Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 39264 [2010-16472]

Download as PDF 39264 Federal Register / Vol. 75, No. 130 / Thursday, July 8, 2010 / Notices includes 29 specific questions and answers for IRBs as well as guidance to HDE holders on whether and how they may become eligible to receive profit from the sale of their device. In the Federal Register of August 5, 2008 (73 FR 45460), FDA published a 60-day notice requesting public comment. The comment period closed on November 3, 2008. FDA published a 30-day notice on September 30, 2009 (74 FR 50214), but republished a 30-day notice on February 18, 2010 (75 FR 7270), to provide a more descriptive response to the comments received in response to the August 5, 2008, notice. This document supersedes: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers, issued July 18, 2006. V. 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. (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: July 1, 2010. Nancy Stade, Acting Associate Director for Regulations and Policy, Center for Devices and Radiological Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. Significance of Guidance [FR Doc. 2010–16548 Filed 7–7–10; 8:45 am] This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on the ‘‘HDE Regulation: Questions and Answers.’’ 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 statute and regulations. BILLING CODE 4160–01–S Health Resources and Services Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘HDE Regulation: Questions and Answers,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1668 to identify the guidance you are requesting. A search capability for all CDRH guidance documents is available at https://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or the CBER Internet site at https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. srobinson on DSKHWCL6B1PROD with NOTICES IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that 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 this guidance were approved under OMB control number 0910–0661, May 31, 2013, expiration date. VerDate Mar<15>2010 17:09 Jul 07, 2010 Jkt 220001 National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and 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: Therapeutic Application of Dyrk1A Inhibitors for Down Syndrome. Date: July 26, 2010. Time: 2 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, 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, 6100 Executive Boulevard, Room 5B01G, Bethesda, MD 20892–7510, (301) 435–6889, ravindrn@mail.nih.gov. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Dated: June 30, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–16472 Filed 7–7–10; 8:45 am] BILLING CODE 4140–01–P Centers for Disease Control and Prevention In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the CDC and HRSA announce the following committee meeting. Time and Date: 2 p.m.–3:30 p.m., July 29, 2010. Place: Teleconference. To participate, please dial (877) 952–1988 and enter passcode 2162797 for access. Status: Open to the public, limited only by availability of telephone ports. Purpose: This Committee is charged with advising the Director, CDC and the Administrator, HRSA, regarding activities related to prevention and control of HIV/ AIDS and other STDs, the support of health care services to persons living with HIV/ AIDS, and education of health professionals and the public about HIV/AIDS and other STDs. Matters To Be Discussed: The purpose of the teleconference is for CHACHSPT to deliberate and discuss the outcomes of a CDC/HRSA Advisory Committee workgroup that will convene on July 8, 2010. The workgroup will conduct a program review to provide information to CHACHSPT on the strategic realignment of funding to support priorities in sexual health and STD disparities among racial and ethnic minorities. The objectives of the workgroup are: (1) To identify to CHACHSPT future opportunities to accelerate the impact in health disparities through programs, policy, and research and public health ethics; (2) To provide information to CHACHSPT regarding potential use of realigned funding; and, (3) To provide key principles (e.g., program, policy, research) to be considered by CHACHSPT in the development of a new funding opportunity announcement for the use of realigned resources. For More Information Contact: Margie Scott-Cseh, CDC, National Center for HIV/ AIDS, Viral Hepatitis, STD, and TB E:\FR\FM\08JYN1.SGM 08JYN1

Agencies

[Federal Register Volume 75, Number 130 (Thursday, July 8, 2010)]
[Notices]
[Page 39264]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health and 
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: Therapeutic Application of 
Dyrk1A Inhibitors for Down Syndrome.
    Date: July 26, 2010.
    Time: 2 p.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6100 Executive Boulevard, 
Room 5B01, 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, 6100 
Executive Boulevard, Room 5B01G, Bethesda, MD 20892-7510, (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: June 30, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-16472 Filed 7-7-10; 8:45 am]
BILLING CODE 4140-01-P
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