Faster Treatments and Cures for Eye Diseases Act
This bill requires the Department of Health and Human Services to establish a pilot program through which vision impairment research projects are funded by specified bonds.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6421 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 6421
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
July 18, 2018
Mr. Sessions (for himself, Mr. Bishop of Georgia, Mr. Upton, and Mr.
Bilirakis) 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 funding for translational research, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Faster Treatments and Cures for Eye
Diseases Act''.
SEC. 2. DEFINITIONS.
For purposes of this Act:
(1) 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 Banking, Housing, and
Urban Affairs and Health, Education, Labor, and Pensions of the
Senate.
(2) Appropriate federal banking agency.--The term
``appropriate Federal banking agency'' has the meaning given
that term in section 3 of the Federal Deposit Insurance Act (12
U.S.C. 1813).
(3) Cost.--The term ``cost'' has the meaning given to the
term ``cost of a loan guarantee'' in section 502(5)(C) of the
Federal Credit Reform Act of 1990 (2 U.S.C. 661a(5)(C)).
(4) Depository institution; depository institution holding
company.--The term ``depository institution'' and ``depository
institution holding company'' have the meaning given those
terms under section 3 of the Federal Deposit Insurance Act (12
U.S.C. 1813).
(5) Eye bond.--The term ``eye bond'' means a bond--
(A) issued by an issuer pursuant to this Act;
(B) the proceeds of which are used to fund projects
selected under section 6(b)(1), except as otherwise
described in this Act; and
(C) that complies with the regulations issued under
section 4.
(6) Funded project.--The term ``funded project'' means a
translational research project that is selected to be funded
using the proceeds of an eye bond.
(7) Guarantee.--The term ``guarantee'' has the meaning
given to the term ``loan guarantee'' in section 502 of the
Federal Credit Reform Act of 1990 (2 U.S.C. 661a) and includes
a loan guarantee commitment (as defined in such section 502).
(8) Issuer.--The term ``issuer'' means an entity that--
(A) is a depository institution, a depository
institution holding company, or a broker or dealer
registered with the Securities and Exchange Commission;
(B) complies with the schedule for the issuance of
eye bonds established under section 3(c); and
(C) complies with the regulations issued under
section 5.
(9) Program.--The term ``Program'' means the Eye Bond Pilot
Program established under section 3.
(10) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services, except in references to the
Secretary of the Treasury.
(11) State.--The term ``State'' means--
(A) each State of the United States;
(B) the District of Columbia;
(C) the Commonwealth of Puerto Rico; and
(D) any other territory or possession of the United
States.
(12) Translational research.--The term ``translational
research''--
(A) means any research project that is designed to
cure vision blindness and any conditions attendant to
vision impairment that are, as determined by the
Director of the National Eye Institute, congenital to
the vision impairment and not incidental to vision
impairment or caused by vision impairment;
(B) includes projects designed to cure--
(i) hearing impairment genetically linked
to vision impairment, such as Usher Syndrome;
(ii) retinal degenerative diseases such as
retinitis pigmentosa, macular degeneration, and
Usher Syndrome;
(iii) vision trauma due to injury such as
that experienced by wounded veterans;
(iv) glaucoma;
(v) optic nerve disorders that result in
vision impairment or blindness, such as morning
glory syndrome; and
(vi) diabetic reinopathy; and
(C) subject to subparagraph (B)(vi), does not
include projects designed to cure any underlying
disease or condition whose symptoms may include vision
impairment, such as diabetes.
SEC. 3. EYE BOND PILOT PROGRAM.
(a) Establishment.--Not earlier than 1 year after the date of
enactment of this Act, the Secretary, in consultation with the
Secretary of the Treasury and the appropriate Federal banking agencies,
shall establish a pilot program to be known as the Eye Bond Pilot
Program under which--
(1) the Director of the National Eye Institute shall, in
accordance with section 6, select translational research
projects to be funded by eye bonds; and
(2) the Secretary shall--
(A) provide a partial Federal guarantee of the eye
bonds;
(B) contract with an issuer to issue the eye bonds;
and
(C) use the proceeds from the sale of the eye bonds
to fund the selected projects and to pay for other
related expenses, as permitted by this Act.
