82 FR 10365 - 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 82, Issue 27 (February 10, 2017)
Office of the Secretary
Federal Register Volume 82, Issue 27 (February 10, 2017)
| Page Range | 10365-10370 | |
| FR Document | 2017-02778 |
[Federal Register Volume 82, Number 27 (Friday, February 10, 2017)] [Notices] [Pages 10365-10370] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-02778] ----------------------------------------------------------------------- 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
![Federal Register / Vol. 82, No. 27 / Friday, February 10, 2017 / Notices 10365
evaluation will be conducted in 39 sexual activity, and reducing or comprehensive approach to teen
schools nationwide. The data collected preventing sexual risk behaviors and pregnancy prevention.
from this instrument will provide a STDs and intermediate outcomes, such Likely Respondents: The follow-up
detailed understanding of program as improving exposure, knowledge and surveys will be administered to study
impacts. Clearance is requested for three attitudes between treatment (program) participants, who will primarily be in
years. and control youth.
Need and Proposed Use of the The findings from these analyses of 10th–12th grade at the time of the
Information: The follow-up survey data program impacts will be of interest to follow-up surveys.
will be used to determine program the general public, to policymakers, and Burden Statement: The total annual
effectiveness by comparing sexual to schools and other organizations burden hours estimated for this ICR are
behavior outcomes, such as postponing interested in supporting a summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total
Form name responses per
respondents response burden hours
respondent (in hours)
Follow up survey (9 months post baseline) ..................................................... 819 1 30/60 409.5
Follow up survey (15 months post baseline) ................................................... 774 1 30/60 387
Total .......................................................................................................... 1593 ........................ ........................ 796.5
OS specifically requests comments on Services, 200 Independence Avenue Drug & Cosmetic (FD&C) Act to provide
(1) the necessity and utility of the SW., Washington, DC 20201; Telephone: new authorities for the emergency use of
proposed information collection for the 202–205–2882. approved products in emergencies and
proper performance of the agency’s SUPPLEMENTARY INFORMATION: The products held for emergency use.
functions, (2) the accuracy of the Public Readiness and Emergency PAHPRA accordingly amended the
estimated burden, (3) ways to enhance Preparedness Act (PREP Act) authorizes definitions of ‘‘Covered
the quality, utility, and clarity of the the Secretary of Health and Human Countermeasures’’ and ‘‘qualified
information to be collected, and (4) the Services (the Secretary) to issue a pandemic and epidemic products’’ in
use of automated collection techniques Declaration to provide liability Section 319F–3 of the Public Health
or other forms of information immunity to certain individuals and Service Act (PREP Act provisions), so
technology to minimize the information entities (Covered Persons) against any that products made available under
collection burden. claim of loss caused by, arising out of, these new FD&C Act authorities could
relating to, or resulting from the be covered under PREP Act
Terry S. Clark,
administration or use of medical Declarations. PAHPRA also extended
Asst Information Collection Clearance
countermeasures (Covered the definition of qualified pandemic and
Officer.
Countermeasures), except for claims epidemic products that may be covered
[FR Doc. 2017–02794 Filed 2–9–17; 8:45 am]
that meet the PREP Act’s definition of under a PREP Act Declaration to include
BILLING CODE 4168–11–P
willful misconduct. The Secretary may, products or technologies intended to
through publication in the Federal enhance the use or effect of a drug,
Register, amend any portion of a biological product, or device used
DEPARTMENT OF HEALTH AND
Declaration. Using this authority, the against the pandemic or epidemic or
HUMAN SERVICES
Acting Secretary is issuing a Declaration against adverse events from these
Office of the Secretary to provide liability immunity to Covered products.
