II Calendar No. 577 114th CONGRESS 2d Session S. 2967 [Report No. 114–306] IN THE SENATE OF THE UNITED STATES May 23, 2016 Mr. Johnson (for himself and Mrs. Ernst ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs August 30, 2016 Reported under authority of the order of the Senate of July 14, 2016, by Mr. Johnson , with amendments and an amendment to the title Omit the part struck through and insert the part printed in italic A BILL To amend the Homeland Security Act of 2002 to require the Office of Management and Budget to execute a national biodefense strategy, and for other purposes.

1. Short title This Act may be cited as the National Biodefense Strategy Act of 2016 . 2. Biodefense strategy (a) In general Title V of the Homeland Security Act of 2002 ( 6 U.S.C. 311 et seq. ) is amended by adding at the end the following: 526 527 . National Biodefense Strategy (a) Definitions In this section— (1) the term biodefense means any involvement in mitigating the risks of major biological incidents and public health emergencies to the United States, including with respect to— (A) threat awareness; (B) prevention and protection; (C) surveillance and detection; (D) response and recovery; and (E) attribution of an intentional biological incident; (2) the term biodefense enterprise means the programs, projects, activities, and resources across the Federal Government that are involved in biodefense; (3) (2) the term Council means the Biodefense Coordination Council established under subsection (b); and (3) the term Federal biodefense enterprise means the programs, projects, activities, and resources across the Federal Government that are involved in biodefense; and (4) the term Strategy means the National Biodefense Strategy required to be established under subsection (b)(5). (b) Biodefense Coordination Council (1) Establishment The President shall establish a Biodefense Coordination Council, which shall be comprised of, at a minimum— (A) the Secretary of Health and Human Services; (B) the Secretary of Agriculture; (C) the Secretary of Defense; (D) the Secretary of Homeland Security ; (E) the Secretary of State; (F) the Director of National Intelligence; and (G) the Administrator of the Environmental Protection Agency. (2) Duties The Council shall— (A) provide the expertise necessary to develop the Strategy; and (B) in coordination with the Office of Management and Budget, review, prioritize, and align necessary biodefense activities and spending across the Federal Government, in a manner consistent with the Strategy. (3) Rotating chair During the 4-year period beginning on the date on which the Council is established, and each 4-year period thereafter, each of the 4 Secretaries described in subparagraphs (A) through (D) of paragraph (1) shall serve as the chairperson for the Council for 1 year. The first chairperson of the Council shall be the Secretary of Health and Human Services. (4) President’s annual budget The recommendations of the Council shall inform the budget submitted by the President under section 1105 of title 31, United States Code, with respect to biodefense activities. (5) Strategy The President shall develop a National Biodefense Strategy to direct and align the inter-governmental and multi-disciplinary efforts of the Federal Government towards an effective and continuously improving biodefense enterprise, including threat awareness, prevention and protection, surveillance and detection, and response and recovery to major biological incidents. (c) Coordination (1) Council In developing the Strategy, the President shall utilize the Council. (2) Other agencies In developing the Strategy, the President may utilize— (A) the Secretary of Commerce; (B) the Attorney General; and (C) any other Federal department or agency the President determines appropriate , agency, or interagency body the President determines appropriate, including the Public Health Emergency Medical Countermeasures Enterprise . (3) Private sector entities The President may receive input on elements of the Strategy from private sector biodefense entities. (3) Other entities The President may receive input on elements of the Strategy from private sector biodefense entities and State, local, tribal, and territorial governments. (4) Academic institutions The President may receive input on elements of the Strategy from academic institutions. (d) Coordination with existing strategies The Strategy shall serve as a comprehensive guide for United States biodefense that directs and harmonizes all other strategies or plans established or maintained by a Federal department or agency with respect to biodefense. (e) Contents (1) Requirements The Strategy shall include, at a minimum— (A) a comprehensive description of the entities and positions of leadership with responsibility, authority, and accountability for implementing, overseeing, and coordinating Federal biodefense activities described in subsection (b)(5), including a description of how such entities coordinate on each aspect of biodefense; (B) a review of current and previous collaborative efforts between the Armed Forces and the civilian sector of the Federal Government on biodefense activities and coordination; (C) a detailed analysis of the— (i) relevant recommendations issued by external biodefense review panels or commissions, and the extent to which the recommendations have been considered and implemented by Federal departments and agencies; (ii) lessons learned from the response of the Federal Government to public health emergencies occurring within the 5 years preceding the submission of the strategy; (iii) risks associated with major