Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 55490-55491 [06-8114]

Download as PDF 55490 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 21 CFR Section/ FDA Form Annual Frequency perResponse No. of Respondents Total Annual Records Hours per Response Total Capital Costs Total Hours Total Operating & Maintenance Costs 900.24(b) 1.2 1 1.2 30 36 900.24(b)(1) 0.3 1 0.3 200 60 $26 900.24(b)(3) 0.15 1 0.15 100 15 $13 900.25(a) 0.2 1 0.2 16 3.2 FDA Form 3422 700 1 700 0.25 175 Total 1 Refers to to to 4 Refers to 5 Refers to 2 Refers 3 Refers 3,072,138 $40,000 $14,612,872 entities that are applying for the first time. accreditation bodies applying to accredit specific Full Field Digital Mammography units. the facility component of the burden for this requirement. the accreditation body component of the burden for this requirement. the situation where a patient specifically does not want to receive the lay summary of her exam. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 Annual Frequency of Recordkeeping Total Annual Records 6 1 6 1 89 1 89 8 712 900.12(a)(4) 8,840 4 35,360 1 35,360 900.12(c)(4) 8,840 1 8,840 1 8,840 900.12(e)(13) 8,840 52 459,680 0.083 38,154 900.12(f) 8,840 1 8,840 16 141,440 900.12(h)(2) 8,840 2 17,680 1 17,680 900.22(a) 6 1 6 1 6 900.22(d) 6 1 6 1 6 900.22(e) 6 1 6 1 6 900.22(f) 3 1 3 1 3 900.22(g) 6 1 6 1 6 900.25(b) 6 1 6 1 6 Number of Recordkeepers 900.4(g) 900.12(a)(1)(i)(B)(2) Hours per Recordkeeper Total Hours Total sroberts on PROD1PC70 with NOTICES Total Operating & Maintenance Costs 6 CFR Section 242,225 This request for OMB approval now serves to consolidate previously approved information collection, OMB Control Number 0910–0580 into 0910– 0309. The hourly burden as well as the associated operating costs were increased to better represent the actual burden and costs on facilities and accreditation bodies. The following regulations were not included in the above burden tables because they were considered usual and customary practice and were part of the standard of care prior to the implementation of the regulations. VerDate Aug<31>2005 Total Capital Costs 20:37 Sep 21, 2006 Jkt 208001 Therefore, they resulted in no additional reporting or recordkeeping burden: 21 CFR 900.12(c)(1), 900.12(c)(3), and 900.3(f)(1). The following regulations were not included in the previously mentioned burden tables because they were not considered applicable during the information collection period or their burdens were reported under other regulatory requirements. Therefore, they resulted in no additional reporting or recordkeeping burden: 21 CFR 900.3(c), 900.11(b)(1), 900.11(b)(2), and 900.24(c). PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 $25,000 $60 $25,000 $60 Dated: September 15, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06–8027 Filed 9–21–06; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\22SEN1.SGM 22SEN1 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 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: Neurological 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 October 31, 2006, from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, Ballroom Salons C, D, and E, 620 Perry Pkwy., Gaithersburg, MD. 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. Agenda: The committee will discuss and make recommendations on a premarket notification application for a device intended for the treatment of major depressive disorder. The committee will also hear and discuss the post approval study reports for two recently approved neurological device premarket approval applications. Background information for the topics, 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 October 17, 2006. Oral presentations from the public will be scheduled for 30 minutes at the beginning of the committee VerDate Aug<31>2005 20:37 Sep 21, 2006 Jkt 208001 deliberations and for 30 minutes near the end of the committee 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 October 17, 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 AnnMarie Williams, Conference Management Staff, at 301–827–7291, 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: September 18, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. 06–8114 Filed 9–21–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 2006N–0292] Unique Device Identification; Notice of Public Meeting AGENCY: Food and Drug Administration, HHS. Notice of public meeting and vendor display. ACTION: SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting and vendor display to discuss the issues associated with the development, implementation, and use of a unique device identification (UDI) system and the use of various automatic identification technologies. We are inviting individuals, companies, organizations, and other stakeholders to attend this public meeting, which will focus on the development and implementation of a UDI system; the benefits and costs of a UDI system; the use of automatic identification technologies; and the development, maintenance, and use of a repository for UDI related information. We are also PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 55491 inviting vendors of automatic identification technologies to display their products for the educational benefits of FDA and other attendees. DATES AND TIMES: The public meeting will be held on Wednesday, October 25, 2006, from 9 a.m. to 4 p.m. Registration to attend the meeting, to present at the meeting, and to participate in the vendor display must be received by October 10, 2006. Submit written comments by November 9, 2006. You may register electronically at www.fda.gov/cdrh/ocd/udi/ (see SUPPLEMENTARY INFORMATION, section V of this document for information on registration. ADDRESSES: The public meeting will be held at the Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg, MD 20878, 1–301–590–0044. A block of rooms is being held for the evening of Tuesday, October 24, 2006. Please mention the ‘‘FDA UDI Meeting’’ when calling the hotel. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/dockets/ ecomments. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: David Racine or Jay Crowley, Center for Devices and Radiological Health (HFZ– 500), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240–276–3400, e-mail: CDRHUDI@fda.hhs.gov If you need special accommodations due to a disability, please contact Ann Marie Williams at 301–827–7291 at least 7 days in advance of the meeting. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 26, 2004, we published a final rule (the ‘‘bar code rule’’) (69 FR 9120) requiring bar codes on certain human drug and biological products to help reduce medication errors in hospitals and other health care settings. The bar code is intended to enable health care professionals to use bar code scanning equipment in conjunction with computerized medication administration systems to verify that the right drug, in the right dose, is being given to the right patient at the right time. This rule (now codified at 21 CFR 201.25 and 610.67) requires that manufacturers encode the unique E:\FR\FM\22SEN1.SGM 22SEN1

Agencies

[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55490-55491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8114]



[[Page 55491]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Neurological 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: Neurological 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 October 31, 2006, from 8 
a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Ballroom Salons 
C, D, and E, 620 Perry Pkwy., Gaithersburg, MD.
    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.
    Agenda: The committee will discuss and make recommendations on a 
premarket notification application for a device intended for the 
treatment of major depressive disorder. The committee will also hear 
and discuss the post approval study reports for two recently approved 
neurological device premarket approval applications. Background 
information for the topics, 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 
October 17, 2006. Oral presentations from the public will be scheduled 
for 30 minutes at the beginning of the committee deliberations and for 
30 minutes near the end of the committee 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 October 17, 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 AnnMarie Williams, 
Conference Management Staff, at 301-827-7291, 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: September 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 06-8114 Filed 9-21-06; 8:45 am]
BILLING CODE 4160-01-S

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