r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE wiki — defined terms
The statute’s own glossary: every term Title 42 defines, in section order.
“State” applies in that section
The term “State” means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States.;
“ultimate user” applies in that section
The term “ultimate user” means a person who has obtained from a dispenser, and who possesses, a controlled substance for the person’s own use, for the use of a member of the person’s household, or for the use of an animal owned by the person or by a member of the person’s household.;
“community health aide” applies in that section
The terms “community health aide” and “community health practitioner” have the meanings given such terms for purposes of section 1616 l of title 25. (2) Health care provider
“community health practitioner” applies in that section
The terms “community health aide” and “community health practitioner” have the meanings given such terms for purposes of section 1616 l of title 25. (2) Health care provider
“health care provider” applies in that section
The term “health care provider” has the meaning given such term by the Secretary, and includes registered nurses, nurse practitioners, nurse midwives, clinical nurse specialists, physician assistants, and physicians. (3) Indian tribe; Tribal organization The terms “Indian Tribe” and “Tribal organization” shall have the meanings given such terms in section 5304 of title 25 . (4) Institution of higher education
“institution of higher education” applies in that section
The term “institution of higher education” has the meaning given such term in section 1001 of title 20 . (5) Interpersonal violence
“interpersonal violence” applies in that section
The term “interpersonal violence” means any form of violence that is emotional and trauma-inducing for victims, families of victims, perpetrators, and communities. (6) Native Hawaiian organization
“Native Hawaiian organization” applies in that section
The term “Native Hawaiian organization” has the meaning given such term in section 11711 of this title . (7) Secretary
“Secretary” applies in that section
The term “Secretary” means the Secretary of Health and Human Services. (8) Trauma-informed care
“trauma-informed care” applies in that section
The term “trauma-informed care” means care received by trauma survivors that is culturally competent in accordance with professional standards of practice and accounting for patients’ experiences and preferences in order to eliminate or mitigate triggers that may cause re-traumatization of the patient. (9) Urban Indian organization
“Urban Indian organization” applies in that section
The term “Urban Indian organization” has the meaning given such term in section 1603 of title 25 . (b) Demonstration grants for comprehensive forensic training (1) Establishment of program The Secretary shall establish a demonstration program to award grants to eligible entities for the clinical training of health care providers to provide generalist forensic services and trauma-informed care to survivors of interpersonal violence of all ages.
“national voluntary health association” applies in that section
the term “national voluntary health association” means a national non-profit organization with chapters or other affiliated organizations in States throughout the United States with experience serving the population of individuals with ALS and have demonstrated experience in ALS research, care, and patient services.
“national voluntary health association” applies in that section
the term “national voluntary health association” means a national nonprofit organization with chapters, other affiliated organizations, or networks in States throughout the United States with experience serving the population of individuals with neurological disease and have demonstrated experience in neurological disease research, care, and patient services. (k) Authorization of appropriations To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2018 through 2022.
“eligible entity” applies in that section
the term “eligible entity” means an entity that— (1) is— (A) an institution of higher education (as such term is defined in section 1001 1 of title 20) or a consortium of such institutions; or (B) an organization described in section 501(c)(3) of title 26 and exempt from tax under subsection (a) of such section; (2) has experienced personnel with clinical and other technical expertise in the field of biomedical sciences and demonstrated connection to the patient population; (3) demonstrates to the Secretary’s satisfaction that the entity is capable of identifying and establishing collaborations between public and private entities and individuals with expertise in neurodegenerative diseases, …
“eligible entity” applies in that section
the term “eligible entity” means— (A) a State or a political subdivision of a State; (B) a consortium of 2 or more States or political subdivisions of States; (C) a territory; (D) a health facility or program operated by or pursuant to a contract with or grant from the Indian Health Service; or (E) any other entity with appropriate expertise in prenatally and postnatally diagnosed conditions (including nationally recognized disability groups), as determined by the Secretary. (3) Distribution In distributing funds under this subsection, the Secretary shall place an emphasis on funding partnerships between health care professional groups and disability advocacy organizations.
“health care provider” applies in that section
The term “health care provider” means any person or entity required by State or Federal law or regulation to be licensed, registered, or certified to provide health care services, and who is so licensed, registered, or certified. (3) Postnatally diagnosed condition
“postnatally diagnosed condition” applies in that section
The term “postnatally diagnosed condition” means any health condition identified during the 12-month period beginning at birth. (4) Prenatally diagnosed condition
“prenatal test” applies in that section
The term “prenatal test” means diagnostic or screening tests offered to pregnant women seeking routine prenatal care that are administered on a required or recommended basis by a health care provider based on medical history, family background, ethnic background, previous test results, or other risk factors.
“prenatally diagnosed condition” applies in that section
The term “prenatally diagnosed condition” means any fetal health condition identified by prenatal genetic testing or prenatal screening procedures. (5) Prenatal test
“children and adolescents” applies in that section
the term “children and adolescents” means individuals who do not exceed 18 years of age. (h) Authorization of appropriations There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005.
