83_FR_53043 83 FR 52841 - Posting of the National Security Presidential Memorandum 14, “Support for National Biodefense”

83 FR 52841 - Posting of the National Security Presidential Memorandum 14, “Support for National Biodefense”

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 83, Issue 202 (October 18, 2018)

Page Range52841-52843
FR Document2018-22742

National Security Presidential Memorandum 14 directs

Federal Register, Volume 83 Issue 202 (Thursday, October 18, 2018)
[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)]
[Notices]
[Pages 52841-52843]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22742]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES



Office of the Secretary




Posting of the National Security Presidential Memorandum 14, 

``Support for National Biodefense''



ACTION: Notice.



-----------------------------------------------------------------------



SUMMARY: National Security Presidential Memorandum 14 directs 

implementation of the National Biodefense Strategy. The Secretary is 

authorized and directed to publish the Memorandum in the Federal 

Register.



DATES: National Security Presidential Memorandum 14 was signed on 

September 18, 2018.



FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, MTM&H, MS, 

Assistant Secretary for Preparedness and Response, Office of the 

Secretary, Department of Health and Human Services, 200 Independence 

Avenue SW, Washington, DC 20201; Telephone: 202-205-2882.



SUPPLEMENTARY INFORMATION: 

    National Security Presidential Memorandum: Support for National 

Biodefense.

    Memorandum for: The Vice President; The Secretary of State; The 

Secretary of the Treasury; The Secretary of Defense; The Attorney 

General; The Secretary of the Interior; The Secretary of Agriculture; 

The Secretary of Commerce; The Secretary of Labor; The Secretary of 

Health and Human Services; The Secretary of Transportation; The 

Secretary of Energy; The Secretary of Veterans Affairs; The Secretary 

of Homeland Security; Assistant to the President and Chief of Staff; 

Administrator of the Environmental Protection Agency; Director of the 

Office of Management and Budget; The Representative of the United 

States to the United Nations; Director of National Intelligence;



[[Page 52842]]



Assistant to the President for Science and Technology and Director of 

the Office of Science and Technology Policy; Chairman of the Joint 

Chiefs of Staff; Administrator of the United States Agency for 

International Development; Director of the Federal Bureau of 

Investigation.

    It is a vital interest of the United States to prepare for, 

counter, respond to, and recover from biological incidents at home and 

abroad. Nearly all executive departments and agencies (agencies) 

contribute to the biodefense mission of the United States Government. 

Those contributions occur through a variety of authorities and 

programs. To ensure an integrated, comprehensive approach, agencies 

shall coordinate and manage biodefense activities in support of the 

broader biodefense enterprise, which consists of all stakeholders with 

a role in the detection of, prevention of, preparedness for, response 

to, and recovery from biological incidents, including Federal, State, 

local, tribal, and territorial governments, the private sector, and 

international partners.

    Section 1. Policy. (a) It is the policy of the United States to 

preserve our national and economic security by protecting the Nation 

from biological threats. Acting within the biodefense enterprise, the 

United States Government will undertake actions at home and with 

partners abroad to reduce the risk of natural, accidental, and 

deliberate biological threats to humans, animals, agriculture, and the 

environment that have the potential to significantly affect the 

national and economic security of the United States.

    (b) The foundation for the United States Government's role in the 

biodefense enterprise is the National Biodefense Strategy and its 

implementation plan (Strategy), which serve as the authoritative 

sources for the goals, objectives, and definitions for United States 

Government activities in support of the broader biodefense enterprise. 

Agency biodefense activities shall be conducted consistent with section 

1086 of the National Defense Authorization Act for Fiscal Year 2017 and 

the Strategy, including activities undertaken to implement prior 

Executive Orders and Presidential Directives, such as Homeland Security 

Presidential Directive (HSPD)-5 of February 28, 2003 (Management of 

Domestic Incidents); HSPD-9 of January 30, 2004 (Defense of United 

States Agriculture and Food); HSPD-18 of January 31, 2007 (Medical 

Countermeasures against Weapons of Mass Destruction); HSPD-21 of 

October 18, 2007 (Public Health and Medical Preparedness); Executive 

Order 13676 of September 18, 2014 (Combating Antibiotic-Resistant 

Bacteria); and Executive Order 13747 of November 4, 2016 (Advancing the 

Global Health Security Agenda To Achieve a World Safe and Secure From 

Infectious Disease Threats).

