Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 65608-65609 [E8-26230]
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65608
Federal Register / Vol. 73, No. 214 / Tuesday, November 4, 2008 / Notices
Dated: October 27, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–26244 Filed 11–3–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Immunology Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
dwashington3 on PRODPC61 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: Immunology
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 December 3, 2008, from 8:30
a.m. to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Dai J. Li, Center for
Devices and Radiological Health (HFZ–
440), Food and Drug Administration,
2098 Gaither Rd., Rockville, MD 20850,
240–276–0997, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512516. 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: The committee will discuss
and make recommendations on the
premarket notification application for
the Fujirebio HE4 EIA kit and associated
Risk of Malignancy algorithm
(ROMATM) Test. The HE4 EIA is an
enzyme immunometric assay for the
quantitative determination of HE4 in
human serum. The HE4 EIA, used in
VerDate Aug<31>2005
15:23 Nov 03, 2008
Jkt 217001
conjunction with the ARCHITECT CA
125 II assay, creates a predictive
probability of epithelial ovarian cancer
using a mathematical function referred
to as the ROMATM, for use in
premenopausal and postmenopausal
women presenting with an adnexal
mass who have already been referred to
an oncologic specialist and are
scheduled for surgery. Subjects
categorized as low risk for epithelial
ovarian cancer using the ROMATM
value may have surgical intervention
performed by a non-oncology specialist.
The results must be interpreted in
conjunction with other clinical findings
in accordance with standard clinical
management guidelines. The assay is
not indicated as an aid in a decision to
proceed to surgery.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and 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 November 19, 2008.
Oral presentations from the public will
be scheduled for approximately 30
minutes at the beginning of committee
deliberations and for approximately 30
minutes near the end of the
deliberations. Those desiring to make
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 November 11, 2008. 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
November 12, 2008.
Persons attending FDA’s advisory
committee meetings are advised that the
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Fmt 4703
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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 at 240–276–8932 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/oc/advisory/
default.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: October 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–26243 Filed 11–3–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Orthopaedic and Rehabilitation
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: Orthopaedic and
Rehabilitation 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 November 14, 2008, from 8:30
a.m. to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Ronald P. Jean,
Center for Devices and Radiological
Health (HFZ–410), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD, 20850, 240–276–3676, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
E:\FR\FM\04NON1.SGM
04NON1
dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 214 / Tuesday, November 4, 2008 / Notices
3014512521. 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: The committee will discuss
and make recommendations on a
premarket notification application for
the ReGen Collagen Scaffold (CS),
sponsored by ReGen Biologics, Inc. This
device is intended for use in surgical
procedures for the reinforcement and
repair of chronic soft tissue injuries of
the meniscus (one to three prior
surgeries to the involved meniscus)
where weakness exists. In repairing and
reinforcing meniscal defects, the patient
must have an intact meniscal rim and
anterior and posterior horns for
attachment of the mesh. In addition, the
surgically prepared site for the CS must
extend at least into the red/white zone
of the meniscus to provide sufficient
vascularization.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and 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 November 7, 2008.
Oral presentations from the public will
be scheduled for 30 minutes at the
beginning of the committee
deliberations and for 30 minutes near
the end of the deliberations. Those
desiring to make 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
November 6, 2008. Time allotted for
each presentation may be limited. If the
VerDate Aug<31>2005
15:23 Nov 03, 2008
Jkt 217001
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 November 7, 2008.
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 Ann Marie
Williams, Conference Management
Staff, 240–276–8932, 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/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
FDA regrets that it was unable to
publish this notice 15 days prior to the
Orthopaedic and Rehabilitation Devices
Panel of the Medical Devices Advisory
Committee meeting. Because the agency
believes there is some urgency to bring
these issues to public discussion and
qualified members of the Orthopaedic
and Rehabilitation Devices Panel of the
Medical Devices Advisory Committee
were available at this time, the
Commissioner of Food and Drugs
concluded that it was in the public
interest to hold this meeting even if
there was not sufficient time for the
customary 15-day public notice.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–26230 Filed 10–30–08; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
PO 00000
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65609
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Enrollment and ReCertification of Entities in the 340B
Drug Pricing Program (NEW)
Section 602 of Public Law 102–585,
the Veterans Health Care Act of 1992,
enacted section 340B of the Public
Health Service Act (PHS Act)
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities.’’ Section
340B provides that a manufacturer who
sells covered outpatient drugs to eligible
entities must sign a pharmaceutical
pricing agreement with the Secretary of
Health and Human Services in which
the manufacturer agrees to charge a
price for covered outpatient drugs that
will not exceed an amount determined
under a statutory formula.
Covered entities which choose to
participate in the section 340B Drug
Pricing Program must comply with the
requirements of 340B(a)(5) of the PHS
Act. Section 340B(a)(5)(A) prohibits a
covered entity from accepting a
discount for a drug that would also
generate a Medicaid rebate. Further,
section 340B(a)(5)(B) prohibits a
covered entity from reselling or
otherwise transferring a discounted drug
to a person who is not a patient of the
entity.
In response to the statutory mandate
of section 340B(a)(9) to notify
manufacturers of the identities of
covered entities and the mandate of
section 340B(a)(5)(A)(ii) to establish a
mechanism to ensure against duplicate
discounts and the ongoing
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[Federal Register Volume 73, Number 214 (Tuesday, November 4, 2008)]
[Notices]
[Pages 65608-65609]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26230]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 November 14, 2008, from
8:30 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Ronald P. Jean, Center for Devices and Radiological
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD, 20850, 240-276-3676, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code
[[Page 65609]]
3014512521. 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: The committee will discuss and make recommendations on a
premarket notification application for the ReGen Collagen Scaffold
(CS), sponsored by ReGen Biologics, Inc. This device is intended for
use in surgical procedures for the reinforcement and repair of chronic
soft tissue injuries of the meniscus (one to three prior surgeries to
the involved meniscus) where weakness exists. In repairing and
reinforcing meniscal defects, the patient must have an intact meniscal
rim and anterior and posterior horns for attachment of the mesh. In
addition, the surgically prepared site for the CS must extend at least
into the red/white zone of the meniscus to provide sufficient
vascularization.
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/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and 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
November 7, 2008. Oral presentations from the public will be scheduled
for 30 minutes at the beginning of the committee deliberations and for
30 minutes near the end of the deliberations. Those desiring to make
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 November 6, 2008. 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 November 7, 2008.
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 Ann Marie Williams,
Conference Management Staff, 240-276-8932, 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/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
FDA regrets that it was unable to publish this notice 15 days prior
to the Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee meeting. Because the agency believes there
is some urgency to bring these issues to public discussion and
qualified members of the Orthopaedic and Rehabilitation Devices Panel
of the Medical Devices Advisory Committee were available at this time,
the Commissioner of Food and Drugs concluded that it was in the public
interest to hold this meeting even if there was not sufficient time for
the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26230 Filed 10-30-08; 4:15 pm]
BILLING CODE 4160-01-S
