U.S. GOVERNMENT PUBLISHING OFFICE

WASHINGTON : 

1 

59–010 

" ! SENATE 

114TH CONGRESS

2d Session 

REPORT

2016

114–306 

Calendar No. 577 

BIODEFENSE STRATEGY ACT OF 2016 

R E P O R T 

OF THE

COMMITTEE ON HOMELAND SECURITY AND 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE 

TO ACCOMPANY

S. 2967 

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 

AUGUST 30, 2016.—Ordered to be printed 

Filed, under authority of the order of the Senate of July 14, 2016 


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(II) 

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

RON JOHNSON, Wisconsin, Chairman 

JOHN MCCAIN, Arizona 

ROB PORTMAN, Ohio 

RAND PAUL, Kentucky 

JAMES LANKFORD, Oklahoma 

MICHAEL B. ENZI, Wyoming 

KELLY AYOTTE, New Hampshire 

JONI ERNST, Iowa 

BEN SASSE, Nebraska 

THOMAS R. CARPER, Delaware 

CLAIRE MCCASKILL, Missouri 

JON TESTER, Montana 

TAMMY BALDWIN, Wisconsin 

HEIDI HEITKAMP, North Dakota 

CORY A. BOOKER, New Jersey 

GARY C. PETERS, Michigan 

CHRISTOPHER R. HIXON, Staff Director 

GABRIELLE D’ADAMO SINGER, Chief Counsel 

LEXIA M. LITTLEJOHN, U.S. Coast Guard Detailee 

GABRIELLE A. BATKIN, Minority Staff Director 

JOHN P. KILVINGTON, Minority Deputy Staff Director 

MARY BETH SCHULTZ, Minority Chief Counsel 

ROBERT H. BRADLEY II, Minority Professional Staff Member 

LAURA W. KILBRIDE, Chief Clerk 


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Calendar No. 577 

114TH CONGRESS REPORT " ! SENATE 2d Session 114–306 

BIODEFENSE STRATEGY ACT OF 2016 

AUGUST 30, 2016.—Ordered to be printed 

Filed, under authority of the order of the Senate of July 14, 2016 

Mr. JOHNSON, from the Committee on Homeland Security and 

Governmental Affairs, submitted the following 

R E P O R T 

[To accompany S. 2967] 

The Committee on Homeland Security and Governmental Affairs, 

to which was referred the bill (S. 2967) 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, 

having considered the same, reports favorably thereon with amendments and an amendment to the title and recommends that the 

bill, as amended, do pass. 

CONTENTS 

Page 

I. Purpose and Summary .................................................................................. 1 

II. Background and Need for the Legislation ................................................... 2 

III. Legislative History ......................................................................................... 5 

IV. Section-by-Section Analysis .......................................................................... 6 

V. Evaluation of Regulatory Impact .................................................................. 7 

VI. Congressional Budget Office Cost Estimate ................................................ 8 

VII. Changes in Existing Law Made by the Bill, as Reported ........................... 8 

I. PURPOSE AND SUMMARY

The purpose of S. 2967, the National Biodefense Strategy Act of 

2016, is to require the President to develop and execute a comprehensive national biodefense strategy. In 2014, several highranking Government officials, including former Senator Joseph Lieberman and former Department of Homeland Security (DHS) Secretary Thomas Ridge, convened the Blue Ribbon Study Panel on 

Biodefense to assess the state of our nation’s biodefense capabilities 


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1 A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts, Blue Ribbon Study Panel on Biodefense (Oct. 28, 2015), http://www.hudson.org/research/ 

11824-a-national-blueprint-for-biodefense-leadership-and-major-reform-needed-to-optimize-efforts. 2Dept. of Justice, Amerithrax Investigative Summary (2010), http://www.justice.gov/archive/ 

amerithrax/docs/amx-investigative-summary.pdf [hereinafter Dept. of Justice, Amerithrax Investigative Summary]. 3 Id. 

4Gov’t Accountability Office, GAO–15–80, Anthrax: Agency Approaches to Validation and Statistical Analyses Could Be Improved 5 (2014), http://gao.gov/products/GAO-15-80. 5Dept. of Justice, Amerithrax Investigative Summary. 

