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					                        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                         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,
                                                                                           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: (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
                                              5 p.m.
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

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