80 FR 76541 - Ebola Virus Disease Vaccines-Amendment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 236 (December 9, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 236 (December 9, 2015)
| Page Range | 76541-76546 | |
| FR Document | 2015-31088 |
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)] [Notices] [Pages 76541-76546] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31088] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Ebola Virus Disease Vaccines--Amendment ACTION: Notice of Amendment to the December 3, 2014 Declaration under the Public Readiness and Emergency Preparedness Act. ----------------------------------------------------------------------- SUMMARY: The Secretary is amending the Declaration issued pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) on December 3, 2014 (79 FR 73314) to extend the effective time period for an additional twelve (12 months) to clarify the list of Covered Countermeasures, and to clarify Covered Persons consistent with the terms of the declaration and republishing the Declaration in its entirety as amended. DATES: The Amended Declaration is effective as of December 3, 2015. FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, MSPH, 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: Background 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 administration or use of medical countermeasures (Covered Countermeasures), except for claims that meet the PREP Act's definition of willful misconduct. The Secretary may, though publication in the Federal Register, amend any portion of a Declaration. Using this authority, the Secretary is amending the Declaration that provides liability immunity to Covered Persons for activities related to the Covered Countermeasures, Ebola Virus Disease Vaccines listed in Section VI of the Declaration, to extend the effective time period for an additional [[Page 76542]] twelve (12) months; to clarify the identification of Covered Countermeasures, and clarify Covered Persons, consistent with the terms of this Declaration. 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 in the U.S. Code as 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, & 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. The Ebola virus causes an acute, serious illness that is often fatal. Since March 2014, West Africa has experienced the largest and most complex Ebola outbreak since the virus was discovered in 1976, affecting populations in West African countries and travelers who leave West Africa. The World Health Organization declared the Ebola Virus Disease Outbreak as a Public Health Emergency of International Concern under the framework of the International Health Regulations (2005). Unless otherwise noted, all statutory citations below are to the U.S. Code. 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 a Declaration issued by the Secretary 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, the Secretary determines that there is a credible risk that the spread of Ebola virus and the resulting disease may constitute a public health emergency. Section II, Factors Considered 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, the Secretary states that she 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 of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer. A distributor means a person or entity engaged in the distribution of drug, biologics, or devices, including but not limited to: Manufacturers; repackers; 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 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 [[Page 76543]] 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. We have revised the last category to remove the specific references to emergency use instructions and orders issued under section 564A of the FD&C Act, to clarify that any activities in accordance with that section are covered. 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 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 the Ebola Virus Disease Vaccines that are Covered Countermeasures. The Secretary is amending the list to identify the vaccines without names of manufacturers. This change is intended to clarify that the listed vaccines are Covered Countermeasures regardless of the arrangements made by manufactures for production of the vaccine. The change is intended to clarify existing coverage; it is not intended to be a substantive legal change. In addition, the Secretary changed ``BPSC1001 (rVSV-ZEBOV-GP)'' to the current name for the same vaccine, ``Recombinant Vesicular Stomatitis Virus-vectored vaccine expressing EBOV-Zaire glycoprotein (rVSV-ZEBOV-GP),'' for accuracy. 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, 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 she recommends administration or use of the Covered Countermeasures is Ebola virus disease. Section IX, Administration of Covered Countermeasures The PREP Act does not explicitly define the term ``administration'' but [[Page 76544]] 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 Secretary's 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. 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. This section explains 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.'' 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 West Africa. 