<searchTitle>Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes; Federal Register Vol. 74, Issue </searchTitle>
<granuleClass>NOTICE</granuleClass>
<accessId>E9-22012</accessId>
<agency order="1">DEPARTMENT OF HEALTH AND HUMAN SERVICES</agency>
<agency order="2">Food and Drug Administration</agency>
<departmentDoc>Docket No. FDA-2009-N-0407</departmentDoc>
<billingCode>4160-01-S</billingCode>
<frDocNumber>E9-22012</frDocNumber>
<action>Notice of public workshop; request for comments.</action>
<summary>The Food and Drug Administration (FDA) is announcing a public workshop entitled "Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes." The purpose of the public workshop is to solicit information from primary and secondary health care providers, academia, industry, and professional societies on various aspects of device clinical trials involving pediatric diseases and patients. Information from this public workshop will help stimulate interest in pediatric device clinical trial research methods, and develop topics for further discussion regarding the safety of pediatric device clinical trials. The information gathered in this and future workshops will help to develop future guidance for developing safe clinical trials for devices intended for pediatric patients. We encourage participation and comments from workshop attendees on the topics and questions discussed. Please see instructions for registration and for providing comments in the sections of this document entitled "Registration" and "Comments." Dates and Times: The public workshop will be held on October 29, 2009, from 8 a.m. to 5:30 p.m. and October 30, 2009, from 8 a.m. to 12 noon. Location: The public workshop will be held at the Holiday Inn College Park located off I-95 at 10000 Baltimore Ave., College Park, MD 20740. The hotel front desk number is 1-301-345-6700. For directions, please refer to the meeting Web page: http://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/ucm170938.htm Contact Person: Barbara Buch, Center For Devices and Radiological Health, Food and Drug Administration, Bldg. 66, rm. 1406, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-5650, FAX: 301-847- 8117, e-mail: barbara.buch@fda.hhs.gov. If you need special accommodations due to a disability, (such as wheelchair access or a sign language interpreter), please notify Barbara Buch by September 30, 2009. Registration: Registration and seating will be on a first-come, first-served basis and discussion preference will be afforded to clinical research investigators involved in pediatric clinical device trials, health care givers, and patient advocates. Please provide your name, title, organization affiliation, address, and e-mail contact information. There is no registration fee to attend the workshop. There will be no onsite registration. Please register electronically at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ default.htm by September 30, 2009. Due to limited space, and to maximize participation, attendees are asked to delegate one or two representatives from their organizations to participate in the general sessions. A report of The Workshop and The Information presented will be available following the meeting via a link on the meeting Web page. If you wish to make an oral comment during or to attend the public workshop, please note this in your registration information. The online registration form will instruct you as to the information you should provide prior to the meeting. In general, a summary of the presentation and an electronic copy of the presentation should be submitted by October 1, 2009. We will try to accommodate all persons who wish to make oral comments during the general sessions. However, we strongly recommend that you provide written comments as instructed in this document to ensure that your opinion, comments, and suggestions are captured. Please refer to the section, "Comments" for instructions on how to submit written comments. Comments: The deadline for submitting comments regarding this public workshop is November 30, 2009. Regardless of attendance at the public workshop, interested persons may submit written or electronic comments. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments should be submitted to http://www.regulations.gov. Comments should be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.</summary>
<tocSubject1>Pediatric Clinical Trials Workshop:</tocSubject1>
<tocDoc>Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes
, </tocDoc>
<emailRef>barbara.buch@fda.hhs.gov</emailRef>
<urlRef>http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm</urlRef>
<urlRef>http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm170938.htm</urlRef>
<urlRef>http://www.regulations.gov</urlRef>