6See infra notes 7–14, 18, 20–25. 7 Report, U.S. Comm’n on National Security, New World Coming: American Security in the 

21st Century (2001), http://fas.org/man/docs/nwc/. 8 Report, National Comm’n on Terrorist Attacks Upon the U.S., 9–11 Comm’n Report (2004), 

http://www.9-11commission.gov/report/. 

and to recommend improvement measures.1 S. 2967 codifies key 

recommendations of this panel by requiring a holistic national 

strategy that aims to direct and harmonize all existing agency-specific strategies with respect to biodefense. This strategy would be 

required to be updated every five years. The bill also requires the 

President to establish and utilize a Biodefense Coordination Council, which consists of representatives from key Federal agencies in 

developing the strategy. The Council is directed to review, 

prioritize and align biodefense activities and spending across the 

Federal Government in coordination with the Office of Management and Budget. Finally, the bill requires the creation of an annual biodefense expenditures report that details amounts spent on 

biodefense activities by all Federal departments and agencies. 

II. BACKGROUND AND THE NEED FOR LEGISLATION

In 2001, immediately following the September 11, 2001 terrorist 

attacks, deadly anthrax spores were mailed in letters to several offices in the United States.2 The 2001 anthrax attacks serve as an 

example of a biological agent used domestically for nefarious purposes.3 During the course of these attacks, at least 22 people were 

infected, with five of them succumbing to the disease.4 Identification of a suspect by the FBI took six years.5 In the years leading 

up to and following these attacks, the topic of biodefense came 

under intense scrutiny. Several bipartisan and independent commissions along with the Government Accountability Office (GAO) 

and Congressional Research Service (CRS) have issued reports 

identifying significant gaps in the nation’s biodefense capabilities 

and within the biodefense enterprise as a whole, which includes 

preparedness for natural disease outbreaks.6

Most of the commissions convened on biodefense have urged the 

United States to place a higher priority on addressing biological 

threats through various broad, but interrelated recommendations. 

For example, the U.S. Commission on National Security/21st Century (Hart-Rudman Commission) reported that the United States 

needs an enforceable international ban on the transfer, trade, and 

weaponization of biological pathogens.7 The National Commission 

on Terrorist Attacks upon the United States (9/11 Commission) expressed concern in 2004 about the number of terrorist groups pursuing chemical, biological, radiological and nuclear materials.8 In 

2008, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (Graham-Talent WMD Commission) said that the United States must place a higher priority 

on biological weapons and bioterrorism in order to bring about subVerDate Sep 11 2014 02:25 Sep 01, 2016 Jkt 059010 PO 00000 Frm 00004 Fmt 6659 Sfmt 6602 E:\HR\OC\SR306.XXX SR306

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9 Report, Prevention of Weapons of Mass Destruction Proliferation and Terrorism Report Card 

(January 2010), http://www.cfr.org/terrorism/world-risk-report-commission-prevention-wmdproliferation-terrorism/p17910. 10 Id. 11Gov’t Accountability Office, GAO–16–413T, Ongoing Challenges and Future Considerations 

for DHS Biosurveillance Efforts (2016), http://www.gao.gov/products/GAO-16-413. 12Gov’t Accountability Office, GAO–10–645, Efforts to Develop a National Biosurveillance Capability Need a National Strategy and a Designated Leader (2010), http://www.gao.gov/assets/ 

310/306362.pdf; see also Gov’t Accountability Office, GAO–11–318SP, Opportunities to Reduce 

Potential Duplication in Government Programs, Save Tax Dollars, and Enhance Revenue (2011), 

http://www.gao.gov/assets/320/315920.pdf (noting that the ‘‘overarching biodefense enterprise 

would benefit from strategic oversight mechanisms, including a focal point such as a national 

biodefense coordinator and a national strategy, to ensure efficient, effective, and accountable results.’’). 13 Id.; see also Gov’t Accountability Office, GAO–15–664T, Biosurveillance: Additional Planning, Oversight, and Coordination Needed to Enhance National Capability (2015), http:// 

www.gao.gov/assets/680/671245.pdf. 14 Homeland Security Presidential Directive 10, ‘‘Biodefense in the 21st Century’’ (2004), 

http://fas.org/irp/offdocs/nspd/hspd-10.html. 15 Homeland Security Presidential Directive 21, ‘‘National Strategy for Public Health and 

