Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 66956-66957 [E6-19492]

Download as PDF jlentini on PROD1PC65 with NOTICES 66956 Federal Register / Vol. 71, No. 222 / Friday, November 17, 2006 / Notices addition, CMS has established policies to limit payment abuse that will be based on FIs tracking patient movement among these co-located providers. Form Number: CMS–10088 (OMB#: 0938– 0897; Frequency: Reporting—as needed; Affected Public: Business or other for profit and Not-for-profit institutions; Number of Respondents: 200; Total Annual Responses: 200; Total Annual Hours: 50. 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations in 42 CFR 486.301–348; Use: Organ Procurement Organizations are required to submit accurate data to CMS through the Organ Procurement and Transplantation Network (OPTN). The data concerns the organ procurement activities, as well as various OPO business activities, including information on its designated service area; structure; various policies, procedures, and protocols; and its quality assessment and performance improvement (QAPI) program. This information is necessary to assure maximum effectiveness in the procurement and distribution of organs. Form Number: CMS–R–13 (OMB#: 0938–0688; Frequency: Reporting— Every 4 years and as needed; Affected Public: Not-for-profit institutions; Number of Respondents: 58; Total Annual Responses: 58; Total Annual Hours: 21,427. 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. VerDate Aug<31>2005 16:31 Nov 16, 2006 Jkt 211001 Dated: November 7, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6–19430 Filed 11–16–06; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R–235] Agency Information Collection Activities: Proposed Collection; 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) 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 functions; (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: Extension of a currently approved collection; Title of Information Collection: Data Use Agreement Information Collection Requirements, Model Language and Supporting Regulations in 45 CFR part 5b. Use: The Data Use Agreement (DUA) is needed as part of the review of each CMS data request to ensure compliance with the requirements of the Privacy Act for disclosure of data that contain individually-identifiable information. In addition, the DUA is used to maintain appropriate accounting and tracking of disclosures of records from Privacy Act systems of records. Form Number: CMSR–235 (OMB#: 0938–0734); Frequency: Reporting-On occasion; Affected Public: Not-for-profit institutions; Number of Respondents: 1,500; Total Annual Responses: 1,500; Total Annual Hours: 750. AGENCY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 at the address below, no later than 5 p.m. on January 16, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—B, Attention: William N. Parham, III, Room C4–26– 05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: November 7, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6–19431 Filed 11–16–06; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology 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: Clinical Chemistry and Clinical Toxicology 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 6, 2006, from 8 a.m. to 4:30 p.m. Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: Veronica J. Calvin, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., E:\FR\FM\17NON1.SGM 17NON1 Federal Register / Vol. 71, No. 222 / Friday, November 17, 2006 / Notices jlentini on PROD1PC65 with NOTICES Rockville, MD 20850, 240–276–0491, ext. 161, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512514. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will hear an update on the status of recent devices brought before the committee. The committee will also hear a presentation regarding the FDA Critical Path Initiative. The committee will discuss general issues concerning high and low density lipoprotein subfraction assays. Background information, 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/. 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 24, 2006. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes 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 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 24, 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 Shirley Meeks, Conference Management Staff, 301–827–7292 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). Name of Committee: National Advisory Board on Medical Rehabilitation Research. Date: December 7–8, 2006. Time: December 7, 2006, 8:30 a.m. to 5 p.m. Agenda: NICHD Director’s Report presentation, NCMRR Director’s Report presentation and various reports on Medical Research Initiatives. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Time: December 8, 2006, 8:30 a.m. to 12:00 p.m. Agenda: Other business dealing with the NABMRR Board. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda,MD 20814. Contact Person: Ralph M. Nitkin, PhD, Director, BSCD, National Center for Medical, Rehabilitation Research, National Institute of Child Health, and Human Development, NIH, 6100 Building, Room 2A03, Bethesda, MD 20892. (301) 402–4206. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nichd.nih.gov/about/ncmrr.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: November 8, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–19492 Filed 11–16–06; 8:45 am] Dated: November 13, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–9254 Filed 11–16–06; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4140–01–M VerDate Aug<31>2005 16:31 Nov 16, 2006 Jkt 211001 66957 DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institutes of Child Health and Human Development; Notice of Meeting National Institute of Child Health and Human Development; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Board of Medical Rehabilitation Research. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Children’s Study Advisory Committee. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: National Children’s Study Advisory Committee. Date: December 5, 2006. Time: 9 a.m. to 5 p.m. Agenda: For questions or to register, please call Circle Solutions at (703) 902–1139 or via the Web site https://www.circlesolutions.com/ ncs/ncsac. Advanced registration is required due to space limitations. Registration deadline is November 28, 2006. The agenda will include progress regarding the study plan and protocol, informed consent and genetic aspects of the study. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852. Contact Person: Marion Balsam, MD, Executive Secretary, National Children’s Study Advisory Committee, 6100 Executive Boulevard, Rockville, MD 20892. 301–594– 9147. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: November 13, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–9255 Filed 11–16–06; 8:45 am] BILLING CODE 4140–01–M E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 71, Number 222 (Friday, November 17, 2006)]
[Notices]
[Pages 66956-66957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Clinical Chemistry and Clinical Toxicology 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: Clinical Chemistry and Clinical Toxicology 
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 6, 2006, from 8 
a.m. to 4:30 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Veronica J. Calvin, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd.,

[[Page 66957]]

Rockville, MD 20850, 240-276-0491, ext. 161, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512514. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will hear an update on the status of recent 
devices brought before the committee. The committee will also hear a 
presentation regarding the FDA Critical Path Initiative. The committee 
will discuss general issues concerning high and low density lipoprotein 
subfraction assays. Background information, 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/.
    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 24, 2006. Oral presentations from the public will be scheduled 
for approximately 30 minutes at the beginning of committee 
deliberations and for approximately 30 minutes 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 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 24, 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 Shirley Meeks, 
Conference Management Staff, 301-827-7292 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: November 8, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-19492 Filed 11-16-06; 8:45 am]
BILLING CODE 4160-01-S

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