The National Cancer Institute (NCI) Announces the Initiation of a Public Private Industry Partnership on Translation of Nanotechnology in Cancer (TONIC) To Promote Translational Research and Development Opportunities of Nanotechnology-Based Cancer Solutions, 66932-66933 [2011-27939]

Download as PDF 66932 Federal Register / Vol. 76, No. 209 / Friday, October 28, 2011 / Notices Medicare & Medicaid Services (CMS) at 7500 Security Boulevard, Baltimore, MD. Participants are responsible for their own travel, parking, meals, and overnight stay expenses. More information about the venue and accommodations can be found at https://acoregister.rti.org/. Potential participants are also strongly encouraged to complete the comprehensive planning tool discussed in section II. of this notice before arriving to the meeting. Meeting Registration, Presentations, and Written Comments: Registration information and documents can be accessed online at https:// acoregister.rti.org/. Registration: Eligible organizations interested in registering for the ADLS should visit https://acoregister.rti.org/ for information about registration. FOR FURTHER INFORMATION CONTACT: Additional information is available on the registration Web site at https:// acoregister.rti.org/. Click on ‘‘contact us’’ to send questions or comments via email. Press inquiries are handled through the CMS Press Office at (202) 690–6145. SUPPLEMENTARY INFORMATION: sroberts on DSK5SPTVN1PROD with NOTICES I. Background Section 1115A of the Social Security Act (the Act), as added by section 3021 of the Patient Protection and Affordable Care Act (Pub. L. 111–148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111– 152) (collectively, the Affordable Care Act), established the Center for Medicare and Medicaid Innovation (Innovation Center) for the purpose of examining new ways of delivering health care and paying health care providers in ways that can save money for Medicare, Medicaid and CHIP while improving the quality of care for beneficiaries. Through Accelerated Development Learning Sessions (ADLS), the Innovation Center will test whether intensive shared learning activities will expand and improve the capabilities of provider organizations to coordinate the care of a population of Medicare beneficiaries more effectively than organizations that do not participate in the ADLS. Well coordinated care can improve beneficiaries’ quality outcomes and reduce the growth of Medicare expenditures. Completion of the ADLS will not be a factor for selection or participation in a CMS ACO program. It is intended to provide ACOs with the opportunity to learn from their peers about essential ACO functions and various ways to build capacity needed to achieve better VerDate Mar<15>2010 16:56 Oct 27, 2011 Jkt 226001 care for individuals, better population health, and lower growth in health care expenditures. The ADLSs were first announced in the May 19, 2011 Federal Register (76 FR 28988). This third and final ADLS will combine the third and fourth sessions called for in the original notice. By holding the meeting at the CMS complex in Baltimore, Maryland, CMS hopes to enhance the dialogue between healthcare providers working to form ACOs and CMS staff developing ACO programs. Each participating team should consist of two to four senior-level leaders (including at least one executive with financial/management responsibility and one with clinical responsibility). Participants are also asked to attend future web based seminars and complete a full ACO implementation plan as part of the broader ADLS initiative to facilitate ongoing learning and evaluation. II. Completion of Planning Tool and Session Registration Information Registrants need to complete the registration form in order to participate in an ACO ADLS. Potential participants are also strongly encouraged to complete a comprehensive planning tool, which will allow them to take full advantage of the hands-on learning activities during the ADLS. The registration form and comprehensive planning tool are available on the ADLS Web site at https://acoregister.rti.org. Authority: Section 1115A of the Social Security Act. Dated: October 20, 2011. Donald M. Berwick, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2011–27958 Filed 10–27–11; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health The National Cancer Institute (NCI) Announces the Initiation of a Public Private Industry Partnership on Translation of Nanotechnology in Cancer (TONIC) To Promote Translational Research and Development Opportunities of