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`Exhibit F
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`DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary
`_____________________________________________________________________________________________________________________________________
` The General Counsel
`Washington, D.C. 20201
`
`
`
`ADVISORY OPINION 20-04 ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT
`AND THE SECRETARY’S DECLARATION UNDER THE ACT
`OCTOBER 22, 2020, AS MODIFIED ON OCTOBER 23, 2020
`
`
`The Office of the General Counsel (OGC) has received questions concerning the scope and
`meaning of “program planner” and “Authority Having Jurisdiction” under the Public Readiness and
`Emergency Preparedness (PREP) Act, 42 U.S.C. § 247d-6d, and its implementing secretarial Declara-
`tions. This Advisory Opinion addresses:
`
`1.
`
`2.
`
`Who is a program planner under the PREP Act and the Secretary’s March 10, 2020
`Declaration, as amended (Declaration)? 1
`What is the scope of the proviso in the Declaration limiting PREP Act coverage to,
`inter alia, activities authorized by an “Authority Having Jurisdiction”?
`
`
`In this Advisory Opinion, OGC re-emphasizes the breadth of PREP Act immunity. It covers
`a broad range of entities when such entities take reasonable steps to follow public-health guidelines
`and directives in using covered medical products. Such entities are not limited to healthcare profes-
`sionals and healthcare companies that are part of a government response to the COVID-19 pandemic.
`Such entities may also include businesses, schools, and places of worship.
`
`
`I.
`
`ANALYSIS
`
`A. BACKGROUND
`
`
`COVID-19 is an unprecedented global challenge. As we learn more about the highly conta-
`gious pathogen that causes COVID-19, public-health guidance and directives tend to change to reflect
`the new knowledge. Those changes do not always occur uniformly or simultaneously among scientists
`and across America’s federal, state, territorial, tribal, local, and other public-health authorities—leading
`to uncertainty.
`
`Those uncertainties present potential legal risk for public and private individuals and organi-
`zations as they combat the pandemic, restore and strengthen America’s economy, ensure that trans-
`portation remains available, and provide safe environments for education and worship. Unfortunately,
`such perceived risks may hinder those essential efforts.
`
`They should not. The PREP Act exists, in part, to remove legal uncertainty and risk. When
`an individual or organization satisfies the requirements of the PREP Act and the Declaration, that
`“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
`the use by an individual of a covered countermeasure.” 2
`
`1 See Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Counter-
`measures Against COVID–19, 85 Fed. Reg. 15,198, 15,202 (Mar. 17, 2020) (Declaration); 85 Fed. Reg.
`21,012 (Apr. 15, 2020) (First Amendment); 85 Fed. Reg. 35,100 (June 8, 2020) (Second Amendment);
`85 Fed. Reg. 52,136 (Aug. 24, 2020) (Third Amendment).
`2 42 U.S.C. § 247d-6d(a)(1).
`
`
`
`1
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`
`Under the PREP Act, the term “covered person” includes a broad range of individuals and
`organizations. The term includes, among other things, anyone who supervises or administers a pro-
`gram with respect to the administration, dispensing, distribution, provision, or use of a security coun-
`termeasure or a qualified pandemic or epidemic product, including anyone who provides a facility to
`administer or use a covered countermeasure in accordance with the Declaration.
`
`The term “covered countermeasure” generally includes products (1) that the Food and Drug
`Administration (FDA) has approved, cleared, licensed, or authorized for emergency or investigational
`use; and (2) that are used to address COVID-19 or associated health threats, including harms that
`COVID-19 might otherwise cause.
