I 

111TH CONGRESS 

1ST SESSION H. R. 3856 

To amend the Public Health Service Act to provide for osteoporosis and 

related bone disease education, research, and surveillance, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 20, 2009 

Ms. BERKLEY (for herself, Mr. BURGESS, Mrs. DAVIS of California, Mr. HIGGINS, Ms. LEE of California, Ms. KILPATRICK of Michigan, Ms. EDDIE

BERNICE JOHNSON of Texas, Ms. CORRINE BROWN of Florida, Mr. 

KLEIN of Florida, Ms. LORETTA SANCHEZ of California, Ms. TITUS, Ms. 

TSONGAS, Ms. DEGETTE, Mr. LEWIS of Georgia, Ms. WOOLSEY, Ms. 

MOORE of Wisconsin, Ms. SCHAKOWSKY, Mr. DONNELLY of Indiana, Ms. 

SCHWARTZ, Mr. DOGGETT, Ms. MATSUI, Ms. HIRONO, Mrs. 

NAPOLITANO, Mr. FARR, Mr. PASCRELL, Mr. CAPUANO, Mr. GENE

GREEN of Texas, Ms. WATSON, Mr. KENNEDY, Mr. HARE, Mr. CLEAVER, 

Mrs. HALVORSON, Ms. PINGREE of Maine, Ms. JACKSON-LEE of Texas, 

Mr. SIRES, Mr. ORTIZ, Mr. DAVIS of Illinois, Mr. NADLER of New York, 

Mr. MATHESON, Ms. BALDWIN, Mr. KAGEN, Ms. WASSERMAN SCHULTZ, 

Ms. HARMAN, Ms. ESHOO, Mr. MCDERMOTT, Mr. THOMPSON of California, Mr. COHEN, Ms. SHEA-PORTER, Mr. ENGEL, Mr. WEXLER, Ms. 

CASTOR of Florida, Mrs. CHRISTENSEN, Ms. RICHARDSON, Mr. CROWLEY, Mr. WEINER, Mr. YARMUTH, Ms. MARKEY of Colorado, Mrs. 

MALONEY, Ms. FUDGE, Mr. PAYNE, Mrs. LOWEY, Ms. ZOE LOFGREN of 

California, and Mr. BILIRAKIS) introduced the following bill; which was 

referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to provide for 

osteoporosis and related bone disease education, research, 

and surveillance, and for other purposes. 


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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 ‘‘Bone Health Pro5 motion and Research Act of 2009’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 

8 (1) Bone health is critical to the overall health 

9 and quality of life of Americans. Bone provides mo10 bility, support, and protection for the body and acts 

11 as a storehouse for essential minerals. 

12 (2) Osteoporosis is a condition in which the 

13 bones become weak and can break from a minor fall 

14 or, in serious cases, from simple actions such as 

15 sneezing. An estimated 34,000,000 Americans have 

16 low bone mass or osteopenia, which puts them at 

17 risk for osteoporosis and bone fractures. In addition, 

18 10,000,000 Americans have osteoporosis. 

19 (3) Eight million of those with osteoporosis are 

20 women, and an estimated 2,000,000 American men 

21 have osteoporosis. The United States Surgeon Gen22 eral says that by 2020 one in two Americans over 

23 age 50 is expected to have or to be at risk of devel24 oping osteoporosis of the hip; even more will be at 


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1 risk of developing osteoporosis at any site in the 

2 skeleton. 

3 (4) According to estimated figures, osteoporosis 

4 was responsible for more than 2,000,000 fractures 

5 in 2005, including hip, spine, wrist, and other frac6 tures. The number of fractures due to osteoporosis 

7 is expected to rise to more than 3,000,000 by 2025. 

8 Approximately 1 in 2 women and up to 1 in 4 men 

9 over age 50 will break a bone because of 

10 osteoporosis. 

11 (5) An average of 24 percent of hip fracture pa12 tients age 50 and older die in the year following 

13 their fracture. 

14 (6) Osteoporosis costs our health care system 

15 an estimated $19,000,000,000 each year. By 2025, 

16 experts predict that osteoporosis will account for 

17 $25,300,000,000 in costs. 

18 (7) Individuals with certain diseases are at 

19 higher risk of developing osteoporosis. For example, 

20 diabetes patients are at increased risk for developing 

21 an osteoporosis-related fracture. Cancer patients are 

22 also at increased risk because many cancer thera23 pies, such as chemotherapy and corticosteroids, have 

24 direct negative effects on bone. Also, certain cancers, 


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1 including prostate and breast cancer, may be treated 

2 with hormonal therapy, which can cause bone loss. 

