Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting, 78283-78284 [2011-32206]
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78283
Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices
the ACF–801. With this extension, ACF
is proposing to add several new data
elements as well as some minor changes
and clarifications to the existing
reporting requirements and instructions.
These proposed revisions to the ACF–
801 would allow OCC to capture childlevel data on provider quality for each
child receiving a child care subsidy.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Mariana Islands.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
ACF–801 ..........................................................................................................
jlentini on DSK4TPTVN1PROD with NOTICES
Estimated Total Annual Burden
Hours: 5,600.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments 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)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–32242 Filed 12–15–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Anesthetic and Analgesic Drug
Products 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: Anesthetic and
Analgesic Drug 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 on February 9, 2012, from 8:30 a.m.
to 4 p.m.
Location: Hilton Washington DC/
Silver Spring (scheduled to be renamed
in January 2012 to DoubleTree by Hilton
Hotel Washington DC/Silver Spring),
8727 Colesville Road, Silver Spring, MD
20910. The hotel’s phone number is
(301) 589–5200.
Contact Person: Philip Bautista,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, (301) 796–9001, FAX:
(301) 847–8533, email: AADPAC@fda.
hhs.gov, 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 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.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
4
Average
burden hours
per response
25
Total burden
hours
5,600
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
the available efficacy and safety data for
supplemental new drug application
(sNDA) 22395/S–013, QUTENZA
(capsaicin 8%) Patch, by NeurogesX,
Inc., for the proposed indication of
management of neuropathic pain (nerve
pain) related to HIV-associated
peripheral neuropathy (nerve pain in
the periphery of the body, such as the
feet and legs).
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 January 26, 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 January
18, 2012. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
E:\FR\FM\16DEN1.SGM
16DEN1
78284
Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices
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 January 19, 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 Philip
Bautista 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: December 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–32206 Filed 12–15–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSK4TPTVN1PROD 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: Pediatric
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 Monday, January 30, 2012 from
8 a.m. to 4 p.m. and on Tuesday,
January 31, 2012 from 9 a.m. to 12 noon.
Location: Hilton Gaithersburg Hotel,
620 Perry Pkwy., Gaithersburg, MD
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20877. The hotel’s phone number is
(301) 977–8900.
Contact Person: Walter Ellenberg,
Office of Pediatric Therapeutics, Office
of the Commissioner, Food and Drug
Administration, Bldg. 32, Rm. 5154,
10903 New Hampshire Ave., Silver
Spring, MD 20993, (301) 796–8524,
email: Walter.Ellenberg@fda.hhs.gov, 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 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: The Pediatric Advisory
Committee will meet to discuss
pediatric-focused safety reviews, as
mandated by the Best Pharmaceuticals
for Children Act and the Pediatric
Research Equity Act for Prevnar 13
(Pneumococcal 13-valent Conjugate
Vaccine (Diphtheria CRM197 Protein),
Cervarix (Human Papillomavirus
Bivalent (Types 16 and 18) vaccine,
recombinant, Focalin XR
(dexmethylphenidate), Daytrana
(methylphenidate), Seroquel
(quetiapine), Pancreaze (pancrelipase),
Zenpep (pancrelipase), Creon
(pancrelipase), Xerese cream 5%/1%
(acyclovir and hydrocortisone), Xolair
(omalizumab), Benicar (olmesartan
medoxomil), Atacand (candesartan
cilexetil), Mirena (levonorgestrel—
releasing intrauterine system), Plan B
One Step (levonorgestrel), and Flomax
(tamsulosin).
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
person on or before January 24, 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 January
16, 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 January 17, 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 Walter
Ellenberg 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: December 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–32205 Filed 12–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; 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.
E:\FR\FM\16DEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Notices]
[Pages 78283-78284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Anesthetic and Analgesic Drug Products 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: Anesthetic and Analgesic Drug 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 on February 9, 2012, from
8:30 a.m. to 4 p.m.
Location: Hilton Washington DC/Silver Spring (scheduled to be
renamed in January 2012 to DoubleTree by Hilton Hotel Washington DC/
Silver Spring), 8727 Colesville Road, Silver Spring, MD 20910. The
hotel's phone number is (301) 589-5200.
Contact Person: Philip Bautista, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002, (301) 796-9001, FAX: (301)
847-8533, email: AADPAC@fda.hhs.gov, 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 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: The committee will discuss the available efficacy and
safety data for supplemental new drug application (sNDA) 22395/S-013,
QUTENZA (capsaicin 8%) Patch, by NeurogesX, Inc., for the proposed
indication of management of neuropathic pain (nerve pain) related to
HIV-associated peripheral neuropathy (nerve pain in the periphery of
the body, such as the feet and legs).
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
January 26, 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 January 18, 2012. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably
[[Page 78284]]
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 January 19, 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 Philip Bautista 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: December 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-32206 Filed 12-15-11; 8:45 am]
BILLING CODE 4160-01-P
