II

Calendar No. 526

107TH CONGRESS

2D SESSION S. 1115

[Report No. 107–227]

To amend the Public Health Service Act with respect to making progress

toward the goal of eliminating tuberculosis, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JUNE 27, 2001

Mr. KENNEDY (for himself, Mr. STEVENS, Mr. INOUYE, Mrs. HUTCHISON,

Mr. CORZINE, Mr. TORRICELLI, Ms. LANDRIEU, Mr. BINGAMAN, and

Mrs. MURRAY) introduced the following bill; which was read twice and

referred to the Committee on Health, Education, Labor, and Pensions

JULY 26, 2002

Reported by Mr. KENNEDY, with an amendment

[Strike out all after the enacting clause and insert the part printed in italic]

A BILL

To amend 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,
2

•S 1115 RS

1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Comprehensive Tuber3 culosis Elimination Act of 2001’’.

4 TITLE I—PREVENTIVE HEALTH

5 SERVICES

6 SEC. 101. ADVISORY COUNCIL FOR THE ELIMINATION OF

7 TUBERCULOSIS.

8 Section 317E(f) of the Public Health Service Act (42

9 U.S.C. 247b–6(f)) is amended—

10 (1) by redesignating paragraph (5) as para11 graph (6);

12 (2) by striking paragraphs (2) through (4), and

13 inserting the following:

14 ‘‘(2) DUTIES.—For the purpose of making

15 progress toward the goal of eliminating tuberculosis,

16 the Council shall provide to the Secretary and other

17 appropriate Federal officials advice on coordinating

18 the activities of the Public Health Service and other

19 Federal agencies that relate to such disease and on

20 efficiently utilizing the Federal resources involved.

21 ‘‘(3) NATIONAL PLAN.—In carrying out para22 graph (2), the Council, in consultation with appro23 priate public and private entities, shall make rec24 ommendations on the development and implementa25 tion of a national plan to eliminate tuberculosis in
3

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1 the United States. In carrying out this paragraph,

2 the Council shall—

3 ‘‘(A) consider the recommendations of the

4 Institute of Medicine regarding the elimination

5 of tuberculosis;

6 ‘‘(B) address the development and applica7 tion of new technologies; and

8 ‘‘(C) review the extent to which progress

9 has been made toward eliminating tuberculosis.

10 ‘‘(4) GLOBAL ACTIVITIES.—In carrying out

11 paragraph (2), the Council, in consultation with ap12 propriate public and private entities, shall make rec13 ommendations for the development and implementa14 tion of a plan to guide the involvement of the United

15 States in global tuberculosis-control activities, in16 cluding recommendations regarding policies, strate17 gies, objectives, and priorities. Such recommenda18 tions for the plan shall have a focus on high inci19 dence countries and on access to a comprehensive

20 package of tuberculosis control measures, as defined

21 by the World Health Organization directly observed

22 treatment, short course strategy (commonly known

23 as DOTS).

24 ‘‘(5) COMPOSITION.—The Council shall be com25 posed of—
4

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1 ‘‘(A) representatives from the Centers for

2 Disease Control and Prevention, the National

3 Institutes of Health, the Agency for Healthcare

4 Research and Quality, the U.S.-Mexico Border

5 Health Commission, and other Federal depart6 ments and agencies that carry out significant

7 activities relating to tuberculosis; and

8 ‘‘(B) members appointed from among indi9 viduals who are not officers or employees of the

10 Federal Government.’’; and

11 (3) by adding at the end the following:

12 ‘‘(7) APPLICABILITY OF FACA.—The Council

13 shall be subject to the Federal Advisory Committee

14 Act (5 U.S.C. App.).’’.

15 TITLE II—CENTERS FOR DIS16 EASE CONTROL AND PREVEN17 TION

18 SEC. 201. NATIONAL PROGRAM FOR TUBERCULOSIS ELIMI19 NATION.

20 Section 317E of the Public Health Service Act (42

21 U.S.C. 247b–6) is amended—

22 (1) by striking the heading for the section and

23 inserting the following:
5

•S 1115 RS

1 ‘‘NATIONAL PROGRAM FOR TUBERCULOSIS

2 ELIMINATION’’;

3 (2) by amending subsection (b) to read as fol4 lows:

5 ‘‘(b) RESEARCH, DEMONSTRATION PROJECTS, EDU6 CATION, AND TRAINING.—With respect to the prevention,

7 control, and elimination of tuberculosis, the Secretary

8 may, directly or through grants to public or nonprofit pri9 vate entities, carry out the following:

10 ‘‘(1) Research, with priority given to research

11 concerning—

12 ‘‘(A) diagnosis and treatment of latent in13 fection of tuberculosis;

14 ‘‘(B) strains of tuberculosis resistant to

15 drugs;

16 ‘‘(C) cases of tuberculosis that affect cer17 tain populations; and

18 ‘‘(D) clinical trials, including a tuberculosis

19 trials consortium.

