107 
health services research, and programs designed to 
improve the public’s health.’’. 
SEC. 403. OFFICE OF MINORITY HEALTH. 
Section 1707 of the Public Health Service Act (42 
U.S.C. 300u–6) is amended— 
(1) by striking subsection (b) and inserting the 
following: 
‘‘(b) DUTIES.—With respect to improving the health 
of racial and ethnic minority groups, the Secretary, acting 
through the Deputy Assistant Secretary for Minority 
Health (in this section referred to as the ‘Deputy Assist-
ant Secretary’), shall carry out the following: 
‘‘(1) Establish, implement, monitor, and evalu-
ate short-range and long-range goals and objectives 
and oversee all other activities within the Public 
Health Service that relate to disease prevention, 
health promotion, service delivery, and research con-
cerning minority groups. The heads of each of the 
agencies of the Service shall consult with the Deputy 
Assistant Secretary to ensure the coordination of 
such activities. 
‘‘(2) Oversee all activities within the Depart-
ment of Health and Human Services that relate to 
reducing or eliminating disparities in health and 
health care in racial and ethnic minority populations 
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and in rural and underserved communities, including 
coordinating— 
‘‘(A) the design of programs, support for 
programs, and the evaluation of programs; 
‘‘(B) the monitoring of trends in health 
and health care; 
‘‘(C) research efforts; 
‘‘(D) the training of health providers; and 
‘‘(E) information and education programs 
and campaigns. 
‘‘(3) Enter into interagency and intra-agency 
agreements with other agencies of the Public Health 
Service. 
‘‘(4) Ensure that the Federal health agencies 
and the National Center for Health Statistics collect 
data on the health status and health care of each 
minority group, using at a minimum the categories 
specified in the 1997 OMB Standards for Maintain-
ing, Collecting, and Presenting Federal Data on 
Race and Ethnicity as required under subtitle B and 
available language standards. 
‘‘(5) Provide technical assistance to States, 
local agencies, territories, Indian tribes, and entities 
for activities relating to the elimination of racial and 
ethnic disparities in health and health care. 
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109 
‘‘(6) Support a national minority health re-
source center to carry out the following: 
‘‘(A) Facilitate the exchange of informa-
tion regarding matters relating to health infor-
mation, health promotion and wellness, preven-
tive health services, clinical trials, health infor-
mation technology, and education in the appro-
priate use of health services. 
‘‘(B) Facilitate timely access to culturally 
and linguistically appropriate information. 
‘‘(C) Assist in the analysis of such infor-
mation. 
‘‘(D) Provide technical assistance with re-
spect to the exchange of such information (in-
cluding facilitating the development of materials 
for such technical assistance). 
‘‘(7) Carry out programs to improve access to 
health care services for individuals with limited 
English proficiency, including developing and car-
rying out programs to provide bilingual or interpre-
tive services through the development and support of 
the Robert T. Matsui Center for Cultural and Lin-
guistic Competence in Health Care as provided for 
in section 3003. 
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110 
‘‘(8) Carry out programs to improve access to 
health care services and to improve the quality of 
health care services for individuals with low func-
tional health literacy. As used in the preceding sen-
tence, the term ‘functional health literacy’ means the 
ability to obtain, process, and understand basic 
health information and services needed to make ap-
propriate health decisions. 
‘‘(9) Advise in matters related to the develop-
ment, implementation, and evaluation of health pro-
fessions education on decreasing disparities in health 
care outcomes, with focus on cultural competency as 
a method of eliminating disparities in health and 
health care in racial and ethnic minority popu-
lations. 
