This PDF is the current document as it appeared on Public Inspection on 10/22/2013 at 08:45 am.
Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration Start Printed Page 63223(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 4, 2013, from 1 p.m. to 5 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: http://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, email: ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Agenda: The recent permanent reauthorization of the Pediatric Research Equity Act (Pub. L. 108-155) and the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and their associated amendments require earlier consideration of pediatric study plans. The need for suitable outcome assessment tools to evaluate treatment benefit of new cancer drugs on how a patient feels and/or functions as well as survives necessitates consideration of the potential challenges to the use of patient reported outcomes (PROs) in the pediatric age group. The 2009 “FDA Guidance for Industry: Patient-Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims” does not specifically address the relevance and potential use of such measures in the pediatric development plans of oncology products. The half-day session will provide an opportunity to review the Agency's position on the use of PROs in the pediatric population in general. As well, participants will review the current state of the science of the evaluation of pertinent health-related quality of life measures in children with cancer across the various age and developmental subgroups of children. Participants will discuss potential contexts of use for measuring both observable and unobservable concepts in specific pediatric cancer diagnoses across relevant age groups and defined disease stages using validated tools. No specific drug or biologic products or class of products will be discussed.
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/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 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 30, 2013. Oral presentations from the public will be scheduled between approximately 2:45 p.m. and 3:45 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 participants, and an indication of the approximate time requested to make their presentation on or before October 28, 2013. 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 29, 2013.
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 http://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).Start Signature
Dated: October 10, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-24805 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P