80 FR 22534 - Ebola Virus Disease Therapeutics
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 77 (April 22, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 77 (April 22, 2015)
| Page Range | 22534-22539 | |
| FR Document | 2015-09412 |
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)] [Notices] [Pages 22534-22539] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09412] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Ebola Virus Disease Therapeutics ACTION: Notice of Declaration Under the Public Readiness and Emergency Preparedness Act. ----------------------------------------------------------------------- SUMMARY: The Secretary is issuing a Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide liability protection for activities related to Ebola Virus Disease Therapeutics consistent with the terms of the Declaration. DATES: The Declaration is effective as of February 27, 2015. FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, MSPH, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: Background The Public Readiness and Emergency Preparedness Act (``PREP Act'') authorizes the Secretary of Health and Human Services (``the Secretary'') to issue a Declaration to provide liability immunity to certain individuals and entities (``Covered Persons'') against any claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (``Covered Countermeasures''), except for claims that meet the PREP Act's definition of willful misconduct. Using this authority, the Secretary is issuing a Declaration to provide liability immunity to Covered Persons for activities related to the Covered Countermeasures, Ebola Virus Disease Therapeutics as listed in Section VI of the Declaration, 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 emergency authorities for dispensing 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 (the PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act Declarations. PAHPRA also extended the definition of qualified pandemic and epidemic products that may be covered under a PREP Act Declaration to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products. The Ebola virus causes an acute, serious illness that is often fatal. Since March 2014, West Africa has been experiencing the largest and most complex Ebola outbreak since the Ebola [[Page 22535]] virus was first discovered in 1976, affecting populations in multiple West African Countries and travelers from West Africa to the United States and other countries. The World Health Organization has declared the Ebola Virus Disease Outbreak as a Public Health Emergency of International Concern (PHEIC) under the framework of the International Health Regulations (2005). Unless otherwise noted, all statutory citations below are to the U.S. Code. Section I, Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency Before issuing a Declaration under the PREP Act, the Secretary is required to determine that a disease or other health condition or threat to health constitutes a public health emergency or that there is a credible risk that the disease, condition, or threat may 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 in the future 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 United States. 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 currently being conducted in the United States and West Africa that are directly supported by the United States. 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 who is 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 ``Covered Countermeasure'' must be: A ``qualified pandemic or epidemic [[Page 22536]] 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 exempted under the FD&C Act for use as an investigational drug or device that 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 ten 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 that are 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, 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 United States. As stated in Section III of the Declaration, the term ``directly support'' means that the United States has provided some form of tangible support such as supplies, funds, products, technical assistance, or staffing. As of the date of this Declaration, those activities primarily are those with a direct connection to the conduct of clinical trials in the United States 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 Act. Under the Secretary's definition, these liability claims are precluded if the claims allege an injury caused by [[Page 22537]] 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: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; and (2) to program planners and qualified persons when the countermeasure is either used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population. Section X includes these statutory conditions in the Declaration for clarity. Section XI, Geographic Area The Secretary must identify, for each Covered Countermeasure specified in the Declaration, the geographic area or areas for which liability immunity is in effect with respect to administration or use of the countermeasure, including, as appropriate, whether the Declaration applies only to individuals physically present in the area or, in addition, applies to individuals who have a described connection to the area. Section XI provides that liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation. This could include claims related to administration or use in West Africa. It is possible that claims may arise in regard to administration or use of the Covered Countermeasures outside the U.S. that may be resolved under U.S. law. In addition, the PREP Act specifies that liability immunity is afforded: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in the geographic areas; and (2) to program planners and qualified persons when the countermeasure is either used or administered in the geographic areas or the program planner or qualified person reasonably could have believed the countermeasure was used or administered in the areas. Section XI includes these statutory conditions in the Declaration for clarity. Section XII, Effective Time Period The Secretary must identify, for each Covered Countermeasure, the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act. Section XII 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 United States, 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 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 