Eduardo Caro Acevedo; Debarment Order, 15106-15107 [05-5781]
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Federal Register / Vol. 70, No. 56 / Thursday, March 24, 2005 / Notices
individuals specified in the application
budget and Social Security Numbers, if
otherwise required for individuals. The
copies may include summary salary
information.
Approved But Unfunded Applications
In cases where more applications are
approved for funding than ACF can
fund with the money available, the
Grants Officer shall fund applications in
their order of approval until funds run
out. In this case, ACF has the option of
carrying over the approved applications
up to a year for funding consideration
in a later competition of the same
program. These applications need not be
reviewed and scored again if the
program’s evaluation criteria have not
changed. However, they must then be
placed in rank order along with other
applications in later competition.
VI. Award Administration Information
1. Award Notices
The successful applicants will be
notified through the issuance of a
Financial Assistance Award document
which sets forth the amount of funds
granted, the terms and conditions of the
grant, the effective date of the grant, the
budget period for which initial support
will be given, the non-Federal share to
be provided, and the total project period
for which support is contemplated. The
Financial Assistance Award will be
signed by the Grants Officer and
transmitted via postal mail.
Organizations whose applications will
not be funded will be notified in
writing.
2. Administrative and National Policy
Requirements
Grantees are subject to the
requirements in 45 CFR part 74 (nongovernmental) or 45 CFR part 92
(governmental).
Direct Federal grants, subaward
funds, or contracts under this Child
Care Research Scholars Program shall
not be used to support inherently
religious activities such as religious
instruction, worship, or proselytization.
Therefore, organizations must take steps
to separate, in time or location, their
inherently religious activities from the
services funded under this Program.
Regulations pertaining to the
prohibition of Federal funds for
inherently religious activities can be
found on the HHS Web site at https://
www.os.dhhs.gov/fbci/waisgate21.pdf.
Special Terms and Conditions of
Awards: The following special term(s)
and condition(s) are in addition to the
ACF standard terms and conditions
which accompany the Financial
Assistance Award (FAA) document.
VerDate jul<14>2003
15:04 Mar 23, 2005
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Conference Attendance. The student
must attend and present a poster at the
Annual Meeting of the Child Care Policy
Research Consortium and preconference each year of the grant. This
conference is typically scheduled
during the spring of each year. In
addition, the student must attend and
present at the State Administrators’
Meeting typically held in the summer of
each year. The budget should reflect
travel funds for both conferences.
Faculty advisors are strongly
encouraged to attend these conferences
as well.
Archiving and Publishing. The
student must agree to archive his/her
approved dissertation document with
Research Connections. The student
must also work with CCB staff and
Research Connections staff to publish a
research/policy brief that can be
published on the Research Connections
Web site.
3. Reporting Requirements
Program Progress Reports: Semiannual.
Financial Reports: Semi-annual.
Grantees will be required to submit
program progress and financial reports
(SF 269) throughout the project period.
Program progress and financial reports
are due 30 days after the reporting
period. In addition, final programmatic
and financial reports are due 90 days
after the close of the project period. The
SF–269 may be found at the following
URL: https://www.acf.hhs.gov/programs/
ofs/forms.htm.
VII. Agency Contacts
Program Office Contact: Dr. Dawn
Ramsburg, Administration for Children
and Families, Child Care Bureau, 330 C
Street, SW., Switzer Building, Room
2046, Washington, DC 20447. Phone:
202–690–6705; Fax: 202–690–5600; email: dramsburg@acf.hhs.gov.
Grants Management Office Contact:
Peter Thompson, Administration for
Children and Families, Office of Grants
Management, Division of Discretionary
Grants, Mary E. Switzer Building, Room
2070, 330 C Street, SW., Washington,
DC 20447. Phone: 202–401–4608; Fax:
202–401–5644; e-mail:
PAThompson@acf.hhs.gov.
VIII. Other Information
Applicants will not be sent
acknowledgements of received
applications.
