1176 
‘‘(C) such other information as the Sec-
retary may require. 
‘‘(e) MATCHING FUNDS.— 
‘‘(1) IN GENERAL.—With respect to the costs of 
the activities to be carried out each year with a con-
tract or grant under subsection (a), a condition for 
the receipt of the contract or grant is that the eligible 
entity involved agrees to make available (directly or 
through donations from public or private entities) 
non-Federal contributions toward such costs in an 
amount that is not less than 25 percent of such costs. 
‘‘(2) DETERMINATION
OF
AMOUNT
CONTRIB-
UTED.—Non-Federal contributions required in para-
graph (1) may be in cash or in kind, fairly evaluated, 
including plant, equipment, or services. Amounts pro-
vided by the Federal Government, or services assisted 
or subsidized to any significant extent by the Federal 
Government, may not be included in determining the 
amount of such non-Federal contributions. 
‘‘(f) PRIORITY.—The Secretary shall give priority for 
the award of the contracts or grants described in subsection 
(a) to any eligible entity that serves a medically under-
served population (as defined in section 330(b)(3)). 
‘‘(g) REPORT.—Not later than 90 days after the com-
pletion of a demonstration program under subsection (a), 
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the recipient of such contract or grant described in such 
subsection shall submit to the Secretary a report containing 
the results of an evaluation of the program, including an 
identification of— 
‘‘(1) the impact of the regional, accountable 
emergency care system on patient outcomes for var-
ious critical care categories, such as trauma, stroke, 
cardiac emergencies, and pediatric emergencies; 
‘‘(2) the system characteristics that contribute to 
the effectiveness and efficiency of the program (or lack 
thereof); 
‘‘(3) methods of assuring the long-term financial 
sustainability of the emergency care system; 
‘‘(4) the State and local legislation necessary to 
implement and to maintain the system; and 
‘‘(5) the barriers to developing regionalized, ac-
countable emergency care systems, as well as the 
methods to overcome such barriers. 
‘‘(h) EVALUATION.—The Secretary, acting through the 
Assistant Secretary for Preparedness and Response, shall 
enter into a contract with an academic institution or other 
entity to conduct an independent evaluation of the dem-
onstration programs funded under subsection (a), including 
an evaluation of— 
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‘‘(1) the performance of the eligible entities re-
ceiving the funds; and 
‘‘(2) the impact of the demonstration programs. 
‘‘(i) DISSEMINATION
OF FINDINGS.—The Secretary 
shall, as appropriate, disseminate to the public and to the 
appropriate committees of the Congress, the information 
contained in a report made under subsection (h). 
‘‘(j) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—There is authorized to be ap-
propriated to carry out this section $12,000,000 for 
each of fiscal years 2010 through 2015. 
‘‘(2) RESERVATION.—Of the amount appro-
priated to carry out this section for a fiscal year, the 
Secretary shall reserve 3 percent of such amount to 
carry out subsection (h) (relating to an independent 
evaluation).’’. 
SEC. 2544. ASSISTING VETERANS WITH MILITARY EMER-
GENCY 
MEDICAL 
TRAINING 
TO 
BECOME 
STATE-LICENSED OR CERTIFIED EMERGENCY 
MEDICAL TECHNICIANS (EMTS). 
(a) IN GENERAL.—Part B of title III (42 U.S.C. 243 
et seq.), as amended, is amended by inserting after section 
315 the following: 
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‘‘SEC. 315A. ASSISTING VETERANS WITH MILITARY EMER-
GENCY 
MEDICAL 
TRAINING 
TO 
BECOME 
STATE-LICENSED OR CERTIFIED EMERGENCY 
MEDICAL TECHNICIANS (EMTS). 
‘‘(a) PROGRAM.—The Secretary shall establish a pro-
gram consisting of awarding grants to States to assist vet-
erans who received and completed military emergency med-
ical training while serving in the Armed Forces of the 
United States to become, upon their discharge or release 
from active duty service, State-licensed or certified emer-
gency medical technicians. 
