Notice2026-10539

Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against Andes Virus

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
May 27, 2026

Issuing agencies

Health and Human Services Department

Abstract

The Secretary is issuing a Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide liability protection for activities related to medical countermeasures against Andes virus consistent with the terms of the Declaration.

Full Text

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<title>Federal Register, Volume 91 Issue 101 (Wednesday, May 27, 2026)</title>
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[Federal Register Volume 91, Number 101 (Wednesday, May 27, 2026)]
[Notices]
[Pages 31467-31471]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Notice of Declaration Under the Public Readiness and Emergency 
Preparedness Act for Medical Countermeasures Against Andes Virus

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice of declaration.

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SUMMARY: The Secretary is issuing a Declaration pursuant to section 
319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide 
liability protection for activities related to medical countermeasures 
against Andes virus consistent with the terms of the Declaration.

DATES: This declaration is effective as of the date of signature.

FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Administration for 
Strategic Preparedness and Response, U.S. Department of Health and 
Human Services, 400 7th St. SW, Washington, DC 20024; 202-260-0365, 
<a href="/cdn-cgi/l/email-protection#384859515f5d165d425d4a56595b537850504b165f574e"><span class="__cf_email__" data-cfemail="aedecfc7c9cb80cbd4cbdcc0cfcdc5eec6c6dd80c9c1d8">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency 
Preparedness (PREP) Act authorizes the Secretary of Health and Human 
Services (the Secretary) to issue a Declaration to provide liability 
immunity to certain individuals and entities (Covered Persons) against 
any claim of loss caused by, arising out of, relating to, or resulting 
from the manufacture, distribution, administration, or use of medical 
countermeasures (Covered Countermeasures), except for claims involving 
``willful misconduct'' as defined in the PREP Act. Under the PREP Act, 
a Declaration may be amended as circumstances warrant. The PREP Act 
also creates a compensation program. Liability immunity is addressed in 
section 319F-3 of the Public Health Service (PHS) Act, 42 U.S.C. 247d-
6d, and the compensation program is addressed in section 319F-4 of the 
PHS Act, 42 U.S.C. 247d-6e.
    Andes virus is a type of hantavirus spread by rodents in South 
America and, less commonly, by other infected people. The rodents that 
carry Andes virus have not been found in the United States. It can 
cause a severe respiratory disease in people, called Hantavirus 
Pulmonary Syndrome (HPS). Andes virus is the only type of hantavirus 
that is known to spread person-to-person. This spread is usually 
limited to people who have close contact with a sick person. This 
includes direct physical contact, prolonged time spent in close or 
enclosed spaces, and exposure to the sick person's body fluids.
    HPS is a severe and potentially deadly disease that affects the 
lungs. HPS can be life-threatening. Among patients who have severe 
respiratory symptoms, the case fatality rate has been estimated at 
approximately 38%. Symptoms of HPS caused by Andes virus usually appear 
within 4-42 days after exposure. Early symptoms can include fever, 
fatigue, and muscle aches, especially in large muscle groups like the 
thighs, hips, back, or shoulders. Early symptoms such as fever, 
headache, muscle aches, nausea, and fatigue can be easily confused with 
influenza or other viral illnesses. About half of all HPS patients have 
experienced headaches, dizziness, chills, and gastrointestinal 
symptoms, including nausea, vomiting, diarrhea, and abdominal pain. 
Late symptoms of HPS appear approximately 4-10 days after the initial 
phase of illness and can include coughing, shortness of breath, and 
chest tightness. Individuals are generally only infectious while 
symptomatic.
    Currently, there are no available antiviral treatments or vaccines 
for HPS that are FDA-approved, or authorized by FDA for investigational 
or emergency use.
    On May 2, 2026, the World Health Organization (WHO) was notified of 
a cluster of severe acute respiratory illness (SARI) among passengers 
and crew of a cruise ship (the M/V Hondius) in the Atlantic Ocean. The 
cluster included two deaths and one critically ill passenger, whose 
laboratory tests confirmed hantavirus. On May 6, 2026, WHO confirmed 
that the type of hantavirus responsible for this outbreak is the Andes 
virus. As of May 8, 2026, WHO has reported eight cases (six confirmed 
and two suspected), including three deaths.
    The cruise ship departed from Ushuaia, Argentina, on April 1, 2026, 
and traveled across the South Atlantic Ocean, stopping at several 
remote locations, including Antarctica, South Georgia Island, Tristan 
da Cunha, Saint Helena, and Ascension Island. It carried 147 people (86 
passengers and 61 crew) from 23 different countries. The United States 
government repatriated 18 passengers from the cruise ship to the United 
States on May 10 and 11, 2026.

