,i #aaeth ,,congress #b;d ,session ,h4 ,r4 #fdba ,,in ,,the ,,house ,,of ,,representatives ,july #ah1 #bjah,mr4 ,sessions 7for himself1 ,mr4 ,bishop of ,georgia1 ,mr4 ,upton1 and ,mr4 ,bilirakis7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to advance treatment and cures for blindness and other retinal conditions and to promote competitiveness in the ,united ,states through a pilot program to increase funding for translational research1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,faster ,treatments and ,cures for ,eye ,diseases ,act4 #b4 ,definitions ,for purposes of this ,act3 7#a7 ,applicable congressional committees ,the term applicable congressional committees means the ,committees on ,energy and ,commerce and ,financial ,services of the ,house of ,representatives and the ,committees on ,banking1 ,housing1 and ,urban ,affairs and ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7#b7 ,appropriate ,federal banking agency ,the term appropriate ,federal banking agency has the meaning given that term in section #c of the ,federal ,deposit ,insurance ,act 7#ab ,u4,s4,c4 #ahac74 7#c7 ,cost ,the term cost has the meaning given to the term cost of a loan guarantee in section #ejb7e77;,c7 of the ,federal ,credit ,reform ,act of #aiij 7#b ,u4,s4,c4 #ffa;a7#e77;,c774 7#d7 ,depository institution2 depository institution holding company ,the term depository institution and depository institution holding company have the meaning given those terms under section #c of the ,federal ,deposit ,insurance ,act 7#ab ,u4,s4,c4 #ahac74 7#e7 ,eye bond ,the term eye bond means a bond-- 7,a7 issued by an issuer pursuant to this ,act2 7,b7 the proceeds of which are used to fund projects selected under section #f7;b77#a71 except as otherwise described in this ,act2 and 7,c7 that complies with the regulations issued under section #d4 7#f7 ,funded project ,the term funded project means a translational research project that is selected to be funded using the proceeds of an eye bond4 7#g7 ,guarantee ,the term guarantee has the meaning given to the term loan guarantee in section #ejb of the ,federal ,credit ,reform ,act of #aiij 7#b ,u4,s4,c4 #ffa;a7 and includes a loan guarantee commitment 7as defined in such section #ejb74 7#h7 ,issuer ,the term issuer means an entity that-- 7,a7 is a depository institution1 a depository institution holding company1 or a broker or dealer registered with the ,securities and ,exchange ,commission2 7,b7 complies with the schedule for the issuance of eye bonds established under section #c7;c72 and 7,c7 complies with the regulations issued under section #e4 7#i7 ,program ,the term ,program means the ,eye ,bond ,pilot ,program established under section #c4 7#aj7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services1 except in references to the ,secretary of the ,treasury4 7#aa7 ,state ,the term ,state means-- 7,a7 each ,state of the ,united ,states2 7,b7 the ,district of ,columbia2 7,c7 the ,commonwealth of ,puerto ,rico2 and 7,d7 any other territory or possession of the ,united ,states4 7#ab7 ,translational research ,the term translational research-- 7,a7 means any research project that is designed to cure vision blindness and any conditions attendant to vision impairment that are1 as determined by the ,director of the ,national ,eye ,institute1 congenital to the vision impairment and not incidental to vision impairment or caused by vision impairment2 7,b7 includes projects designed to cure-- 7i7 hearing impairment genetically linked to vision impairment1 such as ,usher ,syndrome2 7ii7 retinal degenerative diseases such as retinitis pigmentosa1 macular degeneration1 and ,usher ,syndrome2 7iii7 vision trauma due to injury such as that experienced by wounded veterans2 7iv7 glaucoma2 7v7 optic nerve disorders that result in vision impairment or blindness1 such as morning glory syndrome2 and 7vi7 diabetic reinopathy2 and 7,c7 subject to subparagraph 7,b77vi71 does not include projects designed to cure any underlying disease or condition whose symptoms may include vision impairment1 such as diabetes4 #c4 ,eye ,bond ,pilot ,program 7a7 ,establishment ,not earlier than #a year after the date of enactment of this ,act1 the ,secretary1 in consultation with the ,secretary of the ,treasury and the appropriate ,federal banking agencies1 shall establish a pilot program to be known as the ,eye ,bond ,pilot ,program under which-- 7#a7 the ,director of the ,national ,eye ,institute shall1 in accordance with section #f1 select translational research projects to be funded by eye bonds2 and 7#b7 the ,secretary shall-- 7,a7 provide a partial ,federal guarantee of the eye bonds2 7,b7 contract with an issuer to issue the eye bonds2 and 7,c7 use the proceeds from the sale of the eye bonds to fund the selected projects and to pay for other related expenses1 as permitted by this ,act4 7b7 ,federal guarantee 7#a7 ,in general ,the ,secretary shall guarantee the payment of principal 7but not the payment of interest7 on an eye bond1 on a bond-by-bond basis1 in an amount to be determined by the ,secretary1 but in no case may the amount of such guarantee be more than #ej percent of the principal of the eye bond4 7#b7 ,prioritization of taxpayer interests ,all eye bonds shall be structured to give first