81 FR 89476 - Ebola Virus Disease Therapeutics-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 | 89476-89481 | |
| FR Document | 2016-29609 |
[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)] [Notices] [Pages 89476-89481] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29609] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Ebola Virus Disease Therapeutics--Amendment ACTION: Notice of Amendment to the February 27, 2015, Declaration under the Public Readiness and Emergency Preparedness Act for Ebola Virus Disease Therapeutics. ----------------------------------------------------------------------- SUMMARY: The Secretary is amending the February 27, 2015, Declaration issued pursuant to the Public Health Service Act and amended December 9, 2015 (80 FR 76536) to extend the effective time period for an additional 24 months consistent with the terms of the Declaration and republishing the Declaration in its entirety as amended. DATES: The Amended Declaration is effective as of February 27, 2017. 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 Therapeutics as listed in Section VI of the Declaration to extend the effective time period for an additional 24 months, 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 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 first discovered in 1976, affecting populations in multiple West African [[Page 89477]] countries and travelers from West Africa to the United States (U.S.) and other countries. 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 in the future 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 under the conditions stated in the Declaration, including the condition that the activities relate to clinical trials permitted to proceed after review by the Food and Drug Administration (FDA) that administer or use the Covered Countermeasure under an investigational new drug application (IND) and that are directly supported by the U.S. The Secretary specifies that the term ``directly supported'' in this Declaration means that the United States has provided some form of tangible support such as supplies, funds, products, technical assistance, or staffing. This condition is intended to afford liability immunity only to activities related to clinical trials using the Covered Countermeasure being conducted in the U.S. and West Africa that are directly supported by the U.S. 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 U.S. 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. Section VI identifies the countermeasures for which the Secretary has recommended such activities. The PREP Act states that a [[Page 89478]] 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 Therapeutics that are Covered Countermeasures. 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 clinical trials permitted to proceed after FDA review, that administer or use the Covered Countermeasure under an IND, and directly supported by the U.S., as described in Section III of this Declaration, through present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements or arrangements. This limitation is intended to afford liability immunity to activities that are related to clinical trials permitted to proceed after FDA review that administer or use the Covered Countermeasure under an IND and that are directly supported by the U.S. As stated in Section III of the Declaration, the term ``directly support'' means that the U.S. has provided some form of tangible support such as supplies, funds, products, technical assistance, or staffing. As of the date of this Declaration, activities primarily are those with a direct connection to the conduct of clinical trials in the U.S. and West Africa, but this Declaration also would apply to use in qualifying clinical trials outside those areas. 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 [[Page 89479]] Act. Under the Secretary's definition, these liability claims are precluded if the claims 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 therapeutic, 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 to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population and 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 to manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in the geographic areas and 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 identifies the effective time period. The effective time period commences at the start of clinical trials permitted to proceed after FDA review that administer or use the Covered Countermeasure under an IND and that are directly supported by the U.S., as described in Section III of the Declaration. Liability immunity is afforded to claims arising from such administration or use of the Covered Countermeasures after that date that have a causal relationship with any of the Recommended Activities stated in this Declaration. Section XII is amended to extend the effective time period 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 SNS. 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 products obtained for the SNS 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 always align with the requirements for liability immunity provided under the PREP Act. Section XIV, Countermeasures Injury [[Page 89480]] 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 U.S., 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 U.S. may not be eligible for CICP benefits. Section XV, Amendments This is the second amendment to the February 27, 2015, Declaration (80 FR 73314). The first amendment was issued December 9, 2015 (80 FR 76536). The Secretary may amend any portion of a Declaration through publication in the Federal Register. Republished Declaration Declaration, as Amended, Public Readiness and Emergency Preparedness Act Coverage for Ebola Virus Disease Therapeutics This Declaration amends and republishes the February 27, 2015 for coverage under the Public Readiness and Emergency Preparedness (PREP) Act for Ebola Virus Disease Therapeutics. To the extent any term of the February 27, 2015, 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 the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures under the conditions stated in this Declaration, including the condition that the activities relate to clinical trials permitted to proceed after review by the Food and Drug Administration (FDA) that administer or use the Covered Countermeasure under an IND application and that are directly supported by the U.S. The term ``directly supported'' in this Declaration means that the U.S. has provided some form of tangible support such as supplies, funds, products, technical assistance, or staffing. 