Department of Veterans Affairs grant program for supplemental neurorehabilitation approaches to chronic mild TBI treatment
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(a) Grant program (1) In general The Secretary of Veterans Affairs shall establish carry out a grant three-year program (to be known as the TBI Innovation Grant Program) to under which the Secretary shall award grants to eligible entities described in subsection (b) for the development, implementation, and evaluation of approaches and methodologies for prospective randomized control trials for neurorehabilitation treatments for the treatment of chronic mild TBI (mTBI) traumatic brain injury (in this Act referred to as mTBI) in veterans. (2) Relationship to other Department activities The grant program required under paragraph (1) shall be carried out in a manner that— (A) supplements, and does not supplant, other clinical care and research of the Department of Veterans Affairs relating to mTBI; and (B) facilitates, as practicable, coordination with Veterans Health Administration facilities for referral, continuity of care, and dissemination of findings. (b) Eligible entities described An eligible entity described in this subsection is any of the following: (1) A nonprofit organization. organization with demonstrated capability to conduct clinical trials and to deliver or research effective neurorehabilitation treatments for mTBI, including through patient care delivery. (2) An academic institution engaged in that conducts significant research with respect on mTBI and has demonstrated capability to TBI. conduct clinical trials relating to neurorehabilitation treatments. (3) A non-Department health care provider with expertise in neurorehabilitative therapies. therapies and demonstrated capability to conduct clinical trials and to evaluate mTBI treatments through patient care delivery. (4) An entity the Secretary determines appropriate for an award A partnership or consortium of a grant under this section. two or more entities described in paragraphs (1) through (3). (c) Use of funds An eligible entity in receipt of a grant under this section shall use such grant to support activities that include— (1) designing and testing novel or integrative treatments for mTBI that prioritize patient-centered care, including non-pharmacological therapies; (2) conducting clinical studies and assessments to measure the effectiveness of funded approaches to— (A) improve mental health outcomes among veterans; (B) reduce suicidality, and common risk factors for completing suicide, including depression and substance use disorders among veterans; and (C) mitigate long-term effects of mTBI; mTBI and, to the extent outcomes are collected under the applicable clinical protocol, measure durability of outcomes at approximately six months following completion of treatment; (3) providing training for clinicians and outreach to veterans and their families to improve awareness and accessibility of innovative mTBI treatments; treatments, including information on available Department resources and pathways to access such resources; and (4) establishing partnerships with community organizations, academic institutions, and health care facilities, including, as practicable, coordination with Veterans Health Administration facilities to facilitate referral of the Department eligible veterans, continuity of Veterans Affairs to implement care, and evaluate best practices. dissemination of aggregate findings. (d) Limitation on grant amount The Secretary may not award an eligible entity a grant under this section in an amount that exceeds $5,000,000 per for any fiscal year. (e) Priority In awarding grants under this section, the Secretary shall give priority to eligible entities that the Secretary determines have demonstrated experience in delivering or researching effective treatments for mTBI. (f) Program administration (1) Applications An eligible entity desiring a grant under this section shall submit to the Secretary an application in such form, at such time, and containing such information and assurances as the Secretary determines appropriate, including a detailed description of— (A) activities proposed activities; to be conducted using the grant; (B) expected outcomes; and outcomes of such activities; (C) plans for evaluating effectiveness. the effectiveness of such activities; (D) how the eligible entity will coordinate, as practicable, with Veterans Health Administration facilities for referral and continuity of care for veterans who participate in activities carried out using grant funds, and for dissemination of aggregate findings; (E) the budget of the entity for the use of the grant, including a narrative justification and an identification of the estimated amount of grant funds to be used for administrative or overhead costs; and (F) assurances of compliance with applicable Federal laws and regulations relating to human subjects protections and patient safety. (2) Priority In awarding grants under this section, the Secretary shall give priority to eligible entities that have demonstrated the capacity to coordinate with the Department to facilitate referral and continuity of care for veterans who participate in activities carried out using grant funds. (3) Periodic reports An eligible entity in receipt As a condition of receiving a grant under this section section, an eligible entity shall, not less frequently than annually, annually during the grant period and not later than 180 days after the end of the grant period, submit to the Secretary a report that includes, with respect to the period covered by the report— (A) a description of how the eligible entity used such grant; (B) a summary of the progress of activities funded with amounts from such grant; and (C) measured outcomes relating to such activities. (3) activities; (D) a detailed accounting of expenditures of grant funds, including administrative or overhead costs; (E) to the extent collected under the applicable clinical protocol or in the ordinary course of care, a description of any adverse events and serious adverse events, including self-harm or suicide-related events; and (F) a description of actions taken pursuant to the coordination plan described in paragraph (1)(D). (4) Oversight; annual evaluations The Secretary shall— (A) ensure rigorous oversight with respect to of the grant program under this section; section, including by monitoring financial compliance and timely receipt of the reports required under paragraph (2); and (B) on an annual basis during until the period the authority to carry out the grant program is effective, termination date specified in subsection (i)(1), evaluate the efficacy of activities funded carried out using grant funds based on the reports submitted under paragraph (2) and other appropriate information. (5) Rule of construction Nothing in this section shall be construed to authorize the Secretary to require prior approval of, or changes to, any clinical protocol, study design, outcome measures, or follow-up schedule of an eligible entity that receives a grant under this section, except as necessary to ensure compliance with applicable Federal laws and regulations relating to human subjects protections and patient safety. (6) Enforcement authority The Secretary may suspend, modify, or terminate a grant awarded under such program. (g) Coordination with VA mental health services The this section, if the Secretary shall ensure determines that the recipient of such grant program has failed to comply with reporting requirements under this section aligns with the Staff Sergeant Fox Suicide Prevention Grant Program paragraph (2) or other applicable terms and conditions of the Department to— (1) provide for cohesive and comprehensive support for veterans with mTBI and associated mental health conditions; and (2) increase research and development on integrated mTBI and mental health interventions outside of the scope of traditional Department of Veterans Affairs pathways, interventions, programs, procedures, and pharmaceuticals. (h) Regulations Not later than 180 days after the date of the enactment of this Act, the Secretary shall prescribe regulations to carry out this section. (i) grant. (f) Available amounts; authorization of appropriations (1) Available amounts The Secretary may carry out the program under this section using amounts available to the Secretary for general mental health care programs, if the use of such amounts supplements, and does not supplant, amounts otherwise available for Department mental health and traumatic brain injury programs. (2) Authorization of appropriations There are is authorized to be appropriated to the Secretary $30,000,000 $10,000,000 for each of fiscal years 2026 through 2028 to carry out the pilot program under this section, which shall remain available until expended. (j) section. (g) Duration; annual review (1) Duration The authority of the Secretary to carry out the grant program under this section shall terminate at on the end of the 3-year period beginning on date that is three years after the date of the enactment of this Act. Act, except that the Secretary may continue to use amounts made available to carry out this section after such date solely for the purpose of administering activities and obligations incurred before such termination date. (2) Annual review During such three-year period, the Secretary shall, on an annual basis, review the effectiveness of such the grant program to determine the potential of such grant program for continuation or expansion.
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