The 21st Century Cures Act ( P.L. 114-255 ) was signed into law on December 13, 2016, by President Barack Obama. On November 30, 2016, the House passed the House amendment to the Senate amendment to H.R. 34 , the 21st Century Cures Act, on a vote of 392 to 26. The bill was then sent to the Senate where it was considered and passed, with only minor technical modification, on December 7, 2016, on a vote of 94 to 5. The law consists of three divisions: Division A—21st Century Cures Act; Division B—Helping Families in Mental Health Crisis; and Division C—Increasing Choice, Access, and Quality in Health Care for Americans. CRS has published a series of reports on this law, one on each Division. This is the report for Division A of the law. Division A of the law provides funding for biomedical research—including the Precision Medicine Initiative (PMI) and the Cancer Moonshot Initiative—and for the opioid crisis response; modifies Food and Drug Administration (FDA) pathways for the approval of regulated medical products; and makes a number of reforms to the National Institutes of Health (NIH). Division A of the law also includes and builds on provisions from both the previously passed House bill, H.R. 6 (The 21 st Century Cures Act, passed in July 2015), and a package of Senate medical innovation bills that were considered in the early part of 2016. As noted, both the House and the Senate considered previous legislation to support medical innovation, primarily through reforms to the NIH and changes to the drug, biologic and device approval pathways at the FDA. On February 3, 2015, Senators Lamar Alexander and Patty Murray, chairman and ranking Member of the Committee on Health, Education, Labor and Pensions, announced the start of a bipartisan initiative to "examine the process for getting safe treatments, devices and cures to patients and the roles of the [FDA] and the [NIH] in that process." 1 This initiative culminated in a package of 19 bipartisan bills that were reported out of the Senate Health, Labor, Education, and Pensions (HELP) Committee in a series of three executive sessions held on February 9, 2016; March 9, 2016; and April 6, 2016. One of these 19 bills, The Adding Zika Virus to the FDA Priority Review Voucher Program Act ( S. 2512 ), subsequently was passed by both chambers and signed into law on April 19, 2016 ( P.L. 114-146 ). The Senate's medical innovation package was that chamber's companion effort to the House's 21 st Century Cures initiative, which resulted in the House passage of H.R. 6 , the initial version of the 21 st Century Cures Act, on July 10, 2015, on a vote of 344 to 77. H.R. 6 was the result of a series of hearings and roundtable meetings hosted by the House Energy and Commerce Committee dating back to spring 2014. The hearings and roundtables focused on a broad range of topics, including modernizing clinical trials, incorporating patient perspectives into medical research and regulatory processes, precision/personalized medicine, digital health care, and more. While it consisted of many different provisions, H.R. 6 was primarily focused on efforts to increase strategic investments in medical research at NIH and change some aspects of how the FDA executes its regulatory oversight mission with regard to the review and approval of new drugs, biologics, and medical devices. This report provides a brief summary of each provision of the 21 st Century Cures Act (Division A of P.L. 114-255 ), by title, subtitle, and section. The Division includes five titles, as follows: (1) Innovation projects and state responses to opioid abuse; (2) Discovery; (3) Development; (4) Delivery; and (5) Savings. Most provision summaries include a brief background of current law in addition to a description of the new provision of law. Throughout the report, clarity takes priority over consistency. For example, some summaries are more detailed than others where such detail is necessary to highlight important changes. A list of acronyms used throughout this report can be found in Appendix of this report. The National Institutes of Health (NIH) is the lead federal agency charged with performing and supporting biomedical and behavioral research. It also has major roles in training biomedical researchers and disseminating health information. Congress doubled the NIH budget from $13.65 billion to $27.1 billion in the five-year period from FY1998 to FY2003; during that period, annual increases in the 14%-15% range were the norm. Since then, increases from regular appropriations have been between 1.0% and 3.2% each year. The growth rate of the NIH budget has been at or below the rate of inflation, which for biomedical research in FY2015 is estimated to be 2.2%. NIH funding in FY2015 was 22% lower than the FY2003 level, the peak of the doubling period in constant 2012 dollars. A recent analysis of U.S. expenditures on biomedical research found that "U.S. government research funding declined from 