Workshops: Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures

This Notice document was issued by the Food and Drug Administration (FDA)

For related information, Open Docket Folder


Show agency attachment(s)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]

Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public Workshop

Agency

Food and Drug Administration, HHS.

Action

Notice of public workshop.

The Food and Drug Administration (FDA), Office of Pediatric Therapeutics, is announcing a public workshop entitled “Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures.” There is a critical need for pediatric research on medical countermeasures to ensure that these products are safe and effective in the pediatric population. The challenges to developing and evaluating drugs, biologics, and devices for children in the medical countermeasure context are complexand need to be better understood by ethicists, researchers, policymakers, and the general public. The purpose of the public workshop is to provide a forum for careful consideration of scientific, ethical, and regulatory issues confronting FDA and other stakeholders in the area of medical countermeasures and public health preparedness.

Date and Time: The public workshop will be held on February 15, 2012, from 8:30 a.m. to 5 p.m. and February 16, 2012, from 8:30 a.m. to 3 p.m.

Location: The public workshop will be held at the Rockville Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852.

Contact Person: Cindy de Sales, (240) 316-3207, FAX: (240) 316-3201, email: cindy@tepgevents.com.

Registration: Please use the following Web site to register online: http://www.contractmeetings.com. Alternatively, you can email or fax your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by February 1, 2012. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m.

If you need special accommodations due to a disability, please contact Cindy de Sales (see Contact Person) at least 7 days in advance.

Supplementary Information

The workshop will include plenaries and breakout sessions on the ethical and regulatory challenges in the development of medical countermeasures for the pediatric population. Topics of the breakout sessions will include: (1) Institutional Review Board preparedness to review study protocols relevant to pediatric medical countermeasures; (2) potential scientific and ethical justifications for conducting pre-event pediatric medical countermeasures research; (3) leveraging new technologies to develop pediatric medical countermeasures; and (4) risk communication related to pediatric treatment and research during public health emergencies. The workshop also will include discussion of a number of case studies to facilitate discussion of the challenges of pediatric medical countermeasure development and deployment.

Transcripts: Transcripts of the public workshop may be requested in writing from the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, approximately 15 working days after the public workshop at the cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at http://www.regulations.gov, Docket No. FDA-2011-N-0002. Transcripts may also be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: January 12, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-846 Filed 1-17-12; 8:45 am]
BILLING CODE 4160-01-P

Attachments

 (12) Return to top

Panel Session 1 Ethics Track Clarifying Distinctions Between EUAs and INDs dated February 15 2012

View Attachment:

Panel Session 2 Ethics Track IRB Preparendess dated February 15 2012

View Attachment:

Panel Session 1 Science Track dated February 15 2012

View Attachment:

Panel Session 2 Sceince Track Pralidoxime dated February 15 2012

View Attachment:

Panel Session 3 Track Sound Ethical Reasons For A Pre-Event-Study In A 50.54 407 Panel dated February 16 2012

View Attachment:

Panel Session Ethics Track 4 Pediatric MCM Interventions Risk Perception And Risk Communication dated February 16 2012

View Attachment:
Authors: oc
 

Panel Session 5 Ethice Track Policy dated February 16 2012

View Attachment:

Panel Session 3 Science Track Pandemic-influenza dated February 16 2012

View Attachment:

Panel Session 4 Science Track Modeling dated February 16 2012

View Attachment:

Panel Session 5 Human Factors And Pediatric MCM Devices dated February 16 2012

View Attachment:
Authors: oc
 

Plenary Session dated February 15 2012

View Attachment:
Authors: oc
 

Plenary Session dated February 16 2012

View Attachment:
Authors: oc
 

 
 
Comment Period Closed
ID: FDA-2011-N-0002-0156
View original printed format:
PDF

Document Information

Date Posted: Jan 18, 2012
Federal Register Number: 2012-00846
Show More Details  

Comments

0
Comments Received*

* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.

Document text and images courtesy of the
Federal Register