Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 17413-17414 [2013-06416]
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Federal Register / Vol. 78, No. 55 / Thursday, March 21, 2013 / Notices
number of codes in a given transaction
may be necessary to report the same
information reported with ICD–9 codes
because ICD–10 codes are more specific.
Form Number: CMS–R–218 (OCN:
0938–0866). Frequency: Occasionally.
Affected Public: Private Sector (Business
or other for-profits, Not-for-profit
institutions). Number of Respondents:
696,026. Total Annual Responses:
696,026. Total Annual Hours: 6,960,260.
(For policy questions regarding this
collection contact Gladys Wheeler at
410–786–0273. For all other issues call
410–786–1326.)
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 April 22, 2013.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974,
Email: OIRA_submission@omb.eop.gov.
Dated: March 18, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–06534 Filed 3–20–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.576]
Announcement of the Award of an
Urgent Single-Source Grant to the
Center for Survivors of Torture in
Dallas, TX
Office of Refugee Resettlement,
Administration for Children and
Families, Department of Health and
Human Services.
ACTION: Announcement of the award of
an urgent single-source grant to the
Center for Survivors of Torture to
provide mental health services for
refugees.
emcdonald on DSK67QTVN1PROD with NOTICES
AGENCY:
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SUMMARY: The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR) announces
the award of an urgent single-source
grant in the amount of $250,000 to the
Center for Survivors of Torture (CST) in
Dallas, TX to ensure incoming refugee
populations in Texas have access to
mental health services.
DATES: The project period for the award
is February 1, 2013 through January 31,
2014.
FOR FURTHER INFORMATION CONTACT:
Kenneth Tota, Deputy Director, Office of
Refugee Resettlement, 901 D Street SW.,
Washington, DC 20047. Telephone:
202–401–4858. Email:
kenneth.tota@acf.hhs.gov.
SUPPLEMENTARY INFORMATION:
Approximately 45,000 individual
refugees reside in the areas covered by
the Center for Survivors of Torture.
Texas and the surrounding region have
a demonstrated history of being a top
resettlement location with one of the
highest concentrations of refugees in the
United States. In the past few years, the
Office of Refugee Resettlement (ORR)
has seen an increasing need for mental
health services associated with the three
primary refugee populations from Iraq,
Burma and Bhutan who have suffered
extreme trauma and torture due to war
and genocide in those countries.
Refugees from Bhutan have specifically
demonstrated a high incidence of
suicide upon arrival to the U.S. ORR has
been working closely with the Centers
for Disease Control (CDC) to assess this
situation. The CDC recently published a
study recommending enhanced mental
health services for incoming refugees
from Bhutan.
This fiscal year the program is seeing
a significant increase in resettlement of
refugees from the Democratic Republic
of Congo. The United Nations High
Commissioner for Refugees (UNHCR)
has determined this group is
particularly at risk due to decades of
extreme violence in the Democratic
Republic of Congo and recent arrivals
have shown a compelling need for
mental health services upon arrival.
Furthermore, CST is the only accredited
mental health care provider of
specialized refugee mental health
treatment services in Texas and the
surrounding area.
CST services are critical to meeting
refugee mental health needs by
providing services such as an initial
assessment, counseling to: children,
adolescents, adults, couples, and
families. Additionally, CST provides
group therapy, psychoeducational
groups, testing for mental health
conditions, and medication
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17413
management. In addition to these direct
services, CST also provides training to
other agencies in the area to include
schools, health clinics, and social
services agencies on refugee mental
health issues.
Due to the high number of refugees
being resettled in this region, with no
other demonstrated provider of expert
mental health services to this
population, this grant is urgent and
critical to those in need of such services.
According to the Department of State,
Texas is projected to receive the highest
number of refugees admitted to the U.S.
in FY13. Through this grant ORR will
ensure there is no disruption in much
needed mental health services to these
particularly at risk populations. This
urgent grant will support the provision
of these much needed mental health
services to ensure these refugees are
afforded a successful path to selfsufficiency.
Statutory Authority: Section 412
(c)(1)(A)(iii) of the Immigration and
Nationality Act, as amended and the Refugee
Assistance Extension Act of 1986, Pub. L. 99–
605 (8 U.S.C. 1101).
Eskinder Negash,
Director, Office of Refugee Resettlement.