Notice: Beginning with FY 2006, the
Administration for Children and Families
will no longer publish grant announcements
in the Federal Register. Beginning October 1,
2005, applicants will be able to find a
synopsis of all ACF grant opportunities and
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apply electronically for opportunities via:
https://www.Grants.gov. Applicants will also
be able to find the complete text of all ACF
grant announcements on the ACF Web site
located at: https://www.acf.hhs.gov/grants/
index.html.
Dated: March 14, 2005.
Joan E. Ohl,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. 05–5554 Filed 3–23–05; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001N–0541]
Eduardo Caro Acevedo; 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 act) debarring Dr.
Eduardo Caro Acevedo for 5 years 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. Caro was
convicted of a felony under Federal law
for engaging in a conspiracy to defraud
the United States and has demonstrated
a pattern of conduct sufficient to find
that there is reason to believe that he
may violate requirements under the act
relating to drug products. Dr. Caro failed
to request a hearing and, therefore, has
waived his opportunity for a hearing
concerning this action.
DATES: This order is effective March 24,
2005.
ADDRESSES: Submit applications for
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:
Elizabeth Sadove, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION:
I. Background
On February 16, 2001, the U.S.
District Court for the District of Puerto
Rico accepted Dr. Eduardo Caro
Acevedo’s plea of guilty to one count of
conspiracy to offer and pay kickbacks in
E:\FR\FM\24MRN1.SGM
24MRN1
Federal Register / Vol. 70, No. 56 / Thursday, March 24, 2005 / Notices
relation to the referral of Medicare
beneficiaries to a durable medical
equipment company, in violation of the
Medicare antikickback law (42 U.S.C.
1320a–7b), and in violation of 18 U.S.C.
371. The court sentenced Dr. Caro to 2
years probation for the offense (United
States v. Eduardo Caro, Docket No.
00CR020–05 (SEC) (D.P.R. July 13,
2001)).
At the time of Dr. Caro’s criminal
actions, he was a physician authorized
to practice medicine in Puerto Rico as
a Medicare provider and was authorized
to prescribe, among other things,
durable medical equipment to Medicare
beneficiaries. The owner of a durable
medical equipment company,
authorized to sell to Medicare
beneficiaries, offered and paid money to
Dr. Caro to unlawfully induce him to
refer patients to the medical equipment
company. Dr. Caro received money in
return for referring patients to the
company for the furnishing of durable
medical equipment and services payable
under the Medicare program, the
specific amount depending on the value
of the service or equipment referred to
the company. The unlawful kickback
payments made to Dr. Caro allowed the
company to improperly invoice
Medicare for approximately $11,940.
In addition, Dr. Caro demonstrated a
pattern of conduct sufficient to find
reason to believe that he may violate
requirements under the act relating to
drug products. In July 2002, FDA issued
Dr. Caro a Notice of Disqualification to
Receive Investigational New Drugs. This
action was based upon repeated and
deliberate submissions of false
information to drug sponsors in
required reports for studies of
investigational new drugs that are
subject to section 505 of the act. In
addition, Dr. Caro repeatedly and
deliberately failed to comply with
regulations governing the conduct of
clinical investigators and the use of
investigational new drugs in conducting
two protocols sponsored by Daiichi
Pharmaceutical Corp. Among other
things, he submitted false information
in required reports, deviated from
protocols, maintained inaccurate and
inadequate study records, failed to
report adverse events, failed to properly
account for the disposition of study
medications, failed to obtain adequate
institutional review board approval, and
failed to obtain proper consent from
study subjects or their legally
authorized representatives. As a result,
he is no longer entitled to receive
investigational new drugs (Notice of
Disqualification to Receive
Investigational New Drugs, July 30,
2002).
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15:04 Mar 23, 2005
Jkt 205001
As a result of Dr. Caro’s conviction
and pattern of conduct, FDA served him
by certified mail on February 18, 2004,
a notice proposing to debar him for 5
years from providing services in any
capacity to a person that has an
approved or pending drug product
application. The proposal also offered
Dr. Caro an opportunity for a hearing on
the proposal. The proposal was based
on a finding, under section
306(b)(2)(B)(ii) of the act (21 U.S.C.
