I 

113TH CONGRESS 

2D SESSION H. R. 5835 

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 

Service Act with respect to making progress toward the goal of eliminating tuberculosis, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 10, 2014 

Mr. GENE GREEN of Texas introduced the following bill; which was referred 

to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act and 

the Public Health Service Act with respect to making 

progress toward the goal of eliminating tuberculosis, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Comprehensive TB 

5 Elimination Act of 2014’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 


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1 (1) Each year approximately 9,000,000 people 

2 become ill with active tuberculosis (TB), an airborne 

3 infectious disease, and it is estimated that 1,500,000 

4 of those people die, making TB the second leading 

5 global infectious disease killer. 

6 (2) There is a global underinvestment in quality 

7 TB control, and in the research and development of 

8 new drugs, diagnostics and a vaccine, as well as in 

9 the relationship between TB and HIV/AIDS. 

10 (3) The increasing occurrence of multi-drug re11 sistant (‘‘MDR’’) TB, including extensively drug re12 sistant (‘‘XDR’’) TB which is resistant to at least 

13 two of the recommended first-line drugs and the rec14 ommended second-line medications, is a serious and 

15 emerging global health problem. 

16 (4) Cases of TB are reported annually in every 

17 State within the United States, with a total of 9,582 

18 cases of active TB reported in the United States in 

19 2013. 

20 (5) In addition to those with active TB, an esti21 mated 8,000,000 to 10,000,000 people in the United 

22 States are infected with the TB bacteria. 

23 (6) Drug-resistant TB poses a particular chal24 lenge to domestic TB control due to the high costs 

25 of treatment and intensive health care resources reVerDate Sep 11 2014 23:56 Dec 19, 2014 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5835.IH H5835

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1 quired. Treatment costs for MDR TB range from 

2 $100,000 to $300,000, which can cause a serious 

3 strain on State public health budgets. 

4 (7) In 2013, the United States experienced seri5 ous shortages of first- and second-line TB drugs and 

6 biologics, including isoniazid, the first-line TB drug, 

7 and tubersol, the biologic used in TB skin tests. 

8 (8) New tools are urgently needed to more ef9 fectively prevent, diagnose, and treat TB. Within the 

10 last 40 years, only one new TB drug has been devel11 oped and approved in the United States, and the 

12 treatment regimen for MDR TB remains excessively 

13 lengthy, toxic, and difficult for patients to tolerate. 

14 The existing vaccine, which is not used in the United 

15 States, confers no protection to adolescents and 

16 adults, protecting only against pulmonary TB in in17 fants and children. 

18 (9) The expertise in identifying, treating, and 

19 preventing TB is within the Centers for Disease 

20 Control and Prevention and the United States public 

21 health system. The identification and preventive 

22 treatment of the millions of people in the United 

23 States with TB infection, representing the reservoir 

24 of future active TB cases, is a key component of the 

25 strategy to eliminate TB in the United States. 


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1 SEC. 3. FOOD AND DRUG ADMINISTRATION. 

2 Clause (i) of section 506D(a)(1)(B) of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 356d(a)(1)(B)) 

4 is amended to read as follows: 

5 ‘‘(i) plans for enhanced interagency 

6 and intra-agency coordination, communica7 tion, and decisionmaking, including by en8 suring coordination between the task force 

9 established under this section and the Fed10 eral Tuberculosis Task Force under section 

11 317E(g) of the Public Health Service Act 

12 in the development and implementation of 

13 strategies and systems to prevent and miti14 gate shortages of drugs used in connection 

15 with tuberculosis;’’. 

16 SEC. 4. CENTERS FOR DISEASE CONTROL AND PREVEN17 TION; HEALTH RESOURCES AND SERVICES 

18 ADMINISTRATION. 

19 (a) PRIORITIZING PROGRAMS FOR HIGH-RISK POPU20 LATIONS, INCLUDING FOREIGN-BORN, HOMELESS, AND

21 UNINSURED POPULATIONS.—Subsection (a) of section 

22 317E of the Public Health Service Act (42 U.S.C. 247b– 

23 6) is amended— 

24 (1) by striking ‘‘The Secretary’’ and inserting 

25 the following: 

26 ‘‘(1) GRANTS.—The Secretary’’; and 


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1 (2) by adding at the end the following: 

2 ‘‘(2) PRIORITY.—In making grants under this 

3 subsection, the Secretary shall give priority to 

4 awarding grants to State health departments pro5 posing to focus on the prevention, control, and elimi6 nation of tuberculosis in high-risk populations, in7 cluding foreign-born, homeless, and uninsured popu8 lations.’’. 