    Sec. 2. Implementation. The policy set forth in section 1 of this 

memorandum shall be implemented, to the extent permitted by law and 

available appropriations, and subject to the internal programmatic and 

budgetary processes of the agencies, as follows:

    (a) Consistent with the Strategy, the heads of agencies shall:

    (i) Prioritize the implementation of the Strategy and include 

Strategy-related activities within their strategic planning and 

budgetary processes;

    (ii) coordinate their biodefense policies with other agencies that 

have responsibilities or capabilities pertaining to biodefense, as well 

as with appropriate non-Federal entities;

    (iii) share information, as appropriate, and coordinate decision-

making related to the biodefense enterprise; and

    (iv) monitor, evaluate, and hold their agencies accountable for 

implementation of the Strategy.

    (b) The Assistant to the President for National Security Affairs 

(APNSA) shall serve as the lead for policy coordination and review, 

acting through the process described in National Security Presidential 

Memorandum (NSPM)-4 of April 4, 2017 (Organization of the National 

Security Council, the Homeland Security Council, and Subcommittees), to 

provide strategic input and facilitate policy integration for Federal 

biodefense efforts.

    (c) There is hereby established a Biodefense Steering Committee 

(Committee), which shall be chaired by the Secretary of Health and 

Human Services (Secretary). The other members of the Committee shall 

include the Secretary of State, the Secretary of Defense, the Attorney 

General, the Secretary of Agriculture, the Secretary of Veterans 

Affairs, the Secretary of Homeland Security, and the Administrator of 

the Environmental Protection Agency. The heads of other agencies with 

responsibilities or capabilities pertaining to biodefense shall 

participate at the invitation of the Committee, as appropriate. The 

Committee shall be responsible for monitoring and coordinating the 

implementation of the Strategy. The Committee shall seek consensus, 

with disagreements being addressed through the NSPM-4 process. The 

Committee may establish appropriate consultative or advisory mechanisms 

to facilitate interaction with non-Federal stakeholders. The Secretary, 

as the Chair of the Committee, shall serve as the Federal lead in 

coordinating implementation of the Strategy.

    (d) To assist the Committee in carrying out the responsibilities 

described in subsection (c) of this section, the Secretary shall, 

within 90 days of the date of this memorandum, establish a Biodefense 

Coordination Team (Team) administratively located within the Department 

of Health and Human Services.

    (i) The Secretary shall designate a senior official of, or detailed 

to, the Department of Health and Human Services to serve as the 

director of the Team, who shall report to the Secretary.

    (ii) The Secretary, the Secretary of State, the Secretary of 

Defense, the Attorney General, the Secretary of Agriculture, the 

Secretary of Veterans Affairs, the Secretary of Homeland Security, the 

Administrator of the Environmental Protection Agency, and the heads of 

other agencies with responsibilities or capabilities pertaining to 

biodefense shall support the work of the Team, including, where 

appropriate, through the detail of personnel to the Team, consistent 

with law.

    (iii) The Secretary, in consultation with the Committee, shall 

ensure that appropriate resources are provided by the Department of 

Health and Human Services to facilitate the Team's activities.

    (iv) The Team shall, in consultation with existing governance 

bodies with responsibilities or capabilities pertaining to biodefense, 

assist the Committee in monitoring and coordinating implementation of 

the Strategy. The Team may convene working groups with relevant 

agencies as appropriate. In addition, the Team shall, on an ongoing 

basis, maintain awareness of biodefense activities conducted by 

agencies, relevant interagency entities, and non Federal partners in 

the broader biodefense enterprise, including relevant private sector 

stakeholders. The Team shall identify opportunities to increase 

coordination with non-Federal partners, including international 

organizations. Subject to the approval of the Committee, the Team shall 

establish policies, processes, and procedures to govern its activities.

    (v) The Secretary shall notify the APNSA when the Team is 

established.

    (e) To ensure effective implementation of the Strategy, within 30 

days of the formation of the Team and annually thereafter in alignment 

with the annual budget process, the



[[Page 52843]]



Secretary shall submit written requests for information to the heads of 

agencies identified by the Committee as having responsibilities 

pertaining to biodefense (Covered Officials), including the following:

    (i) The Secretary of State;

    (ii) the Secretary of the Treasury;

    (iii) the Secretary of Defense;

    (iv) the Attorney General;

    (v) the Secretary of the Interior;

    (vi) the Secretary of Agriculture;

    (vii) the Secretary of Commerce;

    (viii) the Secretary of Labor;

    (ix) the Secretary of Health and Human Services;

    (x) the Secretary of Transportation;

    (xi) the Secretary of Energy;

    (xii) the Secretary of Veterans Affairs;

    (xiii) the Secretary of Homeland Security;

    (xiv) the Administrator of the Environmental Protection Agency;

    (xv) the Director of National Intelligence;

    (xvi) the Administrator of the United States Agency for 

International Development; and

    (xvii) the Director of the Federal Bureau of Investigation.