`
`The Declaration broadly extends PREP Act immunity to, among other things, a covered per-
`son’s conduct relating to the administration or use of covered countermeasures according to applica-
`ble public-health guidance and directives during this declared emergency.3
`
`As we have previously explained, when a person complies with all other requirements in the
`PREP Act and Declaration, PREP Act immunity applies if
`
`
`
`
`
`
`
`the person reasonably could have believed that the person was a covered person,
`the person reasonably could have believed that the product was a covered counter-
`measure, and
`the person did not engage in willful misconduct that proximately caused serious phys-
`ical injury or death.4
`
`
`This Advisory Opinion discusses the broad availability of that immunity in more detail. Spe-
`cifically, we focus on (1) the definition of a “program planner” and (2) the activities authorized by an
`“Authority Having Jurisdiction.” This Advisory Opinion also provides examples of PREP Act cov-
`erage when a “program planner” follows the public-health guidance or directives of an applicable
`“Authority Having Jurisdiction”—even as guidance or directives change or they conflict with other
`guidance or directives.
`
`B. PROGRAM PLANNERS
`
`
`Under the PREP Act, the term “covered person” includes the United States or “manufactur-
`ers, distributors, program planners, and qualified persons, and their officials, agents, and employees.”5
`
`
`3 See 85 Fed. Reg. at 15,200 (affording liability immunity to “covered persons” for “recommended
`activities” related to activities authorized in accordance with the public-health and medical response
`of the Authority Having Jurisdiction).
`4 See Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10,
`2020 Declaration under the Act (May 19, 2020), https://www.hhs.gov/sites/default/files/prep-act-
`advisory-opinion-hhs-ogc.pdf (last visited Oct. 23, 2020) (PREP Act Advisory Opinion); see also 42
`U.S.C. § 247d-6d(a)(4)(B).
`5 85 Fed. Reg. at 151,199; 42 U.S.C. § 247d-6d(i)(2).
`
`
`
`2
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`The PREP Act broadly defines a “program planner” using three elements: identity, function, and
`compliance.
`
`Identity: A program planner is a state or local government, including an Indian tribe, a person
`employed by the State or local government, or other “person” who carries out the functions described
`immediately below. Under the PREP Act, a “person” includes “an individual, partnership, corpora-
`tion, association, entity, or public or private corporation, including a Federal, state, or local govern-
`ment agency or department.”6
`
`Function: A program planner performs certain functions, including “supervis[ing] or adminis-
`ter[ing] a program with respect to the administration, dispensing, distribution, provision, or use of a
`security countermeasure or a qualified pandemic or epidemic product.”7 The statute explains that
`those functions broadly include “establish[ing] requirements, provid[ing] policy guidance, or
`suppl[ying] technical or scientific advice or assistance or provid[ing] a facility to administer or use a
`covered countermeasure.”8
`
`Compliance: Finally, to qualify as a program planner, the entity must perform those functions
`“in accordance with” the Declaration.9
`
`The Declaration incorporates these definitions.10 The Declaration’s preamble further explains
`that a program planner can be a “private sector employer or community group” that “carries out the
`described activities.”11 Nothing in the preamble or text of the Declaration limits the statutory defini-
`tions.
`
`In short, any individual or organization can potentially be a program planner and receive PREP
`Act coverage. So for example, private businesses, public and private transportation providers, public
`and private schools, and religious organizations are all eligible for PREP Act coverage when they act
`in accordance with the PREP Act and the Declaration. It is important to remember, however, that
`the PREP Act does not provide immunity against federal enforcement actions.12 And PREP Act
`immunity (but not preemption) is limited to claims for death, physical, mental or emotional injury,
`illness, disability or condition, fear of such harm or need for medical monitoring, and damage to
`property, including business interruption loss.13
`
`
`
`
`
`
`6 42 U.S.C. § 247d-6d(i)(5).
`7 Id. at § 247d-6d(i)(6).
`8 Id.
`9 We use the term “entity” to include persons (see 1 U.S.C. § 1) and governmental units, whether state,
`tribal, local, or federal.
`10 See 85 Fed. Reg. at 15,201.
`11 Id. at 15,199.
`12 See PREP Act Advisory Opinion at 2.
`13 See 42 U.S.C. § 247d-6d; PREP Act Advisory Opinion.
