National Eye Institute; Notice of Closed Meeting, 10489 [2010-4584]

Download as PDF srobinson on DSKHWCL6B1PROD with NOTICES Federal Register / Vol. 75, No. 44 / Monday, March 8, 2010 / Notices 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 April 13, 2010, the committee will receive presentations from the Office of Generic Drugs and discuss two bioequivalence topics relevant to generic drug approval: (1) Revising the BE approaches for critical dose drugs and (2) the use of partial area under the curve (AUC) for the evaluation of abbreviated new drug applications for products with complex pharmacokinetic profiles. Bioequivalence refers to the evaluation of equivalence in the rate and extent of drug absorption between two preparations of the same drug. Critical dose drugs are medicines that require a narrow (or ‘‘critical’’) dose range to achieve and maintain their intended effects and to reduce serious adverse drug reactions. The ‘‘area under the curve’’ is the area under a plot of drug concentration in the bloodstream versus time; it is a measure of the extent of exposure to a drug after a dose is administered. 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 March 30, 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 VerDate Nov<24>2008 17:12 Mar 05, 2010 Jkt 220001 requested to make their presentation on or before March 22, 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 March 23, 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 Anuja Patel 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/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: March 2, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–4812 Filed 3–5–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye 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. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 10489 Name of Committee: National Eye Institute Special Emphasis Panel; NEI Clinical Grant Applications and Cooperative Agreements. Date: April 12, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Anne E Schaffner, PhD, Scientific Review Officer, Division of Extramural Research, National Eye Institute, 5635 Fishers Lane, Suite 1300, Msc 9300, Bethesda, MD 20892–9300, (301) 451–2020, aes@nei.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: February 25, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–4584 Filed 3–5–10; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, March 22, 2010, 8 a.m.to March 23, 2010, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on February 24, 2010, 75 FR 8371–8372. The meeting will be held March 29, 2010 to March 30, 2010. The meeting time and location remain the same. The meeting is closed to the public. Dated: February 26, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–4589 Filed 3–5–10; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; 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 E:\FR\FM\08MRN1.SGM 08MRN1

Agencies

[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Notices]
[Page 10489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4584]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Eye 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.

    Name of Committee: National Eye Institute Special Emphasis 
Panel; NEI Clinical Grant Applications and Cooperative Agreements.
    Date: April 12, 2010.
    Time: 8 a.m. to 5 p.m.
    Agenda: To review and evaluate cooperative agreement 
applications.
    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military 
Road, NW., Washington, DC 20015.
    Contact Person: Anne E Schaffner, PhD, Scientific Review 
Officer, Division of Extramural Research, National Eye Institute, 
5635 Fishers Lane, Suite 1300, Msc 9300, Bethesda, MD 20892-9300, 
(301) 451-2020, aes@nei.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.867, 
Vision Research, National Institutes of Health, HHS)

    Dated: February 25, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-4584 Filed 3-5-10; 8:45 am]
BILLING CODE 4140-01-M

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