Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 7310-7311 [E8-2265]

Download as PDF 7310 Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices TABLE 6.—MODELED PERCENTAGE DISTRIBUTION OF FOOD SERVINGS CONTAMINATED WITH L. monocytogenes AT TIME OF CONSUMPTION FOR FOODS THAT DO NOT SUPPORT GROWTH Median Percentage of Food Servings Contaminated with L. monocytogenes at: > 1 - 10 cfu/ servingb (> 0.01-0.1 cfu/g) > 10 - 100 cfu/ servingc (> 0.1 - 1 cfu/g) 100 to 103 cfu/ servingd (> 1 10 cfu/g) > 103 - 104 cfu/servinge (> 10 - 100 cfu/g) > 104 - 105 cfu/servingf (> 100 - 1,000 cfu/g) > 105 - 106 cfu/servingg (> 103 - 104 cfu/ g) 0.9 (<0.1, 3.1)h 2.1 (0.1, 8.0) 1.2 (<0.1, 5.8) 0.6 (<0.1, 4.0) 0.2 (<0.1, 2.3) 0.1 (<0.1, 1.2) 0.1 (<0.1, <0.7) Hard Cheese <0.1 (<0.1, .5) <0.1 (<0.1, 0.6) <0.1 (<0.1, 0.4) <0.1 (<0.1, 0.2) <0.1 (<0.1, 0.1) <0.1 (<0.1, <0.1) <0.1 (<0.1, <0.1) Processed Cheese 0.2 (<0.1, 0.6) 0.3 (<0.1, 0.9) 0.1 (<0.1, 0.4) 0.1 (<0.1, 0.2) <0.1 (<0.1, 0.1) <0.1 (<0.1, 0.1) <0.1 (<0.1, <0.1) Ice Cream/Frozen Dairy 0.1 (<0.1, 0.2) 0.2 (0.1, 0.3) 0.1 (<0.1, 0.1) <0.1 (<0.1, <0.1) <0.1 (<0.1, <0.1) <0.1 (<0.1, <0.1) <0.1 (<0.1, <0.1) Cultured Milk Products 0.1 (<0.1, 1.1) 0.2 (<0.1, 1.5) 0.1 (<0.1, 0.8) <0.1 (<0.1, 0.4) <0.1 (<0.1, 0.2) <0.1 (<0.1, 0.1) <0.1 (<0.1, <0.1) 1.9 (0.7, 3.7) 3.0 (0.9, 5.2) 1.1 (0.3, 1.9) 0.3 (0.1, 0.7) 0.1 (<0.1, 0.2) <0.1 (<0.1, 0.1) <0.1 (<0.1, <0.1) Food Category 1 cfu/serving (0.01 cfu/ga) Seafood Preserved Fish Dairy Deli-type salads a Assumes a uniform serving size of 100 g. combined estimates for doses of 3.16 and 10 cfu. combined estimates for doses of 31.6 and 100 cfu. d Includes combined estimates for doses of 316 and 1,000 cfu. e Includes combined estimates for doses of 3160 and 10,000 cfu. f Includes combined estimates for doses of 31,600 and 100,000 cfu. g Includes combined estimates for doses of 316,000 and 1,000,000 cfu. h Numbers in parentheses denote the 5th and 95th percentile uncertainty levels, respectively. b Includes c Includes Dated: January 23, 2008. Margaret O’K. Glavin, Associate Commissioner for Regulatory Affairs. [FR Doc. 08–549 Filed 2–6–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. jlentini on PROD1PC65 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Radiological 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. VerDate Aug<31>2005 17:02 Feb 06, 2008 Jkt 214001 Date and Time: The meeting will be held on March 4, 2008, from 8 a.m. to 5:30 p.m., and March 5, 2008, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Nancy Wersto, Center for Devices and Radiological Health (HFZ–470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3666, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512526. Please call the Information Line for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On March 4 and 5, 2008, the committee intends to discuss and make recommendations about computer aided detection and diagnosis (CAD) devices PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 for radiological images, e.g., mammograms, chest x-rays, and computed tomography (CT) images of the lungs or colon. There will be a general discussion focusing on the general methodologies for CAD, including how CAD devices are used in clinical decision-making, how the devices are tested, and the information needed to properly assess their safety and effectiveness. The general discussion will be followed by specific discussions related to mammography CAD devices, colon CAD devices, and lung CAD devices. These discussions will include how the different types of CAD devices are used and the literature published regarding these devices, with focus on testing issues related to the different devices. 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/ohrms/ E:\FR\FM\07FEN1.SGM 07FEN1 jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: On March 4, 2008, from 8 a.m. to 5:30 p.m., and on March 5, 2008, from 8:30 a.m. to 5 p.m., the meeting is open to the public. 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 February 19, 2008. Oral presentations from the public will be scheduled between approximately 10 a.m. and 10:30 a.m., and between 3:15 p.m. and 3:45 p.m. on March 4, 2008, and between approximately 9:10 a.m. and 9:40 a.m., and between 2:15 p.m. and 2:45 p.m. on March 5, 2008. 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 February 11, 2008. 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 February 12, 2008. Closed Presentation of Data: On March 5, 2008, from 8 a.m. to 8:30 a.m., the meeting will be closed so that the committee may receive an update from FDA about devices under evaluation that may be brought before the committee in the near future. This portion of the meeting will be closed because it involves the discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 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, at 240–276–8931, 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/oc/advisory/ VerDate Aug<31>2005 17:02 Feb 06, 2008 Jkt 214001 default.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: January 28, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–2265 Filed 2–6–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special Emphasis Panel, T32 Application. Date: March 6, 2008. Time: 12 p.