Medical Preparedness’’ (2007), http://fas.org/irp/offdocs/nspd/hspd-21.htm. 16 National Strategy for Countering Biological Threats, National Security Council, Nov. 2009, 

available at https://www.whitehouse.gov/sites/default/files/National_Strategy_for_ Countering_BioThreats.pdf. 17 Congressional Research Service, R42073, Presidential Policy Directive 8 and the National 

Preparedness System: Background Issues for Congress (Oct. 21, 2011), https://www.fas.org/ 

sgp/crs/homesec/R42073.pdf. 

stantial improvements in global biosecurity.9 Additionally, the Graham-Talent Commission recommended that the United States develop a national strategy for advancing bioforensic capabilities.10

GAO has issued several reports in recent years on the state of 

biodefense strategy development, biosurveillance, and biodefense 

leadership in the United States.11 In 2010 and again in 2011, GAO 

reported that there was neither a comprehensive national strategy, 

nor a designated focal point to lead to the development of a national biosurveillance capability.12 GAO then recommended that 

the Homeland Security Council develop an overarching national 

biodefense strategy as well as a national biosurveillance strategy 

that considers non-Federal capabilities.13

In recognition of the threat posed to the United States by biological threats, recent Presidential Administrations have taken steps 

to strengthen Federal strategies for biodefense. In 2004, President 

George W. Bush issued Homeland Security Presidential Directive 

10, which detailed the pillars of the Federal biodefense system— 

threat awareness, prevention and protection, surveillance and detection, and response and recovery—and assigned responsibilities 

for these efforts to Federal agencies.14 President Bush later issued 

Homeland Security Presidential Directive 21 in 2007, which established a National Strategy for Public Health and Medical Preparedness, including a focus on biosurveillance and medical countermeasures.15

In 2009, President Obama built on the work of his predecessor 

by releasing the National Strategy for Countering Biological 

Threats, which outlined the President’s vision for addressing terrorist use of biological weapons.16 In 2011, President Obama then 

issued Presidential Policy Directive-8, an Executive Order intended 

to guide the nation in an all-hazards approach to preventing, responding to, and recovering from threats including terrorist acts, 

natural disasters, and other man-made incidents.17 Finally, in 

2012, the Obama Administration released the National Strategy for 

Biosurveillance, to strengthen the nation’s ability to gather, inteVerDate Sep 11 2014 02:25 Sep 01, 2016 Jkt 059010 PO 00000 Frm 00005 Fmt 6659 Sfmt 6602 E:\HR\OC\SR306.XXX SR306

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18 National Strategy for Biosurveillance, National Security Council, Jul. 2012, available at 

https://www.whitehouse.gov/sites/default/files/National_Strategy_for_Biosurveillance_ July_2012.pdf. 19Gov’t Accountability Office, GAO–16–547T, The Nation Faces Multiple Challenges in Building and Maintaining Biodefense and Biosurvellance (2016), http://www.gao.gov/assets/680/ 

676548.pdf. 20Duplication and Cost Savings Action Tracker, Gov’t Accountability Office (Mar. 2, 2016) 

http://www.gao.gov/duplication/action_tracker/Biological_Threats/action1#t=1. 21Gov’t Accountability Office, GAO–16–547T, The Nation Faces Multiple Challenges in Building and Maintaining Biodefense and Biosurvellance (2016), http://www.gao.gov/assets/680/ 

676548.pdf. 22 Congressional Research Service, R41123, Federal Efforts to Address the Threat of Bioterrorism: Selected Issues and Options for Congress (Feb. 8, 2011), https://www.fas.org/sgp/crs/ 

terror/R41123.pdf. 23Gov’t Accountability Office, GAO–16–547T, The Nation Faces Multiple Challenges in Building and Maintaining Biodefense and Biosurvellance (2016), http://www.gao.gov/assets/680/ 

676548.pdf. 24 Id. 25 A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts, Blue Ribbon study panel on Biodefense, Oct. 2015, available at http://www.hudson.org/ 

research/11824-a-national-blueprint-for-biodefense-leadership-and-major-reform-needed-to-optimize-efforts. 