“comprehensive primary health services” applies in that section
The term “comprehensive primary health services” means the core services offered by school-based health centers, which shall include the following: (A) Physical Comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic medical conditions, and referrals to, and follow-up for, specialty care and oral and vision health services. (B) Mental health Mental health and substance use disorder assessments, crisis intervention, counseling, treatment, and referral to a continuum of services including emergency psychiatric care, community support programs, inpatient care, and outpatient programs. (2) Medically underserved children and adolescents (A) In general
“medically underserved children and adolescents” applies in that section
The term “medically underserved children and adolescents” means a population of children and adolescents who are residents of an area designated as a medically underserved area or a health professional shortage area by the Secretary.
“school-based health center” applies in that section
The term “school-based health center” means a health clinic that— (A) meets the definition of a school-based health center under section 1397jj(c)(9)(A) of this title and is administered by a sponsoring facility (as defined in section 1397jj(c)(9)(B) of this title ); (B) provides, at a minimum, comprehensive primary health services during school hours to children and adolescents by health professionals in accordance with established standards, community practice, reporting laws, and other State laws, including parental consent and notification laws that are not inconsistent with Federal law; and (C) does not perform abortion services.
“eligible child” applies in that section
The term “eligible child” means a child from birth to not more than 12 years of age who— (A) is at risk for, shows early signs of, or has been diagnosed with a mental illness, including a serious emotional disturbance; and (B) may benefit from infant and early childhood intervention or treatment programs or specialized preschool or elementary school programs that are evidence-based or that have been scientifically demonstrated to show promise but would benefit from further applied development. (2) Eligible entity
“eligible entity” applies in that section
The term “eligible entity” means a human services agency or nonprofit institution that— (A) employs licensed mental health professionals who have specialized training and experience in infant and early childhood mental health assessment, diagnosis, and treatment, or is accredited or approved by the appropriate State agency, as applicable, to provide for children from infancy to 12 years of age mental health promotion, intervention, or treatment services; and (B) provides services or programs described in subsection (a) that are evidence-based or that have been scientifically demonstrated to show promise but would benefit from further applied development.
“elementary school” applies in that section
The term “elementary school” has the meaning given such term in section 7801 of title 20 . (2) Evidence-based
“evidence-based” applies in that section
The term “evidence-based” has the meaning given such term in section 7801(21)(A)(i) of title 20 . (3) Native Hawaiian educational organization
“local educational agency” applies in that section
The term “local educational agency” has the meaning given such term in section 7801 of title 20 . (5) Regional Corporation
“Native Hawaiian educational organization” applies in that section
The term “Native Hawaiian educational organization” has the meaning given such term in section 7517 of title 20 . (4) Local educational agency
“Regional Corporation” applies in that section
The term “Regional Corporation” has the meaning given the term in section 1602 of title 43 ). 1 (6) School
“school” applies in that section
The term “school” means a public elementary school or public secondary school. (7) School leader
“school leader” applies in that section
The term “school leader” has the meaning given such term in section 7801 of title 20 . (8) Secondary school
“secondary school” applies in that section
The term “secondary school” has the meaning given such term in section 7801 of title 20 . (9) Secretary
“Secretary” applies in that section
The term “Secretary” means the Secretary of Education. (10) Specialized instructional support personnel
“specialized instructional support personnel” applies in that section
The term “specialized instructional support personnel” has the meaning given such term in section 7801 of title 20 . (11) State educational agency
“State educational agency” applies in that section
The term “State educational agency” has the meaning given such term in section 7801 of title 20 . (l) Authorization of appropriations There is authorized to be appropriated to carry out this section, $50,000,000 for each of fiscal years 2019 through 2023.
“Indian Tribe” applies throughout its part
The terms “Indian Tribe” and “Tribal organization” have the meanings given such terms in section 1603 of title 25 . (2) Other developmental disabilities
“other developmental disabilities” applies throughout its part
The term “other developmental disabilities” has the meaning given the term “developmental disability” in section 15002(8) of this title . (3) State
“State” applies throughout its part
The term “State” means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, and the Trust Territory of the Pacific Islands. (e) Sunset This section shall not apply after September 30, 2029 .
“Tribal organization” applies throughout its part
The terms “Indian Tribe” and “Tribal organization” have the meanings given such terms in section 1603 of title 25 . (2) Other developmental disabilities
“underserved area” applies in that section
the term “underserved area” means— (i) a health professional shortage area (as defined in section 254e(a)(1)(A) of this title ); and (ii) an urban or rural area designated by the Secretary as an area with a shortage of personal health services (as described in section 254b(b)(3)(A) of this title ). (C) Report Not later than 2 years after December 23, 2024 , the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report that examines the need for, and feasibility of, expanding the developmental-behavioral pediatrician training programs described in subparagraph (A).
