Scott S. Reuben: Debarment Order, 71042-71043 [2011-29538]
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71042
Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Notices
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device Recall Authority—21
CFR Part 810 (OMB Control Number
0910–0432)—Extension
This collection of information
implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360h(e)) and part
810 (21 CFR part 810), medical device
recall authority provisions. Section
518(e) of the FD&C Act provides FDA
with the authority to issue an order
• Notify health professionals and
device user facilities of the order, and
• Instruct those professionals and
facilities to cease use of the device;
2. FDA will provide the person named
in the cease distribution and
notification order with the opportunity
for an informal hearing on whether the
order should be modified, vacated, or
amended to require a mandatory recall
of the device; and
3. After providing the opportunity for
an informal hearing, FDA may issue a
mandatory recall order if the Agency
determines that such an order is
necessary.
The information collected under the
recall authority provisions will be used
by FDA to do the following: (1) Ensure
that all devices entering the market are
safe and effective, (2) accurately and
immediately detect serious problems
with medical devices, and (3) remove
dangerous and defective devices from
the market.
FDA estimates the burden of this
collection of information as follows:
requiring an appropriate person,
including manufacturers, importers,
distributors, and retailers of a device, if
FDA finds that there is reasonable
probability that the device intended for
human use would cause serious adverse
health consequences or death, to: (1)
Immediately cease distribution of such
device, (2) immediately notify health
professionals and device-user facilities
of the order, and (3) instruct such
professionals and facilities to cease use
of such device.
Further, the provisions under section
518(e) of the FD&C Act set out the
following three-step procedure for
issuance of a mandatory device recall
order:
1. If there is a reasonable probability
that a device intended for human use
would cause serious, adverse health
consequences or death, FDA may issue
a cease distribution and notification
order requiring the appropriate person
to immediately:
• Cease distribution of the device,
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
No. of responses
per respondent
Total annual
responses
Average burden
per response
Total hours
810.10(d) ..........................................................
810.11(a) ..........................................................
810.12(a) and (b) .............................................
810.14 ..............................................................
810.15(a), (b), and (c) ......................................
810.15(d) ..........................................................
810.15(e) ..........................................................
810.16(a) and (b) .............................................
810.17(a) ..........................................................
2
1
1
2
2
2
10
2
2
1
1
1
1
1
1
1
12
1
2
1
1
2
2
2
10
24
2
8
8
8
16
12
4
1
40
8
16
8
8
32
24
8
10
960
16
Total ..........................................................
............................
............................
............................
............................
1,082
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
No. of recordkeepers
No. of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
810.15(b) ..........................................................
2
1
1
8
8
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
Explanation for Burden Estimates
The burden estimates for tables 1 and
2 of this document are based on FDA’s
experience with voluntary recalls under
part 810 of the regulations. FDA expects
no more than two mandatory recalls per
year, as most recalls are done
voluntarily. Since the last time this
collection of information was submitted
to OMB for renewal/approval, there has
been one mandatory recall.
Dated: November 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29512 Filed 11–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0377]
Scott S. Reuben: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
SUMMARY:
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17:45 Nov 15, 2011
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Federal Register / Vol. 76, No. 221 / Wednesday, November 16, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
order under the Federal Food, Drug, and
Cosmetic Act permanently debarring
Scott S. Reuben, M.D. from providing
services in any capacity to a person that
has an approved or pending drug
product application. FDA bases this
order on a finding that Dr. Reuben was
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the Federal Food,
Drug, and Cosmetic Act. Dr. Reuben was
given notice of the proposed permanent
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. Dr. Reuben
failed to respond. Dr. Reuben’s failure to
respond constitutes a waiver of his right
to a hearing concerning this action.
DATES: This order is effective November
16, 2011.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 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,
5600 Fishers Lane, Rockville, MD
20857, (301) 796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
335a(a)(2)(B)) 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 regulation of any drug
product under the Federal Food, Drug,
and Cosmetic Act.
On June 24, 2010, the U.S. District
Court for the District of Massachusetts
entered judgment against Dr. Reuben for
health care fraud in violation of 18
U.S.C. 1347.
The FDA’s finding that debarment is
appropriate is based on the felony
conviction referenced herein for
conduct relating to the regulation of a
drug product. The factual basis for this
conviction is as follows: Dr. Reuben was
a physician licensed by the State of
Massachusetts working as an
anesthesiologist providing anesthesia
services to patients in connection with
surgeries, and also treating patients
post-surgery in the District of
Massachusetts. Dr. Reuben served as the
chief of acute pain at a hospital in
Western Massachusetts and maintained
an office at the hospital for the purpose
of conducting research. Dr. Reuben’s
interest, from a research perspective,
VerDate Mar<15>2010
17:45 Nov 15, 2011
Jkt 226001
was in post-operative multimodal
analgesia therapy. Dr. Reuben made
proposals for research funding to
pharmaceutical companies that
manufactured drugs that he used or
proposed to use in multimodal analgesia
therapy. Dr. Reuben represented to the
companies that, as the principal
investigator, he would be performing
clinical studies with actual patients to
whom he would administer the drug
that was the subject of the research
grant.
Dr. Reuben entered into contracts to
perform research studies funded by the
companies from at least as early as 1999.
Dr. Reuben purported to perform the
research called for by the contracts, and
published articles in various medical
journals based on the purported results
of the research, when in fact those
studies had not been performed, and
therefore the research results reported in
the medical journals were false.