priority to protecting the interests of the ,united ,states by ensuring that-- 7,a7 all cash proceeds received from the repayment of an eye bond are first used to reduce the amount of principal guaranteed by the ,secretary under the terms of the eye bond2 and 7,b7 the ,secretary has a senior claim on all assets and collateral under the eye bond to the extent the guarantee provided by the ,secretary is not extinguished4 7#c7 ,limitation ,the ,secretary may not guarantee-- 7,a7 more than #a1jjj1jjj1jjj for all eye bonds issued pursuant to this ,act2 and 7,b7 more than #bej1jjj1jjj for all eye bonds issued pursuant to this ,act in any single fiscal year4 7c7 ,issuance schedule ,the ,secretary shall1 in consultation with the ,secretary of the ,treasury and issuers1 establish a schedule for the issuance of eye bonds that ensures that funded projects represent a reasonable sample of diverse causes of vision loss4 7d7 ,risk-,share pool 7#a7 ,in general ,with respect to an eye bond guaranteed under this section1 the ,secretary may allow a risk-share pool capitalized by issuers to provide a first-loss guarantee of the principal and interest of such bond1 if the ,secretary determines that such first-loss guarantee would-- 7,a7 be a robust source of protection for the ,united ,states1 as guarantor of the eye bond1 that reduces the cost of the ,federal guarantee to the ,united ,states2 7,b7 encourage the flow of private sector capital into biomedical translational research2 7,c7 create a prudent incentive for issuers to contribute additional private capital for biomedical translational research2 or 7,d7 meet other public interest1 safety1 and soundness goals4 7#b7 ,consultation ,in making a determination under paragraph 7#a71 the ,secretary shall consult with the ,secretary of the ,treasury and the appropriate ,federal banking agencies4 7#c7 ,funding ,the cost of contracting with a risk-share pool under this subsection shall be paid from the proceeds from the sale of eye bonds pursuant to the ,program4 7e7 ,equity position option for the ,secretary 7#a7 ,in general ,with respect to an eye bond issued pursuant to this ,act1 the ,secretary1 in consultation with the ,secretary of the ,treasury and other appropriate parties1 including eye bond issuers and investors1 may negotiate an equity position for the ,united ,states ,government in the projects to be funded by such eye bond if the ,secretary determines that such an equity position will further the interests of the ,program and the ,united ,states4 7#b7 ,limitations 7,a7 ,supplemental ,any equity position taken in a project pursuant to paragraph 7#a7 shall be supplemental to1 not in lieu of1 a guarantee provided by the ,secretary with respect to the eye bond funding such project4 7,b7 ,total amount ,the total of amount of an eye bond guarantee under this section and any equity position taken by the ,secretary in a project funded by such bond that is supplemental to such guarantee shall not exceed #ej percent of the principal amount of the eye bond4 7#c7 ,notification and consultation ,prior to finalization of any equity position under paragraph 7#a71 the ,secretary shall notify the applicable congressional committees and consult with such committees on the proposed terms of such equity position and whether taking such equity position will further the interests of the ,program and the ,united ,states4 7f7 ,termination of the program 7#a7 ,in general ,except as provided in paragraph 7#b71 the ,program shall terminate on the date that is #f years after the date of enactment of this ,act4 7#b7 ,early termination 7,a7 ,in general ,the ,secretary may terminate the ,program before the date described in paragraph 7#a74 7,b7 ,congressional notification ,if the ,secretary determines that the ,program shall be terminated under subparagraph 7,a71 not later than #fj days before the date on which the termination is effective1 the ,secretary shall-- 7i7 submit to the applicable congressional committees a report that includes-- 7,i7 a description of the reasons for the termination2 7,,ii7 any corrective actions that may be taken2 and 7,,iii7 any other actions that may be taken to promote the use of private capital and to increase the amount of ,federal funds made available to carry out basic and translational biomedical research2 and 7ii7 make publicly available the report described in clause 7i74 7#c7 ,effect on eye bonds issued and ,federal guarantees ,the termination of the ,program shall not affect the validity of-- 7,a7 any eye bond issued before the date on which the ,program is terminated2 or 7,b7 any ,federal guarantee under this ,act for an eye bond described in subparagraph 7,a74 7g7 ,program funding 7#a7 ,administrative expenses paid from bond sales ,except as provided under paragraph 7#b71 the cost of carrying out this ,act1 including the cost to the ,secretary in administering the ,program1 shall be recovered from the proceeds from the sale of eye bonds pursuant to the ,program or from fees as set forth in paragraph 7#c74 7#b7 ,specific appropriation or contribution ,no guarantee shall be made under this section unless-- 7,a7 an appropriation for the full cost of the guarantee has been made2 7,b7 the ,secretary has received from the eye bond issuer a payment