biological incidents; (iv) resources and capabilities needed to address identified risks; (v) resource and capability gaps in the biodefense enterprise, including gaps in— (I) each category of biodefense activity described in subsection (a)(1); (II) identification and research of emerging biological threats; (III) programs, projects, and activities in effect before the date of enactment of this section; (IV) strategies and implementation plans related to biodefense activities in effect before the date of enactment of this section; (V) the ability to reallocate Federal resources to address risks posed by emerging biological threats; and (VI) meeting the needs of vulnerable populations during the response to and recovery from a public health emergency; and (vi) prioritization and allocation of investment across the biodefense enterprise; (D) (B) 5-year goals, priorities, and metrics to improve and strengthen the ability of the Federal Government to prevent, detect, respond to, and recover from a major biological incident; (E) (C) short- and long-term research and development projects or initiatives planned to improve biodefense capability; and (F) (D) recommendations for legislative action needed to expedite progression toward the goals identified in the Strategy. (2) Considerations In developing the Strategy, the President may consider— (A) the trade-offs made between differing goals and requirements, due to constraints in expected assets and resources over the time period of such goals and requirements; and (B) any other analysis the President determines appropriate. (3) Analysis The Strategy shall include an appendix, which shall contain— (A) a review of current and previous collaborative efforts between the Armed Forces and the civilian sector of the Federal Government on biodefense activities and coordination; (B) a detailed analysis of the— (i) relevant recommendations issued by external biodefense review panels or commissions, and the extent to which the recommendations have been considered and implemented by Federal departments and agencies; (ii) lessons learned from the response of the Federal Government to public health emergencies occurring within the 5 years preceding the submission of the strategy; (iii) risks associated with major biological incidents; (iv) resources and capabilities needed to address identified risks; and (v) resource and capability gaps in the Federal biodefense enterprise, including gaps in— (I) each category of biodefense activity described in subsection (a)(1); (II) identification and research of emerging biological threats; (III) programs, projects, and activities in effect before the date of enactment of this section; (IV) strategies and implementation plans related to biodefense activities in effect before the date of enactment of this section; (V) the ability to reallocate Federal resources to address risks posed by emerging biological threats; and (VI) meeting the needs of vulnerable populations during the response to and recovery from a public health emergency; and (C) prioritization and allocation of investment across the Federal biodefense enterprise. (f) Deadline Not later than 24 months after the date of enactment of this section and notwithstanding in accordance with subsection (k), the President shall submit the Strategy to the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Homeland Security of the House of Representatives. (g) Status updates Not later than 180 days after the date of enactment of this section, and every 180 days thereafter until the date on which the Strategy is submitted to the congressional committees described in subsection (f), the President shall submit to such congressional committees an update on the status of the Strategy. (h) Requirement Notwithstanding In accordance with subsection (k), the Strategy shall be made available on a public Internet website. (i) Five-Year update Beginning 5 years after the date on which the Strategy is submitted to the congressional committees described in subsection (f), and not less frequently than every 5 years thereafter, the President shall update the Strategy. (j) Annual biodefense expenditures report (1) In general Not later than 30 days after the date on which the President submits a budget to Congress under section 1105 of title 31, United States Code, the President shall submit to the appropriate congressional committees a report detailing the total amount of expenditures on biodefense activities by all Federal departments and agencies and how the expenditures relate to the goals and priorities required under subsection (e)(1)(B) . (2) Requirement The first report submitted under paragraph (1) shall provide historical context by detailing the total amount of expenditures on biodefense for the 3 preceding fiscal years, in addition to the fiscal year requirements for the fiscal year covered by the report. (k) Classified annex To the fullest extent possible, any reports required to be made publicly available under this section shall be unclassified, but may include classified annexes that shall be submitted concurrently to the congressional homeland security committees. . (b) Table of contents The table of contents in section 1(b) of the Homeland Security Act of 2002 ( 6 U.S.C. 101 note) is amended by inserting after the item relating to section 525 526 the following: Sec. 526 527 . National Biodefense Strategy. .

Amend the title so as to read: A bill to amend the Homeland Security Act of 2002 to require the President to execute a national biodefense strategy, and for other purposes. .

August 30, 2016 Reported with amendments and an amendment to the title