827–4659.
debarment should be granted, and that
cardiopulmonary resuscitation. On June SUPPLEMENTARY INFORMATION: In the
the period of debarment should
30, 1998, the committee will discuss Federal Register of March 26, 1998 (63
terminate immediately, thereby
and make recommendations on FR 14717), the agency announced that
allowing him to provide services in any
permanent cardiovascular implants the proposed information collection had
capacity to a person with an approved
such as heart valves and vascular grafts. been submitted to OMB for review and
or pending drug product application.
Procedure: Interested persons may clearance under section 3507 of the PRA
The Deputy Commissioner for
present data, information, or views, (44 U.S.C. 3507). An agency may not
Operations further finds that because
orally or in writing, on issues pending conduct or sponsor, and a person is not
the agency is granting Dr. Chatterji’s
before the committee. Written required to respond to, a collection of
application, an informal hearing under
submissions may be made to the contact information unless it displays a
section 306(d)(4)(C) of the act is
person by June 18, 1998. Oral currently valid OMB control number.
As a result of the foregoing findings, presentations from the public will be OMB has now approved the information
Dr. Dulal C. Chatterji’s debarment is scheduled between approximately 8 collection and has assigned OMB
terminated effective June 11, 1998 a.m. and 8:30 a.m. on June 29 and 30, control number 0910–0192. The
(section 306(d)(4)(C) and (d)(4)(D) of the 1998. Near the end of committee approval expires on May 31, 2001.
act). deliberations on both days, a 30-minute
open public session will be conducted Dated: June 5, 1998.
Dated: June 5, 1998. to address issues specific to the William K. Hubbard,
Michael A. Friedman, submission or topic before the Associate Commissioner for Policy
Acting Commissioner of Food and Drugs. committee. Time allotted for each Coordination.
[FR Doc. 98–15555 Filed 6–10–98; 8:45 am] presentation may be limited. Those [FR Doc. 98–15602 Filed 6–10–98; 8:45 am]
BILLING CODE 4160–01–F desiring to make formal oral BILLING CODE 4160–01–F