‘‘(10) Assist health care professionals, commu-
nity and advocacy organizations, academic centers 
and public health departments in the design and im-
plementation of programs that will improve the qual-
ity of health outcomes by strengthening the pro-
vider-patient relationship.’’; 
(2) by redesignating subsections (f) through (h) 
as subsections (g) through (i) , respectively; 
(3) by inserting after subsection (d) the fol-
lowing: 
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111 
‘‘(f) PREPARATION OF HEALTH PROFESSIONALS TO 
PROVIDE HEALTH CARE TO MINORITY POPULATIONS.— 
The Secretary, in collaboration with the Director of the 
Bureau of Health Professions and the Deputy Assistant 
Secretary for Minority Health, shall require that health 
professional schools that receive Federal funds train fu-
ture health professionals to provide culturally and linguis-
tically appropriate health care to diverse populations.’’; 
and 
(4) by striking subsection (i) (as so redesig-
nated) and inserting the following: 
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated $100,000,000 for fiscal year 2008, and 
such sums as may be necessary for each of fiscal years 
2009 through 2013.’’. 
SEC. 404. ESTABLISHMENT OF THE INDIAN HEALTH SERV-
ICE AS AN AGENCY OF THE PUBLIC HEALTH 
SERVICE. 
(a) ESTABLISHMENT.— 
(1) IN GENERAL.—In order to more effectively 
and efficiently carry out the responsibilities, authori-
ties, and functions of the United States to provide 
health care services to Indians and Indian tribes, as 
are or may be hereafter provided by Federal statute 
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112 
or treaties, there is established within the Public 
Health Service of the Department of Health and 
Human Services the Indian Health Service. 
(2) 
ASSISTANT
SECRETARY
OF
INDIAN 
HEALTH.—The Service shall be administered by an 
Assistant Secretary of Indian Health, who shall be 
appointed by the President, by and with the advice 
and consent of the Senate. The Assistant Secretary 
shall report to the Secretary. Effective with respect 
to an individual appointed by the President, by and 
with the advice and consent of the Senate the term 
of service of the Assistant Secretary shall be 4 years. 
An Assistant Secretary may serve more than 1 term. 
(b) AGENCY.—The Service shall be an agency within 
the Public Health Service of the Department, and shall 
not be an office, component, or unit of any other agency 
of the Department. 
(c) FUNCTIONS AND DUTIES.—The Secretary shall 
carry out through the Assistant Secretary of the Service— 
(1) all functions which were, on the day before 
the date of enactment of the Indian Health Care 
Amendments of 1988, carried out by or under the 
direction of the individual serving as Director of the 
Service on such day; 
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113 
(2) all functions of the Secretary relating to the 
maintenance and operation of hospital and health fa-
cilities for Indians and the planning for, and provi-
sion and utilization of, health services for Indians; 
(3) all health programs under which health care 
is provided to Indians based upon their status as In-
dians which are administered by the Secretary, in-
cluding programs under— 
(A) the Indian Health Care Improvement 
Act; 
(B) the Act of November 2, 1921 (25 
U.S.C. 13); 
(C) the Act of August 5, 1954 (42 U.S.C. 
2001, et seq.); 
(D) the Act of August 16, 1957 (42 
U.S.C. 2005 et seq.); 
(E) the Indian Self-Determination Act (25 
U.S.C. 450f, et seq.); and 
(F) title XXX of the Public Health Service 
Act, as added by this Act; and 
(4) all scholarship and loan functions carried 
out under title I of the Indian Health Care Improve-
ment Act. 
(d) AUTHORITY.— 
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114 
(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Assistant Secretary, shall have the au-
thority— 
(A) except to the extent provided for in 
paragraph (2), to appoint and compensate em-
ployees for the Service in accordance with title 
5, United States Code; 
(B) to enter into contracts for the procure-
ment of goods and services to carry out the 
functions of the Service; and 
(C) to manage, expend, and obligate all 
funds appropriated for the Service. 
(2) PERSONNEL
ACTIONS.—Notwithstanding 
any other provision of law, the provisions of section 
12 of the Act of June 18, 1934 (48 Stat. 986; 25 
U.S.C. 472), shall apply to all personnel actions 
taken with respect to new positions created within 
the Service as a result of its establishment under 
subsection (a). 
(e) RATE OF PAY.— 
(1) POSITIONS AT LEVEL IV.—Section 5315 of 
title 5, United States Code, is amended by striking 
the following: ‘‘Assistant Secretaries of Health and 
Human Services (6).’’ and inserting ‘‘Assistant Sec-
retaries of Health and Human Services (7).’’. 
