1840 
•AMDT. NO. 2786 
uation of whether the funding provided under the 
grant is expended only for the purposes for which it 
is made. 
‘‘(2) AUDITS.—The Secretary shall conduct ap-
propriate audits of grants made under section 
2041(b). 
‘‘SEC. 2045. REPORT. 
‘‘Not later than October 1, 2014, the Secretary shall 
submit to the Elder Justice Coordinating Council estab-
lished under section 2021, the Committee on Ways and 
Means and the Committee on Energy and Commerce of 
the House of Representatives, and the Committee on Fi-
nance of the Senate a report— 
‘‘(1) compiling, summarizing, and analyzing the 
information contained in the State reports submitted 
under subsections (b)(4) and (c)(4) of section 2042; 
and 
‘‘(2) containing such recommendations for legis-
lative or administrative action as the Secretary de-
termines to be appropriate. 
‘‘SEC. 2046. RULE OF CONSTRUCTION. 
‘‘Nothing in this subtitle shall be construed as— 
‘‘(1) limiting any cause of action or other relief 
related to obligations under this subtitle that is 
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•AMDT. NO. 2786 
available under the law of any State, or political sub-
division thereof; or 
‘‘(2) creating a private cause of action for a vio-
lation of this subtitle.’’. 
(2) OPTION FOR STATE PLAN UNDER PROGRAM 
FOR
TEMPORARY
ASSISTANCE
FOR
NEEDY
FAMI-
LIES.— 
(A) IN GENERAL.—Section 402(a)(1)(B) of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
602(a)(1)(B)) is amended by adding at the end 
the following new clause: 
‘‘(v) The document shall indicate 
whether the State intends to assist individ-
uals to train for, seek, and maintain em-
ployment— 
‘‘(I) providing direct care in a 
long-term care facility (as such terms 
are defined under section 2011); or 
‘‘(II) in other occupations related 
to elder care determined appropriate 
by the State for which the State iden-
tifies an unmet need for service per-
sonnel, 
and, if so, shall include an overview of such 
assistance.’’. 
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•AMDT. NO. 2786 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
January 1, 2011. 
(b) PROTECTING RESIDENTS OF LONG-TERM CARE 
FACILITIES.— 
(1) NATIONAL TRAINING INSTITUTE FOR SUR-
VEYORS.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services shall enter into a 
contract with an entity for the purpose of estab-
lishing and operating a National Training Insti-
tute for Federal and State surveyors. Such In-
stitute shall provide and improve the training of 
surveyors with respect to investigating allega-
tions of abuse, neglect, and misappropriation of 
property in programs and long-term care facili-
ties that receive payments under title XVIII or 
XIX of the Social Security Act. 
(B) ACTIVITIES CARRIED OUT BY THE IN-
STITUTE.—The contract entered into under 
subparagraph (A) shall require the Institute es-
tablished and operated under such contract to 
carry out the following activities: 
(i) Assess the extent to which State 
agencies use specialized surveyors for the 
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•AMDT. NO. 2786 
investigation of reported allegations of 
abuse, neglect, and misappropriation of 
property in such programs and long-term 
care facilities. 
(ii) Evaluate how the competencies of 
surveyors may be improved to more effec-
tively investigate reported allegations of 
such abuse, neglect, and misappropriation 
of property, and provide feedback to Fed-
eral and State agencies on the evaluations 
conducted. 
(iii) Provide a national program of 
training, tools, and technical assistance to 
Federal and State surveyors on inves-
tigating reports of such abuse, neglect, and 
misappropriation of property. 
(iv) Develop and disseminate informa-
tion on best practices for the investigation 
of such abuse, neglect, and misappropria-
tion of property. 
(v) Assess the performance of State 
complaint intake systems, in order to en-
sure that the intake of complaints occurs 
24 hours per day, 7 days a week (including 
holidays). 
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•AMDT. NO. 2786 
(vi) To the extent approved by the 
Secretary of Health and Human Services, 
provide a national 24 hours per day, 7 
days a week (including holidays), back-up 
system to State complaint intake systems 
in order to ensure optimum national re-
sponsiveness to complaints of such abuse, 
neglect, and misappropriation of property. 
(vii) Analyze and report annually on 
the following: 
(I) The total number and sources 
of complaints of such abuse, neglect, 
and misappropriation of property. 
(II) The extent to which such 
complaints are referred to law en-
forcement agencies. 
(III) General results of Federal 
and State investigations of such com-
plaints. 
