I 

113TH CONGRESS 

1ST SESSION H. R. 1591 

To amend the Public Health Service Act to provide for the establishment 

and maintenance of an undiagnosed diseases network, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 17, 2013 

Mr. CARTER (for himself, Mr. BURGESS, Ms. SPEIER, Mr. KING of New York, 

Mr. MCCAUL, and Mr. RANGEL) 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 

the establishment and maintenance of an undiagnosed 

diseases network, 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 ‘‘Charles August Long 

5 Undiagnosed Diseases Research and Collaboration Net6 work Act of 2013’’ or the ‘‘CAL Undiagnosed Diseases 

7 Research and Collaboration Network Act of 2013’’. 


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1 SEC. 2. CAL NETWORK OF UNDIAGNOSED DISEASES. 

2 Title III of the Public Health Service Act (42 U.S.C. 

3 241 et seq.) is amended by inserting after section 317T 

4 the following: 

5 ‘‘SEC. 317U. THE NATIONAL CAL NETWORK OF 

6 UNDIAGNOSED DISEASES. 

7 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

8 through the Director of NIH, shall establish and maintain 

9 an undiagnosed diseases patient network (in this section 

10 referred to as the ‘CAL Network’). 

11 ‘‘(b) PURPOSES.—The purposes of the CAL Network 

12 shall be to— 

13 ‘‘(1) provide physicians who are handling cases 

14 of undiagnosed diseases with a means, consistent 

15 with applicable privacy laws, including HIPAA pri16 vacy and security law (as defined in section 

17 3009(a)(2)), to search for similar cases and to net18 work and collaborate with the physicians handling 

19 such similar cases in order to find a diagnosis and 

20 to improve patient care and outcomes; 

21 ‘‘(2) better enable and examine cross-disease re22 search whereby cases of undiagnosed diseases can be 

23 cross-referenced against attributes of common dis24 eases and rare diseases to assist in the rendering of 

25 a diagnosis; elucidate commonalities; identify atypiVerDate Mar 15 2010 20:39 Apr 19, 2013 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1591.IH H1591

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1 cal presentations, rare subgroups, similar findings; 

2 and identify potential treatments; 

3 ‘‘(3) better describe the types and prevalence of 

4 cases of undiagnosed diseases in the United States; 

5 ‘‘(4) make necessary data available to elucidate 

6 appropriate factors (such as genetic, environmental, 

7 and occupational factors) that may be associated 

8 with the various types of cases of undiagnosed dis9 eases reported by individuals specified by the Direc10 tor of NIH; 

11 ‘‘(5) better outline key demographic factors 

12 (such as age, race or ethnicity, gender, sex, geo13 graphic location, and family medical history) of indi14 viduals who are undiagnosed; 

15 ‘‘(6) provide such data necessary to better un16 derstand the length of time for a diagnoses to be 

17 rendered in cases of undiagnosed diseases and to 

18 identify barriers to diagnoses and reasons for mis19 diagnosis of diseases; and 

20 ‘‘(7) provide such information necessary to de21 termine, in order to improve access of individuals 

22 with undiagnosed diseases throughout the United 

23 States (including those with severe illnesses which 

24 limit or restrict travel) to programs similar to the 

25 Undiagnosed Disease Program conducted at the NaVerDate Mar 15 2010 20:39 Apr 19, 2013 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1591.IH H1591

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1 tional Institutes of Health, if the needs and number 

2 of such individuals support— 

3 ‘‘(A) the expansion of such Undiagnosed 

4 Disease Program, as in existence as of the date 

5 of the enactment of this section, to include the 

6 establishment of additional undiagnosed dis7 eases programs of like scope and nature at 

8 other locations throughout the United States; 

9 and 

10 ‘‘(B) the establishment by entities other 

11 than the National Institutes of Health of sepa12 rate undiagnosed disease programs of like scope 

13 and nature to the Undiagnosed Disease Pro14 gram at locations throughout the United States 

15 under the guidance of and through grants pro16 vided by and through such Undiagnosed Dis17 eases Program. 

18 ‘‘(c) CONTENT OF THE CAL NETWORK.—The Sec19 retary shall include in the CAL Network such information 

20 respecting undiagnosed diseases as the Secretary deems 

21 appropriate for the purposes described in subsection (b) 

22 and other purposes to facilitate the early recognition, 

23 treatment, cure, and control of such diseases. 