“eligible hospital” applies in that section
the term “eligible hospital” means a hospital that the Secretary determines has a high rate of risk adjusted readmissions for the conditions described in section 1395ww(q)(8)(A) of this title and has not taken appropriate steps to reduce such readmissions and improve patient safety as evidenced through historically high rates of readmissions, as determined by the Secretary. (3) Risk adjustment The Secretary shall utilize appropriate risk adjustment measures to determine eligible hospitals.
“tooth-level surveillance” applies in that section
the term “tooth-level surveillance” means a clinical examination where an examiner looks at each dental surface, on each tooth in the mouth and as expanded by the Division of Oral Health of the Centers for Disease Control and Prevention. (3) Medical Expenditures Panel Survey The Secretary shall ensure that the Medical Expenditures Panel Survey by the Agency for Healthcare Research and Quality includes the verification of dental utilization, expenditure, and coverage findings through conduct of a look-back analysis.
“young women” applies in that section
the term “young women” means women 15 to 44 years of age. (h) Authorization of appropriations To carry out subsections (a), (b), (c)(1), and (d), there are authorized to be appropriated $9,000,000 for each of fiscal years 2022 through 2026.
“Parkinson’s” applies in that section
the term “Parkinson’s” means— (1) Parkinson’s disease; and (2) all other neurodegenerative Parkinsonisms, including multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, and Parkinson’s-related dementia. (b) Establishment The Secretary shall carry out a national project, to be known as the National Parkinson’s Project (referred to in this section as the “Project”), to prevent, diagnose, treat, and cure Parkinson’s.
“Director of NIH” applies throughout its subchapter
The term “Director of NIH” means the Director of the National Institutes of Health.;
“national center” applies throughout its subchapter
The terms “national research institute” and “national center” mean an agency of the National Institutes of Health that is— (A) listed in subsection (b) and not terminated under subsection (d)(2)(A); or (B) established by the Director of NIH under such subsection. (h) References to NIH For purposes of this subchapter, a reference to the National Institutes of Health includes its agencies.
“national research institute” applies throughout its subchapter
The terms “national research institute” and “national center” mean an agency of the National Institutes of Health that is— (A) listed in subsection (b) and not terminated under subsection (d)(2)(A); or (B) established by the Director of NIH under such subsection. (h) References to NIH For purposes of this subchapter, a reference to the National Institutes of Health includes its agencies.
“applicable clinical trial” applies in that section
The term “applicable clinical trial” means an applicable device clinical trial or an applicable drug clinical trial. (ii) Applicable device clinical trial
“applicable device clinical trial” applies in that section
The term “applicable device clinical trial” means— (I) a prospective clinical study of health outcomes comparing an intervention with a device subject to section 360(k), 360e, or 360j(m) of title 21 against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and (II) a pediatric postmarket surveillance as required under section 360 l of title 21. (iii) Applicable drug clinical trial (I) In general
“applicable drug clinical trial” applies in that section
The term “applicable drug clinical trial” means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 355 of title 21 or to section 262 of this title . (II) Clinical investigation For purposes of subclause (I),
“clinical investigation” applies in that section
the term “clinical investigation” has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations (or any successor regulation). (III) Phase I For purposes of subclause (I),
“clinical trial information” applies in that section
The term “clinical trial information” means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3). (v) Completion date
“completion date” applies in that section
The term “completion date” means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. (vi) Device
“device” applies in that section
The term “device” means a device as defined in section 321(h) of title 21 . (vii) Drug
“drug” applies in that section
The term “drug” means a drug as defined in section 321(g) of title 21 or a biological product as defined in section 262 of this title . (viii) Ongoing
“ongoing” applies in that section
The term “ongoing” means, with respect to a clinical trial of a drug or a device and to a date, that— (I) 1 or more patients is enrolled in the clinical trial; and (II) the date is before the completion date of the clinical trial.
“phase I” applies in that section
the term “phase I” has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations (or any successor regulation). (iv) Clinical trial information
“sanctuary system” applies in that section
The term “sanctuary system” means the system described in subsection (a). (3) Secretary
“Secretary” applies in that section
The term “Secretary” means the Secretary of Health and Human Services. (4) Surplus chimpanzees
“surplus chimpanzees” applies in that section
The term “surplus chimpanzees” has the meaning given that term in subsection (a). (g) Funding (1) In general Of the amount appropriated for the National Institutes of Health, there are authorized to be appropriated to carry out this section and for the care, maintenance, and transportation of all chimpanzees otherwise under the ownership or control of the National Institutes of Health, and to enable the National Institutes of Health to operate more efficiently and economically by decreasing the overall Federal cost of providing for the care, maintenance, and transportation of chimpanzees— (A) for fiscal year 2014, $12,400,000; (B) for fiscal year 2015, $11,650,000; (C) for fiscal year 2016, …
“administrative expenses” applies in that section
the term “administrative expenses” means expenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health. (b) For fiscal year 1989 and subsequent fiscal years, amounts made available to the National Institutes of Health shall be available for payment of nurses and allied health professionals in accordance with payment authorities, scheduling options, benefits, and other authorities provided under chapter 73 of title 38 for nurses of the Department of Veterans Affairs.