(viii) Conduct a national study of the 
cost to State agencies of conducting com-
plaint investigations of skilled nursing fa-
cilities and nursing facilities under sections 
1819 and 1919, respectively, of the Social 
Security Act (42 U.S.C. 1395i–3; 1396r), 
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•AMDT. NO. 2786 
and making recommendations to the Sec-
retary of Health and Human Services with 
respect to options to increase the efficiency 
and cost-effectiveness of such investiga-
tions. 
(C) AUTHORIZATION.—There are author-
ized to be appropriated to carry out this para-
graph, for the period of fiscal years 2011 
through 2014, $12,000,000. 
(2) GRANTS TO STATE SURVEY AGENCIES.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services shall make grants 
to State agencies that perform surveys of 
skilled nursing facilities or nursing facilities 
under sections 1819 or 1919, respectively, of 
the Social Security Act (42 U.S.C. 1395i–3; 
1395r). 
(B) USE
OF
FUNDS.—A grant awarded 
under subparagraph (A) shall be used for the 
purpose of designing and implementing com-
plaint investigations systems that— 
(i) promptly prioritize complaints in 
order to ensure a rapid response to the 
most serious and urgent complaints; 
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•AMDT. NO. 2786 
inserting after section 1150A the following new sec-
tion: 
‘‘REPORTING TO LAW ENFORCEMENT OF CRIMES OCCUR-
RING IN FEDERALLY FUNDED LONG-TERM CARE FA-
CILITIES 
‘‘SEC. 1150B. (a) DETERMINATION AND NOTIFICA-
TION.— 
‘‘(1) DETERMINATION.—The owner or operator 
of each long-term care facility that receives Federal 
funds under this Act shall annually determine 
whether the facility received at least $10,000 in such 
Federal funds during the preceding year. 
‘‘(2) NOTIFICATION.—If the owner or operator 
determines under paragraph (1) that the facility re-
ceived at least $10,000 in such Federal funds during 
the preceding year, such owner or operator shall an-
nually notify each covered individual (as defined in 
paragraph (3)) of that individual’s obligation to 
comply with the reporting requirements described in 
subsection (b). 
‘‘(3) COVERED INDIVIDUAL DEFINED.—In this 
section, the term ‘covered individual’ means each in-
dividual who is an owner, operator, employee, man-
ager, agent, or contractor of a long-term care facility 
that is the subject of a determination described in 
paragraph (1). 
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•AMDT. NO. 2786 
‘‘(b) REPORTING REQUIREMENTS.— 
‘‘(1) IN
GENERAL.—Each covered individual 
shall report to the Secretary and 1 or more law en-
forcement entities for the political subdivision in 
which the facility is located any reasonable suspicion 
of a crime (as defined by the law of the applicable 
political subdivision) against any individual who is a 
resident of, or is receiving care from, the facility. 
‘‘(2) TIMING.—If the events that cause the sus-
picion— 
‘‘(A) result in serious bodily injury, the in-
dividual shall report the suspicion immediately, 
but not later than 2 hours after forming the 
suspicion; and 
‘‘(B) do not result in serious bodily injury, 
the individual shall report the suspicion not 
later than 24 hours after forming the suspicion. 
‘‘(c) PENALTIES.— 
‘‘(1) IN GENERAL.—If a covered individual vio-
lates subsection (b)— 
‘‘(A) the covered individual shall be subject 
to a civil money penalty of not more than 
$200,000; and 
‘‘(B) the Secretary may make a determina-
tion in the same proceeding to exclude the cov-
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•AMDT. NO. 2786 
ered individual from participation in any Fed-
eral health care program (as defined in section 
1128B(f)). 
‘‘(2) INCREASED
HARM.—If a covered indi-
vidual violates subsection (b) and the violation exac-
erbates the harm to the victim of the crime or re-
sults in harm to another individual— 
‘‘(A) the covered individual shall be subject 
to a civil money penalty of not more than 
$300,000; and 
‘‘(B) the Secretary may make a determina-
tion in the same proceeding to exclude the cov-
ered individual from participation in any Fed-
eral health care program (as defined in section 
1128B(f)). 
‘‘(3) EXCLUDED INDIVIDUAL.—During any pe-
riod for which a covered individual is classified as an 
excluded individual under paragraph (1)(B) or 
(2)(B), a long-term care facility that employs such 
individual shall be ineligible to receive Federal funds 
under this Act. 
‘‘(4) EXTENUATING CIRCUMSTANCES.— 
‘‘(A) IN
GENERAL.—The Secretary may 
take into account the financial burden on pro-
viders with underserved populations in deter-
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•AMDT. NO. 2786 
mining any penalty to be imposed under this 
subsection. 
