Findings of Research Misconduct, 52235-52236 [E9-24392]
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52235
Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices
Type of respondent
Number of
respondents
Number of responses per
respondent
Average
burden hours
per response
...........................................................
........................
........................
........................
Forms
(if necessary)
Total ...........................................
Seleda Perryman,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. E9–24470 Filed 10–8–09; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier 0990–0346]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
AGENCY:
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden. To obtain copies of
the supporting statement and any
related forms for the proposed
paperwork collections referenced above,
e-mail your request, including your
address, phone number, OMB number,
and OS document identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above e-mail address within 60
days.
Proposed Project: HITECH Act Breach
Notification—OMB No. 0990–0346–
Extension—Office of Civil Rights.
Abstract: The Health Information
Technology for Economic and Clinical
Health (HITECH) Act, Title XIII of
Division A and Title IV of Division B of
the American Recovery and
Reinvestment Act of 2009 (ARRA) (Pub.
L. 111–5) requires the Office for Civil
Rights to collect information regarding
breaches discovered by covered entities
and their business associates under the
Health Insurance Portability and
Number of
respondents
Type of respondent
Total burden
hours
1,116
Accountability Act of 1996 (HIPAA)
Privacy Rule (45 C.F.R. Part 160 and
Subparts A and E of Part 164). ARRA
was enacted on February 17, 2009. The
Department of Health and Human
Services (HHS) issued interim final
regulations on August 24, 2009 (74 FR
42740), which became effective
September 23, 2009, to require HIPAA
covered entities and their business
associates to provide notification in the
case of breaches of unsecured protected
health information. Section 164.404 of
this interim final regulation requires
HIPAA covered entities to notify
affected individuals of a breach of their
unsecured protected health information
and, in some cases, to notify the media
of such breaches pursuant to § 164.406.
Section 164.408 requires covered
entities to provide the Secretary with
immediate notice of all breaches of
unsecured protected health information
involving more than 500 individuals.
Additionally, the Act requires covered
entities to provide the Secretary with an
annual log of all breaches of unsecured
protected health information that
involve less than 500 individuals.
Finally, business associates must notify
the covered entity of any breaches that
occur subject to § 164.410.
Estimated Annualized Burden Table
Average
number of
responses
per respondent
Average
burden hours
per response
Total burden
hours
106
56
50
70
70
56
1
1
1
1
1
1
206
44
8
1
3,438
1
21,836
2,464
400
70
240,660
56
106
1
140/60
247
TOTAL ......................................................................................................
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Individual Notice—Written and E-mail Notice (drafting, preparing, sending,
and documenting notification) ......................................................................
500 or More Affected Individuals (investigating and documenting breach) ....
Less than 500 Affected Individuals (investigating and documenting breach)
Individual Notice—Substitute Notice (posting or publishing) ...........................
Individual Notice—Substitute Notice (toll-free number) ...................................
Media Notice ....................................................................................................
Notice to Secretary (notice for breaches affecting 500 or more individuals
and annual notice and maintenance of annual log) ....................................
........................
........................
........................
265,733
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E9–24471 Filed 10–8–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4153–01–P
Findings of Research Misconduct
Office of the Secretary
AGENCY:
ACTION:
VerDate Nov<24>2008
16:05 Oct 08, 2009
Jkt 220001
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Office of the Secretary, HHS.
Notice.
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SUMMARY: Notice is hereby given that
the Office of Research Integrity (ORI)
and the Assistant Secretary for Health
have taken final action in the following
case:
Norma Couvertier, APT Foundation:
Based on the report of an investigation
conducted by the APT Foundation and
additional analysis conducted by ORI in
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09OCN1
mstockstill on DSKH9S0YB1PROD with NOTICES
52236
Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices
its oversight review, ORI found that
Norma Couvertier, former Research
Assistant II, APT Foundation in New
Haven, Connecticut, engaged in research
misconduct in research supported by
National Institute of Drug Abuse
(NIDA), National Institutes of Health
(NIH), award R37 DA015969.
Specifically, ORI found that Ms.
Couvertier engaged in research
misconduct by falsifying and fabricating
data that were reported on Participant
Urine Monitoring and Breathalyzer
Result Forms (CRFs) completed by the
Respondent for thirty two (32) of the
enrolled study participants in the
computer Based Training in Cognitive
Behavioral Therapy (CBT4CBT) research
study. A total of 253 alcohol
breathalyzer (BALS) results were
recorded for the 32 participants as being
0.000 indicating no alcohol detected,
rather than the code 999 used when no
breathalyzer test was done.
ORI also found that Ms. Couvetier, on
253 occasions, with 32 different study
participants, falsified alcohol
breathalyzer test results and knowingly
and consistently entered a false negative
test (indicated by 0.000) rather than
identifying the result as a missing data
collection (indicated by code 999).
ORI acknowledges Ms. Couvetier’s
verbal admissions and willingness to
cooperate and assist during the APT
Foundation’s investigation.
Ms. Couvertier has entered into a
Voluntary Settlement Agreement in
which she has voluntarily agreed, for a
period of three (3) years, beginning on
September 18, 2009:
(1) To exclude herself from serving in
any advisory capacity to the U.S. Public
Health Service (PHS), including but not
limited to service on any PHS advisory
committee, board, and/or peer review
committee, or as a consultant;
(2) that any institution that submits an
application for PHS support for a
research project on which the
Respondent’s participation is proposed
or that uses her in any capacity on PHSsupported research or that submits a
report of PHS-funded research in which
she is involved must concurrently
submit a plan for supervision of her
duties to ORI. The supervisory plan
must be designed to ensure the integrity
of her research contribution.
