Annual Public Meeting, 23960-23961 [2013-09441]

Download as PDF 23960 Federal Register / Vol. 78, No. 78 / Tuesday, April 23, 2013 / Notices Schedule Drug JWH–250 (6250) .......................... SR–18 also known as RCS–8 (7008). JWH–019 (7019) .......................... JWH–081 (7081) .......................... SR–19 also known as RCS–4 (7104). JWH–122 (7122) .......................... AM–2201 (7201) ........................... JWH–203 (7203) .......................... 2C–T–2 (7385) ............................. JWH–398 (7398) .......................... Psilocybin (7437) .......................... Psilocyn (7438) ............................. 2C–D (7508) ................................. 2C–E (7509) ................................. 2C–H (7517) ................................. 2C–I (7518) .................................. 2C–C (7519) ................................. 2C–N (7521) ................................. 2C–P (7524) ................................. 2C–T–4 (7532) ............................. AM–694 (7694) ............................. Phenylacetone (8501) .................. NUCLEAR REGULATORY COMMISSION I I [NRC–2013–0001] Sunshine Act Meetings I I I AGENCY HOLDING THE MEETINGS: Nuclear Regulatory Commission. DATES: Weeks of April 22, 29, May 6, 13, 20, 27, 2013. PLACE: Commissioners’ Conference Room, 11555 Rockville Pike, Rockville, Maryland. STATUS: Public and Closed. I I I I I I I I I I I I I I I I I Week of April 22, 2013 Monday April 22, 2013 9:00 a.m. Meeting with the Department of Energy Office of Nuclear Energy (Public Meeting) (Contact: Brett Rini, 301–251–7615). This meeting will be webcast live at the Web address—www.nrc.gov. 2:30 p.m. Discussion of Management and Personnel Issues (Closed—Ex. 2 and 6). mstockstill on DSK4VPTVN1PROD with NOTICES The company plans to manufacture the listed controlled substances for distribution to their research and forensic customers conducting drug testing and analysis. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cayman Chemical Company to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Cayman Chemical Company to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed. Dated: April 16, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–09530 Filed 4–22–13; 8:45 am] BILLING CODE 4410–09–P VerDate Mar<15>2010 17:51 Apr 22, 2013 Jkt 229001 Tuesday April 23, 2013 9:00 a.m. Briefing on the Status of Lessons Learned from the Fukushima Dai’ichi Accident (Public Meeting) (Contact: William D. Reckley, 301–415–7490). This meeting will be webcast live at the Web address—www.nrc.gov. Week of April 29, 2013—Tentative There are no meetings scheduled for the week of April 29, 2013. Week of May 6, 2013—Tentative There are no meetings scheduled for the week of May 6, 2013. * The schedule for Commission meetings is subject to change on short notice. To verify the status of meetings, call (recording)—301–415–1292. Contact person for more information: Rochelle Bavol, 301–415–1651. * * * * * The NRC Commission Meeting Schedule can be found on the Internet at: https://www.nrc.gov/public-involve/ public-meetings/schedule.html. * * * * * The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (e.g., Braille, large print), please notify Kimberly Meyer, NRC Disability Program Manager, at 301–287–0727, or by email at kimberly.meyerchambers@nrc.gov. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. * * * * * This notice is distributed electronically to subscribers. If you no longer wish to receive it, or would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301–415–1969), or send an email to darlene.wright@nrc.gov. Dated: April 18, 2013. Rochelle C. Bavol, Policy Coordinator, Office of the Secretary. [FR Doc. 2013–09652 Filed 4–19–13; 4:15 pm] BILLING CODE 7590–01–P Week of May 13, 2013—Tentative There are no meetings scheduled for the week of May 13, 2013. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION Week of May 20, 2013—Tentative [BAC 416404] Monday, May 20, 2013 9:30 a.m. Briefing on Human Capital and Equal Employment Opportunity (EEO) (Public Meeting) (Contact: Kristin Davis, 301–287– 0707). This meeting will be webcast live at the Web address—www.nrc.gov. Annual Public Meeting Week of May 27, 2013—Tentative Wednesday, May 29, 2013 9:00 a.m. Briefing on Results of the Agency Action Review Meeting (AARM) (Public Meeting) (Contact: Rani Franovich, 301–415–1868). This meeting will be webcast live at the Web address—www.nrc.gov. * * * * * PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 ACTION: Notice of annual meeting. The Reagan-Udall Foundation for the Food and Drug Administration (FDA), which was created by Title VI of the Food and Drug Amendments of 2007, is announcing an annual open public meeting. The Foundation will provide an overview of its history, project updates, as well as projected activities going forward. DATES: The open public meeting will be held on May 23, 2013, from 10 a.m. until 12 noon. Interested persons may sign up to attend in person and/or make comments at the meeting or submit written comments by visiting https:// SUMMARY: E:\FR\FM\23APN1.SGM 23APN1 Federal Register / Vol. 78, No. 78 / Tuesday, April 23, 2013 / Notices www.ReaganUdall.org on or before May 17, 2013. Oral comments from the public will be scheduled between approximately 11 a.m. and 12 p.m. Time allotted for each registrant will be 3 minutes. The contact person will notify interested persons regarding their request to speak by May 23, 2013. Written comments are encouraged. Those individuals interested in making formal comments should notify the contact person and submit a brief statement of the general nature of the comments they wish to present. Written comments are encouraged through May 22, 2013. Location: West Policy Center, 1909 K St. NW., Suite 730, Washington, DC 20006. Jane Reese-Coulbourne, Reagan-Udall Foundation for the FDA, 202–828–1206, Meetings@ReaganUdall.org. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: mstockstill on DSK4VPTVN1PROD with NOTICES The Reagan-Udall Foundation for the FDA (the Foundation) is an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development; accelerate innovation; and enhance product safety. With the ultimate goal of improving public health, the Foundation provides a unique opportunity for different sectors (FDA, patient groups, academia, other government entities, and industry) to work together in a transparent way to create exciting new research projects to advance regulatory science. The Foundation acts as a neutral third party to establish novel, scientific collaborations. Much like any other independently developed information, FDA evaluates the scientific information from these collaborations to determine how Reagan-Udall Foundation projects can help the Agency to fulfill its mission. The Foundation’s projects include: The Innovation in Medical Evidence Development and Surveillance (IMEDS) Program, methods for using observational electronic health care data for postmarket evidence generation, including postmarket safety surveillance; the Systems Toxicology Project, an evaluation of a systems biology approach to preclinical safety testing; and the Critical Path to Tuberculosis Multidrug Regimens (CPTR) Project, looking at new ways to develop tuberculosis combination therapies. The Foundation seeks 17:51 Apr 22, 2013 II. Agenda The Foundation will be providing an overview of its history, project updates, as well as projected activities going forward. Find the Meeting Agenda at https://www.ReaganUdall.org. Dated: April 17, 2013. Jane Reese-Coulbourne, Executive Director, Reagan-Udall Foundation for the FDA. [FR Doc. 2013–09441 Filed 4–22–13; 8:45 am] BILLING CODE 4164–04–P REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION [BAC 416404] Request for Steering Committee Nominations Request for nominations to the Steering Committee for the Foundation’s Innovation in Medical Evidence Development and Surveillance program. ACTION: I. Background VerDate Mar<15>2010 comments on these and other potential topics for future activities. Jkt 229001 The Reagan-Udall Foundation for the Food and Drug Administration (FDA), which was created by Title VI of the Food and Drug Amendments of 2007, is requesting nominations for its Innovation in Medical Evidence Development and Surveillance (IMEDS) Steering Committee. The IMEDS Steering Committee will provide oversight and guidance of the IMEDS Program, and will report to the ReaganUdall Foundation for the FDA’s Board of Directors. Instructions on making nominations are listed in the ‘‘Background’’ section. DATES: All nominations must be submitted to the Reagan-Udall Foundation for the FDA by April 30, 2013. IMEDS Steering Committee members will be selected by the ReaganUdall Foundation for the FDA’s Board of Directors on May 23, 2013; those selected will be notified by May 30 regarding the Board’s decision. Location: The Reagan-Udall Foundation for the FDA is located at 1025 Connecticut Ave. NW., Suite 1000, Washington, DC 20036. FOR FURTHER INFORMATION CONTACT: Jane Reese-Coulbourne, Reagan-Udall Foundation for the FDA, 202–828–1206. Nominations should be sent to IMEDS@ReaganUdall.org. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background The Reagan-Udall Foundation for the FDA (the Foundation or RUF) is an PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 23961 independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development; accelerate innovation; and enhance product safety. With the ultimate goal of improving public health, the Foundation provides a unique opportunity for different sectors (FDA, patient groups, academia, other government entities, and industry) to work together in a transparent way to create exciting new research projects to advance regulatory science. The Foundation acts as a neutral third party to establish novel, scientific collaborations. Much like any other independently developed information, FDA evaluates the scientific information from these collaborations to determine how Reagan-Udall Foundation projects can help the Agency to fulfill its mission. The IMEDS program is offered by the Foundation. IMEDS is a public-private partnership created to build upon the significant progress made on research methodology by the Sentinel Initiative, including its Mini-Sentinel pilot and the Observational Medical Outcomes Partnership (OMOP). IMEDS’s primary objective is to advance the science and tools necessary to support postmarket evidence generation on regulated products, including safety surveillance and evaluations, and to facilitate utilization of a robust electronic health care data platform for generating better evidence on regulated products in the postmarket settings. To accomplish this objective, the IMEDS program includes three projects: 1. IMEDS-Methods: Supports the development of a methods research agenda and coordination of methods research in support of using electronic health data for safety surveillance conducted by FDA as well as the broader community of researchers. 2. IMEDS-Education: Offers educational opportunities in areas related to medical product safety surveillance, and methods research and application for scientific professionals. 3. IMEDS-Evaluation: Applies Methods and Education lessons learned for medical product assessments to facilitate leveraging Sentinel tools and capabilities toward a national resource for evidence generation. The IMEDS Steering Committee will have oversight of all IMEDS projects. II. IMEDS Steering Committee Positions and Selection Criteria RUF is seeking nominations for seven voting members of the IMEDS Steering E:\FR\FM\23APN1.SGM 23APN1

