[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Pages 11455-11456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-04376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Pediatric Neurocognitive Workshop; Advancing the Development of 
Pediatric Therapeutics Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA) Division of 
Gastroenterology and Inborn Errors Products Division and Division of 
Pediatric and Maternal Health in the Center for Drug Evaluation and 
Research, and the Office of Pediatric Therapeutics in the Office of the 
Commissioner are announcing a 2-day public workshop. Day 1 of the 
workshop is entitled ``Assessment of Neurocognitive Outcomes in the 
Inborn Errors of Metabolism''. Day 2 of the workshop is entitled, 
``Advancing the Development of Pediatric Therapeutics: Assessment of 
Pediatric Neurocognitive Outcomes''. The purpose of this 2-day workshop 
is to provide a forum to consider issues related to advancing pediatric 
regulatory science in the evaluation of neurocognitive outcomes in 
pediatric patients.

DATES: The public workshop will be held on April 16 and 17, 2015, from 
8 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held in the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: For questions regarding Day 1 of the 
workshop, contact Richard (Wes) Ishihara, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-0069, 
[email protected].
    For questions regarding Day 2 of the workshop, contact Denise Pica-
Branco, Center for Drug Evaluation and Research, Food and Drug

[[Page 11456]]

Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002,Telephone: 301-796-1732, FAX: 301-796-9858, 
[email protected].

SUPPLEMENTARY INFORMATION: The first day of the workshop will focus on 
approaches for assessing the efficacy of therapeutic products on 
neurocognitive outcomes in patients diagnosed with inborn errors of 
metabolism disorders. The session will address the role of natural 
history studies and methodological approaches for selecting appropriate 
assessment scales and standardizing neurocognitive assessments. The 
second day of the workshop will discuss identification of signals in 
animal studies and clinical trials that warrant further clinical 
investigation and testing that may be predictive of neurocognitive 
outcome in children. Additionally, strategies and methods to address 
the challenges of assessing long-term neurocognitive outcomes for 
products used to treat pediatric patients will be discussed.

Participation in the Public Workshop

    Registration: There is no fee to attend the public workshop, but 
attendees should register in advance. Space is limited, and 
registration will be on a first-come, first-served basis. Persons 
interested in attending this workshop must register online at 
[email protected] before March 31, 2015. For those 
without Internet access, please contact Denise Pica-Branco (see FOR 
FURTHER INFORMATION CONTACT) to register. Onsite registration will not 
be available.
    If you need special accommodations due to a disability, please 
contact Denise Pica-Branco (see FOR FURTHER INFORMATION CONTACT) at 
least 7 days in advance.
    Transcripts: Transcripts of the workshop will be available for 
review at the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and 
at http://www.regulations.gov approximately 30 days after the workshop. 
A transcript will also be available in either hard copy or on CD-ROM, 
after submission of a Freedom of Information request. Send written 
requests to the Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857. Send faxed requests to 301-827-9267.

    Dated: February 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04376 Filed 3-2-15; 8:45 am]
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