under 42 U.S.C. 247d-6b(a), the effective period of the Declaration extends through the time the countermeasure is used or administered pursuant to a distribution or release from the Stockpile. Liability immunity under the provisions of the PREP Act and the conditions of the Declaration continues during these additional time periods. Thus, liability immunity is afforded during the ``Effective Time Period,'' described under XII of the Declaration, plus the ``Additional Time Period''' described under section XIII of the Declaration. Section XIII provides for twelve (12) months as the additional time period of coverage after expiration of the Declaration. Section XIII also explains the extended coverage that applies to any products obtained for the Strategic National Stockpile during the effective period of the Declaration. Section XIV, Countermeasures Injury Compensation Program Section 319F-4 of the PREP Act authorizes a 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 Compensation Program'' explains the types of injury and standard of evidence needed to be considered for compensation under the CICP. [[Page 22538]] 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 The Secretary may amend any portion of a Declaration through publication in the Federal Register. Declaration, Public Readiness and Emergency Preparedness Act Coverage for Ebola Virus Disease Therapeutics 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 investigational new drug application (IND) and that are directly supported by the United States. 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. 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: 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. 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 22539]] 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 begins on the effective date and extends for twelve (12) months from that date. XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C) I have determined that an additional twelve (12) months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures. Covered Countermeasures obtained for the Strategic National Stockpile (``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 a 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 (``HRSA''), 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) Any amendments to this Declaration will be published in the Federal Register. Authority: 42 U.S.C. 247d-6d. Dated: April 9, 2015. Sylvia M. Burwell, Secretary. [FR Doc. 2015-09412 Filed 4-21-15; 8:45 am] BILLING CODE 4150-03-P
![22534 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
TABLE 1—INFORMATION ON PARTICIPATING IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET 1—
Continued
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Submit electronic Submit com- Federal eRulemaking Portal: Mail/Hand delivery/Courier (for Identify your comments with the
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IV. Comments and Transcripts protection for activities related to Ebola the Public Health Service (‘‘PHS’’) Act,
Virus Disease Therapeutics consistent adding section 319F–3, which addresses
Regardless of attendance at the public
with the terms of the Declaration. liability immunity, and section 319F–4,
meeting, interested persons may submit
DATES: The Declaration is effective as of which creates a compensation program.
to FDA’s Division of Dockets
February 27, 2015. These sections are codified in the U.S.
Management (see Addresses in table 1)
FOR FURTHER INFORMATION CONTACT: Code as 42 U.S.C. 247d–6d and 42
either electronic or written comments
Nicole Lurie, MD, MSPH, Assistant U.S.C. 247d–6e, respectively.
on the interim assessment of the
Program for Enhanced Review Secretary for Preparedness and The Pandemic and All-Hazards
Transparency and Communication for Response, Office of the Secretary, Preparedness Reauthorization Act
NME NDAs and Original BLAs. You Department of Health and Human (PAHPRA), Public Law 113–5, was
only need to send one set of comments. Services, 200 Independence Avenue enacted on March 13, 2013. Among
Identify the comments with the docket SW., Washington, DC 20201, Telephone other things, PAHPRA added sections
number provided in brackets in the (202) 205–2882 (this is not a toll-free 564A and 564B to the Federal Food,
heading of this document. number). Drug, and Cosmetic (FD&C) Act to
With respect to transcripts, please be provide new emergency authorities for
SUPPLEMENTARY INFORMATION:
advised that as soon as a transcript is dispensing approved products in
Background emergencies and products held for
available, it will be accessible at
www.fda.gov/ForIndustry/UserFees/ The Public Readiness and Emergency emergency use.
PrescriptionDrugUserFee/ Preparedness Act (‘‘PREP Act’’) PAHPRA accordingly amended the
ucm327030.htm. authorizes the Secretary of Health and definitions of ‘‘Covered
Human Services (‘‘the Secretary’’) to Countermeasures’’ and ‘‘qualified
Dated: April 16, 2015. pandemic and epidemic products’’ in
issue a Declaration to provide liability
Leslie Kux, section 319F–3 of the Public Health
immunity to certain individuals and
Associate Commissioner for Policy. entities (‘‘Covered Persons’’) against any Service Act (the PREP Act provisions),
[FR Doc. 2015–09300 Filed 4–21–15; 8:45 am] claim of loss caused by, arising out of, so that products made available under
BILLING CODE 4164–01–P relating to, or resulting from the these new FD&C Act authorities could
administration or use of medical be covered under PREP Act
countermeasures (‘‘Covered Declarations. PAHPRA also extended
DEPARTMENT OF HEALTH AND Countermeasures’’), except for claims the definition of qualified pandemic and
HUMAN SERVICES that meet the PREP Act’s definition of epidemic products that may be covered
willful misconduct. Using this under a PREP Act Declaration to include
Office of the Secretary products or technologies intended to
authority, the Secretary is issuing a
Declaration to provide liability enhance the use or effect of a drug,
Ebola Virus Disease Therapeutics
immunity to Covered Persons for biological product, or device used
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION: Notice of Declaration Under the activities related to the Covered against the pandemic or epidemic or
Public Readiness and Emergency Countermeasures, Ebola Virus Disease against adverse events from these
Preparedness Act. Therapeutics as listed in Section VI of products.
