Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 17413-17414 [2013-06416]

Download as PDF 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 http://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: VerDate Mar<14>2013 15:09 Mar 20, 2013 Jkt 229001 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 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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: http://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 http:// 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 http://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, VerDate Mar<14>2013 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 http://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). PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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: http://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 http:// 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]


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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: 
http://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 http://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 http://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 http://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