Office of the Director, Office of Biotechnology Activities; Notice of a Safety Symposium, 25282-25283 [2010-10864]

Download as PDF 25282 jlentini on DSKJ8SOYB1PROD with NOTICES ACTION: Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in cosponsorship with the University of Arkansas (UA) Institute of Food Science and Engineering, is announcing a public workshop entitled ‘‘Food Protection Workshop.’’ This public workshop is intended to provide information about food safety, food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to the Food Protection Plan as it relates to food establishments such as farms, manufacturers, processors, distributors, retailers, and restaurants. Date and Time: This public workshop will be held on June 9 and 10, 2010, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Continuing Education Center, Two East Center St., Fayetteville, AR (located downtown). Contact: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214–253– 4952, FAX: 214–253–4970, or e-mail: david.arvelo@fda.hhs.gov. For information on accommodation options, visit https://www.uark.edu/ua/ foodpro/Workshops/Food_Safety_ Defense_Workshop.html or contact Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479–575–4221, FAX: 479–575–2165, or e-mail: seideman@uark.edu. Registration: You are encouraged to register by May 26, 2010. The University of Arkansas has a $250 registration fee to cover the cost of facilities, materials, speakers, and breaks. There is no fee for FDA employees. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $350 payable to: ‘‘The University of Arkansas.’’ If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact) at least 14 days in advance. To register, please visit https:// www.uark.edu/ua/foodpro/Workshops/ Food_Safety_Defense_Workshop.html to VerDate Mar<15>2010 19:19 May 06, 2010 Jkt 220001 register online or submit a check or money order for $250 payable to the ‘‘The University of Arkansas.’’ Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704 along with the following information: Your name, affiliation, mailing address, phone number, fax, e-mail, and whether special accommodations are required. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Workshop handouts may be requested at cost through the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A–16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. SUPPLEMENTARY INFORMATION: This public workshop is being held in response to the large volume of food protection concerns from food establishments (such as farms, manufacturers, processors, distributors, retailers, and restaurants) originating from the area covered by the FDA Dallas District Office. The SWRO presents this workshop to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This is consistent with the purposes of the Small Business Representative Program, which are in part to respond to industry inquiries, develop educational materials, sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA’s guidance, requirements, and compliance policies. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104–121), as outreach activities by Government agencies to small businesses. The goal of this public workshop is to present information that will enable food establishments (such as farms, manufacturers, processors, distributors, retailers, and restaurants) to better comply with any regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) relevant to such establishments, and to be aware of recommendations in food protection guidance, especially in light of growing concerns about food safety and defense. Information presented will be based on regulations, guidances, and information previously PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 made available to the public. Topics to be discussed at the workshop include: (1) Food defense programs, (2) good manufacturing practices, (3) reportable food registry, (4) Hazard Analysis Critical Control Point (HACCP), (5) good agricultural practices, (6) food recalls, (7) pathogens of public health concern, and (8) risk management and vulnerability assessments and other related topics. For more information, please visit https://www.uark.edu/ua/ foodpro/Workshops/Food_Safety_ Defense_Workshop.html. FDA expects that participation in this public workshop will provide regulated industry with greater understanding of the regulatory and guidance perspectives on food protection and increase voluntary compliance and food defense awareness. Dated: May 3, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–10792 Filed 5–6–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, Office of Biotechnology Activities; Notice of a Safety Symposium There will be a safety symposium entitled ‘‘Gene-Modified T Cells: Challenges in Clinical Trial Design with Novel Receptors.’’ 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. For further information concerning this meeting contact Ms. Chezelle George, Administrative Assistant, Office of Biotechnology Activities, Office of the Director, National Institutes of Health, 6705 Rockledge Drive, Room 750, Bethesda, MD 20892–7985, 301–496–9838, georgec@mail.nih.gov. Name of Committee: Recombinant DNA Advisory Committee. Date: June 15, 2010. Time: 8 a.m. to 5:30 p.m. Agenda: The Office of Biotechnology Activities (OBA) and NIH Recombinant DNA Advisory Committee will host a symposium entitled ‘‘Gene Modified T Cells: Challenges in Clinical Trial Design with Novel Receptors’’ on June 15, 2010 at the Rockville Hotel and Executive Center. Experts will discuss data from trials conducted to date, the selection of novel antigen targets, the E:\FR\FM\07MYN1.SGM 07MYN1 Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices potential risks of off-target effects and clinical trial design strategies that can maximize both anti-tumor effect and safety. An agenda will be posted to OBA’s Web site closer to the meeting date. Please check the meeting agenda at https://oba.od.nih.gov/ rdna/rdna.html for more information. Place: Rockville Hotel and Executive Center, 1750 Rockville Pike, Rockville, MD 20892. Contact Person: Chezelle George, Administrative Assistant, Office of Science Policy, Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750–A1, Bethesda, MD 20892, 301–496–9838, georgec@mail.nih.gov. Any interested person may file written comments with the panel 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. Background information may be obtained by contacting NIH OBA by e-mail oba@od.nih.gov Dated: April 29, 2010. Jacqueline Corrigan-Curay, Acting Director, Office of Biotechnology Activities, National Institutes of Health. [FR Doc. 2010–10864 Filed 5–6–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–1906– DR; Docket ID FEMA–2010–0002] Mississippi; Major Disaster and Related Determinations jlentini on DSKJ8SOYB1PROD with NOTICES AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Mississippi (FEMA–1906–DR), dated April 29, 2010, and related determinations. DATES: Effective Date: April 29, 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 April 29, 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 Mississippi VerDate Mar<15>2010 19:19 May 06, 2010 Jkt 220001 resulting from severe storms, tornadoes, and flooding during the period of April 23–24, 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 Mississippi. 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 assistance for debris removal (Category A) for 72 hours of the State’s choosing and emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program and 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 Public Assistance, 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 assistance to the extent allowable under the Stafford Act. 25283 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. 2010–10789 Filed 5–6–10; 8:45 am] BILLING CODE 9111–23–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–1906– DR; Docket ID FEMA–2010–0002] Mississippi; Amendment No. 2 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. 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, Michael Bolch, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster. The following areas of the State of Mississippi have been designated as adversely affected by this major disaster: Choctaw and Yazoo Counties for Individual Assistance. Choctaw and Yazoo Counties for debris removal (Category A), for 72 hours of the State’s choosing and emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program. All counties in the State of Mississippi 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— SUMMARY: This notice amends the notice of a major disaster declaration for the State of Mississippi (FEMA–1906–DR), dated April 29, 2010, and related determinations. DATES: Effective Date: May 1, 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: The notice of a major disaster declaration for the State of Mississippi is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of April 29, 2010. Monroe and Union Counties for Individual Assistance Choctaw and Yazoo Counties for Public Assistance, including direct Federal assistance (already designated for Individual Assistance and debris removal [Category A], for 72 hours of the State’s choosing and emergency protective measures [Category B], limited to direct Federal assistance, under the Public Assistance program). Attala and Holmes Counties for Public Assistance, including direct Federal assistance, (already designated for Individual Assistance). 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; PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 E:\FR\FM\07MYN1.SGM 07MYN1

