NIH Cooperative Research and Development Agreement Program: Invitation To Solicit Nonclinical and Clinical Research Proposals From NIH Intramural Research Program Scientists

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

The Office of Technology Transfer (OTT), Office of the Director (OD), the National Institutes of Health (NIH), invites industry organizations (including corporations, partnerships, limited partnerships, and industrial development organizations); public and private foundations and nonprofit organizations to solicit research proposals from scientists across the NIH Intramural Research Program (IRP) for multiple focused research projects under a the NIH Cooperative Research And Development Agreement (CRADA) Program. This CRADA Program is an extension of collaboration opportunities solicited by NIH or developed on a one-on-one basis. As such, it is consistent with PHS Technology Transfer policy and the public health mission of the NIH. These collaboration opportunities are structured under the authority of 15 U.S.C. 3710a—Cooperative Research and Development Agreements. Note that the CRADA mechanism does not permit the transfer of funds from the NIH to a collaborator but does permit the collaborator to provide funding to the NIH researcher.

FOR FURTHER INFORMATION CONTACT:

Ann Hammersla, J.D., Director, Division of Policy, Office of Technology Transfer, NIH, 6011 Executive Blvd., Suite 325, Rockville, MD 20852; Email: hammerslaa@od.nih.gov.

SUPPLEMENTARY INFORMATION:

The NIH Wide CRADA Program is a means for a single collaborative research partner to coordinate a number of focused research projects across the IRP of the NIH Institutes and Centers (ICs). The CRADA Program will be driven by the collaborator's interest to solicit research proposals from NIH IRP scientists in multiple ICs for highly focused collaborative research in areas of mutual interest. NIH investigators' proposals responsive to a solicitation will be reviewed by their IC's Scientific Director to assure that: (1) The proposed project advances the mission of that IC, (2) the scientist has the resources to complete his or her part of the project, and (3) the IC supports the use of the investigator's time and resources. Once the research proposal is approved by the IC Scientific Director, the NIH IRP scientist(s) will submit to the soliciting organization the non-confidential, non-binding research proposal. NIH research proposals selected by the organization will be developed more fully and if appropriate under confidentiality agreements governing the confidentiality and use of such additional information. The collaboration will be governed by CRADA terms that address intellectual property rights, publications, and reporting obligations using the model CRADA as a basis for negotiation, see: www.nih.gov/forms_model_agreements/forms_model agreements.aspx .

For each collaboration, the CRADA will include a specific Research Plan, which delineates the scope of the NIH and collaborator's research to be conducted and establishes benchmarks to chronicle its progress. The CRADA will include a description of the resources to be contributed by the collaborator (e.g., scientific expertise, R&D support, proprietary materials, and funding), and the NIH IC (e.g., scientific expertise, R&D support, and proprietary materials). The CRADA statute does not permit the NIH to provide funding to a collaborator. The NIH is willing to work with each collaborator to establish a CRADA template agreement to be used by any IC interested in collaborating under this type of CRADA Program.

NIH Criteria for Submitting a Summary Research Proposal to a Collaborator's Solicitation

Alignment with NIH IC scientific mission and identified public health objectives;

Advancement of NIH IRP scientist's ongoing research or an extension of that research; and

Availability of NIH resources sufficient to conduct the research project.