    (f) These requests shall ask how agency programs and activities 

contribute to the objectives of the Strategy. Covered Officials shall 

respond to these requests within 60 days of receipt of the request 

through a Biodefense Memorandum, as described in paragraphs (i)-(ii) of 

this subsection.

    (i) The Biodefense Memorandum shall identify those activities, 

programs, and projects that are planned, programmed, or have been 

executed that advance or are expected to advance the Strategy; 

quantify, to the extent feasible, resources allocated to biodefense 

within the agency; assess the extent to which the goals, objectives, 

and sub-objectives of the Strategy are being met; and identify 

impediments to timely and effective implementation and options for 

their resolution. Each agency shall provide its Biodefense Memorandum 

to the Committee, the Team, the National Security Council (NSC) staff, 

and the Office of Management and Budget (OMB). The Team shall 

distribute the collected Memoranda to Covered Officials.

    (ii) Covered Officials are not required to provide information on 

specific law enforcement activities, counterproliferation activities, 

military plans or operations, intelligence activities, or criminal 

investigations.

    (g) The Team, as informed by each Biodefense Memorandum and 

consultations with the agencies, shall prepare a Biodefense Assessment 

(Assessment) to identify any gaps, shortfalls, and redundancies; 

describe any challenges to the implementation and execution of the 

Strategy; and recommend any necessary updates or changes to the 

Strategy. The Assessment shall include an analysis of the extent to 

which current United States Government resources support the goals and 

objectives of the Strategy, how existing programs and resources could 

be better executed or allocated to align with the Strategy, and how 

additional resources could, if available, be applied to support the 

goals of the Strategy. The Team shall coordinate the Assessment with 

the NSC staff and the OMB prior to its finalization. The Assessment 

shall be submitted to the Committee for approval and provided to the 

APNSA and the Director of the OMB within 180 days of the formation of 

the Team and annually thereafter.

    (h) Each year, within 90 days of the approval of the Assessment, 

the Team shall summarize the Assessment and prepare, subject to the 

approval of the Committee and in coordination with the NSC staff, a 

public report describing the actions taken to reduce the risk of 

biological threats to the American people.

    (i) Each year, Covered Officials, in coordination with the APNSA 

through the NSPM-4 process, shall prepare joint policy guidance 

(Guidance) on priority areas of biodefense. The Guidance shall be 

informed by the Assessment, and Covered Officials shall consider the 

Guidance when they develop their annual budget requests. Based on the 

Guidance, the Covered Officials shall include in their respective 

annual budget requests to the OMB information on the programs within 

the budget requests that support the implementation of the Strategy and 

conform to budget formulation requirements established by the OMB, 

including specified funding levels. Concurrently, Covered Officials 

shall submit a memorandum to the NSC staff and the OMB conveying their 

response to the policy Guidance. Covered Officials shall ensure that 

new and existing activities are prioritized and can be accommodated 

within budget guidance from the OMB.

    (j) Within 120 days of the issuance of this memorandum, the Team, 

in coordination with the NSC staff through the NSPM-4 process, shall 

develop a proposal for metrics, milestones, end states, and roles and 

responsibilities of agencies, with respect to biodefense activities, 

particularly in meeting the goals, objectives, and sub-objectives of 

the Strategy. This proposal will be approved by Deputies, consistent 

with the NSPM-4 process.

    (k) Within 2 years of the date of this memorandum, and every 2 

years thereafter, Covered Officials shall review and, as appropriate, 

revise the Strategy. The APNSA, acting through the NSC staff, shall 

coordinate the development of updates to the Strategy. The updates to 

the Strategy shall be submitted to the President through the APNSA and, 

to the extent permitted by and consistent with applicable law and 

policy, released to the public.

    (l) The APNSA, with the approval of every member of the Committee, 

may designate a different member of the Committee to serve as Chair of 

the Committee and perform the responsibilities specified in subsection 

2(c).

