Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting, 12768-12769 [2010-5813]
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12768
Federal Register / Vol. 75, No. 51 / Wednesday, March 17, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Blood Products
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 by teleconference on April 12,
2010, from 1 p.m. to 5:30 p.m.
Location: National Institutes of
Health, 9000 Rockville Pike, Bldg. 29,
conference rm. 121, Bethesda, MD,
20892. The public is welcome to attend
the meeting at the specified location
where a speakerphone will be provided.
Public participation in the meeting is
limited to the use of the speakerphone
in the conference room. Important
information about transportation and
directions to the NIH campus, parking,
and security procedures is available on
the Internet at https://www.nih.gov/
about/visitor/index.htm. (FDA has
verified the Web site address, but FDA
is not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.) Visitors must show two forms
of identification, one of which must be
a Government-issued photo
identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. Detailed
information about security procedures is
located at https://www.nih.gov/about/
visitorsecurity.htm. Due to the limited
available parking, visitors are
encouraged to use public transportation.
Contact Person: Bryan Emery or
Pearline K. Muckelvene, Center for
Biologics Evaluation and Research
(CBER) (HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–0314, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014519516. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
VerDate Nov<24>2008
15:08 Mar 16, 2010
Jkt 220001
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 April 12, 2010, the
committee will meet in open session to
hear updates on the research programs
of the Laboratory of Cellular
Hematology and the Laboratory of
Biochemistry and Vascular Biology,
Division of Hematology, Office of Blood
Research and Review, CBER, FDA.
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: On April 12, 2010, from 1
p.m. to approximately 4:15 p.m., the
meeting is open to the public. 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 7, 2010. Oral
presentations from the public will be
scheduled between approximately 3:15
p.m. and 4:15 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 March 30, 2010. 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 March 31, 2010.
Closed Committee Deliberations: On
April 12, 2010, from approximately 4:15
p.m. to approximately 5:30 p.m., the
meeting will be closed to permit
discussion where disclosure would
constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
552b(c)(6)). The committee will discuss
the site visit report of the intramural
research programs and make
recommendations regarding personnel
staffing decisions.
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 Bryan Emery
or Pearline Muckelvene 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/Advisory
Committees/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: March 11, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–5814 Filed 3–16–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Peripheral and Central Nervous
System 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: Peripheral and
Central Nervous System 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 May 6, 2010, from 8 a.m. to 5
p.m.
Location: The Inn and Conference
Center, University of Maryland
University College (UMUC), Marriott
E:\FR\FM\17MRN1.SGM
17MRN1
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 51 / Wednesday, March 17, 2010 / Notices
Conference Centers, 3501 University
Blvd. East, Adelphi, MD. The hotel
telephone number is 301–985–7300.
Contact Person: Diem-Kieu Ngo,
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, email:
diem.ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512543. 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 May 6, 2010, the
committee will discuss supplemental
new drug application (sNDA) 22–432,
H.P. ACTHAR Gel (repository
corticotropin injection), 80 USP units
per milliliter, Questcor Pharmaceuticals,
proposed for the treatment of infantile
spasms.
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 April 22, 2010. Oral
presentations from the public will be
scheduled between approximately 11
a.m. and 12 noon. 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 14, 2010. Time allotted
for each presentation may be limited. If
VerDate Nov<24>2008
15:08 Mar 16, 2010
Jkt 220001
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 15, 2010.
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 Diem-Kieu
Ngo 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/Advisory
Committees/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: March 11, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–5813 Filed 3–16–10; 8:45 am]
12769
Emphasis Panel; HLA Region Genetics in
Immune-Mediated Diseases.
Date: April 7–8, 2010.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza Hotel—Silver Spring,
8777 Georgia Avenue, Silver Spring, MD
20910.
Contact Person: Maryam Feili-Hariri, PhD,
Scientific Review Officer, Immunology
Review Branch, Scientific Review Program,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892–7616, 301–
402–5658, haririmf@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: March 10, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–5769 Filed 3–16–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary
and Alternative Medicine
Announcement of Workshop on
Control/Comparison Groups for Trials
of Non-Pharmacologic Interventions
ACTION:
Notice.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
SUMMARY: The National Center for
Complementary and Alternative
Medicine (NCCAM) invites the public to
participate at a Workshop on the choice
of control and comparison groups for
trials of non-pharmacological
interventions (NPI). The purpose of this
workshop is to review the strengths and
weaknesses of the various control/
comparison groups used in studies of
NPI and the most appropriate use of
these control/comparison groups. This
workshop will be divided into six
sessions that will feature presentations
and discussions focusing on the
selection of a particular control/
comparison group(s) for a given research
question. The first session will provide
case studies from the NPI literature,
while the remainder will address the
choice of control/comparison groups
when researching the following
questions: What is/are the major active
component(s) of the NPI? What is/are
the major effective mechanism(s) of the
NPI? Does this NPI work at all? Is this
NPI as good as (or better than) some
other intervention? Does this NPI
improve standard-of-care?
E:\FR\FM\17MRN1.SGM
17MRN1
]]>Agencies
[Federal Register Volume 75, Number 51 (Wednesday, March 17, 2010)]
[Notices]
[Pages 12768-12769]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5813]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 May 6, 2010, from 8 a.m.
to 5 p.m.
Location: The Inn and Conference Center, University of Maryland
University College (UMUC), Marriott
[[Page 12769]]
Conference Centers, 3501 University Blvd. East, Adelphi, MD. The hotel
telephone number is 301-985-7300.
Contact Person: Diem-Kieu Ngo, 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, email: diem.ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512543. 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 May 6, 2010, the committee will discuss supplemental new
drug application (sNDA) 22-432, H.P. ACTHAR Gel (repository
corticotropin injection), 80 USP units per milliliter, Questcor
Pharmaceuticals, proposed for the treatment of infantile spasms.
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
April 22, 2010. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 noon. 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 14, 2010. 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 15, 2010.
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 Diem-Kieu Ngo 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: March 11, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-5813 Filed 3-16-10; 8:45 am]
BILLING CODE 4160-01-S
