83 FR 38701 - Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 83, Issue 152 (August 7, 2018)
Office of the Secretary
Federal Register Volume 83, Issue 152 (August 7, 2018)
| Page Range | 38701-38707 | |
| FR Document | 2018-16856 |
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)] [Notices] [Pages 38701-38707] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16856] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines AGENCY: Department of Health and Human Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Secretary is amending 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, 2018. [[Page 38702]] FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, MTM&H, MS, 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, effective August 1, 2016 (82 FR 10365 (February 10, 2017)), Acting Secretary Norris Cochran issued 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 the Declaration. The Secretary is amending the August 1, 2016 Declaration to extend the effective time period of the declaration through December 31, 2022 and to clarify and add to the list of covered countermeasures to include all Zika virus vaccine types and technologies. 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 is linked to Guillain-Barre Syndrome. Beginning in 2015, Brazil 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 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 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, former Secretary Sylvia M. Burwell determined that a public health emergency of national significance existed within the Commonwealth of Puerto Rico relating to pregnant women and children born to pregnant women with Zika. Former Secretary Burwell renewed that determination on November 4, 2016; Acting Secretary Norris Cochran renewed that determination on January 31, 2017; and former Secretary Thomas E. Price renewed that declaration on April 28, 2017. The Secretary's public health emergency declaration expired on July 26, 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. In 2018, cases continue to be reported throughout the U.S. states and territories of laboratory-confirmed Zika virus disease in individuals returning from travel to affected areas, or presumed local mosquito-borne transmission, or other modes of transmission.\1\ --------------------------------------------------------------------------- \1\ CDC Zika case reporting; https://www.cdc.gov/zika/reporting/2018-case-counts.html, accessed 23July2018, 1630. --------------------------------------------------------------------------- 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 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 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 [[Page 38703]] one or more Covered Countermeasures (Recommended Activities). In Section III, the Secretary recommends activities for which the immunity is in effect. Section IV, Liability Immunity The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, ``[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.'' In Section IV, the Secretary states that liability protections are in effect with respect to the Recommended Activities. Section V, Covered Persons The PREP Act's liability immunity applies to ``Covered Persons'' with respect to administration or use of a Covered Countermeasure. The term ``Covered Persons'' has a specific meaning and is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States. The PREP Act further defines the terms ``manufacturer,'' ``distributor,'' ``program planner,'' and ``qualified person'' as described below. A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all 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. 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 Countermeasures for which the Secretary has recommended such activities. The PREP Act states that a ``Covered Countermeasure'' must be: A ``qualified pandemic or epidemic product,'' or a ``security countermeasure,'' as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act. A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is: (i) Manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device; (iii) or a product or technology intended to enhance the use or effect of such a drug, biological product, or device. A security countermeasure is a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that: (i)(a) The Secretary determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and (ii) is determined by the Secretary of Health and Human Services to be a necessary countermeasure to protect public health. To be a Covered Countermeasure, qualified pandemic or epidemic 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 Zika virus vaccines that are Covered Countermeasures. The Secretary is amending the list of vaccines by: Deleting ``whole particle'' from the first category of vaccines listed to clarify that the category includes all inactivated virus vaccines; adding ``and/or polysaccharide and/or conjugate'' to the sixth category of vaccines listed to include these types of peptide vaccine; and adding a new ninth category, ``recombinant vaccines'' to include any Zika virus vaccines using this type of technology. Section VI also refers to the statutory definitions of Covered Countermeasures [[Page 38704]] to make clear that these statutory definitions limit the scope of Covered Countermeasures. Specifically, the Declaration notes that Covered Countermeasures must be ``qualified pandemic or epidemic products,'' or ``security countermeasures,'' or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act. Section VII, Limitations on Distribution The Secretary may specify that liability immunity is in effect only to Covered Countermeasures obtained through a particular means of distribution. The Declaration states that liability immunity is afforded to Covered Persons for Recommended Activities related to: (a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements; or (b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a Declaration of an emergency. Section VII defines the terms ``Authority Having Jurisdiction'' and ``Declaration of an emergency.'' We have specified in the definition that Authorities having jurisdiction include federal, state, local, and tribal authorities and institutions or organizations acting on behalf of those governmental entities. For governmental program planners only, liability immunity is afforded only to the extent they obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles. This last limitation on distribution is intended to deter program planners that are government entities from seizing privately held stockpiles of Covered Countermeasures. It does not apply to any other Covered Persons, including other program planners who are not government entities. Section VIII, Category of Disease, Health Condition, or Threat The Secretary must identify, for each