Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines, 10365-10370 [2017-02778]

Download as PDF 10365 Federal Register / Vol. 82, No. 27 / Friday, February 10, 2017 / Notices evaluation will be conducted in 39 schools nationwide. The data collected from this instrument will provide a detailed understanding of program impacts. Clearance is requested for three years. Need and Proposed Use of the Information: The follow-up survey data will be used to determine program effectiveness by comparing sexual behavior outcomes, such as postponing sexual activity, and reducing or preventing sexual risk behaviors and STDs and intermediate outcomes, such as improving exposure, knowledge and attitudes between treatment (program) and control youth. The findings from these analyses of program impacts will be of interest to the general public, to policymakers, and to schools and other organizations interested in supporting a comprehensive approach to teen pregnancy prevention. Likely Respondents: The follow-up surveys will be administered to study participants, who will primarily be in 10th–12th grade at the time of the follow-up surveys. Burden Statement: The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of responses per respondent Number of respondents Form name Average burden per response (in hours) Total burden hours Follow up survey (9 months post baseline) ..................................................... Follow up survey (15 months post baseline) ................................................... 819 774 1 1 30/60 30/60 409.5 387 Total .......................................................................................................... 1593 ........................ ........................ 796.5 OS specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Terry S. Clark, Asst Information Collection Clearance Officer. [FR Doc. 2017–02794 Filed 2–9–17; 8:45 am] BILLING CODE 4168–11–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines ACTION: Notice. The Acting Secretary is issuing a Declaration pursuant to the Public Health Service Act to provide liability immunity protection for activities related to Zika Virus vaccines consistent with the terms of the Declaration. DATES: The Declaration is effective as of August 1, 2016. FOR FURTHER INFORMATION CONTACT: George Korch, Ph.D., Acting Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:35 Feb 09, 2017 Jkt 241001 Services, 200 Independence Avenue SW., Washington, DC 20201; Telephone: 202–205–2882. SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (Covered Countermeasures), except for claims that meet the PREP Act’s definition of willful misconduct. The Secretary may, through publication in the Federal Register, amend any portion of a Declaration. Using this authority, the Acting Secretary is issuing a Declaration to provide liability immunity to Covered Persons for activities related to the Covered Countermeasures, Zika Virus vaccines 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, PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Drug & Cosmetic (FD&C) Act to provide new authorities for the emergency use of approved products in emergencies and products held for emergency use. PAHPRA accordingly amended the definitions of ‘‘Covered Countermeasures’’ and ‘‘qualified pandemic and epidemic products’’ in Section 319F–3 of the Public Health Service Act (PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act Declarations. PAHPRA also extended the definition of qualified pandemic and epidemic products that may be covered under a PREP Act Declaration to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products. Zika virus is a mosquito-borne flavivirus that usually causes mild symptoms, but has been determined to cause microcephaly and other severe brain abnormalities in fetuses and infants born to women infected with Zika virus before birth. Zika virus has also been associated with other adverse pregnancy outcomes, including miscarriage, stillbirth, and congenital Zika syndrome, and with Guillain-Barre Syndrome. Beginning in 2015, Brazil has experienced the largest outbreak of disease caused by Zika infection since its discovery in Uganda in 1947. On February 1, 2016, the World Health Organization (WHO) determined that microcephaly cases and other neurologic disorders reported in Brazil constituted a Public Health Emergency of International Concern (PHEIC) in accordance with the International E:\FR\FM\10FEN1.SGM 10FEN1 10366 Federal Register / Vol. 82, No. 27 / Friday, February 10, 2017 / Notices mstockstill on DSK3G9T082PROD with NOTICES Health Regulations (IHR). Since 2015, Zika virus has been detected in nations throughout the world. In the United States, traveler-associated cases have been identified in all of the states, and local transmission of Zika virus is occurring in Puerto Rico; American Samoa; areas of Miami, Florida; and Texas. On August 12, 2016, the Secretary determined that a public health emergency of national significance exists within the Commonwealth of Puerto Rico relating to pregnant women and children born to pregnant women with Zika. The Secretary, Sylvia M. Burwell, renewed that determination on November 4, 2016, and Acting Secretary Norris Cochran renewed that determination on January 31, 2017. On November 18, 2016, the WHO Director-General declared the end of the PHEIC based on recommendations of the WHO Emergency Committee that Zika virus and associated consequences no longer represent a PHEIC as defined under the IHR, but remain a significant enduring public health challenge requiring intense action that should be escalated into a sustained program of work with dedicated resources to address the longterm nature of the disease and its associated consequences. Unless otherwise noted, all statutory citations below are to the U.S. Code. Section I, Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency Before issuing a Declaration under the PREP Act, the Secretary is required to determine that a disease or other health condition or threat to health constitutes a public health emergency or that there is a credible risk that the disease, condition, or threat may constitute such an emergency. This determination is separate and apart from a Declaration issued by the Secretary under Section 319 of the PHS Act that a disease or disorder presents a public health emergency or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, or other Declarations or determinations made under other authorities of the Secretary. Accordingly, in Section I, the Acting Secretary determines that there is a credible risk that the spread of Zika virus and the resulting disease may constitute a public health emergency. Section II, Factors Considered In deciding whether and under what circumstances to issue a Declaration with respect to a Covered Countermeasure, the Secretary must consider the desirability of encouraging VerDate Sep<11>2014 18:35 Feb 09, 2017 Jkt 241001 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 Acting Secretary states that he 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 Acting Secretary recommends activities for which the immunity is in effect. Section IV, Liability Immunity The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, ‘‘[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.’’ In Section IV, the Acting 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 00039 Fmt 4703 Sfmt 4703 affiliates, successors, and assigns of a manufacturer. A distributor means a person or entity engaged in the distribution of drugs, 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 authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the Covered 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. We have revised the last category to remove the specific references to emergency use instructions and orders issued under Section 564A of the FD&C Act, to clarify that any activities in accordance with that section are covered. Section VI, Covered Countermeasures As noted above, Section III describes the Secretary’s Recommended Activities for which liability immunity is in effect. This section identifies the Covered E:\FR\FM\10FEN1.SGM 10FEN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 82, No. 27 / Friday, February 10, 2017 / Notices Countermeasures for which the Acting Secretary has recommended such activities. The PREP Act states that a ‘‘Covered Countermeasure’’ must be: A ‘‘qualified pandemic or epidemic product,’’ or a ‘‘security countermeasure,’’ as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act. A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is: (i) Manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or 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 subject to an exemption (that is, it is permitted to be used under an Investigational Drug Application or an Investigational Device Exemption) under the FD&C Act and is the object of research for possible use for diagnosis, mitigation, prevention, treatment, or cure, or to limit harm of VerDate Sep<11>2014 18:35 Feb 09, 2017 Jkt 241001 a pandemic or epidemic or serious or life-threatening condition caused by such a drug or device. A security countermeasure also may be a Covered Countermeasure if it may reasonably be determined to qualify for approval or licensing within 10 years after the Department’s determination that procurement of the countermeasure is appropriate. Section VI lists the Zika Virus Vaccines 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: (a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements; or (b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a Declaration of an emergency. Section VII defines the terms ‘‘Authority Having Jurisdiction’’ and ‘‘Declaration of an emergency.’’ We have specified in the definition that Authorities having jurisdiction include federal, state, local, and tribal authorities and institutions or organizations acting on behalf of those governmental entities. For governmental program planners only, liability immunity is afforded only to the extent they obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 10367 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 Acting Secretary states that the disease threat for which he recommends administration or use of the Covered Countermeasures is Zika virus. 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 Acting 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 definition, these liability claims are precluded if they allege an injury caused by physical provision of a countermeasure to a recipient, or if the claims are directly due to conditions of E:\FR\FM\10FEN1.SGM 10FEN1 10368 Federal Register / Vol. 82, No. 27 / Friday, February 10, 2017 / Notices mstockstill on DSK3G9T082PROD with NOTICES delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites. Thus, it is the Acting Secretary’s interpretation that, when a Declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control. However, a liability claim alleging an injury occurring at the site that was not directly related to the countermeasure activities is not covered, such as a slip and fall with no direct connection to the countermeasure’s administration or use. In each case, whether immunity is applicable will depend on the particular facts and circumstances. Section X, Population The Secretary must identify, for each Covered Countermeasure specified in a Declaration, the population or populations of individuals for which liability immunity is in effect with respect to administration or use of the countermeasure. This section explains which individuals should use the countermeasure or to whom the countermeasure should be administered—in short, those who should be vaccinated or take a drug or other countermeasure. Section X provides that the population includes ‘‘any individual who uses or who is administered a Covered Countermeasure in accordance with the Declaration.’’ In addition, the PREP Act specifies that liability immunity is afforded: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; and (2) to program planners and qualified persons when the countermeasure is either used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population. Section X includes these statutory conditions in the Declaration for clarity. Section XI, Geographic Area The Secretary must identify, for each Covered Countermeasure specified in VerDate Sep<11>2014 18:35 Feb 09, 2017 Jkt 241001 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 countries outside the U.S. It is possible that claims may arise in regard to administration or use of the Covered Countermeasures outside the U.S. that may be resolved under U.S. law. In addition, the PREP Act specifies that liability immunity is afforded: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in the geographic areas; and (2) to program planners and qualified persons when the countermeasure is either used or administered in the geographic areas or the program planner or qualified person reasonably could have believed the countermeasure was used or administered in the areas. Section XI includes these statutory conditions in the Declaration for clarity. Section XII, Effective Time Period The Secretary must identify, for each Covered Countermeasure, the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act. Section XII extends the effective time period for different means of distribution of Covered Countermeasures for 24 months. Section XIII, Additional Time Period of Coverage The Secretary must specify a date after the ending date of the effective period of the Declaration that is reasonable for manufacturers to arrange for disposition of the Covered Countermeasure, including return of the product to the manufacturer, and for other Covered Persons to take appropriate actions to limit administration or use of the Covered Countermeasure. In addition, the PREP Act specifies that for Covered Countermeasures that are subject to a Declaration at the time they are obtained for the Strategic National Stockpile (SNS) under 42 U.S.C. 247d–6b(a), the effective period of the Declaration extends through the time the PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 countermeasure is used or administered pursuant to a distribution or release from the stockpile. Liability immunity under the provisions of the PREP Act and the conditions of the Declaration continues during these additional time periods. Thus, liability immunity is afforded during the ‘‘Effective Time Period,’’ described under XII of the Declaration, plus the ‘‘Additional Time Period’’ described under Section XIII of the Declaration. Section XIII provides for 12 months as the additional time period of coverage after expiration of the Declaration. Section XIII also explains the extended coverage that applies to any products obtained for the Strategic National Stockpile during the effective period of the Declaration. Section XIV, Countermeasures Injury Compensation Program Section 319F–4 of the PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered Countermeasure. Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this Declaration, the administrative rules for the Program, and the statute. To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires ‘‘compelling, reliable, valid, medical and scientific evidence.’’ The administrative rules for the Program further explain the necessary requirements for eligibility under the CICP. Please note that, by statute, requirements for compensation under the CICP may not align with the requirements for liability immunity provided under the PREP Act. Section XIV, ‘‘Countermeasures Injury Compensation Program’’ explains the types of injury and standard of evidence needed to be considered for compensation under the CICP. Further, the administrative rules for the CICP specify if countermeasures are administered or used outside the United States, only otherwise eligible individuals at American embassies, military installations abroad (such as military bases, ships, and camps) or at North Atlantic Treaty Organization (NATO) installations (subject to the NATO Status of Forces Agreement) where American servicemen and servicewomen are stationed may be considered for CICP benefits. Other individuals outside the United States may not be eligible for CICP benefits. E:\FR\FM\10FEN1.SGM 10FEN1 Federal Register / Vol. 82, No. 27 / Friday, February 10, 2017 / Notices Section XV, Amendments The Secretary may amend any portion of this Declaration through publication in the Federal Register. Declaration Declaration for Public Readiness and Emergency Preparedness Act Coverage for Zika Virus Vaccines. 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 Zika virus and the resulting disease or conditions may in the future constitute a public health emergency. II. Factors Considered 42 U.S.C. 247d–6d(b)(6) I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures. III. Recommended Activities 42 U.S.C. 247d–6d(b)(1) I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures. IV. Liability Immunity 42 U.S.C. 247d–6d(a), 247d–6d(b)(1) Liability immunity as prescribed in the PREP Act and conditions stated in this Declaration is in effect for the Recommended Activities described in Section III. mstockstill on DSK3G9T082PROD with NOTICES Covered Persons who are afforded liability immunity under this Declaration are ‘‘manufacturers,’’ ‘‘distributors,’’ ‘‘program planners,’’ ‘‘qualified persons,’’ and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons: (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII Jkt 241001 42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. 247d–6d(i)(1) and (7) Covered Countermeasures are the following Zika Virus vaccines, all components and constituent materials of these vaccines, and all devices and their constituent components used in the administration of these vaccines: (1) Whole-particle inactivated virus vaccines (2) Live-attenuated vaccines (3) mRNA vaccines (4) DNA vaccines (5) Subunit vaccines (6) Peptide vaccines (7) Virus like particles vaccines (8) Nanoparticle vaccines. 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. 42 U.S.C. 247d–6d(a)(5) and (b)(2)(E) 42 U.S.C. 247d–6d(i)(2), (3), (4), (6), (8)(A) and (B) 18:35 Feb 09, 2017 VI. Covered Countermeasures VII. Limitations on Distribution V. Covered Persons VerDate Sep<11>2014 below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency; (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. I have determined that liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to: (a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements; or, (b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of an emergency. i. The Authority Having Jurisdiction means the public agency or its delegate PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 10369 that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority. ii. A Declaration of Emergency means any Declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal Declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such Declaration specifies otherwise; I have also determined that for governmental program planners only, liability immunity is afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles. VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d–6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is Zika Virus. 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 E:\FR\FM\10FEN1.SGM 10FEN1 10370 Federal Register / Vol. 82, No. 27 / Friday, February 10, 2017 / Notices regard to whether the countermeasure is used by or administered to this population; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population. XI. Geographic Area 42 U.S.C. 247d–6d(a)(4), 247d– 6d(b)(2)(D) Liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation. Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in any designated geographic area; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area. XII. Effective Time Period Covered Countermeasures obtained for the Strategic Nations 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 the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at the toll-free number 1–855– 266–2427 or http://www.hrsa.gov/cicp/. Dated: February 6, 2017. Norris Cochran, Acting Secretary of Health and Human Services. XIII. Additional Time Period of Coverage mstockstill on DSK3G9T082PROD with NOTICES 42 U.S.C. 247d–6d(b)(2)(B) Liability immunity for Covered Countermeasures through means of distribution, as identified in Section VII(a) of this Declaration, other than in accordance with the public health and medical response of the Authority Having Jurisdiction and extends for 24 months from the effective date of this Declaration. Liability immunity for Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction begins with a Declaration and lasts through (1) the final day the emergency Declaration is in effect, or (2) 24 months from the effective date of this Declaration, whichever occurs first. National Heart, Lung, and Blood Institute; Notice of Closed Meetings 42 U.S.C. 247d–6d(b)(3)(B) and (C) I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures. 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, VerDate Sep<11>2014 18:35 Feb 09, 2017 Jkt 241001 XV. Amendments 42 U.S.C. 247d–6d(b)(4) Amendments to this Declaration will be published in the Federal Register. Authority: 42 U.S.C. 247d–6d. [FR Doc. 2017–02778 Filed 2–9–17; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health PO 00000 Frm 00043 Fmt 4703 Sfmt 9990 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 Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI CLTR SEP Review. Date: March 3, 2017. Time: 8:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard by Marriott, 5520 Wisconsin Avenue, Chevy Chase, MD 20815. Contact Person: Chang Sook Kim, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7188, Bethesda, MD 20892–7924, 301–827– 7940, carolko@mail.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Career Development Program to Promote Diversity in Health Research. Date: March 3, 2017. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: YingYing Li-Smerin, MD, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD 20892– 7924, 301–827–7942, lismerin@nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Cystic Fibrosis Transmembrane Conductance Regulator—Directed Therapeutics. Date: March 3, 2017. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge Two, 7185, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Kristen Page, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7185, Bethesda, MD 20892, 301–827–7953, kristen.page@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: February 6, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–02723 Filed 2–9–17; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\10FEN1.SGM 10FEN1

