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)
Food and Drug Administration
Federal Register Volume 80, Issue 42 (March 4, 2015)
| Page Range | 11681-11682 | |
| FR Document | 2015-04394 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: walter.ellenberg@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 [[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] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Notices 11681
Location: FDA White Oak Campus, diabetes is not associated with an Notice of this meeting is given under
10903 New Hampshire Ave., Bldg. 31 unacceptable increase in cardiovascular the Federal Advisory Committee Act (5
Conference Center, the Great Room (Rm. risk. U.S.C. app. 2).
1503), Silver Spring, MD 20993–0002. FDA intends to make background Dated: February 26, 2015.
Answers to commonly asked questions material available to the public no later
Jill Hartzler Warner,
including information regarding special than 2 business days before the meeting.
Associate Commissioner for Special Medical
accommodations due to a disability, If FDA is unable to post the background
Programs.
visitor parking, and transportation may material on its Web site prior to the
[FR Doc. 2015–04395 Filed 3–3–15; 8:45 am]
be accessed at: http://www.fda.gov/ meeting, the background material will
BILLING CODE 4164–01–P
AdvisoryCommittees/AboutAdvisory be made publicly available at the
Committees/ucm408555.htm. location of the advisory committee
Contact Person: Philip Bautista, meeting, and the background material
DEPARTMENT OF HEALTH AND
Center for Drug Evaluation and will be posted on FDA’s Web site after
HUMAN SERVICES
Research, Food and Drug the meeting. Background material is
Administration, 10903 New Hampshire available at http://www.fda.gov/ Food and Drug Administration
Ave., Bldg. 31, Rm. 2417, Silver Spring, AdvisoryCommittees/Calendar/
MD 20993–0002, 301–796–9001, FAX: default.htm. Scroll down to the [Docket No. FDA–2015–N–0001]
301–847–8533, EMDAC@fda.hhs.gov, or appropriate advisory committee meeting
FDA Advisory Committee Information link. Pediatric Advisory Committee; Notice
Line, 1–800–741–8138 (301–443–0572 Procedure: Interested persons may of Meeting
in the Washington, DC area). A notice in present data, information, or views, AGENCY: Food and Drug Administration,
the Federal Register about last minute orally or in writing, on issues pending HHS.
modifications that impact a previously before the committee. Written ACTION: Notice.
announced advisory committee meeting submissions may be made to the contact
cannot always be published quickly person on or before March 31, 2015. This notice announces a forthcoming
enough to provide timely notice. Oral presentations from the public will meeting of a public advisory committee
Therefore, you should always check the be scheduled between approximately of the Food and Drug Administration
Agency’s Web site at http://www.fda. 10:10 a.m. to 10:40 a.m., and 3:30 p.m. (FDA). The meeting will be open to the
gov/AdvisoryCommittees/default.htm to 4 p.m. Those individuals interested public.
and scroll down to the appropriate in making formal oral presentations Name of Committee: Pediatric
advisory committee meeting link, or call should notify the contact person and Advisory Committee.
the advisory committee information line submit a brief statement of the general General Function of the Committee:
to learn about possible modifications nature of the evidence or arguments To provide advice and
before coming to the meeting. they wish to present, the names and recommendations to the Agency on
Agenda: During the morning session, addresses of proposed participants, and FDA’s regulatory issues.
the committee will discuss the results of an indication of the approximate time Date and Time: The meeting will be
the cardiovascular outcomes trial requested to make their presentation on held on March 24, 2015, from 8 a.m. to
(CVOT), Saxagliptin Assessment of or before March 23, 2015. Time allotted 5:30 p.m.
Vascular Outcomes Recorded in Patients for each presentation may be limited. If Location: Double Tree by Hilton, 8727
with Diabetes Mellitus, for new drug the number of registrants requesting to Colesville Rd., Silver Spring, MD 20910,
application (NDA) 22350, Onglyza speak is greater than can be reasonably 301–589–5200. Answers to commonly
(saxagliptin) and NDA 200678, accommodated during the scheduled asked questions including information
Kombiglyze XR (saxagliptin and open public hearing session, FDA may regarding special accommodations due
metformin HCl extended-release) tablets conduct a lottery to determine the to a disability, visitor parking, and
manufactured/marketed by AstraZeneca speakers for the scheduled open public transportation may be accessed at:
AB. hearing session. The contact person will http://www.fda.gov/Advisory
During the afternoon session, the notify interested persons regarding their Committees/AboutAdvisoryCommittees/
committee will discuss the results of the request to speak by March 24, 2015. ucm408555.htm.
