II 

112TH CONGRESS 

1ST SESSION S. 966 

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 SENATE OF THE UNITED STATES 

MAY 12, 2011 

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

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

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. 

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 2011’’. 

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 momstockstill on DSK4VPTVN1PROD with BILLS

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1 bility, support, and protection for the body and acts 

2 as a storehouse for essential minerals. 

3 (2) Osteoporosis is a condition in which the 

4 bones become weak and can break from a minor fall 

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

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

7 low bone mass or osteopenia, which puts them at 

8 risk for osteoporosis and bone fractures. In addition, 

9 10,000,000 Americans have osteoporosis. 

10 (3) Eight million of those with osteoporosis are 

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

12 have osteoporosis. The United States Surgeon Gen13 eral says that by 2020 one in two Americans over 

14 age 50 is expected to have or to be at risk of devel15 oping osteoporosis of the hip; even more will be at 

16 risk of developing osteoporosis at any site in the 

17 skeleton. 

18 (4) According to estimated figures, osteoporosis 

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

20 in 2005, including hip, spine, wrist, and other frac21 tures. The number of fractures due to osteoporosis 

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

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

24 over age 50 will break a bone because of 

25 osteoporosis. 

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1 (5) An average of 24 percent of hip fracture pa2 tients age 50 and older die in the year following 

3 their fracture. 

4 (6) Osteoporosis costs our health care system 

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

6 experts predict that osteoporosis will account for 

7 $25,300,000,000 in costs. 

8 (7) Individuals with certain diseases are at 

9 higher risk of developing osteoporosis. For example, 

10 diabetes patients are at increased risk for developing 

11 an osteoporosis-related fracture. Cancer patients are 

12 also at increased risk because many cancer thera13 pies, such as chemotherapy and corticosteroids, have 

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

15 including prostate and breast cancer, may be treated 

16 with hormonal therapy, which can cause bone loss. 

17 (8) Osteogenesis imperfecta is characterized by 

18 fragile bones and frequent fractures. It is estimated 

19 to afflict an estimated 40,000 people. 

20 (9) Paget’s disease of the bone, a geriatric dis21 order that results in enlarged and deformed bones in 

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

23 700,000 Americans over the age of 60. 

24 (10) Lifestyle factors can affect bone health. 

25 For example, the chemicals in cigarette smoke are 

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1 harmful to bone cells and smoking may make it 

2 harder to absorb calcium. Heavy drinking can re3 duce bone formation and may also affect the body’s 

4 calcium supply. 

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

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

7 Surgeon General’’, said that Americans must be en8 couraged to: get enough calcium and vitamin D; en9 gage in regular weight-bearing and muscle-strength10 ening exercise; avoid smoking and excessive alcohol; 

11 and talk to their healthcare providers about bone 

12 health. 

13 (12) The Nation’s annual direct and indirect 

14 costs for bone and joint health are 

15 $849,000,000,000—7.7 percent of the United States 

16 gross domestic product. 

17 (13) Greater efforts and commitments are need18 ed from Congress, the States, providers, and pa19 tients to lessen the burden of osteoporosis and re20 lated bone diseases on Americans. 

21 SEC. 3. NATIONAL BONE HEALTH PROGRAM. 

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

23 (42 U.S.C. 243 et seq.) is amended by inserting after sec24 tion 314 the following: 

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

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

3 may develop and implement a National Bone Health Pro4 gram (in this section referred to as the ‘Program’) con5 sistent with this section. 

6 ‘‘(b) CONTROL, PREVENTION, AND SURVEIL7 LANCE.— 

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

9 Secretary, acting through the Director of the Cen10 ters for Disease Control and Prevention, may, di11 rectly or through competitive grants to eligible enti12 ties, conduct, support, and promote the coordination 

13 of research, investigations, demonstrations, training, 

14 and studies relating to the control, prevention, and 

15 surveillance of osteoporosis and related bone dis16 eases. 

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

18 With respect to the planning, development, and op19 eration of any activity carried out under paragraph 

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

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

22 assign any officer or employee of the Department of 

23 Health and Human Services to a State or local 

24 health agency, or to any public or nonprofit entity 

25 designated by a State health agency, in lieu of pro26 viding grant funds under this subsection. 