Agencies

[Federal Register Volume 82, Number 27 (Friday, February 10, 2017)]
[Notices]
[Pages 10365-10370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02778]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Declaration Under the Public Readiness and Emergency Preparedness 
Act for Zika Virus Vaccines

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Acting Secretary is issuing a Declaration pursuant to the 
Public Health Service Act to provide liability immunity protection for 
activities related to Zika Virus vaccines consistent with the terms of 
the Declaration.

DATES: The Declaration is effective as of August 1, 2016.

FOR FURTHER INFORMATION CONTACT: George Korch, Ph.D., Acting Assistant 
Secretary for Preparedness and Response, Office of the Secretary, 
Department of Health and Human Services, 200 Independence Avenue SW., 
Washington, DC 20201; Telephone: 202-205-2882.

SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency 
Preparedness Act (PREP Act) authorizes the Secretary of Health and 
Human Services (the Secretary) to issue a Declaration to provide 
liability immunity to certain individuals and entities (Covered 
Persons) against any claim of loss caused by, arising out of, relating 
to, or resulting from the administration or use of medical 
countermeasures (Covered Countermeasures), except for claims that meet 
the PREP Act's definition of willful misconduct. The Secretary may, 
through publication in the Federal Register, amend any portion of a 
Declaration. Using this authority, the Acting Secretary is issuing a 
Declaration to provide liability immunity to Covered Persons for 
activities related to the Covered Countermeasures, Zika Virus vaccines 
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 & 
Cosmetic (FD&C) Act to provide new authorities for the emergency use of 
approved products in emergencies and products held for emergency use. 
PAHPRA accordingly amended the definitions of ``Covered 
Countermeasures'' and ``qualified pandemic and epidemic products'' in 
Section 319F-3 of the Public Health Service Act (PREP Act provisions), 
so that products made available under these new FD&C Act authorities 
could be covered under PREP Act Declarations. PAHPRA also extended the 
definition of qualified pandemic and epidemic products that may be 
covered under a PREP Act Declaration to include products or 
technologies intended to enhance the use or effect of a drug, 
biological product, or device used against the pandemic or epidemic or 
against adverse events from these products.
    Zika virus is a mosquito-borne flavivirus that usually causes mild 
symptoms, but has been determined to cause microcephaly and other 
severe brain abnormalities in fetuses and infants born to women 
infected with Zika virus before birth. Zika virus has also been 
associated with other adverse pregnancy outcomes, including 
miscarriage, stillbirth, and congenital Zika syndrome, and with 
Guillain-Barre Syndrome. Beginning in 2015, Brazil has experienced the 
largest outbreak of disease caused by Zika infection since its 
discovery in Uganda in 1947. On February 1, 2016, the World Health 
Organization (WHO) determined that microcephaly cases and other 
neurologic disorders reported in Brazil constituted a Public Health 
Emergency of International Concern (PHEIC) in accordance with the 
International

[[Page 10366]]

Health Regulations (IHR). Since 2015, Zika virus has been detected in 
nations throughout the world. In the United States, traveler-associated 
cases have been identified in all of the states, and local transmission 
of Zika virus is occurring in Puerto Rico; American Samoa; areas of 
Miami, Florida; and Texas. On August 12, 2016, the Secretary determined 
that a public health emergency of national significance exists within 
the Commonwealth of Puerto Rico relating to pregnant women and children 
born to pregnant women with Zika. The Secretary, Sylvia M. Burwell, 
renewed that determination on November 4, 2016, and Acting Secretary 
Norris Cochran renewed that determination on January 31, 2017. On 
November 18, 2016, the WHO Director-General declared the end of the 
PHEIC based on recommendations of the WHO Emergency Committee that Zika 
virus and associated consequences no longer represent a PHEIC as 
defined under the IHR, but remain a significant enduring public health 
challenge requiring intense action that should be escalated into a 
sustained program of work with dedicated resources to address the long-
term nature of the disease and its associated consequences.
    Unless otherwise noted, all statutory citations below are to the 
U.S. Code.

