Pediatric Advisory Committee; Notice of Meeting, 26265-26266 [2010-11038]

Download as PDF emcdonald on DSK2BSOYB1PROD with NOTICES Federal Register / Vol. 75, No. 90 / Tuesday, May 11, 2010 / Notices 301–796–9001, yvette.waples@ fda.hhs.gov) or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512534. 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: On June 28, 2010, the committee will discuss new drug application (NDA) 22–340, voclosporin 10-milligram capsules, by Lux Biosciences, Inc. The proposed indication for this new drug product is treatment of noninfectious uveitis involving the posterior or intermediate segments of the eye. 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 June 14, 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 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 June 4, 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 VerDate Mar<15>2010 21:13 May 10, 2010 Jkt 220001 notify interested persons regarding their request to speak by June 7, 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 Yvette Waples 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/AboutAdvisory Committees/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: May 5, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–11039 Filed 5–10–10; 8:45 am] BILLING CODE 4160–01–S 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 Monday, June 21, 2010, from 9 a.m. to 5 p.m. Location: Bethesda Marriott Hotel, Congressional Ballroom, 5151 Pooks Hill Rd., Bethesda, MD. 20814. Contact Person: Doreen Kezer, Office of Science and Health Coordination, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4254, Silver Spring, MD 20993–0002, PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 26265 301–796–8524, e-mail: Doreen.Kezer@fda.hhs.gov, 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: On Monday, June 21, 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 Kogenate FS (antihemophilic factor (recombinant)), Casodex (bicalutamide), Apidra (insulin glulisine [rDNA]), NovoLog (insulin aspart [rDNA]), Arimidex (anastrozole), Desmopressin Acetate, Prevacid (lansoprazole), Nexium (esomeprazole magnesium), Aciphex (rabeprazole sodium), Prilosec (omeprazole), OraVerse (phentolamine mesylate), Zemuron (rocuronium bromide). The committee will also receive a followup presentation on Suprane (desflurane). 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 June 7, 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 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 E:\FR\FM\11MYN1.SGM 11MYN1 26266 Federal Register / Vol. 75, No. 90 / Tuesday, May 11, 2010 / Notices or before May 28, 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 June 1, 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 Doreen Kezer 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/AboutAdvisory Committees/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: May 5, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–11038 Filed 5–10–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention emcdonald on DSK2BSOYB1PROD with NOTICES Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Developing Novel Diagnostic Tests To Improve Surveillance for Antimicrobial Resistant Pathogens, Funding Opportunity Announcement CI10–002; Initial Review Correction: This notice was published in the Federal Register on April 23, 2010, Volume 75, Number 78, page 21339. The time and date, and place should read as follows: Time and Date: 12 p.m.–3 p.m., May 18, 2010 (Closed). Place: Teleconference. Contact Person for More Information: Gregory Anderson, M.S., M.P.H., VerDate Mar<15>2010 19:22 May 10, 2010 Jkt 220001 Scientific Review Officer, CDC, 1600 Clifton Road, NE., Mailstop E60, Atlanta, GA 30333, Telephone: (404) 498–2293. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 29, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–11189 Filed 5–10–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned committee: Times And Dates: 8 a.m.–5 p.m., June 22, 2010. (Closed). 8 a.m.–5 p.m., June 23, 2010. (Closed). Place: Omni Hotel, 500 California Street, San Francisco, California 94104, Telephone (415) 677–9494, Fax (415) 273–3038. Status: These portions of the meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, Centers for Disease Control and Prevention, pursuant to Section 10(d) Public Law 92–463. Purpose: The Safety and Occupational Health Study Section will review, discuss, and evaluate grant application(s) received in response to the Institute’s standard grants review and funding cycles pertaining to research issues in occupational safety and health, and allied areas. It is the intent of NIOSH to support broad-based research endeavors in keeping with the Institute’s program goals. This will lead to improved understanding and appreciation for the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 support more focused research projects, which will lead to improvements in the delivery of occupational safety and health services, and the prevention of work-related injury and illness. It is anticipated that research funded will promote these program goals. Matters to be Discussed: The meeting will convene to address matters related to the conduct of Study Section business and for the study section to consider safety and occupational healthrelated grant applications. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Price Connor, PhD., NIOSH Health Scientist, 1600 Clifton Road, NE., Mailstop E–20, Atlanta, Georgia 30333, Telephone (404) 498–2511, Fax (404) 498–2571. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: April 29, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–11186 Filed 5–10–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute (NCI); National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); and Office of Research on Women’s Health (ORWH), Office of the Director (OD), NIH AGENCY: National Institutes of Health (NIH). ACTION: Notice of Open Conference. Notice is hereby given that the NIH, an agency of the Department of Health and Human Services, in collaboration with the Lupus Foundation of America, Washington, DC, will hold a scientific conference. Title: ‘‘Systemic Lupus Erythematosus: From Mouse Models to Human Disease and Treatment.’’ Dates: September 2–3, 2010. Location: Lister Hill Auditorium, Building 38A, NIH, Bethesda, Maryland. E:\FR\FM\11MYN1.SGM 11MYN1

Agencies

[Federal Register Volume 75, Number 90 (Tuesday, May 11, 2010)]
[Notices]
[Pages 26265-26266]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11038]


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

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 Monday, June 21, 2010, 
from 9 a.m. to 5 p.m.
    Location: Bethesda Marriott Hotel, Congressional Ballroom, 5151 
Pooks Hill Rd., Bethesda, MD. 20814.
    Contact Person: Doreen Kezer, Office of Science and Health 
Coordination, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, rm. 4254, Silver Spring, MD 20993-0002, 301-796-8524, e-mail: 
Doreen.Kezer@fda.hhs.gov, 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: On Monday, June 21, 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 Kogenate FS (antihemophilic factor (recombinant)), Casodex 
(bicalutamide), Apidra (insulin glulisine [rDNA]), NovoLog (insulin 
aspart [rDNA]), Arimidex (anastrozole), Desmopressin Acetate, Prevacid 
(lansoprazole), Nexium (esomeprazole magnesium), Aciphex (rabeprazole 
sodium), Prilosec (omeprazole), OraVerse (phentolamine mesylate), 
Zemuron (rocuronium bromide). The committee will also receive a 
followup presentation on Suprane (desflurane).
    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 June 
7, 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 
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

[[Page 26266]]

or before May 28, 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 June 1, 
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 Doreen Kezer 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: May 5, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-11038 Filed 5-10-10; 8:45 am]
BILLING CODE 4160-01-S

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