Native Hawaiians, or Pacific Islanders, and 
other underrepresented populations; and 
‘‘(B) may solicit the participation of rep-
resentatives from other Federal departments 
and agencies. 
‘‘(b) PROGRESS REPORT.—Not later than 2 years 
after the date of the enactment of this section, the Sec-
retary shall submit to the Congress a progress report, 
which shall include the national strategy described in sub-
section (a)(1). 
‘‘(c) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated such sums as may be necessary for fiscal years 
2017 through 2022.’’. 
SEC. 107. GEO-ACCESS STUDY. 
The Administrator of the Substance Abuse and Men-
tal Health Services Administration shall— 
(1) conduct a study to— 
(A) determine which geographic areas of 
the United States have shortages of specialty 
mental health providers; and 
(B) assess the preparedness of speciality 
mental health providers to deliver culturally and 
linguistically appropriate, affordable, and acces-
sible services; and 
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(2) submit a report to the Congress on the re-
sults of such study. 
SEC. 108. RACIAL, ETHNIC, AND PRIMARY LANGUAGE DATA 
COLLECTED BY THE FEDERAL GOVERNMENT. 
(a) COLLECTION; SUBMISSION.—Not later than 90 
days after the date of the enactment of this Act, and Jan-
uary 31 of each year thereafter, each department, agency, 
and office of the Federal Government that has collected 
racial, ethnic, or primary language data during the pre-
ceding calendar year shall submit such data to the Sec-
retary of Health and Human Services. 
(b) ANALYSIS; PUBLIC AVAILABILITY; REPORTING.— 
Not later than April 30, 2017, and each April 30 there-
after, the Secretary of Health and Human Services, acting 
through the Director of the National Institute on Minority 
Health and Health Disparities and the Deputy Assistant 
Secretary for Minority Health, shall— 
(1) collect and analyze the racial, ethnic, and 
primary language data submitted under subsection 
(a) for the preceding calendar year; 
(2) make publicly available such data and the 
results of such analysis; and 
(3) submit a report to the Congress on such 
data and analysis. 
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SEC. 109. DATA COLLECTION AND ANALYSIS GRANTS TO MI-
NORITY-SERVING INSTITUTIONS. 
(a) AUTHORITY.—The Secretary of Health and 
Human Services, acting through the National Institute on 
Minority Health and Health Disparities and the Office of 
Minority Health, may award grants to access and analyze 
racial and ethnic, and where possible other health dis-
parity data, to monitor and report on progress to reduce 
and eliminate disparities in health and health care. 
(b) ELIGIBLE ENTITY.—In this section, the term ‘‘el-
igible entity’’ means a historically Black college or univer-
sity, an Hispanic-serving institution, a tribal college or 
university, or an Asian-American, Native American, or Pa-
cific Islander-serving institution with an accredited public 
health, health policy, or health services research program. 
SEC. 110. STANDARDS FOR MEASURING SEXUAL ORIENTA-
TION AND GENDER IDENTITY IN COLLECTION 
OF HEALTH DATA. 
Section 3101(a) of the Public Health Service Act (42 
U.S.C. 300kk(a)) is amended— 
(1) in paragraph (1)(A), by inserting ‘‘sexual 
orientation, gender identity,’’ before ‘‘and disability 
status’’; 
(2) in paragraph (1)(C), by inserting ‘‘sexual 
orientation, gender identity,’’ before ‘‘and disability 
status’’; and 
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(3) in paragraph (2)(B), by inserting ‘‘sexual 
orientation, gender identity,’’ before ‘‘and disability 
status’’. 
SEC. 111. STANDARDS FOR MEASURING SOCIOECONOMIC 
STATUS IN COLLECTION OF HEALTH DATA. 
Section 3101(a) of the Public Health Service Act (42 
U.S.C. 300kk(a)), as amended, is amended— 
(1) in paragraph (1)(A), by inserting ‘‘socio-
economic status,’’ before ‘‘and disability status’’; 
(2) in paragraph (1)(C), by inserting ‘‘socio-
economic status,’’ before ‘‘and disability status’’; and 
(3) in paragraph (2)(B), by inserting ‘‘socio-
economic status,’’ before ‘‘and disability status’’. 
SEC. 112. SAFETY AND EFFECTIVENESS OF DRUGS WITH 
RESPECT TO RACIAL AND ETHNIC BACK-
GROUND. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding after section 505E the following: 
‘‘SEC. 505F. SAFETY AND EFFECTIVENESS OF DRUGS WITH 
RESPECT TO RACIAL AND ETHNIC BACK-
GROUND. 