3 (8) Osteogenesis imperfecta is characterized by 

4 fragile bones and frequent fractures. It is estimated 

5 to afflict an estimated 40,000 people. 

6 (9) Paget’s disease of the bone, a geriatric dis7 order that results in enlarged and deformed bones in 

8 one or more parts of the body, afflicts an estimated 

9 700,000 Americans over the age of 60. 

10 (10) Lifestyle factors can affect bone health. 

11 For example, the chemicals in cigarette smoke are 

12 harmful to bone cells and smoking may make it 

13 harder to absorb calcium. Heavy drinking can re14 duce bone formation and may also affect the body’s 

15 calcium supply. 

16 (11) The 2004 Surgeon General’s Report, 

17 ‘‘Bone Health and Osteoporosis: A Report of the 

18 Surgeon General,’’ said that Americans must be en19 couraged to: get enough calcium and vitamin D; en20 gage in regular weight-bearing and muscle-strength21 ening exercise; avoid smoking and excessive alcohol; 

22 and talk to their healthcare providers about bone 

23 health. 

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1 tients to lessen the burden of osteoporosis and re2 lated bone diseases on Americans. 

3 SEC. 3. NATIONAL BONE HEALTH PROGRAM. 

4 Part B of title III of the Public Health Service Act 

5 (42 U.S.C. 243 et seq.) is amended by inserting after sec6 tion 314 the following: 

7 ‘‘SEC. 315. NATIONAL BONE HEALTH PROGRAM. 

8 ‘‘(a) ESTABLISHMENT OF PROGRAM.—The Secretary 

9 may develop and implement a National Bone Health Pro10 gram (in this section referred to as the ‘Program’) con11 sistent with this section. 

12 ‘‘(b) CONTROL, PREVENTION, AND SURVEIL13 LANCE.— 

14 ‘‘(1) IN GENERAL.—Under the Program, the 

15 Secretary, acting through the Director of the Cen16 ters for Disease Control and Prevention, may, di17 rectly or through competitive grants to eligible enti18 ties, conduct, support, and promote the coordination 

19 of research, investigations, demonstrations, training, 

20 and studies relating to the control, prevention, and 

21 surveillance of osteoporosis and related bone dis22 eases. 

23 ‘‘(2) TRAINING AND TECHNICAL ASSISTANCE.— 

24 With respect to the planning, development, and op25 eration of any activity carried out under paragraph 


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1 (1), the Secretary may provide training, technical 

2 assistance, supplies, equipment, or services, and may 

3 assign any officer or employee of the Department of 

4 Health and Human Services to a State or local 

5 health agency, or to any public or nonprofit entity 

6 designated by a State health agency, in lieu of pro7 viding grant funds under this subsection. 

8 ‘‘(3) OSTEOPOROSIS AND RELATED BONE DIS9 EASE PREVENTION RESEARCH AT THE CENTERS FOR

10 DISEASE CONTROL AND PREVENTION.—The Sec11 retary may provide additional grant support under 

12 this subsection to encourage the expansion of re13 search related to the prevention and management of 

14 osteoporosis and related bone diseases at the Centers 

15 for Disease Control and Prevention. 

16 ‘‘(4) ELIGIBLE ENTITY.—For purposes of this 

17 subsection, the term ‘eligible entity’ means a na18 tional public or private nonprofit entity that dem19 onstrates to the satisfaction of the Secretary, in the 

20 application described in subsection (e), the ability of 

21 the entity to carry out the activities described in 

22 paragraph (1). 

23 ‘‘(c) EDUCATION AND OUTREACH.— 

24 ‘‘(1) IN GENERAL.—Under the Program, the 

25 Secretary may coordinate and carry out national 


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1 education and outreach activities, directly or through 

2 the provision of grants to eligible entities, to sup3 port, develop, and implement education initiatives 

4 and outreach strategies appropriate for osteoporosis 

5 and related bone diseases. 

6 ‘‘(2) INITIATIVES AND STRATEGIES.—Initiatives 

7 and strategies implemented under paragraph (1) 

8 may include public awareness campaigns, public 

9 service announcements, and community partnership 

10 workshops, as well as programs targeted at busi11 nesses and employers, managed care organizations, 

12 and health care providers. 

13 ‘‘(3) PRIORITY.—In carrying out paragraph (1), 

14 the Secretary— 

15 ‘‘(A) may emphasize prevention, early di16 agnosis, and appropriate management of 

17 osteoporosis and related bone disease, and op18 portunities for effective patient self-manage19 ment; and 

20 ‘‘(B) may give priority to reaching high21 risk or underserved populations. 