    Sec. 3. Earlier Presidential Actions. (a) Presidential Policy 

Directive-2 of November 23, 2009 (Implementation of the National 

Strategy for Countering Biological Threats) and HSPD 10/National 

Security Presidential Directive-33 of April 21, 2004 (National Policy 

for Biodefense) are hereby superseded and replaced.

    Sec. 4. General Provisions. (a) Nothing in this memorandum shall be 

construed to impair or otherwise affect:

    (i) The authority granted by law to an executive department or 

agency, or the head thereof; or

    (ii) the functions of the Director of the OMB relating to 

budgetary, administrative, or legislative proposals.

    (b) This memorandum shall be implemented consistent with applicable 

laws and subject to the availability of appropriations.

    (c) This memorandum is not intended to, and does not, create any 

right or benefit, substantive or procedural, enforceable at law or in 

equity by any party against the United States, its departments, 

agencies, or entities, its officers, employees, or agents, or any other 

person.

    (d) The Secretary is hereby authorized and directed to publish this 

memorandum in the Federal Register.



    Dated: October 12, 2018.

Alex M. Azar II,

Secretary.

[FR Doc. 2018-22742 Filed 10-17-18; 8:45 am]

 BILLING CODE P





                                                                                Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices                                                                  52841

                                               collected in the HRSA Performance                                  management strategy and make only                             recruitment, training, and placement of
                                               Report for Grants and Cooperative                                  minor changes that reflect new HHS and                        under-represented groups in the health
                                               Agreements. Specific performance                                   HRSA priorities with the addition of a                        workforce; and (5) supporting
                                               measurement requirements for each                                  question asking awardees how many                             educational infrastructure to increase
                                               program may be found on the HRSA                                   trainees received training in telehealth,                     the capacity to train more health
                                               website at https://bhw.hrsa.gov/grants/                            substance use treatment, and/or                               professionals in high demand areas.
                                               reportonyourgrant. Data collection                                 medication-assisted treatment.                                   Likely Respondents: Respondents are
                                               activities consist of two reports, an                                 Need and Proposed Use of the                               awardees of BHW health professions
                                               annual progress and annual                                         Information: The purpose of the                               grant programs.
                                               performance report that are submitted                              proposed data collection is to continue                          Burden Statement: Burden in this
                                               by awardees to comply with statutory                               analysis and reporting of awardee                             context means the time expended by
                                               and programmatic requirements for                                  training activities and educational                           persons to generate, maintain, retain,
                                               performance measurement and                                        programs, identify intended practice                          disclose or provide the information
                                               evaluation (including specific Title III,                          locations, and report outcomes of                             requested. This includes the time
                                               VII and VIII requirements), as well as                             funded initiatives. Data collected from                       needed to review instructions; to
                                               the Government Performance and                                     these grant programs will also provide                        develop, acquire, install and utilize
                                               Results Act of 1993 (GPRA) and the                                 a description of the program activities of                    technology and systems for the purpose
                                               GPRA Modernization Act of 2010                                     approximately 1,500 reporting grantees                        of collecting, validating and verifying
                                               requirements. The performance                                      to inform policymakers on the barriers,                       information, processing and
                                               measures were last revised in 2016 to                              opportunities, and outcomes involved                          maintaining information, and disclosing
                                               ensure they addressed programmatic                                 in health care workforce development.                         and providing information; to train
                                               changes, met evolving program                                      The proposed measures focus on five                           personnel and to be able to respond to
                                               management needs, and responded to                                 key outcomes: (1) Increasing the                              a collection of information; to search
                                               emerging workforce concerns. As these                              workforce supply of well-educated                             data sources; to complete and review
                                               changes successfully enabled BHW to                                practitioners in needed professions; (2)                      the collection of information; and to
                                               demonstrate accurate outputs and                                   increasing the number of practitioners                        transmit or otherwise disclose the
                                               outcomes associated with the health                                that practice in underserved and rural                        information. The total annual burden
                                               professions programs, BHW will                                     areas; (3) enhancing the quality of                           hours estimated for this ICR are
                                               continue with its current performance                              education; (4) increasing the                                 summarized in the table below.

