[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]
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