Justia Department Of Health And Human Services Food And Drug Administration Memorandum of Understanding With Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, The University of Texas Medical Branch at Galveston, and The Methodist Hospital Research Institute for the FDA-ANH Nanotechnology Initiative, 10926-10944 [E9-5492]

Memorandum of Understanding With Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, The University of Texas Medical Branch at Galveston, and The Methodist Hospital Research Institute for the FDA-ANH Nanotechnology Initiative, 10926-10944 [E9-5492]

Download as PDF 10926 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices Dated: March 6, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–5494 Filed 3–12–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA–2009–N–0667] [FDA 225–07–8006] Memorandum of Understanding With Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, The University of Texas Medical Branch at Galveston, and The Methodist Hospital Research Institute for the FDA-ANH Nanotechnology Initiative AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice. VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with The Alliance for NanoHealth (ANH), a collaboration among: Baylor College of Medicine, The University of Texas M.D. Anderson Cancer Center, Rice University, University of Houston, The University of Texas Health Science Center at Houston, Texas A&M Health Science Center, The University of Texas Medical Branch at Galveston, and The Methodist Hospital Research Institute. This MOU identifies the terms of collaboration between FDA and ANH in the area of nanotechnology. Specifically, this MOU establishes the FDA-ANH Nanotechnology Initiative (FANTI), a public-private partnership dedicated to the identification of scientific and translational gaps in moving nanoengineered medical products from the preclinical stages of development through clinical stages and then to commercialization, all with immediate benefit to public health. The activities are aligned with the mutual interests and respective missions of the Parties, including the FDA’s Critical Path Initiative which seeks to modernize the PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 product development and regulatory sciences needed to reduce uncertainties about product performance throughout the product life cycle. Thus, a key goal for the Parties is to improve the safety and efficacy of nanoengineered products and speed their delivery to the patients who need them and the consumers who use them. DATES: The agreement became effective February 11, 2009. FOR FURTHER INFORMATION CONTACT: Wendy R. Sanhai, Office of the Commissioner (HZ–1), Food and Drug Administration, 5600 Fishers Lane, suite 6A–08, Rockville, MD 20857, 301– 827–7867. In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the Federal Register, the agency is publishing notice of this MOU. SUPPLEMENTARY INFORMATION: Dated: March 4, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. BILLING CODE 4160–01–S E:\FR\FM\13MRN1.SGM 13MRN1 VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 10927 EN13MR09.001</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices VerDate Nov<24>2008 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 EN13MR09.002</GPH> sroberts on PROD1PC70 with NOTICES 10928 VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 10929 EN13MR09.003</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices VerDate Nov<24>2008 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 EN13MR09.004</GPH> sroberts on PROD1PC70 with NOTICES 10930 VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 10931 EN13MR09.005</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices VerDate Nov<24>2008 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 EN13MR09.006</GPH> sroberts on PROD1PC70 with NOTICES 10932 VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 10933 EN13MR09.007</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices VerDate Nov<24>2008 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 EN13MR09.008</GPH> sroberts on PROD1PC70 with NOTICES 10934 VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 10935 EN13MR09.009</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices VerDate Nov<24>2008 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 EN13MR09.010</GPH> sroberts on PROD1PC70 with NOTICES 10936 VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 10937 EN13MR09.011</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices VerDate Nov<24>2008 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 EN13MR09.012</GPH> sroberts on PROD1PC70 with NOTICES 10938 VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 10939 EN13MR09.013</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices VerDate Nov<24>2008 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 EN13MR09.014</GPH> sroberts on PROD1PC70 with NOTICES 10940 VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 10941 EN13MR09.015</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices VerDate Nov<24>2008 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4725 E:\FR\FM\13MRN1.SGM 13MRN1 EN13MR09.016</GPH> sroberts on PROD1PC70 with NOTICES 10942 VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\13MRN1.SGM 13MRN1 10943 EN13MR09.017</GPH> sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices 10944 Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices [FR Doc. E9–5492 Filed 3–12–09; 8:45 am] BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Clinical Trials Endpoints for Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation; Public Workshop AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice of public workshop. The Food and Drug Administration (FDA) and National Institutes of Health (NIH) in co-sponsorship with the Center for International Blood and Marrow Transplantation Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT) are announcing a public workshop entitled ‘‘Clinical Trials Endpoints for Acute Graft-Versus-Host Disease (GVHD) After Allogeneic Hematopoietic Stem Cell Transplantation.’’ This is a 1-day workshop for academics, government researchers, clinical trial experts, government regulators, and industry representatives. The purpose of the public workshop is to review the data that will serve as the foundation for protocol design and clinical trial evidence-based endpoints intended to support the approval of new drugs or biologics to prevent or treat acute GVHD. The public workshop also will inform FDA and assist investigators in facilitating clinical development programs for products to prevent or treat acute GVHD indications. Date and Time: The public workshop will be held on May 19, 2009, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at the Hilton Washington DC/ Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Overnight accommodations can be booked at the Hilton under group code ‘‘MCW’’ for the conference rate by calling 1–800–445–8667 or by using the Reservation Web site athttps:// www.hilton.com/en/hi/groups/ personalized/IADMRHF–MCW– 20090518/index.jhtml. Accommodation agreement courtesy of CIBMTR. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). Contact Person: Leslie Haynes, Center for Biologics Evaluation and Research VerDate Nov<24>2008 17:55 Mar 12, 2009 Jkt 217001 (HFM–43), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–2000, FAX: 301–827–3079; email: CBERTraining@fda.hhs.gov (Subject line: Acute GVHD Workshop). Registration: Mail or fax your registration information (including name, title, firm name, address, telephone and fax numbers) to the Contact Person by April 18, 2009. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8:15 a.m. If you need special accommodations due to a disability, please contact Leslie Haynes at least 7 days in advance. SUPPLEMENTARY INFORMATION: At the present time, there are no drugs or biologics approved for prevention or treatment of acute GVHD. Development of products to prevent or treat acute GVHD poses several challenges. First, the market is not very big, so there is little incentive for investment if the process is cumbersome; second, analyses of these studies are complicated by confounding factors; and third, there is a lack of evidencebased endpoints that can be used to demonstrate a clinically meaningful benefit of any therapy. The Center for Biologics Evaluation and Research is the FDA Center with regulatory responsibility for vaccines, blood and blood products, allergenic products, and therapies involving cells, tissues, and genes. The mission of FDA is to protect and enhance the public health including the safety and purity of medical products and the Nation’s blood supply. The purpose of this event is to review the data that can be used to develop evidence-based endpoints for clinical trials targeting acute GVHD. ASBMT is a professional organization that promotes advancement of the field of blood and bone marrow transplantation. Its members are both in clinical practice and in research. CIBMTR is a research network comprised of the National Marrow Donor Program© and the International Bone Marrow Transplant Registry and Autologous Blood and Marrow Transplant Registry. Its activities include support for the National Heart, Lung and Blood Institute (NHLBI)funded Blood and Marrow Transplantation Clinical Trials Network and Health Resources and Services Administration’s C.W. Bill Young Cell Transplantation Program. The goals of the CIBMTR include defining key areas PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 for future research in collaboration with leading scientists, physicians, and others in the blood and marrow transplant community; the design and implementation of clinical studies; and making available research resources including a clinical database of related blood and marrow transplants, along with repositories of matched tissue samples from transplant recipients and their donors. The NHLBI, National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI), and Office of Rare Diseases (ORD) are at the National Institutes of Health (NIH), the primary Federal agency for conducting and supporting medical research. NIH’s mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. The public workshop will feature presentations by FDA, CIBMTR, and members of ASBMT. The topics to be discussed include the following: (1) Regulatory requirements for clinical trials, (2) extant data which support the endpoints currently used in clinical trials, (3) data analyses to support the validity of the proposed endpoints, (4) statistical approaches to minimize confounding factors in stem cell transplantation study analysis, (5) biomarkers for acute GVHD, and (6) patient-reported outcomes for acute GVHD prevention and treatment trials. Presentations: Presentations from the public workshop will be maintained on the CIBMTR’s Web site for at least 1 year. Dated: March 6, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–5496 Filed 3–12–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Women’s Health Initiative Observational Study Summary: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection E:\FR\FM\13MRN1.SGM 13MRN1