‘‘(B) UNDERSERVED
POPULATION
DE-
FINED.—In this paragraph, the term ‘under-
served population’ means the population of an 
area designated by the Secretary as an area 
with a shortage of elder justice programs or a 
population group designated by the Secretary 
as having a shortage of such programs. Such 
areas or groups designated by the Secretary 
may include— 
‘‘(i) areas or groups that are geo-
graphically isolated (such as isolated in a 
rural area); 
‘‘(ii) racial and ethnic minority popu-
lations; and 
‘‘(iii) populations underserved because 
of special needs (such as language barriers, 
disabilities, alien status, or age). 
‘‘(d) ADDITIONAL PENALTIES FOR RETALIATION.— 
‘‘(1) IN GENERAL.—A long-term care facility 
may not— 
‘‘(A) discharge, demote, suspend, threaten, 
harass, or deny a promotion or other employ-
ment-related benefit to an employee, or in any 
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•AMDT. NO. 2786 
other manner discriminate against an employee 
in the terms and conditions of employment be-
cause of lawful acts done by the employee; or 
‘‘(B) file a complaint or a report against a 
nurse or other employee with the appropriate 
State professional disciplinary agency because 
of lawful acts done by the nurse or employee, 
for making a report, causing a report to be made, 
or for taking steps in furtherance of making a report 
pursuant to subsection (b)(1). 
‘‘(2) PENALTIES FOR RETALIATION.—If a long- 
term care facility violates subparagraph (A) or (B) 
of paragraph (1) the facility shall be subject to a 
civil money penalty of not more than $200,000 or 
the Secretary may classify the entity as an excluded 
entity for a period of 2 years pursuant to section 
1128(b), or both. 
‘‘(3) REQUIREMENT
TO
POST
NOTICE.—Each 
long-term care facility shall post conspicuously in an 
appropriate location a sign (in a form specified by 
the Secretary) specifying the rights of employees 
under this section. Such sign shall include a state-
ment that an employee may file a complaint with the 
Secretary against a long-term care facility that vio-
lates the provisions of this subsection and informa-
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•AMDT. NO. 2786 
tion with respect to the manner of filing such a com-
plaint. 
‘‘(e) PROCEDURE.—The provisions of section 1128A 
(other than subsections (a) and (b) and the second sen-
tence of subsection (f)) shall apply to a civil money penalty 
or exclusion under this section in the same manner as such 
provisions apply to a penalty or proceeding under section 
1128A(a). 
‘‘(f) DEFINITIONS.—In this section, the terms ‘elder 
justice’, ‘long-term care facility’, and ‘law enforcement’ 
have the meanings given those terms in section 2011.’’. 
(c) NATIONAL NURSE AIDE REGISTRY.— 
(1) DEFINITION OF NURSE AIDE.—In this sub-
section, the term ‘‘nurse aide’’ has the meaning 
given that term in sections 1819(b)(5)(F) and 
1919(b)(5)(F) of the Social Security Act (42 U.S.C. 
1395i–3(b)(5)(F); 1396r(b)(5)(F)). 
(2) STUDY AND REPORT.— 
(A) IN GENERAL.—The Secretary, in con-
sultation with appropriate government agencies 
and private sector organizations, shall conduct 
a study on establishing a national nurse aide 
registry. 
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•AMDT. NO. 2786 
(B) AREAS EVALUATED.—The study con-
ducted under this subsection shall include an 
evaluation of— 
(i) who should be included in the reg-
istry; 
(ii) how such a registry would comply 
with Federal and State privacy laws and 
regulations; 
(iii) how data would be collected for 
the registry; 
(iv) what entities and individuals 
would have access to the data collected; 
(v) how the registry would provide ap-
propriate information regarding violations 
of Federal and State law by individuals in-
cluded in the registry; 
(vi) how the functions of a national 
nurse aide registry would be coordinated 
with the nationwide program for national 
and State background checks on direct pa-
tient access employees of long-term care 
facilities and providers under section 4301; 
and 
(vii) how the information included in 
State nurse aide registries developed and 
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•AMDT. NO. 2786 
maintained under sections 1819(e)(2) and 
1919(e)(2) of the Social Security Act (42 
U.S.C. 
1395i–3(e)(2); 
1396r(e)(2)(2)) 
would be provided as part of a national 
nurse aide registry. 
(C) CONSIDERATIONS.—In conducting the 
study and preparing the report required under 
this subsection, the Secretary shall take into 
consideration the findings and conclusions of 
relevant reports and other relevant resources, 
including the following: 
(i) The Department of Health and 
Human Services Office of Inspector Gen-
eral Report, Nurse Aide Registries: State 
Compliance 
and 
Practices 
(February 
2005). 
(ii) The General Accounting Office 
(now known as the Government Account-
ability Office) Report, Nursing Homes: 
More Can Be Done to Protect Residents 
from Abuse (March 2002). 
