81 FR 89471 - Ebola Virus Disease Vaccines-Amendment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 81, Issue 238 (December 12, 2016)
Office of the Secretary
Federal Register Volume 81, Issue 238 (December 12, 2016)
| Page Range | 89471-89476 | |
| FR Document | 2016-29610 |
[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)] [Notices] [Pages 89471-89476] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29610] ----------------------------------------------------------------------- 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 for Ebola Virus Disease Vaccines. ----------------------------------------------------------------------- SUMMARY: The Secretary is amending the Declaration issued pursuant to section 319F-3 of the Public Health Service Act on December 3, 2014 (79 FR 73314) and amended on December 1, 2015 (80 FR 76541) to extend the effective time period for an additional 24 months and to clarify the description of Covered Countermeasures 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, 2016. 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: The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services 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, through 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 24 months and to clarify the description of Covered Countermeasures 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, 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. The Ebola virus causes an acute, serious illness that is often fatal. From 2014 to 2015, West Africa experienced the largest and most complex Ebola outbreak since the virus was discovered in 1976, affecting populations in West African countries and travelers who left West Africa. In 2014, the World Health Organization (WHO) declared the Ebola Virus Disease Outbreak as a Public Health Emergency of International Concern under the framework of the International Health Regulations (2005). In March 2016, WHO determined that the Ebola outbreak no longer constituted a Public Health Emergency of International Concern, but emphasized the crucial need for continued support to prevent, detect and respond rapidly to any new Ebola outbreak in West Africa. Thus, there is a continuing need for development of vaccines against Ebola Virus Disease. 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 [[Page 89472]] 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 Persons. Section V describes other qualified persons covered by this Declaration. The PREP Act also defines the word ``person'' as used in the Act: A person includes an individual, partnership, corporation, association, entity, or public or private corporation, including a federal, state, or local government agency or department. Section V describes Covered Persons under the Declaration, including Qualified Persons. Section VI, Covered Countermeasures As noted above, section III describes the Secretary's Recommended Activities for which liability immunity is in effect. This section identifies the 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 [[Page 89473]] 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 description of Covered Countermeasures to clarify that coverage for vaccines includes coverage of all components and constituent materials of the vaccines, and all devices and their constituent components used in the administration of these vaccines. The change is intended to clarify existing coverage; is consistent with PREP Act declarations for vaccines against other potential public health threats, and it is not intended to be a substantive legal change. 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 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 [[Page 89474]] 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 or other locations 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 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 24 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 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 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 second amendment to the Declaration issued December 3, 2014 (79 FR 73314). The first amendment was issued December 1, 2015 (80 FR 76541). 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, as amended on December 1, 2015, 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, as amended on December 1, 2015, 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 [[Page 89475]] 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, all components and constituent materials of these vaccines, and all devices and their constituent components used in the administration of these 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 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 [[Page 89476]] 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 through December 2, 2018. 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) through December 2, 2018, 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 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 2, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services. [FR Doc. 2016-29610 Filed 12-9-16; 8:45 am] BILLING CODE P
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Product List’’ section of the Orange DEPARTMENT OF HEALTH AND which creates a compensation program.
Book. HUMAN SERVICES These sections are codified in the U.S.
Gordon Johnston Regulatory Code as 42 U.S.C. 247d–6d and 42
Office of the Secretary U.S.C. 247d–6e, respectively.
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The Pandemic and All-Hazards
petition dated May 25, 2016 (Docket No. Ebola Virus Disease Vaccines— Preparedness Reauthorization Act
FDA–2016–P–1363), under 21 CFR Amendment (PAHPRA), Public Law 113–5, was
10.30, requesting that the Agency enacted on March 13, 2013. Among
determine whether SODIUM CHLORIDE ACTION: Notice of Amendment to the
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provide new authorities for the
reasons of safety or effectiveness. Disease Vaccines.
