I

103D CONGRESS

1ST SESSION H. R. 1844

To amend the Public Health Service Act to expand and intensify programs

of the National Institutes of Health with respect to research and related

activities concerning osteoporosis and related bone disorders.

IN THE HOUSE OF REPRESENTATIVES

APRIL 22, 1993

Ms. SNOWE introduced the following bill; which was referred to the Committee

on Energy and Commerce

A BILL

To amend the Public Health Service Act to expand and

intensify programs of the National Institutes of Health

with respect to research and related activities concerning

osteoporosis and related bone disorders.

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 ‘‘Osteoporosis and Re5 lated Bone Disorders Research, Education, and Health

6 Services Act of 1993’’.

7 SEC. 2. FINDINGS.

8 The Congress finds that—
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1 (1) osteoporosis, or porous bone, is a condition

2 characterized by an excessive loss of bone tissue and

3 an increased susceptibility to fractures of the hip,

4 spine, and wrist;

5 (2) an estimated 25,000,000 Americans have

6 osteoporosis, with many cases undiagnosed because

7 the condition develops without symptoms until a

8 strain, bump, or fall causes a fracture;

9 (3) between 3 and 4 million Americans have

10 Paget’s disease, Osteogenesis Imperfecta, and other

11 related metabolic bone disorders;

12 (4) osteoporosis is responsible for 1,300,000

13 bone fractures annually, including more than

14 250,000 hip fractures, 500,000 vertebral fractures,

15 200,000 fractures of the wrist, and the remaining

16 fractures at other limb sites;

17 (5) osteoporosis affects one-third to one-half of

18 all postmenopausal women and nearly half of all

19 people over age 75;

20 (6) direct medical costs of osteoporosis reached

21 an estimated $10,000,000,000 in 1988 for the Unit22 ed States, not including the costs of family care and

23 lost work for caregivers;

24 (7) direct medical costs of osteoporosis are ex25 pected to increase precipitously because the propor-
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1 tion of the population comprised of older persons is

2 expanding and each generation of older persons

3 tends to have a higher incidence of osteoporosis than

4 preceding generations;

5 (8) technology now exists, and new technology

6 is developing, that will permit early diagnosis and

7 prevention of osteoporosis as well as management of

8 the condition once it has developed;

9 (9) funding for research on osteoporosis and re10 lated bone disorders is severely constrained at key

11 research institutes, including the National Institute

12 of Arthritis and Musculoskeletal and Skin Diseases,

13 the National Institute on Aging, and the National

14 Institute of Diabetes and Digestive and Kidney Dis15 eases;

16 (10) further research is needed to improve med17 ical knowledge concerning—

18 (A) cellular mechanisms related to the

19 processes of bone resorption and bone forma20 tion, and the effect of different agents on bone

21 remodeling;

22 (B) risk factors for osteoporosis, including

23 newly discovered risk factors, risk factors relat24 ed to groups not ordinarily studied, such as

25 men and minorities, and the relationship of
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1 aging processes to the development of

2 osteoporosis;

3 (C) bone mass measurement technology,

4 including techniques for making faster and

5 more precise measurements and for interpreting

6 measurements;

7 (D) calcium, including bioavailability, in8 take requirements, and the role of calcium in

9 building heavier and denser skeletons;

10 (E) prevention and treatment, including

11 the efficacy of current therapies, alternative

12 drug therapies for prevention and treatment,

13 and the role of exercise; and

14 (F) rehabilitation; and

15 (11) further educational efforts are needed to

16 increase public and professional knowledge of the

17 causes of, methods for avoiding, and treatment of

18 osteoporosis.

19 SEC. 3. OSTEOPOROSIS RESEARCH.

20 Subpart 4 of part C of title IV of the Public Health

21 Service Act (42 U.S.C. 285d et seq.) is amended—

22 (1) by inserting after the subpart designation

23 and heading the following:

24 ‘‘DIVISION A—ARTHRITIS’’;

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

2 ‘‘DIVISION B—OSTEOPOROSIS

3 ‘‘SEC. 442A. DEFINITIONS.