22 ‘‘(4) COLLABORATION.—In carrying out this 

23 subsection, the Secretary shall consult and collabo24 rate with the Advisory Committee established in sub25 section (g). 


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1 ‘‘(5) ELIGIBLE ENTITY.—For purposes of this 

2 subsection, the term ‘eligible entity’ means a na3 tional public or private nonprofit entity that dem4 onstrates to the satisfaction of the Secretary, in the 

5 application described in subsection (e), the ability of 

6 the entity to carry out the activities described in 

7 paragraph (1). 

8 ‘‘(d) COMPREHENSIVE STATE GRANTS.— 

9 ‘‘(1) IN GENERAL.—Under the Program, the 

10 Secretary may award grants to eligible entities to 

11 provide support for comprehensive osteoporosis and 

12 related bone disease control and prevention pro13 grams and to enable such entities to provide public 

14 health surveillance, prevention, and control activities 

15 related to osteoporosis and related bone diseases. 

16 ‘‘(2) ELIGIBILITY.—To be eligible to receive a 

17 grant under this subsection, an entity shall be a 

18 State or Indian tribe. 

19 ‘‘(3) APPLICATION.—To be eligible to receive a 

20 grant under this subsection, an entity shall submit 

21 to the Secretary an application at such time, in such 

22 manner, and containing such agreements, assur23 ances, and information as the Secretary may re24 quire, including a comprehensive osteoporosis and 


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1 related bone disease control and prevention plan 

2 that— 

3 ‘‘(A) is developed with the advice of stake4 holders from the public, private, and nonprofit 

5 sectors that have expertise relating to 

6 osteoporosis and related bone disease control, 

7 prevention, and treatment that increase the 

8 quality of life and decrease the level of dis9 ability; 

10 ‘‘(B) is intended to reduce the morbidity of 

11 osteoporosis and related bone diseases, with pri12 ority on preventing and controlling osteoporosis 

13 and related bone diseases in at-risk populations 

14 and reducing disparities in osteoporosis and re15 lated bone disease prevention, diagnosis, man16 agement, and quality of care in underserved 

17 populations; 

18 ‘‘(C) describes the osteoporosis and related 

19 bone disease services and activities to be under20 taken or supported by the entity; and 

21 ‘‘(D) demonstrates the relationship the en22 tity has with the community and local entities 

23 and how the entity plans to involve such com24 munity and local entities in carrying out the ac25 tivities described in paragraph (1). 


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1 ‘‘(4) USE OF FUNDS.—An eligible entity may 

2 use amounts received under a grant awarded under 

3 this subsection to conduct, in a manner consistent 

4 with the comprehensive osteoporosis and related 

5 bone disease control and prevention plan submitted 

6 by the entity in the application under paragraph 

7 (3)— 

8 ‘‘(A) public health surveillance and epide9 miological activities relating to the prevalence of 

10 osteoporosis and related bone disease and as11 sessment of disparities in osteoporosis and re12 lated bone disease prevention, diagnosis, man13 agement, and care; 

14 ‘‘(B) public information and education pro15 grams; and 

16 ‘‘(C) education, training, and clinical skills 

17 improvement activities for health professionals, 

18 including allied health personnel. 

19 ‘‘(e) GENERAL APPLICATION.—To be eligible to re20 ceive a grant under this section, except under subsection 

21 (d), an entity shall submit to the Secretary an application 

22 at such time, in such manner, and containing such agree23 ments, assurances, and information as the Secretary may 

24 require, including a description of how funds received 

25 under a grant awarded under this section will supplement 


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1 or fulfill unmet needs identified in a comprehensive 

2 osteoporosis and related bone disease control and preven3 tion plan of the entity. 

4 ‘‘(f) DEFINITIONS.—For purposes of this section: 

5 ‘‘(1) INDIAN TRIBE.—The term ‘Indian tribe’ 

6 has the meaning given such term in section 4(e) of 

7 the Indian Self-Determination and Education Assist8 ance Act. 