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 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 is amended to extend the effective time period for different means of distribution of Covered Countermeasures up to an additional twelve (12) months. Section XIII, Additional Time Period of Coverage The Secretary must specify a date after the ending date of the effective 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 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 twelve (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 products obtained for the Strategic National Stockpile during the effective period of the Declaration. Section XIV, Countermeasures Injury Compensation Program Section 319F-4 of the PREP Act authorizes the Countermeasures Injury [[Page 76545]] 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, ``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 if countermeasures are administered or used outside the United States, only otherwise eligible individuals at American 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 This is the first amendment to the Declaration issued December 3, 2014 (79 FR 73314). The Secretary may amend any portion of this Declaration through publication in the Federal Register. Republished Declaration Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Ebola Virus Disease Vaccines. This Declaration amends and republishes the December 3, 2014, Declaration for coverage under the Public Readiness and Emergency Preparedness (``PREP'') Act for Ebola Virus Disease Vaccines. To the extent any term of the December 3, 2014, Declaration is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling. 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 there is a credible risk that the spread of Ebola virus and the resulting disease or conditions may in the future constitute 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 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; (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 the following Ebola Virus Disease Vaccines: (1) Recombinant Replication Deficient Chimpanzee Adenovirus Type 3- Vectored Ebola Zaire Vaccine (ChAd3-EBO-Z); (2) Recombinant Vesicular Stomatitis Virus-vectored vaccine expressing EBOV-Zaire glycoprotein (rVSV-ZEBOV-GP), and; (3) Ad26.ZEBOV/MVA-BN-Filo (MVA-mBN226B). 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. 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, public health) range or sphere of authority. ii. A Declaration of emergency means any Declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of [[Page 76546]] a federal Declaration in support of an Emergency Use Authorization under section 564 of the FD&C Act unless such Declaration specifies otherwise; I have also determined that for governmental program planners only, liability immunity is afforded only to the extent such program planners 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. 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 Ebola virus disease. 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 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. X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C) The populations of individuals include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration. Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability immunity is 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 immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation. Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in any designated geographic area; liability immunity is 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 Time Period 42 U.S.C. 247d-6d(b)(2)(B) Liability immunity for Covered Countermeasures through means of distribution, as identified in Section VII(a) of this Declaration, other than in accordance with the public health and medical response of the Authority Having Jurisdiction began on December 3, 2014, and extends for twenty-four (24) months from that date. Liability immunity for Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction begins with a Declaration and lasts through (1) the final day the emergency Declaration is in effect or (2) twenty-four (24) months from December 3, 2014, whichever occurs first. XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C) I have determined that an additional twelve (12) months 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 the 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 Department of Health and Human Services. Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/cicp/. XV. Amendments 42 U.S.C. 247d-6d(b)(4) Amendments to this Declaration will be published in the Federal Register. Authority: 42 U.S.C. 247d-6d. Dated: December 1, 2015. Sylvia M. Burwell, Secretary. [FR Doc. 2015-31088 Filed 12-8-15; 8:45 am] BILLING CODE P
![Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76541
VIII. Category of Disease, Health XII. Effective Time Period Dated: December 1, 2015.
Condition, or Threat Sylvia M. Burwell,
42 U.S.C. 247d–6d(b)(2)(B)
Secretary.
42 U.S.C. 247d–6d(b)(2)(A)
Liability immunity for Covered [FR Doc. 2015–31089 Filed 12–8–15; 8:45 am]
The category of disease, health Countermeasures began on February 27, BILLING CODE P
condition, or threat for which I
2015, and extends for twenty-four (24)
recommend the administration or use of
months.
the Covered Countermeasures is Ebola DEPARTMENT OF HEALTH AND
virus disease. XIII. Additional Time Period of HUMAN SERVICES
IX. Administration of Covered Coverage
Office of the Secretary
Countermeasures 42 U.S.C. 247d–6d(b)(3)(B) and (C)
42 U.S.C. 247d–6d(a)(2)(B) Ebola Virus Disease Vaccines—
I have determined that an additional Amendment
Administration of the Covered twelve (12) months of liability
Countermeasure means physical protection is reasonable to allow for the ACTION: Notice of Amendment to the
provision of the countermeasures to manufacturer(s) to arrange for December 3, 2014 Declaration under the
recipients, or activities and decisions disposition of the Covered Public Readiness and Emergency
directly relating to public and private Countermeasure, including return of the Preparedness Act.