[FR Doc. 2013–06517 Filed 3–20–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Pulmonary-Allergy 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. This meeting is being
rescheduled due to the postponement of
the March 7, 2013, Pulmonary-Allergy
Drugs Advisory Committee meeting due
to unanticipated weather conditions.
Name of Committee: PulmonaryAllergy 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 April 17, 2013, from 8 a.m. to
5 p.m. This meeting is being
rescheduled because of a postponed
meeting announced in the Federal
E:\FR\FM\21MRN1.SGM
21MRN1
emcdonald on DSK67QTVN1PROD with NOTICES
17414
Federal Register / Vol. 78, No. 55 / Thursday, March 21, 2013 / Notices
Register of December 14, 2012 (77 FR
74486), originally scheduled for March
7, 2013.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), 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: Cindy Hong, 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:
PADAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
the new drug application (NDA) 204275,
for fluticasone furoate and vilanterol dry
powder inhaler (proposed trade name
BREO ELLIPTA), sponsored by
GlaxoSmithKline, for the long-term
maintenance treatment of airflow
obstruction and for reducing
exacerbations in patients with chronic
obstructive pulmonary disease.
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,
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15:09 Mar 20, 2013
Jkt 229001
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 9, 2013. 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, including those who had
previously requested time to speak at
the originally scheduled March 7, 2013,
Pulmonary-Allergy Drugs Advisory
Committee meeting, 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 1, 2013. Any individuals
who requested time to speak at the
originally scheduled March 7, 2013,
Pulmonary-Allergy Drugs Advisory
Committee meeting, will need to follow
the instructions in this document to
request time to speak at the April 17,
2013, Pulmonary-Allergy Drugs
Advisory Committee, meeting as any
previous requests to speak at the
originally scheduled meeting do not
convey to this new April 17, 2013,
Pulmonary-Allergy Drugs Advisory
Committee meeting. 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 2, 2013.
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 Cindy Hong
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).
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Dated: March 15, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–06416 Filed 3–20–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Risk Communications 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: Risk
Communications 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 April 29, 2013, from 8 a.m. to
5 p.m. and on April 30, 2013, from 8
a.m. to 3 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
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: Luis G. Bravo,
Designated Federal Officer, Risk
Communication Staff, Office of
Planning, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3274, Silver Spring,
MD 20993, 240–402–5274, FAX: 301–
847–8609, email: RCAC@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
E:\FR\FM\21MRN1.SGM
21MRN1
]]>Agencies
[Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)]
[Notices]
[Pages 17413-17414]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06416]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Pulmonary-Allergy 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. This meeting is being rescheduled due to the
postponement of the March 7, 2013, Pulmonary-Allergy Drugs Advisory
Committee meeting due to unanticipated weather conditions.
Name of Committee: Pulmonary-Allergy 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 April 17, 2013, from 8
a.m. to 5 p.m. This meeting is being rescheduled because of a postponed
meeting announced in the Federal
[[Page 17414]]
Register of December 14, 2012 (77 FR 74486), originally scheduled for
March 7, 2013.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), 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: Cindy Hong, 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: PADAC@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: The committee will discuss the new drug application (NDA)
204275, for fluticasone furoate and vilanterol dry powder inhaler
(proposed trade name BREO ELLIPTA), sponsored by GlaxoSmithKline, for
the long-term maintenance treatment of airflow obstruction and for
reducing exacerbations in patients with chronic obstructive pulmonary
disease.
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
April 9, 2013. 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, including those who had previously
requested time to speak at the originally scheduled March 7, 2013,
Pulmonary-Allergy Drugs Advisory Committee meeting, 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 1, 2013. Any
individuals who requested time to speak at the originally scheduled
March 7, 2013, Pulmonary-Allergy Drugs Advisory Committee meeting, will
need to follow the instructions in this document to request time to
speak at the April 17, 2013, Pulmonary-Allergy Drugs Advisory
Committee, meeting as any previous requests to speak at the originally
scheduled meeting do not convey to this new April 17, 2013, Pulmonary-
Allergy Drugs Advisory Committee meeting. 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 2, 2013.
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 Cindy Hong 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 15, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-06416 Filed 3-20-13; 8:45 am]
BILLING CODE 4160-01-P
