r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE wiki — defined terms

“addict” applies throughout its chapter

The term “addict” means any person who habitually uses any habit-forming narcotic drugs so as to endanger the public morals, health, safety, or welfare, or who is or has been so far addicted to the use of such habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction;

“dental diseases and conditions” applies throughout its chapter

The term “dental diseases and conditions” means diseases and conditions affecting teeth and their supporting structures, and other related diseases of the mouth; and;

“drug dependent person” applies throughout its chapter

The term “drug dependent person” means a person who is using a controlled substance (as defined in section 802 of title 21 ) and who is in a state of psychic or physical dependence, or both, arising from the use of that substance on a continuous basis. Drug dependence is characterized by behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in order to experience its psychic effects or to avoid the discomfort caused by its absence.

“executive department” applies throughout its chapter

The term “executive department” means any executive department, agency, or independent establishment of the United States or any corporation wholly owned by the United States; (f) Except as provided in sections 246(g)(4)(B), 1 247c(c)(1), 1 254d(h)(3), 1 263c(5), 1 264(d), 292a(9), 1 300a(c), 300f(13), and 300n(1) 1 of this title,

“habit-forming narcotic drug” applies throughout its chapter

The term “habit-forming narcotic drug” or “narcotic” means opium and coca leaves and the several alkaloids derived therefrom, the best known of these alkaloids being morphia, heroin, and codeine, obtained from opium, and cocaine derived from the coca plant; all compounds, salts, preparations, or other derivatives obtained either from the raw material or from the various alkaloids; Indian hemp and its various derivatives, compounds, and preparations, and peyote in its various forms; isonipecaine and its derivatives, compounds, salts, and preparations; opiates (as defined in section 4731(g) 1 of title 26);

“heart diseases” applies throughout its chapter

The term “heart diseases” means diseases of the heart and circulation;

“narcotic” applies throughout its chapter

The term “habit-forming narcotic drug” or “narcotic” means opium and coca leaves and the several alkaloids derived therefrom, the best known of these alkaloids being morphia, heroin, and codeine, obtained from opium, and cocaine derived from the coca plant; all compounds, salts, preparations, or other derivatives obtained either from the raw material or from the various alkaloids; Indian hemp and its various derivatives, compounds, and preparations, and peyote in its various forms; isonipecaine and its derivatives, compounds, salts, and preparations; opiates (as defined in section 4731(g) 1 of title 26);

“possession” applies throughout its chapter

The term “possession” includes, among other possessions, Puerto Rico and the Virgin Islands; (h) Repealed. Pub. L. 97–35, title IX, § 986(a) , Aug. 13, 1981 , 95 Stat. 603 .;

“psychiatric disorders” applies throughout its chapter

The term “psychiatric disorders” includes diseases of the nervous system which affect mental health;

“Secretary” applies throughout its chapter

the term “Secretary” means the Secretary of Health and Human Services. (d) The term “regulations”, except when otherwise specified, means rules and regulations made by the Surgeon General with the approval of the Secretary;

“Service” applies throughout its chapter

The term “Service” means the Public Health Service;

“State” applies throughout its chapter

the term “State” includes, in addition to the several States, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.;

“State mental health authority” applies throughout its chapter

The term “State mental health authority” means the State health authority, except that, in the case of any State in which there is a single State agency, other than the State health authority, charged with responsibility for administering the mental health program of the State, it means such other State agency;

“Surgeon General” applies throughout its chapter

The term “Surgeon General” means the Surgeon General of the Public Health Service; (c) Unless the context otherwise requires,

“uniformed service” applies throughout its chapter

The term “uniformed service” means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health Service, or National Oceanic and Atmospheric Administration.;

“vessel” applies throughout its chapter

The term “vessel” includes every description of watercraft or other artificial contrivance used, or capable of being used, as a means of transportation on water, exclusive of aircraft and amphibious contrivances;

“urgent or emergency public health care need” applies in that section

the term “urgent or emergency public health care need” means a health care need, as determined by the Secretary, arising as the result of— (A) a national emergency declared by the President under the National Emergencies Act ( 50 U.S.C. 1601 et seq.); (B) an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act ( 42 U.S.C. 5121 et seq.); (C) a public health emergency declared by the Secretary under section 247d of this title ; or (D) any emergency that, in the judgment of the Secretary, is appropriate for the deployment of members of the Corps.

“accrued annual leave” applies in that section

the term “accrued annual leave” means the annual leave accruing to an officer during one leave year.