emergency use of approved products in
After considering the citizen petition SUMMARY: The Secretary is amending the emergencies and products held for
and reviewing Agency records and Declaration issued pursuant to section emergency use. PAHPRA accordingly
based on the information we have at this 319F–3 of the Public Health Service Act amended the definitions of ‘‘Covered
time, FDA has determined under on December 3, 2014 (79 FR 73314) and Countermeasures’’ and ‘‘qualified
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mL, was not withdrawn for reasons of these new FD&C Act authorities could
safety or effectiveness. The petitioner Countermeasures consistent with the
terms of the Declaration and be covered under PREP Act
has identified no data or other Declarations. PAHPRA also extended
republishing the Declaration in its
information suggesting that SODIUM the definition of qualified pandemic and
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DATES: The Amended Declaration is
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FOR FURTHER INFORMATION CONTACT:
for reasons of safety or effectiveness. We enhance the use or effect of a drug,
Nicole Lurie, MD, MSPH, Assistant
have carefully reviewed our files for biological product, or device used
Secretary for Preparedness and
records concerning the withdrawal of against the pandemic or epidemic or
Response, Office of the Secretary,
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Department of Health and Human products.
PLASTIC CONTAINER (sodium Services, 200 Independence Avenue
chloride), injectable, 234 mg/mL, from The Ebola virus causes an acute,
SW., Washington, DC 20201, Telephone serious illness that is often fatal. From
sale. We have also independently 202–205–2882.
evaluated relevant literature and data 2014 to 2015, West Africa experienced
SUPPLEMENTARY INFORMATION: The the largest and most complex Ebola
for possible postmarketing adverse Public Readiness and Emergency outbreak since the virus was discovered
events. We have reviewed the available Preparedness Act (PREP Act) authorizes in 1976, affecting populations in West
evidence and determined that this drug the Secretary of Health and Human African countries and travelers who left
product was not withdrawn from sale Services to issue a Declaration to West Africa. In 2014, the World Health
for reasons of safety or effectiveness. provide liability immunity to certain Organization (WHO) declared the Ebola
Accordingly, the Agency will individuals and entities (Covered Virus Disease Outbreak as a Public
continue to list SODIUM CHLORIDE Persons) against any claim of loss Health Emergency of International
23.4% IN PLASTIC CONTAINER caused by, arising out of, relating to, or Concern under the framework of the
(sodium chloride), injectable, 234 mg/ resulting from the administration or use International Health Regulations (2005).
mL, in the ‘‘Discontinued Drug Product of medical countermeasures (Covered In March 2016, WHO determined that
List’’ section of the Orange Book. The Countermeasures), except for claims the Ebola outbreak no longer constituted
‘‘Discontinued Drug Product List’’ that meet the PREP Act’s definition of a Public Health Emergency of
delineates, among other items, drug willful misconduct. The Secretary may, International Concern, but emphasized
products that have been discontinued through publication in the Federal the crucial need for continued support
Register, amend any portion of a to prevent, detect and respond rapidly
from marketing for reasons other than
Declaration. Using this authority, the to any new Ebola outbreak in West
safety or effectiveness. ANDAs that refer
Secretary is amending the Declaration Africa. Thus, there is a continuing need
to this drug product may be approved that provides liability immunity to
by the Agency as long as they meet all for development of vaccines against
Covered Persons for activities related to Ebola Virus Disease.
other legal and regulatory requirements the Covered Countermeasures, Ebola Unless otherwise noted, all statutory
for the approval of ANDAs. If FDA Virus Disease Vaccines listed in Section citations below are to the U.S. Code.
determines that labeling for this drug VI of the Declaration, to extend the
product should be revised to meet effective time period for an additional Section I, Determination of Public
current standards, the Agency will 24 months and to clarify the description Health Emergency or Credible Risk of
advise ANDA applicants to submit such of Covered Countermeasures consistent Future Public Health Emergency
mstockstill on DSK3G9T082PROD with NOTICES
labeling. with the terms of this Declaration. Before issuing a Declaration under the
Dated: December 7, 2016. The PREP Act was enacted on PREP Act, the Secretary is required to
December 30, 2005, as Public Law 109– determine that a disease or other health
Leslie Kux,
148, Division C, Section 2. It amended condition or threat to health constitutes
Associate Commissioner for Policy. the Public Health Service (PHS) Act, a public health emergency or that there
[FR Doc. 2016–29674 Filed 12–9–16; 8:45 am] adding section 319F–3, which addresses is a credible risk that the disease,
BILLING CODE 4164–01–P liability immunity, and section 319F–4, condition, or threat may constitute such
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![89472 Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices
an emergency. This determination is respect to administration or use of a The PREP Act also defines the word
separate and apart from a Declaration Covered Countermeasure. The term ‘‘person’’ as used in the Act: A person
issued by the Secretary under section ‘‘Covered Persons’’ has a specific includes an individual, partnership,
319 of the PHS Act that a disease or meaning and is defined in the PREP Act corporation, association, entity, or
disorder presents a public health to include manufacturers, distributors, public or private corporation, including
emergency or that a public health program planners, and qualified a federal, state, or local government
emergency, including significant persons, and their officials, agents, and agency or department.