the Declaration, consistent with the The Ebola virus causes an acute,
SUMMARY: The Secretary is issuing a terms of this Declaration. serious illness that is often fatal. Since
Declaration pursuant to section 319F–3 The PREP Act was enacted on March 2014, West Africa has been
of the Public Health Service Act (42 December 30, 2005, as Public Law 109– experiencing the largest and most
U.S.C. 247d–6d) to provide liability 148, Division C, Section 2. It amended complex Ebola outbreak since the Ebola
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![Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22535
virus was first discovered in 1976, for which the immunity is in effect affiliates, successors, and assigns of a
affecting populations in multiple West under the conditions stated in the manufacturer.
African Countries and travelers from Declaration, including the condition A distributor means a person or entity
West Africa to the United States and that the activities relate to clinical trials engaged in the distribution of drug,
other countries. The World Health permitted to proceed after review by the biologics, or devices, including but not
Organization has declared the Ebola Food and Drug Administration (FDA) limited to: Manufacturers; repackers;
Virus Disease Outbreak as a Public that administer or use the Covered common carriers; contract carriers; air
Health Emergency of International Countermeasure under an carriers; own-label distributors; private-
Concern (PHEIC) under the framework investigational new drug application label distributors; jobbers; brokers;
of the International Health Regulations (IND) and that are directly supported by warehouses and wholesale drug
(2005). the United States. The Secretary warehouses; independent wholesale
Unless otherwise noted, all statutory specifies that the term ‘‘directly drug traders; and retail pharmacies.
citations below are to the U.S. Code. supported’’ in this Declaration means A program planner means a State or
that the United States has provided local government, including an Indian
Section I, Determination of Public Tribe; a person employed by the State
Health Emergency or Credible Risk of some form of tangible support such as
supplies, funds, products, technical or local government; or other person
Future Public Health Emergency who supervises or administers a
assistance, or staffing. This condition is
Before issuing a Declaration under the intended to afford liability immunity program with respect to the
PREP Act, the Secretary is required to only to activities related to clinical trials administration, dispensing, distribution,
determine that a disease or other health using the Covered Countermeasure provision, or use of a Covered
condition or threat to health constitutes currently being conducted in the United Countermeasure, including a person
a public health emergency or that there States and West Africa that are directly who establishes requirements, provides
is a credible risk that the disease, supported by the United States. policy guidance, or supplies technical
condition, or threat may in the future or scientific advice or assistance or
constitute such an emergency. This Section IV, Liability Immunity provides a facility to administer or use
determination is separate and apart from The Secretary must also state that a Covered Countermeasure in
a Declaration issued by the Secretary liability protections available under the accordance with the Secretary’s
under section 319 of the PHS Act that Declaration. Under this definition, a
PREP Act are in effect with respect to
a disease or disorder presents a public private sector employer or community
the Recommended Activities. These
health emergency or that a public health group or other ‘‘person’’ can be a
liability protections provide that,
emergency, including significant program planner when it carries out the
‘‘[s]ubject to other provisions of [the
outbreaks of infectious diseases or described activities.
PREP Act], a covered person shall be A qualified person means a licensed
bioterrorist attacks, otherwise exists, or immune from suit and liability under
other declarations or determinations health professional or other individual
Federal and State law with respect to all who is authorized to prescribe,
made under other authorities of the claims for loss caused by, arising out of,
Secretary. Accordingly, in Section I, the administer, or dispense Covered
relating to, or resulting from the Countermeasures under the law of the
Secretary determines that there is a administration to or use by an
credible risk that the spread of Ebola State in which the countermeasure was
individual of a covered countermeasure prescribed, administered, or dispensed;
virus and the resulting disease may in if a declaration . . . has been issued
the future constitute a public health or a person within a category of persons
with respect to such countermeasure.’’ identified as qualified in the Secretary’s
emergency. In Section IV, the Secretary states that Declaration. Under this definition, the
Section II, Factors Considered liability protections are in effect with Secretary can describe in the
In deciding whether and under what respect to the Recommended Activities. Declaration other qualified persons,
circumstances to issue a Declaration Section V, Covered Persons such as volunteers, who are Covered
with respect to a Covered Persons. Section V describes other
Countermeasure, the Secretary must The PREP Act’s liability immunity qualified persons covered by this
consider the desirability of encouraging applies to ‘‘Covered Persons’’ with Declaration.