Section I, Determination of Public Health Emergency or Credible Risk of 
Future Public Health Emergency

    Before issuing a Declaration under the PREP Act, the Secretary is 
required to determine that a disease or other health condition or 
threat to health constitutes a public health emergency or that there is 
a credible risk that the disease, condition, or threat may constitute 
such an emergency. Accordingly, in Section I, the Secretary determines 
that the spread of Andes virus and the resulting disease HPS 
constitutes a credible risk of a public health emergency for purposes 
of this Declaration.

Section II, Factors Considered

    In deciding whether and under what circumstances to issue a 
Declaration

[[Page 31468]]

with respect to a Covered Countermeasure, the Secretary must consider 
the desirability of encouraging the design, development, clinical 
testing or investigation, manufacture, labeling, distribution, 
formulation, packaging, marketing, promotion, sale, purchase, donation, 
dispensing, prescribing, administration, licensing, and use of the 
countermeasure. In Section II, the Secretary states that he has 
considered these factors.

Section III, Recommended Activities

    The Secretary must recommend the activities for which the PREP 
Act's liability immunity is in effect. These activities may include, 
under conditions as the Secretary may specify, the manufacture, 
testing, development, distribution, administration, or use of one or 
more Covered Countermeasures (Recommended Activities). In Section III, 
the Secretary recommends activities for which the immunity is in 
effect.

Section IV, Liability Immunity

    The Secretary must also state that liability protections available 
under the PREP Act are in effect with respect to the Recommended 
Activities. These liability protections provide that, ``[s]ubject to 
other provisions of [the PREP Act], a covered person shall be immune 
from suit and liability under federal and state law with respect to all 
claims for loss caused by, arising out of, relating to, or resulting 
from the administration to or use by an individual of a covered 
countermeasure if a Declaration has been issued with respect to such 
countermeasure.'' In Section IV, the Secretary states that liability 
protections are in effect with respect to the Recommended Activities.

Section V, Covered Persons

    The PREP Act's liability immunity applies to ``Covered Persons'' 
with respect to administration or use of a Covered Countermeasure. The 
term ``Covered Persons'' has a specific meaning and is defined in the 
PREP Act to include manufacturers, distributors, program planners, and 
qualified persons, and their officials, agents, and employees, and the 
United States. The PREP Act further defines the terms ``manufacturer,'' 
``distributor,'' ``program planner,'' and ``qualified person'' as 
described below.
    A manufacturer includes a contractor or subcontractor of a 
manufacturer; a supplier or licenser of any product, intellectual 
property, service, research tool or component or other article used in 
the design, development, clinical testing, investigation or 
manufacturing of a Covered Countermeasure; and any or all the parents, 
subsidiaries, affiliates, successors, and assigns of a manufacturer.
    A distributor means a person or entity engaged in the distribution 
of drugs, biologics, or devices, including but not limited to: 
manufacturers; re-packers; common carriers; contract carriers; air 
carriers; own-label distributors; private-label distributors; jobbers; 
brokers; warehouses and wholesale drug warehouses; independent 
wholesale drug traders; and retail pharmacies.
    A program planner means a state or local government, including an 
Indian tribe; a person employed by the state or local government; or 
other person who supervises or administers a program with respect to 
the administration, dispensing, distribution, provision, or use of a 
Covered Countermeasure, including a person who establishes 
requirements, provides policy guidance, or supplies technical or 
scientific advice or assistance or provides a facility to administer or 
use a Covered Countermeasure in accordance with the Secretary's 
Declaration. Under this definition, a private sector employer or 
community group or other ``person'' can be a program planner when it 
carries out the described activities.
    A qualified person means a licensed health professional or other 
individual authorized to prescribe, administer, or dispense Covered 
Countermeasures under the law of the state in which the Covered 
Countermeasure was prescribed, administered, or dispensed; or a person 
within a category of persons identified as qualified in the Secretary's 
Declaration. Under this definition, the Secretary can describe in the 
Declaration other qualified persons, such as volunteers, who are 
Covered Persons. Section V describes other qualified persons covered by 
this Declaration.
    The PREP Act also defines the word ``person'' as used in the Act: A 
person includes an individual, partnership, corporation, association, 
entity, or public or private corporation, including a federal, state, 
or local government agency or department.
    Section V describes Covered Persons under the Declaration, 
including Qualified Persons.