`
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`C. AUTHORITY HAVING JURISDICTION
`
`
`
`In order for there to be PREP Act coverage, there must be a PREP Act declaration.14 Among
`other things, such a declaration may specify whether PREP Act immunity “is effective only to a par-
`ticular means of distribution as provided in subsection (a)(5) for obtaining the countermeasure, and if
`so, the particular means to which such subsection is effective.”15
`
`For the COVID-19 public-health emergency, section VII of the Declaration specifies that
`“liability immunity is afforded to Covered Persons only for Recommended Activities involving Cov-
`ered Countermeasures that are related to” (1) federal agreements or (2) “[a]ctivities authorized in ac-
`cordance with the public health and medical response of the Authority Having Jurisdiction to pre-
`scribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declara-
`tion of an emergency.”16 An Authority Having Jurisdiction may authorize such activities through,
`among other things, guidance, requests for assistance, agreements, directives, or other arrangements
`(collectively guidance).17
`
`
`Public-health guidance from an applicable Authority Having Jurisdiction that recommends or
`requires using covered countermeasures in certain circumstances may qualify as authorizations under
`the PREP Act and the Declaration. But to obtain such authorization, a covered person must follow
`that public-health guidance. The Declaration explains that the Authority Having Jurisdiction means
`the “public agency or its delegate that has legal responsibility and authority for responding to an inci-
`dent, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or
`functional (e.g., law enforcement, public health) range or sphere of authority.”18 Therefore, a covered
`person must comply with the public-health guidance issued by an Authority Having Jurisdiction over
`the person’s activity or location in order to qualify for PREP Act immunity.
`
`If there are conflicts, PREP Act coverage will apply to a covered person using a covered coun-
`termeasure in accordance with any of the guidance. A conflict exists when (1) one guidance includes
`a recommendation or mandate that another guidance does not, and (2) there is no order of precedence
`under applicable law or in the guidance itself. If the applicable law or the guidance explains which
`authority takes precedence, a covered person must follow the guidance of the Authority Having Ju-
`risdiction that takes precedence in order to obtain PREP Act coverage.
`
`To illustrate, if a governor’s order on using face masks preempts or otherwise takes precedence
`over a mayor’s order under that state’s law, then the former must be the basis for PREP Act coverage.
`If one guidance says that it does not replace another guidance, the latter must be the basis for PREP
`Act coverage. For example, the Centers for Disease Control and Prevention’s (CDC) guidance for
`“Preparing for a Safe Return to School” specifies that “[t]his guidance is meant to supplement—not
`replace—any state, local, territorial, or tribal health and safety laws, rules, and regulations with which
`
`
`14 See 42 U.S.C. § 247d-6d(a)(1).
`15 42 U.S.C. § 247d-6d(b)(2)(E).
`16 See 85 Fed. Reg. at 15,202.
`17 PREP Act Advisory Opinion at 2.
`18 85 Fed. Reg. at 15,202.
`
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`schools must comply.”19 So if there were a conflict between that CDC guidance and “any state, local,
`territorial, or tribal health and safety laws, rules, and regulations with which schools must comply,” a
`covered person must rely on guidance of the latter jurisdiction, and not CDC’s guidance, as the basis
`for PREP Act coverage.
`
`If a guidance changes, the guidance in effect during the activity at issue will determine whether
`there is PREP Act coverage.
`
`
`D. EXAMPLES
`
`
`To illustrate more concretely the discussion above, we provide the following hypothetical ex-
`amples of program planners using covered countermeasures according to the guidance of an Authority
`Having Jurisdiction. We use these examples to help illustrate only the PREP Act doctrines discussed
`above.
`
`
`Testing: Federal, state, and local Authorities Having Jurisdiction issue conflicting guidance on
`how frequently to test at universities. Neither the state or federal law, nor the guidance from the state
`or federal Authorities Having Jurisdiction, preempts or supersedes the guidance from the local Au-
`thority Having Jurisdiction. A private university that has re-opened for in-person learning follows the
`guidance of the local Authority Having Jurisdiction in the geographic area where the university is
`located. The university uses a COVID-19 test that has received an Emergency Use Authorization
`(EUA) by the FDA. The local Authority Having Jurisdiction recommends a lower testing frequency
`than the state or federal Authorities Having Jurisdiction. A student who gets COVID-19 sues the
`university, claiming that its failure to follow the guidance from the state or federal Authority Having
`Jurisdiction caused the student’s injuries.