20 ‘‘(2) Demonstration projects, including for—

21 ‘‘(A) the development of regional capabili22 ties for the prevention, control, and elimination

23 of tuberculosis; and

24 ‘‘(B) collaboration with the Immigration

25 and Naturalization Service to identify and treat
6

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1 immigrants with active or latent tuberculosis in2 fection.

3 ‘‘(3) Public information and education pro4 grams.

5 ‘‘(4) Education, training and clinical skills im6 provement activities for health professionals, includ7 ing allied health personnel.

8 ‘‘(5) Support of model centers to carry out ac9 tivities under paragraphs (2) through (4).

10 ‘‘(6) Collaboration with international organiza11 tions and foreign countries in carrying out such ac12 tivities, including coordinating activities through the

13 Advisory Council for the Elimination of Tuber14 culosis.’’; and

15 (3) by striking subsection (g) and inserting the

16 following:

17 ‘‘(g) REPORTS.—The Secretary, acting through the

18 Director of the Centers for Disease Control and Preven19 tion and in consultation with the Advisory Council for the

20 Elimination of Tuberculosis, shall biennially prepare and

21 submit to the Committee on Health, Education, Labor,

22 and Pensions of the Senate and the Committee on Energy

23 and Commerce of the House of Representatives, a report

24 on the activities carried out under this section. Each re25 port shall include the opinion of the Council on the extent
7

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1 to which the recommendations of the Institute of Medicine

2 regarding tuberculosis have been implemented.’’; and

3 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the

4 purpose of carrying out this section, there are authorized

5 to be appropriated $528,000,000 for fiscal year 2002, and

6 such sums as may be necessary for each of the fiscal years

7 2003 through 2006.’’.

8 TITLE III—NATIONAL

9 INSTITUTES OF HEALTH

10 SEC. 301. ACTIVITIES OF NATIONAL HEART, LUNG, AND

11 BLOOD INSTITUTE.

12 Subpart 2 of part C of title IV of the Public Health

13 Service Act (42 U.S.C. 285b et seq.) is amended by insert14 ing after section 424B the following:

15 ‘‘TUBERCULOSIS

16 ‘‘SEC. 424C. (a) IN GENERAL.—The Director of the

17 Institute shall expand, intensify, and coordinate research

18 and related activities of the Institute with respect to tuber19 culosis, including activities toward the goal of eliminating

20 such disease.

21 ‘‘(b) CERTAIN ACTIVITIES.—Activities under sub22 section (a) shall include—

23 ‘‘(1) enhancing basic and clinical research on

24 tuberculosis; and
8

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1 ‘‘(2) expanding research on the relationship be2 tween such disease and the human immunodeficiency

3 virus.

4 ‘‘(c) RESEARCH EDUCATION.—

5 ‘‘(1) TUBERCULOSIS ACADEMIC AWARDS.—The

6 Director of the Institute may provide awards to fac7 ulty of schools of medicine, nursing, or osteopathic

8 medicine for information and education programs,

9 including the development of curricula, to signifi10 cantly increase the opportunities for students and

11 for practicing providers to learn the principles and

12 practices of preventing, managing, and controlling

13 tuberculosis.

14 ‘‘(2) TUBERCULOSIS/PULMONARY INFECTION

15 AWARDS.—The Director of the Institute may provide

16 awards to support the career development of clini17 cally trained professionals who are committed to re18 search regarding pulmonary infections, including tu19 berculosis, by providing for supervised study and re20 search.

21 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

22 ‘‘(A) TUBERCULOSIS ACADEMIC

23 AWARDS.—For the purpose of carrying out

24 paragraph (1), there are authorized to be ap25 propriated $5,000,000 for fiscal year 2002, and
9

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1 such sums as may be necessary for each of the

2 fiscal years 2003 through 2006.

3 ‘‘(B) TUBERCULOSIS/PULMONARY INFEC4 TION AWARDS.—For the purpose of carrying

5 out paragraph (2), there are authorized to be

6 appropriated $5,000,000 for fiscal year 2002,

7 and such sums as may be necessary for each of

8 the fiscal years 2003 through 2006.’’.

