Document ID: FDA-2017-N-4885-0001
Agency: fda
Document Type: Notice
Title: Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments
Posted Date: 2017-08-22T04:00Z

[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39790-39792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17726]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4885]

Pediatric Advisory Committee; Notice of Meeting; Establishment of 
a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) announces 
a forthcoming public advisory committee meeting of the Pediatric 
Advisory Committee (PAC). The general function of the committee is to 
provide advice and recommendations to the Agency on FDA's regulatory 
issues. The meeting will be open to the public. FDA is establishing a 
docket for public comments.

DATES: The meeting will be held on September 11, 2017, from 8:30 a.m. 
to 5:30 p.m. and September 12, 2017, from 8:30 a.m. to 1 p.m.

ADDRESSES: Hilton Washington DC/Rockville Hotel & Executive Meeting 
Center, 1750 Rockville Pike, Rockville, MD 20852. The hotel's telephone 
number is 301-468-1100. Answers to commonly asked questions including 
information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html.
    FDA is establishing a docket for public comment on this document. 
The docket number is FDA-2017-N-4885. The docket will close on 
September 13, 2017. Submit either electronic or written comments on 
this public meeting by that date. Late, untimely comments will not be 
considered. Electronic comments must be submitted on or before 
September 13, 2017. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
September 13, 2017. 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.
    Comments received on or before August 28, 2017, will be provided to 
the committee. Comments received after that date will be taken into 
consideration by FDA.

[[Page 39791]]

    You may submit comments as follows:

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 a 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 make 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-2017-N-4885 for ``Pediatric Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket 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 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 CFR 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: Marieann Brill, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, 
marieann.brill@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in 
the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm. Scroll down to the appropriate advisory 
committee meeting link, or call the advisory committee information line 
to learn about possible modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The PAC will meet to discuss pediatric-focused safety 
reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. 
L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). 
Comments about the upcoming September advisory committee meeting should 
be submitted to Docket No. FDA-2017-N-4885.
    On September 11, 2017, the PAC will discuss the use of prescription 
opioid products containing hydrocodone or codeine for the treatment of 
cough in pediatric patients. The discussion will include current 
practice for the treatment of cough in children and benefit-risk 
considerations regarding the use of prescription opioid products in 
pediatric patients.
    On September 12, 2017, the PAC will meet to discuss the following 
products (listed by FDA Center):

(1) Center for Drug Evaluation and Research
    a. ABILIFY (aripiprazole)
    b. KEPPRA/KEPPRA XR (levetiracetam)
(2) Center for Devices and Radiological Health
    a. CONTEGRA Pulmonary Valved Conduit (humanitarian device exemption 
(HDE)
    b. ENTERRA Therapy System (HDE)
    c. PLEXIMMUNE (HDE)
    d. ELANA Surgical Kit (HDE)

    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material will be 
available at: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
September 5, 2017. Oral presentations from the public will be scheduled 
on September 11, 2017, between approximately 1 p.m. and 2 p.m. and on 
September 12, 2017, between approximately 9 a.m. and 10 a.m. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of

[[Page 39792]]

proposed participants, and an indication of the approximate time 
requested to make their presentation on or before August 25, 2017. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by August 28, 2017.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    For press inquiries, please contact the Office of Media Affairs at 
fdaoma@fda.hhs.gov or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Marieann Brill at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17726 Filed 8-21-17; 8:45 am]
 BILLING CODE 4164-01-P