`
`The university is a program planner because it has, among other things, “supervised or admin-
`istered a program with respect to the administration … or use of a … qualified pandemic … prod-
`uct.”20 By following the guidance of the local Authority Having Jurisdiction, the university has com-
`plied with the Declaration.
`
`The university is immune from suit and liability for loss, assuming that it has satisfied all other
`requirements of the PREP Act and Declaration.
`
`Face Masks: FDA has issued an EUA authorizing “the use of face masks, including cloth face
`coverings, as source control for use by members of the general public, as well as [health care personnel]
`in healthcare settings, to cover their noses and mouths, in accordance with CDC recommendations,
`to help prevent the spread of SARS-CoV-2 during the COVID-19 pandemic.”21
`
`19 Preparing K-12 School Administrators
`in Fall 2020, CDC,
`to School
`for a Safe Return
`https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/prepare-safe-re-
`turn.html (last visited Oct. 23, 2020).
`20 42 U.S.C. § 247d-6d(i)(6).
`21 April 24, 2020 Letter
`to Manufacturers of Face Masks, FDA, https://www.fda.gov/me-
`dia/137121/download (last visited Oct. 23, 2020); FAQs on the Emergency Use Authorization for Face
`Masks (Non-Surgical), FDA, https://www.fda.gov/medical-devices/emergency-situations-medical-de-
`vices/faqs-emergency-use-authorization-face-masks-non-surgical (last visited Oct. 23, 2020).
`
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`CDC has issued guidance for “Grocery & Food Retail Workers.”22 In that guidance, “CDC
`recommends wearing cloth face coverings in public settings where other social distancing measures
`are difficult to maintain, especially in areas of significant community-based transmission.” The guid-
`ance also directs employers of grocery and food-retail workers to “[f]ollow all applicable local, state,
`and federal regulations and public health agency guidelines.”23 A county department of health has
`issued a face-mask guidance recommending that those working inside a grocery store should wear
`cloth face covering and maintain social distancing.
`
`Following CDC guidance, a grocery store in that county requires its workers to wear cloth face
`coverings in the public portions of its stores “where other social distancing measures are difficult to
`maintain.” A customer in that store gets COVID-19 and sues the grocery store, claiming that its
`failure to follow the county guideline contributed to the customer’s injuries.
`
`Here, the CDC guidance directed the grocery store to follow all local, state, and federal regu-
`lations and public-health agency guidelines. The grocery store failed to follow the more stringent
`county guideline. Therefore, the grocery store does not have PREP Act immunity against the cus-
`tomer’s claim.
`
`
`COVID-19 Vaccine Administration. CDC prioritizes certain populations to receive the COVID-
`19 vaccine while there are limited doses. A pharmacy prioritizes the CDC-designated populations for
`receiving the COVID-19 vaccine.
`
`Because of that prioritization, someone seeks but does not receive the COVID-19 vaccine
`from the pharmacy because of the limited quantity of vaccine doses. That person gets COVID-19
`and sues the pharmacy.
`
`The pharmacy is a program planner, as set forth above. Administration of covered counter-
`measures, as defined in the Declaration, includes both “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 pro-
`grams, or management and operation of locations for purpose[s] of distributing and dispensing coun-
`termeasures.”24 Management and operation of countermeasure programs and decisions directly relat-
`ing to public and private delivery, distribution, and dispensing of countermeasures involve decisions
`regarding prioritization of populations to receive countermeasures while there are limited doses. And
`prioritization necessarily entails temporarily withholding limited doses from some recipients, as di-
`rected by an Authority Having Jurisdiction.
`
`By administering the COVID-19 vaccine pursuant to CDC prioritization, the pharmacy has
`complied with the guidance of an Authority Having Jurisdiction. The pharmacy has PREP Act cov-
`erage, assuming that it has also complied with all other requirements of the PREP Act and Declaration.