grate, interpret, and communicate information on biological threats 

affecting human, animal, and plant health.18

Though GAO has acknowledged the progress made over the 

years in promoting coordination in the biodefense space as a result 

of Federal efforts, it determined these strategies have not succeeded in fully addressing its recommendations.19 In March 2016, 

GAO noted that despite national security staff statements that the 

National Strategy for Countering Biological Threats works in concert with the National Biosurveillance Strategy and Presidential 

Policy Directive-8 to provide comprehensive strategic guidance to 

stakeholders with biodefense responsibilities, and though these documents demonstrate a clear commitment to coordinating interagency biodefense efforts, the documents do not provide the strategic approach that GAO recommended in 2011.20 In testimony 

given before this Committee, Chris Currie, Director of Homeland 

Security and Justice for GAO, reiterated the urgent need for an 

overarching biodefense strategy, stating that ‘‘while some highlevel biodefense strategies have been developed, there is no broad, 

integrated national strategy that encompasses all stakeholders 

with biodefense responsibilities.’’ 21 Given the aforementioned criticisms, a 2011 CRS report noted that ‘‘Congress, as a body, could 

enact legislation to require a more robust and transparent government-wide strategic plan that articulates clear goals, metrics, and 

priorities.’’ 22

In 2011 and again in 2016, GAO also highlighted the fragmentation of biodefense leadership, reporting that ‘‘there are more than 

two dozen presidentially appointed individuals with biodefense responsibilities and numerous Federal agencies with mission responsibilities for supporting biodefense activities, but no individual or 

entity with responsibility for overseeing the biodefense enterprise.’’ 23 GAO reported that despite National Security Council 

statements that two of its directorates work together as the focal 

point for Federal biodefense efforts, strategic leadership issues still 

persist.24

In 2015, the Blue Ribbon Study Panel on Biodefense (BRSPB) 

underscored critical vulnerabilities in the United States’ biodefense 

enterprise.25 In their final report released on October 28, 2015, the 

BRSPB determined that the United States ‘‘does not afford the biological threat the same level of attention as it does other 


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26 Id. 27 Id. 28 Id. 29See Assessing the State of Our Nation’s Biodefense: Hearing Before the S. Comm. on Homeland Sec. & Governmental Affairs, 114th Cong. (2015). 30Gov’t Accountability Office, GAO–16–547T, The Nation Faces Multiple Challenges in Building and Maintaining Biodefense and Biosurvellance (2016), http://www.gao.gov/assets/680/ 

676548.pdf. 

threats.’’ 26 Among the report’s chief findings was the conclusion 

that the United States lacks a single Federal leader, a comprehensive national strategy, and a dedicated biodefense budget.27 Additionally, the BRSPB found that while the nation spends $6 billion 

each year on biodefense activities, no comprehensive, specific accounting of those activities occurs within the Federal Government.28 Therefore, it is difficult to know how that money is spent, 

and what activities are being pursued by the Federal Government 

in this area. At a hearing before this Committee in October 2015, 

former Senator Lieberman and former Secretary of Homeland Security Ridge reiterated the key findings of this report.29

S. 2967 addresses the recommendations of the BRSPB, GAO, and 

others by requiring a comprehensive National Biodefense Strategy 

and facilitating inter-governmental and multi-disciplinary leadership and coordination through the establishment of a Biodefense 

Coordination Council. This bill will provide the mechanisms for 

overarching leadership and direction for Federal biodefense activities and much needed prioritization and accounting of investments 

across the biodefense enterprise (the combination of systems, including government and private sector entities that contribute to 

protecting the nation from potentially catastrophic biological 

events).30

Status updates on the National Biodefense Strategy must be submitted to appropriate Congressional committees every 180 days 

until complete and updates of the completed strategy are required 

every five years thereafter. The President is also required to submit to Congress, alongside each budget submission, an annual report detailing total biodefense expenditures by all Federal departments and agencies. 

III. LEGISLATIVE HISTORY

Chairman Ron Johnson and Senator Joni Ernst introduced S. 

2967 on May 23, 2016, which was referred to the Committee on 

Homeland Security and Governmental Affairs. 