9 ‘‘(2) STATE.—The term ‘State’ means any 

10 State of the United States, the District of Columbia, 

11 the Commonwealth of Puerto Rico, the Virgin Is12 lands, American Samoa, Guam, and the Northern 

13 Mariana Islands. 

14 ‘‘(g) ADVISORY COMMITTEE.— 

15 ‘‘(1) ESTABLISHMENT.—Not later than 90 days 

16 after the date of the enactment of this section, the 

17 Secretary, acting through the Director of the Cen18 ters for Disease Control and Prevention, shall estab19 lish a committee to be known as the Osteoporosis 

20 and Related Bone Disease Advisory Committee (re21 ferred to in this section as the ‘Advisory Com22 mittee’). The Advisory Committee shall be composed 

23 of at least one member, to be appointed by the Sec24 retary, acting through the Director of the Centers 


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1 for Disease Control and Prevention, representing 

2 each of the following: 

3 ‘‘(A) National voluntary health organiza4 tions that focus on issues relating to 

5 osteoporosis or other bone diseases. 

6 ‘‘(B) Professional societies that focus on 

7 issues relating to osteoporosis or other bone dis8 eases. 

9 ‘‘(C) The Centers for Disease Control and 

10 Prevention, to include, upon the recommenda11 tion of the Director of the Centers, representa12 tives of the Coordinating Center for Health 

13 Promotion, the Coordinating Center for Health 

14 Information and Service, and the Coordinating 

15 Center for Environmental Health and Injury 

16 Prevention. 

17 ‘‘(D) State public health departments. 

18 ‘‘(E) The National Institutes of Health, to 

19 include, upon the recommendation of the Direc20 tor of the National Institutes of Health, rep21 resentatives of the National Institute of Arthri22 tis and Musculoskeletal and Skin Diseases, the 

23 National Cancer Institute, the National Insti24 tute of Biomedical Imaging and Bioengineering, 

25 the National Institute of Child Health and 


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1 Human Development, the National Institute of 

2 Dental and Craniofacial Research, the National 

3 Institute of Diabetes and Digestive and Kidney 

4 Diseases, the National Institute on Aging, the 

5 Office of Dietary Supplements, the Office of 

6 Rare Diseases, and the Office of Research on 

7 Women’s Health. 

8 ‘‘(F) Patients with osteoporosis or related 

9 bone diseases or their family members. 

10 ‘‘(G) The Office on Women’s Health in the 

11 Department of Health and Human Services. 

12 ‘‘(H) Clinicians with expertise on 

13 osteoporosis or related bone diseases. 

14 ‘‘(I) Other stakeholders from the public, 

15 private, and nonprofit sectors with expertise re16 lating to osteoporosis or other bone disease con17 trol, prevention, and treatment. 

18 ‘‘(2) DUTIES.—The Advisory Committee shall 

19 advise the Secretary and the Assistant Secretary for 

20 Health regarding the manner in which such officials 

21 can— 

22 ‘‘(A) ensure interagency coordination and 

23 communication and minimize overlap regarding 

24 efforts to address osteoporosis and related bone 

25 diseases; 


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1 ‘‘(B) conduct and support national edu2 cation and outreach activities; 

3 ‘‘(C) identify opportunities to coordinate 

4 efforts with other Federal and State agencies 

5 and private organizations addressing such dis6 eases; 

7 ‘‘(D) ensure that public health policy deci8 sions and information disseminated to the pub9 lic and physicians are evidence-based and popu10 lation-focused; 

11 ‘‘(E) advise relevant Federal agencies on 

12 priorities related to osteoporosis and related 

13 bone diseases; 

14 ‘‘(F) conduct surveillance and data collec15 tion and disseminate epidemiological informa16 tion in accordance with section 32OB; and 

17 ‘‘(G) expand and intensify research on 

18 osteoporosis and related bone diseases in ac19 cordance with section 404I. 

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

21 are authorized to be appropriated to carry out this sec22 tion— 

23 ‘‘(1) for fiscal year 2010, $22,000,000; 

24 ‘‘(2) for fiscal year 2011, $24,000,000; 

25 ‘‘(3) for fiscal year 2012, $26,000,000; 


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1 ‘‘(4) for fiscal year 2013, $28,000,000; and 

2 ‘‘(5) for fiscal year 2014, $30,000,000.’’. 

3 SEC. 4. HHS RESEARCH ACTIVITIES WITH RESPECT TO 

4 OSTEOPOROSIS AND RELATED BONE DIS5 EASES. 

6 Part A of title IV of the Public Health Service Act 

7 (42 U.S.C. 281 et seq.) is amended by adding at the end 

8 the following: 

9 ‘‘SEC. 404I. BONE HEALTH INITIATIVE. 

