Department of Health and Human Services July 9, 2008 – Federal Register Recent Federal Regulation Documents

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. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice is for planning purposes only. It does not constitute a solicitation or Request for Proposal (RFP), nor does it restrict the Government as to the ultimate acquisition approach. The Government does not intend to award a contract on the basis of this RFI or to otherwise pay for the information solicited. Any contract that might be awarded based on information received or derived from this RFI will be the outcome of the competitive process. Any purchases that might result from information received or derived from this RFI will be at the discretion of the Government. Purpose: To ensure development of a rigorous and comprehensive battery of HTS assays, the NTP seeks information and comments on the identification and selection of critical cellular toxicity pathways for interrogation in cell-based high throughput screens. The NTP is also interested in receiving recommendations on particular molecular targets within these critical cellular toxicity pathways that are most informative for profiling the pathways, both in cell-based and biochemical assay formats. In addition to information on cellular pathways and targets, the NTP seeks information on technologies and assay systems that might be used in the development of a comprehensive approach to high throughput toxicity screening. Responses to RFI: The Government requests a brief (no more than 1 page) description of the proposed presentation addressing one or more of the points listed below or other directly related topics. In considering responses to this RFI, please keep in mind the assay protocol requirements for assays run at the NIH Chemical Genomics Center (NCGC) (https://www.ncgc.nih.gov/guidance/HTS_Assay_Guidance_ Criteria.html ). Recommendations on the identification and selection of critical cellular pathways involved in toxicity and associated with a phenotypic manifestation of toxicity in vivo (disease outcome). Information on assays that can be used to measure the activity of a compound on a target within a critical pathway. Information on the selection of the best targets within pathways and networks in order to accurately and fully characterize the activity of a compound within a specific pathway or the ability of a compound to trigger a stress-responsive pathway resulting in a defined toxicity or disease. Information on assays, technologies, or methods that will aid in identifying compounds which are active only after metabolic activation. New technologies or technologies under development that can be exploited in HTS programs, such as those underway at the NCGC or as secondary, targeted, follow-up testing to expand and more carefully characterize the findings from initial screens. All responses should include the following information: Company name, company address, name of presenter, telephone number, and e-mail address. Responses should be submitted by August 11, 2008, either electronically via the meeting Web site or by fax, e-mail, or mail to: Jennifer Smith, Contract Specialist, NIEHS, P.O. Box 12874, Mail Drop EC-02, 79 T.W. Alexander Drive, Building 4401, Room 134, Research Triangle Park, NC 27709; fax: 919-541-2712; e-mail: smithj3@niehs.nih.gov. Responses will be reviewed to ensure that the Government, by extending an invitation to a party to participate in the RFI meeting, will receive information directly relevant to its HTS program for toxicity assessment and that the party fully understands the nature of the meeting and the type of information sought. Acknowledgement of receipt of responses will not be made nor will respondents be notified of the Government's assessment of the information received. No basis for claims against the Government shall arise as a result of a response to this request for information or in the Government's use of such information as either part of its evaluation process or to develop specifications for any subsequent announcement. Responses will not be returned. The summarized responses (without identifiers) may appear in internal reports or be made public. Although the NIH will provide safeguards to prevent the release of identifying information, there is no guarantee of confidentiality. Attendance and Registration: An informational public meeting will be held on September 11-12, 2008, at the National Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. Attendance at the meeting is limited only by the available space. The purpose of this meeting is for interested parties to provide the Government information about assays, molecular targets, and cellular pathways through brief presentations and a question and answer session. Parties interested in making a presentation at the meeting must register on the meeting Web site: (https://ntp.niehs.nih.gov/go/32908). Attendees not making presentations are also encouraged to register at the Web site for planning purposes. The Government anticipates that registered presenters will be allotted 20 minutes each for presentations (limit of one speaker per organization); however, the Government retains the right to limit the number of presentations and/ or limit the allotted time for presentations based upon the number of registered presenters. Presenters will be notified about the scheduled order of presentations and the list of presenters will be posted on the meeting Web site at least one week prior to the meeting. It is anticipated that the meeting will include time for questions and information exchange. The slides from the presentations may appear in internal reports or be made public. Further information will be made available on the meeting Web site. Persons needing interpreting services in order to attend should contact 301-402-8180 (voice) or 301- 435-1908 (TTY). For other special accommodations while on NIEHS campus, contact 919-541-2475 or e-mail niehsoeeo@niehs.nih.gov.