CVOT, Examination of Cardiovascular Persons attending FDA’s advisory Contact Person: Walter Ellenberg,
Outcomes with Alogliptin versus committee meetings are advised that the Office of the Commissioner, Food and
Standard of Care, for NDA 22271, Agency is not responsible for providing Drug Administration, 10903 New
Nesina (ALOGLIPTIN); NDA 022426, access to electrical outlets. Hampshire Ave., Bldg. 32, rm. 5154,
Oseni (ALOGLIPTIN and FDA welcomes the attendance of the Silver Spring, MD 20993, 301–796–
PIOGLITAZONE); and NDA 203414, public at its advisory committee 0885, email: walter.ellenberg@
Kazano (ALOGLIPTIN and meetings and will make every effort to fda.hhs.gov, or FDA Advisory
METFORMIN) tablets marketed by accommodate persons with physical Committee Information Line, 1–800–
Takeda Pharmaceutical U.S.A., Inc. disabilities or special needs. If you 741–8138 (301–443–0572 in the
Saxagliptin and ALOGLIPTIN are require special accommodations due to Washington, DC area). A notice in the
dipeptidyl peptidase-4 inhibitors, both a disability, please contact Philip Federal Register about last minute
indicated as an adjunct to diet and Bautista at least 7 days in advance of the modifications that impact a previously
exercise to improve glycemic control in meeting. announced advisory committee meeting
mstockstill on DSK4VPTVN1PROD with NOTICES
adults with type 2 diabetes mellitus. FDA is committed to the orderly cannot always be published quickly
Both CVOTs were submitted in conduct of its advisory committee enough to provide timely notice.
accordance with the 2008 FDA Draft meetings. Please visit our Web site at Therefore, you should always check the
Guidance, ‘‘Diabetes Mellitus— http://www.fda.gov/Advisory Agency’s Web site at http://www.fda.
Evaluating Cardiovascular Risk in New Committees/AboutAdvisoryCommittees/ gov/AdvisoryCommittees/default.htm
Antidiabetic Therapies to Treat Type 2 ucm111462.htm for procedures on and scroll down to the appropriate
Diabetes,’’ to demonstrate that a new public conduct during advisory advisory committee meeting link, or call
antidiabetic therapy to treat type 2 committee meetings. the advisory committee information line
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![11682 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Notices
to learn about possible modifications the number of registrants requesting to DEPARTMENT OF HEALTH AND
before coming to the meeting. speak is greater than can be reasonably HUMAN SERVICES
Agenda: On March 24, 2015, the accommodated during the scheduled
Pediatric Advisory Committee (PAC) open public hearing session, FDA may National Institutes of Health
will meet to discuss pediatric-focused conduct a lottery to determine the
safety reviews, as mandated by the Best speakers for the scheduled open public National Institute of Neurological
Pharmaceuticals for Children Act (Pub. hearing session. The contact person will Disorders and Stroke; Notice of
L. 107–109) and the Pediatric Research notify interested persons regarding their Meeting
Equity Act (Pub. L. 108–155). The PAC request to speak by March 9, 2015. Pursuant to section 10(d) of the
will meet to discuss the following Persons attending FDA’s advisory Federal Advisory Committee Act, as
products: CYMBALTA (duloxetine committee meetings are advised that the amended (5 U.S.C. App.), notice is
hydrochloride), QUILLIVANT XR Agency is not responsible for providing hereby given of a meeting of the
(methylphenidate hydrochloride), access to electrical outlets. National Advisory Neurological
LUNESTA (eszopiclone), RISPERDAL FDA welcomes the attendance of the Disorders and Stroke Council.
(risperidone), OXTELLAR XR public at its advisory committee The meeting will be open to the
(oxcarbazepine), REVATIO (sildenafil), meetings and will make every effort to public as indicated below, with
ADVAIR HFA (fluticasone propionate/ accommodate persons with physical attendance limited to space available.
salmeterol), DYMISTA (azelastine disabilities or special needs. If you Individuals who plan to attend and
hydrochloride/fluticasone proprionate), require special accommodations due to need special assistance, such as sign
QNASL (beclomethasone dipropionate), a disability, please contact Walter language interpretation or other
VENOFER (iron sucrose), INVIRASE Ellenberg at least 7 days in advance of reasonable accommodations, should
(saquinavir), ALTABAX Ointment the meeting. notify the Contact Person listed below
(retapamulin), FluMist FDA is committed to the orderly in advance of the meeting.
