Wayne E. Spencer: Debarment Order, 56646-56647 [2012-22606]
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Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Notices
B. Annual Reporting Burden
The estimated reporting burden has
been adjusted since published in the
Federal Register at 74 FR 41133, on
August 14, 2009. The adjustment is
based on an evaluation of Federal
Procurement Data System award
information for the services applicable
to FAR Clause 52.213–36, and
consultation with subject matter experts
within the Government that procure
such services.
Respondents: 350.
Responses per Respondent: 1.
Annual Responses: 350.
Hours per Response: 24.
Total Burden Hours: 8,400
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVCB), 1275
First Street NE., Washington, DC 20417,
telephone (202) 501–4755. Please cite
OMB Control No. 9000–0060, Accident
Prevention Plans and Recordkeeping, in
all correspondence.
Dated: September 7, 2012.
William Clark,
Acting Director, Federal Acquisition Policy
Division, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2012–22558 Filed 9–12–12; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: ORR Requirements for Refugee
Cash Assistance; and Refugee Medical
Assistance (45 CFR Part 400).
OMB No.: 0970–0036.
Description: As required by section
412(e) of the Immigration and
Nationality Act, the Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), is
requesting the information from Form
ORR–6 to determine the effectiveness of
the State cash and medical assistance,
child welfare, social services, and
targeted assistance programs. State-byState Refugee Cash Assistance (RCA)
and Refugee Medical Assistance (RMA)
utilization rates derived from Form
ORR–6 are calculated for use in
formulating program initiatives,
priorities, standards, budget requests,
and assistance policies. ORR regulations
require that State Refugee Resettlement
and Wilson-Fish agencies, and local and
Tribal governments complete Form
ORR–6 in order to participate in the
above-mentioned programs.
Respondents: State Refugee
Resettlement and Wilson-Fish Agencies,
local, and Tribal governments.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ORR–6 .............................................................................................................
50
3
3.88
582
Estimated Total Annual Burden
Hours: 582.
Administration for Children and
Families.
Additional Information
Robert Sargis,
Reports Clearance Officer.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
OMB Comment
19:13 Sep 12, 2012
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0355]
Wayne E. Spencer: Debarment Order
AGENCY:
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, Fax: 202–395–7285,
Email:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
VerDate Mar<15>2010
[FR Doc. 2012–22563 Filed 9–12–12; 8:45 am]
Jkt 226001
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act)
permanently debarring Wayne E.
Spencer from providing services in any
capacity to a person that has an
approved or pending drug product
application. We base this order on a
finding that Dr. Spencer was convicted
of a felony under Federal law for
conduct relating to the development or
approval, including the process for
development or approval, of a drug
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
product under the FD&C Act. Dr.
Spencer was given notice of the
proposed permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation,
but failed to respond. Dr. Spencer’s
failure to respond constitutes a waiver
of his right to a hearing concerning this
action.
DATES: This order is effective September
13, 2012.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Room 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Compliance
Policy (HFC–230), Office of
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the FD&C Act
(21 U.S.C. 335a(a)(2)(A)) requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the development or
E:\FR\FM\13SEN1.SGM
13SEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 178 / Thursday, September 13, 2012 / Notices
approval, including the process for
development or approval, of a drug
product under the FD&C Act.
On March 7, 2012, the U.S. District
Court for the District of Kansas entered
judgment against Dr. Spencer after he
entered a guilty plea to, among others,
a felony count of failing to prepare and
maintain records required under section
505(i) of the FD&C Act, with the intent
to defraud and mislead, in violation of
sections 301(e) and 303(a)(2) of the
FD&C Act (21 U.S.C. 331(e), 333(a)(2),
and 18 U.S.C. 2).
FDA’s finding that debarment is
appropriate is based on the felony
conviction referenced herein for
conduct relating to the development or
approval, including the process for
development or approval, of a drug
product under the FD&C Act.
The factual basis for this conviction is
as follows: Dr. Spencer was a licensed
medical doctor practicing medicine in
the District of Kansas. Schering/Plough
was a pharmaceutical company engaged
in developing and marketing
pharmaceutical products. In or about
July 2009, Schering/Plough chose Lee
Research Institute, Dr. Spencer’s
employer, to perform a clinical study
known as ‘‘A 28-Day Study Evaluating
the Safety of Ragweed Sublingual Tablet
in Adult Subjects 50 Years of Age and
Older with Ragweed-Induced Rhino
Conjunctivitis.’’ Dr. Spencer was the
principal investigator for the clinical
study.