‘‘(b) USE OF FUNDS.—Amounts received as a grant 
under this section may be used to assist veterans described 
in subsection (a) to become State-licensed or certified emer-
gency medical technicians as follows: 
‘‘(1) Providing training. 
‘‘(2) Providing reimbursement for costs associ-
ated with— 
‘‘(A) training; or 
‘‘(B) applying for licensure or certification. 
‘‘(3) Expediting the licensing or certification 
process. 
‘‘(c) ELIGIBILITY.—To be eligible for a grant under 
this section, a State shall demonstrate to the Secretary’s sat-
isfaction that the State has a shortage of emergency medical 
technicians. 
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‘‘(d) REPORT.—The Secretary shall submit to the Con-
gress an annual report on the program under this section. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary for fiscal years 2010 through 
2014.’’. 
(b) GAO STUDY AND REPORT.—The Comptroller Gen-
eral of the United States shall— 
(1) conduct a study on the barriers experienced 
by veterans who received training as medical per-
sonnel while serving in the Armed Forces of the 
United States and, upon their discharge or release 
from active duty service, seek to become licensed or 
certified in a State as civilian health professionals; 
and 
(2) not later than 2 years after the date of the 
enactment of this Act, submit to the Congress a report 
on the results of such study, including recommenda-
tions on whether the program established under sec-
tion 315A of the Public Health Service Act, as added 
by subsection (a), should be expanded to assist vet-
erans seeking to become licensed or certified in a 
State as health providers other than emergency med-
ical technicians. 
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(c) CHIEF MEDICAL OFFICER.—Paragraph (5) of sec-
tion 516(c) of the Homeland Security Act of 2002 (6 U.S.C. 
321e(c)) is amended by striking ‘‘medical community’’ and 
inserting ‘‘medical and dental communities’’. 
PART 4—PAIN CARE AND MANAGEMENT 
PROGRAMS 
SEC. 2551. INSTITUTE OF MEDICINE CONFERENCE ON PAIN. 
(a) CONVENING.—Not later than June 30, 2010, the 
Secretary of Health and Human Services shall seek to enter 
into an agreement with the Institute of Medicine of the Na-
tional Academies to convene a Conference on Pain (in this 
section referred to as ‘‘the Conference’’). 
(b) PURPOSES.—The purposes of the Conference shall 
be to— 
(1) increase the recognition of pain as a signifi-
cant public health problem in the United States; 
(2) evaluate the adequacy of assessment, diag-
nosis, treatment, and management of acute and 
chronic pain in the general population, and in iden-
tified racial, ethnic, gender, age, and other demo-
graphic groups that may be disproportionately af-
fected by inadequacies in the assessment, diagnosis, 
treatment, and management of pain; 
(3) identify barriers to appropriate pain care, 
including— 
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(A) lack of understanding and education 
among employers, patients, health care pro-
viders, regulators, and third-party payors; 
(B) barriers to access to care at the pri-
mary, specialty, and tertiary care levels, includ-
ing barriers— 
(i) specific to those populations that 
are 
disproportionately 
undertreated 
for 
pain; 
(ii) related to physician concerns over 
regulatory and law enforcement policies ap-
plicable to some pain therapies; and 
(iii) attributable to benefit, coverage, 
and payment policies in both the public and 
private sectors; and 
(C) gaps in basic and clinical research on 
the symptoms and causes of pain, and potential 
assessment methods and new treatments to im-
prove pain care; and 
(4) establish an agenda for action in both the 
public and private sectors that will reduce such bar-
riers and significantly improve the state of pain care 
research, education, and clinical care in the United 
States. 
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(c) OTHER APPROPRIATE ENTITY.—If the Institute of 
Medicine declines to enter into an agreement under sub-
section (a), the Secretary of Health and Human Services 
may enter into such agreement with another appropriate 
entity. 
(d) REPORT.—A report summarizing the Conference’s 
findings and recommendations shall be submitted to the 
Congress not later than June 30, 2011. 
(e) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there is authorized to 
be appropriated $500,000 for each of fiscal years 2010 and 
2011. 