outbreaks of infectious diseases or employees, and the United States. The Section V describes Covered Persons
bioterrorist attacks, otherwise exists, or PREP Act further defines the terms under the Declaration, including
other Declarations or determinations ‘‘manufacturer,’’ ‘‘distributor,’’ Qualified Persons.
made under other authorities of the ‘‘program planner,’’ and ‘‘qualified Section VI, Covered Countermeasures
Secretary. Accordingly, in Section I, the person’’ as described below.
Secretary determines that there is a A manufacturer includes a contractor As noted above, section III describes
credible risk that the spread of Ebola or subcontractor of a manufacturer; a the Secretary’s Recommended Activities
virus and the resulting disease may supplier or licenser of any product, for which liability immunity is in effect.
constitute a public health emergency. intellectual property, service, research This section identifies the
countermeasures for which the
Section II, Factors Considered tool or component or other article used
Secretary has recommended such
in the design, development, clinical
In deciding whether and under what activities. The PREP Act states that a
testing, investigation or manufacturing
circumstances to issue a Declaration ‘‘Covered Countermeasure’’ must be: A
of a Covered Countermeasure; and any
with respect to a Covered ‘‘qualified pandemic or epidemic
or all of the parents, subsidiaries,
Countermeasure, the Secretary must product,’’ or a ‘‘security
affiliates, successors, and assigns of a
consider the desirability of encouraging countermeasure,’’ as described
manufacturer.
the design, development, clinical testing immediately below; or a drug, biological
A distributor means a person or entity product or device authorized for
or investigation, manufacture, labeling, engaged in the distribution of drug,
distribution, formulation, packaging, emergency use in accordance with
biologics, or devices, including but not sections 564, 564A, or 564B of the FD&C
marketing, promotion, sale, purchase, limited to: Manufacturers; repackers;
donation, dispensing, prescribing, Act.
common carriers; contract carriers; air A qualified pandemic or epidemic
administration, licensing, and use of the carriers; own-label distributors; private-
countermeasure. In Section II, the product means a drug or device, as
label distributors; jobbers; brokers; defined in the FD&C Act or a biological
Secretary states that she has considered warehouses and wholesale drug
these factors. product, as defined in the PHS Act that
warehouses; independent wholesale is: (i) Manufactured, used, designed,
Section III, Recommended Activities drug traders; and retail pharmacies. developed, modified, licensed or
A program planner means a state or procured to diagnose, mitigate, prevent,
The Secretary must recommend the
local government, including an Indian treat, or cure a pandemic or epidemic or
activities for which the PREP Act’s
tribe; a person employed by the state or limit the harm such a pandemic or
liability immunity is in effect. These
local government; or other person who epidemic might otherwise cause; (ii)
activities may include, under conditions
supervises or administers a program manufactured, used, designed,
as the Secretary may specify, the
with respect to the administration, developed, modified, licensed, or
manufacture, testing, development,
dispensing, distribution, provision, or procured to diagnose, mitigate, prevent,
distribution, administration, or use of
use of a Covered Countermeasure, treat, or cure a serious or life-
one or more Covered Countermeasures
including a person who establishes threatening disease or condition caused
(Recommended Activities). In Section
requirements, provides policy guidance, by such a drug, biological product, or
III, the Secretary recommends activities
or supplies technical or scientific advice device; (iii) or a product or technology
for which the immunity is in effect.