“accumulated annual leave” applies in that section

the term “accumulated annual leave” means unused accrued annual leave carried forward from one leave year into a succeeding leave year, and

“covered countermeasure” applies in that section

The term “covered countermeasure” or “covered countermeasure against smallpox”, means a substance that is— (i) (I) used to prevent or treat smallpox (including the vaccinia or another vaccine); or (II) used to control or treat the adverse effects of vaccinia inoculation or of administration of another covered countermeasure; and (ii) specified in a declaration under paragraph (2).

“covered countermeasure against smallpox” applies in that section

The term “covered countermeasure” or “covered countermeasure against smallpox”, means a substance that is— (i) (I) used to prevent or treat smallpox (including the vaccinia or another vaccine); or (II) used to control or treat the adverse effects of vaccinia inoculation or of administration of another covered countermeasure; and (ii) specified in a declaration under paragraph (2).

“free clinic” applies in that section

the term “free clinic” means a health care facility operated by a nonprofit private entity meeting the following requirements: (i) The entity does not, in providing health services through the facility, accept reimbursement from any third-party payor (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program). (ii) The entity, in providing health services through the facility, either does not impose charges on the individuals to whom the services are provided, or imposes a charge according to the ability of the individual involved to pay the charge.

“managed care plan” applies in that section

the term “managed care plan” shall mean health maintenance organizations and similar entities that contract at-risk with payors for the provision of health services or plan enrollees and which contract with providers (such as entities described in subsection (g)(4)) for the delivery of such services to plan enrollees. (n) Report on risk exposure of covered entities (1) Not later than one year after December 26, 1995 , the Comptroller General of the United States shall submit to the Congress a report on the following: (A) The medical malpractice liability claims experience of entities that have been deemed to be employees for purposes of this section. (B) The risk exposure of such entities.

“qualifying health service” applies in that section

the term “qualifying health service” means any medical assistance required or authorized to be provided in the program under title XIX of the Social Security Act [ 42 U.S.C. 1396 et seq.], without regard to whether the medical assistance is included in the plan submitted under such program by the State in which the health care practitioner involved provides the medical assistance. References in the preceding sentence to such program shall as applicable be considered to be references to any successor to such program.

“health care professional” applies in that section

The term “health care professional” means an individual licensed, registered, or certified under Federal or State laws or regulations to provide health care services.;

“health care services” applies in that section

The term “health care services” means any services provided by a health care professional, or by any individual working under the supervision of a health care professional, that relate to— (A) the diagnosis, prevention, or treatment of any human disease or impairment; or (B) the assessment or care of the health of human beings. (e) Effective date (1) In general This section shall take effect 90 days after June 24, 2019 . (2) Application This section shall apply to a claim for harm only if the act or omission that caused such harm occurred on or after the effective date described in paragraph (1).

“fiscal agent” applies in that section

the term “fiscal agent” means a carrier described in section 1395u(f)(1) 1 of this title and includes, with respect to contracts under subsection (a)(1)(A), an Indian tribe or tribal organization acting under contract with the Secretary under the Indian Self-Determination Act ( Public Law 93–638 ) [ 25 U.S.C. 5321 et seq.].

“health care entity” applies in that section

The term “health care entity” includes an individual physician, a postgraduate physician training program, and a participant in a program of training in the health professions.;

“postgraduate physician training program” applies in that section

The term “postgraduate physician training program” includes a residency training program.

“automated external defibrillator device” applies in that section

The term “automated external defibrillator device” has the meaning given such term in section 238q of this title .;

“Federal building” applies in that section

The term “Federal building” includes a building or portion of a building leased or rented by a Federal agency, and includes buildings on military installations of the United States.

“automated external defibrillator device” applies in that section

The term “automated external defibrillator device” means a defibrillator device that— (i) is commercially distributed in accordance with the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.]; (ii) is capable of recognizing the presence or absence of ventricular fibrillation, and is capable of determining without intervention by the user of the device whether defibrillation should be performed; (iii) upon determining that defibrillation should be performed, is able to deliver an electrical shock to an individual; and (iv) in the case of a defibrillator device that may be operated in either an automated or a manual mode, is set to operate in the automated mode. (B);

“economic loss” applies in that section

The term “economic loss” means any pecuniary loss resulting from harm (including the loss of earnings or other benefits related to employment, medical expense loss, replacement services loss, loss due to death, burial costs, and loss of business or employment opportunities) to the extent recovery for such loss is allowed under applicable State law.;

“harm” applies in that section

The term “harm” includes physical, nonphysical, economic, and noneconomic losses.;

“noneconomic losses” applies in that section

The term “noneconomic losses” means losses for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of consortium (other than loss of domestic service), hedonic damages, injury to reputation and all other nonpecuniary losses of any kind or nature.