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115 
(2) POSITIONS AT LEVEL V.—Section 5316 of 
such title is amended by striking the following: ‘‘Di-
rector, Indian Health Service, Department of Health 
and Human Services.’’. 
(f) DUTIES OF ASSISTANT SECRETARY FOR INDIAN 
HEALTH.—Section 601 of the Indian Health Care Im-
provement Act (25 U.S.C. 1661) is amended in subsection 
(a)— 
(1) by inserting ‘‘(1)’’ after ‘‘(a)’’; 
(2) in the second sentence of paragraph (1), as 
so designated, by striking ‘‘a Director,’’ and insert-
ing ‘‘the Assistant Secretary for Indian Health,’’; 
(3) by striking the third sentence of paragraph 
(1), as so designated, and all that follows through 
the end of the subsection (a) of such section and in-
serting the following: ‘‘The Assistant Secretary for 
Indian Health shall carry out the duties specified in 
paragraph (2).’’; and 
(4) by adding after paragraph (1) the following: 
‘‘(2) The Assistant Secretary for Indian Health 
shall— 
‘‘(A) report directly to the secretary con-
cerning all policy and budget-related matters 
affecting Indian health; 
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116 
‘‘(B) collaborate with the Assistant Sec-
retary for Health concerning appropriate mat-
ters of Indian health that affect the agencies of 
the Public Health Service; 
‘‘(C) advise each Assistant Secretary of the 
Department of Health and Human Services 
concerning matters of Indian health with re-
spect to which that Assistant Secretary has au-
thority and responsibility; 
‘‘(D) advise the heads of other agencies 
and programs of the Department of Health and 
Human Services concerning matters of Indian 
health with respect to which those heads have 
authority and responsibility; and 
‘‘(E) coordinate the activities of the De-
partment of Health and Human Services con-
cerning matters of Indian health.’’. 
(g) CONTINUED SERVICE BY INCUMBENT.—The indi-
vidual serving in the position of Director of the Indian 
Health Service on the date preceding the date of enact-
ment of this Act may serve as Assistant Secretary for In-
dian Health, at the pleasure of the President after the 
date of enactment of this Act. 
(h) CONFORMING AMENDMENTS.— 
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117 
(1) AMENDMENTS TO INDIAN HEALTH CARE IM-
PROVEMENT
ACT.—The Indian Health Care Im-
provement Act (25 U.S.C. 1601 et seq.) is amend-
ed— 
(A) in section 601— 
(i) in subsection (c), by striking ‘‘Di-
rector of the Indian Health Service’’ both 
places it appears and inserting ‘‘Assistant 
Secretary for Indian Health’’; and 
(ii) in subsection (d), by striking ‘‘Di-
rector of the Indian Health Service’’ and 
inserting ‘‘Assistant Secretary for Indian 
Health’’; and 
(B) in section 816(c)(1), by striking ‘‘Di-
rector of the Indian Health Service’’ and insert-
ing ‘‘Assistant Secretary for Indian Health’’. 
(2) AMENDMENTS TO OTHER PROVISIONS OF 
LAW.—The following provisions are each amended 
by striking ‘‘Director of the Indian Health Service’’ 
each place it appears and inserting ‘‘Assistant Sec-
retary for Indian Health’’: 
(A) Section 203(a)(1) of the Rehabilitation 
Act of 1973 (29 U.S.C. 763(a)(1)). 
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118 
(B) Subsections (b) and (e) of section 518 
of the Federal Water Pollution Control Act (33 
U.S.C. 1377 (b) and (e)). 
(C) Section 803B(d)(1) of the Native 
American Programs Act of 1974 (42 U.S.C. 
2991b–2(d)(1)). 
(i) REFERENCES.—Reference in any other Federal 
law, Executive order, rule, regulation, or delegation of au-
thority, or any document of or relating to the Director 
of the Indian Health Service shall be deemed to refer to 
the Assistant Secretary for Indian Health. 
(j) DEFINITIONS.—For purposes of this section, the 
definitions contained in section 4 of the Indian Health 
Care Improvement Act shall apply. 
