Faster Treatments and Cures for Eye Diseases Act

I 116TH CONGRESS 1ST SESSION H. R. 2620 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 research, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 9, 2019 Mr. BISHOP of Georgia (for himself, Mrs. RODGERS of Washington, Mr. BILI- RAKIS, Mr. COHEN, Mr. O’HALLERAN, Mr. SCHNEIDER, and Mr. FITZPATRICK) introduced the following bill; 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 fund- ing for translational research, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Faster Treatments and 4 Cures for Eye Diseases Act’’. 5 SEC. 2. DEFINITIONS. 6 For purposes of this Act: 7 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 2 •HR 2620 IH (1) APPLICABLE CONGRESSIONAL COMMIT- 1 TEES.—The term ‘‘applicable congressional commit- 2 tees’’ means the Committees on Energy and Com- 3 merce and Financial Services of the House of Rep- 4 resentatives and the Committees on Banking, Hous- 5 ing, and Urban Affairs and Health, Education, 6 Labor, and Pensions of the Senate. 7 (2) APPROPRIATE FEDERAL BANKING AGEN- 8 CY.—The term ‘‘appropriate Federal banking agen- 9 cy’’ has the meaning given that term in section 3 of 10 the Federal Deposit Insurance Act (12 U.S.C. 11 1813). 12 (3) COST.—The term ‘‘cost’’ has the meaning 13 given to the term ‘‘cost of a loan guarantee’’ in sec- 14 tion 502(5)(C) of the Federal Credit Reform Act of 15 1990 (2 U.S.C. 661a(5)(C)). 16 (4) DEPOSITORY INSTITUTION; DEPOSITORY IN- 17 STITUTION HOLDING COMPANY.—The term ‘‘deposi- 18 tory institution’’ and ‘‘depository institution holding 19 company’’ have the meaning given those terms under 20 section 3 of the Federal Deposit Insurance Act (12 21 U.S.C. 1813). 22 (5) EYE BOND.—The term ‘‘eye bond’’ means a 23 bond— 24 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 3 •HR 2620 IH (A) issued by an issuer pursuant to this 1 Act; 2 (B) the proceeds of which are used to fund 3 projects selected under section 6(b)(1), except 4 as otherwise described in this Act; and 5 (C) that complies with the regulations 6 issued under section 4. 7 (6) FUNDED PROJECT.—The term ‘‘funded 8 project’’ means a translational research project that 9 is selected to be funded using the proceeds of an eye 10 bond. 11 (7) GUARANTEE.—The term ‘‘guarantee’’ has 12 the meaning given to the term ‘‘loan guarantee’’ in 13 section 502 of the Federal Credit Reform Act of 14 1990 (2 U.S.C. 661a) and includes a loan guarantee 15 commitment (as defined in such section 502). 16 (8) ISSUER.—The term ‘‘issuer’’ means an enti- 17 ty that— 18 (A) is a depository institution, a depository 19 institution holding company, or a broker or 20 dealer registered with the Securities and Ex- 21 change Commission; 22 (B) complies with the schedule for the 23 issuance of eye bonds established under section 24 3(c); and 25 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 4 •HR 2620 IH (C) complies with the regulations issued 1 under section 5. 2 (9) PROGRAM.—The term ‘‘Program’’ means 3 the Eye Bond Pilot Program established under sec- 4 tion 3. 5 (10) SECRETARY.—The term ‘‘Secretary’’ 6 means the Secretary of Health and Human Services, 7 except in references to the Secretary of the Treas- 8 ury. 9 (11) STATE.—The term ‘‘State’’ means— 10 (A) each State of the United States; 11 (B) the District of Columbia; 12 (C) the Commonwealth of Puerto Rico; 13 and 14 (D) any other territory or possession of the 15 United States. 16 (12) TRANSLATIONAL RESEARCH.—The term 17 ‘‘translational research’’— 18 (A) means any research project that is de- 19 signed to cure vision blindness and any condi- 20 tions attendant to vision impairment that are, 21 as determined by the Director of the National 22 Eye Institute, congenital to the vision impair- 23 ment and not incidental to vision impairment or 24 caused by vision impairment; 25 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 5 •HR 2620 IH (B) includes projects designed to cure— 1 (i) hearing impairment genetically 2 linked to vision impairment, such as Usher 3 Syndrome; 4 (ii) retinal degenerative diseases such 5 as retinitis pigmentosa, macular degenera- 6 tion, and Usher Syndrome; 7 (iii) vision trauma due to injury such 8 as that experienced by wounded veterans; 9 (iv) glaucoma; 10 (v) optic nerve disorders that result in 11 vision impairment or blindness, such as 12 morning glory syndrome; and 13 (vi) diabetic reinopathy; and 14 (C) subject to subparagraph (B)(vi), does 15 not include projects designed to cure any under- 16 lying disease or condition whose symptoms may 17 include vision impairment, such as diabetes. 