Section I, Determination of Public Health Emergency or Credible Risk of 
Future Public Health Emergency

    Before issuing a Declaration under the PREP Act, the Secretary is 
required to determine that a disease or other health condition or 
threat to health constitutes a public health emergency or that there is 
a credible risk that the disease, condition, or threat may constitute 
such an emergency. This determination is separate and apart from a 
Declaration issued by the Secretary under Section 319 of the PHS Act 
that a disease or disorder presents a public health emergency or that a 
public health emergency, including significant outbreaks of infectious 
diseases or bioterrorist attacks, otherwise exists, or other 
Declarations or determinations made under other authorities of the 
Secretary. Accordingly, in Section I, the Acting Secretary determines 
that there is a credible risk that the spread of Zika virus and the 
resulting disease may constitute a public health emergency.

Section II, Factors Considered

    In deciding whether and under what circumstances to issue a 
Declaration with respect to a Covered Countermeasure, the Secretary 
must consider the desirability of encouraging the design, development, 
clinical testing or investigation, manufacture, labeling, distribution, 
formulation, packaging, marketing, promotion, sale, purchase, donation, 
dispensing, prescribing, administration, licensing, and use of the 
countermeasure. In Section II, the Acting Secretary states that he 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 Acting Secretary recommends activities for which the immunity is in 
effect.

Section IV, Liability Immunity

    The Secretary must also state that liability protections available 
under the PREP Act are in effect with respect to the Recommended 
Activities. These liability protections provide that, ``[s]ubject to 
other provisions of [the PREP Act], a covered person shall be immune 
from suit and liability under federal and state law with respect to all 
claims for loss caused by, arising out of, relating to, or resulting 
from the administration to or use by an individual of a covered 
countermeasure if a Declaration has been issued with respect to such 
countermeasure.'' In Section IV, the Acting 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 drugs, biologics, or devices, including but not limited to: 
Manufacturers; repackers; common carriers; contract carriers; air 
carriers; own-label distributors; private-label distributors; jobbers; 
brokers; warehouses and wholesale drug warehouses; independent 
wholesale drug traders; and retail pharmacies.
    A program planner means a state or local government, including an 
Indian tribe; a person employed by the state or local government; or 
other person who supervises or administers a program with respect to 
the administration, dispensing, distribution, provision, or use of a 
Covered Countermeasure, including a person who establishes 
requirements, provides policy guidance, or supplies technical or 
scientific advice or assistance or provides a facility to administer or 
use a Covered Countermeasure in accordance with the Secretary's 
Declaration. Under this definition, a private sector employer or 
community group or other ``person'' can be a program planner when it 
carries out the described activities.
    A qualified person means a licensed health professional or other 
individual authorized to prescribe, administer, or dispense Covered 
Countermeasures under the law of the state in which the Covered 
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. We have revised the last category to 
remove the specific references to emergency use instructions and orders 
issued under Section 564A of the FD&C Act, to clarify that any 
activities in accordance with that section are covered.

Section VI, Covered Countermeasures

    As noted above, Section III describes the Secretary's Recommended 
Activities for which liability immunity is in effect. This section 
identifies the Covered

[[Page 10367]]

Countermeasures for which the Acting Secretary has recommended such 
activities. The PREP Act states that a ``Covered Countermeasure'' must 
be: A ``qualified pandemic or epidemic product,'' or a ``security 
countermeasure,'' as described immediately below; or a drug, biological 
product or device authorized for emergency use in accordance with 
Sections 564, 564A, or 564B of the FD&C Act.
    A qualified pandemic or epidemic product means a drug or device, as 
defined in the FD&C Act or a biological product, as defined in the PHS 
Act that is: (i) Manufactured, used, designed, developed, modified, 
licensed or procured to diagnose, mitigate, prevent, treat, or cure a 
pandemic or epidemic or limit the harm such a pandemic or epidemic 
might otherwise cause; (ii) manufactured, used, designed, developed, 
modified, licensed, or procured to diagnose, mitigate, prevent, treat, 
or cure a serious or life-threatening disease or condition caused by 
such a drug, biological product, or device; (iii) or a product or 
technology intended to enhance the use or effect of such a drug, 
biological product, or device.
    A security countermeasure is a drug or device, as defined in the 
FD&C Act or a biological product, as defined in the PHS Act that: 
(i)(a) The Secretary determines to be a priority to diagnose, mitigate, 
prevent, or treat harm from any biological, chemical, radiological, or 
nuclear agent identified as a material threat by the Secretary of 
Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm 
from a condition that may result in adverse health consequences or 
death and may be caused by administering a drug, biological product, or 
device against such an agent; and (ii) is determined by the Secretary 
of Health and Human Services to be a necessary countermeasure to 
protect public health.
    To be a Covered Countermeasure, qualified pandemic or epidemic 
products or security countermeasures also must be approved or cleared 
under the FD&C Act; licensed under the PHS Act; or authorized for 
emergency use under Sections 564, 564A, or 564B of the FD&C Act.
    A qualified pandemic or epidemic product also may be a Covered 
Countermeasure when it is subject to an exemption (that is, it is 
permitted to be used under an Investigational Drug Application or an 
Investigational Device Exemption) under the FD&C Act and is the object 
of research for possible use for diagnosis, mitigation, prevention, 
treatment, or cure, or to limit harm of a pandemic or epidemic or 
serious or life-threatening condition caused by such a drug or device. 
A security countermeasure also may be a Covered Countermeasure if it 
may reasonably be determined to qualify for approval or licensing 
within 10 years after the Department's determination that procurement 
of the countermeasure is appropriate.
    Section VI lists the Zika Virus Vaccines 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: (a) 
Present or future federal contracts, cooperative agreements, grants, 
other transactions, interagency agreements, or memoranda of 
understanding or other federal agreements; or (b) Activities authorized 
in accordance with the public health and medical response of the 
Authority Having Jurisdiction to prescribe, administer, deliver, 
distribute, or dispense the Covered Countermeasures following a 
Declaration of an emergency.
    Section VII defines the terms ``Authority Having Jurisdiction'' and 
``Declaration of an emergency.'' We have specified in the definition 
that Authorities having jurisdiction include federal, state, local, and 
tribal authorities and institutions or organizations acting on behalf 
of those governmental entities.
    For governmental program planners only, liability immunity is 
afforded only to the extent they obtain Covered Countermeasures through 
voluntary means, such as (1) donation; (2) commercial sale; (3) 
deployment of Covered Countermeasures from federal stockpiles; or (4) 
deployment of donated, purchased, or otherwise voluntarily obtained 
Covered Countermeasures from state, local, or private stockpiles. This 
last limitation on distribution is intended to deter program planners 
that are government entities from seizing privately held stockpiles of 
Covered Countermeasures. It does not apply to any other Covered 
Persons, including other program planners who are not government 
entities.