4 ‘‘As used in this division:

5 ‘‘(1) ADVISORY PANEL.—The term ‘Advisory

6 Panel’ means the Advisory Panel on Osteoporosis

7 and Related Disorders, established in section 442D.

8 ‘‘(2) COUNCIL.—The term ‘Council’ means the

9 Interagency Council on Osteoporosis and Related

10 Disorders, established in section 442C.

11 ‘‘(3) DEPARTMENT.—The term ‘Department’

12 means the Department of Health and Human Serv13 ices.

14 ‘‘(4) RELATED DISORDERS.—The term ‘related

15 bone disorders’ includes—

16 ‘‘(A) Paget’s disease, a bone disease char17 acterized by enlargement and loss of density

18 with bowing and deformity of the bones;

19 ‘‘(B) Osteogenesis Imperfecta, a familial

20 disease marked by extreme brittleness of the

21 long bones;

22 ‘‘(C) hyperparathyroidism, a condition

23 characterized by the presence of excess para24 thormone in the body resulting in disturbance
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1 of calcium metabolism with loss of calcium from

2 bone and renal damage;

3 ‘‘(D) hypoparathyroidism, a condition

4 characterized by the absence of parathormone

5 resulting in disturbances of calcium metabolism;

6 ‘‘(E) renal bone disease, a disease charac7 terized by metabolic disturbances from dialysis,

8 renal transplants, or other renal disturbances;

9 ‘‘(F) primary or postmenopausal

10 osteoporosis and secondary osteoporosis, such

11 as that induced by corticosteroids; and

12 ‘‘(G) other general disorders of bone and

13 mineral metabolism including abnormalities of

14 vitamin D.

15 ‘‘(5) RESOURCE CENTER.—The term ‘Resource

16 Center’ means the Resource Center on Osteoporosis

17 and Related Disorders, established in section 442E.

18 ‘‘SEC. 442B. EXPANSION OF RESEARCH ON OSTEOPOROSIS

19 AND RELATED BONE DISORDERS.

20 ‘‘(a) RESEARCH.—The Director of the National Insti21 tute of Arthritis and Musculoskeletal and Skin Diseases,

22 the Director of the National Institute on Aging, and the

23 Director of the National Institute of Diabetes and Diges24 tive and Kidney Diseases shall expand and intensify re25 search on osteoporosis and related bone disorders. The re-
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1 search shall be in addition to research that is authorized

2 under any other provision of law.

3 ‘‘(b) RESEARCH CENTERS.—The Director of the Na4 tional Institute of Arthritis and Musculoskeletal and Skin

5 Diseases shall increase the number of Specialized Centers

6 of Research devoted to research on osteoporosis and relat7 ed bone disorders. The Director of the National Institute

8 on Aging shall increase the number of program project

9 grants devoted to creating centers of excellence in

10 osteoporosis and related bone disorders. The Director of

11 the National Institute of Diabetes and Digestive and Kid12 ney Diseases shall increase the number of program

13 projects grants in osteoporosis.

14 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

15 are authorized to be appropriated to carry out this section

16 $36,000,000 for the National Institute of Arthritis and

17 Musculoskeletal and Skin Diseases, $24,000,000 for the

18 National Institute on Aging, and $2,000,000 for the Na19 tional Institute of Diabetes and Digestive and Kidney Dis20 eases for each of the fiscal years 1994 through 1996, and

21 such sums as may be necessary for subsequent fiscal

22 years. These funds are in addition to amounts authorized

23 to be appropriated for biomedical research relating to

24 osteoporosis and related bone disorders under any other

25 provision of law.
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1 ‘‘SEC. 442C. INTERAGENCY COUNCIL ON OSTEOPOROSIS

2 AND RELATED BONE DISORDERS.

3 ‘‘(a) ESTABLISHMENT.—There is established in the

4 Department an Interagency Council on Osteoporosis and

5 Related Disorders. The Council shall be composed of—

6 ‘‘(1) the Assistant Secretary for Health;

7 ‘‘(2) the Surgeon General of the United States;

