No idea! Here are a few interesting snippets from the full text. It ranges on topics including expediting clinical trials, setting up shared resources for health data, creating a tick borne diseases task force, research incentives, relaxation on new drug and device regulations, and medicare changes. Beyond just regulatory changes, it offers billions in funding.
Subtitle C—Supporting Young Emerging Scientists
LOAN REPAYMENT PROGRAM.
“(a) In General.—The Secretary shall establish a program, based on workforce and scientific needs, of entering into contracts with qualified health professionals under which such health professionals agree to engage in research in consideration of the Federal Government agreeing to pay, for each year of engaging in such research, not more than $50,000 of the principal and interest of the educational loans of such health professionals.
“(b) Adjustment For Inflation.—Beginning with respect to fiscal year 2017, the Secretary may increase the maximum amount specified in subsection (a) by an amount that is determined by the Secretary, on an annual basis, to reflect inflation.
Subtitle D—Modern Trial Design And Evidence Development
SEC. 2061. BROADER APPLICATION OF BAYESIAN STATISTICS AND ADAPTIVE TRIAL DESIGNS.
21 U.S.C. 355
) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262
), the Secretary shall conduct a public meeting and issue guidance in accordance with subsection (b).
“SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.
“(a) In General.—The Secretary shall establish a program to evaluate the potential use of evidence from clinical experience—
“(1) to help to support the approval of a new indication for a drug approved under section 505(b); and
“(2) to help to support or satisfy postapproval study requirements.
“(b) Evidence From Clinical Experience Defined.—In this section, the term ‘evidence from clinical experience’ means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.
QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
(a) Findings.—Congress finds the following:
(1) Development of new drugs has become increasingly challenging and resource intensive.
(b) Sense Of Congress.—It is the sense of Congress that—
(1) Congress should promote and facilitate a collaborative effort among the biomedical research consortia described in subsection (a)(3)—
(A) to develop, through a transparent public process, data standards and scientific approaches to data collection accepted by the medical and clinical research community for purposes of qualifying drug development tools;
(B) to coordinate efforts toward developing and qualifying drug development tools in key therapeutic areas; and
(C) to encourage the development of accessible databases for collecting relevant drug development tool data for such purposes; and
CLINICAL TRIAL DATA SYSTEM.
(a) Establishment.—The Secretary, acting through the Commissioner of Food and Drugs and the Director of the National Institutes of Health, shall enter into a cooperative agreement, contract, or grant for a period of 7 years, to be known as the Clinical Trial Data System Agreement, with one or more eligible entities to implement a pilot program with respect to all clinical trial data obtained from qualified clinical trials for purposes of registered users conducting further research on such data.
SURVEILLANCE OF NEUROLOGICAL DISEASES.
“(a) In General.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other agencies as determined appropriate by the Secretary, shall—
“(1) enhance and expand infrastructure and activities to track the epidemiology of neurological diseases, including multiple sclerosis and Parkinson’s disease; and
“(2) incorporate information obtained through such activities into a statistically sound, scientifically credible, integrated surveillance system, to be known as the National Neurological Diseases Surveillance System.
“(b) Research.—The Secretary shall ensure that the National Neurological Diseases Surveillance System is designed in a manner that facilitates further research on neurological diseases.
“(c) Content.—In carrying out subsection (a), the Secretary—
“(1) shall provide for the collection and storage of information on the incidence and prevalence of neurological diseases in the United States;
DEFINING HEALTH DATA RESEARCH AS PART OF HEALTH CARE OPERATIONS.
“(a) In General.—Subject to subsection (b), the Secretary shall revise or clarify the Rule to allow the use and disclosure of protected health information by a covered entity for research purposes, including studies whose purpose is to obtain generalizable knowledge, to be treated as the use and disclosure of such information for health care operations described in subparagraph (1) of the definition of health care operations in section 164.501 of part 164.
“PART E—COUNCIL FOR 21ST CENTURY CURES
“SEC. 281. ESTABLISHMENT.
“A nonprofit corporation to be known as the Council for 21st Century Cures (referred to in this part as the ‘Council’) shall be established in accordance with this section. The Council shall be a public-private partnership headed by an Executive Director (referred to in this part as the ‘Executive Director’), appointed by the members of the Board of Directors. The Council shall not be an agency or instrumentality of the United States Government.
“SEC. 281A. PURPOSE.
“The purpose of the Council is to accelerate the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients.
Development And Use Of Patient Experience Data To Enhance Structured Risk-Benefit Assessment Framework.—
“(1) IN GENERAL.—Not later than 2 years after the date of the enactment of this subsection, the Secretary shall establish and implement processes under which—
“(A) an entity seeking to develop patient experience data may submit to the Secretary—
“(i) initial research concepts for feedback from the Secretary; and
“(ii) with respect to patient experience data collected by the entity, draft guidance documents, completed data, and summaries and analyses of such data;
“(B) the Secretary may request such an entity to submit such documents, data, and summaries and analyses; and
“(C) patient experience data may be developed and used to enhance the structured risk-benefit assessment framework under subsection (x).
“(2) PATIENT EXPERIENCE DATA.
—In this subsection, the term ‘patient experience data’ means data collected by patients, parents, caregivers, patient advocacy organizations, disease research foundations, medical researchers, research sponsors, or other parties determined appropriate by the Secretary that is intended to facilitate or enhance the Secretary’s risk-benefit assessments, including information about the impact of a disease or a therapy on patients’ lives.”
Subtitle J—Domestic Manufacturing And Export Efficiencies
SEC. 2161. GRANTS FOR STUDYING THE PROCESS OF CONTINUOUS DRUG MANUFACTURING.
(a) In General.—The Commissioner of Food and Drugs may award grants to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.
“SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.
“(a) In General.—In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, the Secretary shall establish a program to provide priority review for devices—
Subtitle O—Streamlining Clinical Trials
SEC. 2261. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; APPLICABILITY OF RULES.
(a) In General.—In order to simplify and facilitate compliance by researchers with applicable regulations for the protection of human subjects in research, the Secretary of Health and Human Services shall, to the extent possible and consistent with other statutory provisions, harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations in accordance with subsection (b).
(b) Avoiding Regulatory Duplication And Unnecessary Delays.—
(1) IN GENERAL.—The Secretary shall—
(A) make such modifications to the provisions of the HHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable-populations rules as may be necessary—
(i) to reduce regulatory duplication and unnecessary delays;
(ii) to modernize such provisions in the context of multisite and cooperative research projects; and
(iii) to incorporate local considerations, community values, and mechanisms to protect vulnerable populations; and
(B) ensure that human subject research that is subject to the HHS Human Subject Regulations or to the FDA Human Subject Regulations may—
(i) use joint or shared review;
(ii) rely upon the review of—
(I) an independent institutional review board; or
(II) an institutional review board of an entity other than the sponsor of the research; or
(iii) use similar arrangements to avoid duplication of effort.
SEC. 2262. USE OF NON-LOCAL INSTITUTIONAL REVIEW BOARDS FOR REVIEW OF INVESTIGATIONAL DEVICE EXEMPTIONS AND HUMAN DEVICE EXEMPTIONS.
SEC. 2263. ALTERATION OR WAIVER OF INFORMED CONSENT FOR CLINICAL INVESTIGATIONS.
21 U.S.C. 360j(g)(3)
) is amended—
(1) in subparagraph (D), by striking “except where subject to such conditions as the Secretary may prescribe, the investigator” and inserting the following: “except where, subject to such conditions as the Secretary may prescribe—
“(i) the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject; or