Special Fraud Alert: Physician-Owned Entities, 22270-22271 [2013-08749]
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Federal Register / Vol. 78, No. 72 / Monday, April 15, 2013 / Notices
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at
https://www.regulations.gov,
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.
Dated: April 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–08723 Filed 4–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Joint Meeting of the Endocrinologic
and Metabolic Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSK5SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Endocrinologic
and Metabolic Drugs Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 5 and 6, 2013, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (rm. 1503), 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
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https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Minh Doan, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, 301–796–9001,
FAX: 301–847–8533, email:
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee link, or call the advisory
committee information line to learn
about possible modifications before
coming to the meeting.
Agenda: On June 5 and 6, 2013, the
committees will discuss the results of an
independent readjudication of the
Rosiglitazone Evaluated for
Cardiovascular Outcomes and
Regulation of Glycemia in Diabetes
(RECORD) trial, for new drug
application (NDA) 21071, AVANDIA
(rosiglitazone maleate) tablets.
Rosiglitazone is a thiazolidinedione,
indicated as an adjunct to diet and
exercise to improve glycemic control in
adults with type 2 diabetes mellitus.
AVANDIA is manufactured by
GlaxoSmithKline.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. Written
submissions may be made to the contact
person on or before May 21, 2013. Oral
presentations from the public will be
scheduled between approximately 10:15
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a.m. and 11:15 a.m. on June 6, 2013.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before May 13, 2013. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by May 14, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Minh Doan
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 5, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–08744 Filed 4–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
[Docket Number: OIG–1302–N2]
Special Fraud Alert: Physician-Owned
Entities
Office of Inspector General
(OIG), HHS.
ACTION: Notice; Correction.
AGENCY:
This document sets forth a
correction to the OIG Federal Register
SUMMARY:
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Federal Register / Vol. 78, No. 72 / Monday, April 15, 2013 / Notices
notice published on March 29, 2012 (78
FR 19271), on our recently issued
Special Fraud Alert on PhysicianOwned Entities. Specifically, the
Special Fraud Alert addressed
physician-owned entities that derive
revenue from selling, or arranging for
the sale of, implantable medical devices
ordered by their physician-owners for
use in procedures the physician-owners
perform on their own patients at
hospitals or ambulatory surgical centers.
An inadvertent error appeared in the
DATES caption of that document
regarding the effective date.
Accordingly, we are removing the
language regarding the effective date to
ensure technical correctness of the
document.
FOR FURTHER INFORMATION CONTACT:
Patrice S. Drew, Congressional and
Regulatory Affairs, Office of Inspector
General, (202) 619–1368.
SUPPLEMENTARY INFORMATION: In our
publication of the Special Fraud Alert
on Physician-Owned Entities, an
inadvertent error appeared in the DATES
caption on page 19271 regarding the
effective date of the Special Fraud Alert.
The caption incorrectly indicated that
the effective date is March 29, 2013.
Since this document is a notice, no
effective date is applicable and all
language regarding any effective date is
deleted.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2013–08749 Filed 4–12–13; 8:45 am]
BILLING CODE 4152–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed collection; 60-day comment
request: NLM PEOPLE LOCATOR®
System
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Library of Medicine (NLM),
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
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SUMMARY:
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Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’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 those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: David Sharlip, NLM
Project Clearance Liaison, Office of
Administrative and Management
Analysis Services, OAMAS, NLM, NIH,
Building 38A, Room B2N12, 8600
Rockville Pike, Bethesda, MD 20894, or
call non-toll-free number (301) 496–
5441, or Email your request, including
your address to: sharlipd@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection
NLM People Locator System 0925–
0612, Expiration Date: 06/30/2013, Type
of submission: Revision, National
Library of Medicine (NLM), National
Institutes of Health (NIH).
Need and Use of Information Collection
This collection of data is intended to
assist in the reunification of family
members and friends who are separated
during a disaster. Experience in
operational drills and during real-world
disasters such as the January 2010
earthquakes in Haiti demonstrates that
family members and loved ones are
often separated during disasters and
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have significant difficulty determining
each other’s safety, condition, and
location. Reunification can not only
improve their emotional well-being
during the recovery period, but also
improve the chances that injured
victims will be cared for once they are
released from urgent medical care.
Family and friends are also a valuable
source of medical information that may
be important to the care of injured
victims (e.g., by providing family or
personal medical history, information
about allergies). The National Library of
Medicine (NLM) aims to assist Federal,
State and Local agencies in disaster
relief efforts and to serve its mission of
supporting national efforts to the
response to disasters via the PEOPLE
LOCATOR® system and related mobile
app (ReUniteTM) developed as part of
the intramural Lost Person Finder (LPF)
R&D project. The information collection
would support efforts to reunite family
and friends who are separated during a
disaster. Information about missing
(‘‘lost’’) people would be collected from
family members or loved ones who are
searching for them. Information about
recovered (‘‘found’’) people could be
provided by medical personnel,
volunteers and other relief workers
assisting in the disaster recovery effort.
Information collected about missing and
recovered persons would vary including
any one of the following and possibly
all: a photograph, name (if available for
a found person), age group (child, adult)
and/or range, gender, status (alive and
well, injured, deceased, unknown), and
location. The information collection
would be voluntary. It would be
activated only during times of declared
emergencies, training and
demonstration support activities, and
would operate in declared emergencies
until relief efforts have ceased in
response to a particular disaster. This
data collection is authorized pursuant to
sections 301, 307, 465 and 478A of the
Public Health Service Act [42 U.S.C.
241, 242l, 286 and 286d]. NLM has in
its mission the development and
coordination of communication
technology to improve the delivery of
health services.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
7,500.
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]]>Agencies
[Federal Register Volume 78, Number 72 (Monday, April 15, 2013)]
[Notices]
[Pages 22270-22271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08749]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
[Docket Number: OIG-1302-N2]
Special Fraud Alert: Physician-Owned Entities
AGENCY: Office of Inspector General (OIG), HHS.
ACTION: Notice; Correction.
-----------------------------------------------------------------------
SUMMARY: This document sets forth a correction to the OIG Federal
Register
[[Page 22271]]
notice published on March 29, 2012 (78 FR 19271), on our recently
issued Special Fraud Alert on Physician-Owned Entities. Specifically,
the Special Fraud Alert addressed physician-owned entities that derive
revenue from selling, or arranging for the sale of, implantable medical
devices ordered by their physician-owners for use in procedures the
physician-owners perform on their own patients at hospitals or
ambulatory surgical centers. An inadvertent error appeared in the DATES
caption of that document regarding the effective date. Accordingly, we
are removing the language regarding the effective date to ensure
technical correctness of the document.
FOR FURTHER INFORMATION CONTACT: Patrice S. Drew, Congressional and
Regulatory Affairs, Office of Inspector General, (202) 619-1368.
SUPPLEMENTARY INFORMATION: In our publication of the Special Fraud
Alert on Physician-Owned Entities, an inadvertent error appeared in the
DATES caption on page 19271 regarding the effective date of the Special
Fraud Alert. The caption incorrectly indicated that the effective date
is March 29, 2013. Since this document is a notice, no effective date
is applicable and all language regarding any effective date is deleted.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2013-08749 Filed 4-12-13; 8:45 am]
BILLING CODE 4152-01-P