“clinical research” applies throughout its subchapter
the term “clinical research” means patient oriented clinical research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.
“health services research” applies throughout its subchapter
the term “health services research” means research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care. Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical conditions. (b) Clinical research As used in this subchapter,
“autoimmune disease” applies in that section
The term “autoimmune disease” includes, for purposes of this section such diseases or disorders with evidence of autoimmune pathogensis 1 as the Secretary determines to be appropriate. (b) Coordinating Committee (1) In general The Secretary shall ensure that the Autoimmune Diseases Coordinating Committee (referred to in this section as the “Coordinating Committee”) coordinates activities across the National Institutes and with other Federal health programs and activities relating to such diseases.
“advanced degree programs in clinical investigation” applies in that section
the term “advanced degree programs in clinical investigation” means programs that award a master’s or Ph.D. degree in clinical investigation after 2 or more years of training in areas such as the following: (A) Analytical methods, biostatistics, and study design. (B) Principles of clinical pharmacology and pharmacokinetics. (C) Clinical epidemiology. (D) Computer data management and medical informatics. (E) Ethical and regulatory issues. (F) Biomedical writing.
“Pain Consortium” applies in that section
the term “Pain Consortium” means the Pain Consortium of the National Institutes of Health or a similar trans-National Institutes of Health coordinating entity designated by the Secretary for purposes of this subsection. (b) Interagency Pain Research Coordinating Committee (1) Establishment The Secretary shall establish not later than 1 year after March 23, 2010 , and as necessary maintain a committee, to be known as the Interagency Pain Research Coordinating Committee (in this section referred to as the “Committee”), to coordinate all efforts within the Department of Health and Human Services and other Federal agencies that relate to pain research.
“award” applies in that section
The term “award” includes a grant, contract, or cooperative agreement determined by the Secretary. (B) Biospecimen
“biospecimen” applies in that section
The term “biospecimen” includes— (i) solid tumor tissue or bone marrow; (ii) normal or control tissue; (iii) blood and plasma; (iv) DNA and RNA extractions; (v) familial DNA; and (vi) any other sample relevant to cancer research, as required by the Secretary. (C) Clinical and demographic information
“clinical and demographic information” applies in that section
The term “clinical and demographic information” includes— (i) date of diagnosis; (ii) age at diagnosis; (iii) the patient’s sex, race, ethnicity, and environmental exposures; (iv) extent of disease at enrollment; (v) site of metastases; (vi) location of primary tumor coded; (vii) histologic diagnosis; (viii) tumor marker data when available; (ix) treatment and outcome data; (x) information related to specimen quality; and (xi) any other applicable information required by the Secretary.
“eligible entity” applies in that section
the term “eligible entity” means— (i) a medical school; (ii) a children’s hospital; (iii) a cancer center; (iv) a community-based medical facility; or (v) any other entity with significant experience and expertise in carrying out the activities described in paragraph (1).
“recalcitrant cancer” applies in that section
the term “recalcitrant cancer” means a cancer for which the five-year relative survival rate is below 50 percent.
“entity” applies in that section
the term “entity” means any— (1) National Cancer Institute-designated cancer center; (2) Department of Veterans Affairs hospital or medical center; (3) Federally Qualified Health Center, community health center, or hospital; (4) agency of any State or local government, including any State department of health; or (5) nonprofit organization.
“modernization” applies in that section
the term “modernization” means the alteration, remodeling, improvement, expansion, and repair of existing buildings and the provision of equipment for such buildings to the extent necessary to make them suitable for use as centers described in the preceding sentence.
“Council on Alzheimer’s Disease” applies in that section
the term “Council on Alzheimer’s Disease” means the council established in section 11211(a) 2 of this title.
“medical rehabilitation research” applies in that section
the term “medical rehabilitation research” means the science of mechanisms and interventions that prevent, improve, restore, or replace lost, underdeveloped, or deteriorating function.
“alternative test method” applies in that section
The term “alternative test method” means a test method that— (A) includes any new or revised test method; and (B) (i) reduces the number of animals required; (ii) refines procedures to lessen or eliminate pain or distress to animals, or enhances animal well-being; or (iii) replaces animals with non-animal systems or one animal species with a phylogenetically lower animal species, such as replacing a mammal with an invertebrate. (2) ICCVAM test recommendation
“ICCVAM test recommendation” applies in that section
The term “ICCVAM test recommendation” means a summary report prepared by the ICCVAM characterizing the results of a scientific expert peer review of a test method.