in full for the cost of the guarantee2 or 7,c7 a combination of an appropriation and the deposit of a payment from the bond issuer into the ,treasury has been made in a sufficient amount to cover the full cost of the guarantee4 7#c7 ,cost of ,guarantees 7,a7 ,in general ,the ,secretary shall charge and collect fees for guarantees under this section in amounts the ,secretary determines are sufficient to recover applicable administrative expenses4 7,b7 ,availability ,fees collected under this subsection-- 7i7 shall be deposited by the ,secretary into the ,treasury2 and 7ii7 are authorized to remain available until expended4 #d4 ,eye bond terms1 conditions1 and structure 7a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary1 in consultation with the ,secretary of the ,treasury1 the ,chairman of the ,securities and ,exchange ,commission1 the heads of the appropriate ,federal banking agencies1 the ,director of the ,national ,institutes of ,health1 and the heads of other ,federal departments and agencies and other interested parties as the ,secretary determines appropriate1 shall issue regulations to specify the terms1 conditions1 and structure for an eye bond4 7b7 ,auctions ,in issuing the regulations under subsection 7a7-- 7#a7 the ,secretary may provide for an auction to select the purchasers of eye bonds2 and 7#b7 any such auction may include a process that minimizes the risk to the ,government of the ,federal guarantee involved by allowing bidders for an eye bond to compete against each other by bidding on the percentage of the ,federal guarantee under section #d7;b7 with respect to the eye bond1 with the bid for the lowest percentage winning the auction1 taking into account other terms and conditions set by the issuer to ensure the lowest total cost to the ,government4 #e4 ,eye bond issuers 7a7 ,issuer criteria ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary1 in consultation with the ,secretary of the ,treasury1 shall issue regulations-- 7#a7 to establish the criteria for selecting issuers2 7#b7 to ensure that issuers perform in a manner that ensures the successful issuance of eye bonds that promote biomedical translational research in the ,united ,states2 and 7#c7 to ensure that issuers use sound underwriting practices that protect the interests of-- 7,a7 the ,united ,states2 7,b7 eye bond investors2 and 7,c7 the long-term promotion of translational research for vision impairment and other diseases1 disabilities1 and syndromes congenital to vision impairment or caused by vision impairment1 taking into account features that are valuable after any authorization for expanded use of a limited ,federal guarantee for biomedical translational research for other diseases and disabilities4 7b7 ,compensation for issuers ,the issuer of an eye bond shall be compensated from the proceeds from the sale of such eye bond at such rate and on such terms as the ,secretary may provide4 7c7 ,public disclosures with respect to eye bonds 7#a7 ,in general ,not less than #b business days before the date on which an issuer issues an eye bond1 the issuer shall file with the ,securities and ,exchange ,commission1 and make available to the public1 the following information3 7,a7 ,the nature of all projects funded by the eye bond4 7,b7 ,the name of any principal individual or institution that will be conducting each project4 7,c7 ,the milestones established for each project4 7,d7 ,a determination by the issuer as to whether each project funded by the eye bond has appropriately protected intellectual property4 7,e7 ,the structure of the eye bond4 7,f7 ,the interest payment schedule for the eye bond4 7,g7 ,the anticipated returns and risks of the eye bond4 7,h7 ,such other information as the ,commission determines necessary or appropriate in the public interest or for the protection of investors4 7#b7 ,rulemaking 7,a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,securities and ,exchange ,commission shall issue regulations to carry out this subsection4 7,b7 ,authority of the ,secretary ,if the ,securities and ,exchange ,commission does not issue the regulations required under subparagraph 7,a7 before the end of the #ahj-;day period described under subparagraph 7,a71 the ,secretary shall issue regulations to carry out this subsection before the end of the #fj-;day period beginning on the end of the #ahj-;day period described under subparagraph 7,a74 #f4 ,translational research projects 7a7 ,eligibility requirements ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary1 in consultation with the ,secretary of the ,treasury1 the ,director of the ,national ,eye ,institute1 and other interested parties1 shall issue final regulations for the eligibility criteria for selecting translational research projects that will be funded through eye bonds4 ,such regulations shall address-- 7#a7 the stage of clinical trial for projects to provide the greatest likelihood of commercial application2 7#b7 the variations among disease and conditions needed to ensure sufficient diversification in each eye bond2 and 7#c7 the number of possible cures and treatments that are needed as determined by the ,secretary1 in consultation with issuers and the ,director of the ,national ,eye ,institute1 to ensure the successful issuance of eye