To amend the Public Health Service Act to provide for an NIH research strategic plan.

To amend the Public Health Service Act to provide for an NIH research strategic plan. 1. NIH research strategic plan Section 402 of the Public Health Service Act ( 42 U.S.C. 282 (1) in subsection (b), by amending paragraph (5) to read as follows: (5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health, including through development, use, and updating of the research strategic plan under subsection (m); ; and (2) by adding at the end the following: (m) Research strategic plan (1) Five-year plans for biomedical research strategy (A) In general For each successive five-year period beginning with the period of fiscal years 2016 through 2020, the Director of NIH, in consultation with the entities described in subparagraph (B), shall develop and maintain a biomedical research strategic plan. (B) Entities described The entities described in this subparagraph are the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders. (2) Use of plan The Director of NIH and the directors of the national research institutes and national centers shall use the strategic plan— (A) to identify research opportunities; and (B) to develop individual strategic plans for the research activities of each of the national research institutes and national centers that— (i) have a common template; and (ii) identify strategic focus areas in which the resources of the national research institutes and national centers can best contribute to the goal of expanding knowledge on human health in the United States through biomedical research. (3) Contents of plans (A) Strategic focus areas The strategic focus areas identified pursuant to paragraph (2)(B) shall— (i) be identified in a manner that— (I) considers the return on investment to the United States public through the investments of the National Institutes of Health in biomedical research; and (II) contributes to expanding knowledge to improve the United States public’s health through biomedical research; and (ii) include overarching and trans-National Institutes of Health strategic focus areas, to be known as Mission Priority Focus Areas, which best serve the goals of preventing or eliminating the burden of a disease or condition and scientifically merit enhanced and focused research over the next 5 years. (B) Rare and pediatric diseases and conditions In developing and maintaining a strategic plan under this subsection, the Director of NIH shall ensure that rare and pediatric diseases and conditions remain a priority. (4) Initial plan Not later than 270 days after the date of enactment of this subsection, the Director of NIH and the directors of the national research institutes and national centers shall— (A) complete the initial strategic plan required by paragraphs (1) and (2); and (B) make such initial strategic plan publicly available on the website of the National Institutes of Health. (5) Review; updates (A) Progress reviews Not less than annually, the Director of NIH, in consultation with the directors of the national research institutes and national centers, shall conduct progress reviews for each strategic focus area identified under paragraph (2)(B). (B) Updates Not later than the end of the 5-year period covered by the initial strategic plan under this subsection, and every 5 years thereafter, the Director of NIH, in consultation with the directors of the national research institutes and national centers, stakeholders in the scientific field, advocates, and the public at large, shall— (i) conduct a review of the plan, including each strategic focus area identified under paragraph (2)(B); and (ii) update such plan in accordance with this section. .

Summary: This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to develop and maintain a biomedical research strategic plan. The NIH must use the strategic plan to identify research opportunities and to develop individual strategic plans for each of the national research institutes and national centers. Strategic plans must identify strategic focus areas in a manner that considers the return on investment of biomedical research and contributes to expanding knowledge to improve the public's health. Strategic focus areas must include overarching Mission Priority Focus Areas, which serve the goal of preventing or eliminating the burden of a medical condition. The NIH must: (1) ensure that rare and pediatric diseases and conditions remain a priority under the strategic plan, (2) publish the initial strategic plan within 270 days, (3) conduct progress reviews for each strategic focus area at least annually, and (4) update the strategic plan every five years.