delivery, distribution and dispensing of Covered Countermeasures to the
the countermeasures to recipients, SUMMARY: The Secretary is amending the
manufacturer, and for Covered Persons Declaration issued pursuant to section
management and operation of to take such other actions as are
countermeasure programs, or 319F–3 of the Public Health Service Act
appropriate to limit the administration (42 U.S.C. 247d–6d) on December 3,
management and operation of locations or use of the Covered Countermeasures.
for purpose of distributing and 2014 (79 FR 73314) to extend the
dispensing countermeasures. Covered Countermeasures obtained effective time period for an additional
for the SNS during the effective period twelve (12 months) to clarify the list of
X. Population of this Declaration are covered through Covered Countermeasures, and to clarify
42 U.S.C. 247d–6d(a)(4), 247d– the date of administration or use Covered Persons consistent with the
6d(b)(2)(C) pursuant to a distribution or release terms of the declaration and
from the SNS. republishing the Declaration in its
The populations of individuals entirety as amended.
include any individual who uses or is XIV. Countermeasures Injury DATES: The Amended Declaration is
administered the Covered Compensation Program effective as of December 3, 2015.
Countermeasures in accordance with
42 U.S.C 247d–6e FOR FURTHER INFORMATION CONTACT:
this Declaration.
Nicole Lurie, MD, MSPH, Assistant
Liability immunity is afforded to The PREP Act authorizes the Secretary for Preparedness and
manufacturers and distributors without Countermeasures Injury Compensation Response, Office of the Secretary,
regard to whether the countermeasure is
Program (CICP) to provide benefits to Department of Health and Human
used by or administered to this
certain individuals or estates of Services, 200 Independence Avenue
population; liability immunity is
individuals who sustain a covered SW., Washington, DC 20201, Telephone
afforded to program planners and
serious physical injury as the direct 202–205–2882.
qualified persons when the
countermeasure is used by or result of the administration or use of the SUPPLEMENTARY INFORMATION:
administered to this population, or the Covered Countermeasures, and benefits
Background
program planner or qualified person to certain survivors of individuals who
die as a direct result of the The Public Readiness and Emergency
reasonably could have believed the Preparedness Act (PREP Act) authorizes
recipient was in this population. administration or use of the Covered
Countermeasures. The causal the Secretary of Health and Human
XI. Geographic Area connection between the countermeasure Services (the Secretary) to issue a
and the serious physical injury must be Declaration to provide liability
42 U.S.C. 247d–6d(a)(4), 247d– immunity to certain individuals and
6d(b)(2)(D) supported by compelling, reliable, valid,
medical and scientific evidence in order entities (Covered Persons) against any
Liability immunity is afforded for the claim of loss caused by, arising out of,
for the individual to be considered for
administration or use of a Covered relating to, or resulting from the
compensation. The CICP is
Countermeasure without geographic administration or use of medical
administered by the Health Resources
limitation. countermeasures (Covered
Liability immunity is afforded to and Services Administration, within the Countermeasures), except for claims
manufacturers and distributors without Department of Health and Human that meet the PREP Act’s definition of
regard to whether the countermeasure is Services. Information about the CICP is willful misconduct. The Secretary may,
used by or administered in any available by telephone at 855–266–2427 though publication in the Federal
designated geographic area; liability (toll-free) or http://www.hrsa.gov/cicp/. Register, amend any portion of a
mstockstill on DSK4VPTVN1PROD with NOTICES
immunity is afforded to program XV. Amendments Declaration. Using this authority, the
planners and qualified persons when Secretary is amending the Declaration
the countermeasure is used by or 42 U.S.C. 247d–6d(b)(4) that provides liability immunity to
administered in any designated Covered Persons for activities related to
