FILED: WESTCHESTER COUNTY CLERK 04/11/2024 06:05 PM
`NYSCEF DOC. NO. 12
`RECEIVED NYSCEF: 04/11/2024
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`INDEX NO. 56462/2024
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`Exhibit D
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`

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`FILED: WESTCHESTER COUNTY CLERK 04/11/2024 06:05 PM
`NYSCEF DOC. NO. 12
`RECEIVED NYSCEF: 04/11/2024
`15198
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`Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
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`INDEX NO. 56462/2024
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`Ohio, Court of Federal Claims No: 20–
`0225V
`71. Shannon Pyers, Dresher, Pennsylvania,
`Court of Federal Claims No: 20–0231V
`72. Lisa Macon, Englewood, New Jersey,
`Court of Federal Claims No: 20–0232V
`
`[FR Doc. 2020–05525 Filed 3–16–20; 8:45 am]
`
`BILLING CODE 4165–15–P
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`Office of the Secretary
`
`Declaration Under the Public
`Readiness and Emergency
`Preparedness Act for Medical
`Countermeasures Against COVID–19
`
`ACTION: Notice of declaration.
`
`SUMMARY: The Secretary is issuing this
`Declaration pursuant to section 319F–3
`of the Public Health Service Act to
`provide liability immunity for activities
`related to medical countermeasures
`against COVID–19.
`DATES: The Declaration was effective as
`of February 4, 2020.
`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: The
`Public Readiness and Emergency
`Preparedness Act (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. This
`Declaration is subject to amendment as
`circumstances warrant.
`The PREP Act was enacted on
`December 30, 2005, as Public Law 109–
`148, Division C, Section 2. It amended
`the Public Health Service (PHS) Act,
`adding Section 319F–3, which
`addresses liability immunity, and
`Section 319F–4, which creates a
`compensation program. These sections
`are codified at 42 U.S.C. 247d-6d and 42
`U.S.C. 247d–6e, respectively.
`The Pandemic and All-Hazards
`Preparedness Reauthorization Act
`(PAHPRA), Public Law 113–5, was
`
`enacted on March 13, 2013. Among
`other things, PAHPRA added sections
`564A and 564B to the Federal Food,
`Drug, and Cosmetic (FD&C) Act to
`provide new authorities for the
`emergency use of approved products in
`emergencies and products held for
`emergency use. PAHPRA accordingly
`amended the definitions of ‘‘Covered
`Countermeasures’’ and ‘‘qualified
`pandemic and epidemic products’’ in
`Section 319F–3 of the Public Health
`Service Act (PREP Act provisions), so
`that products made available under
`these new FD&C Act authorities could
`be covered under PREP Act
`Declarations. PAHPRA also extended
`the definition of qualified pandemic and
`epidemic products that may be covered
`under a PREP Act Declaration to include
`products or technologies intended to
`enhance the use or effect of a drug,
`biological product, or device used
`against the pandemic or epidemic or
`against adverse events from these
`products.
`COVID–19 is an acute respiratory
`disease caused by the SARS-CoV-2
`betacoronavirus or a virus mutating
`therefrom. This virus is similar to other
`betacoronaviruses, such as Middle
`Eastern Respiratory Syndrome (MERS)
`and Severe Acute Respiratory Syndrome
`(SARS). Although the complete clinical
`picture regarding SARS-CoV-2 or a virus
`mutating therefrom is not fully
`understood, the virus has been known
`to cause severe respiratory illness and
`death in a subset of those people
`infected with such virus(es).
`In December 2019, the novel
`coronavirus was detected in Wuhan
`City, Hubei Province, China. Today,
`over 101 countries, including the United
`States have reported multiple cases.
`Acknowledging that cases had been
`reported in five WHO regions in one
`month, on January 30, 2020, WHO
`declared the COVID–19 outbreak to be
`a Public Health Emergency of
`International Concern (PHEIC) following
`a second meeting of the Emergency
`Committee convened under the
`International Health Regulations (IHR).
`To date, United States traveler-
`associated cases have been identified in
`a number of States and community-
`based transmission is suspected. On
`January 31, 2020, Secretary Azar
`declared a public health emergency
`pursuant to section 319 of the PHS Act,
`42 U.S.C. 247d, for the entire United
`States to aid in the nation’s health care
`community response to the COVID–19
`outbreak.1 The outbreak remains a
`significant public health challenge that
`
`requires a sustained, coordinated
`proactive response by the Government
`in order to contain and mitigate the
`spread of COVID–19.2
`
`Description of This Declaration by
`Section
`
`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. This determination is
`separate and apart from the Declaration
`issued by the Secretary on January 31,
`2020 under Section 319 of the PHS Act
`that a disease or disorder presents a
`public health emergency or that a public
`health emergency, including significant
`outbreaks of infectious diseases or
`bioterrorist attacks, otherwise exists, or
`other Declarations or determinations
`made under other authorities of the
`Secretary. Accordingly in Section I of
`the Declaration, the Secretary
`determines that the spread of SARS-
`CoV-2 or a virus mutating therefrom and
`the resulting disease, COVID–19,
`constitutes a public health emergency
`for purposes of this Declaration under
`the PREP Act.