bonds so as to protect the ,united ,states as guarantor of the eye bonds1 including-- 7,a7 drug therapies2 7,b7 gene therapies2 and 7,c7 artificial restoration of sight and similar mechanisms4 7b7 ,selection of projects 7#a7 ,in general ,the ,director of the ,national ,eye ,institute1 in consultation with the ,director of the ,national ,institutes of ,health and the ,secretary of the ,treasury1 shall select translational research projects to be funded with the proceeds of an eye bond4 7#b7 ,factors for selection ,not later than #cj days after the date on which the final regulations are issued under subsection 7a71 the ,secretary shall submit to the ,director of the ,national ,eye ,institute factors that the ,director of the ,national ,eye ,institute shall consider in making the selection under paragraph 7#a71 including-- 7,a7 the amount of equity any intellectual property holder will hold in the project2 7,b7 the resources any individual or institution will be required to demonstrate to ensure the ability of the individual or institution to repay the obligation under the eye bond1 regardless of the success or failure of the project funded with the proceeds of the eye bond2 7,c7 the number of projects needed to ensure diversification of risk2 7,d7 the manner in which funded projects will be defunded if the interim goals of the project are not satisfied2 and 7,e7 such other factors related to biomedical translational research project selection as the ,secretary determines appropriate4 7#c7 ,additional consultations 7,a7 ,in general ,in carrying out paragraph 7#a71 the ,director of the ,national ,eye ,institute may establish any consultative body that the ,director determines is necessary to provide for a complete1 transparent1 and forward-looking selection of projects4 7,b7 ,scientific advisers ,in carrying out paragraph 7#a71 the ,director of the ,national ,eye ,institute may consult with any group of scientific advisers that the ,director determines is necessary4 7c7 ,establishment of milestones 7#a7 ,in general ,the ,director of the ,national ,eye ,institute shall1 for each project funded by an eye bond1 establish milestones to determine the probability of success or failure for such project4 7#b7 ,inclusion in filings ,the ,director of the ,national ,eye ,institute shall submit to the issuer of an eye bond the milestones for each project funded from such eye bond1 so such milestones may be included in the filings made available by the issuer to the public under section #e7;c74 7d7 ,research requirement ,translational research carried out under a project funded by an eye bond shall be conducted-- 7#a7 in a ,state2 and 7#b7 by an individual or institution that is-- 7,a7 chartered in accordance with the laws of that ,state2 and 7,b7 clearly subject to verification of beneficial ownership by the issuer and1 upon request1 by the ,secretary4 #g4 ,inapplicability of certain laws ,eye bonds shall not be subject to-- 7#a7 section #ae;,g of the ,securities ,exchange ,act of #aicd 7#ae ,u4,s4,c4 #gho-#aa72 7#b7 except as provided under section #e7;c71 any registration or disclosure requirement promulgated by the ,securities and ,exchange ,commission2 and 7#c7 section #ac of the ,bank ,holding ,company ,act of #aief 7#ab ,u4,s4,c4 #ahea74 #h4 ,reports 7a7 ,,gao study and reports on other research projects 7#a7 ,ongoing study ,the ,comptroller ,general of the ,united ,states shall carry out an ongoing study to consider whether a program similar to the ,eye ,bond ,pilot ,program under this ,act should be established for other biomedical research projects4 7#b7 ,report ,the ,comptroller ,general shall1 during the period beginning on the date of the establishment of the ,program and ending on the termination date of the ,program1 issue a report to the applicable congressional committees1 not less frequently than annually1 on all findings and determinations made in carrying out the study required under paragraph 7#a74 7b7 ,reports on the ,program ,not later than #b years after the date on which eye bonds are first issued under this ,act1 and annually thereafter during the period ending on the date that is #d years after the date on which eye bonds are first issued under this ,act1 the ,comptroller ,general and the ,director of the ,national ,institutes of ,health 7in consultation with the ,director of the ,national ,center for ,advancing ,translational ,sciences7 shall each issue a separate report to the applicable congressional committees on-- 7#a7 the progress of the issuance of eye bonds2 7#b7 the reasons for any problems achieving desired volumes of eye bonds or the ability of the ,program to proceed at a faster pace2 7#c7 an analysis of the risk to the ,government in providing the ,federal guarantee described under section #d7;b72 7#d7 any improvements to eye bonds that the ,secretary should consider2 7#e7 the applicability of financial instruments similar to eye bonds to other biomedical research areas such as cancer1 ,alzheimer's disease1 rare diseases or conditions 7as defined in section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb77 and syndromes of particular concern to children2 and 7#f7 any other matter that the ,comptroller ,general or the ,director1 respectively1 determines is appropriate4