Pediatric Advisory Committee; Notice of Meeting, 67378-67379 [2010-27539]

Download as PDF 67378 Federal Register / Vol. 75, No. 211 / Tuesday, November 2, 2010 / Notices Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: October 28, 2010. Robert Sargis, Reports Clearance Officer. Special Emphasis Panel, Ancillary Study in Necrotizing Enterocolitis. Date: December 1, 2010. Time: 3 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892. (Telephone Conference Call) Contact Person: Maria E. Davila-Bloom, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 758, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7637, davilabloomm@extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: October 26, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–27569 Filed 11–1–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA–2010–N–0001] Pediatric Advisory Committee; Notice of Meeting [FR Doc. 2010–27596 Filed 11–1–10; 8:45 am] BILLING CODE 4184–01–P AGENCY: Food and Drug Administration, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health hsrobinson on DSK69SOYB1PROD with NOTICES National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting 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 meeting. The meeting 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: National Institute of Diabetes and Digestive and Kidney Diseases VerDate Mar<15>2010 18:39 Nov 01, 2010 Jkt 223001 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 December 7, 2010, from 8 a.m. to 6 p.m. Location: Bethesda Marriott Hotel, 5151 Pooks Hill Rd., Bethesda, MD 20814. Contact Person: Walter Ellenberg, Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 32, rm. 5154, Silver Spring, MD 20993, 301–796–0885, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Washington, DC area), code 8732310001. Please call the Information Line for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: 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 Prevista (darunavir ethanolate), PegIntron (peginterferon alfa–2b), Xyzal (levocetirizine dihydrochloride) tablet and solution, Flovent HFA (fluticasone propionate), Acanya Gel (clindamycin/ benzoyl peroxide combination), Epiduo Gel (adapalene and benzoyl peroxide), Ulesfia Lotion 5% (benzyl alcohol), Axert (almotriptan), Gardasil (human papillomavirus quadrivalent types 6, 11, 16, 18, vaccine recombinant), Lamictal and Lamictal XR (lamotrigine), and Neulasta (pegfilgrastim). The committee will also receive a followup on Depakote ER (divalproex sodium). Committee members who participated in the Cardiovascular and Renal Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee meetings held on July 29, 2010, and November 5, 2010, respectively, will provide a brief summary of the meetings. 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 https://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 November 29, 2010. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief E:\FR\FM\02NON1.SGM 02NON1 Federal Register / Vol. 75, No. 211 / Tuesday, November 2, 2010 / Notices 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 November 18, 2010. 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 November 19, 2010. 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 https://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: October 27, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health hsrobinson on DSK69SOYB1PROD with NOTICES National Institute of Mental Health; Notice of Closed Meeting 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 meeting. The meeting 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 18:39 Nov 01, 2010 Jkt 223001 Name of Committee: National Institute of Mental Health Special Emphasis Panel, Mental Health Disparities Supplements. Date: November 17, 2010. Time: 11 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852. (Telephone Conference Call) Contact Person: Vinod Charles, PhD, Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6151, MSC 9606, Bethesda, MD 20892–9606, 301–443–1606, charlesvi@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Dated: October 26, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–27628 Filed 11–1–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 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; Member Conflict: Weight Loss, Obesity and Physical Activity. Date: November 15, 2010. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Time: 10 a.m. to 11:30 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Lee S. Mann, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3186, MSC 7848, Bethesda, MD 20892, 301–435– 0677, mannl@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR 10– 021: AIDS–Science Track Award for Research Transition (A–START) in Drug Abuse and HIV/AIDS. Date: November 29, 2010. Time: 11 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: Jose H. Guerrier, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1137, guerriej@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 26, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–27627 Filed 11–1–10; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health Center for Scientific Review; Notice of Closed Meetings [FR Doc. 2010–27539 Filed 11–1–10; 8:45 am] VerDate Mar<15>2010 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. 67379 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting 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 meeting. The meeting 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. E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 75, Number 211 (Tuesday, November 2, 2010)]
[Notices]
[Pages 67378-67379]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27539]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2010-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 December 7, 2010, from 8 
a.m. to 6 p.m.
    Location: Bethesda Marriott Hotel, 5151 Pooks Hill Rd., Bethesda, 
MD 20814.
    Contact Person: Walter Ellenberg, Office of Pediatric Therapeutics, 
Office of Special Medical Programs, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg 32, rm. 5154, 
Silver Spring, MD 20993, 301-796-0885, 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. 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 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: 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 Prevista (darunavir ethanolate), PegIntron (peginterferon alfa-2b), 
Xyzal (levocetirizine dihydrochloride) tablet and solution, Flovent HFA 
(fluticasone propionate), Acanya Gel (clindamycin/benzoyl peroxide 
combination), Epiduo Gel (adapalene and benzoyl peroxide), Ulesfia 
Lotion 5% (benzyl alcohol), Axert (almotriptan), Gardasil (human 
papillomavirus quadrivalent types 6, 11, 16, 18, vaccine recombinant), 
Lamictal and Lamictal XR (lamotrigine), and Neulasta (pegfilgrastim). 
The committee will also receive a followup on Depakote ER (divalproex 
sodium). Committee members who participated in the Cardiovascular and 
Renal Drugs Advisory Committee and the Gastrointestinal Drugs Advisory 
Committee meetings held on July 29, 2010, and November 5, 2010, 
respectively, will provide a brief summary of the meetings.
    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 https://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 
November 29, 2010. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those desiring to make formal 
oral presentations should notify the contact person and submit a brief

[[Page 67379]]

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 November 18, 2010. 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 November 
19, 2010.
    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 https://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: October 27, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-27539 Filed 11-1-10; 8:45 am]
BILLING CODE 4160-01-P

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