18 SEC. 3. EYE BOND PILOT PROGRAM. 19 (a) ESTABLISHMENT.—Not earlier than 1 year after 20 the date of enactment of this Act, the Secretary, in con- 21 sultation with the Secretary of the Treasury and the ap- 22 propriate Federal banking agencies, shall establish a pilot 23 program to be known as the Eye Bond Pilot Program 24 under which— 25 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 6 •HR 2620 IH (1) the Director of the National Eye Institute 1 shall, in accordance with section 6, select 2 translational research projects to be funded by eye 3 bonds; and 4 (2) the Secretary shall— 5 (A) provide a partial Federal guarantee of 6 the eye bonds; 7 (B) contract with an issuer to issue the eye 8 bonds; and 9 (C) use the proceeds from the sale of the 10 eye bonds to fund the selected projects and to 11 pay for other related expenses, as permitted by 12 this Act. 13 (b) FEDERAL GUARANTEE.— 14 (1) IN GENERAL.—The Secretary shall guar- 15 antee the payment of principal (but not the payment 16 of interest) on an eye bond, on a bond-by-bond 17 basis, in an amount to be determined by the Sec- 18 retary, but in no case may the amount of such guar- 19 antee be more than 50 percent of the principal of 20 the eye bond. 21 (2) PRIORITIZATION OF TAXPAYER INTER- 22 ESTS.—All eye bonds shall be structured to give first 23 priority to protecting the interests of the United 24 States by ensuring that— 25 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 7 •HR 2620 IH (A) all cash proceeds received from the re- 1 payment of an eye bond are first used to reduce 2 the amount of principal guaranteed by the Sec- 3 retary under the terms of the eye bond; and 4 (B) the Secretary has a senior claim on all 5 assets and collateral under the eye bond to the 6 extent the guarantee provided by the Secretary 7 is not extinguished. 8 (3) LIMITATION.—The Secretary may not guar- 9 antee— 10 (A) more than $1,000,000,000 for all eye 11 bonds issued pursuant to this Act; and 12 (B) more than $250,000,000 for all eye 13 bonds issued pursuant to this Act in any single 14 fiscal year. 15 (c) ISSUANCE SCHEDULE.—The Secretary shall, in 16 consultation with the Secretary of the Treasury and 17 issuers, establish a schedule for the issuance of eye bonds 18 that ensures that funded projects represent a reasonable 19 sample of diverse causes of vision loss. 20 (d) RISK-SHARE POOL.— 21 (1) IN GENERAL.—With respect to an eye bond 22 guaranteed under this section, the Secretary may 23 allow a risk-share pool capitalized by issuers to pro- 24 vide a first-loss guarantee of the principal and inter- 25 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 8 •HR 2620 IH est of such bond, if the Secretary determines that 1 such first-loss guarantee would— 2 (A) be a robust source of protection for the 3 United States, as guarantor of the eye bond, 4 that reduces the cost of the Federal guarantee 5 to the United States; 6 (B) encourage the flow of private sector 7 capital into biomedical translational research; 8 (C) create a prudent incentive for issuers 9 to contribute additional private capital for bio- 10 medical translational research; or 11 (D) meet other public interest, safety, and 12 soundness goals. 13 (2) CONSULTATION.—In making a determina- 14 tion under paragraph (1), the Secretary shall consult 15 with the Secretary of the Treasury and the appro- 16 priate Federal banking agencies. 17 (3) FUNDING.—The cost of contracting with a 18 risk-share pool under this subsection shall be paid 19 from the proceeds from the sale of eye bonds pursu- 20 ant to the Program. 21 (e) EQUITY POSITION OPTION FOR THE SEC- 22 RETARY.— 23 (1) IN GENERAL.—With respect to an eye bond 24 issued pursuant to this Act, the Secretary, in con- 25 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 9 •HR 2620 IH sultation with the Secretary of the Treasury and 1 other appropriate parties, including eye bond issuers 2 and investors, may negotiate an equity position for 3 the United States Government in the projects to be 4 funded by such eye bond if the Secretary determines 5 that such an equity position will further the interests 6 of the Program and the United States. 7 (2) LIMITATIONS.— 8 (A) SUPPLEMENTAL.