Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants, 42718-42719 [2016-15444]

Download as PDF 42718 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Department of Health and Human Services. ACTION: Notice. AGENCY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892–2479; telephone: 301–402–5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: Long Acting Therapeutic Conjugates With Evans Blue This invention is a platform technology that pertains to the advantages of conjugating therapeutics to Evans Blue thus providing long lasting pharmacokinetic profiles by complexing with albumin. Notably, albumin bound therapeutic- or prodrugEvans Blue conjugates provide a complex with a total molecular size above 60 kDa thus eliminating the risk for renal clearance. Interestingly, since albumin also crosses the blood-brain barrier and since all circulating Evans Blue is bound to albumin, Evans Blue bound therapeutics or prodrugs can also cross the blood-brain barrier. By way for example but not limitation, Evans Blue can be conjugated to insulin, GLP-1, exendin-4, exendin (9-39), octreotide, bombesin, RGD peptide (arginylglycylaspartic acid), vascular endothelial growth factor (VEGF), interferon (IFN), tumor necrosis factor (TNF), asparaginase, or adenosine deaminase, exenatide, dipeptidyl peptidase-4 inhibitors, neuropilin, epidermal growth factor, islet neogenesis associated protein, alpha-1 antitrypsin, anti-inflammatory agents, glulisine, glucagons, local cytokines, modulators of cytokines, anti-apoptotic VerDate Sep<11>2014 20:01 Jun 29, 2016 Jkt 238001 molecules, aptamers, asparaginase, adenosine deaminase, interferon a2a, interferon a2b, granulocyte colony stimulating factor, growth hormone receptor antagonists, doxorubicin, paclitaxel, gemcitabine, camptothecin, and temozolomide. Evans Blue conjugates according to this invention can additionally include radionuclides like 18F, 76Br, 124I, 125I, or 131I, or 117mSn for tracking or use in diagnostics. Potential Commercial Applications: —Diabetes therapeutics —Cancer therapeutics —CNS therapeutics —Pharmacokinetic/distribution studies Competitive Advantages: —long pharmacokinetic profile —no renal clearance of circulating drug Development Stage: • Early stage Inventors: Xiaoyuan Chen, Lixin Lang, Gang NIU (all of NIBIB). Intellectual Property: HHS Reference No. E–143–2015/0; U.S. Provisional Patent Application 62/182,694 filed June 22, 2015; International Patent Application PCT/US2016/38475 filed June 21, 2016. Licensing Contact: Michael Shmilovich, Esq, CLP; 301–435–5019; shmilovm@mail.nih.gov. Dated: June 23, 2016. Michael Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. [FR Doc. 2016–15442 Filed 6–29–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used for identifying potential developmental toxicants. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring. DATES: Receipt of information: Deadline is August 15, 2016. SUMMARY: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 Data and information should be submitted electronically to niceatm@niehs.nih.gov. FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (919) 316–4729. SUPPLEMENTARY INFORMATION: Background: NICEATM, which fosters the evaluation and promotion of alternative test methods for regulatory use, is supporting efforts to develop, validate, and implement alternative approaches for identifying potential developmental toxicants. The goal of these alternative approaches is to replace, reduce, or refine the use of animals in testing. Testing a chemical’s potential to cause developmental toxicity is required by multiple regulatory agencies and may require the use of large numbers of animals. Request for Information: NICEATM requests available data and information on approaches and/or technologies currently used to identify potential developmental toxicants. Respondents should provide information on any activities relevant to the development or validation of alternatives to in vivo developmental toxicity test methods currently required by regulatory agencies, including data from nonanimal chemical tests for developmental hazard potential. NICEATM also requests any available data resulting from in vivo developmental studies, ethical human or animal studies, or accidental human exposures, using the same chemicals. Respondents to this request for information should include their name, affiliation (if applicable), mailing address, telephone, email, and sponsoring organization (if any) with their communications. The deadline for receipt of the requested information is August 15, 2016. Responses to this notice will be posted at: https:// ntp.niehs.nih.gov/go/dev-nonanimal. Persons submitting responses will be identified on the Web page by name and affiliation or sponsoring organization, if applicable. Responses to this request are voluntary. No proprietary, classified, confidential, or sensitive information should be included in responses. This request for information is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to the request. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information. ADDRESSES: E:\FR\FM\30JNN1.SGM 30JNN1 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Notices Background Information on NICEATM: NICEATM conducts data analyses, workshops, independent validation studies, and other activities to assess new, revised, and alternative test methods and strategies. NICEATM also provides support for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3) provides authority for ICCVAM and NICEATM in the development of alternative test methods. Information about NICEATM and ICCVAM is found at https:// ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam. Dated: June 24, 2016. John R. Bucher, Associate Director, National Toxicology Program. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Notice. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892–2479; telephone: 301–402–5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Technology description follows. SUMMARY: National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. mstockstill on DSK3G9T082PROD with NOTICES BILLING CODE 4140–01–P ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel. Date: July 27, 2016. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: James T. Snyder, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities/ Room 3G31B, National Institutes of Health, NIAID, 5601 Fishers Lane MSC 9823, Bethesda, MD 20892–9823, (240) 669–5060, james.snyder@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, Jkt 238001 [FR Doc. 2016–15443 Filed 6–29–16; 8:45 am] HHS. BILLING CODE 4140–01–P 20:01 Jun 29, 2016 Dated: June 24, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. AGENCY: [FR Doc. 2016–15444 Filed 6–29–16; 8:45 am] VerDate Sep<11>2014 and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Multi-Photon Microscopy System Configured for Multiview Non-Linear Optical Imaging This invention is a microscopy device and system for multi-photon microscopy utilizing multi-view nonlinear optical imaging. Nonlinear optical imaging remains the premier technique for deep-tissue imaging in which typically a multi photon arrangement may be used to illuminate and excite a sample. However, the penetration depth, signal-to-noise ratio, and resolution of this technique is ultimately limited by scattering. The present system addresses these issues by sequential excitation of a sample through three or more objective lenses oriented at different axes intersecting the sample. Each objective lens is capable of focused sequential excitation that elicits fluorescence emissions from the excited sample, which is then PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 42719 simultaneously detected by each respective objective lens along a respective longitudinal axis. Including multiple lenses will improve the penetration depth and at the same time decrease the loss of detail because of scattering. The system also can overcome losses in spatial resolution because of the scattering of the excitation and emission light. Potential Commercial Applications: —High resolution multi-photon microscopy —Deep tissue visualization —Competitive Advantages: —Improved signal-to-noise ratio —improved spatial resolution —Development Stage: • Prototype Inventors: Yicong Wu (NIBIB), Hari Shroff (NIBIB), Jianyong Tang (NIAID), Ronald Germain (NIAID). Intellectual Property: HHS Reference No. E–229–2015/0; U.S. Provisional Patent Application 62/210,153 filed August 26, 2015. Licensing Contact: Michael Shmilovich, Esq, CLP; 301–435–5019; shmilovm@mail.nih.gov. Dated: June 24, 2016. Michael Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. [FR Doc. 2016–15441 Filed 6–29–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Member Conflict SEP. Date: July 6, 2016. E:\FR\FM\30JNN1.SGM 30JNN1