Before beginning the clinical study,
FDA required Schering/Plough to
provide the Agency with a study
protocol. The study protocol contained
information about how the clinical
study would be conducted, where
studies would be done and by whom,
how the drug’s safety would be
evaluated, and what findings would
require the study to be changed or
halted. According to the study protocol,
each subject had to be 50 years of age
or older. Additionally, the study
protocol excluded subjects who were a
member or a family member of the
personnel of the investigational or
sponsor staff directly involved with the
clinical trial. Under section 505(i) of the
FD&C Act (21 U.S.C. 355(i)) and 21 CFR
312.62(b), Dr. Spencer was required to
maintain adequate and accurate case
histories on each individual who was
administered Schering/Plough’s
investigational drug.
Beginning in or about January 2010,
and continuing through in or about May
2010, Dr. Spencer, with the intent to
defraud and mislead, failed to prepare
and maintain the records required
described above. Specifically, Dr.
Spencer falsified the birth dates of two
VerDate Mar<15>2010
19:13 Sep 12, 2012
Jkt 226001
participants such that they appeared to
be older than 50 years of age; falsely
indicated that physical examinations
had been performed when they had not
been performed; and indicated on
required forms that two participants met
the inclusion criteria and had no
reasons for exclusion when he knew
that the participants did not meet the
inclusion criteria of age and should
have been excluded as employees of Lee
Research Institute.
As a result of his conviction, on June
20, 2012, FDA sent Dr. Spencer a notice
by certified mail proposing to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(A) of the FD&C Act (21 U.S.C.
335a(a)(2)(A)), that Dr. Spencer was
convicted of a felony under Federal law
for conduct relating to the development
or approval, including the process for
development or approval, of a drug
product under the FD&C Act.
The proposal also offered Dr. Spencer
an opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Dr.
Spencer received the proposal on June
25, 2012. He failed to respond and has,
therefore, waived his opportunity for a
hearing and has waived any contentions
concerning his debarment (21 CFR part
12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(a)(2)(A) of the
FD&C Act (21 U.S.C. 335a(a)(2)(A)),
under authority delegated to the
Director (Staff Manual Guide 1410.35),
finds that Wayne E. Spencer has been
convicted of a felony under Federal law
for conduct relating to the development
or approval, including the process for
development or approval, of a drug
product under the FD&C Act.
As a result of the foregoing finding,
Wayne E. Spencer is permanently
debarred from providing services in any
capacity to a person with an approved
or pending drug product application
under sections 505, 512, or 802 of the
Act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective
(see DATES) (see section 306(c)(1)(B),
(c)(2)(A)(ii), and 201(dd) of the FD&C
Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii),
and 321(dd))). Any person with an
approved or pending drug product
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
56647
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses the services of Dr.
Spencer, in any capacity during Dr.
Spencer’s debarment, will be subject to
civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Dr. Spencer provides services in any
capacity to a person with an approved
or pending drug product application
during his period of debarment he will
be subject to civil money penalties
(section 307(a)(7) of the FD&C Act (21
U.S.C. 335b(a)(7))). In addition, FDA
will not accept or review any
abbreviated new drug applications
submitted by or with the assistance of
Dr. Spencer during his period of
debarment (section 306(c)(1)(A) of the
FD&C Act (21 U.S.C. 335a(c)(1)(A))).
Any application by Dr. Spencer for
special termination of debarment under
section 306(d)(4) of the FD&C Act (21
U.S.C. 335a(d)(4)) should be identified
with Docket No. FDA–2012–N–0355
and sent to the Division of Dockets
Management (see ADDRESSES). All such
submissions are to be filed in four
copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: September 4, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2012–22606 Filed 9–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0356]
Lisa Jean Sharp: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act)
permanently debarring Lisa Jean Sharp
from providing services in any capacity
to a person that has an approved or
pending drug product application. We
base this order on a finding that Lisa
Jean Sharp was convicted of a felony
under Federal law for conduct relating
to the development or approval,
including the process for development
or approval, of a drug product under the
SUMMARY:
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Notices]
[Pages 56646-56647]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22606]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0355]
Wayne E. Spencer: Debarment Order
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 FD&C Act)
permanently debarring Wayne E. Spencer from providing services in any
capacity to a person that has an approved or pending drug product
application. We base this order on a finding that Dr. Spencer was
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of a drug product under the FD&C Act. Dr. Spencer was given
notice of the proposed permanent debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation, but
failed to respond. Dr. Spencer's failure to respond constitutes a
waiver of his right to a hearing concerning this action.
DATES: This order is effective September 13, 2012.
ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs,
Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857,
301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A))
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct relating
to the development or
[[Page 56647]]
approval, including the process for development or approval, of a drug
product under the FD&C Act.
