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

Federal Register: Volume 77, Number 11 (Wednesday, January 18, 2012)
                  Pages 2556-2557

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 complex

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and 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]
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