“modernization” applies in that section
the term “modernization” means the alteration, remodeling, improvement, expansion, and repair of existing buildings and the provision of equipment for such buildings to the extent necessary to make them suitable for use as centers described in the preceding sentence. (b) Use of facilities; qualifications Each center assisted under this section shall— (1) use the facilities of a single institution or a consortium of cooperating institutions; and (2) meet such qualifications as may be prescribed by the Secretary.
“construction” applies in that section
the term “construction” has the meaning given that term by section 292a(1) 2 of this title. The Secretary shall include in the grants made under this section for fiscal years beginning after September 30, 1981 , a grant to a designated Center for research on the effects of alcohol on the elderly.
“construction” applies in that section
the term “construction” has the meaning given that term by section 292a(1) 2 of this title. (c) Drug abuse and addiction research (1) Grants or cooperative agreements The Director of the Institute may make grants or enter into cooperative agreements to expand the current and ongoing interdisciplinary research and clinical trials with treatment centers of the National Drug Abuse Treatment Clinical Trials Network relating to drug abuse and addiction, including related biomedical, behavioral, and social issues.
“pharmacotherapeutics” applies in that section
the term “pharmacotherapeutics” means medications used to treat the symptoms and disease of drug abuse, including medications to— (1) block the effects of abused drugs; (2) reduce the craving for abused drugs; (3) moderate or eliminate withdrawal symptoms; (4) block or reverse the toxic effect of abused drugs; or (5) prevent relapse in persons who have been detoxified from drugs of abuse.
“health disparities research” applies throughout its subpart
The term “health disparities research” means basic, clinical, and behavioral research on health disparity populations (including individual members and communities of such populations) that relates to health disparities as defined under paragraph (1), including the causes of such disparities and methods to prevent, diagnose, and treat such disparities.
“minority group” applies throughout its subpart
The term “minority group” has the meaning given the term “racial and ethnic minority group” in section 300u–6 of this title . (4) The terms “minority” and “minorities” refer to individuals from a minority group. (d) Health disparity populations For purposes of this subpart: (1) A population is a health disparity population if, as determined by the Director of the Institute after consultation with the Director of the Agency for Healthcare Research and Quality, there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population.
“minority health disparities research” applies throughout its subpart
The term “minority health disparities research” means basic, clinical, and behavioral research on minority health conditions (as defined in paragraph (2)), including research to prevent, diagnose, and treat such conditions.
“designated biomedical and behavioral research institution” applies in that section
The term “designated biomedical and behavioral research institution” has the meaning indicated for such term in subsection (c)(1). Such term includes any health professions school receiving an award of a grant or contract under section 293 of this title .;
“program of excellence” applies in that section
The term “program of excellence” means any program carried out by a designated biomedical and behavioral research institution with an award under subsection (a), if the program is for purposes for which the institution involved is authorized in subsection (b) to expend the grant.
“medical library” applies throughout its subpart
the term “medical library” means a library related to the sciences related to health; and;
“sciences related to health” applies throughout its subpart
the term “sciences related to health” includes medicine, osteopathy, dentistry, and public health, and fundamental and applied sciences when related thereto.
“biological product” applies in that section
The term “biological product” has the meaning given such term in section 262 of this title . (2) Drug; device
“device” applies in that section
The terms “drug” and “device” have the meanings given such terms in section 321 of title 21 . (3) High need cure
“drug” applies in that section
The terms “drug” and “device” have the meanings given such terms in section 321 of title 21 . (3) High need cure
“high need cure” applies in that section
The term “high need cure” means a drug (as that term is defined by section 321(g)(1) of title 21 , 1 biological product (as that term is defined by section 262(i) 2 of this title), or device (as that term is defined by section 321(h) of title 21 ) that, in the determination of the Director of the Center— (A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and (B) for which the incentives of the commercial market are unlikely to result in its adequate or timely development. (4) Medical product
“medical product” applies in that section
The term “medical product” means a drug, device, biological product, or product that is a combination of drugs, devices, and biological products. (b) Establishment of the Cures Acceleration Network Subject to the appropriation of funds as described in subsection (g), there is established within the Center a program to be known as the Cures Acceleration Network (referred to in this section as “CAN”), which shall— (1) be under the direction of the Director of the Center, taking into account the recommendations of a CAN Review Board (referred to in this section as the “Board”), described in subsection (d); and (2) award grants and contracts to eligible entities, as described in subsection (e), …
“rare disease” applies in that section
the term “rare disease” means any disease or condition that affects less than 200,000 persons in the United States.
“dietary supplement” applies in that section
the term “dietary supplement” has the meaning given the term in section 321(ff) of title 21 .
“research on women’s health” applies throughout its part
The term “research on women’s health” means research on women’s health conditions, including research on preventing such conditions.
“ethical considerations” applies in that section
the term “ethical considerations” means considerations as to whether the nature of the research involved is such that it is unethical to conduct or support the research.