335a(b)(2)(B)(ii)), that Dr. Caro was
convicted of a felony under Federal law
for engaging in a conspiracy to defraud
the United States and has demonstrated
a pattern of conduct sufficient to find
that there is reason to believe that he
may violate requirements under the act
relating to drug products. Dr. Caro was
provided 30 days to file objections and
request a hearing. Dr. Caro did not
request a hearing. His failure to request
a hearing constitutes a waiver of his
opportunity for a hearing and a waiver
of any contentions concerning his
debarment.
II. Findings and Order
Therefore, the Director, Center for
Drug Evaluation and Research, under
section 306(b)(2)(B)(ii) of the act and
under authority delegated to him (Staff
Manual Guide 1410.035), finds that Dr.
Eduardo Caro Acevedo has been
convicted of a felony under Federal law
for engaging in a conspiracy to defraud
the United States and has demonstrated
a pattern of conduct sufficient to find
that there is reason to believe that he
may violate requirements under the act
relating to drug products.
As a result of the foregoing findings,
Dr. Caro is debarred for 5 years 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 March 24, 2005
(see sections 306(c)(1)(B) and
(c)(2)(A)(iii) and 201(dd) of the act (21
U.S.C. 321(dd))). Any person with an
approved or pending drug product
application who knowingly uses the
services of Dr. Caro, in any capacity,
during his period of debarment, will be
subject to civil money penalties (section
307(a)(6) of the act (21 U.S.C.
355b(a)(6))). If Dr. Caro, during his
period of debarment, provides services
in any capacity to a person with an
approved or pending drug product
application, he will be subject to civil
money penalties (section 307(a)(7) of the
act). In addition, FDA will not accept or
review any abbreviated new drug
applications submitted by or with the
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
15107
assistance of Dr. Caro during his period
of debarment.
Any application by Dr. Caro for
termination of debarment under section
306(d)(4) of the act should be identified
with Docket No. 2001N–0541 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: March 5, 2005.
Steven K. Galson,
Acting Director, Center for Drug Evaluation
and Research.
[FR Doc. 05–5781 Filed 3–23–05; 8:45 am]
BILLING CODE 160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, DHHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
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inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
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be required to receive copies of the
patent applications.
Minimally Immunogenic Germline
Sequence Variants of COL–1 Antibody
and Their Use
Syed Kashmiri (NCI), Eduardo Padlan
(NIDDK), and Jeffrey Schlom (NCI)
U.S. Provisional Application No. 60/
562,781 filed 15 Apr 2004 (DHHS
Reference No. E–105–2004/0–US–01)
and U.S. Provisional Application No.
E:\FR\FM\24MRN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 56 (Thursday, March 24, 2005)]
[Notices]
[Pages 15106-15107]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5781]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001N-0541]
Eduardo Caro Acevedo; 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 act) debarring Dr.
Eduardo Caro Acevedo for 5 years 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. Caro was
convicted of a felony under Federal law for engaging in a conspiracy to
defraud the United States and has demonstrated a pattern of conduct
sufficient to find that there is reason to believe that he may violate
requirements under the act relating to drug products. Dr. Caro failed
to request a hearing and, therefore, has waived his opportunity for a
hearing concerning this action.
DATES: This order is effective March 24, 2005.
ADDRESSES: Submit applications for 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: Elizabeth Sadove, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
On February 16, 2001, the U.S. District Court for the District of
Puerto Rico accepted Dr. Eduardo Caro Acevedo's plea of guilty to one
count of conspiracy to offer and pay kickbacks in
[[Page 15107]]
relation to the referral of Medicare beneficiaries to a durable medical
equipment company, in violation of the Medicare antikickback law (42
U.S.C. 1320a-7b), and in violation of 18 U.S.C. 371. The court
sentenced Dr. Caro to 2 years probation for the offense (United States
v. Eduardo Caro, Docket No. 00CR020-05 (SEC) (D.P.R. July 13, 2001)).