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. (Telephone Conference Call) Contact Person: Rudy O. Pozzatti, PhD, Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9306, Rockville, MD 20852, (301) 402–0838, pozzattr@mail.nih.gov. (Catalogue of Federal Domestic Assistance Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) January 31, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08–520 Filed 2–6–08; 8:45 am] BILLING CODE 4140–01–M PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 7311 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. the grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Initial Review Group, Neurological Sciences and Disorders B. Date: February 28–29, 2008. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Admiral Fell Inn, Historic Fell’s Point, 888 South Broadway, Baltimore, MD 21231. Contact Person: W. Ernest Lyons, PhD, Scientific Review Officer, Scientific Review Branch NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301– 496–4056. Name of Committee: National Institute of Neurological Disorders and Stroke Initial Review Group, Neurological Science and Disorders K. Date: March 3–4, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: The Fairmont Washington, DC, 2401 M Street, NW., Washington, DC 20037. Contact Person: Shanta Rajaram, PhD, Scientific Review Officer, Division of Extramural Research, NIH/NIND/SRB, Neuroscience Center, 6601 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20852, (301) 435–6033, rajarams@mail.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Initial Review Group, Neurological Sciences and Disorders A. Date: March 5–6, 2008. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: The Portofino Hotel, 260 Portofino Way, Redondo Beach, CA 90277. Contact Person: Richard D. Crosland, PhD, Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 73, Number 26 (Thursday, February 7, 2008)]
[Notices]
[Pages 7310-7311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2265]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Radiological 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Radiological 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 March 4, 2008, from 8 
a.m. to 5:30 p.m., and March 5, 2008, from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Nancy Wersto, Center for Devices and Radiological 
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-3666, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512526. Please call the Information Line for up-to-date 
information on this meeting. 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 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On March 4 and 5, 2008, the committee intends to discuss 
and make recommendations about computer aided detection and diagnosis 
(CAD) devices for radiological images, e.g., mammograms, chest x-rays, 
and computed tomography (CT) images of the lungs or colon. There will 
be a general discussion focusing on the general methodologies for CAD, 
including how CAD devices are used in clinical decision-making, how the 
devices are tested, and the information needed to properly assess their 
safety and effectiveness. The general discussion will be followed by 
specific discussions related to mammography CAD devices, colon CAD 
devices, and lung CAD devices. These discussions will include how the 
different types of CAD devices are used and the literature published 
regarding these devices, with focus on testing issues related to the 
different devices.
    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/ohrms/

[[Page 7311]]

dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the 
appropriate advisory committee link.
    Procedure: On March 4, 2008, from 8 a.m. to 5:30 p.m., and on March 
5, 2008, from 8:30 a.m. to 5 p.m., the meeting is open to the public. 
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 February 19, 2008. Oral 
presentations from the public will be scheduled between approximately 
10 a.m. and 10:30 a.m., and between 3:15 p.m. and 3:45 p.m. on March 4, 
2008, and between approximately 9:10 a.m. and 9:40 a.m., and between 
2:15 p.m. and 2:45 p.m. on March 5, 2008. 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 February 11, 2008. 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 February 
12, 2008.
    Closed Presentation of Data: On March 5, 2008, from 8 a.m. to 8:30 
a.m., the meeting will be closed so that the committee may receive an 
update from FDA about devices under evaluation that may be brought 
before the committee in the near future. This portion of the meeting 
will be closed because it involves the discussion and review of trade 
secret and/or confidential information (5 U.S.C. 552b(c)(4)).
    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, at 240-276-8931, 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/oc/advisory/
default.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: January 28, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-2265 Filed 2-6-08; 8:45 am]
BILLING CODE 4160-01-S

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