10 ‘‘(a) EXPANSION AND INTENSIFICATION OF ACTIVI11 TIES.— 

12 ‘‘(1) IN GENERAL.—The Director of NIH shall 

13 expand and intensify programs of the National Insti14 tutes of Health with respect to research and related 

15 activities concerning osteoporosis and related bone 

16 diseases, including osteogenesis imperfecta, Paget’s 

17 disease of bone, and rare bone diseases. 

18 ‘‘(2) COORDINATION; CONSULTATION.—The Di19 rector of NIH shall carry out paragraph (1)— 

20 ‘‘(A) in coordination with the directors of 

21 the National Institute of Arthritis and Musculo22 skeletal and Skin Diseases, the National Cancer 

23 Institute, the National Institute of Biomedical 

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1 ment, the National Institute of Dental and 

2 Craniofacial Research, the National Institute of 

3 Diabetes and Digestive and Kidney Diseases, 

4 the National Institute on Aging, the Office of 

5 Rare Diseases, the Office of Research on Wom6 en’s Health, and any other national research in7 stitutes or offices, as appropriate; and 

8 ‘‘(B) in consultation with additional Fed9 eral officials, the advisory committee established 

10 under section 315(g), and any national vol11 untary health organizations, professional soci12 eties, and private entities, as appropriate. 

13 ‘‘(b) PLANNING GRANTS AND CONTRACTS FOR INNO14 VATIVE RESEARCH IN OSTEOPOROSIS AND RELATED

15 BONE DISEASES.— 

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

17 (a)(1), the Director of NIH shall award planning 

18 grants or contracts for the establishment of new re19 search programs, or enhancement of existing re20 search programs, that focus on osteoporosis and re21 lated bone diseases, including osteogenesis 

22 imperfecta, Paget’s disease of bone, and rare bone 

23 diseases. 

24 ‘‘(2) RESEARCH.— 


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1 ‘‘(A) TYPES OF RESEARCH.—In carrying 

2 out this subsection, the Secretary shall encour3 age basic, clinical, and translational research 

4 that focuses on osteoporosis and related bone 

5 diseases, including osteogenesis imperfecta, 

6 Paget’s disease of bone, and rare bone diseases. 

7 ‘‘(B) PRIORITY.—In awarding planning 

8 grants or contracts under paragraph (1), the 

9 Director of NIH may give priority to collabo10 rative partnerships, which may include aca11 demic health centers, private sector entities, 

12 and nonprofit organizations. 

13 ‘‘(C) NEW AND EARLY STAGE INVESTIGA14 TORS.—The Director of NIH shall make an ef15 fort to fund research by new and early stage in16 vestigators under paragraph (1). 

17 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the 

18 purpose of carrying out this section, there is authorized 

19 to be appropriated $300,000,000 for each of fiscal years 

20 2010 through 2014. Such authorization shall be in addi21 tion to any authorization of appropriations under any 

22 other provision of law to carry out research activities on 

23 osteoporosis or related bone diseases.’’. 


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1 SEC. 5. SURVEILLANCE ACTIVITIES RELATED TO BONE DIS2 EASES AT THE CENTERS FOR DISEASE CON3 TROL AND PREVENTION. 

4 Part B of title III of the Public Health Service Act 

5 (42 U.S.C. 243 et seq.) is amended by inserting after sec6 tion 320A the following: 

7 ‘‘SEC. 320B. SURVEILLANCE REGARDING OSTEOPOROSIS 

8 AND RELATED BONE DISEASES. 

9 ‘‘(a) IN GENERAL.—The Secretary, acting through 

10 the Director of the Centers for Disease Control and Pre11 vention, may award grants to and enter into cooperative 

12 agreements with public or nonprofit private entities for the 

13 collection, analysis, and reporting of data on osteoporosis 

14 and related bone diseases, including osteogenesis 

15 imperfecta and Paget’s disease of bone. 

16 ‘‘(b) TECHNICAL ASSISTANCE.—In awarding grants 

17 and entering into agreements under subsection (a), the 

18 Secretary may provide direct technical assistance in lieu 

19 of cash. 

20 ‘‘(c) COORDINATION WITH ADVISORY COMMITTEE

21 AND NIH.—The Secretary shall ensure that epidemiolog22 ical and other types of information obtained under sub23 section (a) is made available to the National Institutes of 

24 Health. The advisory committee established under section 

25 315(g) shall advise the Secretary in the coordination of 

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1 sification of programs for conducting surveillance and 

2 data collection activities under this section. 

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

4 purpose of carrying out this section, there is authorized 

5 to be appropriated $25,000,000 for each of fiscal years 

6 2010 through 2014.’’. 

Æ 


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