(iii) The Department of Health and 
Human Services Office of the Inspector 
General Report, Nurse Aide Registries: 
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•AMDT. NO. 2786 
Long-Term Care Facility Compliance and 
Practices (July 2005). 
(iv) The Department of Health and 
Human Services Health Resources and 
Services Administration Report, Nursing 
Aides, Home Health Aides, and Related 
Health Care Occupations—National and 
Local Workforce Shortages and Associated 
Data Needs (2004) (in particular with re-
spect to chapter 7 and appendix F). 
(v) The 2001 Report to CMS from 
the School of Rural Public Health, Texas 
A&M University, Preventing Abuse and 
Neglect in Nursing Homes: The Role of 
Nurse Aide Registries. 
(vi) Information included in State 
nurse aide registries developed and main-
tained under sections 1819(e)(2) and 
1919(e)(2) of the Social Security Act (42 
U.S.C. 1395i–3(e)(2); 1396r(e)(2)(2)). 
(D) REPORT.—Not later than 18 months 
after the date of enactment of this Act, the Sec-
retary shall submit to the Elder Justice Coordi-
nating Council established under section 2021 
of the Social Security Act, as added by section 
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•AMDT. NO. 2786 
1805(a), the Committee on Finance of the Sen-
ate, and the Committee on Ways and Means 
and the Committee on Energy and Commerce 
of the House of Representatives a report con-
taining the findings and recommendations of 
the study conducted under this paragraph. 
(E) FUNDING
LIMITATION.—Funding for 
the study conducted under this subsection shall 
not exceed $500,000. 
(3) CONGRESSIONAL ACTION.—After receiving 
the report submitted by the Secretary under para-
graph (2)(D), the Committee on Finance of the Sen-
ate and the Committee on Ways and Means and the 
Committee on Energy and Commerce of the House 
of Representatives shall, as they deem appropriate, 
take action based on the recommendations contained 
in the report. 
(4) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated such sums 
as are necessary for the purpose of carrying out this 
subsection. 
(d) CONFORMING AMENDMENTS.— 
(1) TITLE XX.—Title XX of the Social Security 
Act (42 U.S.C. 1397 et seq.), as amended by section 
6703(a), is amended— 
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•AMDT. NO. 2786 
(A) in the heading of section 2001, by 
striking ‘‘TITLE’’ and inserting ‘‘SUBTITLE’’; 
and 
(B) in subtitle 1, by striking ‘‘this title’’ 
each place it appears and inserting ‘‘this sub-
title’’. 
(2) TITLE IV.—Title IV of the Social Security 
Act (42 U.S.C. 601 et seq.) is amended— 
(A) in section 404(d)— 
(i) in paragraphs (1)(A), (2)(A), and 
(3)(B), by inserting ‘‘subtitle 1 of’’ before 
‘‘title XX’’ each place it appears; 
(ii) in the heading of paragraph (2), 
by inserting ‘‘SUBTITLE
1 OF’’ before 
‘‘TITLE XX’’; and 
(iii) in the heading of paragraph 
(3)(B), by inserting ‘‘SUBTITLE 1 OF’’ be-
fore ‘‘TITLE XX’’; and 
(B) 
in 
sections 
422(b), 
471(a)(4), 
472(h)(1), and 473(b)(2), by inserting ‘‘subtitle 
1 of’’ before ‘‘title XX’’ each place it appears. 
(3) TITLE XI.—Title XI of the Social Security 
Act (42 U.S.C. 1301 et seq.) is amended— 
(A) in section 1128(h)(3)— 
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•AMDT. NO. 2786 
(i) by inserting ‘‘subtitle 1 of’’ before 
‘‘title XX’’; and 
(ii) by striking ‘‘such title’’ and in-
serting ‘‘such subtitle’’; and 
(B) in section 1128A(i)(1), by inserting 
‘‘subtitle 1 of’’ before ‘‘title XX’’. 
Subtitle I—Sense of the Senate 
Regarding Medical Malpractice 
SEC. 6801. SENSE OF THE SENATE REGARDING MEDICAL 
MALPRACTICE. 
It is the sense of the Senate that— 
(1) health care reform presents an opportunity 
to address issues related to medical malpractice and 
medical liability insurance; 
(2) States should be encouraged to develop and 
test alternatives to the existing civil litigation system 
as a way of improving patient safety, reducing med-
ical errors, encouraging the efficient resolution of 
disputes, increasing the availability of prompt and 
fair resolution of disputes, and improving access to 
liability insurance, while preserving an individual’s 
right to seek redress in court; and 
(3) Congress should consider establishing a 
State demonstration program to evaluate alter-
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•AMDT. NO. 2786 
natives to the existing civil litigation system with re-
spect to the resolution of medical malpractice claims. 