“perceived medical emergency” applies in that section

the term “perceived medical emergency” means circumstances in which the behavior of an individual leads a reasonable person to believe that the individual is experiencing a life-threatening medical condition that requires an immediate medical response regarding the heart or other cardiopulmonary functioning of the individual. (2) Other definitions For purposes of this section:;

“covered countermeasure” applies throughout its part

The term “covered countermeasure” means a covered countermeasure as specified in a Declaration made pursuant to section 233(p) of this title . (2) Covered individual

“covered individual” applies throughout its part

The term “covered individual” means an individual— (A) who is a health care worker, law enforcement officer, firefighter, security personnel, emergency medical personnel, other public safety personnel, or support personnel for such occupational specialities 1 ; (B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human Services smallpox emergency response plan (as defined in paragraph (7)) approved by the Secretary; (C) who has volunteered and been selected to be a member of a smallpox emergency response plan described in subparagraph (B) prior to the time at which the Secretary publicly announces that an active case of smallpox has been …

“covered injury” applies throughout its part

The term “covered injury” means an injury, disability, illness, condition, or death (other than a minor injury such as minor scarring or minor local reaction) determined, pursuant to the procedures established under section 239a of this title , to have been sustained by an individual as the direct result of— (A) administration to the individual of a covered countermeasure during the effective period of the Declaration; or (B) accidental vaccinia inoculation of the individual in circumstances in which— (i) the vaccinia is contracted during the effective period of the Declaration or within 30 days after the end of such period; (ii) smallpox vaccine has not been administered to the individual; …

“Declaration” applies throughout its part

The term “Declaration” means the Declaration Regarding Administration of Smallpox Countermeasures issued by the Secretary on January 24, 2003 , and published in the Federal Register on January 28, 2003 . (5) Effective period of the Declaration

“effective period of the Declaration” applies throughout its part

The term “effective period of the Declaration” means the effective period specified in the Declaration, unless extended by the Secretary. (6) Eligible individual

“eligible individual” applies throughout its part

The term “eligible individual” means an individual who is (as determined in accordance with section 239a of this title )— (A) a covered individual who sustains a covered injury in the manner described in paragraph (3)(A); or (B) an individual who sustains a covered injury in the manner described in paragraph (3)(B). (7) Smallpox emergency response plan

“plan” applies throughout its part

The term “smallpox emergency response plan” or “plan” means a response plan detailing actions to be taken in preparation for a possible smallpox-related emergency during the period prior to the identification of an active case of smallpox either within or outside the United States.

“smallpox emergency response plan” applies throughout its part

The term “smallpox emergency response plan” or “plan” means a response plan detailing actions to be taken in preparation for a possible smallpox-related emergency during the period prior to the identification of an active case of smallpox either within or outside the United States.

“employment income” applies in that section

the term “employment income” includes income from self-employment. (c) Limitations (1) Benefits secondary to other coverage (A) In general Any compensation under subsection (a) shall be secondary to the obligation of the United States or any third party (including any State or local governmental entity, private insurance carrier, or employer), under any other law or contractual agreement, to pay compensation for loss of employment income or to provide disability or retirement benefits.

“identifiable, sensitive information” applies in that section

the term “identifiable, sensitive information” means information that is about an individual and that is gathered or used during the course of research described in paragraph (1)(A) and— (A) through which an individual is identified; or (B) for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.

“aging research” applies in that section

The term “aging research” means research on the aging process and on the diagnosis and treatment of diseases, disorders, and complications related to aging, including menopause. Such research includes research on such treatments, and on medical devices and other medical interventions regarding such diseases, disorders, and complications, that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals.

“Secretary” applies in that section

The term “Secretary” means the Secretary of Health and Human Services. (3) Task Force

“Task Force” applies in that section

The term “Task Force” means the Task Force on Aging Research established under section 242q(a) of this title .

“cardiomyopathy” applies in that section

The term “cardiomyopathy” means a heart disease that affects the heart’s muscle (myocardium)— (A) the symptoms of which may vary from case to case, including— (i) cases in which no symptoms are present (asymptomatic); and (ii) cases in which there are symptoms of a progressive condition that may result from an impaired ability of the heart to pump blood, such as fatigue, irregular heartbeats (arrhythmia), heart failure, and, potentially, sudden cardiac death; and (B) the recognized types of which include dilated, hypertrophic, restrictive, arrhythmogenic right ventricular dysplasia, and left ventricular non-compaction.;

“Director” applies in that section

The term “Director” means the Director of the Centers for Disease Control and Prevention.;

“early childhood education program” applies in that section

The terms “early childhood education program”, “elementary school”, and “secondary school” have the meanings given to those terms in section 7801 of title 20 .;

“elementary school” applies in that section

The terms “early childhood education program”, “elementary school”, and “secondary school” have the meanings given to those terms in section 7801 of title 20 .;

“school administrator” applies in that section

The term “school administrator” means a principal, director, manager, or other supervisor or leader within an elementary school, secondary school, State-based early childhood education program, or child care center.;

“school health professional” applies in that section

The term “school health professional” means a health professional serving at an elementary school, secondary school, State-based early childhood education program, or child care center.

