drugs, biologics, and devices and sponsors of applications 
for approval or licensure of new drugs, biologics, and de-
vices comply with Food and Drug Administration require-
ments and follow guidance for presentation of clinical 
study safety and effectiveness data by sex, age, and racial 
and ethnic subgroups. 
(b) REPORT BY GAO.— 
(1) SUBMISSION.—Not later than 18 months 
after the date of the enactment of this Act, the 
Comptroller General shall complete the study under 
subsection (a) and submit to the Committee on En-
ergy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report on the results 
of such study. 
(2) CONTENTS.—The report required by para-
graph (1) shall include each of the following: 
(A) An assessment of the extent to which 
the Food and Drug Administration assists 
sponsors in complying with the requirements 
and following the guidance referred to in sub-
section (a). 
(B) An assessment of the effectiveness of 
the Food and Drug Administration’s enforce-
ment of compliance with such requirements. 
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(C) An analysis of the extent to which fe-
males, racial and ethnic minorities, and adults 
of all ages are adequately represented in Food 
and 
Drug 
Administration-approved 
clinical 
studies (at all phases) so that product safety 
and effectiveness data can be evaluated by sex, 
age, and racial and ethnic subgroup. 
(D) An analysis of the extent to which a 
summary of product safety and effectiveness 
data disaggregated by sex, age, and racial and 
ethnic subgroup is readily available to the pub-
lic in a timely manner by means of the product 
label or the Food and Drug Administration’s 
Web site. 
(E) Recommendations for— 
(i) modifications to the requirements 
and guidance referred to in subsection (a); 
or 
(ii) oversight by the Food and Drug 
Administration of such requirements. 
(c) REPORT BY HHS.—Not later than 6 months 
after the submission by the Comptroller General of the 
report required under subsection (b), the Secretary of 
Health and Human Services shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
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resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a response to that re-
port, including a corrective action plan as needed to re-
spond to the recommendations in that report. 
(d) DEFINITIONS.—In this section: 
(1) The term ‘‘biologic’’ has the meaning given 
to the term ‘‘biological product’’ in section 351(i) of 
the Public Health Service Act (42 U.S.C. 262(i)). 
(2) The term ‘‘device’’ has the meaning given to 
such term in section 201(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(h)). 
(3) The term ‘‘drug’’ has the meaning given to 
such term in section 201(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(g)). 
SEC. 115. 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: 
‘‘(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 
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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 
American Samoa, the Commonwealth of the North-
ern Mariana Islands, the Federated States of Micro-
nesia, Guam, Hawaii, the Republic of the Marshall 
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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, 
the Republic of Palau, and the Republic of the Mar-
shall Islands. 
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‘‘(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 2011, 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. 
‘‘(2) CONTENTS.—The health survey described 
in paragraph (1) shall include health data and any 
other data the Secretary determines to be— 
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‘‘(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 2011. 
‘‘(d) PROGRESS REPORT.—Not later than 2 years 
after the date of enactment of the Health Equity and Ac-
countability Act of 2011, 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.— 
‘‘(1) IN GENERAL.—The Secretary shall enter 
into an agreement with the Institute of Medicine to 
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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 
later than 2 years after the date of the enactment 
of the Health Equity and Accountability Act of 
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2011, 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 
2012 through 2017.’’. 
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 languages barriers 
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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. 
(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 
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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 healthcare 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 
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 languages services in health care 
settings should be available as a matter of course. 
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