Arthritis Advisory Committee; Notice of Meeting, 61979-61980 [06-8787]

Download as PDF Federal Register / Vol. 71, No. 203 / Friday, October 20, 2006 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10078] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency’s function; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Matching Grants to States for the Operation of High Risk Pools and Supporting Regulations at 42 CFR 148.316, 148.318, and 148.320; Use: CMS is requiring this information as a condition of eligibility for grants that were authorized in the Trade Act of 2002 (Pub. L. 107–210). The information is necessary to determine if a State applicant meets the necessary eligibility criteria for a grant as required by the law. The respondents will be States that have a high risk pool as defined in Section 2744(c)(2) of the Public Health Service Act. The grants will provide matching funds to States that incur losses in the operation of high risk pools. High risk pools are set up by States to provide health insurance to individuals that cannot obtain health insurance in the private market because of a history of illness. Form Number: CMS–10078 (OMB#: 0938–0887); Frequency: Reporting—On occasion; Affected Public: State, local, or tribal government; Number of Respondents: 33; Total Annual Responses: 33; Total Annual Hours: 1,320. jlentini on PROD1PC65 with NOTICES AGENCY: VerDate Aug<31>2005 15:52 Oct 19, 2006 Jkt 211001 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. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: (202) 395–6974. Dated: October 4, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6–17034 Filed 10–19–06; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10202] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency’s function; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. AGENCY: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 61979 1. Type of Information Collection Request: New Collection; Title of Information Collection: Data Collection for Administering the Medicare Health Improvement Survey; Use: This beneficiary survey is to obtain information about beneficiary behavior, physical functioning and satisfaction with the care management programs data required to evaluate the Medicare Care Management for High Cost Beneficiaries demonstration (CMHCB). This demonstration provides an opportunity to test new models of care for Medicare beneficiaries who are highcost and who have complex chronic conditions with the goals of reducing future costs, improving quality of care and quality of life, and improving beneficiary and provider satisfaction. Form Number: CMS–10202 (OMB#: 0938–New); Frequency: Reporting—On occasion; Affected Public: Individuals or Households; Number of Respondents: 3633; Total Annual Responses: 3633; Total Annual Hours: 908. 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 e-mail 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. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, fax number: (202) 395–6974. Dated: October 12, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6–17353 Filed 10–19–06; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\20OCN1.SGM Notice. 20OCN1 jlentini on PROD1PC65 with NOTICES 61980 Federal Register / Vol. 71, No. 203 / Friday, October 20, 2006 / Notices 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: Arthritis 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 November 29, 2006, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Johanna M. Clifford, 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: Johanna.Clifford@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512532. Please call the Information Line for up-to-date information on this meeting. The background material will become available no later than the day before the meeting and will be posted on FDA’s Web site at https:// www.fda.gov/ohrms/dockets/ac/ acmenu.htm under the heading ‘‘Arthritis Advisory Committee.’’ (Click on the year 2006 and scroll down to the above named committee meeting). Agenda: The committee will discuss the safety and efficacy of the nonsteriodal anti-inflammatory drug (COX–2 inhibitor) new drug application (NDA) 20–998/S021, CELEBREX (celecoxib), Pfizer, Inc., for the proposed indication of the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older. 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 November 15, 2006. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m. Time allotted for each presentation may be limited. 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 November 15, 2006. VerDate Aug<31>2005 15:52 Oct 19, 2006 Jkt 211001 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 Johanna Clifford at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 13, 2006. Randall W. Lutter, Associate Commissioner for Policy. [FR Doc. 06–8787 Filed 10–19–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is postponing the meeting of the Neurological Devices Panel scheduled for October 31, 2006. The meeting was announced in the Federal Register of September 22, 2006 (71 FR 55491). FDA’s Center for Devices and Radiological Health will further evaluate data relevant to the topic. A future meeting date will be announced in the Federal Register. Contact Person: Janet L. Scudiero, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–1184, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512513. Please call the Information Line for up-to-date information on this meeting. Dated: October 13, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. 06–8788 Filed 10–19–06; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System 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: Circulatory System 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 December 7 and 8, 2006, from 8 a.m. to 5:30 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: James Swink, Center for Devices and Radiological Health (CDRH) (HFZ–450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–443–8262, ext. 163, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512625. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss and make recommendations regarding issues related to stent thrombosis in coronary drug-eluting stents. Background information for the topic, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at https:// www.fda.gov/cdrh/panel (click on Upcoming CDRH Advisory Panel/ Committee Meetings). 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 November 15, 2006. Oral presentations from the public will be scheduled on both days for approximately 1 hour at the beginning of committee deliberations and for approximately 1 hour near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 71, Number 203 (Friday, October 20, 2006)]
[Notices]
[Pages 61979-61980]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Arthritis Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 61980]]

    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: Arthritis 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 November 29, 2006, from 
8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Johanna M. Clifford, 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: Johanna.Clifford@fda.hhs.gov, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512532. Please call the 
Information Line for up-to-date information on this meeting. The 
background material will become available no later than the day before 
the meeting and will be posted on FDA's Web site at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm under the heading ``Arthritis Advisory 
Committee.'' (Click on the year 2006 and scroll down to the above named 
committee meeting).
    Agenda: The committee will discuss the safety and efficacy of the 
nonsteriodal anti-inflammatory drug (COX-2 inhibitor) new drug 
application (NDA) 20-998/S021, CELEBREX (celecoxib), Pfizer, Inc., for 
the proposed indication of the relief of the signs and symptoms of 
juvenile rheumatoid arthritis in patients 2 years and older.
    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 
November 15, 2006. Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 12:30 p.m. Time allotted for each 
presentation may be limited. 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 November 15, 2006.
    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 Johanna Clifford at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 13, 2006.
Randall W. Lutter,
Associate Commissioner for Policy.
[FR Doc. 06-8787 Filed 10-19-06; 8:45 am]
BILLING CODE 4160-01-S
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