Respondent agreed that she will not
participate in any PHS-supported
research until such a supervisory plan is
approved by ORI.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
VerDate Nov<24>2008
16:05 Oct 08, 2009
Jkt 220001
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852. (240) 453–8800.
John Dahlberg,
Director, Division of Investigative Oversight,
Office of Research Integrity.
[FR Doc. E9–24392 Filed 10–8–09; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10142, CMS–R–
262, CMS–10300, CMS–10298 and CMS–
10294]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: CY 2011 Bid
Pricing Tool (BPT) for Medicare
Advantage (MA) Plans and Prescription
Drug Plans (PDP); Use: Under the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA), and implementing
regulations at 42 CFR, Medicare
Advantage organizations (MAO) and
Prescription Drug Plans are required to
submit an actuarial pricing ‘‘bid’’ for
each plan offered to Medicare
beneficiaries for approval CMS.
MAOs and PDPs use the Bid Pricing
Tool (BPT) software to develop their
actuarial pricing bid. The information
provided in the BPT is the basis for the
plan’s enrollee premiums and CMS
payments for each contract year. The
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
tool collects data such as medical
expense development (from claims data
and/or manual rating), administrative
expenses, profit levels, and projected
plan enrollment information. By statute,
completed BPTs are due to CMS by the
first Monday of June each year.
CMS reviews and analyzes the
information provided on the Bid Pricing
Tool. Ultimately, CMS decides whether
to approve the plan pricing (i.e.,
payment and premium) proposed by
each organization. Refer to the
supporting document attachment ‘‘C’’
for a list of changes. Form Number:
CMS–10142 (OMB#: 0938–0944);
Frequency: Reporting—Yearly; Affected
Public: Business or other for-profit and
not-for-profit institutions; Number of
Respondents: 550; Total Annual
Responses: 6,050; Total Annual Hours:
42,350. (For policy questions regarding
this collection contact Diane Spitalnic at
410–786–5745. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: CY 2011 Plan
Benefit Package (PBP) Software and
Formulary Submission Use: Under the
Medicare Modernization Act (MMA),
Medicare Advantage (MA) and
Prescription Drug Plan (PDP)
organizations are required to submit
plan benefit packages for all Medicare
beneficiaries residing in their service
area. The plan benefit package
submission consists of the PBP software,
formulary file, and supporting
documentation, as necessary. MA and
PDP organizations use the PBP software
to describe their organization’s plan
benefit packages, including information
on premiums, cost sharing,
authorization rules, and supplemental
benefits. They also generate a formulary
to describe their list of drugs, including
information on prior authorization, step
therapy, tiering, and quantity limits.
Additionally, CMS uses the PBP and
formulary data to review and approve
the plan benefit packages proposed by
each MA and PDP organization.
CMS requires that MA and PDP
organizations submit a completed PBP
and formulary as part of the annual
bidding process. During this process,
organizations prepare their proposed
plan benefit packages for the upcoming
contract year and submit them to CMS
for review and approval. Based on
operational changes and policy
clarifications to the Medicare program
and continued input and feedback by
the industry, CMS has made the
necessary changes to the plan benefit
package submission. Refer to the
supporting document ‘‘Appendix B’’ for
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09OCN1
]]>Agencies
[Federal Register Volume 74, Number 195 (Friday, October 9, 2009)]
[Notices]
[Pages 52235-52236]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24392]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the Office of Research Integrity
(ORI) and the Assistant Secretary for Health have taken final action in
the following case:
Norma Couvertier, APT Foundation: Based on the report of an
investigation conducted by the APT Foundation and additional analysis
conducted by ORI in
[[Page 52236]]
its oversight review, ORI found that Norma Couvertier, former Research
Assistant II, APT Foundation in New Haven, Connecticut, engaged in
research misconduct in research supported by National Institute of Drug
Abuse (NIDA), National Institutes of Health (NIH), award R37 DA015969.
Specifically, ORI found that Ms. Couvertier engaged in research
misconduct by falsifying and fabricating data that were reported on
Participant Urine Monitoring and Breathalyzer Result Forms (CRFs)
completed by the Respondent for thirty two (32) of the enrolled study
participants in the computer Based Training in Cognitive Behavioral
Therapy (CBT4CBT) research study. A total of 253 alcohol breathalyzer
(BALS) results were recorded for the 32 participants as being 0.000
indicating no alcohol detected, rather than the code 999 used when no
breathalyzer test was done.
ORI also found that Ms. Couvetier, on 253 occasions, with 32
different study participants, falsified alcohol breathalyzer test
results and knowingly and consistently entered a false negative test
(indicated by 0.000) rather than identifying the result as a missing
data collection (indicated by code 999).
ORI acknowledges Ms. Couvetier's verbal admissions and willingness
to cooperate and assist during the APT Foundation's investigation.
Ms. Couvertier has entered into a Voluntary Settlement Agreement in
which she has voluntarily agreed, for a period of three (3) years,
beginning on September 18, 2009:
(1) To exclude herself from serving in any advisory capacity to the
U.S. Public Health Service (PHS), including but not limited to service
on any PHS advisory committee, board, and/or peer review committee, or
as a consultant;
(2) that any institution that submits an application for PHS
support for a research project on which the Respondent's participation
is proposed or that uses her in any capacity on PHS-supported research
or that submits a report of PHS-funded research in which she is
involved must concurrently submit a plan for supervision of her duties
to ORI. The supervisory plan must be designed to ensure the integrity
of her research contribution. Respondent agreed that she will not
participate in any PHS-supported research until such a supervisory plan
is approved by ORI.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852. (240) 453-8800.
John Dahlberg,
Director, Division of Investigative Oversight, Office of Research
Integrity.
[FR Doc. E9-24392 Filed 10-8-09; 8:45 am]
BILLING CODE 4150-31-P