geographic area, or the program planner Any amendments to this Declaration the Covered Countermeasures, Ebola
or qualified person reasonably could will be published in the Federal Virus Disease Vaccines listed in Section
have believed the recipient was in that Register. VI of the Declaration, to extend the
geographic area. Authority: 42 U.S.C. 247d–6d. effective time period for an additional
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![76542 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices
twelve (12) months; to clarify the is a credible risk that the disease, Section V, Covered Persons
identification of Covered condition, or threat may constitute such The PREP Act’s liability immunity
Countermeasures, and clarify Covered an emergency. This determination is applies to ‘‘Covered Persons’’ with
Persons, consistent with the terms of separate and apart from a Declaration respect to administration or use of a
this Declaration. issued by the Secretary under section Covered Countermeasure. The term
The PREP Act was enacted on 319 of the PHS Act that a disease or ‘‘Covered Persons’’ has a specific
December 30, 2005, as Public Law 109– disorder presents a public health meaning and is defined in the PREP Act
148, Division C, Section 2. It amended emergency or that a public health to include manufacturers, distributors,
the Public Health Service (PHS) Act, emergency, including significant program planners, and qualified
adding section 319F–3, which addresses outbreaks of infectious diseases or persons, and their officials, agents, and
liability immunity, and section 319F–4, bioterrorist attacks, otherwise exists, or employees, and the United States. The
which creates a compensation program. other Declarations or determinations PREP Act further defines the terms
These sections are codified in the U.S. made under other authorities of the ‘‘manufacturer,’’ ‘‘distributor,’’
Code as 42 U.S.C. 247d–6d and 42 Secretary. Accordingly, in Section I, the
U.S.C. 247d–6e, respectively. ‘‘program planner,’’ and ‘‘qualified
Secretary determines that there is a person’’ as described below.
The Pandemic and All-Hazards credible risk that the spread of Ebola
Preparedness Reauthorization Act A manufacturer includes a contractor
virus and the resulting disease may or subcontractor of a manufacturer; a
(PAHPRA), Public Law 113–5, was
constitute a public health emergency. supplier or licenser of any product,
enacted on March 13, 2013. Among
other things, PAHPRA added sections Section II, Factors Considered intellectual property, service, research
564A and 564B to the Federal Food, tool or component or other article used
Drug, & Cosmetic (FD&C) Act to provide In deciding whether and under what in the design, development, clinical
new authorities for the emergency use of circumstances to issue a Declaration testing, investigation or manufacturing
approved products in emergencies and with respect to a Covered of a Covered Countermeasure; and any
products held for emergency use. Countermeasure, the Secretary must or all of the parents, subsidiaries,
PAHPRA accordingly amended the consider the desirability of encouraging affiliates, successors, and assigns of a
definitions of ‘‘Covered the design, development, clinical testing manufacturer.
Countermeasures’’ and ‘‘qualified or investigation, manufacture, labeling, A distributor means a person or entity
pandemic and epidemic products’’ in distribution, formulation, packaging, engaged in the distribution of drug,
section 319F–3 of the Public Health marketing, promotion, sale, purchase, biologics, or devices, including but not
Service Act (PREP Act provisions), so donation, dispensing, prescribing, limited to: Manufacturers; repackers;
that products made available under administration, licensing, and use of the common carriers; contract carriers; air
these new FD&C Act authorities could countermeasure. In Section II, the carriers; own-label distributors; private-
be covered under PREP Act Secretary states that she has considered label distributors; jobbers; brokers;
Declarations. PAHPRA also extended these factors. warehouses and wholesale drug
the definition of qualified pandemic and warehouses; independent wholesale
epidemic products that may be covered Section III, Recommended Activities drug traders; and retail pharmacies.
