Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics Subcommittee (ES), 72831-72832 [2010-29774]
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Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
efficient and effective manner, and
perform reviews of quality of care in an
area of medical practice where actual
performance is measured against
objective criteria, which defines
acceptable and adequate practice. The
selected organization must have a
consumer representative on its
governing board.
The Omnibus Budget Reconciliation
Act of 1987 (Pub. L. 100–203) amended
section 1153 of the Act by adding
paragraph (i). This provision prohibits
CMS from renewing the contract of any
QIO that is not an in-State QIO without
first publishing in the Federal Register
a notice announcing when the contract
will expire. This notice must be
published no later than 6 months before
the date the contract expires and must
specify the period of time during which
an in-State organization may submit a
proposal for the QIO contract for that
State. If one or more qualified in-State
organizations submit a proposal for the
QIO contract within the specified period
of time, we cannot automatically renew
the current contract on a
noncompetitive basis, but must instead
provide for competition for the contract
in the same manner used for a new
contract under section 1153(b) of the
Act. An in-State QIO is defined under
section 1153(i)(3) of the Act as a QIO
that has its primary place of business in
the State in which review will be
conducted (or, be a subsidiary of a
parent corporation, whose headquarters
is located in that State).
There are currently 4 QIO contracts
with entities that do not meet the
statutory definition of an in-State QIO.
The areas affected for purposes of this
notice along with the respective contract
expiration dates are as follows:
Vermont—July 31, 2011
Maine—July 31, 2011
Idaho—July 31, 2011
South Carolina—July 31, 2011
II. Provisions of the Notice
This notice announces the scheduled
expiration dates of the current contracts
between CMS and the out-of-State QIOs
responsible for review in the areas
mentioned above.
Interested in-State organizations may
submit a proposal in competing to
become the QIO for these States. In
order to be eligible for contract award,
the organization must have its primary
place of business in the States in which
review will be conducted or be a
subsidiary of a parent corporation,
whose headquarters is located in that
State. In order to be eligible for contract
award, each interested organization
must further demonstrate that it meets
the following requirements:
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A. Be Either a Physician-Sponsored or a
Physician-Access Organization
1. Physician-Sponsored Organization
a. The organization must be composed
of a substantial number of the licensed
doctors of medicine and osteopathy
practicing medicine or surgery in the
review area, who are representative of
the physicians practicing in the review
area.
b. The organization must not be a
health care facility, health care facility
association, health care facility affiliate,
or payor organization. However, statutes
and regulations provide that, in the
event CMS determines no otherwise
qualified non-payor organization is
available to undertake a given QIO
contract, CMS may select a payor
organization which otherwise meets
requirements to be eligible to conduct
Utilization and Quality Control Peer
Review as specified in Part B of Title XI
of the Act and its implementing
regulations.
c. In order to meet the ‘‘substantial
number of doctors of medicine and
osteopathy’’ requirements as specified
above in paragraph A.1.a, an
organization must state and have
documentation in its files showing that
it is composed of at least 10 percent of
the licensed doctors of medicine and
osteopathy practicing medicine or
surgery in the review area. In order to
meet the representation requirements as
specified above in paragraph A.1.a, an
organization must state and have
documentation in its files demonstrating
that it is composed of at least 20 percent
of the licensed doctors of medicine and
osteopathy practicing medicine or
surgery in the review area.
Alternatively, if the organization does
not demonstrate that it is composed of
at least 20 percent of the licensed
doctors of medicine and osteopathy
practicing medicine or surgery in the
review area, the organization must
demonstrate in its proposal, through
letters of support from physicians or
physician organizations, or through
other means, that it is representative of
the area physicians.
2. Physician-Access Organization
a. The organization must have
available to it, by arrangement or
otherwise, the services of a sufficient
number of licensed doctors of medicine
or osteopathy practicing medicine or
surgery in the review area to ensure
adequate peer review of the services
furnished by the various medical
specialties and subspecialties.
b. The organization must not be a
health care facility, health care facility
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association, health care facility affiliate,
or payor organization.
c. An organization meets the
requirements specified above in
paragraph A.2.a., if it demonstrates that
it has available to it at least one
physician in every generally recognized
specialty and has an arrangement or
arrangements with physicians under
which the physicians would conduct
review for the organization.