`
`Section II. Factors Considered by the
`Secretary
`In deciding whether and under what
`circumstances to issue a Declaration
`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 of the
`Declaration, the Secretary states that he
`has considered these factors.
`
`Section III. Activities Covered by This
`Declaration Under the PREP Act’s
`Liability Immunity
`The Secretary must delineate 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
`
`1 https://www.phe.gov/emergency/news/
`healthactions/phe/Pages/2019-nCoV.aspx.
`
`2 CDC COVID–19 Summary; https://www.cdc.gov/
`coronavirus/2019-ncov/summary.html, accessed
`27Feb2020,
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`FILED: WESTCHESTER COUNTY CLERK 04/11/2024 06:05 PM
`NYSCEF DOC. NO. 12
`RECEIVED NYSCEF: 04/11/2024
`15199
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`INDEX NO. 56462/2024
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`(Recommended Activities). In Section
`III of the Declaration, the Secretary sets
`out the activities for which the
`immunity is in effect.
`
`Section IV. Limited 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 of the Declaration, the
`Secretary states that liability protections
`are in effect with respect to the
`Recommended Activities.
`
`Section V. Covered Persons
`Section V of the Declaration describes
`Covered Persons, including Qualified
`Persons. The PREP Act defines Covered
`Persons to include, among others, the
`United States, and those that
`manufacturer, distribute, administer,
`prescribe or use Covered
`Countermeasures. This Declaration
`includes all persons and entities defined
`as Covered Persons under the PREP Act
`(PHS Act 317F–3(i)(2)) as well as others
`set out in paragraphs (3), (4), (6), (8)(A)
`and (8)(B).
`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 VI. Covered Countermeasures
`
`As noted above, Section III of the
`Declaration describes the activities
`(referred to as ‘‘Recommended
`Activities’’) for which liability
`immunity is in effect. Section VI of the
`Declaration 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 Drug
`Application or an Investigational Device
`Exemption) 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.
`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 COVID–19 that
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`FILED: WESTCHESTER COUNTY CLERK 04/11/2024 06:05 PM
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`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 (a) present or future
`federal contracts, cooperative
`agreements, grants, other transactions,
`interagency agreements, or memoranda
`of understanding or other federal
`agreements; or (b) activities authorized
`in accordance with the public health
`and medical response of the Authority
`Having Jurisdiction to prescribe,
`administer, deliver, distribute, or
`dispense the Covered Countermeasures
`following a Declaration of an
`emergency.
`Section VII defines the terms
`‘‘Authority Having Jurisdiction’’ and
`‘‘Declaration of an emergency.’’ We have
`specified in the definition that
`Authorities having jurisdiction include
`federal, state, local, and tribal
`authorities and institutions or
`organizations acting on behalf of those
`governmental entities.
`For governmental program planners
`only, liability immunity is afforded only
`to the extent they obtain Covered
`Countermeasures through voluntary
`means, such as (1) donation; (2)
`commercial sale; (3) deployment of
`Covered Countermeasures from federal
`stockpiles; or (4) deployment of
`donated, purchased, or otherwise
`voluntarily obtained Covered
`Countermeasures from state, local, or
`private stockpiles. This last limitation
`on distribution is intended to deter
`program planners that are government
`entities from seizing privately held
`stockpiles of Covered Countermeasures.
`It does not apply to any other Covered
`Persons, including other program
`planners who are not government
`entities.
`
`Section VIII. Category of Disease, Health
`Condition, or Threat
`
`The Secretary must identify in the
`Declaration, 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 of
`the Declaration, the Secretary states that
`the disease threat for which he
`recommends administration or use of
`the Covered Countermeasures is
`COVID–19 caused by SARS-CoV-2 or a
`virus mutating therefrom.
`
`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 of the Declaration, the Secretary
`defines ‘‘Administration of a Covered
`Countermeasure,’’ as follows:
`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 a countermeasure, or if
`the claims are due to manufacture,
`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. Likewise, the
`Act precludes a liability claim relating
`to the management and operation of a
`countermeasure distribution program or
`site, such as a slip-and-fall injury or
`vehicle collision by a recipient receiving
`a countermeasure at a retail store
`serving as an administration or
`dispensing location that alleges, for
`example, lax security or chaotic crowd
`control. However, a liability claim
`alleging an injury occurring at the site
`that was not directly related to the
`countermeasure activities is not
`covered, such as a slip and fall with no
`direct connection to the
`countermeasure’s administration or use.
`In each case, whether immunity is
`applicable will depend on the particular
`facts and circumstances.
`
`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. Section X of the
`Declaration identifies which individuals
`should use the countermeasure or to
`whom the countermeasure should be
`administered—in short, those who
`should be vaccinated or 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.’’