8 ‘‘(3) the Assistant Secretary for Planning and

9 Evaluation of the Department;

10 ‘‘(4) the Director of the National Institute of

11 Arthritis and Musculoskeletal and Skin Diseases;

12 ‘‘(5) the Director of the National Institute on

13 Aging;

14 ‘‘(6) the Director of the National Institute of

15 Diabetes, Digestive, and Kidney Diseases;

16 ‘‘(7) the Director of the National Institute of

17 Mental Health;

18 ‘‘(8) the Director of the National Institute of

19 Child Health and Human Development;

20 ‘‘(9) the Administrator of the Health Care Fi21 nancing Administration;

22 ‘‘(10) the Administrator for Health Care Policy

23 and Research;

24 ‘‘(11) the Director of the Bureau of Child and

25 Maternal Health;

26 ‘‘(12) the Commissioner of Food and Drugs;
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1 ‘‘(13) the Director of the National Institute of

2 Dental Research;

3 ‘‘(14) the Commissioner on Aging;

4 ‘‘(15) the Director of the Office of Disease Pre5 vention and Health Promotion; and

6 ‘‘(16) such additional members as the Secretary

7 considers appropriate.

8 ‘‘(b) FUNCTIONS.—The Council shall—

9 ‘‘(1) coordinate research conducted by or

10 through the Department on osteoporosis and related

11 bone disorders;

12 ‘‘(2) establish a mechanism for sharing infor13 mation on osteoporosis and related bone disorders

14 among all officers and employees of the Department

15 involved in carrying out programs serving older per16 sons, midlife women, and young persons, in order to

17 provide for full communication and exchange of in18 formation;

19 ‘‘(3) review and coordinate the most promising

20 areas of research concerning osteoporosis and relat21 ed bone disorders;

22 ‘‘(4) assist the National Institute of Arthritis

23 and Musculoskeletal and Skin Diseases, the National

24 Institute on Aging, the National Institute of Diabe25 tes, Digestive and Kidney Disease, the National In-
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1 stitute on Dental Research, and other institutes in

2 developing and coordinating plans for research on

3 osteoporosis and related bone disorders;

4 ‘‘(5) assist the Office of Disease Prevention and

5 Health Promotion and the Administration on Aging

6 and other offices in developing and coordinating

7 plans for education and health promotion on

8 osteoporosis and related bone disorders; and

9 ‘‘(6) establish mechanisms to use the results of

10 research concerning osteoporosis and related bone

11 disorders in the development of policies, programs,

12 and other measures to improve the quality of life for

13 older Americans.

14 ‘‘(c) CHAIRPERSON.—The Secretary shall select a

15 Chairperson or co-Chairpersons for the Council from

16 among its members.

17 ‘‘(d) QUORUM.—A majority of the members of the

18 Council shall constitute a quorum, but a lesser number

19 may hold hearings.

20 ‘‘(e) MEETINGS.—The Council shall meet periodically

21 at the call of the Chairperson, but not less often than twice

22 each year.

23 ‘‘(f) EXECUTIVE SECRETARY.—The Secretary shall

24 appoint an Executive Secretary for the Council.
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1 ‘‘(g) ADMINISTRATIVE STAFF AND SUPPORT.—The

2 Secretary shall provide the Council with such additional

3 administrative staff and support as may be necessary to

4 enable the Council to carry out its functions.

5 ‘‘(h) REPORTS.—

6 ‘‘(1) INITIAL REPORT.—

7 ‘‘(A) PREPARATION.—Not later than 9

8 months after the date of enactment of this divi9 sion, the Executive Secretary of the Council

10 shall prepare a report detailing the research

11 plans referred to in paragraphs (4) and (5) of

12 subsection (b). The report shall describe the ac13 tivities to be carried out under the research

14 plans during each of the fiscal years 1994

15 through 1996.