As a result of his convictions, on
August 22, 2011, FDA sent Dr. Reuben
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)(B) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
335a(a)(2)(B)), that Dr. Reuben was
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the Federal Food,
Drug, and Cosmetic Act. This
conclusion was based on the fact that
FDA regulates clinical trials related to
drug products such as those described
previously as part of the Agency’s
regulation of drug products. The
proposal also offered Dr. Reuben 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. The
proposal was received on August 26,
2011. Dr. Reuben failed to respond
within the timeframe prescribed by
regulation 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)(B) of the
(21 U.S.C. 335a(a)(2)(B)) of the Federal
Food, Drug, and Cosmetic Act, under
authority delegated to the Director (Staff
Manual Guide 1410.35), finds that Scott
S. Reuben has been convicted of a
PO 00000
Frm 00090
Fmt 4703
Sfmt 9990
71043
felony under Federal law for conduct
relating to the regulation of a drug
product under the Federal Food, Drug,
and Cosmetic Act.
As a result of the foregoing finding,
Dr. Reuben 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 Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355, 360b, or 382), or under section 351
of the Public Health Service (42 U.S.C.
262), effective (see DATES) (see section
306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of
the Federal Food, Drug, and Cosmetic
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.
Reuben, in any capacity during Dr.
Reuben’s debarment, will be subject to
civil money penalties (section 307(a)(6)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 335b(a)(6))). If Dr. Reuben
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 Federal Food, Drug, and
Cosmetic 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. Reuben during his period of
debarment (section 306(c)(1)(A) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 335a(c)(1)(A))).
Any application by Dr. Reuben for
special termination of debarment under
section 306(d)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
335a(d)(4)) should be identified with
Docket No. FDA–2011–N–0377 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: November 7, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2011–29538 Filed 11–15–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\16NON1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71042-71043]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29538]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0377]
Scott S. Reuben: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an
[[Page 71043]]
order under the Federal Food, Drug, and Cosmetic Act permanently
debarring Scott S. Reuben, M.D. from providing services in any capacity
to a person that has an approved or pending drug product application.
FDA bases this order on a finding that Dr. Reuben was convicted of a
felony under Federal law for conduct relating to the regulation of a
drug product under the Federal Food, Drug, and Cosmetic Act. Dr. Reuben
was given notice of the proposed permanent debarment and an opportunity
to request a hearing within the timeframe prescribed by regulation. Dr.
Reuben failed to respond. Dr. Reuben's failure to respond constitutes a
waiver of his right to a hearing concerning this action.
DATES: This order is effective November 16, 2011.
ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 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, 5600 Fishers Lane, Rockville, MD 20857,
(301) 796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 335a(a)(2)(B)) 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 regulation of any drug product under
the Federal Food, Drug, and Cosmetic Act.
On June 24, 2010, the U.S. District Court for the District of
Massachusetts entered judgment against Dr. Reuben for health care fraud
in violation of 18 U.S.C. 1347.
The FDA's finding that debarment is appropriate is based on the
felony conviction referenced herein for conduct relating to the
regulation of a drug product. The factual basis for this conviction is
as follows: Dr. Reuben was a physician licensed by the State of
Massachusetts working as an anesthesiologist providing anesthesia
services to patients in connection with surgeries, and also treating
patients post-surgery in the District of Massachusetts. Dr. Reuben
served as the chief of acute pain at a hospital in Western
Massachusetts and maintained an office at the hospital for the purpose
of conducting research. Dr. Reuben's interest, from a research
perspective, was in post-operative multimodal analgesia therapy. Dr.
Reuben made proposals for research funding to pharmaceutical companies
that manufactured drugs that he used or proposed to use in multimodal
analgesia therapy. Dr. Reuben represented to the companies that, as the
principal investigator, he would be performing clinical studies with
actual patients to whom he would administer the drug that was the
subject of the research grant.
Dr. Reuben entered into contracts to perform research studies
funded by the companies from at least as early as 1999. Dr. Reuben
purported to perform the research called for by the contracts, and
published articles in various medical journals based on the purported
results of the research, when in fact those studies had not been
performed, and therefore the research results reported in the medical
journals were false.
As a result of his convictions, on August 22, 2011, FDA sent Dr.
Reuben 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)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 335a(a)(2)(B)), that Dr. Reuben was convicted
of a felony under Federal law for conduct relating to the regulation of
a drug product under the Federal Food, Drug, and Cosmetic Act. This
conclusion was based on the fact that FDA regulates clinical trials
related to drug products such as those described previously as part of
the Agency's regulation of drug products. The proposal also offered Dr.
Reuben 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. The proposal was received on August 26, 2011. Dr. Reuben failed
to respond within the timeframe prescribed by regulation 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)(B) of the (21 U.S.C.
335a(a)(2)(B)) of the Federal Food, Drug, and Cosmetic Act, under
authority delegated to the Director (Staff Manual Guide 1410.35), finds
that Scott S. Reuben has been convicted of a felony under Federal law
for conduct relating to the regulation of a drug product under the
Federal Food, Drug, and Cosmetic Act.
As a result of the foregoing finding, Dr. Reuben 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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355,
360b, or 382), or under section 351 of the Public Health Service (42
U.S.C. 262), effective (see DATES) (see section 306(c)(1)(B),
(c)(2)(A)(ii), and 201(dd) of the Federal Food, Drug, and Cosmetic 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. Reuben, in any capacity during Dr. Reuben's debarment,
will be subject to civil money penalties (section 307(a)(6) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335b(a)(6))). If Dr.
Reuben 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
Federal Food, Drug, and Cosmetic 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. Reuben during
his period of debarment (section 306(c)(1)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 335a(c)(1)(A))).
Any application by Dr. Reuben for special termination of debarment
under section 306(d)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 335a(d)(4)) should be identified with Docket No. FDA-2011-N-0377
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: November 7, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-29538 Filed 11-15-11; 8:45 am]
BILLING CODE 4160-01-P
