Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-October 21, 2009, 44373-44374 [E9-20844]
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Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Centers for Medicare & Medicaid
Services
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
[CMS–3214–N]
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 meeting.
The meeting 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.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
hsrobinson on DSK69SOYB1PROD with NOTICES
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Initial
Review Group; Epidemiology, Prevention
and Behavior Research Review
Subcommittee.
Date: October 28–29, 2009.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz Carlton Hotel, 1150 22nd Street,
NW., Washington, DC 20037.
Contact Person: Lorraine Gunzerath, PhD,
MBA, Scientific Review Officer, National
Institute on Alcohol Abuse and Alcoholism,
Office of Extramural Activities, Extramural
Project Review Branch, 5635 Fishers Lane,
Room 2121, Bethesda, MD 20892–9304, 301–
443–2369, lgunzera@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
Dated: August 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–20773 Filed 8–27–09; 8:45 am]
BILLING CODE 4140–01–M
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Medicare Program; Meeting of the
Medicare Evidence Development and
Coverage Advisory Committee—
October 21, 2009
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
SUMMARY: This notice announces that a
public meeting of the Medicare
Evidence Development & Coverage
Advisory Committee (MEDCAC)
(‘‘Committee’’) will be held on
Wednesday, October 21, 2009. The
Committee generally provides advice
and recommendations concerning the
adequacy of scientific evidence needed
to determine whether certain medical
items and services can be covered under
the Medicare statute. This meeting will
focus on the use of catheter ablation for
the treatment of atrial fibrillation. This
meeting is open to the public in
accordance with the Federal Advisory
Committee Act (5 U.S.C. App. 2, section
10(a)).
DATES: Meeting date: The public
meeting will be held on Wednesday,
October 21, 2009 from 7:30 a.m. until
4:30 p.m., d.s.t.
Deadline for Submission of Written
Comments: Written comments must be
received at the address specified in the
ADDRESSES section of this notice by 5
p.m., d.s.t. on Monday, September 21,
2009. Once submitted all comments are
final.
Deadlines for Speaker Registration
and Presentation Materials: The
deadline to register to be a speaker and
to submit powerpoint presentation
materials and writings that will be used
in support of an oral presentation, is 5
p.m., d.s.t. on Monday, September 21,
2009. Speakers may register by phone or
via e-mail by contacting the person
listed in the FOR FURTHER INFORMATION
CONTACT section of this notice.
Presentation materials must be received
at the address specified in the
ADDRESSES section of this notice.
Deadline for All Other Attendees
Registration: Individuals may register by
phone or via e-mail by contacting the
person listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice by 5 p.m., d.s.t. on Wednesday,
October 14, 2009.
Deadline for Submitting a Request for
Special Accommodations: Persons
attending the meeting who are hearing
PO 00000
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44373
or visually impaired, or have a
condition that requires special
assistance or accommodations, are
asked to contact the Executive Secretary
as specified in the FOR FURTHER
INFORMATION CONTACT section of this
notice no later than 5 p.m., d.s.t. Friday,
October 2, 2009.
ADDRESSES: Meeting Location: The
meeting will be held in the main
auditorium of the Centers for Medicare
& Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244.
Submission of Presentations and
Comments: Presentation materials and
written comments that will be presented
at the meeting must be submitted via email to
MedCACpresentations@cms.hhs.gov or
by regular mail to the contact listed in
the FOR FURTHER INFORMATION CONTACT
section of this notice by the date
specified in the DATES section of this
notice.
FOR FURTHER INFORMATION CONTACT:
Maria Ellis, Executive Secretary for
MEDCAC, Centers for Medicare &
Medicaid Services, Office of Clinical
Standards and Quality, Coverage and
Analysis Group, C1–09–06, 7500
Security Boulevard, Baltimore, MD
21244 or contact Ms. Ellis by phone
(410–786–0309) or via e-mail at
Maria.Ellis@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
MEDCAC, formerly known as the
Medicare Coverage Advisory Committee
(MCAC), provides advice and
recommendations to CMS regarding
clinical issues. (For more information
on MCAC, see the December 14, 1998
Federal Register (63 FR 68780.) This
notice announces the October 21, 2009,
public meeting of the Committee.
During this meeting, the Committee will
discuss the use of catheter ablation for
the treatment of atrial fibrillation.
Background information about this
topic, including panel materials, is
available at https://ww.cms.hhs.gov/
coverage. We encourage the
participation of appropriate
organizations with expertise in the use
of catheter ablation for the treatment of
atrial fibrillation.
II. Meeting Format
This meeting is open to the public.
The Committee will hear oral
presentations from the public for
approximately 45 minutes. The
Committee may limit the number and
duration of oral presentations to the
time available. Your comments should
focus on issues specific to the list of
topics that we have proposed to the
E:\FR\FM\28AUN1.SGM
28AUN1
44374
Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices
Committee. The list of research topics to
be discussed at the meeting will be
available on the following Web site
prior to the meeting: https://
www.cms.hhs.gov/mcd/
index_list.asp?list_type=mcac. We
require that you declare at the meeting
whether you have any financial
involvement with manufacturers (or
their competitors) of any items or
services being discussed.