The Committee considered S. 2967 at a business meeting on May 

25, 2016. An amendment was offered by Chairman Johnson to correct the long title of the bill and to require the President to execute 

the National Biodefense Strategy, rather than the Office of Management and Budget. Another amendment was offered by Chairman Johnson to move the analysis section of the strategy to an appendix within the strategy. An amendment was offered by Senator 

Claire McCaskill to make it clear that the President may use the 

Public Health Emergency Medical Countermeasures Enterprise in 

developing the strategy. Senator McCaskill subsequently modified 

her amendment to include any interagency body in the strategy’s 

development. 

The Committee adopted both Johnson amendments and the 

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ed, reported favorably, all by voice vote. Senators present for each 

of the votes were: Johnson, Portman, Paul, Lankford, Ayotte, 

Ernst, Sasse, Carper, McCaskill, Tester, Baldwin, Heitkamp, Booker, and Peters. 

Consistent with the Committee’s order on technical and conforming changes at the business meeting, the Committee reports 

the bill with a technical amendment by mutual agreement of the 

full Committee majority and minority staff. 

IV. SECTION-BY-SECTION ANALYSIS OF THE BILL, AS REPORTED

Section 1. Short title 

This section provides the bill’s short title, the ‘‘National Biodefense Strategy Act of 2016.’’ 

Section 2. Biodefense strategy 

This section amends Title V of the Homeland Security Act of 

2002 to add the National Biodefense Strategy. 

Subsection (a) defines the terms ‘‘biodefense,’’ ‘‘Council,’’ ‘‘Federal 

biodefense enterprise,’’ and ‘‘Strategy.’’ 

Subsection (b) directs the President to establish a Biodefense Coordination Council (Council), which, at a minimum, will be comprised of the Secretary of Health and Human Services, the Secretary of Agriculture, the Secretary of Defense, the Secretary of 

Homeland Security, the Secretary of State, the Director of National 

Intelligence, and the Administrator of the Environmental Protection Agency. Subsection (b) also requires the President to develop 

a National Biodefense Strategy which shall direct and align intergovernmental efforts of the Federal government towards an effective biodefense enterprise, including threat awareness, prevention 

and protection surveillance and detection and response and recovery to major biological incidents. 

The Council is to provide the expertise necessary to develop the 

National Biodefense Strategy and, in coordination with the Office 

of Management and Budget, review, prioritize and align necessary 

Federal Government activities and expenditures on biodefense. The 

Council will be chaired by the Secretary of Health and Human 

Services, the Secretary of Agriculture, the Secretary of Defense, or 

the Secretary of Homeland Security for one-year intervals. The Secretary of Health and Human Services shall serve as the first chairperson of the Council. At the end of the one-year term, the chairperson position shall rotate to another Department Secretary. The 

subsection also requires the recommendations of the Council to inform the President’s annual budget submission with respect to biodefense activities. 

Subsection (c) requires the President to utilize the Council in the 

development of the National Biodefense Strategy. In addition to 

Council members, the President may choose to utilize the Secretary 

of Commerce, the Attorney General, and any agency or interagency 

body deemed appropriate, including the Public Health Emergency 

Medical Countermeasures Enterprise. The President may also receive input from private companies, academia, and state, local, 

tribal, and territorial governments in developing the strategy. 

Subsection (d) stipulates that the National Biodefense Strategy 

shall serve as a comprehensive guide for United States biodefense 


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that directs and harmonizes all existing Federal Government biodefense plans and strategies. 

Subsection (e) specifies the contents of the National Biodefense 

Strategy, requiring the strategy to include a description of the entities and positions of leadership with responsibility, authority, and 

accountability for implementing, overseeing and coordinating Federal biodefense activities, as well as a description of how these entities coordinate; five-year priorities, goals, and metrics to prevent, 

detect, respond to, and recover from a major biological incident; 

and short and long-term research and development projects and 

recommended legislative action needed to move towards the Strategy’s goals. Further, the strategy shall include an appendix with a 

detailed analysis of current and previous collaborative efforts between military and civilian federal entities on biodefense activities 

and coordination; prior recommendations from panels and commissions, lessons learned from prior public health emergency responses; risks associated with major biological incidents; resources 

and capabilities needed to address identified risks; and resource 

and capability gaps in the Federal biodefense enterprise. The appendix shall also contain a prioritization and allocation of investments across the Federal biodefense enterprise. 

