Ebola Virus Disease Therapeutics, 22534-22539 [2015-09412]

Download as PDF 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 Dates Electronic addresses View Web cast .... May 20, 2015, from 10 a.m. to 1 p.m. Request special accommodations due to disability. Submit electronic or written comments. Request at least 7 days before the meeting. Addresses Other information Individuals who are unable to attend the meeting in person, can register to view a live Web cast. You will be asked to indicate in your registration whether you plan to attend in person or via the Web cast. Graham Thompson, email: Graham.Thompson@fda.hhs.gov. ...................................................... The Web cast will have closed captioning. Submit comFederal eRulemaking Portal: ments by https://www.regulations.gov. FolJune 30, 2015. low the instructions for submitting comments. See FOR FURTHER INFORMATION CONTACT. Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify your comments with the docket number listed in brackets in the heading of this document. We encourage you to submit electronic comments by using the Federal eRulemaking Portal. 1 You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration information and send to: Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301–796–5003, FAX: 301–847–8443, Graham.Thompson@fda.hhs.gov. IV. Comments and Transcripts Regardless of attendance at the public meeting, interested persons may submit to FDA’s Division of Dockets Management (see Addresses in table 1) either electronic or written comments on the interim assessment of the Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs. You only need to send one set of comments. Identify the comments with the docket number provided in brackets in the heading of this document. With respect to transcripts, please be advised that as soon as a transcript is available, it will be accessible at www.fda.gov/ForIndustry/UserFees/ PrescriptionDrugUserFee/ ucm327030.htm. Dated: April 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–09300 Filed 4–21–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES asabaliauskas on DSK5VPTVN1PROD with NOTICES Office of the Secretary Ebola Virus Disease Therapeutics Notice of Declaration Under the Public Readiness and Emergency Preparedness Act. ACTION: 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 SUMMARY: VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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 E:\FR\FM\22APN1.SGM 22APN1 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 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, PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 22535 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; privatelabel 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 E:\FR\FM\22APN1.SGM 22APN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 22536 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 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 lifethreatening 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 VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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 E:\FR\FM\22APN1.SGM 22APN1 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 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 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 22537 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. E:\FR\FM\22APN1.SGM 22APN1 22538 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 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 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES 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. 18:00 Apr 21, 2015 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) 42 U.S.C. 247d–6d(b)(6) VerDate Sep<11>2014 IV. Liability Immunity Jkt 235001 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 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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 E:\FR\FM\22APN1.SGM 22APN1 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 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 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 https:// www.hrsa.gov/cicp/. the Secretary, Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy and Accountability, Office of Acquisition Policy at 202–690–6361 or Lori.Sakalos@hhs.gov. XV. Amendments Dated: April 16, 2015. Angela Billups Associate Deputy Assistant Secretary for Acquisition, Senior Procurement Executive, Assistant Secretary for Financial Resources, Office of the Secretary. 42 U.S.C. 247d–6d(b)(4) Any amendments to this Declaration will be published in the Federal Register. [FR Doc. 2015–09415 Filed 4–21–15; 8:45 am] Authority: 42 U.S.C. 247d–6d. BILLING CODE 4150–28–P Dated: April 9, 2015. Sylvia M. Burwell, Secretary. 42 U.S.C. 247d–6d(b)(2)(B) [FR Doc. 2015–09412 Filed 4–21–15; 8:45 am] Liability immunity for Covered Countermeasures begins on the effective date and extends for twelve (12) months from that date. BILLING CODE 4150–03–P XIII. Additional Time Period of Coverage 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy and Accountability, Division of Acquisition, Department of Health and Human Services. ACTION: Notice of Public Availability of FY 2014 Service Contract Inventories. AGENCY: In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Public Law 111–117), Department of Health and Human Services (HHS) is publishing this notice to advise the public of the availability of its FY 2014 Service Contract Inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2014. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 and December 19, 2011 by the Office of Management and Budget’s Office of Federal Procurement Policy (OFPP). OFPP’s guidance is available at https:// www.whitehouse.gov/sites/default/files/ omb/procurement/memo/servicecontract-inventories-guidance11052010.pdf. HHS has posted its inventory and a summary of the inventory on the HHS homepage at the following link: https://www.hhs.gov/ grants/servicecontracts/. FOR FURTHER INFORMATION CONTACT: Questions regarding the service contract inventory should be directed to Lori Sakalos, Director in the HHS/Office of SUMMARY: PO 00000 Frm 00067 Fmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Public Availability of the Department of Health and Human Services FY 2014 Service Contract Inventory 42 U.S.C. 247d–6d(b)(3)(B) and (C) 22539 Sfmt 4703 National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c) (4) and 552b(c) (6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI EDRN Review I. Date: June 9, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Delia Tang, MD, Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W602, Rockville, MD 20850, 240–276–6456 tangd@mail.nih.gov. Name of Committee: National Cancer Institute Initial Review Group; NCI Subcommittee F-Institutional Training and Education. Date: June 9, 2015. Time: 11:30 a.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W606, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Timothy C. Meeker, Ph.D., MD, Scientific Review Officer, Resource and Training Review Branch, Division of E:\FR\FM\22APN1.SGM 22APN1

Agencies

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22534-22539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09412]


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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 https://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

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