II

103D CONGRESS

1ST SESSION S. 1249

To amend the Public Health Service Act to provide for the prevention,

control, and elimination of tuberculosis, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JULY 15 (legislative day, JUNE 30), 1993

Mr. KENNEDY (for himself, Mrs. KASSEBAUM, Mr. METZENBAUM, Mr. JEFFORDS, Mr. HATCH, Mr. WOFFORD, Mr. DURENBERGER, Mr.

WELLSTONE, and Mr. SIMON) introduced the following bill; which was

read twice and referred to the Committee on Labor and Human Resources

A BILL

To amend the Public Health Service Act to provide for

the prevention, control, and elimination of 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 ‘‘Tuberculosis Preven5 tion and Control Amendments of 1993’’.

6 SEC. 2. FINDINGS.

7 Congress finds that—
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1 (1) between 10,000,000 and 15,000,000 people

2 in the United States have been infected with tuber3 culosis, nearly 26,000 new active cases are reported

4 each year, and over 1,700 tuberculosis-related

5 deaths occur each year;

6 (2) the number of reported cases of tuberculosis

7 has risen from 22,201 in 1985 to 26,673 in 1992,

8 representing 51,000 more cases than those that

9 would have been expected since 1985;

10 (3) a recent national survey discovered that

11 14.4 percent of all active tuberculosis cases were re12 sistant to at least one drug;

13 (4) drug resistant tuberculosis strains can cost

14 more than $150,000 to treat, and even then, be15 tween 40 and 60 percent of the patients receiving

16 such treatment die;

17 (5) in 1992, tuberculosis cases were reported to

18 the Centers for Disease Control and Prevention by

19 all 50 States, and cases resistant to one or more tu20 berculosis drugs were reported in at least 36 States,

21 the District of Columbia and Puerto Rico;

22 (6) in 1992, 27 percent of the reported cases of

23 tuberculosis occurred in foreign born persons;

24 (7) one third of the world’s population harbors

25 tuberculosis; and
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1 (8) among infectious diseases tuberculosis is

2 still the number one killer in the world with an esti3 mated 8,000,000 new cases each year and 2,900,000

4 deaths.

5 SEC. 3. PROGRAMS OF CENTERS FOR DISEASE CONTROL

6 AND PREVENTION.

7 (a) PROVISION OF SERVICES FOR PREVENTION, CON8 TROL, AND ELIMINATION.—Section 317(j)(2) of the Pub9 lic Health Service Act (42 U.S.C. 247b(j)(2)) is amended

10 in the first sentence by striking ‘‘and’’ after ‘‘1991,’’ and

11 all that follows through ‘‘1995’’ and inserting the follow12 ing: ‘‘, $104,000,000 for fiscal year 1994, and such sums

13 as may be necessary for each of the fiscal years 1995

14 through 1997’’.

15 (b) STATE TUBERCULOSIS PLAN.—Section 317(j) of

16 the Public Health Service Act (42 U.S.C. 247b(j)) is

17 amended by adding at the end thereof the following new

18 paragraph:

19 ‘‘(3)(A) With respect to an application submitted by

20 a State for a grant under this section for the prevention,

21 control and elimination of tuberculosis, such application

22 shall contain a State plan that demonstrates that amounts

23 received under the grant will be expended in a manner

24 that ensures that tuberculosis services will be provided to

25 those at the highest risk of contracting tuberculosis, or
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1 in those areas with the highest rates of tuberculosis infec2 tion.

3 ‘‘(B) Such plans shall demonstrate that the applicant

4 will work closely with and provide support to entities re5 ceiving funds under sections 329, 330, 340, 340A, or titles

6 V or XIX, and to correctional facilities, and nongovern7 mental organizations such as community-based organiza8 tions.

9 ‘‘(C) Such plans shall demonstrate that grant funds

10 will be used for directly observed therapy or other effective

11 interventions with respect to populations with the highest

12 rates of active infection with tuberculosis.’’.