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1 ‘‘(3) OSTEOPOROSIS AND RELATED BONE DIS2 EASE PREVENTION RESEARCH AT THE CENTERS FOR

3 DISEASE CONTROL AND PREVENTION.—The Sec4 retary may provide additional grant support under 

5 this subsection to encourage the expansion of re6 search related to the prevention and management of 

7 osteoporosis and related bone diseases at the Centers 

8 for Disease Control and Prevention. 

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

10 subsection, the term ‘eligible entity’ means a na11 tional public or private nonprofit entity that dem12 onstrates to the satisfaction of the Secretary, in the 

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

14 the entity to carry out the activities described in 

15 paragraph (1). 

16 ‘‘(c) EDUCATION AND OUTREACH.— 

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

18 Secretary may coordinate and carry out national 

19 education and outreach activities, directly or through 

20 the provision of grants to eligible entities, to sup21 port, develop, and implement education initiatives 

22 and outreach strategies appropriate for osteoporosis 

23 and related bone diseases. 

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

25 and strategies implemented under paragraph (1) 

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1 may include public awareness campaigns, public 

2 service announcements, and community partnership 

3 workshops, as well as programs targeted at busi4 nesses and employers, managed care organizations, 

5 and health care providers. 

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

7 the Secretary— 

8 ‘‘(A) may emphasize prevention, early di9 agnosis, and appropriate management of 

10 osteoporosis and related bone disease, and op11 portunities for effective patient self-manage12 ment; and 

13 ‘‘(B) may give priority to reaching high14 risk or underserved populations. 

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

16 subsection, the Secretary shall consult and collabo17 rate with the Advisory Committee established in sub18 section (g). 

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

20 subsection, the term ‘eligible entity’ means a na21 tional public or private nonprofit entity that dem22 onstrates to the satisfaction of the Secretary, in the 

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

24 the entity to carry out the activities described in 

25 paragraph (1). 

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1 ‘‘(d) COMPREHENSIVE STATE GRANTS.— 

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

3 Secretary may award grants to eligible entities to 

4 provide support for comprehensive osteoporosis and 

5 related bone disease control and prevention pro6 grams and to enable such entities to provide public 

7 health surveillance, prevention, and control activities 

8 related to osteoporosis and related bone diseases. 

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

10 grant under this subsection, an entity shall be a 

11 State or Indian tribe. 

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

13 grant under this subsection, an entity shall submit 

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

15 manner, and containing such agreements, assur16 ances, and information as the Secretary may re17 quire, including a comprehensive osteoporosis and 

18 related bone disease control and prevention plan 

19 that— 

20 ‘‘(A) is developed with the advice of stake21 holders from the public, private, and nonprofit 

22 sectors that have expertise relating to 

23 osteoporosis and related bone disease control, 

24 prevention, and treatment that increase the 

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1 quality of life and decrease the level of dis2 ability; 

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

4 osteoporosis and related bone diseases, with pri5 ority on preventing and controlling osteoporosis 

6 and related bone diseases in at-risk populations 

7 and reducing disparities in osteoporosis and re8 lated bone disease prevention, diagnosis, man9 agement, and quality of care in underserved 

10 populations; 

11 ‘‘(C) describes the osteoporosis and related 

12 bone disease services and activities to be under13 taken or supported by the entity; and 

14 ‘‘(D) demonstrates the relationship the en15 tity has with the community and local entities 

16 and how the entity plans to involve such com17 munity and local entities in carrying out the ac18 tivities described in paragraph (1). 

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

20 use amounts received under a grant awarded under 

21 this subsection to conduct, in a manner consistent 

22 with the comprehensive osteoporosis and related 

23 bone disease control and prevention plan submitted 

24 by the entity in the application under paragraph 

25 (3)— 

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1 ‘‘(A) public health surveillance and epide2 miological activities relating to the prevalence of 

3 osteoporosis and related bone disease and as4 sessment of disparities in osteoporosis and re5 lated bone disease prevention, diagnosis, man6 agement, and care; 

7 ‘‘(B) public information and education pro8 grams; and 

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

10 improvement activities for health professionals, 

11 including allied health personnel. 