Subsection (f) directs the President to submit the National Biodefense Strategy to Congress not later than two years following the 

bill’s enactment. 

Subsection (g) requires status updates on the strategy to be submitted to appropriate Congressional committees every 180 days 

from enactment until the strategy is complete. 

Subsection (h) requires the President to make all parts of the 

strategy that are releasable to the public available on a public 

internet website. 

Subsection (i) requires updates of the completed strategy every 

five years. 

Subsection (j) requires the President to submit to Congress a biodefense expenditure report with each fiscal year budget, and to detail how those expenditures relate to the goals and priorities in the 

Strategy. 

Subsection (k) allows for the strategy to include classified annexes. 

V. EVALUATION OF REGULATORY IMPACT

Pursuant to the requirements of paragraph 11(b) of rule XXVI of 

the Standing Rules of the Senate, the Committee has considered 

the regulatory impact of this bill and determined that the bill will 

have no regulatory impact within the meaning of the rules. The 

Committee agrees with the Congressional Budget Office’s statement that the bill contains no intergovernmental or private-sector 

mandates as defined in the Unfunded Mandates Reform Act 

(UMRA) and would impose no costs on state, local, or tribal governments. 


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VI. CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

JULY 11, 2016. 

Hon. RON JOHNSON, Chairman, 

Committee on Homeland Security and Governmental Affairs, 

U.S. Senate, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 2967, the National Biodefense Strategy Act of 2016. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Ellen Werble. 

Sincerely, 

KEITH HALL. 

Enclosure. 

S. 2967—National Biodefense Strategy Act of 2016 

S. 2967 would require the President to establish a Biodefense Coordination Council to develop a national strategy to help the federal government prevent and respond to major biological incidents. 

Under the bill, the President would be required to report to the 

Congress on the status of the strategy every 180 days until it is 

completed and to update the strategy at least every five years 

thereafter. The bill also would require the President to submit an 

annual report detailing total federal expenditures on biodefence activities and how those expenses relate to the priorities established 

in the strategy. 

CBO estimates that implementing S. 2967 would require a couple of employees annually to coordinate the Council’s work and to 

produce the reports. CBO estimates that enacting S. 2967 would 

cost less than $500,000 annually and about $2 million over the 

2017–2021 period; any such spending would be subject to the availability of appropriated funds. Pay-as-you-go procedures do not 

apply to this legislation because it would not affect direct spending 

or revenues. 

CBO estimates that enacting S. 2967 would not increase net direct spending or on-budget deficits in any of the four consecutive 

10-year periods beginning in 2027. 

S. 2967 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would 

not affect the budgets of state, local, or tribal governments. 

The CBO staff contact for this estimate is Ellen Werble. The estimate was approved by Theresa Gullo, Assistant Director for Budget 

Analysis. 

VII. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with paragraph 12 of rule XXVI of the Standing 

Rules of the Senate, changes in existing law made by S. 2967 as 

reported are shown as follows (existing law proposed to be omitted 

is enclosed in brackets, new matter is printed in italic, and existing 

law in which no change is proposed is shown in roman): 

HOMELAND SECURITY ACT OF 2002 

* * * * * * * 


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TITLE V—EMERGENCY PREPAREDNESS AND 

RESPONSE 

* * * * * * * 

Sec. 501. Definitions. 

* * * * * * * 

Sec. 526. Integrated Public Alert and Warning System Modernization. 

Sec. 527. National Biodefense Strategy. 

SEC. 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 ‘Council’ means the Biodefense Coordination 

Council established under subsection (b); 

(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 

(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. 


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(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 agency, or interagency 

body the President determines appropriate, including the 

Public Health Emergency Medical Countermeasures Enterprise. 

(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) 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; 

(C) short- and long-term research and development 

projects or initiatives planned to improve biodefense capability; and 

(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. 


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(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 form 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 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.—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.— 


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12 

(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. 

* * * * * * * 

Æ 


emcdonald on DSK9F6TC42PROD with HEARING