the design, development, clinical testing respect to administration or use of a The PREP Act also defines the word
or investigation, manufacture, labeling, Covered Countermeasure. The term ‘‘person’’ as used in the Act: A person
distribution, formulation, packaging, ‘‘Covered Persons’’ has a specific includes an individual, partnership,
marketing, promotion, sale, purchase, meaning and is defined in the PREP Act corporation, association, entity, or
donation, dispensing, prescribing, to include manufacturers, distributors, public or private corporation, including
administration, licensing, and use of the program planners, and qualified a Federal, State, or local government
countermeasure. In Section II, the persons, and their officials, agents, and agency or department. Section V
Secretary states that she has considered employees, and the United States. The describes Covered Persons under the
these factors. PREP Act further defines the terms Declaration, including Qualified
‘‘manufacturer,’’ ‘‘distributor,’’ Persons.
Section III, Recommended Activities ‘‘program planner,’’ and ‘‘qualified
The Secretary must recommend the person’’ as described below. Section VI, Covered Countermeasures
activities for which the PREP Act’s A manufacturer includes a contractor As noted above, section III describes
asabaliauskas on DSK5VPTVN1PROD with NOTICES
liability immunity is in effect. These or subcontractor of a manufacturer; a the Secretary’s Recommended Activities
activities may include, under conditions supplier or licenser of any product, for which liability immunity is in effect.
as the Secretary may specify, the intellectual property, service, research Section VI identifies the
manufacture, testing, development, tool or component or other article used countermeasures for which the
distribution, administration, or use of in the design, development, clinical Secretary has recommended such
one or more Covered Countermeasures testing, investigation or manufacturing activities. The PREP Act states that a
(‘‘Recommended Activities’’). In Section of a Covered Countermeasure; and any ‘‘Covered Countermeasure’’ must be: A
III, the Secretary recommends activities or all of the parents, subsidiaries, ‘‘qualified pandemic or epidemic
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![Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22539
Countermeasure without geographic and Services Administration (‘‘HRSA’’), the Secretary, Assistant Secretary for
limitation. within the Department of Health and Financial Resources, Office of Grants
Liability immunity is afforded to Human Services. Information about the and Acquisition Policy and
manufacturers and distributors without CICP is available at the toll free number Accountability, Office of Acquisition
regard to whether the countermeasure is 1–855–266–2427 or http:// Policy at 202–690–6361 or
used by or administered in any www.hrsa.gov/cicp/. Lori.Sakalos@hhs.gov.
designated geographic area; liability Dated: April 16, 2015.
XV. Amendments
immunity is afforded to program Angela Billups
planners and qualified persons when 42 U.S.C. 247d–6d(b)(4)
Associate Deputy Assistant Secretary for
the countermeasure is used by or Any amendments to this Declaration Acquisition, Senior Procurement Executive,
administered in any designated will be published in the Federal Assistant Secretary for Financial Resources,
geographic area, or the program planner Register. Office of the Secretary.
or qualified person reasonably could [FR Doc. 2015–09415 Filed 4–21–15; 8:45 am]
Authority: 42 U.S.C. 247d–6d.
have believed the recipient was in that BILLING CODE 4150–28–P
geographic area. Dated: April 9, 2015.
Sylvia M. Burwell,
XII. Effective Time Period
Secretary. DEPARTMENT OF HEALTH AND
42 U.S.C. 247d–6d(b)(2)(B) [FR Doc. 2015–09412 Filed 4–21–15; 8:45 am] HUMAN SERVICES
Liability immunity for Covered BILLING CODE 4150–03–P
National Institutes of Health
Countermeasures begins on the effective
date and extends for twelve (12) months National Cancer Institute; Notice of
from that date. DEPARTMENT OF HEALTH AND
HUMAN SERVICES Closed Meetings
XIII. Additional Time Period of Pursuant to section 10(d) of the
Coverage Public Availability of the Department of Federal Advisory Committee Act, as
Health and Human Services FY 2014 amended (5 U.S.C. App.), notice is
42 U.S.C. 247d–6d(b)(3)(B) and (C) Service Contract Inventory hereby given of the following meetings.
I have determined that an additional The meetings will be closed to the
AGENCY: Office of the Assistant
twelve (12) months of liability public in accordance with the
Secretary for Financial Resources, Office
protection is reasonable to allow for the provisions set forth in sections 552b(c)
of Grants and Acquisition Policy and
manufacturer(s) to arrange for (4) and 552b(c) (6), Title 5 U.S.C., as
Accountability, Division of Acquisition,
disposition of the Covered amended. The grant applications and
Department of Health and Human
Countermeasure, including return of the the discussions could disclose
Services.