9 SEC. 302. ACTIVITIES OF NATIONAL INSTITUTE OF AL10 LERGY AND INFECTIOUS DISEASES.

11 Section 447A of the Public Health Service Act (42

12 U.S.C. 285f–2) is amended—

13 (1) by redesignating subsection (b) as sub14 section (c);

15 (2) by inserting after subsection (a) the fol16 lowing subsection:

17 ‘‘(b) Activities under subsection (a) shall include ac18 tivities to develop a tuberculosis vaccine. Such activities

19 shall be carried out in accordance with the blueprint for

20 tuberculosis vaccine development described in the report

21 prepared pursuant to the workshop convened in March

22 1998 by the Advisory Council for Elimination of Tuber23 culosis, the Director of the National Vaccine Program,

24 and the Director of the Institute.’’; and
10

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1 (3) in subsection (c) (as so redesignated), in the

2 first sentence—

3 (A) by striking ‘‘and’’ after ‘‘1994,’’; and

4 (B) by inserting before the period the fol5 lowing: ‘‘, $240,000,000 for fiscal year 2002,

6 and such sums as may be necessary for each of

7 the fiscal years 2003 through 2006’’.

8 SEC. 303. JOHN E. FOGARTY INTERNATIONAL CENTER FOR

9 ADVANCED STUDY IN THE HEALTH

10 SCIENCES.

11 Section 482 of the Public Health Service Act (42

12 U.S.C. 287b) is amended—

13 (1) by inserting ‘‘(a) IN GENERAL.—’’ before

14 ‘‘The general purpose’’;

15 (2) in subsection (a) (as so designated), by in16 serting after ‘‘Health Sciences’’ the following: ‘‘(in

17 this subpart referred to as the ‘Center’)’’; and

18 (3) by adding at the end the following:

19 ‘‘(b) TUBERCULOSIS.—

20 ‘‘(1) IN GENERAL.—In carrying out subsection

21 (a) with respect to tuberculosis, the Center shall ex22 pand, intensify, and coordinate international activi23 ties of the Center for research and training. In par24 ticular, the Center shall expand its activities to in-
11

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1 clude support for clinical, operational, and health

2 services research and training.

3 ‘‘(2) INTERNATIONAL TRAINING PROGRAM.—In

4 carrying out paragraph (1), the Center shall carry

5 out an international training program regarding tu6 berculosis. Such program shall be modeled after the

7 international training program carried out by the

8 Center with respect to the human immunodeficiency

9 virus.’’.

10 SEC. 304. LOAN REPAYMENT PROGRAMS REGARDING RE11 SEARCH ON TUBERCULOSIS.

12 Part G of title IV of the Public Health Service Act

13 (42 U.S.C. 288 et seq.) is amended—

14 (1) by redesignating the second section 487F as

15 section 487G; and

16 (2) by inserting after section 487G (as so re17 designated) the following section:

18 ‘‘LOAN REPAYMENTS REGARDING RESEARCH ON

19 TUBERCULOSIS

20 ‘‘SEC. 487H. In carrying out sections 487C, 487E,

21 and 487F, the Secretary shall seek to ensure that, for fis22 cal year 2002 and subsequent fiscal years, a portion of

23 amounts appropriated to carry out such sections is re24 served for the purpose of entering into contracts under

25 which (in accordance with the section involved) individuals

26 will conduct research on tuberculosis.’’.
12

•S 1115 RS

1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Comprehensive Tuber3 culosis Elimination Act of 2002’’.

4 TITLE I—PREVENTIVE HEALTH

5 SERVICES

6 SEC. 101. ADVISORY COUNCIL FOR THE ELIMINATION OF

7 TUBERCULOSIS.

8 Section 317E(f) of the Public Health Service Act (42

9 U.S.C. 247b–6(f)) is amended—

10 (1) by redesignating paragraph (5) as para11 graph (6); and

12 (2) by striking paragraphs (2) through (4), and

13 inserting the following:

14 ‘‘(2) DUTIES.—For the purpose of making

15 progress toward the goal of eliminating tuberculosis

16 from the United States, the Council shall provide to

17 the Secretary and other appropriate Federal officials

18 advice on coordinating the activities of the Public

19 Health Service and other Federal agencies that relate

20 to such disease and on efficiently utilizing the Federal

21 resources involved.