Nanotechnology-Based Cancer Solutions National Cancer Institute (NCI), Office of Cancer Nanotechnology Research (OCNR), National Institutes of Health (NIH), Department of Health and Human Services (HHS). AGENCY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 ACTION: Notice. The Alliance for Nanotechnology in Cancer of the National Cancer Institute (NCI) is initiating a public private industry partnership called TONIC (Translation Of Nanotechnology In Cancer) to promote translational research and development opportunities of nanotechnology-based cancer solutions. An immediate consequence of this effort will be the formation of a consortium involving government and pharmaceutical, and biotechnology companies. This consortium will evaluate promising nanotechnology platforms and facilitate their successful translation from academic research to clinical environment, resulting in safe, timely, effective and novel diagnosis and treatment options for cancer patients. The purpose of this notice is to inform the community about the Alliance for Nanotechnology in Cancer of NCI’s intention to form the consortium and to invite eligible companies (as defined in last paragraph) to participate. DATES: Interested parties should contact Ms. Sonia Calcagno (calcagnosl@mail.nih.gov) and inform her of their intention to participate. This notice will remain open to accept the inquiries and letters of intent. FOR FURTHER INFORMATION CONTACT: Ms. Sonia Calcagno (calcagnosl@mail.nih.gov). SUMMARY: SUPPLEMENTARY INFORMATION: Background: The National Cancer Institute established the Alliance for Nanotechnology in Cancer (ANC) program in September 2004 to facilitate the discovery and development of innovative nanotechnologies for applications in cancer prevention, diagnosis, and treatment and to address different stages of the developmental pipeline ranging from discovery, applied research through translation. The program has been providing funding to academic groups to support large multi-disciplinary projects— Centers for Cancer Nanotechnology Excellence (CCNEs) along with smaller Cancer Nanotechnology Platform Partnerships (CNPPs) and training programs. NCI also formed an intramural laboratory, the Nanotechnology Characterization Laboratory (NCL), to serve as a centralized facility to characterize nanomaterials. A proposed TONIC consortium will operate in parallel with the Alliance program and will bring together individuals from sufficiently capitalized pharmaceutical, biotechnology and E:\FR\FM\28OCN1.SGM 28OCN1 sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 209 / Friday, October 28, 2011 / Notices other healthcare-related companies and start-ups, which either have ongoing internal efforts within their organization or have strategic interest in evaluating the nanotechnology platforms for oncology care solutions, through participating in a academic-private partnership aimed at promoting translational opportunities. Consortium Goals: Specifically, the TONIC consortium will undertake the key tasks of: 1. Creating a Discussion Forum for opportunities in the nanotechnology platform drug delivery, monitoring and imaging specifically in cancer, but may extend it to other therapeutic indications if an opportunity arises; 2. Developing a Roadmap for the development of nanotechnology-based cancer products; 3. Developing a robust translational model to move promising opportunities based on nanotechnology from academic research to the clinical environment; 4. Evaluating the most promising technology candidates within existing R&D developments and generating Case Studies based on them; 5. Recognizing and promoting translational efforts at every stage of development through appropriate partnerships among industry, academia, government, and philanthropy. Consortium Membership: Membership to the TONIC consortium will be limited to companies which (1) Have a successful track record of translating diagnostics and drug formulations and reaching their regulatory approval and, (2) are engaged in the development of nanotechnologybased formulations with application to imaging, diagnostics and therapy. In addition, these companies should have (1) A corporate structure with centralized operations and, (2) the capability and resources to move along the translational efforts effectively and to provide feedback to the academic researchers on industry technological needs. Consortia members will be expected to attend regular meetings and participate in the project evaluation funded through TONIC consortium. The following information must be provided by parties interested in participating in the consortium: (1) The company profile; (2) The name and specific function of the company representative for the TONIC consortium; and (3) A brief rationale and/or statement of intent for participating in the consortium. VerDate Mar<15>2010 16:56 Oct 27, 2011 Jkt 226001 Dated: October 21, 2011. Piotr Grodzinski, Director, Office of Cancer Nanotechnology Research, Center for Strategic and Scientific Initiatives, National Cancer Institute. 