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 Range		52841-52843
FR Document		2018-22742
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.



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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 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.

VerDate Sep<11>2014 17:28 Oct 17, 2018 Jkt 247001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\18OCN1.SGM 18OCN1
Document Created: 2018-10-18 03:05:51
Document Modified: 2018-10-18 03:05:51
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		National Security Presidential Memorandum 14 was signed on
Contact		Robert P. Kadlec, MD, MTM&H, MS,
FR Citation		83 FR 52841
83 FR 52841 - Posting of the National Security Presidential Memorandum 14, “Support for National Biodefense”

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