SEC. 405. ESTABLISHMENT OF INDIVIDUAL OFFICES OF MI-
NORITY HEALTH WITHIN AGENCIES OF THE 
PUBLIC HEALTH SERVICE. 
Title XVII of the Public Health Service Act (42 
U.S.C. 300u et seq.) is amended by inserting after section 
1707 the following section: 
‘‘INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN 
PUBLIC HEALTH SERVICE 
‘‘SEC. 1707A. 
‘‘(a) IN GENERAL.—The head of each agency speci-
fied in subsection (b)(1) shall establish within the agency 
an office to be known as the Office of Minority Health. 
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119 
Each such Office shall be headed by a director, who shall 
be appointed by the head of the agency within which the 
Office is established, and who shall report directly to the 
head of the agency. The head of such agency shall carry 
out this section (as this section relates to the agency) act-
ing through such Director. 
‘‘(b) SPECIFIED AGENCIES.— 
‘‘(1) IN GENERAL.—The agencies referred to in 
subsection (a) are the following: 
‘‘(A) The Centers for Disease Control and 
Prevention. 
‘‘(B) The Health Resources and Services 
Administration. 
‘‘(C) The Substance Abuse and Mental 
Health Services Administration; and 
‘‘(D) The Administration on Aging. 
‘‘(c) COMPOSITION.—The head of each specified 
agency shall ensure that the officers and employees of the 
minority health office of the agency are, collectively, expe-
rienced in carrying out community-based health programs 
for each of the various racial and ethnic minority groups 
that are present in significant numbers in the United 
States. 
‘‘(d) DUTIES.—Each Director of a minority health of-
fice shall establish and monitor the programs of the speci-
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120 
fied agency of such office in order to carry out the fol-
lowing: 
‘‘(1) Determine the extent to which the pur-
poses of the programs are being carried out with re-
spect to racial and ethnic minority groups; 
‘‘(2) Determine the extent to which members of 
such groups are represented among the Federal offi-
cers and employees who administer the programs; 
and 
‘‘(3) Make recommendations to the head of 
such agency on carrying out the programs with re-
spect to such groups. In the case of programs that 
provide services, such recommendations shall include 
recommendations toward ensuring that— 
‘‘(A) the services are equitably delivered 
with respect to racial and ethnic minority 
groups; 
‘‘(B) the programs provide the services in 
the language and cultural context that is most 
appropriate for the individuals for whom the 
services are intended; and 
‘‘(C) the programs utilize racial and ethnic 
minority community-based organizations to de-
liver services. 
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121 
‘‘(e) BIENNIAL REPORTS TO SECRETARY.—The head 
of each specified agency shall submit to the Secretary for 
inclusion in each biennial report describing— 
‘‘(1) the extent to which the minority health of-
fice of the agency employs individuals who are mem-
bers of racial and ethnic minority groups, including 
a specification by minority group of the number of 
such individuals employed by such office. 
‘‘(f) FUNDING.— 
‘‘(1) ALLOCATIONS.—Of the amounts appro-
priated for a specified agency for a fiscal year, the 
Secretary must designate an appropriate amount of 
funds for the purpose of carrying out activities 
under this section through the minority health office 
of the agency. In reserving an amount under the 
preceding sentence for a minority health office for a 
fiscal year, the Secretary shall reduce, by substan-
tially the same percentage, the amount that other-
wise would be available for each of the programs of 
the designated agency involved. 
‘‘(2) AVAILABILITY
OF
FUNDS
FOR
STAFF-
ING.—The purposes for which amounts made avail-
able under paragraph may be expended by a minor-
ity health office include the costs of employing staff 
for such office.’’. 
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122 
SEC. 406. OFFICE OF MINORITY HEALTH AT THE CENTERS 
FOR MEDICARE & MEDICAID SERVICES. 
(a) IN GENERAL.—Not later than 60 days after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall establish within the Centers for 
Medicare & Medicaid Services an Office of Minority 
Health (referred to in this section as the ‘‘Office’’). 