“minority group” applies in that section
The term “minority group” includes subpopulations of minority groups. The Director of NIH shall, through the guidelines established under subsection (d), define the terms “minority group” and “subpopulation” for purposes of the preceding sentence.
“project of clinical research” applies in that section
The term “project of clinical research” includes a clinical trial.;
“financial assistance” applies in that section
the term “financial assistance” means a grant, contract, or cooperative agreement. (b) Existence of administrative processes as condition of funding for research The Secretary shall by regulation require that each entity that applies for financial assistance under this chapter for any project or program that involves the conduct of biomedical or behavioral research submit in or with its application for such assistance— (1) assurances satisfactory to the Secretary that such entity has established and has in effect (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of research misconduct in connection with biomedical and behavioral …
“financial interest” applies in that section
The term “financial interest” includes the receipt of consulting fees or honoraria and the ownership of stock or equity. (2) The term “assistance”, with respect to conducting a project of research, means a grant, contract, or cooperative agreement.
“human fetal tissue” applies in that section
the term “human fetal tissue” means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.
“human fetal tissue” applies in that section
The term “human fetal tissue” has the meaning given such term in section 289g–1(g) of this title .;
“interstate commerce” applies in that section
The term “interstate commerce” has the meaning given such term in section 321(b) of title 21 . (3) The term “valuable consideration” does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.
“breast implant” applies in that section
the term “breast implant” means a breast prosthesis that is implanted to augment or reconstruct the female breast.
“applicable committees” applies in that section
The term “applicable committees” means— (i) the Committee on Health, Education, Labor and Pensions of the Senate; and (ii) the Committee on Energy and Commerce of the House of Representatives. (B) Covered grant
“covered grant” applies in that section
The term “covered grant” means a grant awarded by the Secretary under a program established under this Act (or an amendment made by this Act, other than sections 703 through 707), including any grant administered by the Administrator of the Substance Abuse and Mental Health Services Administration under section 1536 of title 21 . (C) Grantee
“grantee” applies in that section
The term “grantee” means the recipient of a covered grant. (D) Secretary
“Secretary” applies in that section
The term “Secretary” means the Secretary of Health and Human Services. (2) Accountability measures Each covered grant shall be subject to the following accountability requirements: (A) Effectiveness report The Secretary shall require grantees to report on the effectiveness of the activities carried out with amounts made available to carry out the program under which the covered grant is awarded, including the number of persons served by such grant, if applicable, the number of persons seeking services who could not be served by such grant, and such other information as the Secretary may prescribe.
“assisted outpatient treatment” applies in that section
The term “assisted outpatient treatment” means medically prescribed mental health treatment that a patient receives while living in a community under the terms of a law authorizing a State or local court to order such treatment.;
“eligible entity” applies in that section
The term “eligible entity” means a county, city, mental health system, mental health court, or any other entity with authority under the law of the State in which the grantee is located to implement, monitor, and oversee assisted outpatient treatment programs.;
“Secretary” applies in that section
The term “Secretary” means the Secretary of Health and Human Services. (g) Funding (1) Amount of grants A grant under this section shall be in an amount that is not more than $1,000,000 for each of fiscal years 2023 through 2027. Subject to the preceding sentence, the Secretary shall determine the amount of each grant based on the population of the area, including estimated patients, to be served under the grant. (2) Authorization of appropriations There is authorized to be appropriated to carry out this section $22,000,000 for each of fiscal years 2023 through 2027.
“eligible entity” applies in that section
The term “eligible entity” means any health program administered directly by the Indian Health Service, a Tribal health program, an Indian Tribe, a Tribal organization, an Urban Indian organization, and a Native Hawaiian health organization.;
“health program administered directly by the Indian Health Service” applies in that section
The term “health program administered directly by the Indian Health Service” means a “health program administered by the Service” 2 as such term is used in section 1603(12)(A) of title 25 .;
“Indian Tribe” applies in that section
The terms “Indian Tribe”, “Tribal health program”, “Tribal organization”, and “Urban Indian organization” have the meanings given to the terms “Indian tribe”, “Tribal 1 health program”, “tribal organization”, and “Urban Indian organization” in section 1603 of title 25 .;
“Native Hawaiian health organization” applies in that section
The term “Native Hawaiian health organization” means “Papa Ola Lokahi” as defined in section 11711 of this title . (b) Grant program (1) In general The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use, and in consultation with the Director of the Indian Health Service, as appropriate, shall award funds to eligible entities, in amounts developed in accordance with paragraph (2), to be used by the eligible entity to provide services for the prevention of, treatment of, and recovery from mental health and substance use disorders among American Indians, Alaska Natives, and Native Hawaiians.
