Sec. 499B–2. Expedited Long COVID research
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The Director of NIH shall establish a process to expedite the award of grants, contracts, and cooperative agreements for research projects conducted or supported by the National Institutes of Health and relating to Long COVID. With respect to programs of grants, contracts, and cooperative agreements described in subsection (a), the Director of NIH shall— make publicly available the deadlines for submitting applications for such programs, and ensure that such deadlines provide applicants with sufficient time from the date of the announcement for such grant, contract, and cooperative agreement to submit an application; ensure that applicants receive a final decision on their applications within 120 days of submission; and with respect to applications that are denied, provide a written explanation to the applicant on the reasons for the denial.
In making a determination to award a grant, contract, and cooperative agreement for research projects described in subsection (a), the Director of NIH shall— give priority to research that— tests the outcomes of existing drug and device interventions in patients with Long COVID; focuses on identifying interventions for pediatric patients with Long COVID; aids in the development of new interventions that have evidence to suggest effectiveness in treating or curing Long COVID; or includes institutions that represent, or have a successful track record of providing equitable care or services to, historically underserved communities; consider research that has the ability to begin interventions in a timely manner; consider research that uses decentralized trials or remote monitoring techniques for data collection; and consider research that includes patients with other infection-associated chronic conditions with similar phenotypes, such as myalgic encephalomyelitis/chronic fatigue syndrome, postural orthostatic tachycardia syndrome, and post-treatment Lyme disease syndrome/persistent Lyme disease.
In awarding contracts, grants, and cooperative agreements for research projects described in subsection
(a)that relates to the development of a drug or device for the potential treatment or management of Long COVID, or identifying a new indication or use specific to the treatment or management of Long COVID in a drug or device that is already approved or cleared by the Food and Drug Administration, the Director of NIH shall include terms and conditions requiring that the price of such a drug or device for purposes of procurement by the Federal Government or if sold on the commercial market, whether procured from, or sold by, the recipient of such Federal award or another person— is fair and reasonable, taking into account— the value of the drug and device to the public health, including the impact of the price on access to the drug or device; the costs incurred by the Federal Government in research and development of the drug or device; the costs incurred by the recipient of the award in research and development of the drug or device, and the costs of manufacturing such drug or device; whether the drug or device provided a significant improvement in health outcomes, compared to other therapies available at the time of its approval or authorization; the cumulative expected global revenues generated by the drug or device; and other factors, as the Secretary determines appropriate; and does not exceed the lowest price charged for such drug or device, among Canada, France, Germany, Italy, Japan, and the United Kingdom. In making a determination to award a grant, contract, or cooperative agreement for research projects relating to Long COVID, the Director of NIH shall consult with the Long COVID Research Advisory Board. Members of the Long COVID Research Advisory Board shall provide a recommendation on any final funding decisions. If the Director of NIH makes a decision that is different than the recommendation, the Director of NIH shall provide a written justification for the decision within 5 days.