—Any equity position 9 taken in a project pursuant to paragraph (1) 10 shall be supplemental to, not in lieu of, a guar- 11 antee provided by the Secretary with respect to 12 the eye bond funding such project. 13 (B) TOTAL AMOUNT.—The total of amount 14 of an eye bond guarantee under this section and 15 any equity position taken by the Secretary in a 16 project funded by such bond that is supple- 17 mental to such guarantee shall not exceed 50 18 percent of the principal amount of the eye 19 bond. 20 (3) NOTIFICATION AND CONSULTATION.—Prior 21 to finalization of any equity position under para- 22 graph (1), the Secretary shall notify the applicable 23 congressional committees and consult with such 24 committees on the proposed terms of such equity po- 25 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 10 •HR 2620 IH sition and whether taking such equity position will 1 further the interests of the Program and the United 2 States. 3 (f) TERMINATION OF THE PROGRAM.— 4 (1) IN GENERAL.—Except as provided in para- 5 graph (2), the Program shall terminate on the date 6 that is 6 years after the date of enactment of this 7 Act. 8 (2) EARLY TERMINATION.— 9 (A) IN GENERAL.—The Secretary may ter- 10 minate the Program before the date described 11 in paragraph (1). 12 (B) CONGRESSIONAL NOTIFICATION.—If 13 the Secretary determines that the Program 14 shall be terminated under subparagraph (A), 15 not later than 60 days before the date on which 16 the termination is effective, the Secretary 17 shall— 18 (i) submit to the applicable congres- 19 sional committees a report that includes— 20 (I) a description of the reasons 21 for the termination; 22 (II) any corrective actions that 23 may be taken; and 24 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 11 •HR 2620 IH (III) any other actions that may 1 be taken to promote the use of private 2 capital and to increase the amount of 3 Federal funds made available to carry 4 out basic and translational biomedical 5 research; and 6 (ii) make publicly available the report 7 described in clause (i). 8 (3) EFFECT ON EYE BONDS ISSUED AND FED- 9 ERAL GUARANTEES.—The termination of the Pro- 10 gram shall not affect the validity of— 11 (A) any eye bond issued before the date on 12 which the Program is terminated; or 13 (B) any Federal guarantee under this Act 14 for an eye bond described in subparagraph (A). 15 (g) PROGRAM FUNDING.— 16 (1) ADMINISTRATIVE EXPENSES PAID FROM 17 BOND SALES.—Except as provided under paragraph 18 (2), the cost of carrying out this Act, including the 19 cost to the Secretary in administering the Program, 20 shall be recovered from the proceeds from the sale 21 of eye bonds pursuant to the Program or from fees 22 as set forth in paragraph (3). 23 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 12 •HR 2620 IH (2) SPECIFIC APPROPRIATION OR CONTRIBU- 1 TION.—No guarantee shall be made under this sec- 2 tion unless— 3 (A) an appropriation for the full cost of 4 the guarantee has been made; 5 (B) the Secretary has received from the 6 eye bond issuer a payment in full for the cost 7 of the guarantee; or 8 (C) a combination of an appropriation and 9 the deposit of a payment from the bond issuer 10 into the Treasury has been made in a sufficient 11 amount to cover the full cost of the guarantee. 12 (3) COST OF GUARANTEES.— 13 (A) IN GENERAL.—The Secretary shall 14 charge and collect fees for guarantees under 15 this section in amounts the Secretary deter- 16 mines are sufficient to recover applicable ad- 17 ministrative expenses. 18 (B) AVAILABILITY.—Fees collected under 19 this subsection— 20 (i) shall be deposited by the Secretary 21 into the Treasury; and 22 (ii) are authorized to remain available 23 until expended. 24 VerDate Sep 11 2014 21:50 May 17, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H2620.IH H2620 pbinns on DSK79D2C42PROD with BILLS 13 •HR 2620 IH SEC. 4. EYE BOND TERMS, CONDITIONS, AND STRUCTURE. 1 (a) IN GENERAL.—Not later than 180 days after the 2 date of enactment of this Act, the Secretary, in consulta- 3 tion with the Secretary of the Treasury, the Chairman of 4 the Securities and Exchange Commission, the heads of the 5 appropriate Federal banking agencies, the Director of the 6 National Institutes of Health, and the heads of other Fed- 7 eral departments and agencies and other interested parties 8 as the Secretary determines appropriate, shall issu [Text truncated for display. Full text available on Congress.gov.]