[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50424-50425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20046]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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: [email protected].

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

[[Page 50425]]

    Availability of NIH resources sufficient to conduct the research 
project.

    Dated: August 13, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-20046 Filed 8-16-13; 8:45 am]
BILLING CODE 4140-01-P