“secondary school” applies in that section

The terms “early childhood education program”, “elementary school”, and “secondary school” have the meanings given to those terms in section 7801 of title 20 .;

“cardiomyopathy” applies in that section

the term “cardiomyopathy” has the meaning given to such term in section 244a of this title .

“cardiomyopathy” applies in that section

the term “cardiomyopathy” has the meaning given to such term in section 244a of this title .

“elementary school” applies in that section

The terms “elementary school”, “local educational agency”, and “secondary school” have the meanings given such terms in section 7801 of title 20 . (2) Qualified health care entity

“local educational agency” applies in that section

The terms “elementary school”, “local educational agency”, and “secondary school” have the meanings given such terms in section 7801 of title 20 . (2) Qualified health care entity

“qualified health care entity” applies in that section

The term “qualified health care entity” means a health care entity that— (A) is— (i) a public entity; or (ii) an organization that is described in section 501(c) of title 26 and exempt from taxation under section 501(a) of such title; (B) demonstrates an ability to develop, train, and implement a comprehensive program to promote student access to defibrillation in public elementary and secondary schools; and (C) is qualified in providing technical assistance in AED and CPR training.

“secondary school” applies in that section

The terms “elementary school”, “local educational agency”, and “secondary school” have the meanings given such terms in section 7801 of title 20 . (2) Qualified health care entity

“political subdivision” applies in that section

the term “political subdivision” includes Indian tribes. (l) Funding (1) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2005. (2) Allocation for other programs Of the amounts appropriated under paragraph (1) for any fiscal year, the Secretary may reserve not more than 20 percent for carrying out programs regarding the activities described in subsection (a) in addition to the program of grants established in such subsection.

“Indian tribe” applies in that section

the terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25 ;

“pregnancy-associated death” applies in that section

the term “pregnancy-associated death” means a death of a woman, by any cause, that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and;

“pregnancy-related death” applies in that section

the term “pregnancy-related death” means a death of a woman that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy— (A) from any cause related to, or aggravated by, the pregnancy or its management; and (B) not from accidental or incidental causes. (g) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $100,000,000 for each of fiscal years 2026 through 2030.

“tribal organization” applies in that section

the terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25 ;

“Indian tribe” applies in that section

the term “Indian tribe” means an Indian tribe or tribal organization as defined in section 5304(b) and section 5304(c) 3 of title 25. (f) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.

“Indian tribe” applies in that section

the term “Indian tribe” has the meaning given that term in section 5304 of title 25 . (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for each of the fiscal years 2026 through 2030.

“political subdivision” applies in that section

the term “political subdivision” means the local political jurisdiction immediately below the level of State government, including counties, parishes, and boroughs. If State law recognizes an entity of general government that functions in lieu of, and is not within, a county, parish, or borough, the Secretary may recognize an area under the jurisdiction of such other entities of general government as a political subdivision for purposes of this section. (f) Authorization of appropriations (1) In general For the purpose of carrying out this section, there are authorized to be appropriated $100,000,000 for each of fiscal years 2019 through 2023.

“units of local government” applies in that section

the term “units of local government” includes Indian tribes. (l) Authorization of appropriations (1) In general For the purpose of carrying out this section, there are authorized to be appropriated $20,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2004. (2) Allocation for technical assistance Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall reserve not more than 20 percent for carrying out subsection (j)(1).

“Indian tribe” applies in that section

the terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25 ; and;

“State” applies in that section

the term “State” includes, in addition to the entities listed in the definition of such term in section 201 of this title , the Freely Associated States. (8) Sunset This subsection shall terminate on December 31, 2026 .

“tribal organization” applies in that section

the terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25 ; and;

“individually identifiable health information” applies in that section

the term “individually identifiable health information” has the meaning given such term in section 1320d(6) of this title ;

“proprietary financial information” applies in that section

the term “proprietary financial information” means data that would disclose the terms of a specific contract between an individual health care provider or facility and a specific group health plan, managed care entity (as defined in section 1396u–2(a)(1)(B) of this title ) or other managed care organization, or health insurance issuer offering group or individual health insurance coverage; and;

“State All Payer Claims Database” applies in that section

the term “State All Payer Claims Database” means, with respect to a State, a database that may include medical claims, pharmacy claims, dental claims, and eligibility and provider files, which are collected from private and public payers. (h) Authorization of appropriations To carry out this section, there is authorized to be appropriated $50,000,000 for each of fiscal years 2022 and 2023, and $25,000,000 for fiscal year 2024, to remain available until expended.

