[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48325-48326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19729]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Pediatric Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration

[[Page 48326]]

(FDA). The meeting will be open to the public.
    Name of Committee: Pediatric Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on Wednesday, September 16, 
2015, from 8:30 a.m. to 5:30 p.m.
    Location: Double Tree by Hilton, 8727 Colesville Rd., Silver 
Spring, MD 20910, 301-589-5200. Answers to commonly asked questions 
including information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
http://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-washington-dc-silver-spring-DCASSDT/index.html.
    Contact Person: Walter Ellenberg, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, 
Silver Spring, MD 20993, 301-796-0885, email: 
[email protected] 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.
    Agenda: On September 16, 2015, 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). The PAC will 
meet to discuss the following products:

    1. DUREZOL (difluprednate ophthalmic emulsion) 0.05%, 
Phenylephrine Hydrochloride Ophthalmic Solution,
    2. ZYLET (loteprednol etabonate and tobramycin ophthalmic 
suspension),
    3. BETHKIS (tobramycin Inhalation Solution),
    4. INTELENCE (etravirine),
    5. PREZISTA (darunavir),
    6. VIRAMUNE XR (nevirapine),
    7. EPIDUO (adapalene and benzoyl peroxide),
    8. EXJADE (deferasirox),
    9. DOTAREM (gadoterate meglumine),
    10. FYCOMPA (perampanel),
    11. RECOTHROM (thrombin, topical [recombinant]),
    12. PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine 
[Diphtheria CRM197 Protein]),
    13. PLEXIMMUNE,
    14. ELANA SURGICAL KIT (HUD),
    15. BERLIN HEART EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE 
(VAD),
    16. ENTERRA THERAPY SYSTEM, and
    17. CONTEGRA Pulmonary Valved Conduit.

    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 is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee 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 8, 2015. Oral presentations from the public will be scheduled 
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 proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before September 1, 2015. 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 September 8, 2015.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Walter Ellenberg 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 5, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-19729 Filed 8-11-15; 8:45 am]
 BILLING CODE 4164-01-P