The Committee will deliberate openly
on the topics under consideration.
Interested persons may observe the
deliberations, but the Committee will
not hear further comments during this
time except at the request of the
chairperson. The Committee will also
allow a 15-minute unscheduled open
public session for any attendee to
address issues specific to the topics
under consideration. At the conclusion
of the day, the members will vote and
the Committee will make its
recommendation(s) to CMS.
III. Registration Instructions
CMS’ Coverage and Analysis Group is
coordinating meeting registration. While
there is no registration fee, individuals
must register to attend. You may register
by contacting the person listed in the
FOR FURTHER INFORMATION CONTACT
hsrobinson on DSK69SOYB1PROD with NOTICES
section of this notice by the deadline
listed in the DATES section of this notice.
Please provide your full name (as it
appears on your State-issued driver’s
license), address, organization,
telephone, fax number(s), and e-mail
address. You will receive a registration
confirmation with instructions for your
arrival at the CMS complex or you will
be notified the seating capacity has been
reached.
IV. Security, Building, and Parking
Guidelines
This meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable. We
recommend that confirmed registrants
arrive reasonably early, but no earlier
than 45 minutes prior to the start of the
meeting, to allow additional time to
clear security. Security measures
include the following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel.
• Inspection of vehicle’s interior and
exterior (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Inspection, via metal detector or
other applicable means of all persons
entering the building. We note that all
VerDate Nov<24>2008
21:38 Aug 27, 2009
Jkt 217001
items brought into CMS, whether
personal or for the purpose of
presentation or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for
presentation or to support a
presentation.
Note: Individuals who are not registered in
advance will not be permitted to enter the
building and will be unable to attend the
meeting. The public may not enter the
building earlier than 45 minutes prior to the
convening of the meeting.
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building.
Authority: 5 U.S.C. App. 2, section 10(a).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: August 24, 2009.
Barry M. Straube,
Chief Medical Officer and Director, Office
of Clinical Standards and Quality, Centers
for Medicare & Medicaid Services.
[FR Doc. E9–20844 Filed 8–27–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Blood Establishment Computer
Software: Understanding What to
Include in a 510(k) Submission; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Blood Establishment
Computer Software: Understanding
What to Include in a 510(k)
Submission.’’ The purpose of the public
workshop is to educate industry on the
laws and regulations for medical
devices that are applicable to Blood
Establishment Computer Software
(BECS), including requirements for the
content of a 510(k) submission. The
public workshop will feature
presentations and panel discussions led
by FDA and other experts in software
quality engineering.
Date and Time: The public workshop
will be held on November 4, 2009, from
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8:30 a.m. to 5 p.m. and November 5,
2009, from 8:30 a.m. to 12 noon.
Location: The public workshop will
be held at The Universities at Shady
Grove Conference Center, Bldg. II,
multipurpose room, 9630 Gudelsky Dr.,
Rockville, MD 20850.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 550N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your
registration information (including
name, title, firm name, address,
telephone, and fax numbers) to the
contact person by October 16, 2009.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: BECS is a
device used in the prevention of disease
in humans, by identifying unsuitable
donors and preventing the release of
infectious or otherwise harmful blood
and blood components for transfusion
or for further manufacturing use.
Facilities that manufacture and
distribute BECS are subject to device
provisions of the Federal Food, Drug,
and Cosmetic Act (the act), including
premarket notification under section
510(k) of the act (21 U.S.C. 360(k)) and
applicable regulations at 21 CFR 807,
subpart E. The public workshop will
consist of a series of presentations,
question-and-answer sessions, and a
panel discussion on the following
topics:
• The history and legal framework of
BECS regulation in the United States;
• Content of 510(k) submissions,
applicable regulations, and guidance;
• Common challenges in obtaining
510(k) clearance;
• FDA-recognized software standards;
• General software quality
engineering;
• Transfusion safety management
systems (blood administration software);
• Virtualization; and
• Wireless technology.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
E:\FR\FM\28AUN1.SGM
28AUN1
Agencies
[Federal Register Volume 74, Number 166 (Friday, August 28, 2009)]
[Notices]
[Pages 44373-44374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20844]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3214-N]
Medicare Program; Meeting of the Medicare Evidence Development
and Coverage Advisory Committee--October 21, 2009
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces that a public meeting of the Medicare
Evidence Development & Coverage Advisory Committee (MEDCAC)
(``Committee'') will be held on Wednesday, October 21, 2009. The
Committee generally provides advice and recommendations concerning the
adequacy of scientific evidence needed to determine whether certain
medical items and services can be covered under the Medicare statute.
This meeting will focus on the use of catheter ablation for the
treatment of atrial fibrillation. This meeting is open to the public in
accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2,
section 10(a)).