Covered Countermeasure, the categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure. In Section VIII, the Secretary states that the disease threat for which 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 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 delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites. Thus, it is the Secretary's interpretation that, when a Declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control. However, a liability claim alleging an injury occurring at the site that was not directly related to the countermeasure activities is not covered, such as a slip and fall with no direct connection to the countermeasure's administration or use. In each case, whether immunity is applicable will depend on the particular facts and circumstances. Section X, Population The Secretary must identify, for each Covered Countermeasure specified in a Declaration, the population or populations of individuals for which liability immunity is in effect with respect to administration or use of the 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 [[Page 38705]] 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 period for different means of distribution of Covered Countermeasures through December 31, 2022. Section XIII, Additional Time Period of Coverage The Secretary must specify a date after the ending date of the effective time 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 SNS during the effective period of the Declaration. Section XIV, Countermeasures Injury Compensation Program Section 319F-4 of the PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered Countermeasure. Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this Declaration, the administrative rules for the Program, and the statute. To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires ``compelling, reliable, valid, medical and scientific evidence.'' The administrative rules for the Program further explain the necessary requirements for eligibility under the CICP. Please note that, by statute, requirements for compensation under the CICP may not align with the requirements for liability immunity provided under the PREP Act. Section XIV, ``Countermeasures Injury Compensation Program'' explains the types of injury and standard of evidence needed to be considered for compensation under the CICP. Further, the administrative rules for the CICP specify if countermeasures are administered or used outside the United States, only otherwise eligible individuals at American embassies, military installations abroad (such as military bases, ships, and camps) or at North Atlantic Treaty Organization (NATO) installations (subject to the NATO Status of Forces Agreement) where American servicemen and servicewomen are stationed may be considered for CICP benefits. Other individuals outside the United States may not be eligible for CICP benefits. Section XV, Amendments 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 [[Page 38706]] 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) Inactivated virus vaccines (2) Live-attenuated vaccines (3) mRNA vaccines (4) DNA vaccines (5) Subunit vaccines (6) Peptide and/or polysaccharide and/or conjugate vaccines (7) Virus-like particles vaccines (8) Nanoparticle vaccines (9) Recombinant 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 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 through December 31, 2022. 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) December 31, 2022, whichever occurs first. XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C) I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures. Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS. XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e The PREP Act authorizes the Countermeasures Injury Compensation [[Page 38707]] 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: August 1, 2018. Alex M. Azar II Secretary, Department of Health and Human Services. [FR Doc. 2018-16856 Filed 8-6-18; 8:45 am] BILLING CODE P
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reader may determine whether any are updates to the list of manual provisions and in some instances may initiate an
of particular interest. We expect this that have occurred in the covered 3- action on their own motion.
notice to be used in concert with future month period. This information is In addition, parties may seek Council
published notices. The OCPM can be available on our website at https:// review of decisions and dismissals.
accessed at https://www.hhs.gov/about/ www.hhs.gov/about/agencies/omha/the- CMS and its contractors, or SSA, may
agencies/omha/the-appeals-process/ appeals-process/case-processing- also refer decisions and dismissals to
case-processing-manual/index.html. manual/index.html. the Council for possible own motion
III. How To Use the Notice OCPM Chapter 1: Manual Overview, review. The chapter also describes
Definition, and Governance actions the Council may take on an
This notice lists the OCPM chapters appealed or referred case, including
and subjects published during the Chapter 1, Manual Overview, remanding the case to OMHA.
quarter covered by the notice so the Definition, Governance. This chapter
reader may determine whether any are Dated: July 23, 2018.
describes the OCPM’s purpose and
of particular interest. We expect this organization. It also describes how to Amanda M. Axeen,
notice to be used in concert with future navigate the OCPM, and when and how Acting Chief Advisor, Office of Medicare
published notices. The OCPM can be to cite an OCPM provision as an Hearings and Appeals.
accessed at https://www.hhs.gov/about/ authority in an action issued by an [FR Doc. 2018–16860 Filed 8–6–18; 8:45 am]
agencies/omha/the-appeals-process/ OMHA adjudicator. BILLING CODE 4150–46–P
case-processing-manual/index.html. OMHA receives a variety of appeals,
as discussed in section I above. This
IV. Reorganization and Revision of the DEPARTMENT OF HEALTH AND
chapter describes when a specific
OCPM HUMAN SERVICES
OCPM provision may be read to apply
OMHA is in the process of to all or certain types of appeals, and
restructuring, reorganizing, and describes OCPM conventions for citing Office of the Secretary
reformatting the OCPM to make it more to statutory, regulatory, and other
user friendly. As part of this ongoing Declaration Under the Public
applicable authorities. In addition, this Readiness and Emergency
process, we are drafting new OCPM chapter describes the process for
chapters and revising existing OCPM Preparedness Act for Zika Virus
updating an OCPM chapter, as well as Vaccines
chapters to conform to the new format. how to determine when a revision was
Previously, the OCPM contained issued or became effective, and how to AGENCY: Department of Health and
separate divisions for each Medicare access prior versions of a chapter. Human Services.