16 ‘‘(B) OTHER FEDERAL PROGRAMS.—To

17 the maximum extent feasible, the report shall

18 ensure that activities carried out under the re19 search plans are coordinated with, and use the

20 resources of, other Federal programs concern21 ing osteoporosis and related bone disorders, in22 cluding—

23 ‘‘(i) centers supported by the National

24 Institute of Arthritis and Musculoskeletal

25 and Skin Diseases, the National Institute
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1 on Aging, and the National Institute of Di2 abetes, Digestive and Kidney Disease;

3 ‘‘(ii) other centers supported by Fed4 eral funds involved in research on

5 osteoporosis and related bone disorders;

6 and

7 ‘‘(iii) other programs concerning

8 osteoporosis and related bone disorders

9 that are planned or conducted by Federal

10 agencies such as the Administration on

11 Aging and the Office of Disease Prevention

12 and Health Promotion, Federal agencies

13 outside the Department, State or local

14 agencies, community organizations, or pri15 vate foundations.

16 ‘‘(C) DISTRIBUTION.—The Executive Sec17 retary of the Council shall—

18 ‘‘(i) transmit the report to Congress;

19 and

20 ‘‘(ii) make the report available to the

21 public and to the Advisory Panel.

22 ‘‘(2) SUBSEQUENT REPORTS.—Not later than

23 12 months after the date on which the report re24 quired by paragraph (1) is transmitted to Congress,
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1 and annually thereafter, the Executive Secretary of

2 the Council shall—

3 ‘‘(A) prepare a report that—

4 ‘‘(i) describes research and edu5 cational initiatives sponsored by the Fed6 eral Government on osteoporosis and relat7 ed bone disorders; and

8 ‘‘(ii) makes recommendations for new

9 research and educational initiatives on

10 osteoporosis and related bone disorders;

11 and

12 ‘‘(B) transmit the report to Congress and

13 make the report available to the public.

14 ‘‘SEC. 442D. ADVISORY PANEL ON OSTEOPOROSIS AND RE15 LATED DISORDERS.

16 ‘‘(a) ESTABLISHMENT.—There is established in the

17 Department an Advisory Panel on Osteoporosis and Relat18 ed Disorders. The Advisory Panel shall be composed of

19 the following 15 voting members and additional nonvoting,

20 ex officio members:

21 ‘‘(1) VOTING MEMBERS.—The Director of the

22 Office of Technology Assessment shall appoint to the

23 Advisory Panel—

24 ‘‘(A) 5 members who are biomedical re25 search scientists with demonstrated achieve-
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1 ment in biomedical research on osteoporosis and

2 related bone disorders, including at least 1 re3 searcher at a specialized center for research in

4 osteoporosis;

5 ‘‘(B) 2 members with demonstrated

6 achievements in research on community-based

7 and family services covering osteoporosis and

8 related bone disorders;

9 ‘‘(C) 1 member who is knowledgeable in

10 health promotion and disease prevention pro11 grams concerning osteoporosis and related bone

12 disorders;

13 ‘‘(D) 2 members who are associated with

14 specialized bone programs affiliated with aca15 demic health centers;

16 ‘‘(E) 2 members who are experts in private

17 health care insurance and long-term care fi18 nancing; and

19 ‘‘(F) 3 members who are representatives of

20 national voluntary organizations that are con21 cerned with the problems of individuals with

22 osteoporosis and related bone disorders and

23 their families.
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1 ‘‘(2) NONVOTING, EX OFFICIO MEMBERS.—The

2 Advisory Panel shall include as nonvoting, ex officio

3 members—

4 ‘‘(A) the Chairperson of the Council;

5 ‘‘(B) the Director of National Institute of

6 Arthritis and Musculoskeletal and Skin Dis7 eases;

8 ‘‘(C) the Director of the National Institute

9 on Aging;

10 ‘‘(D) the Director of the National Institute

11 of Diabetes and Digestive and Kidney Diseases;

12 and

13 ‘‘(E) such other members as the Secretary

14 may appoint.

15 ‘‘(3) APPOINTMENT.—The Director of the Of16 fice of Technology Assessment shall appoint mem17 bers to the Advisory Panel within 90 days after the

18 date of enactment of this division. The Director shall

19 not appoint to the Advisory Panel individuals who

20 are officers or employees of the Federal Government.

