This PDF is the current document as it appeared on Public Inspection on 02/22/2013 at 08:45 am.
Office of Research and Development, VA.
The Department of Veterans Affairs (VA) publishes this Request for Information (RFI) on public-private collaborations in pain research, seeking to connect the Veterans Health Administration's (VHA) Office of Research and Development (ORD) with commercial organizations that are conducting, or have an interest in conducting, pain research through a Cooperative Research and Development Agreement (CRADA). The CRADA is to develop public-private collaborations in pain research with the intent of developing novel therapies that will benefit Veterans suffering from chronic pain conditions.
This notice will remain open indefinitely to accept inquiries and responses.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Interested parties should contact Audrey Kusiak, Ph.D., Scientific Program Manager, at (202) 443-5770 or by email at firstname.lastname@example.org. Please use the subject line: “VHA CO ORD PAIN PUBLIC PRIVATE COLLABORATIONS.” You may also write to Veterans Health Administration, Office of Research and Development (10P9R), 810 Vermont Avenue NW., Washington, DC 20420. When responding, please provide the name of your organization, the main area of research interest, your name and title, and contact information (including mailing address, email address, and phone number). Do not include proprietary, classified, confidential, or sensitive information in your response.End Further Info End Preamble Start Supplemental Information
VA is seeking to identify commercial organizations that are interested in the development and translation of novel therapies for chronic pain. Collaboration will be made via a CRADA under the authority of the Federal Technology Transfer Act of 1986 (FTTA), Public Law 99-502, October 20, 1986, codified at 15 U.S.C. 3710a. Under the FTTA, VA and the private party may exchange personnel, services, facilities, equipment, intellectual property, or other resources. No Federal funds may be provided to the collaborator, but the VA laboratory is authorized to accept Federal funds. VA may grant to the collaborating party a license or an assignment to inventions made under the CRADA. VA will select collaborators based on a mutually beneficial relationship that is fair and equitable, with the goal of alleviating pain in the Veteran population.
Under the CRADA, VA's duties will include connecting industry collaborators with appropriate VA investigators conducting pain research. Further, VA will provide expertise in the development and implementation of pre-clinical testing (e.g., good laboratory practice) of viable therapies to investigational new drugs; design and implementation of clinical trials; and development of a data-sharing plan.
This RFI invites feedback from private entities that are interested in conducting public-private collaborations with VA that is focused on translational research of chronic pain. Area(s) of interest to VA include, but are not limited to, the following:
(a) Building on the clinical usefulness of animal models and outcome measures;
(b) Capitalizing on the heterogeneity and complexity of the VA pain population;
(c) Developing relevant therapeutic strategies for the treatment of polytrauma associated pain, including phantom limb, neuropathic pain, headaches, complex regional pain syndrome, burns, chronic back pain, arthritic (joint) pain, etc.;
(d) Conditions co-existing with chronic pain such as Post-traumatic Stress Disorder, fibromyalgia, irritable bowel syndrome, and chronic fatigue syndrome, and how these conditions contribute to pain perception;
(e) Understanding the mechanisms in the development of acute to chronic pain and how to modulate them; and
(f) Safety and the abusive nature of opioid medication.
VA will evaluate submissions, and selected candidates will be requested to enter into a CRADA with VA. Special consideration will be given to small business firms and consortia involving small business firms. Preference will also be given to businesses located in the United States, which agree that those products embodying inventions made under the CRADA will be manufactured substantially in the United States as provided for in 15 U.S.C. 3710a(c)(4).
This RFI does not obligate VA to enter into a CRADA with any respondents. VA reserves the right to establish a CRADA based on scientific analysis and capabilities found by way of this announcement or other searches, if determined to be in the best interest of the government.Start Signature
Approved: February 14, 2013.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.
[FR Doc. 2013-04248 Filed 2-22-13; 8:45 am]
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