Oncologic Drugs Advisory Committee; Amendment of Notice, 71450 [2010-29522]

Download as PDF 71450 Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices National Institutes of Health/NIAID, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892–7616. 301–496–2550. qvos@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: November 17, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. Blood Institute, 6701 Rockledge Drive, Room 7178, Bethesda, MD 20892–7924. 301–435– 0725. johnsonwj@nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) [FR Doc. 2010–29525 Filed 11–22–10; 8:45 am] Dated: November 17, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P [FR Doc. 2010–29524 Filed 11–22–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Food and Drug Administration National Heart, Lung, and Blood Institute; Notice of Closed Meetings [Docket No. FDA–2010–N–0001] mstockstill on DSKH9S0YB1PROD with NOTICES 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 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 Heart, Lung, and Blood Institute Special Emphasis Panel Institutional National Research Service Awards. Date: December 15, 2010. Time: 1 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20817. (Virtual Meeting). Contact Person: Roy L White, PhD, Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7176, Bethesda, MD 20892–7924. 301–435– 0310. whiterl@nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel Conference Grants. Date: December 16–17, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Virtual Meeting). Contact Person: William J Johnson, PhD, Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and VerDate Mar<15>2010 18:02 Nov 22, 2010 Jkt 223001 Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of October 19, 2010 (75 FR 64314). The amendment is being made to reflect changes in the Date and Time, Agenda, and Procedure portions of the document. We also are postponing a session regarding biologics license application (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured by BristolMyers Squibb Co. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. This portion of the meeting has been postponed due to the need to complete the review of additional data submitted by the applicant. Future meeting dates may be announced in the Federal Register. FOR FURTHER INFORMATION CONTACT: Nicole Vesely, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, 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 301–451– 2542. Please call the Information Line SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of October 19, 2010 (75 FR 64314), FDA announced that a meeting of the Oncologic Drugs Advisory Committee would be held on December 2, 2010. On page 64314, in the first column, the Date and Time portion of the document is changed to read as follows: Date and Time: The meeting will be held on December 2, 2010, from 8 a.m. to 12:30 p.m. On page 64314, in the second column, the Agenda portion of the document is changed to read as follows: Agenda: On December 2, 2010, the committee will discuss new drug application (NDA) 022–405, with the proposed trade name Zictifa (vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc., represented by AstraZeneca Pharmaceuticals LP (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer. On page 64314, in the second column, the third sentence in the Procedure portion of the document is changed to read as follows: Procedure: Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:30 a.m. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: November 17, 2010. Joanne Less, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–29522 Filed 11–22–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Sleep Disorders Research Advisory Board. The meeting will be open to the public. Individuals who plan to attend and need special assistance should notify the Contact Person listed below in advance of the meeting. Name of Committee: Sleep Disorders Research Advisory Board. E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Page 71450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Oncologic Drugs Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of a meeting of the Oncologic Drugs Advisory 
Committee. This meeting was announced in the Federal Register of 
October 19, 2010 (75 FR 64314). The amendment is being made to reflect 
changes in the Date and Time, Agenda, and Procedure portions of the 
document. We also are postponing a session regarding biologics license 
application (BLA) 125377, with the proposed trade name Yervoy 
(ipilimumab), manufactured by Bristol-Myers Squibb Co. The proposed 
indication (use) for this product is for the treatment of advanced 
melanoma in patients who have received prior therapy. This portion of 
the meeting has been postponed due to the need to complete the review 
of additional data submitted by the applicant. Future meeting dates may 
be announced in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Nicole Vesely, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, 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 301-451-2542. Please call the Information 
Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 19, 2010 
(75 FR 64314), FDA announced that a meeting of the Oncologic Drugs 
Advisory Committee would be held on December 2, 2010. On page 64314, in 
the first column, the Date and Time portion of the document is changed 
to read as follows:
    Date and Time: The meeting will be held on December 2, 2010, from 8 
a.m. to 12:30 p.m.
    On page 64314, in the second column, the Agenda portion of the 
document is changed to read as follows:
    Agenda: On December 2, 2010, the committee will discuss new drug 
application (NDA) 022-405, with the proposed trade name Zictifa 
(vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc., 
represented by AstraZeneca Pharmaceuticals LP (authorized U.S. agent). 
The proposed indication (use) for this product is for the treatment of 
patients with unresectable (non-operable) locally advanced or 
metastatic medullary thyroid cancer.
    On page 64314, in the second column, the third sentence in the 
Procedure portion of the document is changed to read as follows:
    Procedure: Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11:30 a.m.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: November 17, 2010.
Joanne Less,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-29522 Filed 11-22-10; 8:45 am]
BILLING CODE 4160-01-P
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