or assistance or provides a facility to intended to enhance the use or effect of
Section IV, Liability Immunity administer or use a Covered such a drug, biological product, or
The Secretary must also state that Countermeasure in accordance with the device.
liability protections available under the Secretary’s Declaration. Under this A security countermeasure is a drug
PREP Act are in effect with respect to definition, a private sector employer or or device, as defined in the FD&C Act
the Recommended Activities. These community group or other ‘‘person’’ can or a biological product, as defined in the
liability protections provide that, be a program planner when it carries out PHS Act that: (i)(a) The Secretary
‘‘[s]ubject to other provisions of [the the described activities. determines to be a priority to diagnose,
PREP Act], a covered person shall be A qualified person means a licensed mitigate, prevent, or treat harm from any
immune from suit and liability under health professional or other individual biological, chemical, radiological, or
federal and state law with respect to all authorized to prescribe, administer, or nuclear agent identified as a material
claims for loss caused by, arising out of, dispense Covered Countermeasures threat by the Secretary of Homeland
relating to, or resulting from the under the law of the state in which the Security, or (b) to diagnose, mitigate,
administration to or use by an countermeasure was prescribed, prevent, or treat harm from a condition
individual of a covered countermeasure administered, or dispensed; or a person that may result in adverse health
if a Declaration . . . has been issued within a category of persons identified consequences or death and may be
as qualified in the Secretary’s caused by administering a drug,
mstockstill on DSK3G9T082PROD with NOTICES
with respect to such countermeasure.’’
In Section IV, the Secretary states that Declaration. Under this definition, the biological product, or device against
liability protections are in effect with Secretary can describe in the such an agent; and (ii) is determined by
respect to the Recommended Activities. Declaration other qualified persons, the Secretary of Health and Human
such as volunteers, who are Covered Services to be a necessary
Section V, Covered Persons Persons. Section V describes other countermeasure to protect public health.
The PREP Act’s liability immunity qualified persons covered by this To be a Covered Countermeasure,
applies to ‘‘Covered Persons’’ with Declaration. qualified pandemic or epidemic
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![89476 Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices
Countermeasure without geographic Covered Countermeasures, and benefits Services to issue a Declaration to
limitation. to certain survivors of individuals who provide liability immunity to certain
Liability immunity is afforded to die as a direct result of the individuals and entities (Covered
manufacturers and distributors without administration or use of the Covered Persons) against any claim of loss
regard to whether the countermeasure is Countermeasures. The causal caused by, arising out of, relating to, or
used by or administered in any connection between the countermeasure resulting from the administration or use
designated geographic area; liability and the serious physical injury must be of medical countermeasures (Covered
immunity is afforded to program supported by compelling, reliable, valid, Countermeasures), except for claims
planners and qualified persons when medical and scientific evidence in order that meet the PREP Act’s definition of
the countermeasure is used by or for the individual to be considered for willful misconduct. The Secretary may,
administered in any designated compensation. The CICP is through publication in the Federal
geographic area, or the program planner administered by the Health Resources Register, amend any portion of a
or qualified person reasonably could and Services Administration, within the Declaration. Using this authority, the
have believed the recipient was in that Department of Health and Human Secretary is amending the Declaration
geographic area. Services. Information about the CICP is that provides liability immunity to
XII. Effective Time Period available at the toll-free number 1–855– Covered Persons for activities related to
266–2427 or http://www.hrsa.gov/cicp/. the Covered Countermeasures, Ebola
42 U.S.C. 247d–6d(b)(2)(B) Virus Disease Therapeutics as listed in
XV. Amendments Section VI of the Declaration to extend
Liability immunity for Covered
Countermeasures through means of 42 U.S.C. 247d–6d(b)(4) the effective time period for an
distribution, as identified in Section Amendments to this Declaration will additional 24 months, consistent with
VII(a) of this Declaration, other than in be published in the Federal Register. the terms of this Declaration.