Section VI, Covered Countermeasures

    As noted above, Section III describes the Secretary's Recommended 
Activities for which liability immunity is in effect. This section 
identifies the Covered Countermeasures for which the Secretary has 
recommended such activities. The PREP Act states that a ``Covered 
Countermeasure'' must be: A ``qualified pandemic or epidemic product,'' 
or a ``security countermeasure,'' as described immediately below; or a 
drug, biological product or device authorized for emergency use in 
accordance with Sections 564, 564A, or 564B of the FD&C Act.
    A qualified pandemic or epidemic product means a drug or device, as 
defined in the FD&C Act or a biological product, as defined in the PHS 
Act that is: (i) Manufactured, used, designed, developed, modified, 
licensed or procured to diagnose, mitigate, prevent, treat, or cure a 
pandemic or epidemic or limit the harm such a pandemic or epidemic 
might otherwise cause; (ii) manufactured, used, designed, developed, 
modified, licensed, or procured to diagnose, mitigate, prevent, treat, 
or cure a serious or life-threatening disease or condition caused by 
such a drug, biological product, or device; (iii) or a product or 
technology intended to enhance the use or effect of such a drug, 
biological product, or device.
    A security countermeasure is a drug or device, as defined in the 
FD&C Act or a biological product, as defined in the PHS Act that: 
(i)(a) The Secretary determines to be a priority to diagnose, mitigate, 
prevent, or treat harm from any biological, chemical, radiological, or 
nuclear agent identified as a material threat by the Secretary of 
Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm 
from a condition that may result in adverse health consequences or 
death and may be caused by administering a drug, biological product, or 
device against such an agent; and (ii) is determined by the Secretary 
of Health and Human Services to be a necessary countermeasure to 
protect public health.
    To be a Covered Countermeasure, qualified pandemic or epidemic 
products or security countermeasures also must be approved or cleared 
under the FD&C Act; licensed under the PHS Act; or authorized for 
emergency use under Sections 564, 564A, or 564B of the FD&C Act.
    A qualified pandemic or epidemic product also may be a Covered 
Countermeasure when it is subject to an exemption (that is, it is 
permitted to be used under an Investigational New Drug (IND) 
Application or an Investigational Device Exemption (IDE)) under the 
FD&C Act and is the object of research for possible use for diagnosis, 
mitigation, prevention, treatment, or cure, or to limit harm of a 
pandemic or epidemic or serious or life-threatening condition caused by 
such a drug or device.

[[Page 31469]]

    A security countermeasure also may be a Covered Countermeasure if 
it may reasonably be determined to qualify for approval or licensing 
within 10 years after the Department's determination that procurement 
of the countermeasure is appropriate.
    Section VI lists medical countermeasures against Andes virus and 
HPS that are Covered Countermeasures under this declaration.
    Section VI also refers to the statutory definitions of Covered 
Countermeasures to make clear that these statutory definitions limit 
the scope of Covered Countermeasures. Specifically, the Declaration 
notes that Covered Countermeasures must be ``qualified pandemic or 
epidemic products,'' or ``security countermeasures,'' or drugs, 
biological products, or devices authorized for investigational or 
emergency use, as those terms are defined in the PREP Act, the FD&C 
Act, and the Public Health Service Act.

Section VII, Limitations on Distribution

    The Secretary may specify that liability immunity is in effect only 
to Covered Countermeasures obtained through a particular means of 
distribution. The Declaration states that liability immunity is 
afforded to Covered Persons for Recommended Activities related to 
Covered Countermeasures obtained for voluntary administration to 
individuals in accordance with an IND Application.

Section VIII, Category of Disease, Health Condition, or Threat

    The Secretary must identify, for each Covered Countermeasure, the 
categories of diseases, health conditions, or threats to health for 
which the Secretary recommends the administration or use of the 
countermeasure. In Section VIII, the Secretary states that the disease 
threat for which he recommends administration or use of the Covered 
Countermeasures is HPS caused by Andes virus.