21 ‘‘(b) FUNCTIONS.—The Advisory Panel shall advise

22 the Secretary and Council with respect to the identifica23 tion of—

24 ‘‘(1) research priorities for projects on

25 osteoporosis, related bone disorders, and the care of
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1 individuals with osteoporosis or related bone dis2 orders;

3 ‘‘(2) emerging issues in and promising areas of

4 biomedical, clinical, and behavioral research on

5 osteoporosis and related bone disorders;

6 ‘‘(3) emerging issues in research on health serv7 ices for individuals, and the families of individuals,

8 with osteoporosis or related bone disorders;

9 ‘‘(4) emerging issues in home-based and com10 munity-based services and systems of services for in11 dividuals, and the families of individuals, with

12 osteoporosis or related bone disorders;

13 ‘‘(5) emerging issues in financing health care

14 services and social services for individuals, and the

15 families of individuals, with osteoporosis and related

16 bone disorders;

17 ‘‘(6) emerging issues in health promotion pro18 grams concerning osteoporosis; and

19 ‘‘(7) emerging issues in professional and public

20 education concerning osteoporosis.

21 ‘‘(c) CHAIRPERSON.—The Secretary shall appoint a

22 Chairperson of the Advisory Panel from among the mem23 bers appointed.

24 ‘‘(d) TERM OF OFFICE.—The term of a member of

25 the Advisory Panel shall be for the life of the Advisory
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1 Panel. A vacancy on the Advisory Panel shall be filled in

2 the same manner as the original appointment was made.

3 A vacancy on the Advisory Panel shall not affect its

4 powers.

5 ‘‘(e) QUORUM.—A majority of the members of the

6 Advisory Panel appointed shall constitute a quorum, but

7 a lesser number may hold hearings. The Advisory Panel

8 may establish such subcommittees as the Advisory Panel

9 considers appropriate.

10 ‘‘(f) MEETINGS.—The Advisory Panel shall meet at

11 the call of the Chairperson, but not less often than twice

12 per year.

13 ‘‘(g) EXECUTIVE SECRETARY.—The Executive Sec14 retary of the Council shall serve as Executive Secretary

15 of the Advisory Panel.

16 ‘‘(h) STAFF AND SUPPORT.—The Secretary shall pro17 vide the Advisory Panel with such additional administra18 tive staff and support as may be necessary to enable the

19 Advisory Panel to carry out its functions.

20 ‘‘(i) COMPENSATION AND TRAVEL EXPENSES.—

21 ‘‘(1) COMPENSATION.—Subject to paragraph

22 (2), no member of the Advisory Panel shall receive

23 compensation for service on the Advisory Panel.

24 ‘‘(2) TRAVEL EXPENSES.—Each member of the

25 Advisory Panel shall receive reimbursement for trav-
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1 el, subsistence, and other necessary expenses in2 curred in the performance of duties of the Advisory

3 Panel.

4 ‘‘(j) REPORT.—The Advisory Panel shall—

5 ‘‘(1) prepare an annual report, which shall con6 tain recommendations for administrative and legisla7 tive actions to—

8 ‘‘(A) improve services, education, and in9 formation for individuals, and families of indi10 viduals, with osteoporosis and related bone dis11 orders;

12 ‘‘(B) improve professional education; and

13 ‘‘(C) provide for promising biomedical re14 search related to osteoporosis and related bone

15 disorders; and

16 ‘‘(2) transmit the annual report to the Con17 gress, the Secretary, and the Council and make it

18 available to the public.

19 ‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—There

20 are authorized to be appropriated to carry out this section

21 $200,000 for each of fiscal years 1994 through 1996.

22 ‘‘SEC. 442E. RESOURCE CENTER ON OSTEOPOROSIS AND

23 RELATED DISORDERS.

24 ‘‘(a) ESTABLISHMENT.—The Director of the Na25 tional Institute of Arthritis and Musculoskeletal and Skin
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1 Diseases shall make grants or enter into contracts with

2 eligible organizations to establish a Resource Center on

3 Osteoporosis and Related Disorders.

4 ‘‘(b) PURPOSE.—The purpose of the Resource Center

5 shall be to facilitate and enhance knowledge and under6 standing of osteoporosis and related bone disorders by dis7 seminating information about research results, services

8 and educational materials, to health professionals, pa9 tients, and the public.