“biosurveillance” applies in that section

the term “biosurveillance” means the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity.

“antimicrobial” applies in that section

the term “antimicrobial” includes any antibacterial or antifungal drugs, and may include drugs that eliminate or inhibit the growth of other microorganisms, as appropriate. (n) Supplement not supplant Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section. (o) Authorization of appropriations There are authorized to be appropriated to carry out this section, $40,000,000 for fiscal year 2001, $25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006.

“priority countermeasure” applies in that section

the term “priority countermeasure” means a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that the Secretary determines to be— (A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to section 262a(a)(1) of this title , or harm from any other agent that may cause a public health emergency; or (B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences or death and may be caused by the administering of a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that is a priority under subparagraph (A).

“infectious disease” applies in that section

The term “infectious disease” means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and that reproduces in that person. (3) Interagency cooperation (A) In general In carrying out activities under this section, the Secretary is authorized, subject to subparagraph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of the United States Government. (B) Limitation An agreement or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section.

“qualified countermeasure” applies in that section

The term “qualified countermeasure” means a drug (as that term is defined by section 321(g)(1) of title 21 ), biological product (as that term is defined by section 262(i) of this title ), or device (as that term is defined by section 321(h) of title 21 ), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)— (i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; (ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in …

“advanced research and development” applies in that section

The term “advanced research and development” has the meaning given such term in section 247d–7e(a) of this title .;

“security countermeasure” applies in that section

the term “security countermeasure” means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as that term is defined by section 262(i) of this title ), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C.

“special reserve fund” applies in that section

The term “special reserve fund” means the “Biodefense Countermeasures” appropriations account, any appropriation made available pursuant to section 321j(a) of title 6 , and any appropriation made available pursuant to subsection (g)(1).

“stockpile” applies in that section

the term “stockpile” includes— (1) a physical accumulation (at one or more locations) of the supplies described in subsection (a); or (2) a contractual agreement between the Secretary and a vendor or vendors under which such vendor or vendors agree to provide to such Secretary supplies described in subsection (a). (f) Authorization of appropriations (1) Strategic National Stockpile For the purpose of carrying out subsection (a), there are authorized to be appropriated $610,000,000 for each of fiscal years 2019 through 2021, and $750,000,000 for each of fiscal years 2022 and 2023, to remain available until expended.

“collateral source benefit” applies in that section

the term “collateral source benefit” means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any service, product, or other benefit provided or to be provided in the future to or on behalf of the plaintiff, as a result of the injury or wrongful death, pursuant to— (i) any State or Federal health, sickness, income-disability, accident, or workers’ compensation law; (ii) any health, sickness, income-disability, or accident insurance that provides health benefits or income-disability coverage; (iii) any contract or agreement of any group, organization, partnership, or corporation to provide, pay for, or reimburse the cost of medical, hospital, dental, or income …

“covered countermeasure” applies in that section

The term “covered countermeasure” means— (A) a qualified pandemic or epidemic product (as defined in paragraph (7)); (B) a security countermeasure (as defined in section 247d–6b(c)(1)(B) of this title ); (C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) ), biological product (as such term is defined by section 262(i) of this title ), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. 321(h) ) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C.

“covered remedy” applies in that section

The term “covered remedy” means an outcome— (I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(i) , 360j(g)], a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act [ 21 U.S.C. 360bbb–3 ], or a suspension or withdrawal of an approval or clearance under chapter 5 1 of such Act or of a licensure under section 262 of this title ; and (II) that results from a final determination by a court or from a final agency action.

“distributor” applies in that section

The term “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. (4) Manufacturer

“enforcement action” applies in that section

The term “enforcement action” means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(i) , 360j(g)], a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of such Act [ 21 U.S.C.

“final” applies in that section

The terms “final” and “finally”— (I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and (II) with respect to an agency action, or to a final resolution of an enforcement action that is an agency action, mean an order that is not subject to further review within the agency and that has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a voluntary or stipulated dismissal.

“finally” applies in that section

The terms “final” and “finally”— (I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and (II) with respect to an agency action, or to a final resolution of an enforcement action that is an agency action, mean an order that is not subject to further review within the agency and that has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a voluntary or stipulated dismissal.

“loss” applies in that section

the term “loss” means any type of loss, including— (i) death; (ii) physical, mental, or emotional injury, illness, disability, or condition; (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and (iv) loss of or damage to property, including business interruption loss. Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.