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 U.S. In addition, I have determined that the following additional persons are qualified persons: Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity to carry out clinical trials permitted to proceed after FDA review that administer or use the Covered Countermeasure under an IND and that are directly supported by the United States, as described in Section III of this Declaration. 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 Therapeutics: ZMapp monoclonal antibody therapeutic. 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 clinical trials permitted to proceed after FDA review that administer or use the Covered Countermeasure under an IND and that are directly supported by the United States, as described in Section III of this Declaration, through present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements or arrangements. 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. [[Page 89481]] 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 began on February 27, 2015, and extends through February 26, 2019. 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 by telephone at 855- 266-2427 (toll-free) or http://www.hrsa.gov/cicp/. XV. Amendments 42 U.S.C. 247d-6d(b)(4) Any 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. 2016-29609 Filed 12-9-16; 8:45 am] BILLING CODE 4150-28-P
![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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![Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices 89477
countries and travelers from West Africa as the Secretary may specify, the testing, investigation or manufacturing
to the United States (U.S.) and other manufacture, testing, development, of a Covered Countermeasure; and any
countries. The World Health distribution, administration, or use of or all of the parents, subsidiaries,
Organization (WHO) declared the Ebola one or more Covered Countermeasures affiliates, successors, and assigns of a
Virus Disease Outbreak as a Public (‘‘Recommended Activities’’). In Section manufacturer.
Health Emergency of International III, the Secretary recommends activities A distributor means a person or entity
Concern under the framework of the for which the immunity is in effect engaged in the distribution of drug,
International Health Regulations (2005). under the conditions stated in the biologics, or devices, including but not
In March 2016, WHO determined that Declaration, including the condition limited to: Manufacturers; repackers;
the Ebola outbreak no longer constituted that the activities relate to clinical trials common carriers; contract carriers; air
a Public Health Emergency of permitted to proceed after review by the carriers; own-label distributors; private-
International Concern, but emphasized Food and Drug Administration (FDA) label distributors; jobbers; brokers;
the crucial need for continued support that administer or use the Covered warehouses and wholesale drug
to prevent, detect and respond rapidly Countermeasure under an warehouses; independent wholesale
to any new Ebola outbreak in West investigational new drug application drug traders; and retail pharmacies.
Africa. Thus, there is a continuing need (IND) and that are directly supported by A program planner means a state or
for development of vaccines against the U.S. The Secretary specifies that the local government, including an Indian
Ebola Virus Disease. term ‘‘directly supported’’ in this tribe; a person employed by the state or
Unless otherwise noted, all statutory Declaration means that the United local government; or other person who
citations below are to the U.S. Code. States has provided some form of supervises or administers a program
tangible support such as supplies, with respect to the administration,
Section I, Determination of Public dispensing, distribution, provision, or
funds, products, technical assistance, or
Health Emergency or Credible Risk of use of a Covered Countermeasure,
staffing. This condition is intended to
Future Public Health Emergency including a person who establishes
afford liability immunity only to
Before issuing a Declaration under the activities related to clinical trials using requirements, provides policy guidance,
PREP Act, the Secretary is required to the Covered Countermeasure being or supplies technical or scientific advice
determine that a disease or other health conducted in the U.S. and West Africa or assistance or provides a facility to
condition or threat to health constitutes that are directly supported by the U.S. administer or use a Covered
a public health emergency or that there Countermeasure in accordance with the
is a credible risk that the disease, Section IV, Liability Immunity Secretary’s Declaration. Under this
condition, or threat may in the future The Secretary must also state that definition, a private-sector employer or
constitute such an emergency. This liability protections available under the community group or other ‘‘person’’ can
determination is separate and apart from PREP Act are in effect with respect to be a program planner when it carries out
a Declaration issued by the Secretary the Recommended Activities. These the described activities.
