Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 25183-25184 [2012-10156]
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 82 / Friday, April 27, 2012 / Notices
Total Annual Hours: 365,136. (For
policy questions regarding this
collection contact William Lehrman at
410–786–1037. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Site
Investigation for Durable Medical
Equipment (DME) Suppliers ; Use: CMS
is mandated to identify and implement
measures to prevent fraud and abuse in
the Medicare program. To meet this
challenge, CMS has moved forward to
improve the quality of the process for
enrolling suppliers into the Medicare
program by establishing a uniform
application for enumerating suppliers of
durable medical equipment, prosthetics,
orthotics, and supplies (DMEPOS).
Implementation of enhanced procedures
for verifying the enrollment information
has also improved the enrollment
process. As part of this process,
verification of compliance with supplier
standards is necessary. The site
investigation form has been used in the
past to aid the Medicare contractor (the
National Supplier Clearinghouse and/or
its subcontractors) in verifying
compliance with the required supplier
standards found in 42 CFR 424.57(c).
The primary function of the site
investigation form is to provide a
standardized, uniform tool to gather
information from a DMEPOS supplier
that tells us whether it meets certain
qualifications to be a DMEPOS supplier
(as found in 42 CFR 424.57(c)) and
where it practices or renders its
services.
This site investigation form collects
the same information as its predecessor,
with the exception of one new yes/no
question under the ‘‘Records and
Telephone’’ section (question 11(a))
used to verify if the DMEPOS supplier
maintains physician ordering/referring
records for the supplies and/or services
it renders to Medicare beneficiaries (if
applicable). This information is required
by section 1833(q) of the Social Security
Act (the Act) which states that all
physicians and non-physician
practitioners that meet the definitions at
section 1861(r) and 1842(b)(18)(C) of the
Act, be uniquely identified for all claims
for services that are ordered or referred.
Other information collected on this site
investigation remains unchanged, but
has been reformatted for greater
functionality. Form Number: CMS–R–
263 (OCN: 0938–0749); Frequency:
Once; Affected Public: Private Sector—
Business or other for-profits and not-forprofit institutions; Number of
Respondents: 30,000; Total Annual
Responses: 30,000; Total Annual Hours:
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17:44 Apr 26, 2012
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15,000. (For policy questions regarding
this collection contact Kimberly
McPhillips at 410–786–5374. For all
other issues call 410–786–1326.)
3. Type of Information Collection
Request: Revision of a currently
approved collection;
Title of Information Collection:
Medicare Registration Application; Use:
The CMS 855O allows a physician to
receive a Medicare identification
number (without being approved for
billing privileges) for the sole purpose of
ordering and referring Medicare
beneficiaries to Medicare approved
providers and suppliers. This new
Medicare registration application form
allows physicians who do not provide
services to Medicare beneficiaries to be
given a Medicare identification number
without having to supply all the data
required for the submission of Medicare
claims. It also allows the Medicare
program to identify ordering and
referring physicians without having to
validate the amount of data necessary to
determine claims payment eligibility
(such as banking information), while
continuing to identify the physician’s
credentials as valid for ordering and
referring purposes. Since the physicians
and non-physician practitioners
submitting this application are not
enrolling in Medicare to submit claims
but are only registering with Medicare
as eligible to order and refer, CMS
believes changing the title from
Medicare Enrollment Application to
Medicare Registration Application
better captures the actual purpose of
this form.
Where appropriate, CMS has changed
all references to enrollment or enrolling
to registration and registering and
Medicare billing number to National
Provider Identifier. CMS also added a
check box to allow physicians and nonphysician practitioners to withdraw
from the ordering and referring registry.
A section to collect information on
professional certifications was added for
those practitioners who are not
professionally licensed. Editorial and
formatting corrections were made in
response to prior comments received
during the approval of the current
version of this application. Other minor
editorial and formatting corrections
were made to better clarify the purpose
of this application. Form Number:
CMS–855(O) (OCN: 0938–1135);
Frequency: Occasionally; Affected
Public: Individuals; Number of
Respondents: 48,500; Total Annual
Responses: 48,500; Total Annual Hours:
24,125. (For policy questions regarding
this collection contact Kimberly
McPhillips at 410–786–5374. For all
other issues call 410–786–1326.)
PO 00000
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25183
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on May 29, 2012.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974,
Email: OIRA_submission@omb.eop.gov.
Dated: April 24, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–10225 Filed 4–26–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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: Circulatory System
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 June 13, 2012, from 8 a.m. to 6 p.m.
Location: Hilton Washington DC North/
Gaithersburg, Salons A, B, C, and D, 620
Perry Pkwy., Gaithersburg, MD 20877. The
hotel telephone number is 301–977–8900.