under a PREP Act Declaration to include A program planner means a state or
The Secretary must recommend the local government, including an Indian
products or technologies intended to activities for which the PREP Act’s
enhance the use or effect of a drug, tribe; a person employed by the state or
liability immunity is in effect. These local government; or other person who
biological product, or device used activities may include, under conditions
against the pandemic or epidemic or supervises or administers a program
as the Secretary may specify, the with respect to the administration,
against adverse events from these manufacture, testing, development,
products. dispensing, distribution, provision, or
distribution, administration, or use of use of a Covered Countermeasure,
The Ebola virus causes an acute, one or more Covered Countermeasures
serious illness that is often fatal. Since including a person who establishes
(Recommended Activities). In Section requirements, provides policy guidance,
March 2014, West Africa has III, the Secretary recommends activities
experienced the largest and most or supplies technical or scientific advice
for which the immunity is in effect. or assistance or provides a facility to
complex Ebola outbreak since the virus
was discovered in 1976, affecting Section IV, Liability Immunity administer or use a Covered
populations in West African countries Countermeasure in accordance with the
and travelers who leave West Africa. The Secretary must also state that Secretary’s Declaration. Under this
The World Health Organization liability protections available under the definition, a private sector employer or
declared the Ebola Virus Disease PREP Act are in effect with respect to community group or other ‘‘person’’ can
Outbreak as a Public Health Emergency the Recommended Activities. These be a program planner when it carries out
of International Concern under the liability protections provide that, the described activities.
framework of the International Health ‘‘[s]ubject to other provisions of [the A qualified person means a licensed
Regulations (2005). PREP Act], a covered person shall be health professional or other individual
Unless otherwise noted, all statutory immune from suit and liability under authorized to prescribe, administer, or
citations below are to the U.S. Code. Federal and State law with respect to all dispense Covered Countermeasures
claims for loss caused by, arising out of, under the law of the state in which the
Section I, Determination of Public
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relating to, or resulting from the countermeasure was prescribed,
Health Emergency or Credible Risk of administration to or use by an administered, or dispensed; or a person
Future Public Health Emergency individual of a covered countermeasure within a category of persons identified
Before issuing a Declaration under the if a Declaration . . . has been issued as qualified in the Secretary’s
PREP Act, the Secretary is required to with respect to such countermeasure.’’ Declaration. Under this definition, the
determine that a disease or other health In Section IV, the Secretary states that Secretary can describe in the
condition or threat to health constitutes liability protections are in effect with Declaration other qualified persons,
a public health emergency or that there respect to the Recommended Activities. such as volunteers, who are Covered
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![76546 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices
a federal Declaration in support of an XI. Geographic Area XIV. Countermeasures Injury
Emergency Use Authorization under Compensation Program
42 U.S.C. 247d–6d(a)(4), 247d–
section 564 of the FD&C Act unless such 42 U.S.C 247d–6e
6d(b)(2)(D)
Declaration specifies otherwise;
The PREP Act authorizes the
I have also determined that for Liability immunity is afforded for the
Countermeasures Injury Compensation
governmental program planners only, administration or use of a Covered
Program (CICP) to provide benefits to
liability immunity is afforded only to Countermeasure without geographic
certain individuals or estates of
the extent such program planners obtain limitation. individuals who sustain a covered
Covered Countermeasures through Liability immunity is afforded to serious physical injury as the direct
voluntary means, such as (1) donation; manufacturers and distributors without result of the administration or use of the
(2) commercial sale; (3) deployment of regard to whether the countermeasure is Covered Countermeasures, and benefits
Covered Countermeasures from federal used by or administered in any to certain survivors of individuals who
stockpiles; or (4) deployment of designated geographic area; liability die as a direct result of the
donated, purchased, or otherwise immunity is afforded to program administration or use of the Covered
voluntarily obtained Covered planners and qualified persons when Countermeasures. The causal
Countermeasures from state, local, or the countermeasure is used by or connection between the countermeasure
private stockpiles. administered in any designated and the serious physical injury must be
geographic area, or the program planner supported by compelling, reliable, valid,
VIII. Category of Disease, Health medical and scientific evidence in order
or qualified person reasonably could
Condition, or Threat for the individual to be considered for
have believed the recipient was in that
42 U.S.C. 247d–6d(b)(2)(A) geographic area. compensation. The CICP is
administered by the Health Resources
The category of disease, health XII. Effective Time Period and Services Administration, within the
condition, or threat for which I 42 U.S.C. 247d–6d(b)(2)(B) Department of Health and Human
recommend the administration or use of Services. Information about the CICP is
the Covered Countermeasures is Ebola Liability immunity for Covered available at the toll-free number 1–855–
virus disease. Countermeasures through means of 266–2427 or http://www.hrsa.gov/cicp/.
