Issues in the Development of Medical Products for the Prophylaxis and/or Treatment of Acute Antibody Mediated Rejection in Kidney Transplant Recipients; Public Workshop, 32490-32491 [2010-13669]

Download as PDF 32490 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meeting emcdonald on DSK2BSOYB1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Mental Health. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended, for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Mental Health, including consideration of personnel qualifications and performances, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Institute of Mental Health. Date: June 27–29, 2010. Time: June 27, 2010, 7 p.m. to 10 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Time: June 28, 2010, 8:30 a.m. to 12:40 p.m. Agenda: To review and evaluate the Intramural Laboratories with site visits of the Section on Cognitive Neuroscience, the Section on the Neurobiology of Learning and Memory, and the Unit on Learning and Plasticity and meetings with the PIs, Training Fellows, and Staff Scientists. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Time: June 28, 2010, 1 p.m. to 5 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Time: June 28, 2010, 7 p.m. to 10 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Time: June 29, 2010, 8:30 a.m. to 12:40 p.m. Agenda: To review and evaluate the Intramural Laboratories with site visits of the Unit on Cognitive Neurophysiology and Imaging, the Section on Neural Coding and Computation, the Section on Critical Brain Dynamics, and meetings with the PIs, Training Fellows, and Staff Scientists. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Time: June 29, 2010, 1 p.m. to 4 p.m. VerDate Mar<15>2010 16:31 Jun 07, 2010 Jkt 220001 Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Dawn M. Johnson, PhD, Executive Secretary, Division of Intramural Research Programs, National Institute of Mental Health, 10 Center Drive, Building 10, Room 4N222, Bethesda, MD 20892, 301–402– 5234, dawnjohnson@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos.: 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Dated: June 1, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–13741 Filed 6–7–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Issues in the Development of Medical Products for the Prophylaxis and/or Treatment of Acute Antibody Mediated Rejection in Kidney Transplant Recipients; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of medical products (i.e., human drugs, therapeutic biological products, and medical devices) for prophylaxis and/or treatment of acute antibody mediated rejection (AMR) in kidney transplant recipients. This public workshop is intended to provide information for and gain perspective from health care providers, academia, and industry on various aspects of development of medical products for prophylaxis and/or treatment of acute AMR in kidney transplant recipients, including clinical trial design and endpoints. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on June 28, 2010, from 8 a.m. to 6:30 p.m. and on June 29, 2010, from 8 a.m. to 4 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. PO 00000 Frm 00136 Fmt 4703 Sfmt 4703 Seating is limited and available only on a first-come, first-served basis. Contacts: Christine Moser or Ramou Mauer, Center for Drug Evaluation and Research, Food and Drug Administration, Office of Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring, MD 20993–0002, 301–796–1300 or 301– 796–1600. Registration: Registration is free for the public workshop. Interested parties are encouraged to register early because space is limited. Seating will be available on a first-come, first-served basis. To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to AMRworkshop@fda.hhs.gov. Persons without access to the Internet can call Christine Moser at 301–796–1300 or Ramou Mauer at 301–796–1600 to register. Persons needing a sign language interpreter or other special accommodations should notify Christine Moser or Ramou Mauer (see Contacts) at least 7 days in advance. SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop regarding medical product development for the prophylaxis and/or treatment of acute AMR in kidney transplant recipients. This public workshop will focus on scientific considerations in the clinical development of medical products for prophylaxis and/or treatment of acute AMR in kidney transplant recipients, including the following topics: • Definition and diagnosis of acute AMR • Importance of validation and standardization of devices and diagnostic testing to establish the diagnosis of AMR and to identify patients at high risk of AMR • Results of clinical trials evaluating treatment of acute AMR • Endpoints to be evaluated to assess outcome • Outcomes achieved with currently used regimens Additional discussion will include animal models in AMR, previous experiences in desensitization and prophylaxis of AMR, and chronic AMR. The agency encourages individuals, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons to attend this public workshop. Transcripts: 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 (HFA–305), Food and Drug E:\FR\FM\08JNN1.SGM 08JNN1 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. 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. Transcripts will also be available on the Internet at https://www.fda.gov/Drugs/ NewsEvents/ucm206132.htm approximately 45 days after the workshop. Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant. W. Craig Fugate, Administrator, Federal Emergency Management Agency. Dated: June 2, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [Internal Agency Docket No. FEMA–1917– DR; Docket ID FEMA–2010–0002] BILLING CODE 4160–01–S Federal Emergency Management Agency [Internal Agency Docket No. FEMA–3312– EM; Docket ID FEMA–2010–0002] Massachusetts; Amendment No. 1 to Notice of an Emergency Disaster Declaration AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. emcdonald on DSK2BSOYB1PROD with NOTICES SUMMARY: This notice amends the notice of an emergency declaration for the Commonwealth of Massachusetts (FEMA–3312–EM), dated May 3, 2010, and related determinations. DATES: Effective Date: May 5, 2010. FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886. SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident period for this emergency is closed effective May 5, 2010. The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance— Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Jkt 220001 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. DEPARTMENT OF HOMELAND SECURITY 16:31 Jun 07, 2010 BILLING CODE 9111–23–P Oklahoma; Major Disaster and Related Determinations [FR Doc. 2010–13669 Filed 6–7–10; 8:45 am] VerDate Mar<15>2010 [FR Doc. 2010–13746 Filed 6–7–10; 8:45 am] SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Oklahoma (FEMA–1917–DR), dated May 24, 2010, and related determinations. DATES: Effective Date: May 24, 2010. FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated May 24, 2010, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford Act’’), as follows: I have determined that the damage in certain areas of the State of Oklahoma resulting from severe storms, tornadoes, and straight-line winds during the period of May 10–13, 2010, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford Act’’). Therefore, I declare that such a major disaster exists in the State of Oklahoma. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Individual Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration for the approved PO 00000 Frm 00137 Fmt 4703 Sfmt 4703 32491 assistance to the extent allowable under the Stafford Act. The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration. The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Gregory W. Eaton, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster. The following areas of the State of Oklahoma have been designated as adversely affected by this major disaster: Carter, Cleveland, McIntosh, Okfuskee, Oklahoma, Pottawatomie, and Seminole Counties for Individual Assistance. All counties within the State of Oklahoma are eligible to apply for assistance under the Hazard Mitigation Grant Program. The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance— Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.) W. Craig Fugate, Administrator, Federal Emergency Management Agency. [FR Doc. 2010–13720 Filed 6–7–10; 8:45 am] BILLING CODE 9111–23–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–1912– DR; Docket ID FEMA–2010–0002] Kentucky; Amendment No. 3 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA– E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32490-32491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13669]