`
`
`22 What Grocery
`about COVID-19, CDC,
`to Know
`and Food Retail Workers Need
`https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/grocery-food-retail-work-
`ers.html (last visited Oct. 23, 2020).
`23 Id. (emphasis added).
`24 85 Fed. Reg. at 15,202.
`
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`During the H1N1 pandemic, a New York court addressed a similar situation. In Casabianca v.
`Mount Sinai Medical Center, the court concluded that the PREP Act does not cover a provider that
`followed guidelines from CDC, the New York State Department of Health, and the New York City
`Department of Health. 1014 N.Y. Slip. Op. 33583(U), 2014 WL 10413521 (N.Y. Sup. Dec. 12, 2014).
`Under those guidelines, children, pregnant women, and hospital employees received priority for the
`H1N1 vaccine while there were shortages. The plaintiff’s husband did not fit into any of those eligi-
`bility categories; hence, he did not receive the vaccine. The husband died after a surgical procedure
`and exposure to swine flu. His wife sued the provider. The court held that PREP Act immunity did
`not apply because it “only applies to the actual use of the vaccine.” Id. at *4.
`
`
`The court was wrong. As the court acknowledged, “administration” is broader than the “phys-
`ical provision of a countermeasure to a recipient.” Id. at *3. “Administration” also encompasses
`“activities related to management and operation of programs and locations for providing counter-
`measures to recipients, such as decisions and actions involving security and queuing, but only insofar
`as those activities directly relate to the countermeasure activities.” Id.
`
`
`Activities relating to management and operation of a vaccination program pursuant to an Au-
`thority Having Jurisdiction include following CDC directions on who to vaccinate when there are
`limited doses. If anything, following CDC directions on vaccination priority has a closer relationship
`to the use of the vaccine than decisions about security and queuing recipients of the vaccine, which
`may result in “slip and fall injuries and vehicle accidents that are connected to the vaccination process,
`be it at a retail store or some other facility.” Id. at 4. The court recognized that PREP Act immunity
`can cover such injuries and accidents, but declined to interpret “activities related to management and
`operation of programs and locations for providing countermeasures to recipients” consistent with the
`plain meaning of that phrase. The plain meaning of “management and operation of programs for
`providing countermeasures” includes following CDC vaccine-prioritization guidelines. And if there
`were any doubt, the plain meaning of “activities related to” such management and operation is even
`broader. And that broader definition would certainly cover running a vaccination program pursuant
`to CDC guidelines, even assuming arguendo that “management and operation” does not.
`
`
`II.
`
`Limitations
`
`This Advisory Opinion may be supplemented or modified. It is intended to minimize the
`need for individual advisory opinions. This Advisory Opinion sets forth the current views of the
`Office of the General Counsel.25 It is not a final agency action or a final order. Nor does it bind the
`Department of Health and Human Services or the federal courts. It does not have the force or effect
`of law.
`
`Persons seeking PREP Act immunity are responsible for determining whether their products
`are “covered countermeasures,” whether a person or entity is a “covered person,” whether reasonable
`
`25 See Air Brake Sys., Inc. v. Mineta, 357 F.3d 632, 647-48 (6th Cir. 2004) (holding that the Chief Counsel
`of the National Highway Traffic Safety Administration had delegated authority to issue advisory opin-
`ions to regulated entities in fulfillment of a congressional directive to promote regulatory compliance);
`5 U.S.C. § 301(“The head of an executive department ... may prescribe regulations for the government
`of his department, the conduct of its employees, [and] the distribution and performance of its busi-
`ness[.]”); Statement of Organization, Functions, and Delegations of Authority, 85 Fed. Reg. 54,581
`54,583 (Sept. 2, 2020).
`
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`precautions have been taken to facilitate the safe use of covered countermeasures, and in general,
`whether immunity applies to them and their activities. In order to obtain PREP Act coverage, persons
`must meet all requirements set forth in the PREP Act and the Declaration.
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`Robert P. Charrow
`General Counsel
`October 23, 2020
`
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`8
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