TITLE VII—IMPROVING ACCESS 
TO 
INNOVATIVE 
MEDICAL 
THERAPIES 
Subtitle A—Biologics Price 
Competition and Innovation 
SEC. 7001. SHORT TITLE. 
(a) IN GENERAL.—This subtitle may be cited as the 
‘‘Biologics Price Competition and Innovation Act of 
2009’’. 
(b) SENSE OF THE SENATE.—It is the sense of the 
Senate that a biosimilars pathway balancing innovation 
and consumer interests should be established. 
SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGI-
CAL PRODUCTS. 
(a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO-
SIMILAR
OR INTERCHANGEABLE.—Section 351 of the 
Public Health Service Act (42 U.S.C. 262) is amended— 
(1) in subsection (a)(1)(A), by inserting ‘‘under 
this subsection or subsection (k)’’ after ‘‘biologics li-
cense’’; and 
(2) by adding at the end the following: 
‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO-
SIMILAR OR INTERCHANGEABLE.— 
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•AMDT. NO. 2786 
‘‘(1) IN GENERAL.—Any person may submit an 
application for licensure of a biological product 
under this subsection. 
‘‘(2) CONTENT.— 
‘‘(A) IN GENERAL.— 
‘‘(i) REQUIRED
INFORMATION.—An 
application submitted under this subsection 
shall include information demonstrating 
that— 
‘‘(I) the biological product is bio-
similar to a reference product based 
upon data derived from— 
‘‘(aa) analytical studies that 
demonstrate that the biological 
product is highly similar to the 
reference 
product 
notwith-
standing minor differences in 
clinically inactive components; 
‘‘(bb) animal studies (includ-
ing the assessment of toxicity); 
and 
‘‘(cc) a clinical study or 
studies (including the assessment 
of immunogenicity and phar-
macokinetics 
or 
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•AMDT. NO. 2786 
pharmacodynamics) that are suf-
ficient to demonstrate safety, pu-
rity, and potency in 1 or more 
appropriate conditions of use for 
which the reference product is li-
censed and intended to be used 
and for which licensure is sought 
for the biological product; 
‘‘(II) the biological product and 
reference product utilize the same 
mechanism or mechanisms of action 
for the condition or conditions of use 
prescribed, recommended, or sug-
gested in the proposed labeling, but 
only to the extent the mechanism or 
mechanisms of action are known for 
the reference product; 
‘‘(III) the condition or conditions 
of use prescribed, recommended, or 
suggested in the labeling proposed for 
the biological product have been pre-
viously approved for the reference 
product; 
‘‘(IV) the route of administra-
tion, the dosage form, and the 
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•AMDT. NO. 2786 
strength of the biological product are 
the same as those of the reference 
product; and 
‘‘(V) the facility in which the bio-
logical product is manufactured, proc-
essed, packed, or held meets stand-
ards designed to assure that the bio-
logical product continues to be safe, 
pure, and potent. 
‘‘(ii) 
DETERMINATION
BY
SEC-
RETARY.—The Secretary may determine, 
in the Secretary’s discretion, that an ele-
ment described in clause (i)(I) is unneces-
sary in an application submitted under this 
subsection. 
‘‘(iii) ADDITIONAL
INFORMATION.— 
An application submitted under this sub-
section— 
‘‘(I) shall include publicly-avail-
able information regarding the Sec-
retary’s previous determination that 
the reference product is safe, pure, 
and potent; and 
‘‘(II) may include any additional 
information in support of the applica-
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tion, including publicly-available infor-
mation with respect to the reference 
product or another biological product. 
‘‘(B) INTERCHANGEABILITY.—An applica-
tion (or a supplement to an application) sub-
mitted under this subsection may include infor-
mation demonstrating that the biological prod-
uct meets the standards described in paragraph 
(4). 
‘‘(3) EVALUATION BY SECRETARY.—Upon re-
view of an application (or a supplement to an appli-
cation) submitted under this subsection, the Sec-
retary shall license the biological product under this 
subsection if— 
‘‘(A) the Secretary determines that the in-
formation submitted in the application (or the 
supplement) is sufficient to show that the bio-
logical product— 
‘‘(i) is biosimilar to the reference 
product; or 
‘‘(ii) meets the standards described in 
paragraph (4), and therefore is inter-
changeable with the reference product; and 
‘‘(B) the applicant (or other appropriate 
person) consents to the inspection of the facility 
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•AMDT. NO. 2786 
that is the subject of the application, in accord-
ance with subsection (c). 