24 ‘‘(d) AVAILABILITY.— 


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1 ‘‘(1) DESIGN REQUIREMENTS.—Subject to 

2 paragraph (2), for the purposes described in sub3 section (c) and consistent with applicable privacy 

4 laws, including HIPAA privacy and security law (as 

5 defined in section 3009(a)(2)), the Secretary shall 

6 ensure that the CAL Network is designed in such a 

7 manner as to— 

8 ‘‘(A) make the information in the CAL 

9 Network available to appropriate health care 

10 professionals, patients, and other qualified indi11 viduals and organizations, as determined by the 

12 Secretary, who are registered to access such 

13 network in accordance with such process and 

14 requirements as specified by the Secretary; 

15 ‘‘(B) make epidemiological and other types 

16 of information obtained through the CAL Net17 work available to Federal agencies and health18 related agencies; 

19 ‘‘(C) provide for different levels and types 

20 of access to such network to be granted based 

21 on the circumstances and individuals involved; 

22 and 

23 ‘‘(D) allow for an individual to have only 

24 the level and type of access to the network so 

25 granted. 


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1 ‘‘(2) INFORMATION WHICH MAY NOT BE PUB2 LICALLY DISCLOSED.—The design under paragraph 

3 (1) shall ensure that the following information is not 

4 publicly disclosed: 

5 ‘‘(A) Individually identifiable information. 

6 ‘‘(B) Trade secrets or commercial or finan7 cial information obtained from a person and 

8 privileged or confidential, as provided in section 

9 552(b)(4) of title 5, United States Code. 

10 ‘‘(e) GRANTS.—The Secretary, acting through the 

11 Director of NIH, may award grants to, and enter into con12 tracts and cooperative agreements with, public or private 

13 nonprofit entities for— 

14 ‘‘(1) the collection, analysis, and reporting of 

15 data on cases of undiagnosed diseases and other dis16 orders that can often go undiagnosed or be 

17 misdiagnosed as other diseases or disorders; and 

18 ‘‘(2) the establishment of separate undiagnosed 

19 disease programs described in subsection (b)(7)(B). 

20 ‘‘(f) IMPLEMENTATION SCHEDULE.—In carrying out 

21 this section, the Secretary shall— 

22 ‘‘(1) not later than 1 year after the date of the 

23 enactment of this section, complete any study, re24 search, and development necessary to implement the 

25 CAL Network; and 


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1 ‘‘(2) complete the implementation of the CAL 

2 Network such that it is fully operational by not later 

3 than September 30, 2015. 

4 ‘‘(g) UNDIAGNOSED DISEASES DEFINED.—For pur5 poses of this section, the term ‘undiagnosed disease’ 

6 means a medically unexplained chronic multi-symptom 

7 disease that— 

8 ‘‘(1) causes the decline of, limitations in, or ces9 sation of a person’s developmental status, functional 

10 status, quality of life, or any combination thereof; 

11 ‘‘(2) has not been diagnosed by a medical spe12 cialist in a tertiary medical center; 

13 ‘‘(3) is defined by a cluster of signs or symp14 toms; which by history, physical examination, and 

15 laboratory tests cannot be attributed to any known 

16 clinical diagnosis; 

17 ‘‘(4) is without conclusive pathophysiology or 

18 etiology; 

19 ‘‘(5) is characterized by overlapping symptoms 

20 and signs; or 

21 ‘‘(6) exhibits an inconsistent demonstration of 

22 laboratory abnormalities. 

23 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.— 


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1 ‘‘(1) IN GENERAL.—To carry out this section, 

2 there are authorized to be appropriated $5,000,000 

3 for the period of fiscal years 2014 through 2019. 

4 ‘‘(2) OFFSET.—To offset amounts appropriated 

5 pursuant to the authorization of appropriations in 

6 paragraph (1), the Secretary shall reduce funds that 

7 would otherwise be obligated and expended under 

8 the account heading ‘National Institutes of Health– 

9 Office of the Director’ by $5,000,000 for the period 

10 of fiscal years 2014 through 2019.’’. 

Æ 


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