“manufacturer” applies in that section

The term “manufacturer” includes— (A) a contractor or subcontractor of a manufacturer; (B) 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 (C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer. (5) Person

“noneconomic damages” applies in that section

the term “noneconomic damages” means damages for losses for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses.

“person” applies in that section

The term “person” includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local government agency or department. (6) Program planner

“program planner” applies in that section

The term “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 supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a declaration under subsection (b). (7) Qualified pandemic or epidemic product

“qualified pandemic or epidemic product” applies in that section

The term “qualified pandemic or epidemic product” means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) ), 2 biological product (as such term is defined by section 262(i) of this title ), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C.

“security countermeasure” applies in that section

The term “security countermeasure” has the meaning given such term in section 247d–6b(c)(1)(B) of this title . (10) Serious physical injury

“serious physical injury” applies in that section

The term “serious physical injury” means an injury that— (A) is life threatening; (B) results in permanent impairment of a body function or permanent damage to a body structure; or (C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

“covered countermeasure” applies in that section

The term “covered countermeasure” has the meaning given such term in section 247d–6d of this title . (2) Covered individual The term “covered individual”, with respect to administration or use of a covered countermeasure pursuant to a declaration, means an individual— (A) who is in a population specified in such declaration, and with respect to whom the administration or use of the covered countermeasure satisfies the other specifications of such declaration; or (B) who uses the covered countermeasure, or to whom the covered countermeasure is administered, in a good faith belief that the individual is in the category described by subparagraph (A). (3) Covered injury

“covered injury” applies in that section

The term “covered injury” means serious physical injury or death. (4) Declaration

“declaration” applies in that section

The term “declaration” means a declaration under section 247d–6d(b) of this title . (5) Eligible individual

“eligible individual” applies in that section

The term “eligible individual” means an individual who is determined, in accordance with subsection (b), to be a covered individual who sustains a covered injury.

“advanced research and development” applies in that section

The term “advanced research and development” means, with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly— (i) are conducted after basic research and preclinical development of the product; and (ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] or under section 262 of this title .

“BARDA” applies in that section

The term “BARDA” means the Biomedical Advanced Research and Development Authority. (2) Fund

“Fund” applies in that section

The term “Fund” means the Biodefense Medical Countermeasure Development Fund established under subsection (d). (3) Other transactions

“other transactions” applies in that section

The term “other transactions” means transactions, other than procurement contracts, grants, and cooperative agreements. (4) Qualified countermeasure

“person” applies in that section

The term “person” includes an individual, partnership, corporation, association, entity, or public or private corporation, and a Federal, State, or local government agency or department. (b) Strategic plan for countermeasure research, development, and procurement (1) In general Not later than 6 months after December 19, 2006 , the Secretary shall develop and make public a strategic plan to integrate biodefense and emerging infectious disease requirements with the advanced research and development, strategic initiatives for innovation, support for domestic manufacturing surge capacity and capabilities, and the procurement of qualified countermeasures and qualified pandemic or epidemic …

“program manager” applies in that section

The term “program manager” means an individual appointed to carry out functions under this section and authorized to provide project oversight and management of strategic initiatives. (10) Person

“qualified countermeasure” applies in that section

The term “qualified countermeasure” has the meaning given such term in section 247d–6a of this title . (5) Qualified pandemic or epidemic product

“qualified pandemic or epidemic product” applies in that section

The term “qualified pandemic or epidemic product” has the meaning given the term in section 247d–6d of this title . (6) Advanced research and development (A) In general

“research tool” applies in that section

The term “research tool” means a device, technology, biological material (including a cell line or an antibody), reagent, animal model, computer system, computer software, or analytical technique that is developed to assist in the discovery, development, or manufacture of qualified countermeasures or qualified pandemic or epidemic products. (9) Program manager

“security countermeasure” applies in that section

The term “security countermeasure” has the meaning given such term in section 247d–6b of this title . (8) Research tool

“antitrust laws” applies in that section

The term “antitrust laws”— (A) has the meaning given such term in subsection (a) of section 12 of title 15 , except that such term includes section 45 of title 15 to the extent such section 45 of title 15 applies to unfair methods of competition; and (B) includes any State law similar to the laws referred to in subparagraph (A). (2) Countermeasure or product The term “countermeasure or product” refers to a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product (as those terms are defined in subsection (a)(1)). (3) Covered activities (A) In general Except as provided in subparagraph (B),

