Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting, 61713-61714 [2011-25684]

Download as PDF Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Ms. Seldon received the proposal on May 27, 2011, and failed to respond within the timeframe prescribed by regulation. She therefore has waived her opportunity for a hearing and any contentions concerning her debarment (21 CFR part 12). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 6, 2011. Armando Zamora, Acting Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2011–25680 Filed 10–4–11; 8:45 am] BILLING CODE 4160–01–P mstockstill on DSK4VPTVN1PROD with NOTICES II. Findings and Order Therefore, the Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)), under authority delegated to him (Staff Manual Guide 1410.35), finds that Deborah Martinez Seldon has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. As a result of the foregoing finding, Ms. Seldon is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES), (see section 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Ms. Seldon in any capacity during Ms. Seldon’s debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. Seldon provides services in any capacity to a person with an approved or pending drug product application during her period of debarment she will be subject to civil money penalties (section 307(a)(7) of the FD&C Act) (21 U.S.C. 335b(a)(7)). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Deborah Martinez Seldon during her period of debarment (section 306(c)(1)(A) of the FD&C Act (21 U.S.C. 335a(c)(1)(A)). Any application by Deborah Martinez Seldon for special termination of debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) should be identified with Docket No. FDA–2011–N–0165 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). VerDate Mar<15>2010 19:11 Oct 04, 2011 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Pediatric Oncology Subcommittee of the 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: Pediatric Oncology Subcommittee of the 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 November 1, 2011, from 8 a.m. to 5:30 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You’’, click on ‘‘Public Meetings at the FDA White Oak Campus’’. Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Caleb Briggs, 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: ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 61713 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 November 1, 2011, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA, are in late stage development for an adult oncology indication, or in late stage development in pediatric patients with cancer. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) Sodium thiosulfate injection, application submitted by Adherex Technologies, Inc.; (2) vismodegib (GDC–0449), application submitted by Genentech, Inc.; (3) pazopanib, application submitted by Glaxo Wellcome Manufacturing Pte Ltd., Singapore doing business as GlaxoSmithKline; and (4) Medi-573 (fully human antibody to IGF–I and IGF–II), application submitted by MedImmune, LLC. 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 October 18, 2011. Oral presentations from the public will be scheduled between approximately 9:15 a.m. to 9:30 a.m., 11:15 a.m. to 11:30 a.m., 2:05 p.m. to 2:20 p.m., and 4:10 p.m. to 4:25 p.m. Those individuals interested in making 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 E:\FR\FM\05OCN1.SGM 05OCN1 61714 Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices participants, and an indication of the approximate time requested to make their presentation on or before October 7, 2011. 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 October 11, 2011. 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 Caleb Briggs 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: September 30, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–25684 Filed 10–4–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; STAR METRICS (Science and Technology for America’s Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science) In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director of the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: STAR METRICS (Science and Technology for America’s Reinvestment: Measuring the EffecTs of Research on Innovation, SUMMARY: Competitiveness and Science). Type of Information Collection Request: Reinstatement of OMB number 0925– 0616, expiration date 01/31/2011. Need and Use of Information Collection: The aim of STAR METRICS is twofold. The goal of STAR METRICS is to continue to provide mechanisms that will allow participating universities and Federal agencies with a reliable and consistent means to account for the number of scientists and staff that are on research institution payrolls, supported by Federal funds. In subsequent generations of the program, it is hoped that STAR METRICS will allow for measurement of science impact on economic outcomes (such as job creation), on knowledge generation (such as citations and patents) as well as on social and health outcomes. Frequency of Response: Quarterly. Affected Public: Universities and other research institutions. Type of Respondents: University administrators. The annual reporting burden is as follows: Estimated Number of Respondents: 100. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: 2.5. Estimated Total Annual Burden Hours Requested: 1,315. The annualized cost to respondents is estimated to be $65,750. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. A.12–1 ESTIMATES ANNUAL BURDEN HOURS Number of respondents Form Frequency of response Average time per response (in hours) Annual hour burden 7 100 1 4 45 2.5 315 1000 Total .......................................................................................................... mstockstill on DSK4VPTVN1PROD with NOTICES Stage 1: One time data input .......................................................................... Stage 2: Ongoing quarterly data input ............................................................ ........................ ........................ ........................ 1,315 Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, VerDate Mar<15>2010 19:11 Oct 04, 2011 Jkt 226001 mechanical, or other technological collection techniques or other forms of information technology. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Julia Lane, e-mail: julia.lane@nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: PO 00000 Dated: September 27, 2011. Stefano Bertuzzi, Office of the Director, Office of Science Policy Analysis, Office of Science Policy, National Institutes of Health. [FR Doc. 2011–25732 Filed 10–4–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS ACTION: Notice. AGENCY: Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61713-61714]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25684]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Pediatric Oncology Subcommittee of the 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: Pediatric Oncology Subcommittee of the 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 November 1, 2011, from 8 
a.m. to 5:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 
20993-0002. Information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You'', click on ``Public Meetings at the FDA White Oak 
Campus''. Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Contact Person: Caleb Briggs, 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: ODAC@fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and 
follow the prompts to the desired center or product area. 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 November 1, 2011, information will be presented 
regarding pediatric development plans for four products that were 
either recently approved by FDA, are in late stage development for an 
adult oncology indication, or in late stage development in pediatric 
patients with cancer. The subcommittee will consider and discuss issues 
relating to the development of each product for pediatric use and 
provide guidance to facilitate the formulation of Written Requests for 
pediatric studies, if appropriate. The four products under 
consideration are: (1) Sodium thiosulfate injection, application 
submitted by Adherex Technologies, Inc.; (2) vismodegib (GDC-0449), 
application submitted by Genentech, Inc.; (3) pazopanib, application 
submitted by Glaxo Wellcome Manufacturing Pte Ltd., Singapore doing 
business as GlaxoSmithKline; and (4) Medi-573 (fully human antibody to 
IGF-I and IGF-II), application submitted by MedImmune, LLC.
    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 
October 18, 2011. Oral presentations from the public will be scheduled 
between approximately 9:15 a.m. to 9:30 a.m., 11:15 a.m. to 11:30 a.m., 
2:05 p.m. to 2:20 p.m., and 4:10 p.m. to 4:25 p.m. Those individuals 
interested in making 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

[[Page 61714]]

participants, and an indication of the approximate time requested to 
make their presentation on or before October 7, 2011. 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 October 11, 2011.
    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 Caleb Briggs 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: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25684 Filed 10-4-11; 8:45 am]
BILLING CODE 4160-01-P

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