in determining a suitable distribution mechanism. For research and development contracts, approval should be obtained from the NIH Contracting Officer before distribution of unique resources, unless the terms of the contract permit distribution without prior clearance of the Contracting Officer. In order to facilitate the availability of unique or novel biological materials and resources developed with PHS funds, investigators may distribute the materials through their own laboratory or institution or submit them, if appropriate, to entities such as the American Type Culture Collection or similar repositories. In the case of unique biological information such as DNA sequences or crystallographic coordinates, investigators are expected to submit them to the appropriate data banks because they otherwise are not truly accessible to the scientific community. When distributing unique resources, investigators are encouraged to include pertinent information on the nature, or quality, or characterization of the materials.

Investigators must exercise great care to ensure that resources do not identify original donors or subjects, directly or through identifiers, such as codes linked to the donors or subjects.

Institutions and investigators may charge the requester, if necessary, for the reasonable cost of production of unique biological materials, and for packaging and shipping. Such costs may include personnel, supplies, and other directly related expenses. It should be noted, however, that such a charge accrues as general program income. This should not be an impediment to the distribution of materials, but investigators and institutions are advised that:

1. for grants, the income is governed by 45 CFR Part 74 and it must be reported on the Financial Status Report. Questions regarding these policies and the treatment of income should be directed to the Grants Management Officer.

2. for contracts, the income is governed by Federal Acquisition Regulations (FAR) 45.610-3. Contracting Officers must be contacted before generating any revenues from the distribution of materials. Any contract under which research resources would be sold requires specific contract instructions. Existing contracts may require an amendment and specific approval of the Contracting Officer to render them allowable.