Sec. 702. NIH clinical trial
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Part A of title IV of the Public Health Service Act ( 42 U.S.C. 281 et seq.) is amended by adding at the end the following: The Secretary, acting through the Director of the National Institutes of Health, shall, not later than 2 years after the date of enactment of this Act, establish and implement a pilot program to award multi-year contracts to eligible entities to support phase II clinical trials and phase III clinical trials— to promote innovation in treatments and technologies supporting the advanced research and development and production of high need cures; and to provide support for the development of medical products and therapies.
To be eligible to receive assistance under the pilot program established under subsection (a), an entity shall— be seeking to market a medical product or therapy that is the subject of clinical trial or trials to be supported using such assistance; be a public or private entity, which may include a private or public research institution, a contract research organization, an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 )), a medical center, a biotechnology company, or an academic research institution; and comply with requirements of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product.
The Secretary, acting through the Director of National Institutes of Health, shall— in establishing the pilot program under subsection (a), consult with— the Director of the National Center for Advancing Translational Sciences and the other national research institutes in considering their requests for new or expanded clinical trial support efforts; and the Commissioner of Food and Drugs and any other head of a Federal agency as the Secretary determines to be appropriate to ensure coordination and efficiently advance clinical trial activities; in implementing the pilot program under subsection (a), consider consulting with patients and patient advocates; and in awarding contracts under the pilot program under subsection (a), consider— the expected health impacts of the clinical trial or trials to be supported under the contract; and the degree to which the medical product or therapy that is the subject of such clinical trial or trials is a high need cure.
A contract may not be awarded under the pilot program under subsection
(a)if the drug that is the subject of the clinical trial or trials to be supported under the contract is a drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act as a drug for a rare disease or condition. There is established in the Treasury an account, to be known as the NIH Clinical Trial Accelerator Account (referred to in this section as the Account ), for purposes of carrying out this section. There shall be transferred to the Account from the general fund of the Treasury, $680,000,000 for each of fiscal years 2021 through 2025, to be available until expended without further appropriation. Not later than 180 days after the date of enactment of this Act, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a work plan that includes the proposed implementation of this section and the proposed allocation of funds in the Account. Not later than October 1 of each fiscal year, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on— the implementation of this section; any available results on phase II clinical trials and phase III clinical trials supported under this section during such fiscal year; and the extent to which Federal funds are obligated to support such clinical trials, including the specific amount of such support and awards pursuant to an allocation from the Account under subsection (e). In this section: The term phase II clinical trial means a phase II clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations). The term phase III clinical trial means a phase III clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations). The term high need cure has the meaning given such term in section 480(a)(3). .
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