9 (b) GRANTS FOR COORDINATION OF PROGRAMS AND

10 SERVICES FOR PREVENTION, DIAGNOSIS, AND TREAT11 MENT.— 

12 (1) GRANTS.—Section 317E of the Public 

13 Health Service Act (42 U.S.C. 247b–6) is amend14 ed— 

15 (A) by redesignating subsections (c) 

16 through (h) as subsections (d) through (i), re17 spectively; and 

18 (B) by inserting after subsection (b) the 

19 following: 

20 ‘‘(c) GRANTS FOR COORDINATION OF PROGRAMS AND

21 SERVICES FOR PREVENTION, DIAGNOSIS, AND TREAT22 MENT.— 

23 ‘‘(1) GRANTS.—The Secretary, acting through 

24 the Administrator of the Health Resources and Serv25 ices Administration, may award grants to State and 


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1 local governments and Federally qualified health 

2 centers for coordinating the programs and services 

3 of such governments and centers to ensure timely 

4 and appropriate prevention, diagnosis, and treat5 ment of tuberculosis. 

6 ‘‘(2) DEFINITION.—In this subsection, the term 

7 ‘Federally qualified health center’ has the meaning 

8 given to such term in section 1861(aa) of the Social 

9 Security Act.’’. 

10 (2) CONFORMING CHANGES.—Section 317E of 

11 the Public Health Service Act (42 U.S.C. 247b–6) 

12 is amended— 

13 (A) in subsections (d), (e)(1), (e)(3)(A), 

14 and (f)(1), as redesignated, by striking ‘‘sub15 section (a) or (b)’’ each place it appears and in16 serting ‘‘subsection (a), (b), or (c)’’; and 

17 (B) in subsection (e)(3)(A), as redesig18 nated, by inserting ‘‘(subject to subsection 

19 (a)(2))’’ after ‘‘highest priority’’. 

20 (c) FEDERAL TUBERCULOSIS TASK FORCE.—Para21 graph (1) of section 317E(h) of the Public Health Service 

22 Act (42 U.S.C. 247b–6(g)), as redesignated, is amended 

23 to read as follows: 

24 ‘‘(1) DUTIES.—The Federal Tuberculosis Task 

25 Force (in this subsection referred to as the ‘Task 


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1 Force’) shall provide to the Secretary and other ap2 propriate Federal officials advice on— 

3 ‘‘(A) research into new tools under sub4 section (b)(2) and ensuring access to such new 

5 tools; and 

6 ‘‘(B) the development and implementation 

7 of strategies and systems to prevent and miti8 gate shortages of drugs used in connection with 

9 tuberculosis.’’. 

10 (d) REAUTHORIZATION OF NATIONAL STRATEGY FOR

11 COMBATING AND ELIMINATING TUBERCULOSIS.—Section 

12 317E(i)(1)(A) of the Public Health Service Act (42 U.S.C. 

13 247b–6(h)(1)(A)) is amended by striking ‘‘$243,101,250 

14 for fiscal year 2013’’ and inserting ‘‘$243,101,250 for 

15 each of fiscal years 2013 through 2019’’. 

16 SEC. 5. NATIONAL INSTITUTES OF HEALTH. 

17 Paragraph (1) of section 424C(b) of the Public 

18 Health Service Act (42 U.S.C. 285b–7c(b)) is amended 

19 to read as follows: 

20 ‘‘(1) enhancing basic, clinical, and operational 

21 research on tuberculosis, including with respect to— 

22 ‘‘(A) drug resistant tuberculosis; 

23 ‘‘(B) infection with, and the progression of, 

24 tuberculosis; and 


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1 ‘‘(C) pediatric tuberculosis;’’. 

Æ 


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