“covered activities” applies in that section

the term “covered activities” includes any activity relating to the development, manufacture, distribution, purchase, or storage of a countermeasure or product. (B) Exception The term “covered activities” shall not include, with respect to a meeting or consultation conducted under subsection (a)(1) or an agreement for which an exemption has been granted under subsection (a)(4), the following activities involving 2 or more persons: (i) Exchanging information among competitors relating to costs, profitability, or distribution of any product, process, or service if such information is not reasonably necessary to carry out covered activities— (I) with respect to a countermeasure or product …

“section 314(a) State health planning agency” applies in that section

the term “section 314(a) State health planning agency” means the agency of a State which administers or supervises the administration of a State’s health planning functions under a State plan approved under section 314(a) of the Public Health Service Act (referred to in paragraph (2) as a “section 314(a) plan”); and

“section 314(b) areawide health planning agency” applies in that section

the term “section 314(b) areawide health planning agency” means a public or nonprofit private agency or organization which has developed a comprehensive regional, metropolitan, or other local area plan or plans referred to in section 314(b) of that Act (referred to in paragraph (2) as a “section 314(b) plan”).

“specialized health resources” applies in that section

the term “specialized health resources” means health care resources (whether equipment, space, or personnel) which, because of cost, limited availability, or unusual nature, are either unique in the health care community or are subject to maximum utilization only through mutual use; (2) the term “hospital”, unless otherwise specified, includes (in addition to other hospitals) any Federal hospital.

“additional health services” applies in that section

The term “additional health services” means services that are not included as required primary health services and that are appropriate to meet the health needs of the population served by the health center involved.

“agriculture” applies in that section

The term “agriculture” means farming in all its branches, including— (i) cultivation and tillage of the soil; (ii) the production, cultivation, growing, and harvesting of any commodity grown on, in, or as an adjunct to or part of a commodity grown in or on, the land; and (iii) any practice (including preparation and processing for market and delivery to storage or to market or to carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an activity described in clause (ii).

“eligible health center” applies in that section

the term “eligible health center” means an entity that— (A) is a health center as defined under subsection (a); (B) provides health care services for clients for whom English is a second language; and (C) has exceptional needs with respect to linguistic access or faces exceptional challenges with respect to linguistic access. (3) Grant amount The amount of a grant awarded to a center under this subsection shall be determined by the Administrator. Such determination of such amount shall be based on the number of clients for whom English is a second language that is served by such center, and larger grant amounts shall be awarded to centers serving larger numbers of such clients.

“health center” applies in that section

the term “health center” means an entity that serves a population that is medically underserved, or a special medically underserved population comprised of migratory and seasonal agricultural workers, the homeless, and residents of public housing, by providing, either through the staff and supporting resources of the center or through contracts or cooperative arrangements— (A) required primary health services (as defined in subsection (b)(1)); and (B) as may be appropriate for particular centers, additional health services (as defined in subsection (b)(2)) necessary for the adequate support of the primary health services required under subparagraph (A); for all residents of the area served …

“high poverty area” applies in that section

the term “high poverty area” means a catchment area which is established in a manner that is consistent with the factors in subsection (k)(3)(J), and the poverty rate of which is greater than the national average poverty rate as determined by the Bureau of the Census.

“homeless individual” applies in that section

The term “homeless individual” means an individual who lacks housing (without regard to whether the individual is a member of a family), including an individual whose primary residence during the night is a supervised public or private facility that provides temporary living accommodations and an individual who is a resident in transitional housing. (B) Substance use disorder services

“medically underserved population” applies in that section

The term “medically underserved population” means the population of an urban or rural area designated by the Secretary as an area with a shortage of personal health services or a population group designated by the Secretary as having a shortage of such services. (B) Criteria In carrying out subparagraph (A), the Secretary shall prescribe criteria for determining the specific shortages of personal health services of an area or population group.

“migratory agricultural worker” applies in that section

The term “migratory agricultural worker” means an individual whose principal employment is in agriculture, who has been so employed within the last 24 months, and who establishes for the purposes of such employment a temporary abode. (B) Seasonal agricultural worker

“public center” applies in that section

the term “public center” means a health center funded (or to be funded) through a grant under this section to a public agency. (l) Technical assistance The Secretary shall establish a program through which the Secretary shall provide (either through the Department of Health and Human Services or by grant or contract) technical and other assistance to eligible entities to assist such entities to meet the requirements of subsection (k)(3).