“Tribal health program” applies in that section
The terms “Indian Tribe”, “Tribal health program”, “Tribal organization”, and “Urban Indian organization” have the meanings given to the terms “Indian tribe”, “Tribal 1 health program”, “tribal organization”, and “Urban Indian organization” in section 1603 of title 25 .;
“Tribal organization” applies in that section
The terms “Indian Tribe”, “Tribal health program”, “Tribal organization”, and “Urban Indian organization” have the meanings given to the terms “Indian tribe”, “Tribal 1 health program”, “tribal organization”, and “Urban Indian organization” in section 1603 of title 25 .;
“Urban Indian organization” applies in that section
The terms “Indian Tribe”, “Tribal health program”, “Tribal organization”, and “Urban Indian organization” have the meanings given to the terms “Indian tribe”, “Tribal 1 health program”, “tribal organization”, and “Urban Indian organization” in section 1603 of title 25 .;
“authorized services” applies in that section
The term “authorized services” means treatment services and supplemental services.;
“eligible woman” applies in that section
The term “eligible woman” means a woman who has been admitted to a program operated pursuant to subsection (a). (3) The term “funding agreement”, with respect to an award under subsection (a), means that the Director may make the award only if the applicant makes the agreement involved.;
“institution for mental diseases” applies in that section
the term “institution for mental diseases” has the meaning given such term in section 1905(i) of the Social Security Act [ 42 U.S.C. 1396d(i) ]. (f) Requirement of matching funds (1) In general With respect to the costs of the program to be carried out by an applicant pursuant to subsection (a), a funding agreement for an award under such subsection is that the applicant will make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that— (A) for the first fiscal year for which the applicant receives payments under an award under such subsection, is not less than $1 for each $9 of Federal funds provided in the …
“State substance abuse agency” applies in that section
the term “State substance abuse agency” means, with respect to a State, the agency in such State that manages the Substance Abuse Prevention and Treatment Block Grant under part B of subchapter XVII. (s) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $38,931,000 for each of fiscal years 2026 through 2030. Of the amounts made available for a year pursuant to the previous sentence to carry out this section, not more than 25 percent of such amounts shall be made available for such year to carry out subsection (r), other than paragraph (5) of such subsection.
“supplemental services” applies in that section
The term “supplemental services” means the services described in subsection (d). (r) Pilot program for State substance abuse agencies (1) In general From amounts made available under subsection (s), the Director of the Center for Substance Abuse Treatment shall carry out a pilot program under which competitive grants are made by the Director to State substance abuse agencies— (A) to enhance flexibility in the use of funds designed to support family-based services for pregnant and postpartum women with a primary diagnosis of a substance use disorder, including opioid use disorders; (B) to help State substance abuse agencies address identified gaps in services furnished to such women along …
“treatment services” applies in that section
The term “treatment services” means treatment for a substance use disorder, including the counseling and services described in subsection (c)(2).;
“eligible entity” applies in that section
The term “eligible entity” means a State, county, local, or tribal health or child welfare agency, a private nonprofit organization, a research organization, a treatment service provider, an institution of higher education (as defined under section 1001 of title 20 ), or another entity specified by the Secretary. (2) Family-focused residential treatment program
“family-focused residential treatment program” applies in that section
The term “family-focused residential treatment program” means a trauma-informed residential program primarily for substance use disorder treatment for pregnant and postpartum women and parents and guardians that allows children to reside with such women or their parents or guardians during treatment to the extent appropriate and applicable. (3) Secretary
“Secretary” applies in that section
The term “Secretary” means the Secretary of Health and Human Services. (b) Support for the development of evidence-based family-focused residential treatment programs (1) Authority to award grants The Secretary shall award grants to eligible entities for purposes of developing, enhancing, or evaluating family-focused residential treatment programs to increase the availability of such programs that meet the requirements for promising, supported, or well-supported practices specified in section 671(e)(4)(C) of this title ) 1 (as added by the Family First Prevention Services Act enacted under title VII of division E of Public Law 115–123 ).
“children of substance abusers” applies in that section
The term “children of substance abusers” means— (A) children who have lived or are living in a household with a substance abuser who is acting in a parental role regarding the children; and (B) children who have been prenatally exposed to alcohol or other drugs.;
“Indian tribe” applies in that section
The term “Indian tribe” means any tribe, band, nation, or other organized group or community of Indians, including any Alaska Native village (as defined in, or established pursuant to, the Alaska Native Claims Settlement Act [ 43 U.S.C. 1601 et seq.]), that is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians.;
“substance abuse” applies in that section
The term “substance abuse” means the abuse of alcohol or other drugs. (o) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $50,000,000 for fiscal year 2001, and such sums as may be necessary for each of fiscal years 2002 and 2003.