Contact Person: Jamie Waterhouse, Center
for Devices and Radiological Health, Food
and Drug Administration, 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), and follow the
prompts to the desired center or product
E:\FR\FM\27APN1.SGM
27APN1
mstockstill on DSK4VPTVN1PROD with NOTICES
25184
Federal Register / Vol. 77, No. 82 / Friday, April 27, 2012 / Notices
area. Please call the Information Line for upto-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 June 13, 2012, the committee
will discuss, make recommendations and
vote on information related to the premarket
approval application for the Edwards
SAPIEN Transcatheter Heart Valve sponsored
by Edwards Lifesciences. The Edwards
SAPIEN Transcatheter Heart Valve is
indicated for use in patients with
symptomatic severe aortic stenosis who have
high operative risk.
The Edwards SAPIEN Transcatheter Heart
Valve, model 9000TFX, sizes 23mm and
26mm and accessories implant system
consists of the following:
• A heterologous (bovine) pericardium
leaflet valve sutured within a stainless steel
mesh frame, with a polyester skirt. It is
offered in two sizes, a 23 mm and a 26 mm.
• The RetroFlex 3 Delivery System is used
to advance the bioprosthesis through the
RetroFlex sheath over a guidewire and to
track the bioprosthesis over the aortic arch
and for crossing and positioning in the native
valve. The delivery system also comes with
a sheath, introducer, loader, dilator, balloon
(used to pre-dilate the native annulus) and a
crimper.
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
committee. Written submissions may be
made to the contact person on or before June
5, 2012. On June 13, 2012, oral presentations
from the public will be scheduled between
approximately 1 p.m. and 2 p.m. 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
29, 2012. 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 June 1, 2012.
VerDate Mar<15>2010
17:44 Apr 26, 2012
Jkt 226001
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 James
Clark, Conference Management Staff, at
James.Clark@fda.hhs.gov or 301–796–5293 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 19, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–10156 Filed 4–26–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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: Oncologic Drugs
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 June 20, 2012, 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 Avenue, Silver Spring, MD
20993–0002. Information regarding special
accommodations due to a disability, visitor
parking, and transportation may be accessed
at: 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: Caleb Briggs, Pharm.D.,
Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver Spring,
PO 00000
Frm 00064
Fmt 4703
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MD 20993–0002, (301) 796–9001, Fax: (301)
847–8533, email: ODAC@fda.hhs.gov, or FDA
Advisory Committee Information Line, 1–
800–741–8138 (301–443–0572 in the
Washington, DC area), to find out further
information regarding FDA advisory
committee information. 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 advisory committee information
line or visit our Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm to learn about possible
modifications before coming to the meeting.
Agenda: On June 20, 2012, during the
morning session, the committee will discuss
new drug application (NDA) 203213, with
the established name semuloparin sodium
injection, application submitted by sanofiaventis U.S. LLC. The proposed indication
(use) for this product is for the prophylaxis
of venous thromboembolism (VTE) in
patients receiving chemotherapy for locally
advanced or metastatic pancreatic or lung
cancer or for locally advanced or metastatic
solid tumors with a VTE risk score ≥3.
During the afternoon session, the
committee will discuss NDA 202714, with
the proposed trade name Kyprolis
(carfilzomib) for injection, application
submitted by Onyx Pharmaceuticals, Inc. The
proposed indication (use) for this product is
for the treatment of patients with relapsed
and refractory (recurring and/or not
responsive to other treatments) multiple
myeloma who have received at least 2 prior
lines of therapy that included a proteasome
inhibitor and an immunomodulatory agent.
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 June
6, 2012. Oral presentations from the public
will be scheduled between approximately
10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m.
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 29, 2012. 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
E:\FR\FM\27APN1.SGM
27APN1
]]>Agencies
[Federal Register Volume 77, Number 82 (Friday, April 27, 2012)]
[Notices]
[Pages 25183-25184]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10156]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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: Circulatory System 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 June 13, 2012, from 8
a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B,
C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel
telephone number is 301-977-8900.
Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 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), and follow the prompts to the desired center or product
[[Page 25184]]
area. 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 June 13, 2012, the committee will discuss, make
recommendations and vote on information related to the premarket
approval application for the Edwards SAPIEN Transcatheter Heart
Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN
Transcatheter Heart Valve is indicated for use in patients with
symptomatic severe aortic stenosis who have high operative risk.
The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX,
sizes 23mm and 26mm and accessories implant system consists of the
following:
A heterologous (bovine) pericardium leaflet valve
sutured within a stainless steel mesh frame, with a polyester skirt.
It is offered in two sizes, a 23 mm and a 26 mm.
The RetroFlex 3 Delivery System is used to advance the
bioprosthesis through the RetroFlex sheath over a guidewire and to
track the bioprosthesis over the aortic arch and for crossing and
positioning in the native valve. The delivery system also comes with
a sheath, introducer, loader, dilator, balloon (used to pre-dilate
the native annulus) and a crimper.
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 committee.
Written submissions may be made to the contact person on or before
June 5, 2012. On June 13, 2012, oral presentations from the public
will be scheduled between approximately 1 p.m. and 2 p.m. 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 29, 2012. 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
June 1, 2012.
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 James Clark,
Conference Management Staff, at James.Clark@fda.hhs.gov or 301-796-
5293 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 19, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-10156 Filed 4-26-12; 8:45 am]
BILLING CODE 4160-01-P
