,i #aaeth ,,congress #b;d ,session ,h4 ,r4 #eaae ,,in ,,the ,,house ,,of ,,representatives ,february #bg1 #bjah,mr4 ,carson of ,indiana 7for himself and ,mr4 ,costello of ,pennsylvania7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to expand and improve the programs and activities of the ,department of ,health and ,human ,services for awareness1 education1 research1 surveillance1 diagnosis1 and treatment concerning rare diseases and conditions4 #a4 ,short title ,this ,act may be cited as the ,rare disease ,advancement1 ,research1 and ,education ,act of #bjah or the ,,rare ,act of #bjah4 #b4 ,improving programs and activities of ,,hhs concerning rare diseases and conditions 7a7 ,,nih ,paragraph 7#a7 of section #djb;,a7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb;a7a77 is amended by adding at the end the following3 ,in addition to the amounts authorized to be appropriated by the preceding sentence1 there is authorized to be appropriated #aj1jjj1jjj for each of fiscal years #bjai through #bjbc for carrying out section #dha;,a 7relating to rare disease regional centers of excellence74 4 7b7 ,,cdc surveillance of rare diseases and conditions ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #cag,t of such ,act 7#db ,u4,s4,c4 #bdg;b-#bb7 the following3 #cag,u ,,cdc surveillance of rare diseases and conditions 7a7 ,in ,general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other agencies as the ,secretary determines1 shall1 as appropriate-- 7#a7 enhance and expand infrastructure and activities to track the epidemiology of rare diseases and conditions2 and 7#b7 incorporate information obtained through such activities into an integrated surveillance system1 which may consist of or include a registry1 to be known as the ,national ,rare ,disease or ,condition ,surveillance ,system4 7b7 ,research ,the ,secretary shall ensure that the ,national ,rare ,disease or ,condition ,surveillance ,system is designed in a manner that facilitates further research on rare diseases and conditions4 7c7 ,content ,in carrying out subsection 7a71 the ,secretary-- 7#a7 shall provide for the collection and storage of information on the incidence and prevalence of rare diseases and conditions in the ,united ,states2 7#b7 to the extent practicable1 shall provide for the collection and storage of other available information on rare diseases and conditions1 including information related to persons living with a rare disease or condition who choose to participate1 such as-- 7,a7 demographics1 such as age1 race1 ethnicity1 sex1 geographic location1 family history1 and other information1 as appropriate2 7,b7 risk factors that may be associated with a rare disease or condition1 such as genetic and environmental risk factors and other information1 as appropriate2 and 7,c7 diagnosis and progression markers2 7#c7 to the extent practicable1 shall provide for the collection and storage of information relevant to analysis on rare diseases and conditions1 such as information concerning-- 7,a7 the natural history of the diseases and conditions2 7,b7 the prevention of the diseases and conditions2 7,c7 the detection1 management1 and treatment approaches for the diseases and conditions2 and 7,d7 the development of outcomes measures2 7#d7 may address issues identified during the consultation process under subsection 7d72 and 7#e7 initially may address a limited number of rare diseases or conditions4 7d7 ,consultation ,in carrying out this section1 the ,secretary shall consult with individuals with appropriate expertise1 which may include-- 7#a7 epidemiologists with experience in disease surveillance or registries2 7#b7 representatives of national voluntary health associations that-- 7,a7 focus on rare diseases or conditions2 and 7,b7 have demonstrated experience in research1 care1 or patient services2 7#c7 health information technology experts or other information management specialists2 7#d7 clinicians with expertise in rare diseases or conditions2 7#e7 research scientists with expertise in rare diseases or conditions1 or experience conducting translational research or utilizing surveillance systems for scientific research purposes2 and 7#f7 patients and caregivers of patients with rare diseases or conditions4 7e7 ,grants ,the ,secretary may award grants to1 or enter into contracts or cooperative agreements with1 public or private nonprofit entities to carry out activities under this section4 7f7 ,coordination with other ,federal1 ,state1 and local agencies ,subject to subsection 7h71 the ,secretary shall-- 7#a7 make information and analysis in the ,national ,rare ,disease or ,condition ,surveillance ,system available1 as appropriate-- 7,a7 to ,federal departments and agencies1 such as the ,national ,institutes of ,health and the ,department of ,veterans ,affairs2 and 7,b7 to ,state and local agencies2 and 7#b7 identify1 build upon1 leverage1 and coordinate among existing data and surveillance systems1 surveys1 registries1 and other ,federal public health infrastructure1 wherever practicable4 7g7 ,public access ,subject to subsection 7h71 the ,secretary shall ensure that information and analysis in the ,national ,rare ,disease or ,conditions ,surveillance ,system are available1 as appropriate1 to the public1 including researchers4 7h7 ,privacy ,the ,secretary shall ensure that information and analysis in the ,national ,rare ,disease or ,condition ,surveillance ,system are made available only to the extent permitted by applicable ,federal and ,state law1 and in a manner that protects personal privacy1 to the extent required by applicable ,federal and ,state privacy law1 at a minimum4 7i7 ,reports 7#a7 ,report on information and analyses ,not later than #a year after the date on which any system is established under this section1 the ,secretary shall submit an interim report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding aggregate information collected pursuant to this section and epidemiological analyses1 as appropriate4 ,such report shall be posted on the ,internet website of the ,department of ,health and ,human ,services and shall be updated biennially4 7#b7 ,implementation report ,not later than #d years after the date of the enactment of this section1 the ,secretary shall submit a report to the ,congress concerning the implementation of this section4 ,such report shall include information on-- 7,a7 the development and maintenance of the ,national ,rare ,disease or ,condition ,surveillance ,system2 7,b7 the type of information collected and stored in the surveillance system2 7,c7 the use and availability of such information1 including guidelines for such use2 and 7,d7 the use and coordination of databases that collect or maintain information on rare diseases or conditions4 7j7 ,definitions ,in this section3 7#a7 ,national voluntary health association ,the term national voluntary health association means a national nonprofit organization with chapters1 other affiliated organizations1 or networks in ,states throughout the ,united ,states with experience serving the population of individuals with a rare disease or condition and have demonstrated experience in rare disease or condition research1 care1 and patient services4 7#b7 ,rare ,the term rare1 with respect to a disease or condition1 means affecting fewer than #bjj1jjj individuals in the ,united ,states4 7k7 ,authorization of ,appropriations ,to carry out this section1 there are authorized to be appropriated #e1jjj1jjj for each of fiscal years #bjah through #bjbc4 4 7c7 ,,ahrq health care provider awareness activities 7#a7 ,in general ,the ,director of the ,agency for ,healthcare ,research and ,quality shall expand and intensify the activities of the ,agency to increase the awareness and knowledge of health care providers about rare diseases and conditions4 7#b7 ,definition ,in this subsection1 the term rare diseases and conditions refers to any disease or condition affecting fewer than #bjj1jjj individuals in the ,united ,states4 7d7 ,national ,academies report 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall seek to enter into an arrangement with the ,national ,academies 7or another appropriate entity if the ,national ,academies decline7 to update and republish1 by not later than #c years after the date of enactment of this ,act1 the #bjaj report of the ,national ,academies entitled ,rare ,diseases and ,orphan ,products3 ,accelerating ,research and ,development4 7#b7 ,authorization of appropriations ,to carry out this subsection1 there is authorized to be appropriated #a1jjj1jjj4