Oncologic Drugs Advisory Committee; Notice of Meeting, 30045-30046 [2010-12870]

Download as PDF jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices plans to date, including the NORA Construction, Manufacturing, Public Safety, Services, and Wholesale and Retail Trade Councils. Updates will also be given on cross-sector activities in the areas of Healthy People 2020 and the WorkLife Initiative. After each update, there will be time to discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an e-mail to noracoordinator@cdc.gov containing the participant’s name, organization name, contact telephone number on the day of the meeting, and preference for participation by Web meeting (requirements include: Computer, internet connection, and telephone, preferably with ‘mute’ capability) or in person. An e-mail confirming registration will include the details needed to participate in the Web meeting. Non-US citizens are encouraged to participate in the web meeting. Non-US citizens who do not register to attend in person on or before June 2, 2010, will not be granted access to the meeting site and will not be able to attend the meeting in-person due to mandatory security clearance procedures at the Patriots Plaza facility. Background: NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see https://www.cdc.gov/niosh/ nora/about.html. Since 2006, NORA has been structured according to industrial sectors. Eight major sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the web and town hall meetings, ten NORA Sector Councils have been working to define sectorspecific strategic plans for conducting VerDate Mar<15>2010 17:43 May 27, 2010 Jkt 220001 research and moving the results into widespread practice. During 2008–2009, most of these Councils have posted draft strategic plans for public comment. Seven have posted finalized National Sector Agendas after considering comments on the drafts. For more information, see the link above and choose ‘‘Sector-based Approach,’’ ‘‘NORA Sector Councils,’’ ‘‘Sector Agendas’’ and ‘‘Comment on Draft Sector Agendas’’ from the right-side menu. FOR FURTHER INFORMATION CONTACT: Sidney C. Soderholm, PhD, NORA Coordinator, E-mail noracoordinator@cdc.gov, telephone (202) 245–0665. Dated: May 20, 2010. Tanja Popovic, Deputy Associate Director for Science, Centers for Disease Control and Prevention. [FR Doc. 2010–12743 Filed 5–27–10; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] 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 July 20, 2010, from 8 a.m. to 3 p.m. Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301–977– 8900. Contact Person: Nicole Vesely, c/o Melanie Whelan, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, Silver Spring, MD 20993–0002, FAX: 301–847–8737, to reach by telephone before June 8, 2010, please call 301–827–7001; to reach by telephone after June 8, 2010, please call 301–796–9001, e-mail: nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 30045 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. 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 July 20, 2010, the committee will discuss supplemental biologics license applications (sBLAs) 125085/191 and 192 for AVASTIN (bevacizumab), manufactured by Genentech, Inc. The two proposed indications (uses) for this product are: (1) First-line treatment of a subgroup of women with metastatic breast cancer known as HER2-negative breast cancer, in combination with the chemotherapy drug docetaxel; and (2) first-line treatment of HER2-negative metastatic breast cancer in combination with one of two classes of chemotherapy drugs, known as taxanes and anthracyclines, or with the chemotherapy drug, capecitabine. In addition to the discussion of these two indications, the committee will also consider the impact of the submitted studies on the conversion from accelerated to regular approval of the indication for the treatment, in combination with the chemotherapy drug paclitaxel, of patients who have not received chemotherapy for their locally recurrent or metastatic HER2 negative breast cancer. 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/ AdvisoryCommittees/Calendar/ default.htm. 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 person on or before July 6, 2010. Oral presentations from the public will be scheduled between approximately 12:30 p.m. to 1:30 p.m. Those desiring to make formal oral presentations should E:\FR\FM\28MYN1.SGM 28MYN1 30046 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices 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 June 25, 2010. 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 June 28, 2010. 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 Nicole Vesely 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/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.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: May 25, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. 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 Allergy and Infectious Diseases Special Emphasis Panel; Review of proposals received in response to NIH–NHLBI–HB–11– 02. Date: June 22, 2010. Time: 1 p.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Rockledge 6700, 6700B Rockledge Drive, 3137, Bethesda, MD 20817 (Telephone Conference Call) . Contact Person: Quirijn Vos, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892–7616, 301–451–2666, qvos@niaid.nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Genetics Autoimmunity. Date: June 22, 2010. Time: 12 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call) . Contact Person: Sujata Vijh, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/ NIH/DHHS, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892, 301–594–0985, vijhs@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: May 24, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–12870 Filed 5–27–10; 8:45 am] BILLING CODE 4160–01–S 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 Child Health and Human Development Initial Review Group; Biobehavioral and Behavioral Sciences Subcommittee. Date: June 23–24, 2010. Time: 9 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Washington Plaza Hotel, 10 Thomas Circle, Washington, DC 20005. Contact Person: Marita R. Hopmann, PhD, Scientific Review Administrator, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5b01, Bethesda, MD 20892, 301– 435–6911, hopmannm@mail.nih.gov. (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: May 24, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–12940 Filed 5–27–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–2316–N] DEPARTMENT OF LABOR [FR Doc. 2010–12942 Filed 5–27–10; 8:45 am] BILLING CODE 4140–01–P Employee Benefits Security Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES Medicaid and CHIP Programs; Meeting of the CHIP Working Group—June 14, 2010 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health jlentini on DSKJ8SOYB1PROD with NOTICES National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 VerDate Mar<15>2010 17:43 May 27, 2010 Jkt 220001 National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (DHHS); Employee Benefits Security Administration (EBSA), Department of Labor (DOL). ACTION: Notice. SUMMARY: This notice announces the second meeting of the Medicaid, Children’s Health Insurance Program (‘‘CHIP’’), and Employer-Sponsored Coverage Coordination Working Group E:\FR\FM\28MYN1.SGM 28MYN1

Agencies

[Federal Register Volume 75, Number 103 (Friday, May 28, 2010)]
[Notices]
[Pages 30045-30046]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12870]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


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 July 20, 2010, from 8 
a.m. to 3 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
    Contact Person: Nicole Vesely, c/o Melanie Whelan, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, Silver 
Spring, MD 20993-0002, FAX: 301-847-8737, to reach by telephone before 
June 8, 2010, please call 301-827-7001; to reach by telephone after 
June 8, 2010, please call 301-796-9001, e-mail: 
nicole.vesely@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. 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 July 20, 2010, the committee will discuss supplemental 
biologics license applications (sBLAs) 125085/191 and 192 for AVASTIN 
(bevacizumab), manufactured by Genentech, Inc. The two proposed 
indications (uses) for this product are: (1) First-line treatment of a 
subgroup of women with metastatic breast cancer known as HER2-negative 
breast cancer, in combination with the chemotherapy drug docetaxel; and 
(2) first-line treatment of HER2-negative metastatic breast cancer in 
combination with one of two classes of chemotherapy drugs, known as 
taxanes and anthracyclines, or with the chemotherapy drug, 
capecitabine. In addition to the discussion of these two indications, 
the committee will also consider the impact of the submitted studies on 
the conversion from accelerated to regular approval of the indication 
for the treatment, in combination with the chemotherapy drug 
paclitaxel, of patients who have not received chemotherapy for their 
locally recurrent or metastatic HER2 negative breast cancer.
    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/AdvisoryCommittees/Calendar/default.htm. 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 person on or before July 
6, 2010. Oral presentations from the public will be scheduled between 
approximately 12:30 p.m. to 1:30 p.m. Those desiring to make formal 
oral presentations should

[[Page 30046]]

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 June 
25, 2010. 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 June 28, 2010.
    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 Nicole Vesely 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: May 25, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-12870 Filed 5-27-10; 8:45 am]
BILLING CODE 4160-01-S

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