U. S. Department of health and human services (hhs), the national institutes of health (nih) and the centers for disease control and prevention (cdc) small business innovative research (sbir) program
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ar.5Care of Vertebrate AnimalsThe following notice is applicable when contract performance is expected to involve live vertebrate animals: Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, HHSAR 352.270-5 (January 2006) The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes a number of requirements for research activities involving animals. Before award may be made to an applicant organization, the organization shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance with the PHS Policy, applicant organizations must establish an Institutional Animal Care & Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution's animal program, facilities and procedures. Applicant organizations are required to provide verification of IACUC approval prior to release of an award involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects that involve live vertebrate animals that an Assurance and verification of IACUC approval are required. The Contracting Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of IACUC approval. For further information contact OLAW, at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 (E-mail: olaw@od.nih.gov; Phone: 301-496-7163). The PHS Policy is available on the internet at: http://www.grants.nih.gov/grants/olaw/olaw.htm. ar.6Research Involving Recombinant or Synthetic Nucleic Acid MoleculesRecombinant or synthetic nucleic acid molecules are either(i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids; or, (iii) molecules that result from the replication of those described in (i) or (ii) above. All research involving recombinant or synthetic nucleic acid molecules that is conducted at or sponsored by an entity that receives any support for recombinant or synthetic nucleic acid molecules research from NIH shall be conducted in accordance with the or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Guidelines stipulate biosafety and containment measures for recombinant or synthetic nucleic acid molecules research and delineate points to consider in the development and conduct of human gene transfer clinical trials, including ethical principles and safety reporting requirements (See Appendix M of the Guidelines). More information about compliance with the NIH Guidelines can be found in a set of Frequently Asked Questions. The NIH Guidelines apply to both basic and clinical research studies. Prior to beginning any clinical trials involving the transfer of recombinant or synthetic nucleic acid molecules to humans, the trial must be registered with the NIH OBA and reviewed by the NIH Recombinant DNA Advisory Committee (RAC). If this contract involves new protocols that contain unique and/or novel issues, the RAC may recommend that the protocol also be discussed by the RAC in a public forum. Approval of the Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB) are necessary before the Contracting Officer's Representative (COR) and Contracting Officer may approve the protocol prior to the start of the research. The IBC approval may not occur before the NIH RAC has concluded its review of the protocol. Failure to comply with the NIH Guidelines may result in suspension, limitation, or termination of the contract for any work related to recombinant or synthetic nucleic acid molecules research or a requirement for Contracting Officer prior approval of any or all recombinant or synthetic nucleic acid molecules projects under this contract. This includes the requirements of the Institutional Biosafety Committee (IBC). As specified in Appendix M-1-C-4 of the NIH Guidelines, any serious adverse event that that is both unexpected and associated with the use of the gene transfer product (i.e., there is reasonable possibility that the event may have been caused by the use of the product) must be reported to the NIH OBA and IBC within 15 days, or within 7 days if the event was life-threatening or resulted in a death. A copy of the report must also be filed with the COR and Contracting Officer. Such reports must also be submitted within their mandated time frames to the IRB, Food and Drug Administration, and, if applicable, the HHS Office for Human Research Protections. ar.7DebriefingAn unsuccessful offeror that submits a written request for a debriefing within 3 days of being notified that its proposal was not selected for award will be provided a debriefing. Please note that Component-unique debriefing processes exist; in those cases, the Component debriefing instructions supersede instructions provided here. The written request should be sent to the HHS organization that provided such notification to the offeror. Be advised that an offeror that fails to submit a timely request is not entitled to a debriefing, although untimely debriefing requests may be accommodated at the Government's discretion. Directory: grants -> funding -> SBIRContract SBIRContract -> U. S. Department of health and human services (hhs), the national institutes of health (nih) and the centers for disease control and prevention (cdc) small business innovative research (sbir) program Download 0.57 Mb. Share with your friends:
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