‘‘(a) PREAPPROVAL STUDIES.—If there is evidence 
that there may be a disparity on the basis of racial or 
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ethnic background as to the safety or effectiveness of a 
drug, then— 
‘‘(1)(A) the investigations required under sec-
tion 505(b)(1)(A) shall include adequate and well- 
controlled investigations of the disparity; or 
‘‘(B) the evidence required under section 351(a) 
of the Public Health Service Act for approval of a 
biologics license application for the drug shall in-
clude adequate and well-controlled investigations of 
the disparity; and 
‘‘(2) if the investigations confirm that there is 
a disparity, the labeling of the drug shall include ap-
propriate information about the disparity. 
‘‘(b) POSTMARKET STUDIES.— 
‘‘(1) IN GENERAL.—If there is evidence that 
there may be a disparity on the basis of racial or 
ethnic background as to the safety or effectiveness 
of a drug for which there is an approved application 
under section 505 or a license under section 351 of 
the Public Health Service Act, the Secretary may by 
order require the holder of the approved application 
or license to conduct, by a date specified by the Sec-
retary, postmarketing studies to investigate the dis-
parity. 
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‘‘(2) LABELING.—If the Secretary determines 
that the postmarket studies confirm that there is a 
disparity described in paragraph (1), the labeling of 
the drug shall include appropriate information about 
the disparity. 
‘‘(3) STUDY
DESIGN.—The Secretary may 
specify all aspects of study design, including the 
number of studies and study participants, and the 
other demographic characteristics of study partici-
pants included, in the order requiring postmarket 
studies of the drug. 
‘‘(4) MODIFICATIONS OF STUDY DESIGN.—The 
Secretary may by order modify any aspect of the 
study design as necessary after issuing an order 
under paragraph (1). 
‘‘(5) STUDY RESULTS.—The results from stud-
ies required under paragraph (1) shall be submitted 
to the Secretary as supplements to the drug applica-
tion or biological license application. 
‘‘(c) DISPARITY.—The term ‘evidence that there may 
be a disparity on the basis of racial or ethnic background 
for adult and pediatric populations as to the safety or ef-
fectiveness of a drug’ includes— 
‘‘(1) evidence that there is a disparity on the 
basis of racial or ethnic background as to safety or 
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disparity on the basis of racial or ethnic background 
as to the safety or effectiveness of the drug include 
a statement of any appropriate contraindications, 
warnings, or precautions related to the disparity 
that the Secretary considers necessary.’’. 
(b) ENFORCEMENT.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(dd) If it is a drug and the holder of the approved 
application under section 505 or license under section 351 
of the Public Health Service Act for the drug has failed 
to complete the investigations or studies, or comply with 
any other requirement, of section 505F.’’. 
(c) DRUG FEES.—Section 736(a)(1)(A)(ii) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) 
is amended by adding after ‘‘are required’’ the following: 
‘‘, including supplements required under section 505F’’. 
SEC. 113. IMPROVING HEALTH DATA REGARDING NATIVE 
HAWAIIANS AND OTHER PACIFIC ISLANDERS. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 317U, as added, the following: 
‘‘SEC. 317V. NATIVE HAWAIIAN AND OTHER PACIFIC IS-
LANDER HEALTH DATA. 
‘‘(a) DEFINITIONS.—In this section: 
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‘‘(1) COMMUNITY GROUP.—The term ‘commu-
nity group’ means a group of NHOPI who are orga-
nized at the community level, and may include a 
church group, social service group, national advocacy 
organization, or cultural group. 
‘‘(2) NONPROFIT, NONGOVERNMENTAL ORGANI-
ZATION.—The term ‘nonprofit, nongovernmental or-
ganization’ means a group of NHOPI with a dem-
onstrated history of addressing NHOPI issues, in-
cluding a NHOPI coalition. 
‘‘(3) DESIGNATED
ORGANIZATION.—The term 
‘designated organization’ means an entity estab-
lished to represent NHOPI populations and which 
has statutory responsibilities to provide, or has com-
munity support for providing, health care. 
‘‘(4) GOVERNMENT
REPRESENTATIVES.—The 
term ‘government representatives’ means representa-
tives from Hawaii, American Samoa, the Common-
wealth of the Northern Mariana Islands, the Fed-
erated States of Micronesia, Guam, the Republic of 
Palau, and the Republic of the Marshall Islands. 
‘‘(5) NATIVE HAWAIIANS AND OTHER PACIFIC 
ISLANDERS (NHOPI).—The term ‘Native Hawaiians 
and Other Pacific Islanders’ or ‘NHOPI’ means peo-
ple having origins in any of the original peoples of 
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American Samoa, the Commonwealth of the North-
ern Mariana Islands, the Federated States of Micro-
nesia, Guam, Hawaii, the Republic of the Marshall 
Islands, the Republic of Palau, or any other Pacific 
island. 
