Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting, 65496 [2010-26875]

Download as PDF 65496 Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices development toolkit containing new scientific and technical methods was needed to improve the efficiency of drug development. Too often, attention to a needed DDT is delayed until the time when the registration study protocols are under development and the available DDTs are inadequate. Innovative and improved DDTs are among the methods that can help streamline the drug development process, improve the chances for clinical trial success, and yield more information about the treatment and/or disease. DDTs include, but are not limited to biomarkers and patient reported outcome instruments. This draft guidance describes a formal process that CDER will use in working with sponsors of these tools to guide them as they refine the tools and rigorously evaluate them for use in the regulatory process. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the qualification process for DDTs . It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR 312.30, 21 CFR 314.50(d)(5), and 21 CFR 314.126(b)(6) have been approved under OMB control numbers 0910–0001 and 0910–0014. emcdonald on DSK2BSOYB1PROD with NOTICES III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VerDate Mar<15>2010 16:05 Oct 22, 2010 Jkt 223001 IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: October 19, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–26927 Filed 10–22–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; 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 Child Health and Human Development Special Emphasis Panel; Kochanek T32. Date: November 16, 2010. Time: 1:30 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Peter Zelazowski, PhD, Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child, Health and Human Development, NIH, 6100 Executive Boulevard, Room 5B01, Bethesda, MD 20892–7510, 301–435–6902, peter.zelazowski@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) PO 00000 Frm 00051 Fmt 4703 Sfmt 9990 Dated: October 19, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–26874 Filed 10–22–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; 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 Child Health and Human Development Special Emphasis Panel; Cornelia de Lange Syndrome. Date: November 15, 2010. Time: 2 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Neelakanta Ravindranath, PhD, Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01G, Bethesda, MD 20892, 301–435–6889, ravindrn@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: October 19, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–26875 Filed 10–22–10; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 75, Number 205 (Monday, October 25, 2010)]
[Notices]
[Page 65496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26875]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health & Human 
Development; 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 Child Health and Human 
Development Special Emphasis Panel; Cornelia de Lange Syndrome.
    Date: November 15, 2010.
    Time: 2 p.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6100 Executive Boulevard, 
Rockville, MD 20852 (Telephone Conference Call).
    Contact Person: Neelakanta Ravindranath, PhD, Scientific Review 
Officer, Division of Scientific Review, Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, NIH, 6100 
Executive Blvd., Room 5B01G, Bethesda, MD 20892, 301-435-6889, 
ravindrn@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.864, 
Population Research; 93.865, Research for Mothers and Children; 
93.929, Center for Medical Rehabilitation Research; 93.209, 
Contraception and Infertility Loan Repayment Program, National 
Institutes of Health, HHS)

    Dated: October 19, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-26875 Filed 10-22-10; 8:45 am]
BILLING CODE 4140-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.