66933 DEPARTMENT OF HOMELAND SECURITY For general questions please contact: Marilyn Scott-Perez ((202) 475–3515), Privacy Officer, U.S. Coast Guard, 2100 2nd Street SW., Mail Stop 7101, Washington, DC 20593. For privacy issues please contact: Mary Ellen Callahan ((703) 235–0780), Chief Privacy Officer, Privacy Office, U.S. Department of Homeland Security, Washington, DC 20528. Office of the Secretary SUPPLEMENTARY INFORMATION: [Docket No. DHS–2011–0072] I. Background Privacy Act of 1974; Department of Homeland Security U.S. Coast Guard DHS/USCG—014 Military Pay and Personnel System of Records In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS) U.S. Coast Guard (USCG) proposes to update and reissue an existing DHS/USCG system of records titled, ‘‘DHS/USCG–014 Military Pay and Personnel System of Records’’ 73 FR 77743, December 19, 2008. This system of records notice allows the USCG to collect and maintain records regarding pay and personnel. As a result of the biennial review of this system, categories of individuals covered by the system have been updated to include active and reserve service applicants and prospective applicants, civilian personnel, USCG Auxiliary members, USCG exchange employees, and contractor personnel. Records in the categories of records in the system have been updated to include other Health Insurance Portability and Accountability Act (HIPAA) related/protected data, background investigation and security clearance information, government credit card status, data related to information technology (IT) training, and information technology system accounts, roles, and permissions. The purpose category has been updated to include active and reserve service applicants and prospective applicants, and separated military personnel, USCG civilian personnel, USCG Auxiliary members, USCG exchange employees, and USCG contractor personnel in addition to the continuity of operations (COOP)/personnel accountability function. Lastly, routine uses of records maintained in the system, including categories of users and the purposes of such uses have been updated to include relevant insurance companies for the purpose of health and life insurance requests and eligibility and to the Department of Defense (DoD) for the purpose of preparing for and during actual emergencies, exercises or continuity of operations tests for the purpose of responding to emergency situations or to allow emergency service personnel to locate the individual(s). [FR Doc. 2011–27939 Filed 10–27–11; 8:45 am] BILLING CODE 4140–01–P Privacy Office, DHS. Notice of Privacy Act system of AGENCY: ACTION: records. In accordance with the Privacy Act of 1974, the Department of Homeland Security proposes to update and reissue an existing Department of Homeland Security system of records titled, ‘‘Department of Homeland Security U.S. Coast Guard—014 Military Pay and Personnel System of Records.’’ This system of records allows the Department of Homeland Security U.S. Coast Guard to collect and maintain records regarding pay and personnel. As a result of a biennial review of this system, records have been updated in the categories of individuals, categories of records, purpose, and routine uses. This updated system will be included in the Department of Homeland Security’s inventory of record systems. DATES: Submit comments on or before November 28, 2011. This new system will be effective November 28, 2011. ADDRESSES: You may submit comments, identified by docket number DHS– 2011–0072 by one of the following methods: • Federal e-Rulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. • Fax: 1 (703) 483–2999. • Mail: Mary Ellen Callahan, Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528. • Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change to https:// www.regulations.gov, including any personal information provided. • Docket: For access to the docket, to read background documents, or comments received, go to https:// www.regulations.gov. SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: E:\FR\FM\28OCN1.SGM 28OCN1