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



DEPARTMENT OF HEALTH AND HUMAN SERVICES



Food and Drug Administration



[Docket No. FDA-2010-N-0001]




Issues in the Development of Medical Products for the Prophylaxis 

and/or Treatment of Acute Antibody Mediated Rejection in Kidney 

Transplant Recipients; Public Workshop



AGENCY: Food and Drug Administration, HHS.



ACTION: Notice of public workshop.



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



SUMMARY: The Food and Drug Administration (FDA) is announcing a public 

workshop regarding scientific issues in clinical development of medical 

products (i.e., human drugs, therapeutic biological products, and 

medical devices) for prophylaxis and/or treatment of acute antibody 

mediated rejection (AMR) in kidney transplant recipients. This public 

workshop is intended to provide information for and gain perspective 

from health care providers, academia, and industry on various aspects 

of development of medical products for prophylaxis and/or treatment of 

acute AMR in kidney transplant recipients, including clinical trial 

design and endpoints. The input from this public workshop will help in 

developing topics for further discussion.

    Date and Time: The public workshop will be held on June 28, 2010, 

from 8 a.m. to 6:30 p.m. and on June 29, 2010, from 8 a.m. to 4 p.m.

    Location: The public workshop will be held at the Crowne Plaza 

Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited 

and available only on a first-come, first-served basis.

    Contacts: Christine Moser or Ramou Mauer, Center for Drug 

Evaluation and Research, Food and Drug Administration, Office of 

Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, 

Silver Spring, MD 20993-0002, 301-796-1300 or 301-796-1600.

    Registration: Registration is free for the public workshop. 

Interested parties are encouraged to register early because space is 

limited. Seating will be available on a first-come, first-served basis. 

To register electronically, e-mail registration information (including 

name, title, firm name, address, telephone, and fax number) to 

AMRworkshop@fda.hhs.gov. Persons without access to the Internet can 

call Christine Moser at 301-796-1300 or Ramou Mauer at 301-796-1600 to 

register. Persons needing a sign language interpreter or other special 

accommodations should notify Christine Moser or Ramou Mauer (see 

Contacts) at least 7 days in advance.



SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop 

regarding medical product development for the prophylaxis and/or 

treatment of acute AMR in kidney transplant recipients. This public 

workshop will focus on scientific considerations in the clinical 

development of medical products for prophylaxis and/or treatment of 

acute AMR in kidney transplant recipients, including the following 

topics:

     Definition and diagnosis of acute AMR

     Importance of validation and standardization of devices 

and diagnostic testing to establish the diagnosis of AMR and to 

identify patients at high risk of AMR

     Results of clinical trials evaluating treatment of acute 

AMR

     Endpoints to be evaluated to assess outcome

     Outcomes achieved with currently used regimens

Additional discussion will include animal models in AMR, previous 

experiences in desensitization and prophylaxis of AMR, and chronic AMR.

    The agency encourages individuals, patient advocates, industry, 

consumer groups, health care professionals, researchers, and other 

interested persons to attend this public workshop.

    Transcripts: 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 (HFA-305), Food and 

Drug



[[Page 32491]]



Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. 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. Transcripts will also be available 

on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm206132.htm 

approximately 45 days after the workshop.



    Dated: June 2, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-13669 Filed 6-7-10; 8:45 am]

BILLING CODE 4160-01-S

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