Agencies

[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42718-42719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15444]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Data and Information on Technologies Used for 
Identifying Potential Developmental Toxicants

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) requests 
available data and information on approaches and/or technologies 
currently used for identifying potential developmental toxicants. 
Submitted information will be used to assess the state of the science 
and determine technical needs for non-animal test methods used to 
evaluate the potential of chemicals to induce adverse effects in 
offspring.

DATES: Receipt of information: Deadline is August 15, 2016.

ADDRESSES: Data and information should be submitted electronically to 
niceatm@niehs.nih.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: warren.casey@nih.gov; telephone: (919) 316-4729.

SUPPLEMENTARY INFORMATION: 
    Background: NICEATM, which fosters the evaluation and promotion of 
alternative test methods for regulatory use, is supporting efforts to 
develop, validate, and implement alternative approaches for identifying 
potential developmental toxicants. The goal of these alternative 
approaches is to replace, reduce, or refine the use of animals in 
testing. Testing a chemical's potential to cause developmental toxicity 
is required by multiple regulatory agencies and may require the use of 
large numbers of animals.
    Request for Information: NICEATM requests available data and 
information on approaches and/or technologies currently used to 
identify potential developmental toxicants. Respondents should provide 
information on any activities relevant to the development or validation 
of alternatives to in vivo developmental toxicity test methods 
currently required by regulatory agencies, including data from non-
animal chemical tests for developmental hazard potential. NICEATM also 
requests any available data resulting from in vivo developmental 
studies, ethical human or animal studies, or accidental human 
exposures, using the same chemicals.
    Respondents to this request for information should include their 
name, affiliation (if applicable), mailing address, telephone, email, 
and sponsoring organization (if any) with their communications. The 
deadline for receipt of the requested information is August 15, 2016. 
Responses to this notice will be posted at: https://ntp.niehs.nih.gov/go/dev-nonanimal. Persons submitting responses will be identified on 
the Web page by name and affiliation or sponsoring organization, if 
applicable.
    Responses to this request are voluntary. No proprietary, 
classified, confidential, or sensitive information should be included 
in responses. This request for information is for planning purposes 
only and is not a solicitation for applications or an obligation on the 
part of the U.S. Government to provide support for any ideas identified 
in response to the request. Please note that the U.S. Government will 
not pay for the preparation of any information submitted or for its use 
of that information.

[[Page 42719]]

    Background Information on NICEATM: NICEATM conducts data analyses, 
workshops, independent validation studies, and other activities to 
assess new, revised, and alternative test methods and strategies. 
NICEATM also provides support for the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM 
Authorization Act of 2000 (42 U.S.C. 285l-3) provides authority for 
ICCVAM and NICEATM in the development of alternative test methods. 
Information about NICEATM and ICCVAM is found at https://ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam.

    Dated: June 24, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-15444 Filed 6-29-16; 8:45 am]
 BILLING CODE 4140-01-P
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