Section IX, Administration of Covered Countermeasures

    The PREP Act does not explicitly define the term ``administration'' 
but does assign the Secretary the responsibility to provide relevant 
conditions in the Declaration. In Section IX, the Secretary defines 
``Administration of a Covered Countermeasure:''
    Administration of a Covered Countermeasure means physical provision 
of the countermeasures to recipients, or activities and decisions 
directly relating to public and private delivery, distribution, and 
dispensing of the countermeasures to recipients; management and 
operation of countermeasure programs; or management and operation of 
locations for purpose of distributing and dispensing countermeasures.
    The definition of ``administration'' extends only to physical 
provision of a countermeasure to a recipient, such as vaccination or 
handing drugs to patients, and to activities related to management and 
operation of programs and locations for providing countermeasures to 
recipients, such as decisions and actions involving security and 
queuing, but only insofar as those activities directly relate to the 
countermeasure activities. Claims for which Covered Persons are 
provided immunity under the Act are losses caused by, arising out of, 
relating to, or resulting from the administration to or use by an 
individual of a Covered Countermeasure consistent with the terms of a 
Declaration issued under the Act. Under the definition, these liability 
claims are precluded if they allege an injury caused by physical 
provision of a countermeasure to a recipient, or if the claims are 
directly due to conditions of delivery, distribution, dispensing, or 
management and operation of countermeasure programs at distribution and 
dispensing sites.
    Thus, it is the Secretary's interpretation that, when a Declaration 
is in effect, the Act precludes, for example, liability claims alleging 
negligence by a manufacturer in creating a vaccine, or negligence by a 
health care provider in prescribing the wrong dose, absent willful 
misconduct.

Section X, Population

    The Secretary must identify, for each Covered Countermeasure 
specified in a Declaration, the population or populations of 
individuals for which liability immunity is in effect with respect to 
administration or use of the countermeasure. This section explains 
which individuals should use the countermeasure or to whom the 
countermeasure should be administered--in short, those who should take 
a drug or other countermeasure. Section X provides that the population 
includes ``any individual who uses or who is administered a Covered 
Countermeasure in accordance with the Declaration.''
    In addition, the PREP Act specifies that liability immunity is 
afforded: (1) To manufacturers and distributors without regard to 
whether the countermeasure is used by or administered to this 
population; and (2) to program planners and qualified persons when the 
countermeasure is either used by or administered to this population or 
the program planner or qualified person reasonably could have believed 
the recipient was in this population. Section X includes these 
statutory conditions in the Declaration for clarity.

Section XI, Geographic Area

    The Secretary must identify, for each Covered Countermeasure 
specified in the Declaration, the geographic area or areas for which 
liability immunity is in effect with respect to administration or use 
of the countermeasure, including, as appropriate, whether the 
Declaration applies only to individuals physically present in the area 
or, in addition, applies to individuals who have a described connection 
to the area. Section XI provides that liability immunity is afforded 
for the administration or use of a Covered Countermeasure without 
geographic limitation. This could include claims related to 
administration or use in countries outside the U.S. It is possible that 
claims may arise in regard to administration or use of the Covered 
Countermeasures outside the U.S. that may be resolved under U.S. law.
    In addition, the PREP Act specifies that liability immunity is 
afforded: (1) To manufacturers and distributors without regard to 
whether the countermeasure is used by or administered in the geographic 
areas; and (2) to program planners and qualified persons when the 
countermeasure is either used or administered in the geographic areas 
or the program planner or qualified person reasonably could have 
believed the countermeasure was used or administered in the areas. 
Section XI includes these statutory conditions in the Declaration for 
clarity.

Section XII, Effective Time Period

    The Secretary must identify, for each Covered Countermeasure, the 
period or periods during which liability immunity is in effect, 
designated by dates, milestones, or other description of events, 
including factors specified in the PREP Act. Section XII extends the 
effective period through July 18, 2026.

Section XIII, Additional Time Period of Coverage

    The Secretary must specify a date after the ending date of the 
effective time period of the Declaration that is reasonable for 
manufacturers to arrange for disposition of the Covered Countermeasure, 
including return of the product to the manufacturer, and for other 
Covered Persons to take appropriate actions to limit

[[Page 31470]]

administration or use of the Covered Countermeasure. In addition, the 
PREP Act specifies that for Covered Countermeasures that are subject to 
a Declaration at the time they are obtained for the Strategic National 
Stockpile (SNS) under 42 U.S.C. 247d-6b(a), the effective period of the 
Declaration extends through the time the countermeasure is used or 
administered pursuant to a distribution or release from the stockpile. 
Liability immunity under the provisions of the PREP Act and the 
conditions of the Declaration continues during these additional time 
periods. Thus, liability immunity is afforded during the ``Effective 
Time Period,'' described under XII of the Declaration, plus the 
``Additional Time Period'' described under Section XIII of the 
Declaration.
    Section XIII provides for one month as the additional time period 
of coverage after expiration of the Declaration. Section XIII also 
explains the extended coverage that applies to any products obtained 
for the SNS during the effective period of the Declaration.