under section 319 of the PHS Act that liability protections provide that, A qualified person means a licensed
a disease or disorder presents a public ‘‘[s]ubject to other provisions of [the health professional or other individual
health emergency or that a public health PREP Act], a covered person shall be authorized to prescribe, administer, or
emergency, including significant immune from suit and liability under dispense Covered Countermeasures
outbreaks of infectious diseases or federal and state law with respect to all under the law of the state in which the
bioterrorist attacks, otherwise exists, or claims for loss caused by, arising out of, countermeasure was prescribed,
other Declarations or determinations relating to, or resulting from the administered, or dispensed; or a person
made under other authorities of the administration to or use by an within a category of persons identified
Secretary. Accordingly, in Section I, the individual of a covered countermeasure as qualified in the Secretary’s
Secretary determines that there is a if a Declaration . . . has been issued Declaration. Under this definition, the
credible risk that the spread of Ebola with respect to such countermeasure.’’ Secretary can describe in the
virus and the resulting disease may In Section IV, the Secretary states that Declaration other qualified persons,
constitute a public health emergency. liability protections are in effect with such as volunteers, who are Covered
respect to the Recommended Activities. Persons. Section V describes other
Section II, Factors Considered qualified persons covered by this
In deciding whether and under what Section V, Covered Persons
Declaration.
circumstances to issue a Declaration The PREP Act’s liability immunity The PREP Act also defines the word
with respect to a Covered applies to Covered Persons with respect ‘‘person’’ as used in the Act: A person
Countermeasure, the Secretary must to administration or use of a Covered includes an individual, partnership,
consider the desirability of encouraging Countermeasure. The term ‘‘Covered corporation, association, entity, or
the design, development, clinical testing Persons’’ has a specific meaning and is public or private corporation, including
or investigation, manufacture, labeling, defined in the PREP Act to include a federal, state, or local government
distribution, formulation, packaging, manufacturers, distributors, program agency or department. Section V
marketing, promotion, sale, purchase, planners, and qualified persons, and describes Covered Persons under the
donation, dispensing, prescribing, their officials, agents, and employees, Declaration, including Qualified
administration, licensing, and use of the and the U.S. The PREP Act further Persons.
countermeasure. In Section II, the defines the terms ‘‘manufacturer,’’
‘‘distributor,’’ ‘‘program planner,’’ and Section VI, Covered Countermeasures
mstockstill on DSK3G9T082PROD with NOTICES
Secretary states that she has considered
these factors. ‘‘qualified person’’ as described below. As noted above, section III describes
A manufacturer includes a contractor the Secretary’s Recommended Activities
Section III, Recommended Activities or subcontractor of a manufacturer; a for which liability immunity is in effect.
The Secretary must recommend the supplier or licenser of any product, Section VI identifies the
activities for which the PREP Act’s intellectual property, service, research countermeasures for which the
liability immunity is in effect. These tool or component or other article used Secretary has recommended such
activities may include, under conditions in the design, development, clinical activities. The PREP Act states that a
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![Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices 89481
Liability immunity is afforded to Program (CICP) to provide benefits to Place: National Institutes of Health, 6701
manufacturers and distributors without certain individuals or estates of Rockledge Drive, Bethesda, MD 20892
regard to whether the countermeasure is individuals who sustain a covered (Telephone Conference Call)
Contact Person: Ganesan Ramesh, Center
used by or administered to this serious physical injury as the direct
for Scientific Review, National Institutes of
population; liability immunity is result of the administration or use of the Health, 6701 Rockledge Dr., Room 2182, MSC
afforded to program planners and Covered Countermeasures, and benefits 7818, Bethesda, MD 20892, ganesan.ramesh@
qualified persons when the to certain survivors of individuals who nih.gov.
countermeasure is used by or die as a direct result of the This notice is being published less than 15
administered to this population, or the administration or use of the Covered days prior to the meeting due to the timing
program planner or qualified person Countermeasures. The causal limitations imposed by the review and
reasonably could have believed the connection between the countermeasure funding cycle.
recipient was in this population. and the serious physical injury must be (Catalogue of Federal Domestic Assistance
supported by compelling, reliable, valid, Program Nos. 93.306, Comparative Medicine;
XI. Geographic Area medical and scientific evidence in order 93.333, Clinical Research, 93.306, 93.333,
42 U.S.C. 247d–6d(a)(4), 247d– for the individual to be considered for 93.337, 93.393–93.396, 93.837–93.844,
6d(b)(2)(D) compensation. The CICP is 93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
administered by the Health Resources
Liability immunity is afforded for the Dated: December 6, 2016.
and Services Administration, within the
administration or use of a Covered
Department of Health and Human Natasha M. Copeland,
Countermeasure without geographic
Services. Information about the CICP is Program Analyst, Office of Federal Advisory
limitation.
available by telephone at 855–266–2427 Committee Policy.
