
[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54813-54814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19589]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0567]


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) announces a forthcoming 
public advisory committee of the Pediatric Advisory Committee. 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 
comment on this document.

DATES: The meeting will be held on September 14, 2016, from 8 a.m. to 
5:30 p.m.

ADDRESSES: DoubleTree by Hilton Hotel Bethesda-Washington DC, 8120 
Wisconsin Ave., Bethesda, MD 20814, 301-652-2000. Answers to commonly 
asked questions including information regarding special accommodations 
due to a disability, visitor parking, and transportation may be 
accessed at www.doubletreebethesda.com/. You may submit your comments 
as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 
many not wish to be posted, such as medical information, you 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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 either the 
Docket No. FDA-2016-N-0567 for the ``Pediatric Advisory Committee; 
Notice of Meeting; Establishment of a Public Docket; Request for 
Comments''; or the Docket No. FDA-2016-N-2470 for the ``Pediatric-
focused Safety Reviews'', which will be posted on the Internet, but not 
presented at the Pediatric Advisory Committee meeting. Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information thatyou 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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,

[[Page 54814]]

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 and 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. For press inquiries, please contact the Office of Media 
Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

SUPPLEMENTARY INFORMATION: Agenda: On September 14, 2016, the Pediatric 
Advisory Committee (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 up-coming September advisory committee meeting 
should be submitted to Docket No. FDA-2016-N-0567.
    The PAC will meet to discuss the following products (listed by FDA 
Center):

1. Center for Biologics Evaluation and Research
    a. MENVEO (Meningococcal (groups A, C, Y and W-135) Oligosaccharide 
Diphtheria CRM197 Conjugate Vaccine)
    b. IXIARO (Japanese encephalitis vaccine)
2. Center for Drug Evaluation and Research
    a. ASACOL & ASACOL HD (mesalamine)
    b. BLOXIVERZ (neostigmine methylsulfate)
    c. DELZICOL (mesalamine)
    d. DORYX (doxycycline hyclate)
    e. KARBINAL ER (carbinoxamine maleate)
    f. KEPIVANCE (palifermin)
    g. SUSTIVA (efavirenz)
    h. TOPAMAX (topiramate)
    i. XOLAIR (omalizumab)
3. Center for Devices and Radiological Health
    a. ELANA SURGICAL KIT (HUD)
    b. BERLIN HEART EXCOR[supreg] Pediatric Ventricular Assist Device 
(VAD)
    c. ENTERRATM THERAPY SYSTEM
    d. CONTEGRA PULMONARY VALVED CONDUIT
    e. PLEXIMMUNE

    FDA will also provide an update of their additional ongoing 
analysis of a possible safety signal regarding the use of the drug 
product Exjade (deferasirox) in children with fever and dehydration 
that was discussed at the September 2015 PAC meeting.
    For the products to be discussed at the PAC meeting, 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 7, 2016. Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. to 9:30 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 proposed participants, and an indication of the approximate time 
requested to make their presentation on or before August 30, 2016. 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 31, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA is establishing a docket for public comment for the PAC 
meeting. The docket number is FDA-2016-N-0567. The docket will close on 
August 31, 2016. Comments received on or before August 31, 2016, will 
be provided to the committee. Comments received after the date will be 
taken into consideration by the Agency.
    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).
    Additional Pediatric-focused Safety Reviews: FDA will make 
available additional pediatric safety review reports for selected 
products at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm. 
FDA is establishing a second public docket to receive input on 
additional pediatric-focused safety reviews that will be posted on the 
Internet. The docket number is FDA-2016-N-2470; the docket will open on 
September 12, 2016, and remain open until September 23, 2016. These 
safety review reports are for the following products:

1. BARACLUDE (entecavir)
2. ISENTRESS (raltegravir potassium)
3. LYSTEDA (tranexamic acid)
4. SALONPAS Pain Relief Patch (methyl salicylate 10% and l-menthol 3%).

    Dated: August 11, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-19589 Filed 8-16-16; 8:45 am]
 BILLING CODE 4164-01-P