Section VIII, Category of Disease, Health Condition, or Threat

    The Secretary must identify, for each Covered Countermeasure, the 
categories of diseases, health conditions, or threats to health for 
which the Secretary recommends the administration or use of the 
countermeasure. In Section VIII, the Acting Secretary states that the 
disease threat for which he recommends administration or use of the 
Covered Countermeasures is Zika virus.

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 Acting 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 definition, these liability 
claims are precluded if they allege an injury caused by physical 
provision of a countermeasure to a recipient, or if the claims are 
directly due to conditions of

[[Page 10368]]

delivery, distribution, dispensing, or management and operation of 
countermeasure programs at distribution and dispensing sites.
    Thus, it is the Acting Secretary's interpretation that, when a 
Declaration is in effect, the Act precludes, for example, liability 
claims alleging negligence by a manufacturer in creating a vaccine, or 
negligence by a health care provider in prescribing the wrong dose, 
absent willful misconduct. Likewise, the Act precludes a liability 
claim relating to the management and operation of a countermeasure 
distribution program or site, such as a slip-and-fall injury or vehicle 
collision by a recipient receiving a countermeasure at a retail store 
serving as an administration or dispensing location that alleges, for 
example, lax security or chaotic crowd control. However, a liability 
claim alleging an injury occurring at the site that was not directly 
related to the countermeasure activities is not covered, such as a slip 
and fall with no direct connection to the countermeasure's 
administration or use. In each case, whether immunity is applicable 
will depend on the particular facts and circumstances.

Section X, Population

    The Secretary must identify, for each Covered Countermeasure 
specified in a Declaration, the population or populations of 
individuals for which liability immunity is in effect with respect to 
administration or use of the countermeasure. This section explains 
which individuals should use the countermeasure or to whom the 
countermeasure should be administered--in short, those who should be 
vaccinated or take a drug or other countermeasure. Section X provides 
that the population includes ``any individual who uses or who is 
administered a Covered Countermeasure in accordance with the 
Declaration.''
    In addition, the PREP Act specifies that liability immunity is 
afforded: (1) To manufacturers and distributors without regard to 
whether the countermeasure is used by or administered to this 
population; and (2) to program planners and qualified persons when the 
countermeasure is either used by or administered to this population or 
the program planner or qualified person reasonably could have believed 
the recipient was in this population. Section X includes these 
statutory conditions in the Declaration for clarity.

Section XI, Geographic Area

    The Secretary must identify, for each Covered Countermeasure 
specified in the Declaration, the geographic area or areas for which 
liability immunity is in effect with respect to administration or use 
of the countermeasure, including, as appropriate, whether the 
Declaration applies only to individuals physically present in the area 
or, in addition, applies to individuals who have a described connection 
to the area. Section XI provides that liability immunity is afforded 
for the administration or use of a Covered Countermeasure without 
geographic limitation. This could include claims related to 
administration or use in countries outside the U.S. It is possible that 
claims may arise in regard to administration or use of the Covered 
Countermeasures outside the U.S. that may be resolved under U.S. law.
    In addition, the PREP Act specifies that liability immunity is 
afforded: (1) To manufacturers and distributors without regard to 
whether the countermeasure is used by or administered to individuals in 
the geographic areas; and (2) to program planners and qualified persons 
when the countermeasure is either used or administered in the 
geographic areas or the program planner or qualified person reasonably 
could have believed the countermeasure was used or administered in the 
areas. Section XI includes these statutory conditions in the 
Declaration for clarity.

