Oncologic Drugs Advisory Committee; Notice of Meeting, 18765-18766 [E6-5413]

Download as PDF Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Notices the Agency for Toxic Substances and Disease Registry. Dated: April 6, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6–5359 Filed 4–11–06; 8:45 am] BILLING CODE 4163–18–P 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. wwhite on PROD1PC61 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. Date and Time: The meeting will be held on May 23, 2006, from 9:30 a.m. to 4:30 p.m. Location: Holiday Inn, Walker/ Whetstone Rooms, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: Nancy Wersto, Center for Devices and Radiological Health (HFZ–470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–1212, ext. 144, 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. Agenda: The committee will hear a presentation explaining FDA’s Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. Subsequently, FDA will present key points for the committee to consider for the reclassification of full field digital mammography (FFDM) systems from Class III to Class II devices. The committee will discuss and make recommendations on the reclassification of FFDMs. Background information for this meeting, including the agenda and VerDate Aug<31>2005 17:42 Apr 11, 2006 Jkt 208001 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: On May 23, 2006, from 10 a.m. to 4:30 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 by May 9, 2006. Oral presentations from the public will be scheduled between approximately 11:45 a.m. and 12:45 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 9, 2006, 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. Closed Committee Deliberations: On May 23, 2006, from 9:30 a.m. to 10 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) on current and pending issues regarding radiological devices. 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 240–276–0450, ext. 113, 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: April 5, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–5411 Filed 4–11–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00063 Fmt 4703 Sfmt 4703 18765 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: Oncologic Drugs 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 June 2, 2006, from 10 a.m. to 2 p.m. Location: Omni Hotel at CNN Center, International Ballroom, 100 CNN Center, Atlanta, Georgia. The hotel phone number is 404–659–0000. 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: cliffordj@cder.fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss new drug application (NDA) 21–986, proposed trade name SPRYCEL (dasatinib) tablets, Bristol-Myers Squibb Co., with proposed indications for the: (1) Treatment of adults with chronic, accelerated, or blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib and (2) treatment of adults with Philadelphia chromosome–positive acute lymphoblastic leukemia, and lymphoid blast chronic myeloid leukemia with resistance or intolerance to prior therapy. 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 by May 18, 2006. Oral presentations from the public will be scheduled between approximately 12 noon and 1 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 18, 2006, 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. Persons attending FDA’s advisory committee meetings are advised that the E:\FR\FM\12APN1.SGM 12APN1 18766 Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Notices 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: April 5, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–5413 Filed 4–11–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [DHS–2006–0014] Advisory Committee Candidate Biographical Information Request (DHS Form 0001–1) Office of the Executive Secretariat, DHS. ACTION: Notice and request for comment. wwhite on PROD1PC61 with NOTICES AGENCY: SUMMARY: The Department of Homeland Security (DHS) invites the general public and other federal agencies to comment on a new information collection request (ICR), DHS Advisory Committee Candidate Biographical Information Request Form (DHS Form 0001–1). As required by the Paperwork Reduction Act of 1995, (Pub. L. 104–13, 44 U.S.C. Chapter 35), DHS is soliciting comments for the new information collection request. DATES: Written comments should be received on or before June 12, 2006. This process is conducted in accordance with 5 CFR 1320.10. ADDRESSES: If you desire to submit comments, they must be submitted by June 12, 2006. Comments must be identified by Docket Number [DHS– 2006–0014] and may be submitted by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Office of the Executive Secretariat, 245 Murray Lane, SW., Bldg. #410, Washington, DC 20528. FOR FURTHER INFORMATION CONTACT: Georgia Abraham, 202–282–9150 (this is not a toll free number). VerDate Aug<31>2005 17:42 Apr 11, 2006 Jkt 208001 A copy of this Information Collection Request may be obtained by calling the contact listed above, or by visiting the docket on-line, as described below. Description: The Advisory Committee Biographical Information Request provides persons who express an interest in serving on a DHS Advisory Committee the opportunity to request appointment to the committee by completing an application form (DHS Form 0001–1). SUPPLEMENTARY INFORMATION: Public Participation The Department of Homeland Security and the Office of Management and Budget are particularly interested in comments which: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. Instructions All submissions received must include the agency name and docket number [DHS–2006–0014] for this Information Collection Request. All comments received will be posted without change to https://www. regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov. Analysis Agency: Department of Homeland Security, Office of the Executive Secretariat. Title: Advisory Committee Candidate Biographical Information Request OMB Control Number: 1601–NEW. Frequency: On occasion. Affected Public: Individuals or households. Estimated Number of Respondents: 480. Estimated Time Per Response: 15 minutes. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Total Burden Hours: 120. Total Cost Burden: None. Scott Charbo, Chief Information Officer. [FR Doc. E6–5349 Filed 4–11–06; 8:45 am] BILLING CODE 4410–10–P DEPARTMENT OF INTERIOR Office of the Secretary Blackstone River Valley National Heritage Corridor Commission: Notice of Meeting Notice is hereby given in accordance with Section 552b of Title 5, United States Code, that a meeting of the John H. Chafee Blackstone River Valley National Heritage Corridor Commission will be held on Thursday, May 18, 2006. The Commission was established pursuant to Public Law 99–647. The purpose of the Commission is to assist federal, state and local authorities in the development and implementation of an integrated resource management plan for those lands and waters within the Corridor. The meeting will convene on May 18, 2006 at 7:00 p.m. at Sutton Town Hall, 4 Uxbridge Road, Sutton, MA for the following reasons: 1. Approval of Minutes 2. Chairman’s Report 3. Executive Director’s Report 4. Financial Budget 5. Public Input It is anticipated that about twenty-five people will be able to attend the session in addition to the Commission members. Interested persons may make oral or written presentations to the Commission or file written statements. Such requests should be made prior to the meeting to: Larry Gall, Interim Executive Director, John H. Chafee, Blackstone River Valley National Heritage, Corridor Commission, One Depot Square, Woonsocket, RI 02895, Tel.: (401) 762– 0250. Further information concerning this meeting may be obtained from Larry Gall, Interim Executive Director of the Commission at the aforementioned addreses. Larry Gall, Interim Executive Director BRVNHCC. [FR Doc. E6–5360 Filed 4–11–06; 8:45 am] BILLING CODE 4310–RK–P E:\FR\FM\12APN1.SGM 12APN1