Agencies

  • REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
[Federal Register Volume 78, Number 78 (Tuesday, April 23, 2013)]
[Notices]
[Pages 23960-23961]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09441]


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REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

[BAC 416404]


Annual Public Meeting

ACTION: Notice of annual meeting.

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

SUMMARY: The Reagan-Udall Foundation for the Food and Drug 
Administration (FDA), which was created by Title VI of the Food and 
Drug Amendments of 2007, is announcing an annual open public meeting. 
The Foundation will provide an overview of its history, project 
updates, as well as projected activities going forward.

DATES: The open public meeting will be held on May 23, 2013, from 10 
a.m. until 12 noon. Interested persons may sign up to attend in person 
and/or make comments at the meeting or submit written comments by 
visiting https://

[[Page 23961]]

www.ReaganUdall.org on or before May 17, 2013. Oral comments from the 
public will be scheduled between approximately 11 a.m. and 12 p.m. Time 
allotted for each registrant will be 3 minutes. The contact person will 
notify interested persons regarding their request to speak by May 23, 
2013. Written comments are encouraged. Those individuals interested in 
making formal comments should notify the contact person and submit a 
brief statement of the general nature of the comments they wish to 
present. Written comments are encouraged through May 22, 2013.
    Location: West Policy Center, 1909 K St. NW., Suite 730, 
Washington, DC 20006.

FOR FURTHER INFORMATION CONTACT: Jane Reese-Coulbourne, Reagan-Udall 
Foundation for the FDA, 202-828-1206, Meetings@ReaganUdall.org.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Reagan-Udall Foundation for the FDA (the Foundation) is an 
independent 501(c)(3) not-for-profit organization created by Congress 
to advance the mission of FDA to modernize medical, veterinary, food, 
food ingredient, and cosmetic product development; accelerate 
innovation; and enhance product safety. With the ultimate goal of 
improving public health, the Foundation provides a unique opportunity 
for different sectors (FDA, patient groups, academia, other government 
entities, and industry) to work together in a transparent way to create 
exciting new research projects to advance regulatory science.
    The Foundation acts as a neutral third party to establish novel, 
scientific collaborations. Much like any other independently developed 
information, FDA evaluates the scientific information from these 
collaborations to determine how Reagan-Udall Foundation projects can 
help the Agency to fulfill its mission.
    The Foundation's projects include: The Innovation in Medical 
Evidence Development and Surveillance (IMEDS) Program, methods for 
using observational electronic health care data for postmarket evidence 
generation, including postmarket safety surveillance; the Systems 
Toxicology Project, an evaluation of a systems biology approach to 
preclinical safety testing; and the Critical Path to Tuberculosis 
Multidrug Regimens (CPTR) Project, looking at new ways to develop 
tuberculosis combination therapies. The Foundation seeks comments on 
these and other potential topics for future activities.

II. Agenda

    The Foundation will be providing an overview of its history, 
project updates, as well as projected activities going forward. Find 
the Meeting Agenda at https://www.ReaganUdall.org.

    Dated: April 17, 2013.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2013-09441 Filed 4-22-13; 8:45 am]
BILLING CODE 4164-04-P
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