part, and most chapters were repeated ACTION: Notice.
in each division. New and revised OCPM Chapter 19: Closing the Case
chapters provide information pertaining Chapter 19, Closing the Case. Timely SUMMARY: The Secretary is amending a
daltland on DSKBBV9HB2PROD with NOTICES
to all appeals arising under all Medicare notice of the disposition and closing of Declaration pursuant to the Public
parts. Plain language is used where a case, in compliance with applicable Health Service Act to provide liability
possible and guidance is provided in a laws and policy, is important to ensure immunity protection for activities
user-friendly, question-and-answer that effectuation of a decision, or other related to Zika virus vaccines consistent
format. The manual is also being revised necessary actions, can be undertaken by with the terms of the Declaration.
to reflect regulatory changes made by the parties to the appeal, CMS, CMS DATES: The declaration is effective as of
the final rule that was published in the contractors, plans, SSA, or the Council. August 1, 2018.
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![Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38703
one or more Covered Countermeasures including a person who establishes threatening disease or condition caused
(Recommended Activities). In Section requirements, provides policy guidance, by such a drug, biological product, or
III, the Secretary recommends activities or supplies technical or scientific advice device; (iii) or a product or technology
for which the immunity is in effect. or assistance or provides a facility to intended to enhance the use or effect of
administer or use a Covered such a drug, biological product, or
Section IV, Liability Immunity
Countermeasure in accordance with the device.
The Secretary must also state that Secretary’s Declaration. Under this A security countermeasure is a drug
liability protections available under the definition, a private sector employer or or device, as defined in the FD&C Act
PREP Act are in effect with respect to community group or other ‘‘person’’ can or a biological product, as defined in the
the Recommended Activities. These be a program planner when it carries out PHS Act that: (i)(a) The Secretary
liability protections provide that, the described activities. determines to be a priority to diagnose,
‘‘[s]ubject to other provisions of [the A qualified person means a licensed mitigate, prevent, or treat harm from any
PREP Act], a covered person shall be health professional or other individual biological, chemical, radiological, or
immune from suit and liability under authorized to prescribe, administer, or nuclear agent identified as a material
federal and state law with respect to all dispense Covered Countermeasures threat by the Secretary of Homeland
claims for loss caused by, arising out of, under the law of the state in which the Security, or (b) to diagnose, mitigate,
relating to, or resulting from the Covered Countermeasure was prevent, or treat harm from a condition
administration to or use by an prescribed, administered, or dispensed; that may result in adverse health
individual of a covered countermeasure or a person within a category of persons consequences or death and may be
if a Declaration has been issued with identified as qualified in the Secretary’s caused by administering a drug,
respect to such countermeasure.’’ In Declaration. Under this definition, the biological product, or device against
Section IV, the Secretary states that Secretary can describe in the such an agent; and (ii) is determined by
liability protections are in effect with Declaration other qualified persons, the Secretary of Health and Human
respect to the Recommended Activities. such as volunteers, who are Covered Services to be a necessary
Section V, Covered Persons Persons. Section V describes other countermeasure to protect public health.
qualified persons covered by this To be a Covered Countermeasure,
The PREP Act’s liability immunity Declaration. qualified pandemic or epidemic
applies to ‘‘Covered Persons’’ with The PREP Act also defines the word products or security countermeasures
respect to administration or use of a ‘‘person’’ as used in the Act: A person also must be approved or cleared under
Covered Countermeasure. The term includes an individual, partnership, the FD&C Act; licensed under the PHS
‘‘Covered Persons’’ has a specific corporation, association, entity, or Act; or authorized for emergency use
meaning and is defined in the PREP Act public or private corporation, including under Sections 564, 564A, or 564B of
to include manufacturers, distributors, a federal, state, or local government the FD&C Act.