Agencies

[Federal Register Volume 75, Number 88 (Friday, May 7, 2010)]
[Notices]
[Pages 25282-25283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10864]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, Office of Biotechnology Activities; 
Notice of a Safety Symposium

    There will be a safety symposium entitled ``Gene-Modified T Cells: 
Challenges in Clinical Trial Design with Novel Receptors.'' 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. For 
further information concerning this meeting contact Ms. Chezelle 
George, Administrative Assistant, Office of Biotechnology Activities, 
Office of the Director, National Institutes of Health, 6705 Rockledge 
Drive, Room 750, Bethesda, MD 20892-7985, 301-496-9838, 
georgec@mail.nih.gov.

    Name of Committee: Recombinant DNA Advisory Committee.
    Date: June 15, 2010.
    Time: 8 a.m. to 5:30 p.m.
    Agenda: The Office of Biotechnology Activities (OBA) and NIH 
Recombinant DNA Advisory Committee will host a symposium entitled 
``Gene Modified T Cells: Challenges in Clinical Trial Design with 
Novel Receptors'' on June 15, 2010 at the Rockville Hotel and 
Executive Center. Experts will discuss data from trials conducted to 
date, the selection of novel antigen targets, the

[[Page 25283]]

potential risks of off-target effects and clinical trial design 
strategies that can maximize both anti-tumor effect and safety. An 
agenda will be posted to OBA's Web site closer to the meeting date. 
Please check the meeting agenda at https://oba.od.nih.gov/rdna/rdna.html for more information.
    Place: Rockville Hotel and Executive Center, 1750 Rockville 
Pike, Rockville, MD 20892.
    Contact Person: Chezelle George, Administrative Assistant, 
Office of Science Policy, Office of Biotechnology Activities, 
National Institutes of Health, 6705 Rockledge Drive, Suite 750-A1, 
Bethesda, MD 20892, 301-496-9838, georgec@mail.nih.gov.
    Any interested person may file written comments with the panel 
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. Background information may be obtained by 
contacting NIH OBA by e-mail oba@od.nih.gov

    Dated: April 29, 2010.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology Activities, National 
Institutes of Health.
[FR Doc. 2010-10864 Filed 5-6-10; 8:45 am]
BILLING CODE 4140-01-P
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