Persons for activities related to the Zika virus is a mosquito-borne
Declaration Under the Public Covered Countermeasures, Zika Virus flavivirus that usually causes mild
Readiness and Emergency vaccines as listed in Section VI of the symptoms, but has been determined to
Preparedness Act for Zika Virus Declaration, consistent with the terms of cause microcephaly and other severe
Vaccines this Declaration. brain abnormalities in fetuses and
The PREP Act was enacted on infants born to women infected with
ACTION: Notice. December 30, 2005, as Public Law 109– Zika virus before birth. Zika virus has
148, Division C, Section 2. It amended also been associated with other adverse
SUMMARY: The Acting Secretary is pregnancy outcomes, including
issuing a Declaration pursuant to the the Public Health Service (PHS) Act,
adding Section 319F–3, which miscarriage, stillbirth, and congenital
Public Health Service Act to provide Zika syndrome, and with Guillain-Barre
liability immunity protection for addresses liability immunity, and
Section 319F–4, which creates a Syndrome. Beginning in 2015, Brazil
activities related to Zika Virus vaccines has experienced the largest outbreak of
compensation program. These sections
consistent with the terms of the disease caused by Zika infection since
are codified in the U.S. Code as 42
Declaration. its discovery in Uganda in 1947. On
U.S.C. 247d–6d and 42 U.S.C. 247d–6e,
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DATES: The Declaration is effective as of respectively. February 1, 2016, the World Health
August 1, 2016. The Pandemic and All-Hazards Organization (WHO) determined that
FOR FURTHER INFORMATION CONTACT: Preparedness Reauthorization Act microcephaly cases and other
George Korch, Ph.D., Acting Assistant (PAHPRA), Public Law 113–5, was neurologic disorders reported in Brazil
Secretary for Preparedness and enacted on March 13, 2013. Among constituted a Public Health Emergency
Response, Office of the Secretary, other things, PAHPRA added sections of International Concern (PHEIC) in
Department of Health and Human 564A and 564B to the Federal Food, accordance with the International
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![10366 Federal Register / Vol. 82, No. 27 / Friday, February 10, 2017 / Notices
Health Regulations (IHR). Since 2015, the design, development, clinical testing affiliates, successors, and assigns of a
Zika virus has been detected in nations or investigation, manufacture, labeling, manufacturer.
throughout the world. In the United distribution, formulation, packaging, A distributor means a person or entity
States, traveler-associated cases have marketing, promotion, sale, purchase, engaged in the distribution of drugs,
been identified in all of the states, and donation, dispensing, prescribing, biologics, or devices, including but not
local transmission of Zika virus is administration, licensing, and use of the limited to: Manufacturers; repackers;
occurring in Puerto Rico; American countermeasure. In Section II, the common carriers; contract carriers; air
Samoa; areas of Miami, Florida; and Acting Secretary states that he has carriers; own-label distributors; private-
Texas. On August 12, 2016, the considered these factors. label distributors; jobbers; brokers;
Secretary determined that a public warehouses and wholesale drug
Section III, Recommended Activities warehouses; independent wholesale
health emergency of national
significance exists within the The Secretary must recommend the drug traders; and retail pharmacies.
Commonwealth of Puerto Rico relating activities for which the PREP Act’s A program planner means a state or
to pregnant women and children born to liability immunity is in effect. These local government, including an Indian
pregnant women with Zika. The activities may include, under conditions tribe; a person employed by the state or
Secretary, Sylvia M. Burwell, renewed as the Secretary may specify, the local government; or other person who
that determination on November 4, manufacture, testing, development, supervises or administers a program
2016, and Acting Secretary Norris distribution, administration, or use of with respect to the administration,
Cochran renewed that determination on one or more Covered Countermeasures dispensing, distribution, provision, or
January 31, 2017. On November 18, (Recommended Activities). In Section use of a Covered Countermeasure,
2016, the WHO Director-General III, the Acting Secretary recommends including a person who establishes
declared the end of the PHEIC based on activities for which the immunity is in requirements, provides policy guidance,
recommendations of the WHO effect. or supplies technical or scientific advice
Emergency Committee that Zika virus or assistance or provides a facility to
Section IV, Liability Immunity
and associated consequences no longer administer or use a Covered
represent a PHEIC as defined under the The Secretary must also state that Countermeasure in accordance with the
IHR, but remain a significant enduring liability protections available under the Secretary’s Declaration. Under this
public health challenge requiring PREP Act are in effect with respect to definition, a private sector employer or
intense action that should be escalated the Recommended Activities. These community group or other ‘‘person’’ can
into a sustained program of work with liability protections provide that, be a program planner when it carries out
dedicated resources to address the long- ‘‘[s]ubject to other provisions of [the the described activities.
term nature of the disease and its PREP Act], a covered person shall be A qualified person means a licensed
associated consequences. immune from suit and liability under health professional or other individual
Unless otherwise noted, all statutory federal and state law with respect to all authorized to prescribe, administer, or
citations below are to the U.S. Code. claims for loss caused by, arising out of, dispense Covered Countermeasures
relating to, or resulting from the under the law of the state in which the
Section I, Determination of Public administration to or use by an Covered Countermeasure was
Health Emergency or Credible Risk of individual of a covered countermeasure prescribed, administered, or dispensed;
Future Public Health Emergency if a Declaration has been issued with or a person within a category of persons
Before issuing a Declaration under the respect to such countermeasure.’’ In identified as qualified in the Secretary’s
PREP Act, the Secretary is required to Section IV, the Acting Secretary states Declaration. Under this definition, the
determine that a disease or other health that liability protections are in effect Secretary can describe in the
condition or threat to health constitutes with respect to the Recommended Declaration other qualified persons,
a public health emergency or that there Activities. such as volunteers, who are Covered
is a credible risk that the disease, Persons. Section V describes other
condition, or threat may constitute such Section V, Covered Persons
qualified persons covered by this
an emergency. This determination is The PREP Act’s liability immunity Declaration.