Section XII, Effective Time Period

    The Secretary must identify, for each Covered Countermeasure, the 
period or periods during which liability immunity is in effect, 
designated by dates, milestones, or other description of events, 
including factors specified in the PREP Act. Section XII extends the 
effective time period for different means of distribution of Covered 
Countermeasures for 24 months.

Section XIII, Additional Time Period of Coverage

    The Secretary must specify a date after the ending date of the 
effective period of the Declaration that is reasonable for 
manufacturers to arrange for disposition of the Covered Countermeasure, 
including return of the product to the manufacturer, and for other 
Covered Persons to take appropriate actions to limit administration or 
use of the Covered Countermeasure. In addition, the PREP Act specifies 
that for Covered Countermeasures that are subject to a Declaration at 
the time they are obtained for the Strategic National Stockpile (SNS) 
under 42 U.S.C. 247d-6b(a), the effective period of the Declaration 
extends through the time the countermeasure is used or administered 
pursuant to a distribution or release from the stockpile. Liability 
immunity under the provisions of the PREP Act and the conditions of the 
Declaration continues during these additional time periods. Thus, 
liability immunity is afforded during the ``Effective Time Period,'' 
described under XII of the Declaration, plus the ``Additional Time 
Period'' described under Section XIII of the Declaration.
    Section XIII provides for 12 months as the additional time period 
of coverage after expiration of the Declaration. Section XIII also 
explains the extended coverage that applies to any products obtained 
for the Strategic National Stockpile during the effective period of the 
Declaration.

Section XIV, Countermeasures Injury Compensation Program

    Section 319F-4 of the PREP Act authorizes the Countermeasures 
Injury Compensation Program (CICP) to provide benefits to eligible 
individuals who sustain a serious physical injury or die as a direct 
result of the administration or use of a Covered Countermeasure. 
Compensation under the CICP for an injury directly caused by a Covered 
Countermeasure is based on the requirements set forth in this 
Declaration, the administrative rules for the Program, and the statute. 
To show direct causation between a Covered Countermeasure and a serious 
physical injury, the statute requires ``compelling, reliable, valid, 
medical and scientific evidence.'' The administrative rules for the 
Program further explain the necessary requirements for eligibility 
under the CICP. Please note that, by statute, requirements for 
compensation under the CICP may not align with the requirements for 
liability immunity provided under the PREP Act. Section XIV, 
``Countermeasures Injury Compensation Program'' explains the types of 
injury and standard of evidence needed to be considered for 
compensation under the CICP.
    Further, the administrative rules for the CICP specify if 
countermeasures are administered or used outside the United States, 
only otherwise eligible individuals at American embassies, military 
installations abroad (such as military bases, ships, and camps) or at 
North Atlantic Treaty Organization (NATO) installations (subject to the 
NATO Status of Forces Agreement) where American servicemen and 
servicewomen are stationed may be considered for CICP benefits. Other 
individuals outside the United States may not be eligible for CICP 
benefits.

[[Page 10369]]

Section XV, Amendments

    The Secretary may amend any portion of this Declaration through 
publication in the Federal Register.

Declaration

    Declaration for Public Readiness and Emergency Preparedness Act 
Coverage for Zika Virus Vaccines.

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 
Zika virus and the resulting disease or conditions may in the future 
constitute a public health emergency.

II. Factors Considered

42 U.S.C. 247d-6d(b)(6)

    I have considered the desirability of encouraging the design, 
development, clinical testing, or investigation, manufacture, labeling, 
distribution, formulation, packaging, marketing, promotion, sale, 
purchase, donation, dispensing, prescribing, administration, licensing, 
and use of the Covered Countermeasures.

III. Recommended Activities

42 U.S.C. 247d-6d(b)(1)

    I recommend, under the conditions stated in this Declaration, the 
manufacture, testing, development, distribution, administration, and 
use of the Covered Countermeasures.

IV. Liability Immunity

42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

    Liability immunity as prescribed in the PREP Act and conditions 
stated in this Declaration is in effect for the Recommended Activities 
described in Section III.

V. Covered Persons

42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

    Covered Persons who are afforded liability immunity under this 
Declaration are ``manufacturers,'' ``distributors,'' ``program 
planners,'' ``qualified persons,'' and their officials, agents, and 
employees, as those terms are defined in the PREP Act, and the United 
States.
    In addition, I have determined that the following additional 
persons are qualified persons: (a) Any person authorized in accordance 
with the public health and medical emergency response of the Authority 
Having Jurisdiction, as described in Section VII below, to prescribe, 
administer, deliver, distribute or dispense the Covered 
Countermeasures, and their officials, agents, employees, contractors 
and volunteers, following a Declaration of an emergency; (b) any person 
authorized to prescribe, administer, or dispense the Covered 
Countermeasures or who is otherwise authorized to perform an activity 
under an Emergency Use Authorization in accordance with Section 564 of 
the FD&C Act; (c) any person authorized to prescribe, administer, or 
dispense Covered Countermeasures in accordance with Section 564A of the 
FD&C Act.