(b) Federal Guarantee.--
(1) In general.--The Secretary shall guarantee the payment
of principal (but not the payment of interest) on an eye bond,
on a bond-by-bond basis, in an amount to be determined by the
Secretary, but in no case may the amount of such guarantee be
more than 50 percent of the principal of the eye bond.
(2) 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--
(A) 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 bond; and
(B) 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
extinguished.
(3) Limitation.--The Secretary may not guarantee--
(A) more than $1,000,000,000 for all eye bonds
issued pursuant to this Act; and
(B) more than $250,000,000 for all eye bonds issued
pursuant to this Act in any single fiscal year.
(c) Issuance Schedule.--The Secretary shall, in consultation with
the Secretary of the Treasury and issuers, establish a schedule for the
issuance of eye bonds that ensures that funded projects represent a
reasonable sample of diverse causes of vision loss.
(d) Risk-Share Pool.--
(1) In general.--With respect to an eye bond guaranteed
under this section, the Secretary may allow a risk-share pool
capitalized by issuers to provide a first-loss guarantee of the
principal and interest of such bond, if the Secretary
determines that such first-loss guarantee would--
(A) be a robust source of protection for the United
States, as guarantor of the eye bond, that reduces the
cost of the Federal guarantee to the United States;
(B) encourage the flow of private sector capital
into biomedical translational research;
(C) create a prudent incentive for issuers to
contribute additional private capital for biomedical
translational research; or
(D) meet other public interest, safety, and
soundness goals.
(2) Consultation.--In making a determination under
paragraph (1), the Secretary shall consult with the Secretary
of the Treasury and the appropriate Federal banking agencies.
(3) 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 Program.
(e) Equity Position Option for the Secretary.--
(1) In general.--With respect to an eye bond issued
pursuant to this Act, the Secretary, in consultation with the
Secretary of the Treasury and other appropriate parties,
including eye bond issuers and investors, 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 States.
(2) Limitations.--
(A) Supplemental.--Any equity position taken in a
project pursuant to paragraph (1) shall be supplemental
to, not in lieu of, a guarantee provided by the
Secretary with respect to the eye bond funding such
project.
(B) 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 50 percent of the principal amount of the
eye bond.
(3) Notification and consultation.--Prior to finalization
of any equity position under paragraph (1), 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 States.
(f) Termination of the Program.--
(1) In general.--Except as provided in paragraph (2), the
Program shall terminate on the date that is 6 years after the
date of enactment of this Act.
(2) Early termination.--
(A) In general.--The Secretary may terminate the
Program before the date described in paragraph (1).
(B) Congressional notification.--If the Secretary
determines that the Program shall be terminated under
subparagraph (A), not later than 60 days before the
date on which the termination is effective, the
Secretary shall--
(i) submit to the applicable congressional
committees a report that includes--
(I) a description of the reasons
for the termination;
(II) any corrective actions that
may be taken; and
(III) 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
research; and
(ii) make publicly available the report
described in clause (i).
(3) Effect on eye bonds issued and federal guarantees.--The
termination of the Program shall not affect the validity of--
(A) any eye bond issued before the date on which
the Program is terminated; or
(B) any Federal guarantee under this Act for an eye
bond described in subparagraph (A).
(g) Program Funding.--
(1) Administrative expenses paid from bond sales.--Except
as provided under paragraph (2), the cost of carrying out this
Act, including the cost to the Secretary in administering the
Program, shall be recovered from the proceeds from the sale of
eye bonds pursuant to the Program or from fees as set forth in
paragraph (3).