22 ‘‘(3) NATIONAL PLAN.—In carrying out para23 graph (2), the Council, in consultation with appro24 priate public and private entities, shall make rec25 ommendations on the development, revision, and im26 plementation of a national plan to eliminate tuber-
13

•S 1115 RS

1 culosis in the United States. In carrying out this

2 paragraph, the Council shall—

3 ‘‘(A) consider the recommendations of the

4 Institute of Medicine regarding the elimination

5 of tuberculosis;

6 ‘‘(B) address the development and applica7 tion of new technologies; and

8 ‘‘(C) review the extent to which progress has

9 been made toward eliminating tuberculosis.

10 ‘‘(4) GLOBAL ACTIVITIES.—In carrying out

11 paragraph (2), the Council, in consultation with ap12 propriate public and private entities, shall make rec13 ommendations for the development and implementa14 tion of a plan to guide the involvement of the United

15 States in global and cross border tuberculosis-control

16 activities, including recommendations regarding poli17 cies, strategies, objectives, and priorities. Such rec18 ommendations for the plan shall have a focus on

19 countries where a high incidence of tuberculosis di20 rectly affects the United States, such as Mexico, and

21 on access to a comprehensive package of tuberculosis

22 control measures, as defined by the World Health Or23 ganization directly observed treatment, short course

24 strategy (commonly known as DOTS).
14

•S 1115 RS

1 ‘‘(5) COMPOSITION.—The Council shall be com2 posed of—

3 ‘‘(A) representatives from the Centers for

4 Disease Control and Prevention, the National In5 stitutes of Health, the Agency for Healthcare Re6 search and Quality, the Health Resources and

7 Services Administration, the U.S.-Mexico Border

8 Health Commission, and other Federal depart9 ments and agencies that carry out significant ac10 tivities relating to tuberculosis; and

11 ‘‘(B) members appointed from among indi12 viduals who are not officers or employees of the

13 Federal Government.’’.

14 TITLE II—CENTERS FOR DIS15 EASE CONTROL AND PREVEN16 TION

17 SEC. 201. NATIONAL PROGRAM FOR TUBERCULOSIS ELIMI18 NATION.

19 Section 317E of the Public Health Service Act (42

20 U.S.C. 247b–6) is amended—

21 (1) by striking the heading for the section and

22 inserting the following:

23 ‘‘NATIONAL PROGRAM FOR TUBERCULOSIS ELIMINATION’’;

24 (2) by amending subsection (b) to read as fol25 lows:
15

•S 1115 RS

1 ‘‘(b) RESEARCH, DEMONSTRATION PROJECTS, EDU2 CATION, AND TRAINING.—With respect to the prevention,

3 control, and elimination of tuberculosis, the Secretary may,

4 directly or through grants to public or nonprofit private

5 entities, carry out the following:

6 ‘‘(1) Research, with priority given to research

7 concerning—

8 ‘‘(A) diagnosis and treatment of latent in9 fection of tuberculosis;

10 ‘‘(B) strains of tuberculosis resistant to

11 drugs;

12 ‘‘(C) cases of tuberculosis that affect certain

13 high-risk populations; and

14 ‘‘(D) clinical trials, including those con15 ducted through the Tuberculosis Trials Consor16 tium.

17 ‘‘(2) Demonstration projects, including for—

18 ‘‘(A) the development of regional capabili19 ties for the prevention, control, and elimination

20 of tuberculosis particularly in low-incidence re21 gions; and

22 ‘‘(B) collaboration with the Immigration

23 and Naturalization Service to identify and treat

24 immigrants with active or latent tuberculosis in25 fection.
16

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1 ‘‘(3) Public information and education pro2 grams.

3 ‘‘(4) Education, training and clinical skills im4 provement activities for health professionals, includ5 ing allied health personnel.

6 ‘‘(5) Support of model centers to carry out ac7 tivities under paragraphs (2) through (4).

8 ‘‘(6) Collaboration with international organiza9 tions and foreign countries, including Mexico, in co10 ordination with the United States Agency for Inter11 national Development, in carrying out such activities,

12 including coordinating activities through the Advi13 sory Council for the Elimination of Tuberculosis.’’;

14 and

15 (3) by striking subsection (g) and inserting the

16 following:

17 ‘‘(g) REPORTS.—The Secretary, acting through the Di18 rector of the Centers for Disease Control and Prevention

19 and in consultation with the Advisory Council for the

20 Elimination of Tuberculosis, shall biennially prepare and

21 submit to the Committee on Health, Education, Labor, and

22 Pensions of the Senate and the Committee on Energy and

23 Commerce of the House of Representatives, a report on the

24 activities carried out under this section. Each report shall

25 include the opinion of the Council on the extent to which
17

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1 its recommendations under section 317E(f)(3) regarding tu2 berculosis have been implemented.’’; and

3 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the

4 purpose of carrying out this section, there are authorized

5 to be appropriated $235,000,000 for fiscal year 2003, and

6 such sums as may be necessary for each of the fiscal years

7 2004 through 2007.’’.