(b) DUTIES.—The Office shall be responsible for the 
coordination and facilitation of activities of the Centers 
for Medicare & Medicaid Services to improve minority 
health and health care and to reduce racial and ethnic dis-
parities in health and health care, which shall include— 
(1) creating a strategic plan, which shall be 
made available for public review, to improve the 
health and health care of Medicare, Medicaid, and 
SCHIP beneficiaries; 
(2) promoting agency-wide policies relating to 
health care delivery and financing that could have a 
beneficial impact on the health and health care of 
minority populations; 
(3) assisting health plans, hospitals, and other 
health entities in providing culturally and linguis-
tically appropriate health care services; 
(4) increasing awareness and outreach activities 
for minority health care consumers and providers 
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123 
about the causes and remedies for health and health 
care disparities; 
(5) developing grant programs and demonstra-
tion projects to identify, implement and evaluate in-
novative approaches to improving the health and 
health care of minority beneficiaries in the Medicare, 
Medicaid, and SCHIP programs; 
(6) considering incentive programs relating to 
reimbursement that would reward health entities for 
providing quality health care for minority popu-
lations using established benchmarks for quality of 
care; 
(7) collaborating with the compliance office to 
ensure compliance with the anti-discrimination provi-
sions under title VI of the Civil Rights Act of 1964; 
(8) identifying barriers to enrollment in public 
programs under the jurisdiction of the Centers for 
Medicare & Medicaid Services; 
(9) monitoring and evaluating on a regular 
basis the success of minority health programs and 
initiatives; 
(10) publishing an annual report about the ac-
tivities of the Centers for Medicare & Medicaid Serv-
ices relating to minority health improvement; and 
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124 
(11) other activities determined appropriate by 
the Secretary of Health and Human Services. 
(c) STAFF.—The staff at the Office shall include— 
(1) one or more individuals with expertise in 
minority health and racial and ethnic health dispari-
ties; and 
(2) one or more individuals with expertise in 
health care financing and delivery in underserved 
communities. 
(d) COORDINATION.—In carrying out its duties under 
this section, the Office shall coordinate with— 
(1) the Office of Minority Health in the Office 
of the Secretary of Health and Human Services; 
(2) the National Centers for Minority Health 
and Health Disparities in the National Institutes of 
Health; and 
(3) the Office of Minority Health in the Centers 
for Disease Control and Prevention. 
(e) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated $10,000,000 for fiscal year 2008, and 
such sums may be necessary for each of fiscal years 2009 
through 2014. 
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125 
SEC. 407. OFFICE OF MINORITY AFFAIRS AT THE FOOD AND 
DRUG ADMINISTRATION. 
Chapter IX of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 910. OFFICE OF MINORITY AFFAIRS. 
‘‘(a) IN GENERAL.—Not later than 60 days after the 
date of enactment of this section, the Secretary shall es-
tablish within the Office of the Commissioner of Food and 
Drugs an Office of Minority Affairs (referred to in this 
section as the ‘Office’). 
‘‘(b) DUTIES.—The Office shall be responsible for the 
coordination and facilitation of activities of the Food and 
Drug Administration to improve minority health and 
health care and to reduce racial and ethnic disparities in 
health and health care, which shall include— 
‘‘(1) promoting policies in the development and 
review of medical products that reduce racial and 
ethnic disparities in health and health care; 
‘‘(2) encouraging appropriate data collection, 
analysis, and dissemination of racial and ethnic dif-
ferences using, at a minimum, the categories de-
scribed in the 1997 Office of Management and 
Budget standards, in response to different therapies 
in both adult and pediatric populations; 
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126 
‘‘(3) providing, in coordination with other ap-
propriate government agencies, education, training, 
and support to increase participation of minority pa-
tients and physicians in clinical trials; 
‘‘(4) collecting and analyzing data using, at a 
minimum, the categories described in the 1997 Of-
fice of Management and Budget standards, on the 
number of participants from minority racial and eth-
nic backgrounds in clinical trials used to support 
medical product approvals; 
‘‘(5) the identification of methods to reduce lan-
guage and literacy barriers; and 
‘‘(6) publishing an annual report about the ac-
tivities of the Food and Drug Administration per-
taining to minority health. 
