```

[Senate Report 114-306]
[From the U.S. Government Publishing Office]

                                                      Calendar No. 577
114th Congress      }                                   {       Report
                                 SENATE
 2d Session         }                                   {      114-306

_______________________________________________________________________

  

                    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

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                August 30, 2016.--Ordered to be printed
   Filed, under authority of the order of the Senate of July 14, 2016
                                   ______

                         U.S. GOVERNMENT PUBLISHING OFFICE 

59-010                         WASHINGTON : 2016    
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
        COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

                    RON JOHNSON, Wisconsin, Chairman
JOHN McCAIN, Arizona                 THOMAS R. CARPER, Delaware
ROB PORTMAN, Ohio                    CLAIRE McCASKILL, Missouri
RAND PAUL, Kentucky                  JON TESTER, Montana
JAMES LANKFORD, Oklahoma             TAMMY BALDWIN, Wisconsin
MICHAEL B. ENZI, Wyoming             HEIDI HEITKAMP, North Dakota
KELLY AYOTTE, New Hampshire          CORY A. BOOKER, New Jersey
JONI ERNST, Iowa                     GARY C. PETERS, Michigan
BEN SASSE, Nebraska

                  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

                                                      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 
high-ranking 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 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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------

              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\
---------------------------------------------------------------------------
    \2\Dept. 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.
    \4\Gov'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.
    \5\Dept. of Justice, Amerithrax Investigative Summary.
    \6\See infra notes 7-14, 18, 20-25.
---------------------------------------------------------------------------
    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 substantial 
improvements in global biosecurity.\9\ Additionally, the 
Graham-Talent Commission recommended that the United States 
develop a national strategy for advancing bioforensic 
capabilities.\10\
---------------------------------------------------------------------------
    \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/.
    \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-wmd-proliferation-terrorism/
p17910.
    \10\Id.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \11\Gov't Accountability Office, GAO-16-413T, Ongoing Challenges 
and Future Considerations for DHS Biosurveillance Efforts (2016), 
http://www.gao.gov/products/GAO-16-413.
    \12\Gov'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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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, 
integrate, interpret, and communicate information on biological 
threats affecting human, animal, and plant health.\18\
---------------------------------------------------------------------------
    \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.
    \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.
---------------------------------------------------------------------------
    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 
high-level 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\
---------------------------------------------------------------------------
    \19\Gov'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.
    \20\Duplication and Cost Savings Action Tracker, Gov't 
Accountability Office (Mar. 2, 2016) http://www.gao.gov/duplication/
action_tracker/Biological_Threats/action1#t=1.
    \21\Gov'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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \23\Gov'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.
---------------------------------------------------------------------------
    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 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\
---------------------------------------------------------------------------
    \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.
    \26\Id.
    \27\Id.
    \28\Id.
    \29\See Assessing the State of Our Nation's Biodefense: Hearing 
Before the S. Comm. on Homeland Sec. & Governmental Affairs, 114th 
Cong. (2015).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \30\Gov'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.
---------------------------------------------------------------------------
    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 
McCaskill amendment, as modified, and ordered the bill, as 
amended, 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 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.

             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

           *       *       *       *       *       *       *

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.
          (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.
          (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.--
          (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.

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