8 TITLE III—NATIONAL

9 INSTITUTES OF HEALTH

10 SEC. 301. ACTIVITIES OF NATIONAL HEART, LUNG, AND

11 BLOOD INSTITUTE.

12 Subpart 2 of part C of title IV of the Public Health

13 Service Act (42 U.S.C. 285b et seq.) is amended by inserting

14 after section 424B the following:

15 ‘‘TUBERCULOSIS

16 ‘‘SEC. 424C. (a) IN GENERAL.—The Director of the In17 stitute shall expand, intensify, and coordinate research and

18 related activities of the Institute with respect to the treat19 ment, diagnosis, and prevention of tuberculosis,

20 including—

21 ‘‘(1) basic and clinical research on tuberculosis;

22 and

23 ‘‘(2) research on the relationship between tuber24 culosis and the human immunodeficiency virus.

25 ‘‘(b) RESEARCH EDUCATION.—
18

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1 ‘‘(1) TUBERCULOSIS ACADEMIC AWARDS.—The

2 Director of the Institute may award grants to institu3 tions for the development and support of programs of

4 core curricula for training clinical investigators, in5 cluding medical, nursing, or osteopathic students, in

6 the principles and practices of preventing, managing,

7 and controlling tuberculosis in patients.

8 ‘‘(2) TUBERCULOSIS/PULMONARY INFECTION

9 AWARDS.—The Director of the Institute may provide

10 awards to support the research of trained profes11 sionals into the basic biological processes and mecha12 nisms involved in tuberculosis, as well as research

13 into the development of new diagnostic techniques and

14 treatments.

15 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For

16 the purpose of carrying out this subsection, there are

17 authorized to be appropriated $10,000,000 for fiscal

18 year 2003, and such sums as may be necessary for

19 each of the fiscal years 2004 through 2007.’’.

20 SEC. 302. ACTIVITIES OF NATIONAL INSTITUTE OF ALLERGY

21 AND INFECTIOUS DISEASES.

22 Section 447A of the Public Health Service Act (42

23 U.S.C. 285f–2) is amended—

24 (1) by redesignating subsection (b) as subsection

25 (c);
19

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1 (2) by inserting after subsection (a) the following

2 subsection:

3 ‘‘(b) Activities under subsection (a) may include ac4 tivities to develop a tuberculosis vaccine. The recommenda5 tions contained within the Blueprint for Tuberculosis Vac6 cine Development, described in the report prepared pursu7 ant to the workshop convened in March 1998 by the Direc8 tor of the Institute, shall be taken into consideration.’’; and

9 (3) in subsection (c) (as so redesignated), in the

10 first sentence—

11 (A) by striking ‘‘and’’ after ‘‘1994,’’; and

12 (B) by inserting before the period the fol13 lowing: ‘‘, $136,000,000 for fiscal year 2003,

14 $162,000,000 for fiscal year 2004, and such sums

15 as may be necessary for each of the fiscal years

16 2005 through 2007’’.

17 SEC. 303. JOHN E. FOGARTY INTERNATIONAL CENTER FOR

18 ADVANCED STUDY IN THE HEALTH SCIENCES.

19 (a) IN GENERAL.—With respect to tuberculosis, the

20 John E. Fogarty International Center for Advanced Study

21 in the Health Sciences shall expand, intensify, and coordi22 nate international activities of the Center for research and

23 training. In particular, the Center shall expand its activi24 ties to include support for clinical, operational, and health

25 services research and training.
20

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1 (b) INTERNATIONAL TRAINING PROGRAM.—In car2 rying out subsection (a), the Center shall carry out an

3 international training program regarding tuberculosis.

4 Such program shall be modeled after the international

5 training program carried out by the Center with respect

6 to the human immunodeficiency virus.

Calendar No. 526

107TH CONGRESS

2D SESSION S. 1115

[Report No. 107–227]

A BILL

To amend the Public Health Service Act with respect to making progress toward the goal of

eliminating tuberculosis, and for other purposes.

JULY 26, 2002

Reported with an amendment