VI. Covered Countermeasures

42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

    Covered Countermeasures are the following Zika Virus vaccines, all 
components and constituent materials of these vaccines, and all devices 
and their constituent components used in the administration of these 
vaccines:

    (1) Whole-particle inactivated virus vaccines
    (2) Live-attenuated vaccines
    (3) mRNA vaccines
    (4) DNA vaccines
    (5) Subunit vaccines
    (6) Peptide vaccines
    (7) Virus like particles vaccines
    (8) Nanoparticle vaccines.

    Covered Countermeasures must be ``qualified pandemic or epidemic 
products,'' or ``security countermeasures,'' or drugs, biological 
products, or devices authorized for investigational or emergency use, 
as those terms are defined in the PREP Act, the FD&C Act, and the 
Public Health Service Act.

VII. Limitations on Distribution

42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

    I have determined that liability immunity is afforded to Covered 
Persons only for Recommended Activities involving Covered 
Countermeasures that are related to:
    (a) Present or future federal contracts, cooperative agreements, 
grants, other transactions, interagency agreements, memoranda of 
understanding, or other federal agreements; or,
    (b) Activities authorized in accordance with the public health and 
medical response of the Authority Having Jurisdiction to prescribe, 
administer, deliver, distribute or dispense the Covered Countermeasures 
following a Declaration of an emergency.
    i. The Authority Having Jurisdiction means the public agency or its 
delegate that has legal responsibility and authority for responding to 
an incident, based on political or geographical (e.g., city, county, 
tribal, state, or federal boundary lines) or functional (e.g., law 
enforcement, public health) range or sphere of authority.
    ii. A Declaration of Emergency means any Declaration by any 
authorized local, regional, state, or federal official of an emergency 
specific to events that indicate an immediate need to administer and 
use the Covered Countermeasures, with the exception of a federal 
Declaration in support of an Emergency Use Authorization under Section 
564 of the FD&C Act unless such Declaration specifies otherwise;
    I have also determined that for governmental program planners only, 
liability immunity is afforded only to the extent such program planners 
obtain Covered Countermeasures through voluntary means, such as (1) 
donation; (2) commercial sale; (3) deployment of Covered 
Countermeasures from federal stockpiles; or (4) deployment of donated, 
purchased, or otherwise voluntarily obtained Covered Countermeasures 
from state, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat

42 U.S.C. 247d-6d(b)(2)(A)

    The category of disease, health condition, or threat for which I 
recommend the administration or use of the Covered Countermeasures is 
Zika Virus.

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

[[Page 10370]]

regard to whether the countermeasure is used by or administered to this 
population; liability immunity is afforded to program planners and 
qualified persons when the countermeasure is used by or administered to 
this population, or the program planner or qualified person reasonably 
could have believed the recipient was in this population.

XI. Geographic Area

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

    Liability immunity is afforded for the administration or use of a 
Covered Countermeasure without geographic limitation.
    Liability immunity is afforded to manufacturers and distributors 
without regard to whether the countermeasure is used by or administered 
in any designated geographic area; liability immunity is afforded to 
program planners and qualified persons when the countermeasure is used 
by or administered in any designated geographic area, or the program 
planner or qualified person reasonably could have believed the 
recipient was in that geographic area.

XII. Effective Time Period

42 U.S.C. 247d-6d(b)(2)(B)

    Liability immunity for Covered Countermeasures through means of 
distribution, as identified in Section VII(a) of this Declaration, 
other than in accordance with the public health and medical response of 
the Authority Having Jurisdiction and extends for 24 months from the 
effective date of this Declaration.
    Liability immunity for Covered Countermeasures administered and 
used in accordance with the public health and medical response of the 
Authority Having Jurisdiction begins with a Declaration and lasts 
through (1) the final day the emergency Declaration is in effect, or 
(2) 24 months from the effective date of this Declaration, whichever 
occurs first.

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(B) and (C)

    I have determined that an additional 12 months of liability 
protection is reasonable to allow for the manufacturer(s) to arrange 
for disposition of the Covered Countermeasure, including return of the 
Covered Countermeasures to the manufacturer, and for Covered Persons to 
take such other actions as are appropriate to limit the administration 
or use of the Covered Countermeasures.
    Covered Countermeasures obtained for the Strategic Nations 
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 the Countermeasures Injury Compensation 
Program (CICP) to provide benefits to certain individuals or estates of 
individuals who sustain a covered serious physical injury as the direct 
result of the administration or use of the Covered Countermeasures, and 
benefits to certain survivors of individuals who die as a direct result 
of the administration or use of the Covered Countermeasures. The causal 
connection between the countermeasure and the serious physical injury 
must be supported by compelling, reliable, valid, medical and 
scientific evidence in order for the individual to be considered for 
compensation. The CICP is administered by the Health Resources and 
Services Administration, within the Department of Health and Human 
Services. Information about the CICP is available at the toll-free 
number 1-855-266-2427 or http://www.hrsa.gov/cicp/.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)

    Amendments to this Declaration will be published in the Federal 
Register.

    Authority: 42 U.S.C. 247d-6d.

    Dated: February 6, 2017.
Norris Cochran,
Acting Secretary of Health and Human Services.
[FR Doc. 2017-02778 Filed 2-9-17; 8:45 am]
BILLING CODE 4150-28-P