[Federal Register Volume 80, Number 38 (Thursday, February 26, 2015)]
[Notices]
[Pages 10493-10494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03974]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-20115-N-0456]


Pediatric Stakeholder Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration's (FDA) Office of Pediatric 
Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) 
and the Center for Biologics Evaluation and Research (CBER) are 
announcing a public meeting seeking input from patient groups, consumer 
groups, regulated industry, academia and other interested parties to 
obtain any recommendations or information relevant to the report to 
Congress that FDA is required to submit concerning pediatrics, as 
outlined in section 508 of the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for 
additional background information).

DATES: The public meeting will be held on March 25, 2015, from 9 a.m. 
to 5 p.m. Registration to attend the meeting should be received by 
March 20, 2015 (see the SUPPLEMENTARY INFORMATION section for 
instructions).

ADDRESSES: The meeting will be held at FDA's White Oak Campus, 10903 
New Hampshire Ave., Building 31 Conference Center, the Great Room 
(1503-B & C), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For information on 
parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.
    Submit either electronic or written comments by April 24, 2015. 
Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852. All comments should be identified with the docket number found 
in brackets in the heading of this document.
    FDA will post the agenda approximately 5 days before the meeting 
at: http://wwww.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm433552.htm.

FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of 
Pediatric Therapeutics, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 
[email protected] or Betsy Sanford, Office of Pediatric 
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, the President signed into law the Food and Drug 
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144). 
Section 508 of FDASIA directs the Secretary of HHS to submit a report 
to Congress on the implementation of the Best Pharmaceuticals for 
Children Act (BPCA) and Pediatric Research Equity Act (PREA). The first 
report must be submitted to Congress by July 9, 2016, and every 5 years 
thereafter. FDASIA also requires FDA to obtain, at least 180 days prior 
to submission of the report, stakeholder input from patient groups, 
consumer groups, regulated industry, academia, and any other interested 
parties to obtain any recommendations or information relevant to the 
report including suggestions for modifications that would improve 
pediatric drug research and pediatric labeling of drugs and biological 
products.
    The basic content of the report will include: An assessment of the 
effectiveness of BPCA (section 505A) and PREA (section 505B) in 
improving information about pediatric uses for approved drugs and 
biological products, including the number and type of labeling changes 
made since the enactment of FDASIA and the importance of such uses in 
the improvement of the health of children; various statistics related 
to both PREA and BPCA, including the Written Request referral process 
with the National Institutes of Health; an assessment of the timeliness 
and effectiveness of pediatric study plans; an assessment of studying 
biologics; efforts made to increase the number of studies conducted in 
the neonatal population; the number and importance of drugs and 
biologics studied in children with cancer and any recommendations for 
modification to the programs that would improve pediatric drug research 
and increase labeling of drugs and biologics; an assessment of the 
successes of and limitations to studying drugs for rare diseases; an 
assessment of the efforts to address the suggestions and options 
described in any prior report issued by the Comptroller General, 
Institute of Medicine, or the Secretary, and any stakeholder 
recommendations or modifications that would improve pediatric drug 
research and pediatric labeling of drugs and biological products.
    The specific topics to be discussed at the meeting will include, 
but not be limited to, pediatric labeling changes, waivers and 
deferrals, Written Requests, pediatric study plans, programmatic 
activities with the NIH Written Request referral process, activities 
concerning neonates, pediatric cancers and rare diseases, and 
transparency.

II. Meeting Attendance and Participation

    If you wish to attend this meeting, visit http://stakeholderinput.eventbrite.com. Please register by March 20, 2015. 
Those who are unable to attend the meeting in person can register to 
view a live Webcast of the meeting. You will be asked to indicate in 
your registration if you plan to attend in person or via the Webcast. 
Your registration will also contain your complete contact information, 
including name, title, affiliation, address, email address, and phone 
number. Seating will be limited so early registration is recommended. 
Registration is free and will be on a first-come, first-served basis. 
Onsite registration on the day of the meeting will be based on space 
availability. If you need special accommodations due to a disability, 
please contact Betsy Sanford (see FOR FURTHER INFORMATION CONTACT) at 
least 7 days in advance. Persons attending the meeting are advised that 
FDA is not responsible for providing access to electrical outlets.
    Persons interested in presenting comments at the meeting will be 
asked to indicate this in their registration. FDA will try to 
accommodate all participant requests to speak, however the duration of 
comments may be limited by time constraints.
    Comments: Regardless of attendance at the public meeting, you can 
submit electronic or written comments to the public docket (see 
ADDRESSES) by April 24, 2015. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m.,

[[Page 10494]]

Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: As soon as a transcript is available, FDA will post it 
at http://wwww.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm433552.htm.

    Dated: February 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03974 Filed 2-25-15; 8:45 am]
BILLING CODE 4164-01-P