57% (2004) to 50% (2012) of the global total, as did that of U.S. companies (50% to 41%), with the total U.S. (public plus private) share of global research funding declining from 57% to 44%. Asia, particularly China, tripled investment from $2.6 billion (2004) to $9.7 billion (2012) preferentially for education and personnel." The United States continues to be the top supporter of both public and industry medical research. However, some Members of Congress and many in the biomedical research community have expressed concern over the rapidly increasing investments being made by other countries in this area of research. Many of those who are concerned about the U.S. global position in biomedical research investment have made frequent calls for increased support for research at NIH. However, another recent analysis of U.S. biomedical research funding cautioned that the past pattern of rapid doubling of the NIH budget followed by slowdowns in federal funding "created an unsustainable hypercompetitive system that is discouraging even the most outstanding prospective students from entering our profession—and making it difficult for seasoned investigators to produce their best work." Rather than short-term infusions of cash that disappear, the authors recommend that greater emphasis be placed on the predictable and stable growth of federal funds for the research enterprise. In responding to questions raised by Senator Elizabeth Warren during a May 5, 2015, Senate hearing, NIH Director Francis Collins agreed that continued NIH budget increases—ranging from 3.7% annually to inflation plus 4% or 5%—would be preferred to a temporary larger investment that disappears. The Advisory Committee to the Director of NIH, authorized under PHSA Section 222, provides "advice on matters pertinent to NIH mission responsibilities in the conduct and support of biomedical research." Section 1001 establishes the "NIH Innovation Account" in the Treasury, to which specified amounts are transferred for each of FY2017 through FY2026. Such amounts from the account are authorized to be appropriated to the NIH Director for the purpose of carrying out the NIH Innovation Projects. Amounts appropriated from this account are available until expended. Specifically, the provision authorizes appropriations to support the Precision Medicine Initiative, specified amounts for FY2017 through FY2026, total not to exceed $1.455 billion; the Brain Research through Advancing Innovative Neurotechnologies Initiative (BRAIN Initiative), specified amounts for FY2017 through FY2026, total not to exceed $1.511 billion; cancer research, specified amounts for FY2017 through FY2023, total not to exceed $1.8 billion; and regenerative medicine using adult stem cells, specified amounts for FY2017 through FY2020 that total $30 million; no funds are to be appropriated for this activity after FY2020. This research is to be undertaken in coordination with the FDA. Within six months of enactment, the NIH Director must submit to the specified congressional committees a work plan including the proposed allocation of funds authorized to be appropriated for each year, FY2017 through FY2026, for the NIH Innovation Projects. Prior to submitting the work plan, the NIH Director must seek recommendations on the allocations of funds and the contents of the proposed work plan from the Advisory Committee to the Director of NIH. The work plan must include recommendations from this Advisory Committee, the amount of money to be obligated or expended in each fiscal year for each NIH Innovation Project, a description and justification of each such project, and a description of how each such project supports the strategic research priorities identified in the NIH Strategic Plan. Not later than October 1 of each year, FY2018 through FY2027, the Director of NIH must submit to the specified congressional committees a report including the amount of money obligated or expended in the prior fiscal year for each NIH Innovation Project, a description of any such project using funds provided by this section, and whether such projects are advancing the strategic research priorities identified in the NIH Strategic Plan. The specified House and Senate committees may request an update on the allocation of funding under this section or the description of the NIH Innovation Projects, which the NIH Director must provide in the form of additional reports or testimony. Section 1001 specifies that these funds may be used only for NIH Innovation fund projects (notwithstanding any transfer authority in any appropriations act). The section also specifies that amounts in the account are not available until appropriated in subsequent appropriations acts. Notably, the amounts subsequently appropriated (i.e., the budget authority and the resulting outlays) for FY2017 through FY2026, up to the amounts transferred, are to be subtracted from any cost estimates provided for purposes of budget controls.