                                                                                                           TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                    Average
                                                                                                                                                       Number of                                                           Total
                                                                                                                                    Number of                                      Total          burden per
                                                                               Form name                                                             responses per                                                        burden
                                                                                                                                   respondents                                  responses          response
                                                                                                                                                       respondent                                                          hours
                                                                                                                                                                                                   (in hours)

                                               Direct Financial Support Program .......................................                        500                        1            500                       3.1          1,550
                                               Infrastructure Program .........................................................                100                        1            100                       4.5            450
                                               Multipurpose or Hybrid Program ..........................................                       900                        1            900                       4.3          3,870

                                                                                                                                          1,500      ........................         1,500    ........................       5,870



                                                 HRSA specifically requests comments                              DEPARTMENT OF HEALTH AND                                      SW, Washington, DC 20201; Telephone:
                                               on (1) the necessity and utility of the                            HUMAN SERVICES                                                202–205–2882.
                                               proposed information collection for the                                                                                          SUPPLEMENTARY INFORMATION:
                                               proper performance of the agency’s                                 Office of the Secretary
                                                                                                                                                                                  National Security Presidential
                                               functions; (2) the accuracy of the                                                                                               Memorandum: Support for National
                                                                                                                  Posting of the National Security
                                               estimated burden; (3) ways to enhance                                                                                            Biodefense.
                                                                                                                  Presidential Memorandum 14,
                                               the quality, utility, and clarity of the                                                                                           Memorandum for: The Vice President;
                                                                                                                  ‘‘Support for National Biodefense’’
                                               information to be collected; and (4) the                                                                                         The Secretary of State; The Secretary of
                                               use of automated collection techniques                             ACTION:     Notice.                                           the Treasury; The Secretary of Defense;
                                               or other forms of information                                                                                                    The Attorney General; The Secretary of
                                               technology to minimize the information                             SUMMARY:   National Security Presidential                     the Interior; The Secretary of
                                               collection burden.                                                 Memorandum 14 directs                                         Agriculture; The Secretary of
                                                                                                                  implementation of the National                                Commerce; The Secretary of Labor; The
                                               Amy P. McNulty,                                                    Biodefense Strategy. The Secretary is                         Secretary of Health and Human
                                               Acting Director, Division of the Executive                         authorized and directed to publish the                        Services; The Secretary of
                                               Secretariat.                                                       Memorandum in the Federal Register.                           Transportation; The Secretary of Energy;
                                               [FR Doc. 2018–22708 Filed 10–17–18; 8:45 am]                       DATES: National Security Presidential                         The Secretary of Veterans Affairs; The
                                                                                                                  Memorandum 14 was signed on                                   Secretary of Homeland Security;
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                                               BILLING CODE 4165–15–P
                                                                                                                  September 18, 2018.                                           Assistant to the President and Chief of
                                                                                                                  FOR FURTHER INFORMATION CONTACT:                              Staff; Administrator of the
                                                                                                                  Robert P. Kadlec, MD, MTM&H, MS,                              Environmental Protection Agency;
                                                                                                                  Assistant Secretary for Preparedness                          Director of the Office of Management
                                                                                                                  and Response, Office of the Secretary,                        and Budget; The Representative of the
                                                                                                                  Department of Health and Human                                United States to the United Nations;
                                                                                                                  Services, 200 Independence Avenue                             Director of National Intelligence;


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                                               52842                       Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices

                                               Assistant to the President for Science                  Preparedness); Executive Order 13676 of               interaction with non-Federal
                                               and Technology and Director of the                      September 18, 2014 (Combating                         stakeholders. The Secretary, as the Chair
                                               Office of Science and Technology                        Antibiotic–Resistant Bacteria); and                   of the Committee, shall serve as the
                                               Policy; Chairman of the Joint Chiefs of                 Executive Order 13747 of November 4,                  Federal lead in coordinating
                                               Staff; Administrator of the United States               2016 (Advancing the Global Health                     implementation of the Strategy.
                                               Agency for International Development;                   Security Agenda To Achieve a World                      (d) To assist the Committee in
                                               Director of the Federal Bureau of                       Safe and Secure From Infectious Disease               carrying out the responsibilities
                                               Investigation.                                          Threats).                                             described in subsection (c) of this
                                                  It is a vital interest of the United                   Sec. 2. Implementation. The policy set              section, the Secretary shall, within 90
                                               States to prepare for, counter, respond                 forth in section 1 of this memorandum                 days of the date of this memorandum,
                                               to, and recover from biological incidents               shall be implemented, to the extent                   establish a Biodefense Coordination
                                               at home and abroad. Nearly all                          permitted by law and available                        Team (Team) administratively located
                                               executive departments and agencies                      appropriations, and subject to the                    within the Department of Health and
                                               (agencies) contribute to the biodefense                 internal programmatic and budgetary                   Human Services.
                                               mission of the United States                            processes of the agencies, as follows:                  (i) The Secretary shall designate a
                                               Government. Those contributions occur                     (a) Consistent with the Strategy, the               senior official of, or detailed to, the
                                               through a variety of authorities and                    heads of agencies shall:                              Department of Health and Human
                                               programs. To ensure an integrated,                        (i) Prioritize the implementation of                Services to serve as the director of the
                                               comprehensive approach, agencies shall                  the Strategy and include Strategy-                    Team, who shall report to the Secretary.
                                               coordinate and manage biodefense                        related activities within their strategic               (ii) The Secretary, the Secretary of
                                               activities in support of the broader                    planning and budgetary processes;                     State, the Secretary of Defense, the
                                               biodefense enterprise, which consists of                  (ii) coordinate their biodefense                    Attorney General, the Secretary of
                                               all stakeholders with a role in the                     policies with other agencies that have                Agriculture, the Secretary of Veterans
                                               detection of, prevention of,                            responsibilities or capabilities                      Affairs, the Secretary of Homeland
                                               preparedness for, response to, and                      pertaining to biodefense, as well as with             Security, the Administrator of the
                                               recovery from biological incidents,                     appropriate non-Federal entities;                     Environmental Protection Agency, and
                                               including Federal, State, local, tribal,                  (iii) share information, as appropriate,            the heads of other agencies with
                                               and territorial governments, the private                and coordinate decision-making related                responsibilities or capabilities
                                               sector, and international partners.                     to the biodefense enterprise; and                     pertaining to biodefense shall support
                                                  Section 1. Policy. (a) It is the policy                (iv) monitor, evaluate, and hold their              the work of the Team, including, where
                                               of the United States to preserve our                    agencies accountable for                              appropriate, through the detail of
                                               national and economic security by                       implementation of the Strategy.                       personnel to the Team, consistent with
                                               protecting the Nation from biological                     (b) The Assistant to the President for              law.
                                               threats. Acting within the biodefense                   National Security Affairs (APNSA) shall                 (iii) The Secretary, in consultation
                                               enterprise, the United States                           serve as the lead for policy coordination             with the Committee, shall ensure that
                                               Government will undertake actions at                    and review, acting through the process                appropriate resources are provided by
                                               home and with partners abroad to                        described in National Security                        the Department of Health and Human
                                               reduce the risk of natural, accidental,                 Presidential Memorandum (NSPM)–4 of                   Services to facilitate the Team’s
                                               and deliberate biological threats to                    April 4, 2017 (Organization of the                    activities.
                                               humans, animals, agriculture, and the                   National Security Council, the                          (iv) The Team shall, in consultation
                                               environment that have the potential to                  Homeland Security Council, and                        with existing governance bodies with
                                               significantly affect the national and                   Subcommittees), to provide strategic                  responsibilities or capabilities
                                               economic security of the United States.                 input and facilitate policy integration               pertaining to biodefense, assist the
                                                  (b) The foundation for the United                    for Federal biodefense efforts.                       Committee in monitoring and
                                               States Government’s role in the                           (c) There is hereby established a                   coordinating implementation of the
                                               biodefense enterprise is the National                   Biodefense Steering Committee                         Strategy. The Team may convene
                                               Biodefense Strategy and its                             (Committee), which shall be chaired by                working groups with relevant agencies
                                               implementation plan (Strategy), which                   the Secretary of Health and Human                     as appropriate. In addition, the Team
                                               serve as the authoritative sources for the              Services (Secretary). The other members               shall, on an ongoing basis, maintain
                                               goals, objectives, and definitions for                  of the Committee shall include the                    awareness of biodefense activities
                                               United States Government activities in                  Secretary of State, the Secretary of                  conducted by agencies, relevant
                                               support of the broader biodefense                       Defense, the Attorney General, the                    interagency entities, and non Federal
                                               enterprise. Agency biodefense activities                Secretary of Agriculture, the Secretary               partners in the broader biodefense
                                               shall be conducted consistent with                      of Veterans Affairs, the Secretary of                 enterprise, including relevant private
                                               section 1086 of the National Defense                    Homeland Security, and the                            sector stakeholders. The Team shall
                                               Authorization Act for Fiscal Year 2017                  Administrator of the Environmental                    identify opportunities to increase
                                               and the Strategy, including activities                  Protection Agency. The heads of other                 coordination with non-Federal partners,
                                               undertaken to implement prior                           agencies with responsibilities or                     including international organizations.
                                               Executive Orders and Presidential                       capabilities pertaining to biodefense                 Subject to the approval of the
                                               Directives, such as Homeland Security                   shall participate at the invitation of the            Committee, the Team shall establish
                                               Presidential Directive (HSPD)–5 of                      Committee, as appropriate. The                        policies, processes, and procedures to
                                               February 28, 2003 (Management of                        Committee shall be responsible for
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                                                                                                                                                             govern its activities.
                                               Domestic Incidents); HSPD–9 of January                  monitoring and coordinating the                         (v) The Secretary shall notify the
                                               30, 2004 (Defense of United States                      implementation of the Strategy. The                   APNSA when the Team is established.
                                               Agriculture and Food); HSPD–18 of                       Committee shall seek consensus, with                    (e) To ensure effective
                                               January 31, 2007 (Medical                               disagreements being addressed through                 implementation of the Strategy, within
                                               Countermeasures against Weapons of                      the NSPM–4 process. The Committee                     30 days of the formation of the Team
                                               Mass Destruction); HSPD–21 of October                   may establish appropriate consultative                and annually thereafter in alignment
                                               18, 2007 (Public Health and Medical                     or advisory mechanisms to facilitate                  with the annual budget process, the