program planners, and qualified agency or department. A qualified pandemic or epidemic
persons, and their officials, agents, and Section V describes Covered Persons product also may be a Covered
employees, and the United States. The under the Declaration, including Countermeasure when it is subject to an
PREP Act further defines the terms Qualified Persons. exemption (that is, it is permitted to be
‘‘manufacturer,’’ ‘‘distributor,’’ used under an Investigational Drug
Section VI, Covered Countermeasures
‘‘program planner,’’ and ‘‘qualified Application or an Investigational Device
person’’ as described below. As noted above, Section III describes Exemption) under the FD&C Act and is
A manufacturer includes a contractor the Secretary’s Recommended Activities the object of research for possible use
or subcontractor of a manufacturer; a for which liability immunity is in effect. for diagnosis, mitigation, prevention,
supplier or licenser of any product, This section identifies the Covered treatment, or cure, or to limit harm of
intellectual property, service, research Countermeasures for which the a pandemic or epidemic or serious or
tool or component or other article used Secretary has recommended such life-threatening condition caused by
in the design, development, clinical activities. The PREP Act states that a such a drug or device.
testing, investigation or manufacturing ‘‘Covered Countermeasure’’ must be: A A security countermeasure also may
of a Covered Countermeasure; and any ‘‘qualified pandemic or epidemic be a Covered Countermeasure if it may
or all the parents, subsidiaries, affiliates, product,’’ or a ‘‘security reasonably be determined to qualify for
successors, and assigns of a countermeasure,’’ as described approval or licensing within 10 years
manufacturer. immediately below; or a drug, biological after the Department’s determination
A distributor means a person or entity product or device authorized for that procurement of the countermeasure
engaged in the distribution of drugs, emergency use in accordance with is appropriate.
biologics, or devices, including but not Sections 564, 564A, or 564B of the Section VI lists Zika virus vaccines
limited to: Manufacturers; repackers; FD&C Act. that are Covered Countermeasures. The
common carriers; contract carriers; air A qualified pandemic or epidemic Secretary is amending the list of
carriers; own-label distributors; private- product means a drug or device, as vaccines by: Deleting ‘‘whole particle’’
label distributors; jobbers; brokers; defined in the FD&C Act or a biological from the first category of vaccines listed
warehouses and wholesale drug product, as defined in the PHS Act that to clarify that the category includes all
warehouses; independent wholesale is: (i) Manufactured, used, designed, inactivated virus vaccines; adding ‘‘and/
drug traders; and retail pharmacies. developed, modified, licensed or or polysaccharide and/or conjugate’’ to
A program planner means a state or procured to diagnose, mitigate, prevent, the sixth category of vaccines listed to
daltland on DSKBBV9HB2PROD with NOTICES
local government, including an Indian treat, or cure a pandemic or epidemic or include these types of peptide vaccine;
tribe; a person employed by the state or limit the harm such a pandemic or and adding a new ninth category,
local government; or other person who epidemic might otherwise cause; (ii) ‘‘recombinant vaccines’’ to include any
supervises or administers a program manufactured, used, designed, Zika virus vaccines using this type of
with respect to the administration, developed, modified, licensed, or technology.
dispensing, distribution, provision, or procured to diagnose, mitigate, prevent, Section VI also refers to the statutory
use of a Covered Countermeasure, treat, or cure a serious or life- definitions of Covered Countermeasures
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![Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38707
Program (CICP) to provide benefits to Place: Bethesda Marriott, 5151 Pooks Hill (EB) analog, and further chelated via
certain individuals or estates of Rd., Bethesda, MD 20814. DOTA to therapeutic radionuclide177Lu,
individuals who sustain a covered Contact Person: Alicja L. Markowska, a beta emitter. The EB analog reversibly
Ph.D., DSC, National Institute on Aging,
serious physical injury as the direct National Institutes of Health, Gateway
binds to circulating serum albumin and
result of the administration or use of the Building 2C212, 7201 Wisconsin Avenue, improves the pharmacokinetics of SST
Covered Countermeasures, and benefits Bethesda, MD 20892, 301–496–9666, peptide derivatives and reduce peptide-
to certain survivors of individuals who markowsa@nia.nih.gov. receptor radionuclide therapy toxicity.
die as a direct result of the (Catalogue of Federal Domestic Assistance EB analog conjugated to octreotate (EB–
administration or use of the Covered Program Nos. 93.866, Aging Research, DOTATATE) has been shown by the
Countermeasures. The causal National Institutes of Health, HHS) inventors to provide reversible albumin
connection between the countermeasure Dated: August 1, 2018. binding in vivo and extended half-life in
and the serious physical injury must be Melanie J. Pantoja, circulation. When EB–TATE is slowly
supported by compelling, reliable, valid, released into the tumor
Program Analyst, Office of Federal Advisory
medical and scientific evidence in order Committee Policy. microenvironment, tumor uptake and
for the individual to be considered for internalization into SSTR positive
[FR Doc. 2018–16787 Filed 8–6–18; 8:45 am]
compensation. The CICP is tumors resulted in delivery of
BILLING CODE 4140–01–P
administered by the Health Resources radioactive particles and tumor cell
and Services Administration, within the killing. EB–TATE displayed
Department of Health and Human DEPARTMENT OF HEALTH AND significantly more favorable
Services. Information about the CICP is HUMAN SERVICES pharmacokinetics than TATE alone by
available at the toll-free number 1–855– achieving higher tumor to non-tumor
266–2427 or http://www.hrsa.gov/cicp/. National Institutes of Health penetration as evidenced by positron
emission tomography.
