Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting, 13216-13217 [E9-6786]

Download as PDF 13216 Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices rheumatology collaborative networks, such as the Childhood Arthritis and Rheumatology Research Alliance or the Pediatric Rheumatology Collaborative Study Group. 5. Define, for phase 4 studies in JIA patients, the database standards and elements of data collection (e.g., data quality, monitoring) that are necessary and sufficient to meet FDA regulatory requirements. 6. Discuss how pertinent research initiatives can be accomplished in the framework of a consolidated JIA registry, including: ∑ Ethical considerations. ∑ Data sharing considerations. 7. Discuss the options for funding a consolidated JIA registry. B. Issues for Comment FDA is interested in obtaining public comment on the following issues relating to development of a consolidated pediatric rheumatology observational registry: 1. Should we transition from productspecific registries to a consolidated pediatric rheumatology observational registry? 2. Currently, the product-specific registries are conducted by the individual sponsors of the approved drugs and/or biological products with the safety data submitted to FDA. ∑ How should a consolidated pediatric rheumatology observational registry be structured to collect data and conduct analyses to meet the standards for postmarketing requirements set by FDA and provide information about long-term safety? ∑ What hurdles must be overcome to transition from product-specific registries to a consolidated pediatric rheumatology observational registry (e.g., industry concerns, pediatric rheumatology community concerns, proprietary issues of longer term data and informed consent, fulfilling FDA regulatory requirements, challenges of registry funding, management and ownership or sharing of data)? 3. What data should be collected in a consolidated pediatric rheumatology observational registry? Consider the following topics: Database standards and terminology (e.g., compatibility with large databases). Necessary and sufficient data elements (e.g., safety, effectiveness, growth and development, comorbidities, tracking medication switches over time, as well as concurrent medication). Length of individual patients’ participation and overall duration of the consolidated pediatric rheumatology observational registry (e.g., managing VerDate Nov<24>2008 20:28 Mar 25, 2009 Jkt 217001 pediatric data through and beyond the age of consent). 4. What are the optimal methods to analyze data from a consolidated pediatric rheumatology observational registry to identify safety signals? For example, should the methods define risk windows for attribution to a drug or biological product; internal controls; and/or analyses of confounding by indication, switches in medication, and multiple concurrent medications? 5. What are the opportunities for research initiatives within a consolidated observational rheumatology registry? III. Attendance and Registration to Speak There is no fee to attend the workshop, and attendees who do not wish to make an oral presentation do not need to register. Seating will be on a first-come, first-served basis. If you would like to make an oral presentation during the open public session on day one of the workshop, you must register and provide an abstract of your presentation by close of business on April 21, 2009. To speak, submit your name, title, business affiliation (if applicable), address, telephone and fax numbers, and e-mail address to Diane Ehrlich (see FOR FURTHER INFORMATION CONTACT). FDA has included questions for comment in section II of this document. You should also identify by number each question you wish to address in your presentation, and the approximate time requested for your presentation. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. Persons registered to make an oral presentation should check in before the workshop. Ample time will be allowed during the scheduled agenda for attendees to ask questions of panelists. In addition, we strongly encourage written comments to the docket. Written or electronic comments will be accepted until July 14, 2009. If you need special accommodations because of disability, please contact Diane Ehrlich (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the workshop. IV. Comments Regardless of attendance at the public workshop, interested persons may PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 submit written or electronic comments to the Division of Dockets Management (see ADDRESSES). Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments should be identified with the docket number found in brackets in the heading of this document. To ensure consideration, submit comments by July 14, 2009 (see DATES). Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Transcript Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI–35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857. Dated: March 19, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–6709 Filed 3–25–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Gestational Diabetes Life-Course Study. Date: April 20, 2009. Time: 2 p.m. to 3:30 p.m. Agenda: To provide concept review of proposed concept review. E:\FR\FM\26MRN1.SGM 26MRN1 Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Sathasiva B. Kandasamy, PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 5B01, Bethesda, MD 20892–9304, (301) 435–6680. skandasa@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: March 20, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–6786 Filed 3–25–09; 8:45 am] Date: April 14, 2009. Time: 1 p.m. to 3 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: Richard D. Crosland, PhD, Scientific Review Administrator, Scientific Review Branch, Division Of Extramural Research, NINDS/NIH/DHHS/ Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892–9529. 301– 594–0635. rc218u@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: March 19, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–6660 Filed 3–25–09; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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: National Institute of Neurological Disorders and Stroke Special Emphasis Panel. Mutiple System Atrophy. Date: April 7, 2009. Time: 2 p.m. to 5 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: Ernest W Lyons, PhD, Scientific Review Administrator, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892– 9529. 301–496–4056. lyonse@ninds.nih.gov. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel. Stroke Trial. VerDate Nov<24>2008 20:28 Mar 25, 2009 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES 13217 Date: May 15, 2009. Time: 8:30 a.m. to 11:45 a.m. Agenda: Report from the Institute Director, other Institute Staff and presentations of working group reports. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Closed: 12:30 p.m. to 4 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Anthony Demsey, PhD, Director, National Institute of Biomedical Imaging and Bioengineering, 6707 Democracy Blvd., Room 241, Bethesda, MD 20892. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nibib1.nih.gov/about/NACBIB/ NACBIB.htm, where an agenda and any additional information for the meeting will be posted when available. National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting Dated: March 20, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–6784 Filed 3–25–09; 8:45 am] BILLING CODE 4140–01–P Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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/or contract proposals 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council for Biomedical Imaging and Bioengineering; NACBIB May 2009. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the PubMed Central National Advisory Committee. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: PubMed Central National Advisory Committee. Date: June 15, 2009. Time: 8:30 a.m. to 3 p.m. Agenda: Review and Analysis of Systems. Place: National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20892. Contact Person: David J. Lipman, MD, Director, Natl Ctr for Biotechnology Information, National Library of Medicine, Building 38, Room 8N805, Bethesda, MD E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 74, Number 57 (Thursday, March 26, 2009)]
[Notices]
[Pages 13216-13217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health & Human 
Development; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. Appendix 2), notice is hereby given of the following 
meeting.
    The meeting will be open to the public, with attendance limited to 
space available. Individuals who plan to attend and need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should notify the Contact Person listed below in 
advance of the meeting.

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel; Gestational Diabetes Life-Course 
Study.
    Date: April 20, 2009.
    Time: 2 p.m. to 3:30 p.m.
    Agenda: To provide concept review of proposed concept review.

[[Page 13217]]

    Place: National Institutes of Health, 6100 Executive Boulevard, 
Room 5B01, Rockville, MD 20852 (Telephone Conference Call).
    Contact Person: Sathasiva B. Kandasamy, PhD, Scientific Review 
Administrator, Division of Scientific Review, National Institute of 
Child Health and Human Development, 6100 Executive Boulevard, Room 
5B01, Bethesda, MD 20892-9304, (301) 435-6680. 
skandasa@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: March 20, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-6786 Filed 3-25-09; 8:45 am]
BILLING CODE 4140-01-P
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