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                                                                           Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices                                               52843

                                               Secretary shall submit written requests                 shortfalls, and redundancies; describe                  (k) Within 2 years of the date of this
                                               for information to the heads of agencies                any challenges to the implementation                  memorandum, and every 2 years
                                               identified by the Committee as having                   and execution of the Strategy; and                    thereafter, Covered Officials shall
                                               responsibilities pertaining to biodefense               recommend any necessary updates or                    review and, as appropriate, revise the
                                               (Covered Officials), including the                      changes to the Strategy. The Assessment               Strategy. The APNSA, acting through
                                               following:                                              shall include an analysis of the extent               the NSC staff, shall coordinate the
                                                  (i) The Secretary of State;                          to which current United States                        development of updates to the Strategy.
                                                  (ii) the Secretary of the Treasury;                  Government resources support the goals                The updates to the Strategy shall be
                                                  (iii) the Secretary of Defense;                      and objectives of the Strategy, how                   submitted to the President through the
                                                  (iv) the Attorney General;                           existing programs and resources could                 APNSA and, to the extent permitted by
                                                  (v) the Secretary of the Interior;                   be better executed or allocated to align              and consistent with applicable law and
                                                  (vi) the Secretary of Agriculture;                   with the Strategy, and how additional                 policy, released to the public.
                                                  (vii) the Secretary of Commerce;                     resources could, if available, be applied               (l) The APNSA, with the approval of
                                                  (viii) the Secretary of Labor;                       to support the goals of the Strategy. The             every member of the Committee, may
                                                  (ix) the Secretary of Health and                     Team shall coordinate the Assessment                  designate a different member of the
                                               Human Services;                                         with the NSC staff and the OMB prior                  Committee to serve as Chair of the
                                                  (x) the Secretary of Transportation;                 to its finalization. The Assessment shall             Committee and perform the
                                                  (xi) the Secretary of Energy;                        be submitted to the Committee for                     responsibilities specified in subsection
                                                  (xii) the Secretary of Veterans Affairs;             approval and provided to the APNSA                    2(c).
                                                  (xiii) the Secretary of Homeland                     and the Director of the OMB within 180                  Sec. 3. Earlier Presidential Actions. (a)
                                               Security;                                               days of the formation of the Team and                 Presidential Policy Directive–2 of
                                                  (xiv) the Administrator of the                       annually thereafter.                                  November 23, 2009 (Implementation of
                                               Environmental Protection Agency;                          (h) Each year, within 90 days of the                the National Strategy for Countering
                                                  (xv) the Director of National                        approval of the Assessment, the Team                  Biological Threats) and HSPD 10/
                                               Intelligence;                                           shall summarize the Assessment and                    National Security Presidential Directive-
                                                  (xvi) the Administrator of the United                prepare, subject to the approval of the               33 of April 21, 2004 (National Policy for
                                               States Agency for International                         Committee and in coordination with the                Biodefense) are hereby superseded and
                                               Development; and                                        NSC staff, a public report describing the
                                                  (xvii) the Director of the Federal                                                                         replaced.
                                                                                                       actions taken to reduce the risk of                     Sec. 4. General Provisions. (a) Nothing
                                               Bureau of Investigation.                                biological threats to the American                    in this memorandum shall be construed
                                                  (f) These requests shall ask how                     people.                                               to impair or otherwise affect:
                                               agency programs and activities                            (i) Each year, Covered Officials, in                  (i) The authority granted by law to an
                                               contribute to the objectives of the                     coordination with the APNSA through                   executive department or agency, or the
                                               Strategy. Covered Officials shall                       the NSPM–4 process, shall prepare joint               head thereof; or
                                               respond to these requests within 60                     policy guidance (Guidance) on priority                  (ii) the functions of the Director of the