B. Have at Least One Individual Who Is
a Representative of Consumers on Its
Governing Board
If one or more organizations meet the
above requirements in a QIO area and
submit proposals for the contracts in
accordance with this notice, we will
consider those organizations to be
potential sources for the 4 contracts
upon their expiration. These
organizations will be entitled to
participate in a full and open
competition for the QIO contract to
perform the QIO statement of work.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare-Supplementary Medical Insurance
Program)
Dated: October 28, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2010–28817 Filed 11–24–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)—Ethics
Subcommittee (ES)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the CDC announces
the following meeting of the
aforementioned subcommittee:
Time and Date: 2 p.m.—3:30 p.m. Eastern
Standard Time, January 4, 2011.
Place: Teleconference.
Status: Open to the public, limited only by
availability of telephone ports. The public is
welcome to participate during the public
comment period. A public comment period
is tentatively scheduled from 3 p.m.—3:15
p.m. To participate in the teleconference,
please dial 1–877–928–1204 and enter
conference code 4305992.
Purpose: The ES will provide counsel to
the ACD, CDC, regarding a broad range of
public health ethics questions and issues
arising from programs, scientists and
practitioners.
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Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices
Matter to be Discussed: The ES will discuss
a strategy for addressing its charge to provide
a preliminary overview to the ACD on ethical
issues related to non-communicable disease
prevention and control and an ethics
framework to guide CDC programs and
activities.
The agenda is subject to change as
priorities dictate.
Contact Person for More Information: Drue
Barrett, Ph.D., Designated Federal Officer,
ACD, CDC—ES, CDC, 1600 Clifton Road, NE.,
M/S D–50, Atlanta, Georgia 30333.
Telephone (404) 639–4690. E-mail:
dbarrett@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: November 18, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–29774 Filed 11–24–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0585]
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD 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 Committee: Neurological
Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on January 27 and 28, 2011, from
8 a.m. to 6 p.m.
FDA is opening a docket for public
comment on this meeting. The docket
number is FDA–2010–N–0585. The
docket will open for public comment on
November 26, 2010. The docket will
close on January 25, 2011. Interested
persons may submit electronic or
written comments regarding this
meeting. Submit electronic comments to
https://www.regulations.gov. Submit
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written comments to the Division of
Dockets Management, Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit a
single copy of electronic comments or a
paper copy of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
meeting notice. Received comments
may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Location: Hilton Washington DC
North/Gaithersburg, Ballroom, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: James Engles, Food
and Drug Administration, Center for
Devices and Radiological Health, 10903
New Hampshire Ave., Silver Spring, MD
20993, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512513. Please call the
Information Line for up-to-date
information on this meeting. 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 and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On January 27 and 28, 2011,
the committee will discuss and make
recommendations regarding the possible
reclassification of devices indicated for
use in electroconvulsive therapy.
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 link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before January 14, 2011.
Oral presentations from the public will
be scheduled at approximately 10 a.m.,
immediately following the FDA’s
presentation, on January 27, 2011.
Those individuals interested in making
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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 January 6, 2011. 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 January 7, 2011.
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 AnnMarie Williams,
Conference Management Staff, at 301–
796–5966 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: November 18, 2010.
Thinh Nguyen,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–29824 Filed 11–24–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
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Agencies
[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Notices]
[Pages 72831-72832]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29774]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Committee to the Director (ACD), Centers for Disease
Control and Prevention (CDC)--Ethics Subcommittee (ES)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the CDC announces the following meeting
of the aforementioned subcommittee:
Time and Date: 2 p.m.--3:30 p.m. Eastern Standard Time, January
4, 2011.
Place: Teleconference.
Status: Open to the public, limited only by availability of
telephone ports. The public is welcome to participate during the
public comment period. A public comment period is tentatively
scheduled from 3 p.m.--3:15 p.m. To participate in the
teleconference, please dial 1-877-928-1204 and enter conference code
4305992.
Purpose: The ES will provide counsel to the ACD, CDC, regarding
a broad range of public health ethics questions and issues arising
from programs, scientists and practitioners.
[[Page 72832]]
Matter to be Discussed: The ES will discuss a strategy for
addressing its charge to provide a preliminary overview to the ACD
on ethical issues related to non-communicable disease prevention and
control and an ethics framework to guide CDC programs and
activities.
The agenda is subject to change as priorities dictate.
Contact Person for More Information: Drue Barrett, Ph.D.,
Designated Federal Officer, ACD, CDC--ES, CDC, 1600 Clifton Road,
NE., M/S D-50, Atlanta, Georgia 30333. Telephone (404) 639-4690. E-
mail: dbarrett@cdc.gov.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities, for both the Centers for Disease Control and Prevention
and the Agency for Toxic Substances and Disease Registry.
Dated: November 18, 2010.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2010-29774 Filed 11-24-10; 8:45 am]
BILLING CODE 4163-18-P