At the time of Dr. Caro's criminal actions, he was a physician
authorized to practice medicine in Puerto Rico as a Medicare provider
and was authorized to prescribe, among other things, durable medical
equipment to Medicare beneficiaries. The owner of a durable medical
equipment company, authorized to sell to Medicare beneficiaries,
offered and paid money to Dr. Caro to unlawfully induce him to refer
patients to the medical equipment company. Dr. Caro received money in
return for referring patients to the company for the furnishing of
durable medical equipment and services payable under the Medicare
program, the specific amount depending on the value of the service or
equipment referred to the company. The unlawful kickback payments made
to Dr. Caro allowed the company to improperly invoice Medicare for
approximately $11,940.
In addition, Dr. Caro demonstrated a pattern of conduct sufficient
to find reason to believe that he may violate requirements under the
act relating to drug products. In July 2002, FDA issued Dr. Caro a
Notice of Disqualification to Receive Investigational New Drugs. This
action was based upon repeated and deliberate submissions of false
information to drug sponsors in required reports for studies of
investigational new drugs that are subject to section 505 of the act.
In addition, Dr. Caro repeatedly and deliberately failed to comply with
regulations governing the conduct of clinical investigators and the use
of investigational new drugs in conducting two protocols sponsored by
Daiichi Pharmaceutical Corp. Among other things, he submitted false
information in required reports, deviated from protocols, maintained
inaccurate and inadequate study records, failed to report adverse
events, failed to properly account for the disposition of study
medications, failed to obtain adequate institutional review board
approval, and failed to obtain proper consent from study subjects or
their legally authorized representatives. As a result, he is no longer
entitled to receive investigational new drugs (Notice of
Disqualification to Receive Investigational New Drugs, July 30, 2002).
As a result of Dr. Caro's conviction and pattern of conduct, FDA
served him by certified mail on February 18, 2004, a notice proposing
to debar him for 5 years from providing services in any capacity to a
person that has an approved or pending drug product application. The
proposal also offered Dr. Caro an opportunity for a hearing on the
proposal. The proposal was based on a finding, under section
306(b)(2)(B)(ii) of the act (21 U.S.C. 335a(b)(2)(B)(ii)), that Dr.
Caro was convicted of a felony under Federal law for engaging in a
conspiracy to defraud the United States and has demonstrated a pattern
of conduct sufficient to find that there is reason to believe that he
may violate requirements under the act relating to drug products. Dr.
Caro was provided 30 days to file objections and request a hearing. Dr.
Caro did not request a hearing. His failure to request a hearing
constitutes a waiver of his opportunity for a hearing and a waiver of
any contentions concerning his debarment.
II. Findings and Order
Therefore, the Director, Center for Drug Evaluation and Research,
under section 306(b)(2)(B)(ii) of the act and under authority delegated
to him (Staff Manual Guide 1410.035), finds that Dr. Eduardo Caro
Acevedo has been convicted of a felony under Federal law for engaging
in a conspiracy to defraud the United States and has demonstrated a
pattern of conduct sufficient to find that there is reason to believe
that he may violate requirements under the act relating to drug
products.
As a result of the foregoing findings, Dr. Caro is debarred for 5
years 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 March 24,
2005 (see sections 306(c)(1)(B) and (c)(2)(A)(iii) and 201(dd) of the
act (21 U.S.C. 321(dd))). Any person with an approved or pending drug
product application who knowingly uses the services of Dr. Caro, in any
capacity, during his period of debarment, will be subject to civil
money penalties (section 307(a)(6) of the act (21 U.S.C. 355b(a)(6))).
If Dr. Caro, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, he will be subject to civil money penalties (section
307(a)(7) of the act). In addition, FDA will not accept or review any
abbreviated new drug applications submitted by or with the assistance
of Dr. Caro during his period of debarment.
Any application by Dr. Caro for termination of debarment under
section 306(d)(4) of the act should be identified with Docket No.
2001N-0541 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: March 5, 2005.
Steven K. Galson,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 05-5781 Filed 3-23-05; 8:45 am]
BILLING CODE 160-01-S