‘‘(4) SAFETY
STANDARDS
FOR
DETERMINING 
INTERCHANGEABILITY.—Upon review of an applica-
tion submitted under this subsection or any supple-
ment to such application, the Secretary shall deter-
mine the biological product to be interchangeable 
with the reference product if the Secretary deter-
mines that the information submitted in the applica-
tion (or a supplement to such application) is suffi-
cient to show that— 
‘‘(A) the biological product— 
‘‘(i) is biosimilar to the reference 
product; and 
‘‘(ii) can be expected to produce the 
same clinical result as the reference prod-
uct in any given patient; and 
‘‘(B) for a biological product that is ad-
ministered more than once to an individual, the 
risk in terms of safety or diminished efficacy of 
alternating or switching between use of the bio-
logical product and the reference product is not 
greater than the risk of using the reference 
product without such alternation or switch. 
‘‘(5) GENERAL RULES.— 
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•AMDT. NO. 2786 
‘‘(A) ONE REFERENCE PRODUCT PER AP-
PLICATION.—A biological product, in an appli-
cation submitted under this subsection, may not 
be evaluated against more than 1 reference 
product. 
‘‘(B) REVIEW.—An application submitted 
under this subsection shall be reviewed by the 
division within the Food and Drug Administra-
tion that is responsible for the review and ap-
proval of the application under which the ref-
erence product is licensed. 
‘‘(C) RISK EVALUATION AND MITIGATION 
STRATEGIES.—The authority of the Secretary 
with respect to risk evaluation and mitigation 
strategies under the Federal Food, Drug, and 
Cosmetic Act shall apply to biological products 
licensed under this subsection in the same man-
ner as such authority applies to biological prod-
ucts licensed under subsection (a). 
‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGE-
ABLE
BIOLOGICAL
PRODUCT.—Upon review of an 
application submitted under this subsection relying 
on the same reference product for which a prior bio-
logical product has received a determination of inter-
changeability for any condition of use, the Secretary 
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•AMDT. NO. 2786 
shall not make a determination under paragraph (4) 
that the second or subsequent biological product is 
interchangeable for any condition of use until the 
earlier of— 
‘‘(A) 1 year after the first commercial 
marketing of the first interchangeable bio-
similar biological product to be approved as 
interchangeable for that reference product; 
‘‘(B) 18 months after— 
‘‘(i) a final court decision on all pat-
ents in suit in an action instituted under 
subsection (l)(6) against the applicant that 
submitted the application for the first ap-
proved interchangeable biosimilar biological 
product; or 
‘‘(ii) the dismissal with or without 
prejudice of an action instituted under sub-
section (l)(6) against the applicant that 
submitted the application for the first ap-
proved interchangeable biosimilar biological 
product; or 
‘‘(C)(i) 42 months after approval of the 
first interchangeable biosimilar biological prod-
uct if the applicant that submitted such appli-
cation has been sued under subsection (l)(6) 
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•AMDT. NO. 2786 
and such litigation is still ongoing within such 
42-month period; or 
‘‘(ii) 18 months after approval of the first 
interchangeable biosimilar biological product if 
the applicant that submitted such application 
has not been sued under subsection (l)(6). 
For purposes of this paragraph, the term ‘final court 
decision’ means a final decision of a court from 
which no appeal (other than a petition to the United 
States Supreme Court for a writ of certiorari) has 
been or can be taken. 
‘‘(7) EXCLUSIVITY
FOR
REFERENCE
PROD-
UCT.— 
‘‘(A) EFFECTIVE DATE OF BIOSIMILAR AP-
PLICATION APPROVAL.—Approval of an applica-
tion under this subsection may not be made ef-
fective by the Secretary until the date that is 
12 years after the date on which the reference 
product was first licensed under subsection (a). 
‘‘(B) FILING
PERIOD.—An application 
under this subsection may not be submitted to 
the Secretary until the date that is 4 years 
after the date on which the reference product 
was first licensed under subsection (a). 
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•AMDT. NO. 2786 
‘‘(C) FIRST
LICENSURE.—Subparagraphs 
(A) and (B) shall not apply to a license for or 
approval of— 
‘‘(i) a supplement for the biological 
product that is the reference product; or 
‘‘(ii) a subsequent application filed by 
the same sponsor or manufacturer of the 
biological product that is the reference 
product (or a licensor, predecessor in inter-
est, or other related entity) for— 
‘‘(I) a change (not including a 
modification to the structure of the bi-
ological product) that results in a new 
indication, route of administration, 
dosing schedule, dosage form, delivery 
system, delivery device, or strength; or 
‘‘(II) a modification to the struc-
ture of the biological product that 
does not result in a change in safety, 
purity, or potency. 