                                               days of receipt of the request through a                areas of biodefense. The Guidance shall               OMB relating to budgetary,
                                               Biodefense Memorandum, as described                     be informed by the Assessment, and                    administrative, or legislative proposals.
                                               in paragraphs (i)–(ii) of this subsection.              Covered Officials shall consider the                    (b) This memorandum shall be
                                                  (i) The Biodefense Memorandum shall                  Guidance when they develop their                      implemented consistent with applicable
                                               identify those activities, programs, and                annual budget requests. Based on the                  laws and subject to the availability of
                                               projects that are planned, programmed,                  Guidance, the Covered Officials shall                 appropriations.
                                               or have been executed that advance or                   include in their respective annual                      (c) This memorandum is not intended
                                               are expected to advance the Strategy;                   budget requests to the OMB information                to, and does not, create any right or
                                               quantify, to the extent feasible,                       on the programs within the budget                     benefit, substantive or procedural,
                                               resources allocated to biodefense within                requests that support the                             enforceable at law or in equity by any
                                               the agency; assess the extent to which                  implementation of the Strategy and                    party against the United States, its
                                               the goals, objectives, and sub-objectives               conform to budget formulation                         departments, agencies, or entities, its
                                               of the Strategy are being met; and                      requirements established by the OMB,                  officers, employees, or agents, or any
                                               identify impediments to timely and                      including specified funding levels.                   other person.
                                               effective implementation and options                    Concurrently, Covered Officials shall                   (d) The Secretary is hereby authorized
                                               for their resolution. Each agency shall                 submit a memorandum to the NSC staff                  and directed to publish this
                                               provide its Biodefense Memorandum to                    and the OMB conveying their response                  memorandum in the Federal Register.
                                               the Committee, the Team, the National                   to the policy Guidance. Covered
                                                                                                                                                               Dated: October 12, 2018.
                                               Security Council (NSC) staff, and the                   Officials shall ensure that new and
                                               Office of Management and Budget                                                                               Alex M. Azar II,
                                                                                                       existing activities are prioritized and
                                               (OMB). The Team shall distribute the                    can be accommodated within budget                     Secretary.
                                               collected Memoranda to Covered                          guidance from the OMB.                                [FR Doc. 2018–22742 Filed 10–17–18; 8:45 am]
                                               Officials.                                                (j) Within 120 days of the issuance of              BILLING CODE P
                                                  (ii) Covered Officials are not required              this memorandum, the Team, in
                                               to provide information on specific law                  coordination with the NSC staff through
                                               enforcement activities,                                 the NSPM–4 process, shall develop a                   DEPARTMENT OF HEALTH AND
                                               counterproliferation activities, military               proposal for metrics, milestones, end                 HUMAN SERVICES
khammond on DSK30JT082PROD with NOTICES




                                               plans or operations, intelligence                       states, and roles and responsibilities of
                                               activities, or criminal investigations.                 agencies, with respect to biodefense                  National Institutes of Health
                                                  (g) The Team, as informed by each                    activities, particularly in meeting the
                                                                                                                                                             Government-Owned Inventions;
                                               Biodefense Memorandum and                               goals, objectives, and sub-objectives of
                                                                                                                                                             Availability for Licensing; Correction
                                               consultations with the agencies, shall                  the Strategy. This proposal will be
                                               prepare a Biodefense Assessment                         approved by Deputies, consistent with                 AGENCY:    National Institutes of Health,
                                               (Assessment) to identify any gaps,                      the NSPM–4 process.                                   HHS.


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Document Created: 2018-10-18 03:05:51
Document Modified: 2018-10-18 03:05:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesNational Security Presidential Memorandum 14 was signed on
ContactRobert P. Kadlec, MD, MTM&H, MS,
FR Citation83 FR 52841 

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