accordance with the public health and The PREP Act was enacted on
Authority: 42 U.S.C. 247d–6d. December 30, 2005, as Public Law 109–
medical response of the Authority
Having Jurisdiction began on December Dated: December 2, 2016. 148, Division C, Section 2. It amended
3, 2014, and extends through December Sylvia M. Burwell, the Public Health Service (PHS) Act,
2, 2018. Secretary, Department of Health and Human adding section 319F–3, which addresses
Liability immunity for Covered Services. liability immunity, and section 319F–4,
Countermeasures administered and [FR Doc. 2016–29610 Filed 12–9–16; 8:45 am] which creates a compensation program.
used in accordance with the public BILLING CODE P
These sections are codified in the U.S.
health and medical response of the Code as 42 U.S.C. 247d–6d and 42
Authority Having Jurisdiction begins U.S.C. 247d–6e, respectively.
with a Declaration and lasts through (1) DEPARTMENT OF HEALTH AND The Pandemic and All-Hazards
the final day the emergency Declaration HUMAN SERVICES Preparedness Reauthorization Act
is in effect or (2) through December 2, (PAHPRA), Public Law 113–5, was
2018, whichever occurs first. Office of the Secretary enacted on March 13, 2013. Among
other things, PAHPRA added sections
XIII. Additional Time Period of Ebola Virus Disease Therapeutics— 564A and 564B to the Federal Food,
Coverage Amendment Drug, and Cosmetic (FD&C) Act to
42 U.S.C. 247d–6d(b)(3)(B) and (C) provide authorities for the emergency
ACTION: Notice of Amendment to the use of approved products in
I have determined that an additional February 27, 2015, Declaration under emergencies and products held for
12 months of liability protection is the Public Readiness and Emergency emergency use.
reasonable to allow for the Preparedness Act for Ebola Virus PAHPRA accordingly amended the
manufacturer(s) to arrange for Disease Therapeutics. definitions of ‘‘Covered
disposition of the Covered Countermeasures’’ and ‘‘qualified
Countermeasure, including return of the SUMMARY: The Secretary is amending the
pandemic and epidemic products’’ in
Covered Countermeasures to the February 27, 2015, Declaration issued
section 319F–3 of the Public Health
manufacturer, and for Covered Persons pursuant to the Public Health Service
Service Act (PREP Act provisions), so
to take such other actions as are Act and amended December 9, 2015 (80
that products made available under
appropriate to limit the administration FR 76536) to extend the effective time these new FD&C Act authorities could
or use of the Covered Countermeasures. period for an additional 24 months be covered under PREP Act
Covered Countermeasures obtained consistent with the terms of the Declarations. PAHPRA also extended
for the SNS during the effective period Declaration and republishing the the definition of qualified pandemic and
of this Declaration are covered through Declaration in its entirety as amended. epidemic products that may be covered
the date of administration or use DATES: The Amended Declaration is under a PREP Act Declaration to include
pursuant to a distribution or release effective as of February 27, 2017. products or technologies intended to
from the SNS. FOR FURTHER INFORMATION CONTACT: enhance the use or effect of a drug,
XIV. Countermeasures Injury Nicole Lurie, MD, MSPH, Assistant biological product, or device used
Compensation Program Secretary for Preparedness and against the pandemic or epidemic or
Response, Office of the Secretary, against adverse events from these
42 U.S.C 247d–6e Department of Health and Human products.
mstockstill on DSK3G9T082PROD with NOTICES
The PREP Act authorizes the Services, 200 Independence Avenue The Ebola virus causes an acute,
Countermeasures Injury Compensation SW., Washington, DC 20201; Telephone serious illness that is often fatal. From
Program (CICP) to provide benefits to 202–205–2882. 2014 to 2015, West Africa experienced
certain individuals or estates of SUPPLEMENTARY INFORMATION: The the largest and most complex Ebola
individuals who sustain a covered Public Readiness and Emergency outbreak since the virus was first
serious physical injury as the direct Preparedness Act (PREP Act) authorizes discovered in 1976, affecting
result of the administration or use of the the Secretary of Health and Human populations in multiple West African
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Document Created: 2018-02-14 09:05:21
Document Modified: 2018-02-14 09:05:21
| 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 for Ebola Virus Disease Vaccines. | |
| Dates | The Amended Declaration is effective as of December 3, 2016. | |
| 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 | 81 FR 89471 |
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