XV. Amendments
Government-Owned Inventions; Potential Commercial Applications:
42 U.S.C. 247d–6d(b)(4) Availability for Licensing • Cancer therapeutics
Amendments to this Declaration will AGENCY: National Institutes of Health, • Higher stability/Lower toxicity
be published in the Federal Register. HHS. Development Stage:
Authority: 42 U.S.C. 247d–6d. ACTION: Notice. • Early stage
Dated: August 1, 2018. SUMMARY: The inventions listed below Inventors: Xiaoyuan Chen and Orit
Alex M. Azar II are owned by an agency of the U.S. Jacobson Weiss (both of NIBIB).
Secretary, Department of Health and Human Government and are available for Intellectual Property: HHS Reference
Services. licensing in the U.S. No. E–150–2016–1; International Patent
Application PCT/US2017/031696.
[FR Doc. 2018–16856 Filed 8–6–18; 8:45 am] FOR FURTHER INFORMATION CONTACT:
Licensing Contact: Michael
BILLING CODE P Licensing information may be obtained
Shmilovich, Esq, CLP; 301–435–5019;
by emailing the indicated licensing
shmilovm@mail.nih.gov.
contact at the National Heart, Lung, and
DEPARTMENT OF HEALTH AND Blood, Office of Technology Transfer Dated: July 20, 2018.
HUMAN SERVICES and Development Office of Technology Michael Shmilovich,
Transfer, 31 Center Drive Room 4A29, Senior Licensing and Patenting Manager,
National Institutes of Health MSC2479, Bethesda, MD 20892–2479; National Heart, Lung, and Blood Institute,
telephone: 301–402–5579. A signed Office of Technology Transfer and
National Institute on Aging; Notice of Development.
Closed Meeting Confidential Disclosure Agreement may
be required to receive any unpublished [FR Doc. 2018–16839 Filed 8–6–18; 8:45 am]
Pursuant to section 10(d) of the information. BILLING CODE 4140–01–P
Federal Advisory Committee Act, as SUPPLEMENTARY INFORMATION: This
amended, notice is hereby given of the notice is in accordance with 35 U.S.C.
following meeting. 209 and 37 CFR part 404 to achieve DEPARTMENT OF HEALTH AND
The meeting will be closed to the commercialization of results of HUMAN SERVICES
public in accordance with the federally-funded research and National Institutes of Health
provisions set forth in sections development.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Technology description follows. Prospective Grant of Exclusive Patent
as amended. The grant applications and Neuroendocrine Tumor Evans Blue License: Treatment of Type I Diabetes
the discussions could disclose Containing Radiotherapeutics and its Comorbidities
confidential trade secrets or commercial
property such as patentable material, The invention pertains to a AGENCY: National Institutes of Health,
and personal information concerning radiotherapeutic against neuroendocrine HHS.
individuals associated with the grant tumors that express somatostatin ACTION: Notice.
applications, the disclosure of which receptor. Radionuclide therapies
would constitute a clearly unwarranted directed against tumors that express SUMMARY: The National Heart, Lung and
invasion of personal privacy. somatostatin receptors (SSTRs) have Blood Institute (NHLBI), National
daltland on DSKBBV9HB2PROD with NOTICES
proven effective for the treatment of Institutes of Health, Department of
Name of Committee: National Institute on advanced, low- to intermediate-grade Health and Human Services, is
Aging Initial Review Group; Clinical Aging
Review Committee NIA–C.
neuroendocrine tumors. The subject contemplating the grant of an exclusive
Date: September 27–28, 2018. radiotherapeutic covered by the subject patent License to Inversago Pharma,
Time: 3:00 p.m. to 2:00 p.m. patent estate includes a somatostatin Inc., located in Montreal, Quebec,
Agenda: To review and evaluate grant (SST) peptide derivative like octreotate Canada, to practice the inventions
applications. (TATE), conjugated to an Evans Blue embodied in the patent applications
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Document Created: 2018-11-06 10:38:30
Document Modified: 2018-11-06 10:38:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The declaration is effective as of August 1, 2018. | |
| Contact | Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201; Telephone: 202-205-2882. | |
| FR Citation | 83 FR 38701 |
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