12 ‘‘(e) GENERAL APPLICATION.—To be eligible to re13 ceive a grant under this section, except under subsection 

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

15 at such time, in such manner, and containing such agree16 ments, assurances, and information as the Secretary may 

17 require, including a description of how funds received 

18 under a grant awarded under this section will supplement 

19 or fulfill unmet needs identified in a comprehensive 

20 osteoporosis and related bone disease control and preven21 tion plan of the entity. 

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

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

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

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1 the Indian Self-Determination and Education Assist2 ance Act. 

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

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

5 the Commonwealth of Puerto Rico, the Virgin Is6 lands, American Samoa, Guam, and the Northern 

7 Mariana Islands. 

8 ‘‘(g) ADVISORY COMMITTEE.— 

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

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

11 Secretary, acting through the Director of the Cen12 ters for Disease Control and Prevention, shall estab13 lish a committee to be known as the Osteoporosis 

14 and Related Bone Disease Advisory Committee (re15 ferred to in this section as the ‘Advisory Com16 mittee’). The Advisory Committee shall be composed 

17 of at least one member, to be appointed by the Sec18 retary, acting through the Director of the Centers 

19 for Disease Control and Prevention, representing 

20 each of the following: 

21 ‘‘(A) National voluntary health organiza22 tions that focus on issues relating to 

23 osteoporosis or other bone diseases. 

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1 ‘‘(B) Professional societies that focus on 

2 issues relating to osteoporosis or other bone dis3 eases. 

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

5 Prevention, to include, upon the recommenda6 tion of the Director of the Centers, representa7 tives of the Coordinating Center for Health 

8 Promotion, the Coordinating Center for Health 

9 Information and Service, and the Coordinating 

10 Center for Environmental Health and Injury 

11 Prevention. 

12 ‘‘(D) State public health departments. 

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

14 include, upon the recommendation of the Direc15 tor of the National Institutes of Health, rep16 resentatives of the National Institute of Arthri17 tis and Musculoskeletal and Skin Diseases, the 

18 National Cancer Institute, the National Insti19 tute of Biomedical Imaging and Bioengineering, 

20 the National Institute of Child Health and 

21 Human Development, the National Institute of 

22 Dental and Craniofacial Research, the National 

23 Institute of Diabetes and Digestive and Kidney 

24 Diseases, the National Institute on Aging, the 

25 Office of Dietary Supplements, the Office of 

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1 Rare Diseases, and the Office of Research on 

2 Women’s Health. 

3 ‘‘(F) Patients with osteoporosis or related 

4 bone diseases or their family members. 

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

6 Department of Health and Human Services. 

7 ‘‘(H) Clinicians with expertise on 

8 osteoporosis or related bone diseases. 

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

10 private, and nonprofit sectors with expertise re11 lating to osteoporosis or other bone disease con12 trol, prevention, and treatment. 

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

14 advise the Secretary and the Assistant Secretary for 

15 Health regarding the manner in which such officials 

16 can— 

17 ‘‘(A) ensure interagency coordination and 

18 communication and minimize overlap regarding 

19 efforts to address osteoporosis and related bone 

20 diseases; 

21 ‘‘(B) conduct and support national edu22 cation and outreach activities; 

23 ‘‘(C) identify opportunities to coordinate 

24 efforts with other Federal and State agencies 

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1 and private organizations addressing such dis2 eases; 

3 ‘‘(D) ensure that public health policy deci4 sions and information disseminated to the pub5 lic and physicians are evidence-based and popu6 lation-focused; 

7 ‘‘(E) advise relevant Federal agencies on 

8 priorities related to osteoporosis and related 

9 bone diseases; 

10 ‘‘(F) conduct surveillance and data collec11 tion and disseminate epidemiological informa12 tion in accordance with section 32OB; and 

13 ‘‘(G) expand and intensify research on 

14 osteoporosis and related bone diseases in ac15 cordance with section 404I. 

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

17 are authorized to be appropriated to carry out this section 

18 $22,000,000 for each of fiscal years 2011 through 2013.’’. 