Covered Countermeasures to the confidential trade secrets or commercial
manufacturer, and for Covered Persons ACTION: Notice of Public Availability of
FY 2014 Service Contract Inventories. property such as patentable material,
to take such other actions as are and personal information concerning
appropriate to limit the administration SUMMARY: In accordance with Section individuals associated with the grant
or use of the Covered Countermeasures. 743 of Division C of the Consolidated applications, the disclosure of which
Covered Countermeasures obtained Appropriations Act of 2010 (Public Law would constitute a clearly unwarranted
for the Strategic National Stockpile 111–117), Department of Health and invasion of personal privacy.
(‘‘SNS’’) during the effective period of Human Services (HHS) is publishing
this Declaration are covered through the Name of Committee: National Cancer
this notice to advise the public of the Institute Special Emphasis Panel; NCI EDRN
date of administration or use pursuant availability of its FY 2014 Service Review I.
to a distribution or release from the Contract Inventory. This inventory Date: June 9, 2015.
SNS. provides information on service contract Time: 8:00 a.m. to 5:00 p.m.
actions over $25,000 that were made in Agenda: To review and evaluate grant
XIV. Countermeasures Injury applications.
Compensation Program FY 2014. The information is organized
Place: Hyatt Regency Bethesda, One
by function to show how contracted Bethesda Metro Center, 7400 Wisconsin
42 U.S.C 247d–6e resources are distributed throughout the Avenue, Bethesda, MD 20814.
The PREP Act authorizes a agency. The inventory has been Contact Person: Delia Tang, MD, Scientific
Countermeasures Injury Compensation developed in accordance with guidance Review Officer, Research Programs Review
Program (‘‘CICP’’) to provide benefits to issued on November 5, 2010 and Branch, Division of Extramural Activities,
certain individuals or estates of December 19, 2011 by the Office of National Cancer Institute, NIH, 9609 Medical
Management and Budget’s Office of Center Drive, Room 7W602, Rockville, MD
individuals who sustain a covered 20850, 240–276–6456 tangd@mail.nih.gov.
serious physical injury as the direct Federal Procurement Policy (OFPP).
OFPP’s guidance is available at http:// Name of Committee: National Cancer
result of the administration or use of the Institute Initial Review Group; NCI
Covered Countermeasures, and benefits www.whitehouse.gov/sites/default/files/ Subcommittee F-Institutional Training and
to certain survivors of individuals who omb/procurement/memo/service- Education.
die as a direct result of the contract-inventories-guidance- Date: June 9, 2015.
administration or use of the Covered 11052010.pdf. HHS has posted its Time: 11:30 a.m. to 4:30 p.m.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Countermeasures. The causal inventory and a summary of the Agenda: To review and evaluate grant
connection between the countermeasure inventory on the HHS homepage at the applications.
and the serious physical injury must be following link: http://www.hhs.gov/ Place: National Cancer Institute, Shady
grants/servicecontracts/. Grove, 9609 Medical Center Drive, Room
supported by compelling, reliable, valid, 7W606, Rockville, MD 20850, (Telephone
medical and scientific evidence in order FOR FURTHER INFORMATION CONTACT: Conference Call).
for the individual to be considered for Questions regarding the service contract Contact Person: Timothy C. Meeker, Ph.D.,
compensation. The CICP is inventory should be directed to Lori MD, Scientific Review Officer, Resource and
administered by the Health Resources Sakalos, Director in the HHS/Office of Training Review Branch, Division of
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Document Created: 2015-12-16 08:28:04
Document Modified: 2015-12-16 08:28:04
| 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 Declaration Under the Public Readiness and Emergency Preparedness Act. | |
| Dates | The Declaration is effective as of February 27, 2015. | |
| Contact | Nicole Lurie, MD, MSPH, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free number). | |
| FR Citation | 80 FR 22534 |
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