(2) Specific appropriation or contribution.--No guarantee
shall be made under this section unless--
(A) an appropriation for the full cost of the
guarantee has been made;
(B) the Secretary has received from the eye bond
issuer a payment in full for the cost of the guarantee;
or
(C) 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 guarantee.
(3) Cost of guarantees.--
(A) 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 expenses.
(B) Availability.--Fees collected under this
subsection--
(i) shall be deposited by the Secretary
into the Treasury; and
(ii) are authorized to remain available
until expended.
SEC. 4. EYE BOND TERMS, CONDITIONS, AND STRUCTURE.
(a) In General.--Not later than 180 days after the date of
enactment of this Act, the Secretary, in consultation with the
Secretary of the Treasury, the Chairman of the Securities and Exchange
Commission, the heads of the appropriate Federal banking agencies, the
Director of the National Institutes of Health, and the heads of other
Federal departments and agencies and other interested parties as the
Secretary determines appropriate, shall issue regulations to specify
the terms, conditions, and structure for an eye bond.
(b) Auctions.--In issuing the regulations under subsection (a)--
(1) the Secretary may provide for an auction to select the
purchasers of eye bonds; and
(2) 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 4(b) with respect to the eye bond, with the bid for the
lowest percentage winning the auction, taking into account
other terms and conditions set by the issuer to ensure the
lowest total cost to the Government.
SEC. 5. EYE BOND ISSUERS.
(a) Issuer Criteria.--Not later than 180 days after the date of
enactment of this Act, the Secretary, in consultation with the
Secretary of the Treasury, shall issue regulations--
(1) to establish the criteria for selecting issuers;
(2) to ensure that issuers perform in a manner that ensures
the successful issuance of eye bonds that promote biomedical
translational research in the United States; and
(3) to ensure that issuers use sound underwriting practices
that protect the interests of--
(A) the United States;
(B) eye bond investors; and
(C) the long-term promotion of translational
research for vision impairment and other diseases,
disabilities, and syndromes congenital to vision
impairment or caused by vision impairment, 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 disabilities.
(b) 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 provide.
(c) Public Disclosures With Respect to Eye Bonds.--
(1) In general.--Not less than 2 business days before the
date on which an issuer issues an eye bond, the issuer shall
file with the Securities and Exchange Commission, and make
available to the public, the following information:
(A) The nature of all projects funded by the eye
bond.
(B) The name of any principal individual or
institution that will be conducting each project.
(C) The milestones established for each project.
(D) A determination by the issuer as to whether
each project funded by the eye bond has appropriately
protected intellectual property.
(E) The structure of the eye bond.
(F) The interest payment schedule for the eye bond.
(G) The anticipated returns and risks of the eye
bond.
(H) Such other information as the Commission
determines necessary or appropriate in the public
interest or for the protection of investors.
(2) Rulemaking.--
(A) In general.--Not later than 180 days after the
date of enactment of this Act, the Securities and
Exchange Commission shall issue regulations to carry
out this subsection.
(B) Authority of the secretary.--If the Securities
and Exchange Commission does not issue the regulations
required under subparagraph (A) before the end of the
180-day period described under subparagraph (A), the
Secretary shall issue regulations to carry out this
subsection before the end of the 60-day period
beginning on the end of the 180-day period described
under subparagraph (A).
SEC. 6. TRANSLATIONAL RESEARCH PROJECTS.
(a) Eligibility Requirements.--Not later than 180 days after the
date of enactment of this Act, the Secretary, in consultation with the
Secretary of the Treasury, the Director of the National Eye Institute,
and other interested parties, shall issue final regulations for the
eligibility criteria for selecting translational research projects that
will be funded through eye bonds. Such regulations shall address--
(1) the stage of clinical trial for projects to provide the
greatest likelihood of commercial application;
(2) the variations among disease and conditions needed to
ensure sufficient diversification in each eye bond; and
(3) the number of possible cures and treatments that are
needed as determined by the Secretary, in consultation with
issuers and the Director of the National Eye Institute, to
ensure the successful issuance of eye bonds so as to protect
the United States as guarantor of the eye bonds, including--
(A) drug therapies;
(B) gene therapies; and
(C) artificial restoration of sight and similar
mechanisms.
