1180 
(2) a comprehensive mortality reduction pro-
gram coordinated by the Secretary of Health and 
Human Services is justified and necessary to ade-
quately address and reduce lung cancer mortality. 
(c) LUNG CANCER MORTALITY REDUCTION PRO-
GRAM.— 
(1) IN GENERAL.—Subpart 1 of part C of title 
IV of the Public Health Service Act (42 U.S.C. 285 
et seq.) is amended by adding at the end the fol-
lowing: 
‘‘SEC. 417H. LUNG CANCER MORTALITY REDUCTION PRO-
GRAM. 
‘‘(a) IN GENERAL.—Not later than 6 months after 
the date of the enactment of the Health Equity and Ac-
countability Act of 2022, the Secretary, in consultation 
with the Secretary of Defense, the Secretary of Veterans 
Affairs, the Director of the National Institutes of Health, 
the Director of the Centers for Disease Control and Pre-
vention, the Commissioner of Food and Drugs, the Admin-
istrator of the Centers for Medicare & Medicaid Services, 
the Director of the National Institute on Minority Health 
and Health Disparities, the Administrator of the Environ-
mental Protection Agency, and other members of the 
Lung Cancer Advisory Board established under section 
7001 of the Health Equity and Accountability Act of 
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2022, shall implement a comprehensive program, to be 
known as the Lung Cancer Mortality Reduction Program, 
to achieve a reduction of at least 25 percent in the mor-
tality rate of lung cancer by 2027. 
‘‘(b) REQUIREMENTS.—The Program shall include at 
least the following: 
‘‘(1) With respect to the National Institutes of 
Health— 
‘‘(A) a strategic review and prioritization 
by the National Cancer Institute of research 
grants to achieve the goal specified in sub-
section (a); 
‘‘(B) the provision of funds to enable the 
Airway Biology and Disease Branch of the Na-
tional Heart, Lung, and Blood Institute to ex-
pand its research programs to include pre-
dispositions to lung cancer, the interrelationship 
between lung cancer and other pulmonary and 
cardiac disease, and the diagnosis and treat-
ment of such diseases; 
‘‘(C) the provision of funds to enable the 
National Institute of Biomedical Imaging and 
Bioengineering to expedite the development of 
computer-assisted diagnostic, surgical, treat-
ment, and drug-testing innovations to reduce 
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lung cancer mortality, such as through expan-
sion of the Institute’s Quantum Grant Program 
and Image-Guided Interventions program; and 
‘‘(D) the provision of funds to enable the 
National Institute of Environmental Health 
Sciences to implement research programs rel-
ative to the lung cancer incidence. 
‘‘(2) With respect to the Food and Drug Ad-
ministration— 
‘‘(A) activities under section 529B of the 
Federal Food, Drug, and Cosmetic Act; and 
‘‘(B) activities under section 561 of the 
Federal Food, Drug, and Cosmetic Act to ex-
pand access to investigational drugs and devices 
for the diagnosis, monitoring, or treatment of 
lung cancer. 
‘‘(3) With respect to the Centers for Disease 
Control and Prevention, the establishment of an 
early disease research and management program 
under section 1511. 
‘‘(4) With respect to the Agency for Healthcare 
Research and Quality, the conduct of a biannual re-
view of lung cancer screening, diagnostic, and treat-
ment protocols, and the issuance of updated guide-
lines. 
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‘‘(5) The promotion (including education) of 
lung cancer screening within minority and rural pop-
ulations and the study of the effectiveness of efforts 
to increase such screening. 
‘‘(6) The cooperation and coordination of all 
minority and health disparity programs within the 
Department of Health and Human Services to en-
sure that all aspects of the Lung Cancer Mortality 
Reduction Program under this section adequately 
address the burden of lung cancer on minority and 
rural populations. 
‘‘(7) The cooperation and coordination of all to-
bacco control and cessation programs within agen-
cies of the Department of Health and Human Serv-
ices to achieve the goals of the Lung Cancer Mor-
tality Reduction Program under this section with 
particular emphasis on the coordination of drug and 
other cessation treatments with early detection pro-
tocols.’’. 
(2) FEDERAL
FOOD, DRUG, AND
COSMETIC 
ACT.—Subchapter B of chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360aaa et 
seq.) is amended by adding at the end the following: 
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‘‘SEC. 529B. DRUGS RELATING TO LUNG CANCER. 
‘‘(a) IN GENERAL.—The provisions of this sub-
chapter shall apply to a drug described in subsection (b) 
to the same extent and in the same manner as such provi-
sions apply to a drug for a rare disease or condition (as 
defined in section 526). 
‘‘(b) QUALIFIED DRUGS.—A drug described in this 
subsection is— 
‘‘(1) a chemoprevention drug for precancerous 
conditions of the lung; 
‘‘(2) a drug for targeted therapeutic treat-
ments, including any vaccine, for lung cancer; or 
‘‘(3) a drug to curtail or prevent nicotine addic-
tion. 
‘‘(c) BOARD.—The Board established under section 
7001 of the Health Equity and Accountability Act of 2022 
shall monitor the program implemented under this sec-
tion.’’. 
(3) ACCESS TO UNAPPROVED THERAPIES.—Sec-
tion 561(e) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb(e)) is amended by in-
serting before the period the following: ‘‘and shall 
include expanding access to drugs under section 
529B, with substantial consideration being given to 
whether the totality of information available to the 
Secretary regarding the safety and effectiveness of 
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