Section XIV, Countermeasures Injury Compensation Program

    Section 319F-4 of the PHS Act, 42 U.S.C. 247d-6e, authorizes the 
Countermeasures Injury Compensation Program (CICP) to provide benefits 
to eligible individuals who sustain a serious physical injury or die as 
a direct result of the administration or use of a Covered 
Countermeasure. Compensation under the CICP for an injury directly 
caused by a Covered Countermeasure is based on the requirements set 
forth in this Declaration, the administrative rules for the Program, 
and the statute. To show direct causation between a Covered 
Countermeasure and a serious physical injury, the statute requires 
``compelling, reliable, valid, medical and scientific evidence.'' The 
administrative rules for the Program further explain the necessary 
requirements for eligibility under the CICP.
    Further, the administrative rules for the CICP specify that if 
countermeasures are administered or used outside the United States, 
only otherwise eligible individuals at United States embassies, 
military installations abroad (such as military bases, ships, and 
camps) or at North Atlantic Treaty Organization (NATO) installations 
(subject to the NATO Status of Forces Agreement) where American 
servicemen and servicewomen are stationed may be considered for CICP 
benefits. Other individuals outside the United States may not be 
eligible for CICP benefits.

Section XV, Amendments

    The Secretary may amend any portion of this Declaration through 
publication in the Federal Register.

Declaration by the Secretary of Health and Human Services

I. Determination of Public Health Emergency or Credible Risk of Future 
Public Health Emergency
42 U.S.C. 247d-6d(b)(1)
    I have determined that the spread of Andes virus and the resulting 
disease, hantavirus pulmonary syndrome (HPS), constitutes a credible 
risk of a future public health emergency.
II. Factors Considered
42 U.S.C. 247d-6d(b)(6)
    I have considered the desirability of encouraging the design, 
development, clinical testing, or investigation, manufacture, labeling, 
distribution, formulation, packaging, marketing, promotion, sale, 
purchase, donation, dispensing, prescribing, administration, licensing, 
and use of the Covered Countermeasures.
III. Recommended Activities
42 U.S.C. 247d-6d(b)(1)
    I recommend, under the conditions stated in this Declaration, the 
manufacture, testing, development, distribution, and voluntary 
administration and use of the Covered Countermeasures in individuals 
possibly exposed to Andes virus on the M/V Hondius and in individuals 
who have had close contact with individuals possibly exposed to Andes 
virus on the M/V Hondius.
IV. Liability Protections
42 U.S.C. 247d-6d(a), 247d-6d(b)(1)
    Liability protections as prescribed in the PREP Act and conditions 
stated in this Declaration are in effect for the Recommended Activities 
described in Section III.
V. Covered Persons
42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)
    Covered Persons who are afforded liability immunity under this 
Declaration are ``manufacturers,'' ``distributors,'' ``program 
planners,'' ``qualified persons,'' and their officials, agents, and 
employees, as those terms are defined in the PREP Act, and the United 
States.
    ``Qualified person'' includes (A) a licensed health professional or 
other individual who is authorized to prescribe, administer, or 
dispense such countermeasures under the law of the State in which the 
countermeasure was prescribed, administered, or dispensed; or (B) ``a 
person within a category of persons so identified in a Declaration by 
the Secretary'' under subsection (b) of the PREP Act. 42 U.S.C. 247d-
6d(i)(8)
VI. Covered Countermeasures
42 U.S.C. 247d-6b(c)(1)(B), 247d-6d(i)(1) and (7)
    Covered Countermeasures are favipiravir.
    Covered Countermeasures must be ``qualified pandemic or epidemic 
products,'' or ``security countermeasures,'' or drugs, biological 
products, or devices authorized for investigational or emergency use, 
as those terms are defined in the PREP Act, the FD&C Act, and the PHS 
Act.
VII. Limitations on Distribution
42 U.S.C. 247d-6d(a)(5), 247d-6d(b)(2)(E)
    I have determined that liability protections are afforded to 
Covered Persons only for Recommended Activities involving: Covered 
Countermeasures that are obtained for voluntary administration to 
individuals in accordance with an approved IND application.
    I have also determined that, for governmental program planners 
only, liability protections are afforded only to the extent such 
program planners obtain Covered Countermeasures through voluntary 
means, such as (a) donation; (b) commercial sale; (c) deployment of 
Covered Countermeasures from federal stockpiles; or (d) deployment of 
donated, purchased, or otherwise voluntarily obtained Covered 
Countermeasures from state, local, or private stockpiles and perform 
emergency response functions in accordance with the PREP Act and this 
Declaration.
VIII. Category of Disease, Health Condition, or Threat
42 U.S.C. 247d-6d(b)(2)(A)
    The category of disease, health condition, or threat for which I 
recommend the administration or use of the Covered Countermeasures is 
HPS caused by the Andes virus.
IX. Administration of Covered Countermeasures
42 U.S.C. 247d-6d(a)(2)(B)
    Administration of the Covered Countermeasure means physical 
provision of the countermeasures to recipients, or activities and 
decisions directly relating to public and private