‘‘(8) GUIDANCE DOCUMENTS.— 
‘‘(A) IN
GENERAL.—The Secretary may, 
after opportunity for public comment, issue 
guidance in accordance, except as provided in 
subparagraph (B)(i), with section 701(h) of the 
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•AMDT. NO. 2786 
Federal Food, Drug, and Cosmetic Act with re-
spect to the licensure of a biological product 
under this subsection. Any such guidance may 
be general or specific. 
‘‘(B) PUBLIC COMMENT.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall provide the public an opportunity to 
comment on any proposed guidance issued 
under subparagraph (A) before issuing 
final guidance. 
‘‘(ii) INPUT REGARDING MOST VALU-
ABLE GUIDANCE.—The Secretary shall es-
tablish a process through which the public 
may provide the Secretary with input re-
garding priorities for issuing guidance. 
‘‘(C) NO REQUIREMENT FOR APPLICATION 
CONSIDERATION.—The 
issuance 
(or 
non- 
issuance) of guidance under subparagraph (A) 
shall not preclude the review of, or action on, 
an application submitted under this subsection. 
‘‘(D) REQUIREMENT FOR PRODUCT CLASS- 
SPECIFIC
GUIDANCE.—If the Secretary issues 
product class-specific guidance under subpara-
graph (A), such guidance shall include a de-
scription of— 
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•AMDT. NO. 2786 
‘‘(i) the criteria that the Secretary will 
use to determine whether a biological prod-
uct is highly similar to a reference product 
in such product class; and 
‘‘(ii) the criteria, if available, that the 
Secretary will use to determine whether a 
biological product meets the standards de-
scribed in paragraph (4). 
‘‘(E) CERTAIN PRODUCT CLASSES.— 
‘‘(i) GUIDANCE.—The Secretary may 
indicate in a guidance document that the 
science and experience, as of the date of 
such guidance, with respect to a product or 
product class (not including any recom-
binant protein) does not allow approval of 
an application for a license as provided 
under this subsection for such product or 
product class. 
‘‘(ii) MODIFICATION OR REVERSAL.— 
The Secretary may issue a subsequent 
guidance document under subparagraph 
(A) to modify or reverse a guidance docu-
ment under clause (i). 
‘‘(iii) NO
EFFECT
ON
ABILITY
TO 
DENY
LICENSE.—Clause (i) shall not be 
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•AMDT. NO. 2786 
vided that such attorney does not en-
gage, formally or informally, in patent 
prosecution relevant or related to the 
reference product. 
‘‘(iii) PATENT
OWNER
ACCESS.—A 
representative of the owner of a patent ex-
clusively licensed to a reference product 
sponsor with respect to the reference prod-
uct and who has retained a right to assert 
the patent or participate in litigation con-
cerning the patent may be provided the 
confidential information, provided that the 
representative informs the reference prod-
uct sponsor and the subsection (k) appli-
cant of his or her agreement to be subject 
to the confidentiality provisions set forth in 
this paragraph, including those under 
clause (ii). 
‘‘(C) LIMITATION
ON
DISCLOSURE.—No 
person that receives confidential information 
pursuant to subparagraph (B) shall disclose 
any confidential information to any other per-
son or entity, including the reference product 
sponsor employees, outside scientific consult-
ants, or other outside counsel retained by the 
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•AMDT. NO. 2786 
reference product sponsor, without the prior 
written consent of the subsection (k) applicant, 
which shall not be unreasonably withheld. 
‘‘(D) USE
OF
CONFIDENTIAL
INFORMA-
TION.—Confidential information shall be used 
for the sole and exclusive purpose of deter-
mining, with respect to each patent assigned to 
or exclusively licensed by the reference product 
sponsor, whether a claim of patent infringement 
could reasonably be asserted if the subsection 
(k) applicant engaged in the manufacture, use, 
offering for sale, sale, or importation into the 
United States of the biological product that is 
the subject of the application under subsection 
(k). 
‘‘(E) OWNERSHIP
OF
CONFIDENTIAL
IN-
FORMATION.—The confidential information dis-
closed under this paragraph is, and shall re-
main, the property of the subsection (k) appli-
cant. By providing the confidential information 
pursuant to this paragraph, the subsection (k) 
applicant does not provide the reference product 
sponsor or the outside counsel any interest in or 
license to use the confidential information, for 
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•AMDT. NO. 2786 
purposes other than those specified in subpara-
graph (D). 