Agencies

[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Notices]
[Pages 66932-66933]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27939]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


The National Cancer Institute (NCI) Announces the Initiation of a 
Public Private Industry Partnership on Translation of Nanotechnology in 
Cancer (TONIC) To Promote Translational Research and Development 
Opportunities of Nanotechnology-Based Cancer Solutions

AGENCY: National Cancer Institute (NCI), Office of Cancer 
Nanotechnology Research (OCNR), National Institutes of Health (NIH), 
Department of Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Alliance for Nanotechnology in Cancer of the National 
Cancer Institute (NCI) is initiating a public private industry 
partnership called TONIC (Translation Of Nanotechnology In Cancer) to 
promote translational research and development opportunities of 
nanotechnology-based cancer solutions. An immediate consequence of this 
effort will be the formation of a consortium involving government and 
pharmaceutical, and biotechnology companies. This consortium will 
evaluate promising nanotechnology platforms and facilitate their 
successful translation from academic research to clinical environment, 
resulting in safe, timely, effective and novel diagnosis and treatment 
options for cancer patients.
    The purpose of this notice is to inform the community about the 
Alliance for Nanotechnology in Cancer of NCI's intention to form the 
consortium and to invite eligible companies (as defined in last 
paragraph) to participate.

DATES: Interested parties should contact Ms. Sonia Calcagno 
(calcagnosl@mail.nih.gov) and inform her of their intention to 
participate. This notice will remain open to accept the inquiries and 
letters of intent.

FOR FURTHER INFORMATION CONTACT: Ms. Sonia Calcagno 
(calcagnosl@mail.nih.gov).

SUPPLEMENTARY INFORMATION: 
    Background: The National Cancer Institute established the Alliance 
for Nanotechnology in Cancer (ANC) program in September 2004 to 
facilitate the discovery and development of innovative nanotechnologies 
for applications in cancer prevention, diagnosis, and treatment and to 
address different stages of the developmental pipeline ranging from 
discovery, applied research through translation. The program has been 
providing funding to academic groups to support large multi-
disciplinary projects--Centers for Cancer Nanotechnology Excellence 
(CCNEs) along with smaller Cancer Nanotechnology Platform Partnerships 
(CNPPs) and training programs. NCI also formed an intramural 
laboratory, the Nanotechnology Characterization Laboratory (NCL), to 
serve as a centralized facility to characterize nanomaterials.
    A proposed TONIC consortium will operate in parallel with the 
Alliance program and will bring together individuals from sufficiently 
capitalized pharmaceutical, biotechnology and

[[Page 66933]]

other healthcare-related companies and start-ups, which either have 
ongoing internal efforts within their organization or have strategic 
interest in evaluating the nanotechnology platforms for oncology care 
solutions, through participating in a academic-private partnership 
aimed at promoting translational opportunities.
    Consortium Goals: Specifically, the TONIC consortium will undertake 
the key tasks of:
    1. Creating a Discussion Forum for opportunities in the 
nanotechnology platform drug delivery, monitoring and imaging 
specifically in cancer, but may extend it to other therapeutic 
indications if an opportunity arises;
    2. Developing a Roadmap for the development of nanotechnology-based 
cancer products;
    3. Developing a robust translational model to move promising 
opportunities based on nanotechnology from academic research to the 
clinical environment;
    4. Evaluating the most promising technology candidates within 
existing R&D developments and generating Case Studies based on them;
    5. Recognizing and promoting translational efforts at every stage 
of development through appropriate partnerships among industry, 
academia, government, and philanthropy.
    Consortium Membership: Membership to the TONIC consortium will be 
limited to companies which (1) Have a successful track record of 
translating diagnostics and drug formulations and reaching their 
regulatory approval and, (2) are engaged in the development of 
nanotechnology-based formulations with application to imaging, 
diagnostics and therapy.
    In addition, these companies should have (1) A corporate structure 
with centralized operations and, (2) the capability and resources to 
move along the translational efforts effectively and to provide 
feedback to the academic researchers on industry technological needs.
    Consortia members will be expected to attend regular meetings and 
participate in the project evaluation funded through TONIC consortium.
    The following information must be provided by parties interested in 
participating in the consortium:
    (1) The company profile;
    (2) The name and specific function of the company representative 
for the TONIC consortium; and
    (3) A brief rationale and/or statement of intent for participating 
in the consortium.

    Dated: October 21, 2011.
Piotr Grodzinski,
Director, Office of Cancer Nanotechnology Research, Center for 
Strategic and Scientific Initiatives, National Cancer Institute.
[FR Doc. 2011-27939 Filed 10-27-11; 8:45 am]
BILLING CODE 4140-01-P
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