separate and apart from a Declaration applies to ‘‘Covered Persons’’ with The PREP Act also defines the word
issued by the Secretary under Section respect to administration or use of a ‘‘person’’ as used in the Act: A person
319 of the PHS Act that a disease or Covered Countermeasure. The term includes an individual, partnership,
disorder presents a public health ‘‘Covered Persons’’ has a specific corporation, association, entity, or
emergency or that a public health meaning and is defined in the PREP Act public or private corporation, including
emergency, including significant to include manufacturers, distributors, a federal, state, or local government
outbreaks of infectious diseases or program planners, and qualified agency or department.
bioterrorist attacks, otherwise exists, or persons, and their officials, agents, and Section V describes Covered Persons
other Declarations or determinations employees, and the United States. The under the Declaration, including
made under other authorities of the PREP Act further defines the terms Qualified Persons. We have revised the
Secretary. Accordingly, in Section I, the ‘‘manufacturer,’’ ‘‘distributor,’’ last category to remove the specific
Acting Secretary determines that there ‘‘program planner,’’ and ‘‘qualified references to emergency use instructions
is a credible risk that the spread of Zika person’’ as described below. and orders issued under Section 564A
virus and the resulting disease may A manufacturer includes a contractor of the FD&C Act, to clarify that any
or subcontractor of a manufacturer; a
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constitute a public health emergency. activities in accordance with that
supplier or licenser of any product, section are covered.
Section II, Factors Considered intellectual property, service, research
In deciding whether and under what tool or component or other article used Section VI, Covered Countermeasures
circumstances to issue a Declaration in the design, development, clinical As noted above, Section III describes
with respect to a Covered testing, investigation or manufacturing the Secretary’s Recommended Activities
Countermeasure, the Secretary must of a Covered Countermeasure; and any for which liability immunity is in effect.
consider the desirability of encouraging or all of the parents, subsidiaries, This section identifies the Covered
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![10370 Federal Register / Vol. 82, No. 27 / Friday, February 10, 2017 / Notices
regard to whether the countermeasure is Covered Countermeasures obtained and personal information concerning
used by or administered to this for the Strategic Nations Stockpile (SNS) individuals associated with the grant
population; liability immunity is during the effective period of this applications, the disclosure of which
afforded to program planners and Declaration are covered through the date would constitute a clearly unwarranted
qualified persons when the of administration or use pursuant to a invasion of personal privacy.
countermeasure is used by or distribution or release from the SNS. Name of Committee: National Heart, Lung,
administered to this population, or the and Blood Institute Special Emphasis Panel;
XIV. Countermeasures Injury
program planner or qualified person NHLBI CLTR SEP Review.
reasonably could have believed the Compensation Program
Date: March 3, 2017.
recipient was in this population. 42 U.S.C 247d–6e Time: 8:00 a.m. to 3:00 p.m.
XI. Geographic Area The PREP Act authorizes the Agenda: To review and evaluate grant
Countermeasures Injury Compensation applications.
42 U.S.C. 247d–6d(a)(4), 247d– Program (CICP) to provide benefits to Place: Courtyard by Marriott, 5520
6d(b)(2)(D) certain individuals or estates of Wisconsin Avenue, Chevy Chase, MD 20815.
Liability immunity is afforded for the individuals who sustain a covered Contact Person: Chang Sook Kim, Ph.D.,
administration or use of a Covered serious physical injury as the direct Scientific Review Officer, Office of Scientific
Countermeasure without geographic result of the administration or use of the Review/DERA, National Heart, Lung, and
limitation. Covered Countermeasures, and benefits Blood Institute, 6701 Rockledge Drive, Room
Liability immunity is afforded to to certain survivors of individuals who 7188, Bethesda, MD 20892–7924, 301–827–
manufacturers and distributors without die as a direct result of the 7940, carolko@mail.nih.gov.