19 SEC. 4. HHS RESEARCH ACTIVITIES WITH RESPECT TO 

20 OSTEOPOROSIS AND RELATED BONE DIS21 EASES. 

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

23 (42 U.S.C. 281 et seq.) is amended by adding at the end 

24 the following: 

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

2 ‘‘(a) EXPANSION AND INTENSIFICATION OF ACTIVI3 TIES.— 

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

5 expand and intensify programs of the National Insti6 tutes of Health with respect to research and related 

7 activities concerning osteoporosis and related bone 

8 diseases, including osteogenesis imperfecta, Paget’s 

9 disease of bone, and rare bone diseases. 

10 ‘‘(2) COORDINATION; CONSULTATION.—The Di11 rector of NIH shall carry out paragraph (1)— 

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

13 the National Institute of Arthritis and Musculo14 skeletal and Skin Diseases, the National Cancer 

15 Institute, the National Institute of Biomedical 

16 Imaging and Bioengineering, the National In17 stitute of Child Health and Human Develop18 ment, the National Institute of Dental and 

19 Craniofacial Research, the National Institute of 

20 Diabetes and Digestive and Kidney Diseases, 

21 the National Institute on Aging, the Office of 

22 Rare Diseases, the Office of Research on Wom23 en’s Health, and any other national research in24 stitutes or offices, as appropriate; and 

25 ‘‘(B) in consultation with additional Fed26 eral officials, the advisory committee established 

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1 under section 315(g), and any national vol2 untary health organizations, professional soci3 eties, and private entities, as appropriate. 

4 ‘‘(b) PLANNING GRANTS AND CONTRACTS FOR INNO5 VATIVE RESEARCH IN OSTEOPOROSIS AND RELATED

6 BONE DISEASES.— 

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

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

9 grants or contracts for the establishment of new re10 search programs, or enhancement of existing re11 search programs, that focus on osteoporosis and re12 lated bone diseases, including osteogenesis 

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

14 diseases. 

15 ‘‘(2) RESEARCH.— 

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

17 out this subsection, the Secretary shall encour18 age basic, clinical, and translational research 

19 that focuses on osteoporosis and related bone 

20 diseases, including osteogenesis imperfecta, 

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

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

23 grants or contracts under paragraph (1), the 

24 Director of NIH may give priority to collabo25 rative partnerships, which may include acamstockstill on DSK4VPTVN1PROD with BILLS

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1 demic health centers, private sector entities, 

2 and nonprofit organizations. 

3 ‘‘(C) NEW AND EARLY STAGE INVESTIGA4 TORS.—The Director of NIH shall make an ef5 fort to fund research by new and early stage in6 vestigators under paragraph (1). 

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

8 purpose of carrying out this section, there is authorized 

9 to be appropriated $250,000,000 for each of fiscal years 

10 2011 through 2013. Such authorization shall be in addi11 tion to any authorization of appropriations under any 

12 other provision of law to carry out research activities on 

13 osteoporosis or related bone diseases.’’. 

14 SEC. 5. SURVEILLANCE ACTIVITIES RELATED TO BONE DIS15 EASES AT THE CENTERS FOR DISEASE CON16 TROL AND PREVENTION. 

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

18 (42 U.S.C. 243 et seq.) is amended by inserting after sec19 tion 320A the following: 

20 ‘‘SEC. 320B. SURVEILLANCE REGARDING OSTEOPOROSIS 

21 AND RELATED BONE DISEASES. 

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

23 the Director of the Centers for Disease Control and Pre24 vention, may award grants to and enter into cooperative 

25 agreements with public or nonprofit private entities for the 

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1 collection, analysis, and reporting of data on osteoporosis 

2 and related bone diseases, including osteogenesis 

3 imperfecta and Paget’s disease of bone. 

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

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

6 Secretary may provide direct technical assistance in lieu 

7 of cash. 

8 ‘‘(c) COORDINATION WITH ADVISORY COMMITTEE

9 AND NIH.—The Secretary shall ensure that epidemiolog10 ical and other types of information obtained under sub11 section (a) is made available to the National Institutes of 

12 Health. The advisory committee established under section 

13 315(g) shall advise the Secretary in the coordination of 

14 epidemiological efforts and in the expansion and inten15 sification of programs for conducting surveillance and 

16 data collection activities under this section. 

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

18 purpose of carrying out this section, there is authorized 

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

20 2011 through 2015.’’. 

Æ 

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