As prescribed in 1535.007-70(h), insert the following contract clause:
(a) Definitions. As used in this clause -
Institution means any government agency (Federal, State, tribal, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity conducting research.
Life Sciences research means a systematic investigation designed to develop or contribute to generalizable knowledge involving living organisms (e.g., microbes, human beings, animals, and plants) and their products, including all disciplines and methodologies of biology such as aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, microbiology, synthetic biology, virology, molecular biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches to understanding life at the level of ecosystems, populations, organisms, organs, tissues, cells, and molecules. Life sciences research does not include routine product testing, quality control, mapping, collection of general-purpose statistics, routine monitoring and evaluation of an operational program, observational studies, and the training of scientific and technical personnel.
(b) Compliance. The Contractor agrees that it shall comply with the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” (iDURC Policy) during the period of performance of this contract, including all option periods or other extensions, if the Contractor:
(1) Is an institution within the United States that conducts or sponsors, or begins to conduct or sponsor life sciences research that involves one or more of the agents or toxins listed in Section 6.2.1 of the iDURC Policy, even if the research is not supported by United States Government funds; or
(2) Is an institution outside the United States that receives funds through this contract to conduct or sponsor research that involves one or more of the agents or toxins listed in Section 6.2.1 of the iDURC Policy.
(c) Resources. Information about dual use research in the life sciences as well as specific details on the iDURC Policy can be found on the U.S. Department of Health and Human Services Dual Use Research of Concern page: http://www.phe.gov/s3/dualuse/Pages/default.aspx.
(End of clause)
[81 FR 24500, Apr. 26, 2016]