‘‘(c) STAFF.—The staff of the Office shall include— 
‘‘(1) one or more individuals with expertise in 
the design and conduct of clinical trials of drugs, bi-
ological products, and medical devices; and 
‘‘(2) one or more individuals with expertise in 
therapeutic classes or disease states for which med-
ical evidence suggests a difference based on race or 
ethnicity. 
‘‘(d) COORDINATION.—In carrying out its duties 
under this section, the Office shall coordinate with— 
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127 
‘‘(1) the Office of Minority Health in the Office 
of the Secretary of Health and Human Services; 
‘‘(2) the National Center for Minority Health 
and Health Disparities in the National Institutes of 
Health; and 
‘‘(3) the Office of Minority Health in the Cen-
ters for Disease Control and Prevention. 
‘‘(e) 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 2008 through 2013.’’. 
SEC. 408. 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 505B the following: 
‘‘SEC. 505C. SAFETY AND EFFECTIVENESS OF DRUGS WITH 
RESPECT TO RACIAL AND ETHNIC BACK-
GROUND. 
‘‘(a) PRE-APPROVAL STUDIES.—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, then— 
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128 
‘‘(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) POST-MARKET 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, post-marketing studies to investigate the dis-
parity. 
‘‘(2) LABELING.—If the Secretary determines 
that the post-market studies confirm that there is a 
disparity described in paragraph (1), the labeling of 
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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, in the 
order requiring post-market 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 
effectiveness of a drug in the same chemical class as 
the drug; 
‘‘(2) evidence that there is a disparity on the 
basis of racial or ethnic background in the way the 
drug is metabolized; and 
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‘‘(3) other evidence as the Secretary may deter-
mine. 
‘‘(d) APPLICATIONS UNDER SECTION 505(b)(2) AND 
505(j).— 
‘‘(1) IN GENERAL.—A drug for which an appli-
cation has been submitted or approved under section 
505(j) shall not be considered ineligible for approval 
under that section or misbranded under section 502 
on the basis that the labeling of the drug omits in-
formation relating to a disparity on the basis of ra-
cial or ethnic background as to the safety or effec-
tiveness of the drug, whether derived from investiga-
tions or studies required under this section or de-
rived from other sources, when the omitted informa-
tion is protected by patent or by exclusivity under 
clause (iii) or (iv) of section 505(j)(5)(B). 
‘‘(2) LABELING.—Notwithstanding clauses (iii) 
and (iv) of section 505(j)(5)(B), the Secretary may 
require that the labeling of a drug approved under 
section 505(j) that omits information relating to a 
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.’’. 
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(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: 
‘‘(y) 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 505C.’’. 
(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 505C’’. 
SEC. 409. UNITED STATES COMMISSION ON CIVIL RIGHTS. 
(a) COORDINATION WITHIN DEPARTMENT OF JUS-
TICE
OF
ACTIVITIES
REGARDING
HEALTH
DISPARI-
TIES.—Section 3 of the Civil Rights Commission Act of 
1983 (42 U.S.C. 1975a) is amended— 
(1) in paragraph (1)(B), by striking ‘‘and’’ at 
the end; 
(2) in paragraph (2), in the matter after and 
below subparagraph (D), by striking the period and 
inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(3) shall, with respect to activities carried out 
in health care and correctional facilities toward the 
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goal of eliminating health disparities between the 
general population and members of racial or ethnic 
minority groups, coordinate such activities of— 
‘‘(A) the Office for Civil Rights within the 
Department of Justice; 
‘‘(B) the Office of Justice Programs within 
the Department of Justice; 
‘‘(C) the Office for Civil Rights within the 
Department of Health and Human Services; 
and 
‘‘(D) the Office of Minority Health within 
the Department of Health and Human Services 
(headed by the Deputy Assistant Secretary for 
Minority Health).’’. 
(b) AUTHORIZATION OF APPROPRIATIONS.—Section 
5 of the Civil Rights Commission Act of 1983 (42 U.S.C. 