‘‘(6) INSULAR AREA.—The term ‘insular area’ 
means Guam, the Commonwealth of Northern Mar-
iana Islands, American Samoa, the United States 
Virgin Islands, the Federated States of Micronesia, 
the Republic of Palau, or the Republic of the Mar-
shall Islands. 
‘‘(b) NATIONAL STRATEGY.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the National Center for 
Health Statistics (referred to in this section as 
‘NCHS’) of the Centers for Disease Control and 
Prevention, and other agencies within the Depart-
ment of Health and Human Services as the Sec-
retary determines appropriate, shall develop and im-
plement an ongoing and sustainable national strat-
egy for identifying and evaluating the health status 
and health care needs of NHOPI populations living 
in the continental United States, Hawaii, American 
Samoa, the Commonwealth of the Northern Mariana 
Islands, the Federated States of Micronesia, Guam, 
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the Republic of Palau, and the Republic of the Mar-
shall Islands. 
‘‘(2) CONSULTATION.—In developing and imple-
menting a national strategy, as described in para-
graph (1), not later than 180 days after the date of 
enactment of the Health Equity and Accountability 
Act of 2016, the Secretary— 
‘‘(A) shall consult with representatives of 
community groups, designated organizations, 
and nonprofit, nongovernmental organizations 
and with government representatives of NHOPI 
populations; and 
‘‘(B) may solicit the participation of rep-
resentatives from other Federal departments. 
‘‘(c) PRELIMINARY HEALTH SURVEY.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of NCHS, shall conduct a pre-
liminary health survey in order to identify the major 
areas and regions in the continental United States, 
Hawaii, American Samoa, the Commonwealth of the 
Northern Mariana Islands, the Federated States of 
Micronesia, Guam, the Republic of Palau, and the 
Republic of the Marshall Islands in which NHOPI 
people reside. 
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‘‘(2) CONTENTS.—The health survey described 
in paragraph (1) shall include health data and any 
other data the Secretary determines to be— 
‘‘(A) useful in determining health status 
and health care needs; or 
‘‘(B) required for developing or imple-
menting a national strategy. 
‘‘(3) METHODOLOGY.—Methodology for the 
health survey described in paragraph (1), including 
plans for designing questions, implementation, sam-
pling, and analysis, shall be developed in consulta-
tion with community groups, designated organiza-
tions, nonprofit, nongovernmental organizations, and 
government representatives of NHOPI populations, 
as determined by the Secretary. 
‘‘(4) TIMEFRAME.—The survey required under 
this subsection shall be completed not later than 18 
months after the date of enactment of the Health 
Equity and Accountability Act of 2016. 
‘‘(d) PROGRESS REPORT.—Not later than 2 years 
after the date of enactment of the Health Equity and Ac-
countability Act of 2016, the Secretary shall submit to 
Congress a progress report, which shall include the na-
tional strategy described in subsection (b)(1). 
‘‘(e) STUDY AND REPORT BY THE IOM.— 
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‘‘(1) IN GENERAL.—The Secretary shall enter 
into an agreement with the Institute of Medicine to 
conduct a study, with input from stakeholders in in-
sular areas, on the following: 
‘‘(A) The standards and definitions of 
health care applied to health care systems in in-
sular areas and the appropriateness of such 
standards and definitions. 
‘‘(B) The status and performance of health 
care systems in insular areas, evaluated based 
upon standards and definitions, as the Sec-
retary determines. 
‘‘(C) The effectiveness of donor aid in ad-
dressing health care needs and priorities in in-
sular areas. 
‘‘(D) The progress toward implementation 
of recommendations of the Committee on 
Health Care Services in the United States—As-
sociated Pacific Basin of the Institute of Medi-
cine that are set forth in the 1998 report, ‘Pa-
cific Partnerships for Health: Charting a New 
Course for the 21st Century’. 
‘‘(2) REPORT.—An agreement described in 
paragraph (1) shall require the Institute of Medicine 
to submit to the Secretary and to Congress, not 
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later than 2 years after the date of the enactment 
of the Health Equity and Accountability Act of 
2016, a report containing a description of the results 
of the study conducted under paragraph (1), includ-
ing the conclusions and recommendations of the In-
stitute of Medicine for each of the items described 
in subparagraphs (A) through (D) of such para-
graph. 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated such sums as may be necessary for fiscal years 
2017 through 2022.’’. 