“required primary health services” applies in that section

The term “required primary health services” means— (i) basic health services which, for purposes of this section, shall consist of— (I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gynecology that are furnished by physicians and where appropriate, physician assistants, nurse practitioners, and nurse midwives; (II) diagnostic laboratory and radiologic services; (III) preventive health services, including— (aa) prenatal and perinatal services; (bb) appropriate cancer screening; (cc) well-child services; (dd) immunizations against vaccine-preventable diseases; (ee) screenings for elevated blood lead levels, communicable diseases, and cholesterol; …

“seasonal agricultural worker” applies in that section

The term “seasonal agricultural worker” means an individual whose principal employment is in agriculture on a seasonal basis and who is not a migratory agricultural worker. (C) Agriculture

“substance use disorder services” applies in that section

The term “substance use disorder services” includes detoxification, risk reduction, outpatient treatment, residential treatment, and rehabilitation for substance abuse provided in settings other than hospitals. (i) Residents of public housing (1) In general The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for the planning and delivery of services to a special medically underserved population comprised of residents of public housing (such term, for purposes of this subsection, shall have the same meaning given such term in section 1437a(b)(1) of this title ) and individuals living in areas immediately accessible to such public housing.

“Director” applies in that section

The term “Director” means the Director specified in subsection (d). (2) Federally qualified health center; rural health clinic

“Federally qualified health center” applies in that section

The terms “Federally qualified health center” and “rural health clinic” have the meanings given the terms in section 1395x(aa) of this title . (3) Health professional shortage area

“health professional shortage area” applies in that section

The term “health professional shortage area” means a health professional shortage area designated under section 254e of this title . (4) Medically underserved community

“medically underserved community” applies in that section

The term “medically underserved community” has the meaning given the term in section 295p(6) of this title . (5) Medically underserved population

“medically underserved population” applies in that section

The term “medically underserved population” has the meaning given the term in section 254b(b)(3) of this title . (c) Program The Secretary shall establish, under section 241 of this title , a small health care provider quality improvement grant program. (d) Administration (1) Programs The rural health care services outreach, rural health network development, and small health care provider quality improvement grant programs established under section 241 of this title shall be administered by the Director of the Office of Rural Health Policy of the Health Resources and Services Administration, in consultation with State offices of rural health or other appropriate State government entities.

“rural health clinic” applies in that section

The terms “Federally qualified health center” and “rural health clinic” have the meanings given the terms in section 1395x(aa) of this title . (3) Health professional shortage area

“official poverty line” applies in that section

The term “official poverty line” means the poverty line established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 9902(2) of this title . (2) Secretary

“Secretary” applies in that section

The term “Secretary” means the Secretary of Health and Human Services.

“Director” applies in that section

The terms “Director” and “Office” mean the Director and Office specified in subsection (c). (2) Federally qualified health center and rural health clinic

“Federally qualified health center” applies in that section

The term “Federally qualified health center” and “rural health clinic” have the meanings given the terms in section 1395x(aa) of this title . (3) Frontier community The term “frontier community” shall have the meaning given the term in regulations issued under subsection (r). (4) Medically underserved area

“medically underserved area” applies in that section

The term “medically underserved area” has the meaning given the term “medically underserved community” in section 295p(6) of this title . (5) Medically underserved population

“medically underserved population” applies in that section

The term “medically underserved population” has the meaning given the term in section 254b(b)(3) of this title . (6) Telehealth services

“Office” applies in that section

The terms “Director” and “Office” mean the Director and Office specified in subsection (c). (2) Federally qualified health center and rural health clinic

“rural health clinic” applies in that section

The term “Federally qualified health center” and “rural health clinic” have the meanings given the terms in section 1395x(aa) of this title . (3) Frontier community The term “frontier community” shall have the meaning given the term in regulations issued under subsection (r). (4) Medically underserved area

“telehealth services” applies in that section

The term “telehealth services” means services provided through telehealth technologies. (7) Telehealth technologies

“telehealth technologies” applies in that section

The term “telehealth technologies” means technologies relating to the use of electronic information, and telecommunications technologies, to support and promote, at a distance, health care, patient and professional health-related education, health administration, and public health. (b) Programs The Secretary shall establish, under section 241 of this title , telehealth network and telehealth resource centers grant programs. (c) Administration (1) Establishment There is established in the Health Resources and Services Administration an Office for the Advancement of Telehealth. The Office shall be headed by a Director.

“eligible entity” applies in that section

The term “eligible entity” means a public or nonprofit private telehealth provider network that offers services that include mental health services provided by qualified mental health providers. (2) Qualified mental health professionals The term “qualified mental health professionals” refers to providers of mental health services reimbursed under the medicare program carried out under title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq.) who have additional training in the treatment of mental illness in children and adolescents or who have additional training in the treatment of mental illness in the elderly.

“telehealth” applies in that section

The term “telehealth” means the use of electronic information and telecommunications technologies to support long distance clinical health care, patient and professional health-related education, public health, and health administration.