[[Page 31471]]

delivery, distribution and dispensing of the countermeasures to 
recipients, management and operation of countermeasure programs, or 
management and operation of locations for the purpose of distributing 
and dispensing countermeasures.
X. Population
42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)
    The populations of individuals to whom the liability protections of 
this Declaration extend include any individual (regardless of age) who 
uses or is administered the Covered Countermeasures in accordance with 
this Declaration.
    Liability protections are afforded to manufacturers and 
distributors without regard to whether the countermeasure is used by or 
administered to this population; liability protections are afforded to 
program planners and qualified persons when the countermeasure is used 
by or administered to this population, or the program planner or 
qualified person reasonably could have believed the recipient was in 
this population.
XI. Geographic Area
42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)
    Liability protections are afforded for the administration or use of 
a Covered Countermeasure without geographic limitation.
    Liability protections are afforded to manufacturers and 
distributors without regard to whether the Covered Countermeasure is 
used by or administered in any designated geographic area; liability 
protections are afforded to program planners and qualified persons when 
the countermeasure is used by or administered in any designated 
geographic area, or the program planner or qualified person reasonably 
could have believed the recipient was in that geographic area.
XII. Effective Period
42 U.S.C. 247d-6d(b)(2)(B)
    Liability immunity for Covered Countermeasures extends through July 
18, 2026.
XIII. Additional Period of Coverage
42 U.S.C. 247d-6d(b)(3)(B), 247d-6d(b)(3)(C)
    I have determined that an additional one month of liability 
protection is reasonable to allow for the manufacturer(s) to arrange 
for disposition of the Covered Countermeasure, including return of the 
Covered Countermeasures to the manufacturer, and for Covered Persons to 
take such other actions as are appropriate to limit the administration 
or use of the Covered Countermeasures.
    Covered Countermeasures obtained for the SNS during the effective 
period of this Declaration are covered through the date of 
administration or use pursuant to a distribution or release from the 
SNS.
XIV. Countermeasures Injury Compensation Program
42 U.S.C. 247d-6e
    The PREP Act authorizes the Countermeasures Injury Compensation 
Program (CICP) to provide benefits to certain individuals or estates of 
individuals who sustain a covered serious physical injury as a direct 
result of the administration or use of the Covered Countermeasures, and 
benefits to certain survivors of individuals who die as a direct result 
of the administration or use of the Covered Countermeasures. The causal 
connection between the countermeasure and the serious physical injury 
must be supported by compelling, reliable, valid, medical, and 
scientific evidence in order for the individual to be considered for 
compensation. The CICP is administered by the Health Resources and 
Services Administration, within the U.S. Department of Health and Human 
Services. Information about the CICP is available at the toll-free 
number 1-855-266-2427 or <a href="http://www.hrsa.gov/cicp/">http://www.hrsa.gov/cicp/</a>.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)
    Amendments to this Declaration will be published in the Federal 
Register, as needed.
    Authority: 42 U.S.C. 247d-6d.

Robert F. Kennedy Jr.,
Secretary of Health and Human Services.
[FR Doc. 2026-10539 Filed 5-22-26; 4:15 pm]
BILLING CODE 4150-37-P


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