[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57451-57452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23264]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4560]
Pediatric Stakeholder Meeting; Public 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 or the Agency) 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/
parent 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 November 21, 2019, from 9
a.m. to 3 p.m. Registration to attend the meeting should be received by
November 15, 2019. Onsite registration on the day of the meeting will
be based on space availability. Submit either electronic or written
comments on the public meeting by December 19, 2019. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(1503-A), 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 https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before December 19, 2019. Comments received by mail/
hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-4560 for ``Pediatric Stakeholder Meeting.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docker and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS
[[Page 57452]]
CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Terrie Crescenzi, Office of Pediatric
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, [email protected] or Elizabeth
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 was required to be submitted to Congress by July 9, 2016, and
subsequent reports are required 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.
In addition, on August 18, 2017, the Food and Drug Administration
Reauthorization Act (FDARA) (Pub L. 115-52) was signed into law, which
outlined additional requirements to be included in the report.
Some of the issues to be discussed at the meeting will include, but
not be limited to:
Hearing from patients/parents and patient/parent groups,
industry, academia and other stakeholders about the public health
impact that pediatric legislation may have had on them or their
communities;
Understanding the effects of the requirement of pediatric
studies under PREA or the incentives under BPCA on drug/biologic
development plans; and
Understanding if there are any barriers or resource issues
preventing undertaking or completing studies under PREA and BPCA.
II. Meeting Attendance and Participation
If you wish to attend this meeting, visit https://www.eventbrite.com/e/stakeholder-input-on-pediatric-legislation-registration-74306461627. Please register by November 15, 2019. 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. To view the webcast, visit: https://collaboration.fda.gov/pediatriclegislation/. If you need special
accommodations due to a disability, please contact Elizabeth 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. If you intend to use a
PowerPoint presentation, please email the presentation to
[email protected] by November 15, 2019. 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 December 19, 2019. Received comments may be seen in the
Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23264 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P