`It should be noted that under the
`PREP Act, liability protection extends
`beyond the Population specified in the
`Declaration. Specifically, 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 of the Declaration 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, including, as appropriate,
`whether the Declaration applies only to
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`FILED: WESTCHESTER COUNTY CLERK 04/11/2024 06:05 PM
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`RECEIVED NYSCEF: 04/11/2024
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`individuals physically present in the
`area or, in addition, applies to
`individuals who have a described
`connection to the area. Section XI of the
`Declaration 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 to individuals
`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 of
`the Declaration 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 of the Declaration
`extends the effective period for different
`means of distribution of Covered
`Countermeasures through October 1,
`2024.
`
`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 accepting
`returns of Covered Countermeasures,
`and for other Covered Persons to take
`appropriate actions to limit
`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.
`Liability immunity under the provisions
`of the PREP Act and the conditions of
`the Declaration continue during these
`additional time periods. Thus, liability
`
`immunity is afforded during the
`‘‘Effective Time Period,’’ described
`under Section XII of the Declaration,
`plus the ‘‘Additional Time Period’’
`described under Section XIII of the
`Declaration.
`Section XIII of the Declaration
`provides for 12 months as the
`Additional Time Period of coverage
`after expiration of the Declaration.
`Section XIII also explains the extended
`coverage that applies to any product
`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. Please note that, by
`statute, requirements for compensation
`under the CICP may not align with the
`requirements for liability immunity
`provided under the PREP Act. Section
`XIV of the Declaration,
`‘‘Countermeasures Injury Compensation
`Program,’’ explains the types of injury
`and standard of evidence needed to be
`considered for compensation 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
`
`Section XV of the Declaration
`confirms that the Secretary may amend
`
`any portion of this Declaration through
`publication in the Federal Register.
`
`Declaration
`
`Declaration for Public Readiness and
`Emergency Preparedness Act Coverage
`for medical countermeasures against
`COVID–19.
`
`I. Determination of Public Health
`Emergency
`
`42 U.S.C. 247d–6d(b)(1)
`I have determined that the spread of
`SARS-CoV–2 or a virus mutating
`therefrom and the resulting disease
`COVID–19 constitutes a 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, administration, and use of
`the Covered Countermeasures.
`
`IV. Liability Immunity
`
`42 U.S.C. 247d–6d(a), 247d–6d(b)(1)
`Liability immunity as prescribed in
`the PREP Act and conditions stated in
`this Declaration is 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.
`In addition, I have determined that
`the following additional persons are
`qualified persons: (a) Any person
`authorized in accordance with the
`public health and medical emergency
`response of the Authority Having
`Jurisdiction, as described in Section VII
`below, to prescribe, administer, deliver,
`distribute or dispense the Covered
`Countermeasures, and their officials,
`agents, employees, contractors and
`
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`FILED: WESTCHESTER COUNTY CLERK 04/11/2024 06:05 PM
`NYSCEF DOC. NO. 12
`RECEIVED NYSCEF: 04/11/2024
`15202
`
`Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
`
`INDEX NO. 56462/2024
`
`volunteers, following a Declaration of an
`emergency; (b) any person
`authorized to prescribe, administer, or
`dispense the Covered Countermeasures
`or who is otherwise authorized to
`perform an activity under an Emergency
`Use Authorization in accordance with
`Section 564 of the FD&C Act; and (c)
`any person authorized to prescribe,
`administer, or dispense Covered
`Countermeasures in accordance with
`Section 564A of the
`FD&C Act.
`
`VI. Covered Countermeasures
`
`42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C.
`247d–6d(i)(1) and (7)
`Covered Countermeasures are any
`antiviral, any other drug, any biologic,
`any diagnostic, any other device, or any
`vaccine, used to treat, diagnose, cure,
`prevent, or mitigate COVID–19, or the
`transmission of SARS-CoV–2 or a virus
`mutating therefrom, or any device used
`in the administration of any such
`product, and all components and
`constituent materials of any such
`product.
`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.
`
`VII. Limitations on Distribution
`
`42 U.S.C. 247d–6d(a)(5) and (b)(2)(E)
`I have determined that liability
`immunity is afforded to Covered
`Persons only for Recommended
`Activities involving Covered
`Countermeasures that are related to:
`(a) Present or future federal contracts,
`cooperative agreements, grants, other
`transactions, interagency agreements,
`memoranda of understanding, or other
`federal agreements; or
`(b) Activities authorized in
`accordance with the public health and
`medical response of the Authority
`Having Jurisdiction to prescribe,
`administer, deliver, distribute or
`dispense the Covered Countermeasures
`following a Declaration of an
`emergency.
`As used in this Declaration, the terms
`Authority Having Jurisdiction and
`Declaration of Emergency have the
`following meanings:
`i. The Authority Having Jurisdiction
`means the public agency or its delegate
`that has legal responsibility and
`authority for responding to an incident,
`based on political or geographical (e.g.,
`city, county, tribal, state, or federal
`
`boundary lines) or functional (e.g., law
`enforcement,