Code of Federal Regulations Title 48. Federal Acquisition Regulations System 48.1552.235-81 Institutional oversight of life sciences dual use research of concern—Representation

As prescribed in 1535.007(c), insert the following solicitation provision:

Institutional Oversight of Life Sciences Dual Use Research of Concern—Representation (JUNE 2016)

(a) Definitions. As used in this provision—

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) Representation. By submission of its offer or quotation, the Offeror represents that if it is:

(1) An institution within the United States that conducts or sponsors life sciences research that involves one or more of the agents or toxins listed in section 6.2.1 of the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” (iDURC Policy), even if the research is not supported by United States Government funds;  or

(2) An institution outside of the United States that receives funds 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;  then the Offeror will comply with 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 provision)