Agencies

[Federal Register Volume 71, Number 70 (Wednesday, April 12, 2006)]
[Notices]
[Pages 18765-18766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Oncologic Drugs 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: Oncologic Drugs 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 June 2, 2006, from 10 
a.m. to 2 p.m.
    Location: Omni Hotel at CNN Center, International Ballroom, 100 CNN 
Center, Atlanta, Georgia. The hotel phone number is 404-659-0000.
    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: cliffordj@cder.fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512542. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss new drug application (NDA) 21-
986, proposed trade name SPRYCEL (dasatinib) tablets, Bristol-Myers 
Squibb Co., with proposed indications for the: (1) Treatment of adults 
with chronic, accelerated, or blast phase chronic myeloid leukemia with 
resistance or intolerance to prior therapy including imatinib and (2) 
treatment of adults with Philadelphia chromosome-positive acute 
lymphoblastic leukemia, and lymphoid blast chronic myeloid leukemia 
with resistance or intolerance to prior therapy.
    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 by May 18, 2006. 
Oral presentations from the public will be scheduled between 
approximately 12 noon and 1 p.m. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before May 18, 2006, 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.
    Persons attending FDA's advisory committee meetings are advised 
that the

[[Page 18766]]

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: April 5, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-5413 Filed 4-11-06; 8:45 am]
BILLING CODE 4160-01-S

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