[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Page 71211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28917]


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DEPARTMENT OF VETERANS AFFAIRS


Request for Information: Establish a Public-Private 
Collaboration, ``Drug Development Initiative'' (DDI), for New 
Pharmacological Treatments for Post-Traumatic Stress Disorder (PTSD)

AGENCY: Office of Research and Development (ORD).

ACTION: Notice.

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SUMMARY: The Department of Veterans Affairs (VA) ORD publishes this 
Request for Information (RFI) to solicit interest in forming public-
private collaborations to develop new pharmacological treatments for 
PTSD. ORD is interested in developing collaborations with organizations 
that are interested in pursuing clinical trials specifically focused on 
PTSD. Such research would be detailed through a Cooperative Research 
and Development Agreement (CRADA) under the authority of the Federal 
Technology Transfer Act of 1986 (FTTA), Public Law 99-502, codified as 
amended in scattered sections of title 15, United States Code (U.S.C.). 
The CRADA will delineate the collaboration for PTSD treatment intended 
to test new drugs to benefit Veterans.

DATES: This notice will remain open to accept inquiries and responses.

FOR FURTHER INFORMATION CONTACT: Interested parties should contact 
Theresa Gleason, Ph.D., Senior Program Manager, Clinical Science 
Research and Development Service at (202) 443-5697 or by email at 
[email protected] to provide an intention to participate. Please use 
the subject line: ``DDI.''

SUPPLEMENTARY INFORMATION: ORD has long supported a robust research 
portfolio of studies focused on understanding and treating PTSD, a 
disorder prevalent in Veterans. VA research has contributed extensively 
to advancing knowledge regarding the neurobiological underpinnings and 
leading advances in treatment research through clinical trials, 
especially in the area of psychotherapeutic approaches. Our program has 
the capability to conduct small/early to large/definitive multi-site 
clinical trials with the support of the VA Cooperative Studies Program. 
To identify and test new drug therapies for PTSD and to address the 
continuing need to treat Veterans with this disorder is of high 
interest to VA. This RFI is an invitation for responses from entities 
interested in participating in this DDI focused on new pharmacological 
treatments for PTSD.
    Collaborations will be delineated via a CRADA under the authority 
of the FTTA at 15 U.S.C. 3710a. Under the FTTA, VA and the entity may 
exchange personnel, services, facilities, equipment, intellectual 
property, or other resources. No Federal funds may be provided to any 
third party collaborator, but the VA laboratory is authorized to accept 
funds. VA may grant to the collaborator party a license or an 
assignment to inventions made under the CRADA. We will select 
collaborators based on a mutually beneficial relationship that is fair 
and equitable and scientifically sound with the goal of advancing 
treatment for PTSD.
    Responses to this RFI should include the following information:
    a. Company profile;
    b. Name, contact, and function of company representative; and
    c. Brief rationale for proposed compound as candidate to be tested 
as new treatment for PTSD. Please do not include proprietary, 
classified, confidential, or sensitive information in your response, 
but provide scientific basis for the use of the compound and the 
general status of testing completed to date in human subjects (if any).
    We will evaluate DDI responses for interest. Selected potential 
collaborators may be invited to discussions to develop a CRADA and plan 
potential trials. Non-selected respondents will not receive additional 
feedback other than a non-selected notice. Special consideration will 
be given to small business firms and consortia involving small business 
firms. Preference will be given to businesses located in the United 
States which agree that 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 
respondent. 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.

    Approved: November 26, 2012.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.
[FR Doc. 2012-28917 Filed 11-28-12; 8:45 am]
BILLING CODE 8320-01-P