SEC. 114. CLARIFICATION OF SIMPLIFIED ADMINISTRATIVE 
REPORTING REQUIREMENT. 
Section 11(a) of the Food and Nutrition Act of 2008 
(7 U.S.C. 2020(a)) is amended by adding at the end the 
following: 
‘‘(5) SIMPLIFIED ADMINISTRATIVE REPORTING 
REQUIREMENT.—The administrative notification re-
quirement under section 421(e)(2) of the Personal 
Responsibility and Work Opportunity Reconciliation 
Act of 1996 (8 U.S.C. 1631(e)(2)) shall be satisfied 
by the submission by an agency of a report on the 
aggregate number of exceptions granted under such 
section by such agency in each year.’’. 
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TITLE II—CULTURALLY AND LIN-
GUISTICALLY 
APPROPRIATE 
HEALTH CARE 
SEC. 201. DEFINITIONS. 
In this title, the definitions contained in section 3400 
of the Public Health Service Act, as added by section 202, 
shall apply. 
SEC. 202. AMENDMENT TO THE PUBLIC HEALTH SERVICE 
ACT. 
(a) FINDINGS.—Congress finds the following: 
(1) Effective communication is essential to 
meaningful access to quality physical and mental 
health care. 
(2) Research indicates that the lack of appro-
priate language services creates language barriers 
that result in increased risk of misdiagnosis, ineffec-
tive treatment plans and poor health outcomes for 
limited-English-proficient individuals and individuals 
with communication disabilities such as hearing, vi-
sion, or print impairments. 
(3) The number of limited-English-speaking 
residents in the United States who speak English 
less than very well and, therefore, cannot effectively 
communicate with health and social service providers 
continues to increase significantly. 
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(4) The responsibility to fund language services 
in the provision of health care and health-care-re-
lated services to limited-English-proficient individ-
uals and individuals with communication disabilities 
such as hearing, vision, or print impairments is a so-
cietal one that cannot fairly be visited solely upon 
the health care, public health, or social services com-
munity. 
(5) Title VI of the Civil Rights Act of 1964 
prohibits discrimination based on the grounds of 
race, color, or national origin by any entity receiving 
Federal financial assistance. In order to avoid dis-
crimination on the grounds of national origin, all 
programs or activities administered by the Depart-
ment must take adequate steps to ensure that their 
policies and procedures do not deny or have the ef-
fect of denying limited-English-proficient individuals 
with equal access to benefits and services for which 
such persons qualify. 
(6) Linguistic diversity in the health care and 
health-care-related-services workforce is important 
for providing all patients the environment most con-
ducive to positive health outcomes. 
(7) All members of the health care and health- 
care-related-services community should continue to 
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educate their staff and constituents about limited- 
English-proficient 
and 
disability 
communication 
issues and help them identify resources to improve 
access to quality care for limited-English-proficient 
individuals and individuals with communication dis-
abilities such as hearing, vision, or print impair-
ments. 
(8) Access to English as a second language and 
sign language instructions is an important mecha-
nism for ensuring effective communication and elimi-
nating the language barriers that impede access to 
health care. 
(9) Competent language services in health care 
settings should be available as a matter of course. 
(b) AMENDMENT.—The Public Health Service Act 
(42 U.S.C. 201 et seq.) is amended by adding at the end 
the following: 
‘‘TITLE 
XXXIV—CULTURALLY 
AND LINGUISTICALLY APPRO-
PRIATE HEALTH CARE 
‘‘SEC. 3400. DEFINITIONS. 
‘‘In this title: 
‘‘(1) BILINGUAL.—The term ‘bilingual’ with re-
spect to an individual means a person who has suffi-
cient degree of proficiency in two languages. 
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‘‘(2) COMMUNITY HEALTH WORKER.—The term 
‘community health worker’ includes a community 
health advocate, a lay health educator, a community 
health representative, a peer health promoter, a 
community health outreach worker, and in Spanish, 
promotores de salud. 
‘‘(3) COMPETENT
INTERPRETER
SERVICES.— 
The term ‘competent interpreter services’ means a 
translanguage rendition of a spoken or signed mes-
sage in which the interpreter— 
‘‘(A) comprehends the source language and 
can communicate comprehensively in the target 
language to convey the meaning intended in the 
source language; and 
‘‘(B) knows health and health-related ter-
minology and provides accurate interpretations 
by choosing equivalent expressions that convey 
the best matching and meaning to the source 
language and capture, to the greatest possible 
extent, all nuances intended in the source mes-
sage. 
‘‘(4) COMPETENT
TRANSLATION
SERVICES.— 
The term ‘competent translation services’ means a 
translanguage rendition of a written document in 
which the translator— 
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