Agencies

[Federal Register Volume 74, Number 48 (Friday, March 13, 2009)]
[Notices]
[Pages 10926-10944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA-2009-N-0667]
[FDA 225-07-8006]


Memorandum of Understanding With Baylor College of Medicine, The 
University of Texas M.D. Anderson Cancer Center, Rice University, 
University of Houston, The University of Texas Health Science Center at 
Houston, Texas A&M Health Science Center, The University of Texas 
Medical Branch at Galveston, and The Methodist Hospital Research 
Institute for the FDA-ANH Nanotechnology Initiative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) with The Alliance for NanoHealth 
(ANH), a collaboration among: Baylor College of Medicine, The 
University of Texas M.D. Anderson Cancer Center, Rice University, 
University of Houston, The University of Texas Health Science Center at 
Houston, Texas A&M Health Science Center, The University of Texas 
Medical Branch at Galveston, and The Methodist Hospital Research 
Institute. This MOU identifies the terms of collaboration between FDA 
and ANH in the area of nanotechnology. Specifically, this MOU 
establishes the FDA-ANH Nanotechnology Initiative (FANTI), a public-
private partnership dedicated to the identification of scientific and 
translational gaps in moving nanoengineered medical products from the 
preclinical stages of development through clinical stages and then to 
commercialization, all with immediate benefit to public health. The 
activities are aligned with the mutual interests and respective 
missions of the Parties, including the FDA's Critical Path Initiative 
which seeks to modernize the product development and regulatory 
sciences needed to reduce uncertainties about product performance 
throughout the product life cycle. Thus, a key goal for the Parties is 
to improve the safety and efficacy of nanoengineered products and speed 
their delivery to the patients who need them and the consumers who use 
them.

DATES: The agreement became effective February 11, 2009.

FOR FURTHER INFORMATION CONTACT: Wendy R. Sanhai, Office of the 
Commissioner (HZ-1), Food and Drug Administration, 5600 Fishers Lane, 
suite 6A-08, Rockville, MD 20857, 301-827-7867.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOUs between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of this MOU.

    Dated: March 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
BILLING CODE 4160-01-S

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[FR Doc. E9-5492 Filed 3-12-09; 8:45 am]
BILLING CODE 4160-01-C

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