‘‘(F) EFFECT
OF
INFRINGEMENT
AC-
TION.—In the event that the reference product 
sponsor files a patent infringement suit, the use 
of confidential information shall continue to be 
governed by the terms of this paragraph until 
such time as a court enters a protective order 
regarding the information. Upon entry of such 
order, the subsection (k) applicant may redesig-
nate confidential information in accordance 
with the terms of that order. No confidential in-
formation shall be included in any publicly- 
available complaint or other pleading. In the 
event that the reference product sponsor does 
not file an infringement action by the date spec-
ified in paragraph (6), the reference product 
sponsor shall return or destroy all confidential 
information received under this paragraph, pro-
vided that if the reference product sponsor opts 
to destroy such information, it will confirm de-
struction in writing to the subsection (k) appli-
cant. 
‘‘(G) RULE OF CONSTRUCTION.—Nothing 
in this paragraph shall be construed— 
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•AMDT. NO. 2786 
‘‘(i) as an admission by the subsection 
(k) applicant regarding the validity, en-
forceability, or infringement of any patent; 
or 
‘‘(ii) as an agreement or admission by 
the subsection (k) applicant with respect to 
the competency, relevance, or materiality 
of any confidential information. 
‘‘(H) EFFECT OF VIOLATION.—The disclo-
sure of any confidential information in violation 
of this paragraph shall be deemed to cause the 
subsection (k) applicant to suffer irreparable 
harm for which there is no adequate legal rem-
edy and the court shall consider immediate in-
junctive relief to be an appropriate and nec-
essary remedy for any violation or threatened 
violation of this paragraph. 
‘‘(2) SUBSECTION (k) APPLICATION INFORMA-
TION.—Not later than 20 days after the Secretary 
notifies the subsection (k) applicant that the applica-
tion has been accepted for review, the subsection (k) 
applicant— 
‘‘(A) shall provide to the reference product 
sponsor a copy of the application submitted to 
the Secretary under subsection (k), and such 
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•AMDT. NO. 2786 
other information that describes the process or 
processes used to manufacture the biological 
product that is the subject of such application; 
and 
‘‘(B) may provide to the reference product 
sponsor additional information requested by or 
on behalf of the reference product sponsor. 
‘‘(3) LIST AND DESCRIPTION OF PATENTS.— 
‘‘(A) LIST BY REFERENCE PRODUCT SPON-
SOR.—Not later than 60 days after the receipt 
of the application and information under para-
graph (2), the reference product sponsor shall 
provide to the subsection (k) applicant— 
‘‘(i) a list of patents for which the ref-
erence product sponsor believes a claim of 
patent infringement could reasonably be 
asserted by the reference product sponsor, 
or by a patent owner that has granted an 
exclusive license to the reference product 
sponsor with respect to the reference prod-
uct, if a person not licensed by the ref-
erence product sponsor engaged in the 
making, using, offering to sell, selling, or 
importing into the United States of the bi-
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•AMDT. NO. 2786 
ological product that is the subject of the 
subsection (k) application; and 
‘‘(ii) an identification of the patents 
on such list that the reference product 
sponsor would be prepared to license to the 
subsection (k) applicant. 
‘‘(B) LIST
AND
DESCRIPTION
BY
SUB-
SECTION (k) APPLICANT.—Not later than 60 
days after receipt of the list under subpara-
graph (A), the subsection (k) applicant— 
‘‘(i) may provide to the reference 
product sponsor a list of patents to which 
the subsection (k) applicant believes a 
claim of patent infringement could reason-
ably be asserted by the reference product 
sponsor if a person not licensed by the ref-
erence product sponsor engaged in the 
making, using, offering to sell, selling, or 
importing into the United States of the bi-
ological product that is the subject of the 
subsection (k) application; 
‘‘(ii) shall provide to the reference 
product sponsor, with respect to each pat-
ent listed by the reference product sponsor 
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•AMDT. NO. 2786 
under subparagraph (A) or listed by the 
subsection (k) applicant under clause (i)— 
‘‘(I) a detailed statement that de-
scribes, on a claim by claim basis, the 
factual and legal basis of the opinion 
of the subsection (k) applicant that 
such patent is invalid, unenforceable, 
or will not be infringed by the com-
mercial marketing of the biological 
product that is the subject of the sub-
section (k) application; or 
‘‘(II) a statement that the sub-
section (k) applicant does not intend 
to begin commercial marketing of the 
biological product before the date that 
such patent expires; and 
‘‘(iii) shall provide to the reference 
product sponsor a response regarding each 
patent identified by the reference product 
sponsor under subparagraph (A)(ii). 
‘‘(C) DESCRIPTION BY REFERENCE PROD-
UCT SPONSOR.—Not later than 60 days after 
receipt of the list and statement under subpara-
graph (B), the reference product sponsor shall 
provide to the subsection (k) applicant a de-
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