Pediatric Advisory Committee; Amendment of Notice, 56652 [E9-26262]

Download as PDF 56652 Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices 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 December 1, 2009. 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 AnnMarie Williams, 301–796–5966 or annmarie.williams@fda.hhs.gov by December 4, 2009. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/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: October 27, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–26260 Filed 10–30–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2009–N–0664] Pediatric Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. srobinson on DSKHWCL6B1PROD with NOTICES ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal Register of October 6, 2009 (74 FR 51289). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Doreen Kezer, Office of Medical and Scientific Programs, Office of the Commissioner, Food and Drug VerDate Nov<24>2008 17:03 Oct 30, 2009 Jkt 220001 Administration, 5600 Fishers Lane (HF– 33), rm. 14–65, Rockville, MD 20857, 301–827–1249, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up-to-date information on this meeting. In the Federal Register of October 6, 2009, FDA announced that a meeting of the Pediatric Advisory Committee would be held on December 8, 2009. On page 51290, in the first column, the Agenda portion of the document is changed to read as follows: Agenda: On December 8, 2009, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Abilify (aripiprazole), Argatroban (argatroban), Orencia (abatacept), Humira (adalimumab), Cancidas (caspofungin acetate), Evicel—fibrin sealant (human), Artiss—fibrin sealant (human), Voluven—6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, Reyataz (atazanavir sulfate), Kaletra (lopinavir/ ritonavir), Aptivus (tipranavir), Zetia (ezetimibe), Vytorin (ezetimibe/simvastatin), Ventolin HFA (albuterol sulfate). An update to address some of the committee’s questions from the Pediatric Advisory Committee meeting of November 18, 2008, on atypical antipsychotic drugs will be provided. In addition to Abilify (aripiprazole), Risperidal (risperidone), Zyprexa (olanzapine), Geodon (ziprasidone), and Seroquel (quetiapine) will be included. Two products (Zemuron (rocuronium bromide) and Cardiolite (technetium Tc99m sestamibi) previously planned for presentation at this meeting are rescheduled for a later date. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. SUPPLEMENTARY INFORMATION: Dated: October 27, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–26262 Filed 10–30–09; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; AIDS Predoctoral and Postdoctoral Fellowship. Date: December 2–3, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Hilary D. Sigmon, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, (301) 594– 6377, sigmonh@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Pharmacogenomics. Date: December 3–4, 2009. Time: 8 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Michael K. Schmidt, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2214, MSC 7890, Bethesda, MD 20892, (301) 435– 1147, mschmidt@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Special Topics in Biological Sciences. Date: December 3–4, 2009. Time: 11 a.m. to 10 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Donald L. Schneider, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5160, MSC 7842, Bethesda, MD 20892, (301) 435– 1727, schneidd@csr.nih.gov. E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 74, Number 210 (Monday, November 2, 2009)]
[Notices]
[Page 56652]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26262]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2009-N-0664]


Pediatric Advisory Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the Pediatric Advisory Committee. This 
meeting was announced in the Federal Register of October 6, 2009 (74 FR 
51289). The amendment is being made to reflect a change in the Agenda 
portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:  Doreen Kezer, Office of Medical and 
Scientific Programs, Office of the Commissioner, Food and Drug 
Administration, 5600 Fishers Lane (HF-33), rm. 14-65, Rockville, MD 
20857, 301-827-1249, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 8732310001. 
Please call the Information Line for up-to-date information on this 
meeting.

SUPPLEMENTARY INFORMATION:  In the Federal Register of October 6, 2009, 
FDA announced that a meeting of the Pediatric Advisory Committee would 
be held on December 8, 2009. On page 51290, in the first column, the 
Agenda portion of the document is changed to read as follows:
    Agenda: On December 8, 2009, the Pediatric Advisory Committee will 
meet to discuss pediatric-focused safety reviews, as mandated by the 
Best Pharmaceuticals for Children Act and the Pediatric Research Equity 
Act, for Abilify (aripiprazole), Argatroban (argatroban), Orencia 
(abatacept), Humira (adalimumab), Cancidas (caspofungin acetate), 
Evicel--fibrin sealant (human), Artiss--fibrin sealant (human), 
Voluven--6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride 
injection, Reyataz (atazanavir sulfate), Kaletra (lopinavir/ 
ritonavir), Aptivus (tipranavir), Zetia (ezetimibe), Vytorin 
(ezetimibe/simvastatin), Ventolin HFA (albuterol sulfate). An update to 
address some of the committee's questions from the Pediatric Advisory 
Committee meeting of November 18, 2008, on atypical antipsychotic drugs 
will be provided. In addition to Abilify (aripiprazole), Risperidal 
(risperidone), Zyprexa (olanzapine), Geodon (ziprasidone), and Seroquel 
(quetiapine) will be included. Two products (Zemuron (rocuronium 
bromide) and Cardiolite (technetium Tc99m sestamibi) previously planned 
for presentation at this meeting are rescheduled for a later date.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26262 Filed 10-30-09; 8:45 am]
BILLING CODE 4160-01-S

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