DATES: Meeting date: The public meeting will be held on Wednesday,
October 21, 2009 from 7:30 a.m. until 4:30 p.m., d.s.t.
Deadline for Submission of Written Comments: Written comments must
be received at the address specified in the ADDRESSES section of this
notice by 5 p.m., d.s.t. on Monday, September 21, 2009. Once submitted
all comments are final.
Deadlines for Speaker Registration and Presentation Materials: The
deadline to register to be a speaker and to submit powerpoint
presentation materials and writings that will be used in support of an
oral presentation, is 5 p.m., d.s.t. on Monday, September 21, 2009.
Speakers may register by phone or via e-mail by contacting the person
listed in the FOR FURTHER INFORMATION CONTACT section of this notice.
Presentation materials must be received at the address specified in the
ADDRESSES section of this notice.
Deadline for All Other Attendees Registration: Individuals may
register by phone or via e-mail by contacting the person listed in the
FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m.,
d.s.t. on Wednesday, October 14, 2009.
Deadline for Submitting a Request for Special Accommodations:
Persons attending the meeting who are hearing or visually impaired, or
have a condition that requires special assistance or accommodations,
are asked to contact the Executive Secretary as specified in the FOR
FURTHER INFORMATION CONTACT section of this notice no later than 5
p.m., d.s.t. Friday, October 2, 2009.
ADDRESSES: Meeting Location: The meeting will be held in the main
auditorium of the Centers for Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, MD 21244.
Submission of Presentations and Comments: Presentation materials
and written comments that will be presented at the meeting must be
submitted via e-mail to MedCACpresentations@cms.hhs.gov or by regular
mail to the contact listed in the FOR FURTHER INFORMATION CONTACT
section of this notice by the date specified in the DATES section of
this notice.
FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for
MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical
Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500
Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone
(410-786-0309) or via e-mail at Maria.Ellis@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
MEDCAC, formerly known as the Medicare Coverage Advisory Committee
(MCAC), provides advice and recommendations to CMS regarding clinical
issues. (For more information on MCAC, see the December 14, 1998
Federal Register (63 FR 68780.) This notice announces the October 21,
2009, public meeting of the Committee. During this meeting, the
Committee will discuss the use of catheter ablation for the treatment
of atrial fibrillation. Background information about this topic,
including panel materials, is available at https://ww.cms.hhs.gov/coverage. We encourage the participation of appropriate organizations
with expertise in the use of catheter ablation for the treatment of
atrial fibrillation.
II. Meeting Format
This meeting is open to the public. The Committee will hear oral
presentations from the public for approximately 45 minutes. The
Committee may limit the number and duration of oral presentations to
the time available. Your comments should focus on issues specific to
the list of topics that we have proposed to the
[[Page 44374]]
Committee. The list of research topics to be discussed at the meeting
will be available on the following Web site prior to the meeting:
https://www.cms.hhs.gov/mcd/index_list.asp?list_type=mcac. We require
that you declare at the meeting whether you have any financial
involvement with manufacturers (or their competitors) of any items or
services being discussed.
The Committee will deliberate openly on the topics under
consideration. Interested persons may observe the deliberations, but
the Committee will not hear further comments during this time except at
the request of the chairperson. The Committee will also allow a 15-
minute unscheduled open public session for any attendee to address
issues specific to the topics under consideration. At the conclusion of
the day, the members will vote and the Committee will make its
recommendation(s) to CMS.
III. Registration Instructions
CMS' Coverage and Analysis Group is coordinating meeting
registration. While there is no registration fee, individuals must
register to attend. You may register by contacting the person listed in
the FOR FURTHER INFORMATION CONTACT section of this notice by the
deadline listed in the DATES section of this notice. Please provide
your full name (as it appears on your State-issued driver's license),
address, organization, telephone, fax number(s), and e-mail address.
You will receive a registration confirmation with instructions for your
arrival at the CMS complex or you will be notified the seating capacity
has been reached.
IV. Security, Building, and Parking Guidelines
This meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. We recommend that
confirmed registrants arrive reasonably early, but no earlier than 45
minutes prior to the start of the meeting, to allow additional time to
clear security. Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel.
Inspection of vehicle's interior and exterior (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Inspection, via metal detector or other applicable means
of all persons entering the building. We note that all items brought
into CMS, whether personal or for the purpose of presentation or to
support a presentation, are subject to inspection. We cannot assume
responsibility for coordinating the receipt, transfer, transport,
storage, set-up, safety, or timely arrival of any personal belongings
or items used for presentation or to support a presentation.
Note: Individuals who are not registered in advance will not be
permitted to enter the building and will be unable to attend the
meeting. The public may not enter the building earlier than 45
minutes prior to the convening of the meeting.
All visitors must be escorted in areas other than the lower and first
floor levels in the Central Building.
Authority: 5 U.S.C. App. 2, section 10(a).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: August 24, 2009.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and
Quality, Centers for Medicare & Medicaid Services.
[FR Doc. E9-20844 Filed 8-27-09; 8:45 am]
BILLING CODE 4120-01-P