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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
NOTICE: NOTICES
ACTION: Meetings:
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY: Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
DOCUMENT SUMMARY:
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: Hematology and Pathology 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 July 18, 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: Louise E. Magruder, Center for Devices and Radiological Health (HFZ440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 2402761248, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512515. Please call the Information Line for uptodate 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: The committee will discuss and make recommendations on issues relevant to the potential for automated differential cell counters being waived under the Clinical Laboratory Improvement Amendments of 1988. The discussion will include preanalytical, analytical, and postanalytical issues associated with performing automated hematology complete blood counts and differentials in a waived setting. (See www.fda.gov/cdrh/oivd/guidance/1171.html).
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/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee 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
[[Page 36333]]
person on or before July 9, 2008. Oral presentations from the public
will be scheduled between approximately 8:15 a.m. and 9:15 a.m. 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 July 1, 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 July 8, 2008.
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 2402768932, 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/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: June 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E814495 Filed 62508; 8:45 am]
BILLING CODE 416001S
SUMMARY: Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee,
DOCUMENT BODY:
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: Hematology and Pathology 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 July 18, 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: Louise E. Magruder, Center for Devices and Radiological Health (HFZ440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 2402761248, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512515. Please call the Information Line for uptodate 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: The committee will discuss and make recommendations on issues relevant to the potential for automated differential cell counters being waived under the Clinical Laboratory Improvement Amendments of 1988. The discussion will include preanalytical, analytical, and postanalytical issues associated with performing automated hematology complete blood counts and differentials in a waived setting. (See www.fda.gov/cdrh/oivd/guidance/1171.html).
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/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee 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
[[Page 36333]]
person on or before July 9, 2008. Oral presentations from the public
will be scheduled between approximately 8:15 a.m. and 9:15 a.m. 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 July 1, 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 July 8, 2008.
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 2402768932, 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/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: June 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E814495 Filed 62508; 8:45 am]
BILLING CODE 416001S
Common CFR Searches
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 47 CFR Part 73 26 CFR Part 1 50 CFR Part 679 40 CFR Part 180 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 40 CFR Part 63 6 CFR Part 5 33 CFR Part 100 50 CFR Part 622 50 CFR Part 660 26 CFR Part 301 44 CFR Part 65 39 CFR Part 111 40 CFR Part 271 40 CFR Part 300 47 CFR Part 64 40 CFR Parts 52 and 81 50 CFR Part 665 39 CFR Part 3020 50 CFR Part 229 44 CFR Part 64 49 CFR Part 571