Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 16315-16316 [E8-6290]
Download as PDF
<![CDATA[
pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
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 May 5 and 6, 2008, from 8 a.m.
to 4:30 p.m.
Location: Holiday Inn, The Ballrooms,
Two Montgomery Village Ave.,
Gaithersburg, MD. The hotel telephone
number is 301–948–8900.
Contact Person: Teresa Watkins,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane, (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
Teresa.Watkins@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in
Washington, DC area), codes
3014512529 and 3014512535. 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 hotline/phone line
to learn about possible modifications
before coming to the meeting.
Agenda: On May 5, 2008, the
committees will discuss new drug
application (NDA) 22–272,
OXYCONTIN (oxycodone hydrochloride
controlled-release) Tablets, Purdue
Pharma L.P., and its safety for the
proposed indication of management of
moderate to severe pain when a
continuous, around-the-clock analgesic
is needed for an extended period of
time. The sustained-release
characteristics of this formulation are
purportedly less easily defeated than
other formulations of OXYCONTIN. On
May 6, 2008, the committees will
discuss supplemental new drug
application (sNDA) 21–947/s-005,
FENTORA (fentanyl buccal tablet),
Cephalon, Inc., and its safety for the
proposed indication of breakthrough
pain in opioid tolerant non-cancer
patients with chronic pain.
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/
VerDate Aug<31>2005
16:08 Mar 26, 2008
Jkt 214001
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 April 21, 2008. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. each day. 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 April 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 April 14, 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 Teresa
Watkins 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: March 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–6294 Filed 3–26–08; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
16315
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Obstetrics and Gynecology 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: Obstetrics and
Gynecology 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 May 16, 2008, from 8 a.m. to
5:30 p.m.
Location: Holiday Inn, Grand
Ballroom, Two Montgomery Village
Ave., Gaithersburg, MD.
Contact Person: Michael Bailey,
Center for Devices and Radiological
Health (HFZ–470), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–4100, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512524. 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,
make recommendations, and vote on a
premarket approval application for the
FC2 Female Condom, sponsored by the
Female Health Co. This device is
indicated to help prevent HIV/AIDS and
unintended pregnancy.
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
E:\FR\FM\27MRN1.SGM
27MRN1
16316
Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
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 May 2, 2008. Oral
presentations from the public will be
scheduled between approximately 8:30
a.m. and 9 a.m., and between 3:30 p.m.
and 4 p.m. 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 April 24, 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 April 25, 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, 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: March 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–6290 Filed 3–26–08; 8:45 am]
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
(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 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, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the Agency,
including whether the information shall
have practical utility; (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 the use of
automated collection techniques or
other forms of information technology.
Proposed Project: The Nurse Faculty
Loan Program (NFLP): Program
Specific Data Form (NEW)
The Nurse Faculty Loan Program
(NFLP) is authorized under Title VIII of
the Public Health Service Act, Section
846A, as amended by the Nurse
Reinvestment Act, Public Law 107–205
Number of
respondents
pwalker on PROD1PC71 with NOTICES
Form
Responses
per
respondent
150
1
150
8 hours ....................
1200 hours
150
1
150
8 hours ....................
1200 hours
Nurse Faculty Loan Program Annual Operating Report (AOR).
Total Burden .........................................................
VerDate Aug<31>2005
16:08 Mar 26, 2008
to increase the number of qualified
nurse faculty. The HHS, acting through
HRSA, may enter into an agreement
with schools of nursing and make an
award to establish and operate a distinct
NFLP loan fund. The NFLP loan fund is
used by the applicant School of Nursing
to make loans to eligible students
pursuing an advanced nursing degree
program that will prepare the student to
become qualified as a nursing faculty.
The NFLP Program Specific Data
Form will capture program-related
information provided by the applicant.
NFLP applicants will complete and
submit the Program Specific Data Form
as an electronic attachment with the
required application materials. The form
will provide the Federal Government
with specific data from the applicant to
specify: (1) The amount of the Federal
funds requested by the applicant, (2) the
expected contribution from the
applicant, (3) the student enrollment
and graduation data based on current
and prospective NFLP loan recipients,
(4) the graduate nursing education
programs supported under NFLP, (5) the
program accreditation status, (6) the
current tuition and fee information for
graduate nursing education programs,
and (7) the projected NFLP loan fund
balance that may be considered as part
of the award determination. The data
provided in the form are essential for
the formula-based criteria used to
determine the award amount to the
applicant schools. The new Program
Specific Data Form will facilitate the
current effort to develop an automated
data collection capability for the NFLP.
The electronic data collection capability
will streamline the application
submission process, enable an efficient
award determination process, and serve
as a data repository to facilitate
reporting on the use of funds and
analysis of program outcomes.
Additionally, the data will be used to
ensure programmatic compliance with
the legislative authority and program
guidance, to report program
accomplishments to policy makers and
Congress, and to formulate and justify
the appropriation to the Office of
Management and Budget and Congress.
The estimate of burden for this form
is as follows:
Jkt 214001
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Total
responses
Hours per response
E:\FR\FM\27MRN1.SGM
27MRN1
Total burden hours
]]>Agencies
[Federal Register Volume 73, Number 60 (Thursday, March 27, 2008)]
[Notices]
[Pages 16315-16316]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6290]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Obstetrics and Gynecology 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: Obstetrics and Gynecology 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 May 16, 2008, from 8
a.m. to 5:30 p.m.
Location: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Michael Bailey, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240-276-4100, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512524. 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, make recommendations, and vote
on a premarket approval application for the FC2 Female Condom,
sponsored by the Female Health Co. This device is indicated to help
prevent HIV/AIDS and unintended pregnancy.
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
[[Page 16316]]
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 May
2, 2008. Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9 a.m., and between 3:30 p.m. and 4 p.m.
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 April 24, 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 April 25, 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, 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: March 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-6290 Filed 3-26-08; 8:45 am]
BILLING CODE 4160-01-S