QUADRIVALENT (influenza vaccine conduct of its advisory committee The meeting will be closed to the
live, intranasal), FLUARIX meetings. Please visit our Web site at public in accordance with the
QUADRIVALENT (influenza virus http://www.fda.gov/Advisory provisions set forth in sections
vaccine), Medtronic ACTIVA Committees/AboutAdvisoryCommittees/ 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
DYSTONIA THERAPY, and ucm111462.htm for procedures on as amended. The grant applications and
LIPOSORBER LA–15 System. In public conduct during advisory the discussions could disclose
addition, there will be a short committee meetings. confidential trade secrets or commercial
presentation of the ethical issues Notice of this meeting is given under property such as patentable materials,
discussed by the Pediatric Ethics the Federal Advisory Committee Act (5 and personal information concerning
Subcommittee of the PAC on March 23, U.S.C. app. 2). individuals associated with the grant
2015. applications, the disclosure of which
FDA intends to make background Dated: February 26, 2015.
Jill Hartzler Warner, would constitute a clearly unwarranted
material available to the public no later
invasion of personal privacy.
than 2 business days before the meeting. Associate Commissioner for Special Medical
If FDA is unable to post the background Programs. Name of Committee: National Advisory
material on its Web site prior to the [FR Doc. 2015–04394 Filed 3–3–15; 8:45 am] Neurological Disorders and Stroke Council.
Date: May 28–29, 2015.
meeting, the background material will BILLING CODE 4164–01–P
Open: May 28, 2015, 8:00 a.m. to 3:00 p.m.
be made publicly available at the Agenda: Report by the Director, NINDS;
location of the advisory committee Report by the Associate Director for
meeting, and the background material DEPARTMENT OF HEALTH AND Extramural Research; Administrative and
will be posted on FDA’s Web site after HUMAN SERVICES Program Developments; and an Overview of
the meeting. Background material is the NINDS Intramural Program.
available at http://www.fda.gov/ National Institutes of Health Place: National Institutes of Health,
AdvisoryCommittees/Calendar/ Building 31, 31 Center Drive, Conference
default.htm. Scroll down to the Center for Scientific Review; Amended Room 10, Bethesda, MD 20892.
Notice of Meeting Closed: May 28, 2015, 3:00 p.m. to 4:45
appropriate advisory committee link. p.m.
Procedure: Interested persons may Notice is hereby given of a change in Agenda: To review and evaluate grant
present data, information, or views, the meeting of the Center for Scientific applications.
orally or in writing, on issues pending Review Special Emphasis Panel, March Place: National Institutes of Health,
before the committee. Written 05, 2015, 11:00 a.m. to March 05, 2015, Building 31, 31 Center Drive, Conference
submissions may be made to the contact Room 10, Bethesda, MD 20892.
05:00 p.m., National Institutes of Health, Closed: May 28, 2015, 4:45 p.m. to 5:15
person on or before March 16, 2015. 6701 Rockledge Drive, Bethesda, MD,
Oral presentations from the public will p.m.
20892 which was published in the Agenda: To review and evaluate the
be scheduled on March 24, 2015, Federal Register on February 24, 2015, Division of Intramural Research Board of
between approximately 9 a.m. and 10 80 FR 9738. Scientific Counselors’ Reports.
a.m. Those individuals interested in The meeting will be held on March Place: National Institutes of Health,
making formal oral presentations should 12, 2015. The meeting location and time Building 31, 31 Center Drive, Conference
notify the contact person and submit a remain the same. The meeting is closed Room 10, Bethesda, MD 20892.
mstockstill on DSK4VPTVN1PROD with NOTICES
brief statement of the general nature of Closed: May 29, 2015, 8:00 a.m. to 11:00
to the public. a.m.
the evidence or arguments they wish to
present, the names and addresses of Dated: February 25, 2015. Agenda: To review and evaluate grant
David Clary, applications.
proposed participants, and an Place: National Institutes of Health,
indication of the approximate time Program Analyst, Office of Federal Advisory
Building 31, 31 Center Drive, Conference
requested to make their presentation on Committee Policy.
Room 10, Bethesda, MD 20892.
or before March 6, 2015. Time allotted [FR Doc. 2015–04408 Filed 3–3–15; 8:45 am] Contact Person: Robert Finkelstein, Ph.D.,
for each presentation may be limited. If BILLING CODE 4140–01–P Associate Director for Extramural Research,
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Document Created: 2018-02-21 09:32:00
Document Modified: 2018-02-21 09:32:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| FR Citation | 80 FR 11681 |
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