“alcohol beverage industry” applies in that section
The term “alcohol beverage industry” means the brewers, vintners, distillers, importers, distributors, and retail or online outlets that sell or serve beer, wine, and distilled spirits.;
“brief intervention” applies in that section
The term “brief intervention” means, after screening a patient, providing the patient with brief advice and other brief motivational enhancement techniques designed to increase the insight of the patient regarding the patient’s alcohol use, and any realized or potential consequences of such use to effect the desired related behavioral change. (B) Screening
“eligible entity” applies in that section
the term “eligible entity” means an organization that is currently receiving or has received grant funds under the Drug-Free Communities Act of 1997. (8) Administrative expenses Not more than 6 percent of a grant under this subsection may be expended for administrative expenses. (9) Authorization of appropriations There is authorized to be appropriated to carry out this subsection $11,500,000 for each of fiscal years 2023 through 2027.
“school-based prevention” applies in that section
The term “school-based prevention” means programs, which are institutionalized, and run by staff members or school-designated persons or organizations in any grade of school, kindergarten through 12th grade.;
“screening” applies in that section
The term “screening” means using validated patient interview techniques to identify and assess the existence and extent of alcohol use in a patient. (6) Authorization of appropriations There is authorized to be appropriated to carry out this subsection $3,000,000 for each of fiscal years 2023 through 2027.
“youth” applies in that section
The term “youth” means persons under the age of 21. (b) Sense of Congress It is the sense of the Congress that: (1) A multi-faceted effort is needed to more successfully address the problem of underage drinking in the United States. A coordinated approach to prevention, intervention, treatment, enforcement, and research is key to making progress. This chapter recognizes the need for a focused national effort, and addresses particulars of the Federal portion of that effort, as well as Federal support for State activities.
“evidence-based” applies in that section
The term “evidence-based” has the meaning given such term in section 7801 of title 20 .;
“local educational agency” applies in that section
The term “local educational agency” has the meaning given to such term in section 7801 of title 20 .;
“State educational agency” applies in that section
The term “State educational agency” has the meaning given to such term in section 7801 of title 20 .;
“Tribal educational agency” applies in that section
The term “Tribal educational agency” has the meaning given to the term “tribal educational agency” in section 7452 of title 20 .
“early intervention” applies in that section
The term “early intervention” means a strategy or approach that is intended to prevent an outcome or to alter the course of an existing condition. (2) Educational institution; institution of higher education; school The term— (A) “educational institution” means a school or institution of higher education; (B) “institution of higher education” has the meaning given such term in section 1001 of title 20 ; and (C) “school” means an elementary school or secondary school (as such terms are defined in section 8101 of the Elementary and Secondary Education Act of 1965 [ 20 U.S.C. 7801 ]). (3) Prevention
“eligible entity” applies in that section
the term “eligible entity” means— (A) a State; (B) a public organization or private nonprofit organization designated by a State or Indian Tribe (as defined in section 4 of the Indian Self-Determination and Education Assistance Act [ 25 U.S.C. 5304 ]) to develop or direct the State-sponsored statewide or Tribal youth suicide early intervention and prevention strategy; or (C) a Federally recognized Indian Tribe or Tribal organization (as defined in the Indian Self-Determination and Education Assistance Act [ 25 U.S.C. 5301 et seq.]) or an urban Indian organization (as defined in the Indian Health Care Improvement Act [ 25 U.S.C.
“prevention” applies in that section
The term “prevention” means a strategy or approach that reduces the likelihood or risk of onset, or delays the onset, of adverse health problems that have been known to lead to suicide. (4) Youth
“youth” applies in that section
The term “youth” means individuals who are up to 24 years of age. (m) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for each of fiscal years 2023 through 2027.
“institution of higher education” applies in that section
the term “institution of higher education” has the meaning given such term in section 1001 of title 20 . (h) Technical assistance The Secretary may provide technical assistance to grantees in carrying out this section. (i) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $7,000,000 for each of fiscal years 2023 through 2027.
“eligible entity” applies in that section
the term “eligible entity” means— (1) a consumer-run nonprofit organization that— (A) is principally governed by people living with a mental health condition; and (B) mobilizes resources within and outside of the mental health community, which may include through peer-support networks, to increase the prevalence and quality of long-term wellness of individuals living with a mental health condition, including those with a co-occurring substance use disorder; or (2) an Indian Tribe, Tribal organization, Urban Indian organization, or consortium of Tribes or Tribal organizations.
“behavioral and mental health intervention team” applies in that section
The term “behavioral and mental health intervention team” means a multidisciplinary team of trained individuals who— (A) are trained to identify and assess the behavioral health needs of children and youth and who are responsible for identifying, supporting, and connecting students exhibiting behaviors interfering with learning at school, or who are at risk of harm to self or others, with appropriate behavioral health services; and (B) develop and facilitate implementation of evidence-based interventions to— (i) mitigate the threat of harm to self or others posed by a student described in subparagraph (A); (ii) meet the mental and behavioral health needs of such students; and (iii) support …
“elementary school” applies in that section
The terms “elementary school”, “parent”, and “secondary school” have the meanings given to such terms in section 7801 of title 20 .;