regard to whether the countermeasure is administration or use of the Covered Name of Committee: National Heart, Lung,
used by or administered in any Countermeasures. The causal and Blood Institute Special Emphasis Panel;
designated geographic area; liability connection between the countermeasure Career Development Program to Promote
immunity is afforded to program and the serious physical injury must be Diversity in Health Research.
planners and qualified persons when supported by compelling, reliable, valid, Date: March 3, 2017.
the countermeasure is used by or medical and scientific evidence in order Time: 8:30 a.m. to 5:00 p.m.
administered in any designated for the individual to be considered for Agenda: To review and evaluate grant
geographic area, or the program planner compensation. The CICP is applications.
or qualified person reasonably could administered by the Health Resources Place: Residence Inn Bethesda, 7335
have believed the recipient was in that Wisconsin Avenue, Bethesda, MD 20814.
and Services Administration, within the
geographic area. Contact Person: YingYing Li-Smerin, MD,
Department of Health and Human
Ph.D., Scientific Review Officer, Office of
XII. Effective Time Period Services. Information about the CICP is
Scientific Review/DERA, National Heart,
available at the toll-free number 1–855–
42 U.S.C. 247d–6d(b)(2)(B) Lung, and Blood Institute, 6701 Rockledge
266–2427 or http://www.hrsa.gov/cicp/. Drive, Room 7184, Bethesda, MD 20892–
Liability immunity for Covered
XV. Amendments 7924, 301–827–7942, lismerin@nhlbi.nih.gov.
Countermeasures through means of
distribution, as identified in Section 42 U.S.C. 247d–6d(b)(4) Name of Committee: National Heart, Lung,
VII(a) of this Declaration, other than in and Blood Institute Special Emphasis Panel;
Amendments to this Declaration will Cystic Fibrosis Transmembrane Conductance
accordance with the public health and be published in the Federal Register. Regulator—Directed Therapeutics.
medical response of the Authority
Authority: 42 U.S.C. 247d–6d. Date: March 3, 2017.
Having Jurisdiction and extends for 24
Time: 2:00 p.m. to 5:00 p.m.
months from the effective date of this Dated: February 6, 2017.
Agenda: To review and evaluate grant
Declaration. Norris Cochran,
applications.
Liability immunity for Covered Acting Secretary of Health and Human Place: National Institutes of Health,
Countermeasures administered and Services.
Rockledge Two, 7185, 6701 Rockledge Drive,
used in accordance with the public [FR Doc. 2017–02778 Filed 2–9–17; 8:45 am] Bethesda, MD 20892 (Telephone Conference
health and medical response of the BILLING CODE 4150–28–P Call).
Authority Having Jurisdiction begins
Contact Person: Kristen Page, Ph.D.,
with a Declaration and lasts through (1) Scientific Review Officer, Office of Scientific
the final day the emergency Declaration DEPARTMENT OF HEALTH AND Review/DERA, National Heart, Lung, and
is in effect, or (2) 24 months from the HUMAN SERVICES Blood Institute, National Institutes of Health,
effective date of this Declaration, 6701 Rockledge Drive, Room 7185, Bethesda,
whichever occurs first. National Institutes of Health MD 20892, 301–827–7953, kristen.page@
XIII. Additional Time Period of nih.gov.
National Heart, Lung, and Blood
Coverage Institute; Notice of Closed Meetings (Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
42 U.S.C. 247d–6d(b)(3)(B) and (C) Pursuant to section 10(d) of the Sleep Disorders Research; 93.837, Heart and
I have determined that an additional Federal Advisory Committee Act, as Vascular Diseases Research; 93.838, Lung
12 months of liability protection is amended (5 U.S.C. App.), notice is Diseases Research; 93.839, Blood Diseases
reasonable to allow for the hereby given of the following meetings. and Resources Research, National Institutes
manufacturer(s) to arrange for The meetings will be closed to the
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of Health, HHS)
disposition of the Covered public in accordance with the
Dated: February 6, 2017.
Countermeasure, including return of the provisions set forth in sections
Covered Countermeasures to the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Michelle Trout,
manufacturer, and for Covered Persons as amended. The grant applications and Program Analyst, Office of Federal Advisory
to take such other actions as are the discussions could disclose Committee Policy.
appropriate to limit the administration confidential trade secrets or commercial [FR Doc. 2017–02723 Filed 2–9–17; 8:45 am]
or use of the Covered Countermeasures. property such as patentable material, BILLING CODE 4140–01–P
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Document Created: 2017-02-11 18:15:30
Document Modified: 2017-02-11 18:15:30
| 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, 2016. | |
| 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. | |
| FR Citation | 82 FR 10365 |
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