On March 7, 2012, the U.S. District Court for the District of
Kansas entered judgment against Dr. Spencer after he entered a guilty
plea to, among others, a felony count of failing to prepare and
maintain records required under section 505(i) of the FD&C Act, with
the intent to defraud and mislead, in violation of sections 301(e) and
303(a)(2) of the FD&C Act (21 U.S.C. 331(e), 333(a)(2), and 18 U.S.C.
2).
FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein for conduct relating to the development or
approval, including the process for development or approval, of a drug
product under the FD&C Act.
The factual basis for this conviction is as follows: Dr. Spencer
was a licensed medical doctor practicing medicine in the District of
Kansas. Schering/Plough was a pharmaceutical company engaged in
developing and marketing pharmaceutical products. In or about July
2009, Schering/Plough chose Lee Research Institute, Dr. Spencer's
employer, to perform a clinical study known as ``A 28-Day Study
Evaluating the Safety of Ragweed Sublingual Tablet in Adult Subjects 50
Years of Age and Older with Ragweed-Induced Rhino Conjunctivitis.'' Dr.
Spencer was the principal investigator for the clinical study.
Before beginning the clinical study, FDA required Schering/Plough
to provide the Agency with a study protocol. The study protocol
contained information about how the clinical study would be conducted,
where studies would be done and by whom, how the drug's safety would be
evaluated, and what findings would require the study to be changed or
halted. According to the study protocol, each subject had to be 50
years of age or older. Additionally, the study protocol excluded
subjects who were a member or a family member of the personnel of the
investigational or sponsor staff directly involved with the clinical
trial. Under section 505(i) of the FD&C Act (21 U.S.C. 355(i)) and 21
CFR 312.62(b), Dr. Spencer was required to maintain adequate and
accurate case histories on each individual who was administered
Schering/Plough's investigational drug.
Beginning in or about January 2010, and continuing through in or
about May 2010, Dr. Spencer, with the intent to defraud and mislead,
failed to prepare and maintain the records required described above.
Specifically, Dr. Spencer falsified the birth dates of two participants
such that they appeared to be older than 50 years of age; falsely
indicated that physical examinations had been performed when they had
not been performed; and indicated on required forms that two
participants met the inclusion criteria and had no reasons for
exclusion when he knew that the participants did not meet the inclusion
criteria of age and should have been excluded as employees of Lee
Research Institute.
As a result of his conviction, on June 20, 2012, FDA sent Dr.
Spencer a notice by certified mail proposing to permanently debar him
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(a)(2)(A) of the FD&C Act (21 U.S.C.
335a(a)(2)(A)), that Dr. Spencer was convicted of a felony under
Federal law for conduct relating to the development or approval,
including the process for development or approval, of a drug product
under the FD&C Act.
The proposal also offered Dr. Spencer an opportunity to request a
hearing, providing him 30 days from the date of receipt of the letter
in which to file the request, and advised him that failure to request a
hearing constituted a waiver of the opportunity for a hearing and of
any contentions concerning this action. Dr. Spencer received the
proposal on June 25, 2012. He failed to respond and has, therefore,
waived his opportunity for a hearing and has waived any contentions
concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(A) of the FD&C Act (21
U.S.C. 335a(a)(2)(A)), under authority delegated to the Director (Staff
Manual Guide 1410.35), finds that Wayne E. Spencer has been convicted
of a felony under Federal law for conduct relating to the development
or approval, including the process for development or approval, of a
drug product under the FD&C Act.
As a result of the foregoing finding, Wayne E. Spencer is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application under
sections 505, 512, or 802 of the Act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health Service Act (42 U.S.C. 262),
effective (see DATES) (see section 306(c)(1)(B), (c)(2)(A)(ii), and
201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and
321(dd))). Any person with an approved or pending drug product
application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Dr. Spencer, in any
capacity during Dr. Spencer's debarment, will be subject to civil money
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Dr. Spencer provides services in any capacity to a person with an
approved or pending drug product application during his period of
debarment he will be subject to civil money penalties (section
307(a)(7) of the FD&C Act (21 U.S.C. 335b(a)(7))). In addition, FDA
will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Dr. Spencer during his period of
debarment (section 306(c)(1)(A) of the FD&C Act (21 U.S.C.
335a(c)(1)(A))).
Any application by Dr. Spencer for special termination of debarment
under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should
be identified with Docket No. FDA-2012-N-0355 and sent to the Division
of Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: September 4, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-22606 Filed 9-12-12; 8:45 am]
BILLING CODE 4160-01-P