distribution, as identified in Section XV. Amendments
IX. Administration of Covered
VII(a) of this Declaration, other than in
Countermeasures 42 U.S.C. 247d–6d(b)(4)
accordance with the public health and
42 U.S.C. 247d–6d(a)(2)(B) medical response of the Authority Amendments to this Declaration will
Having Jurisdiction began on December be published in the Federal Register.
Administration of the Covered 3, 2014, and extends for twenty-four
Countermeasure means physical Authority: 42 U.S.C. 247d–6d.
(24) months from that date.
provision of the countermeasures to Dated: December 1, 2015.
Liability immunity for Covered
recipients, or activities and decisions Sylvia M. Burwell,
Countermeasures administered and
directly relating to public and private Secretary.
used in accordance with the public
delivery, distribution and dispensing of health and medical response of the [FR Doc. 2015–31088 Filed 12–8–15; 8:45 am]
the countermeasures to recipients, Authority Having Jurisdiction begins BILLING CODE P
management and operation of with a Declaration and lasts through (1)
countermeasure programs, or the final day the emergency Declaration
management and operation of locations DEPARTMENT OF HEALTH AND
is in effect or (2) twenty-four (24) HUMAN SERVICES
for purpose of distributing and months from December 3, 2014,
dispensing countermeasures. whichever occurs first. Office of the Secretary
X. Population XIII. Additional Time Period of Smallpox Medical Countermeasures—
42 U.S.C. 247d–6d(a)(4), 247d– Coverage Amendment
6d(b)(2)(C) 42 U.S.C. 247d–6d(b)(3)(B) and (C)
ACTION: Notice of Amendment to the
The populations of individuals I have determined that an additional October 10, 2008 Declaration under the
include any individual who uses or is twelve (12) months of liability Public Readiness and Emergency
administered the Covered protection is reasonable to allow for the Preparedness Act.
Countermeasures in accordance with manufacturer(s) to arrange for
this Declaration. SUMMARY: The Secretary is amending the
disposition of the Covered
declaration issued on October 10, 2008,
Liability immunity is afforded to Countermeasure, including return of the
(73 FR 61869) pursuant to section 319F–
manufacturers and distributors without Covered Countermeasures to the
3 of the Public Health Service Act (42
regard to whether the countermeasure is manufacturer, and for Covered Persons
U.S.C. 247d–6d) to: Include
used by or administered to this to take such other actions as are
countermeasures authorized for use
population; liability immunity is appropriate to limit the administration
mstockstill on DSK4VPTVN1PROD with NOTICES
under sections 564A and 564B of the
afforded to program planners and or use of the Covered Countermeasures. Federal Food, Drug, and Cosmetic
qualified persons when the Covered Countermeasures obtained (FD&C) Act (21 U.S.C. 360bbb–3a and
countermeasure is used by or for the SNS during the effective period 360bbb–3b); clarify the description of
administered to this population, or the of this Declaration are covered through covered countermeasures; extend the
program planner or qualified person the date of administration or use effective time period of the declaration;
reasonably could have believed the pursuant to a distribution or release reformat the declaration; modify or
recipient was in this population. from the SNS. clarify terms of the declaration; and
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Document Created: 2015-12-14 13:32:45
Document Modified: 2015-12-14 13:32:45
| 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 of Amendment to the December 3, 2014 Declaration under the Public Readiness and Emergency Preparedness Act. | |
| Dates | The Amended Declaration is effective as of December 3, 2015. | |
| Contact | Nicole Lurie, MD, MSPH, 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. | |
| FR Citation | 80 FR 76541 |
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