1975c) is amended by striking the first sentence and in-
serting the following: ‘‘For the purpose of carrying out 
this Act, there are authorized to be appropriated 
$30,000,000 for fiscal year 2008, and such sums as may 
be necessary for each of the fiscal years 2009 through 
2013.’’. 
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133 
SEC. 410. SENSE OF CONGRESS CONCERNING FULL FUND-
ING OF ACTIVITIES TO ELIMINATE RACIAL 
AND ETHNIC HEALTH DISPARITIES. 
(a) FINDINGS.—Congress makes the following find-
ings: 
(1) The health status of the American populace 
is declining and the United States currently ranks 
below most industrialized nations in health status 
measured by longevity, sickness, and mortality. 
(2) Racial and ethnic minority populations tend 
have the poorest health status and face substantial 
cultural, social, and economic barriers to obtaining 
quality health care. 
(3) Efforts to improve minority health have 
been limited by inadequate resources (funding, staff-
ing, and stewardship) and accountability. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that— 
(1) funding should be doubled by fiscal year 
2008 for the National Center for Minority Health 
Disparities, the Office of Civil Rights in the Depart-
ment of Health and Human Services, the National 
Institute of Nursing Research, and the Office of Mi-
nority Health; 
(2) adequate funding by fiscal year 2008, and 
subsequent funding increases, should be provided for 
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health professions training programs, the Racial and 
Ethnic Approaches to Community Health (REACH) 
at the Center for Disease Control and Prevention, 
the Minority HIV/AIDS Initiative, and the Excel-
lence Centers to Eliminate Ethnic/Racial Disparities 
(EXCEED) Program at the Agency for Healthcare 
Research and Quality; 
(3) current and newly-created health disparity 
elimination incentives, programs, agencies, and de-
partments under this Act (and the amendments 
made by this Act) should receive adequate staffing 
and funding by fiscal year 2008; and 
(4) stewardship and accountability should be 
provided to Congress and the President for measur-
able and sustainable progress toward health dis-
parity elimination. 
SEC. 411. GUIDELINES FOR DISEASE SCREENING FOR MI-
NORITY PATIENTS. 
(a) IN GENERAL.—The Secretary, acting through the 
Director of the Agency for Healthcare Research and Qual-
ity, shall convene a series of meetings to develop guidelines 
for disease screening for minority patient populations 
which have a higher than average risk for many chronic 
diseases and cancers. 
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(b) PARTICIPANTS.—In convening meetings under 
subsection (a), the Secretary shall ensure that meeting 
participants include representatives of— 
(1) professional societies and associations; 
(2) minority health organizations; 
(3) health care researchers and providers, in-
cluding those with expertise in minority health; 
(4) Federal health agencies, including the Of-
fice of Minority Health and the National Institutes 
of Health; and 
(5) other experts determined appropriate by the 
Secretary. 
(c) DISEASES.—Screening guidelines for minority 
populations shall be developed under subsection (a) for— 
(1) hypertension; 
(2) hypercholesterolemia; 
(3) diabetes; 
(4) cardiovascular disease; 
(5) cancers, including breast, prostate, colon, 
cervical, and lung cancer; 
(6) asthma; 
(7) diabetes; 
(8) kidney diseases; 
(9) eye diseases and disorders, including glau-
coma; 
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(10) HIV/AIDS and sexually transmitted dis-
eases; 
(11) uterine fibroids; 
(12) autoimmune disease; 
(13) mental health conditions; 
(14) dental health conditions and oral diseases; 
(15) environmental and related health illnesses 
and conditions; 
(16) Sickle cell disease; 
(17) violence and injury prevention and control; 
(18) genetic and related conditions; 
(19) heart disease and stroke; 
(20) tuberculosis; 
(21) chronic obstructive pulmonary disease; and 
(22) other diseases determined appropriate by 
the Secretary. 
(d) DISSEMINATION.—Not later than 24 months 
after the date of enactment of this title, the Secretary 
shall publish and disseminate to health care provider orga-
nizations the guidelines developed under subsection (a). 
(e) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated to carry out this section, 
sums as may be necessary for each of fiscal years 2008 
through 2013. 
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