Liability immunity is afforded to
(toll-free) or http://www.hrsa.gov/cicp/. [FR Doc. 2016–29603 Filed 12–9–16; 8:45 am]
manufacturers and distributors without
regard to whether the countermeasure is BILLING CODE 4140–01–P
XV. Amendments
used by or administered in any 42 U.S.C. 247d–6d(b)(4)
designated geographic area; liability
Any amendments to this Declaration DEPARTMENT OF HEALTH AND
immunity is afforded to program
will be published in the Federal HUMAN SERVICES
planners and qualified persons when
the countermeasure is used by or Register.
National Institutes of Health
administered in any designated Authority: 42 U.S.C. 247d–6d.
geographic area, or the program planner Dated: December 2, 2016. National Eye Institute; Notice of
or qualified person reasonably could Sylvia M. Burwell, Meeting
have believed the recipient was in that
Secretary, Department of Health and Human Pursuant to section 10(d) of the
geographic area. Services. Federal Advisory Committee Act, as
XII. Effective Time Period [FR Doc. 2016–29609 Filed 12–9–16; 8:45 am] amended (5 U.S.C. App.), notice is
42 U.S.C. 247d–6d(b)(2)(B) BILLING CODE 4150–28–P hereby given of a meeting of the
National Advisory Eye Council.
Liability immunity for Covered The meeting will be open to the
Countermeasures began on February 27, DEPARTMENT OF HEALTH AND public as indicated below, with
2015, and extends through February 26, HUMAN SERVICES attendance limited to space available.
2019. Individuals who plan to attend and
National Institutes of Health
XIII. Additional Time Period of need special assistance, such as sign
Coverage Center for Scientific Review; Notice of language interpretation or other
Closed Meeting reasonable accommodations, should
42 U.S.C. 247d–6d(b)(3)(B) and (C) notify the Contact Person listed below
I have determined that an additional Pursuant to section 10(d) of the in advance of the meeting.
12 months of liability protection is Federal Advisory Committee Act, as The meeting will be closed to the
reasonable to allow for the amended (5 U.S.C. App.), notice is public in accordance with the
manufacturer(s) to arrange for hereby given of the following meeting. provisions set forth in sections
disposition of the Covered The meeting will be closed to the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Countermeasure, including return of the public in accordance with the as amended. The grant applications and
Covered Countermeasures to the provisions set forth in sections the discussions could disclose
manufacturer, and for Covered Persons 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., confidential trade secrets or commercial
to take such other actions as are as amended. The grant applications and property such as patentable material,
appropriate to limit the administration the discussions could disclose and personal information concerning
or use of the Covered Countermeasures. confidential trade secrets or commercial individuals associated with the grant
Covered Countermeasures obtained property such as patentable material, applications, the disclosure of which
for the SNS during the effective period and personal information concerning would constitute a clearly unwarranted
of this Declaration are covered through individuals associated with the grant invasion of personal privacy.
the date of administration or use applications, the disclosure of which
Name of Committee: National Advisory
pursuant to a distribution or release would constitute a clearly unwarranted Eye Council.
mstockstill on DSK3G9T082PROD with NOTICES
from the SNS. invasion of personal privacy. Date: January 19, 2017.
Name of Committee: Center for Scientific Open: 8:30 a.m. to 1:00 p.m.
XIV. Countermeasures Injury Review Special Emphasis Panel; Agenda: Following opening remarks by the
Compensation Program Neurogastroenterology. Director, NEI, there will be presentations by
42 U.S.C 247d–6e Date: December 14, 2016. the staff of the Institute and discussions
Time: 9:00 a.m. to 10:00 a.m. concerning Institute programs.
The PREP Act authorizes the Agenda: To review and evaluate grant Place: Terrace Level Conference Rooms,
Countermeasures Injury Compensation applications. 5635 Fishers Lane, Rockville, MD 20852.
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Document Created: 2018-02-14 09:05:51
Document Modified: 2018-02-14 09:05:51
| 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 February 27, 2015, Declaration under the Public Readiness and Emergency Preparedness Act for Ebola Virus Disease Therapeutics. | |
| Dates | The Amended Declaration is effective as of February 27, 2017. | |
| 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 89476 |
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