13 (c) RESEARCH, DEMONSTRATION PROJECTS, EDU14 CATION, AND TRAINING.—

15 (1) IN GENERAL.—Section 317(k)(2) of the

16 Public Health Service Act (42 U.S.C. 247b(k)(2)) is

17 amended—

18 (A) by redesignating subparagraphs (A)

19 through (D) as clauses (i) through (iv), respec20 tively;

21 (B) by inserting ‘‘(A)’’ after the paragraph

22 designation; and

23 (C) by adding at the end thereof the fol24 lowing new subparagraphs:
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1 ‘‘(B) In support of grants referred to in subpara2 graph (A), the Secretary may conduct or support applied

3 research and training regarding the surveillance, diag4 nostic methodologies, prevention, control, and treatment

5 of tuberculosis, including intramural projects and extra6 mural projects.

7 ‘‘(C) For the purpose of carrying out subparagraph

8 (A), there are authorized to be appropriated $26,000,000

9 for fiscal year 1994, and such sums as may be necessary

10 for each of the fiscal years 1995 through 1997. The au11 thorization of appropriations established in the preceding

12 sentence is in addition to the authorization of appropria13 tions established in subsection (j)(2) for carrying out this

14 paragraph.’’.

15 (2) TECHNICAL AMENDMENT.—Section

16 317(j)(2) of the Public Health Service Act (42

17 U.S.C. 247b(j)(2)) is amended by striking the last

18 sentence.

19 SEC. 4. RESEARCH THROUGH NATIONAL INSTITUTE OF AL20 LERGY AND INFECTIOUS DISEASES.

21 (a) CERTAIN DUTIES.—

22 (1) IN GENERAL.—Subpart 6 of part C of title

23 IV of the Public Health Service Act (42 U.S.C.

24 285f) is amended by inserting after section 446 the

25 following section:
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1 ‘‘RESEARCH AND RESEARCH TRAINING REGARDING

2 TUBERCULOSIS

3 ‘‘SEC. 447. In carrying out section 446, the Director

4 of the Institute shall conduct or support basic research

5 and research training regarding the cause, diagnosis, early

6 detection and treatment of tuberculosis.’’.

7 (2) CONFORMING AMENDMENT.—Section 446

8 of the Public Health Service Act (42 U.S.C. 285f)

9 is amended by inserting after ‘‘Diseases’’ the follow10 ing: ‘‘(hereafter in this subpart referred to as the

11 ‘Institute’)’’.

12 (b) AUTHORIZATION OF APPROPRIATIONS.—Section

13 408(a) of the Public Health Service Act (42 U.S.C.

14 284c(a)) is amended by adding at the end the following

15 new paragraph:

16 ‘‘(3) For the purpose of carrying out section

17 447 (relating to research on tuberculosis through the

18 National Institute on Allergy and Infectious Dis19 eases), there are authorized to be appropriated

20 $46,000,000 for fiscal year 1994, and such sums as

21 may be necessary for each of the fiscal years 1995

22 through 1997. The authorization of appropriations

23 established in the preceding sentence may not be

24 construed as terminating the availability for such
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1 purpose of any other authorization of appropria2 tions.’’.

3 SEC. 5. RESEARCH THROUGH THE FOOD AND DRUG ADMIN4 ISTRATION.

5 Chapter V of the Food, Drug and Cosmetic Act is

6 amended by inserting after section 512 (21 U.S.C. 360b)

7 the following new section:

8 ‘‘SEC. 512A. TUBERCULOSIS DRUG AND DEVICE RESEARCH.

9 ‘‘(a) AUTHORITY.—The Commissioner of Food and

10 Drugs shall implement a tuberculosis drug and device re11 search program under which the Commissioner shall—

12 ‘‘(1) provide assistance to other Federal agen13 cies for the development of tuberculosis protocols;

14 ‘‘(2) review and evaluate medical devices de15 signed for the diagnosis and control of airborne tu16 berculosis; and

17 ‘‘(3) conduct research concerning drugs or de18 vices to be used in diagnosing, controlling and pre19 venting tuberculosis.

20 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There

21 are authorized to be appropriated to carry out this section,

22 $5,000,000 for each fiscal year.’’.

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