(b) Selection of Projects.--
(1) In general.--The Director of the National Eye
Institute, in consultation with the Director of the National
Institutes of Health and the Secretary of the Treasury, shall
select translational research projects to be funded with the
proceeds of an eye bond.
(2) Factors for selection.--Not later than 30 days after
the date on which the final regulations are issued under
subsection (a), 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 (1), including--
(A) the amount of equity any intellectual property
holder will hold in the project;
(B) 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 bond, regardless of the
success or failure of the project funded with the
proceeds of the eye bond;
(C) the number of projects needed to ensure
diversification of risk;
(D) the manner in which funded projects will be
defunded if the interim goals of the project are not
satisfied; and
(E) such other factors related to biomedical
translational research project selection as the
Secretary determines appropriate.
(3) Additional consultations.--
(A) In general.--In carrying out paragraph (1), the
Director of the National Eye Institute may establish
any consultative body that the Director determines is
necessary to provide for a complete, transparent, and
forward-looking selection of projects.
(B) Scientific advisers.--In carrying out paragraph
(1), the Director of the National Eye Institute may
consult with any group of scientific advisers that the
Director determines is necessary.
(c) Establishment of Milestones.--
(1) In general.--The Director of the National Eye Institute
shall, for each project funded by an eye bond, establish
milestones to determine the probability of success or failure
for such project.
(2) 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 bond, so such
milestones may be included in the filings made available by the
issuer to the public under section 5(c).
(d) Research Requirement.--Translational research carried out under
a project funded by an eye bond shall be conducted--
(1) in a State; and
(2) by an individual or institution that is--
(A) chartered in accordance with the laws of that
State; and
(B) clearly subject to verification of beneficial
ownership by the issuer and, upon request, by the
Secretary.
SEC. 7. INAPPLICABILITY OF CERTAIN LAWS.
Eye bonds shall not be subject to--
(1) section 15G of the Securities Exchange Act of 1934 (15
U.S.C. 78o-11);
(2) except as provided under section 5(c), any registration
or disclosure requirement promulgated by the Securities and
Exchange Commission; and
(3) section 13 of the Bank Holding Company Act of 1956 (12
U.S.C. 1851).
SEC. 8. REPORTS.
(a) GAO Study and Reports on Other Research Projects.--
(1) 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 projects.
(2) Report.--The Comptroller General shall, during the
period beginning on the date of the establishment of the
Program and ending on the termination date of the Program,
issue a report to the applicable congressional committees, not
less frequently than annually, on all findings and
determinations made in carrying out the study required under
paragraph (1).
(b) Reports on the Program.--Not later than 2 years after the date
on which eye bonds are first issued under this Act, and annually
thereafter during the period ending on the date that is 4 years after
the date on which eye bonds are first issued under this Act, the
Comptroller General and the Director of the National Institutes of
Health (in consultation with the Director of the National Center for
Advancing Translational Sciences) shall each issue a separate report to
the applicable congressional committees on--
(1) the progress of the issuance of eye bonds;
(2) the reasons for any problems achieving desired volumes
of eye bonds or the ability of the Program to proceed at a
faster pace;
(3) an analysis of the risk to the Government in providing
the Federal guarantee described under section 4(b);
(4) any improvements to eye bonds that the Secretary should
consider;
(5) the applicability of financial instruments similar to
eye bonds to other biomedical research areas such as cancer,
Alzheimer's disease, rare diseases or conditions (as defined in
section 526 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bb)) and syndromes of particular concern to children;
and
(6) any other matter that the Comptroller General or the
Director, respectively, determines is appropriate.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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