80 FR 11681 - Pediatric Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 42 (March 4, 2015)

[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Notices]
[Pages 11681-11682]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-04394]


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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 (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 March 24, 2015, from 8 
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://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    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

[[Page 11682]]

to learn about possible modifications before coming to the meeting.
    Agenda: On March 24, 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: CYMBALTA (duloxetine hydrochloride), 
QUILLIVANT XR (methylphenidate hydrochloride), LUNESTA (eszopiclone), 
RISPERDAL (risperidone), OXTELLAR XR (oxcarbazepine), REVATIO 
(sildenafil), ADVAIR HFA (fluticasone propionate/salmeterol), DYMISTA 
(azelastine hydrochloride/fluticasone proprionate), QNASL 
(beclomethasone dipropionate), VENOFER (iron sucrose), INVIRASE 
(saquinavir), ALTABAX Ointment (retapamulin), FluMist QUADRIVALENT 
(influenza vaccine live, intranasal), FLUARIX QUADRIVALENT (influenza 
virus vaccine), Medtronic ACTIVA DYSTONIA THERAPY, and LIPOSORBER LA-15 
System. In addition, there will be a short presentation of the ethical 
issues discussed by the Pediatric Ethics Subcommittee of the PAC on 
March 23, 2015.
    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 
March 16, 2015. Oral presentations from the public will be scheduled on 
March 24, 2015, 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 
March 6, 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 March 9, 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: February 26, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-04394 Filed 3-3-15; 8:45 am]
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