10 ‘‘(c) FUNCTIONS.—An organization receiving a grant

11 or contract under this section shall—

12 ‘‘(1) compile, archive, and disseminate informa13 tion concerning research, demonstration, evaluation,

14 and training programs and projects concerning

15 osteoporosis and related bone disorders;

16 ‘‘(2) annually publish a summary of the infor17 mation compiled under paragraph (1) during the

18 preceding 12-month period, and make the informa19 tion available on request to appropriate individuals

20 and entities, including educational institutions, re21 search entities, and Federal and public agencies;

22 ‘‘(3) provide information and assistance in

23 accessing community services to patients and the

24 public;
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1 ‘‘(4) coordinate regional training programs for

2 the development of health professional resource net3 works on osteoporosis and related bone disorders;

4 and

5 ‘‘(5) maintain a resource library on osteoporosis

6 and related bone disorders.

7 ‘‘(d) INFORMATION SYSTEM AND TELEPHONE

8 LINE.—

9 ‘‘(1) INFORMATION SYSTEM.—An organization

10 receiving a grant or contract under this section shall

11 establish a central computerized information system

12 to—

13 ‘‘(A) compile and disseminate information

14 concerning initiatives by State and local govern15 ments and private entities to provide programs

16 and services for individuals with osteoporosis;

17 and

18 ‘‘(B) translate scientific and technical in19 formation concerning the initiatives into infor20 mation readily understandable by the general

21 public, and make the information available on

22 request.

23 ‘‘(2) TELEPHONE LINE.—An organization re24 ceiving a grant or contract under this section shall

25 establish a national toll-free telephone line to make
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1 available the information described in paragraph (1)

2 and information concerning Federal programs, serv3 ices, and benefits for individuals with osteoporosis

4 and their families.

5 ‘‘(e) FEES.—In accordance with regulations issued by

6 the Secretary, the organization receiving a grant or con7 tract under this section shall charge appropriate fees for

8 providing information through the Research Center as

9 specified in subsections (c) or (d). The organization may

10 make exceptions to the fees for individuals and organiza11 tions who are not financially able to pay the fees. The or12 ganization shall transfer the sums obtained from payment

13 of the fees to the Secretary, who shall use the sums to

14 carry out this section.

15 ‘‘(f) APPLICATION OR PROPOSAL.—In order to re16 ceive a grant or enter into a contract under this section,

17 an organization shall submit an application or proposal

18 to the Director of the National Institute of Arthritis and

19 Musculoskeletal and Skin Diseases. The application or

20 proposal shall contain—

21 ‘‘(1) information demonstrating that the organi22 zation has a network of contacts that will enable the

23 organization to receive information necessary to op24 erate the central computerized information system

25 described in subsection (d)(1); and
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1 ‘‘(2) such other information as the Director

2 may prescribe.

3 ‘‘(g) ELIGIBLE ORGANIZATIONS.—Organizations eli4 gible to receive grants under this section shall include pub5 lic and private nonprofit organizations that are knowledge6 able about osteoporosis and related bone disorders. The

7 Secretary shall establish additional eligibility criteria for

8 organizations to receive grants or enter into contracts

9 under this section.

10 ‘‘(h) RESEARCH SUMMARIES.—The Director of the

11 National Institute of Arthritis and Musculoskeletal and

12 Skin Diseases, the National Institute on Aging, the Na13 tional Institute of Diabetes, Digestive, and Kidney Dis14 eases, the National Institute on Dental Research, and

15 other agencies specified by the Secretary shall provide to

16 the Resource Center summaries of the findings of research

17 conducted on osteoporosis, related bone disorders, or rel18 evant treatments for osteoporosis or related bone dis19 orders.

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

21 are authorized to be appropriated to carry out this section

22 $500,000 for fiscal year 1994, and such sums as may be

23 necessary for fiscal years 1995 and 1996.’’.

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