SEC. 2552. PAIN RESEARCH AT NATIONAL INSTITUTES OF 
HEALTH. 
Part B of title IV (42 U.S.C. 284 et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 409J. PAIN RESEARCH. 
‘‘(a) RESEARCH INITIATIVES.— 
‘‘(1) IN GENERAL.—The Director of NIH is en-
couraged to continue and expand, through the Pain 
Consortium, an aggressive program of basic and clin-
ical research on the causes of and potential treatments 
for pain. 
‘‘(2) ANNUAL RECOMMENDATIONS.—Not less than 
annually, the Pain Consortium, in consultation with 
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the Division of Program Coordination, Planning, and 
Strategic Initiatives, shall develop and submit to the 
Director of NIH recommendations on appropriate 
pain research initiatives that could be undertaken 
with funds reserved under section 402A(c)(1) for the 
Common Fund or otherwise available for such initia-
tives. 
‘‘(3) DEFINITION.—In this subsection, the term 
‘Pain Consortium’ means the Pain Consortium of the 
National Institutes of Health or a similar trans-Na-
tional Institutes of Health coordinating entity des-
ignated by the Secretary for purposes of this sub-
section. 
‘‘(b) INTERAGENCY PAIN RESEARCH COORDINATING 
COMMITTEE.— 
‘‘(1) ESTABLISHMENT.—The Secretary shall es-
tablish not later than 1 year after the date of the en-
actment of this section and as necessary maintain a 
committee, to be known as the Interagency Pain Re-
search Coordinating Committee (in this section re-
ferred to as the ‘Committee’), to coordinate all efforts 
within the Department of Health and Human Serv-
ices and other Federal agencies that relate to pain re-
search. 
‘‘(2) MEMBERSHIP.— 
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‘‘(A) IN GENERAL.—The Committee shall be 
composed of the following voting members: 
‘‘(i) Not more than 7 voting Federal 
representatives as follows: 
‘‘(I) The Director of the Centers 
for Disease Control and Prevention. 
‘‘(II) The Director of the National 
Institutes of Health and the directors 
of such national research institutes and 
national centers as the Secretary deter-
mines appropriate. 
‘‘(III) The heads of such other 
agencies of the Department of Health 
and Human Services as the Secretary 
determines appropriate. 
‘‘(IV) Representatives of other 
Federal agencies that conduct or sup-
port pain care research and treatment, 
including the Department of Defense 
and the Department of Veterans Af-
fairs. 
‘‘(ii) 12 additional voting members ap-
pointed under subparagraph (B). 
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‘‘(B) ADDITIONAL
MEMBERS.—The Com-
mittee shall include additional voting members 
appointed by the Secretary as follows: 
‘‘(i) 6 members shall be appointed from 
among scientists, physicians, and other 
health professionals, who— 
‘‘(I) are not officers or employees 
of the United States; 
‘‘(II) 
represent 
multiple 
dis-
ciplines, including clinical, basic, and 
public health sciences; 
‘‘(III) represent different geo-
graphical regions of the United States; 
and 
‘‘(IV) are from practice settings, 
academia, manufacturers, or other re-
search settings; and 
‘‘(ii) 6 members shall be appointed 
from members of the general public, who are 
representatives of leading research, advo-
cacy, and service organizations for individ-
uals with pain-related conditions. 
‘‘(C) NONVOTING
MEMBERS.—The Com-
mittee shall include such nonvoting members as 
the Secretary determines to be appropriate. 
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‘‘(3) CHAIRPERSON.—The voting members of the 
Committee shall select a chairperson from among such 
members. The selection of a chairperson shall be sub-
ject to the approval of the Director of NIH. 
‘‘(4) MEETINGS.—The Committee shall meet at 
the call of the chairperson of the Committee or upon 
the request of the Director of NIH, but in no case less 
often than once each year. 
‘‘(5) DUTIES.—The Committee shall— 
‘‘(A) develop a summary of advances in 
pain care research supported or conducted by the 
Federal agencies relevant to the diagnosis, pre-
vention, and treatment of pain and diseases and 
disorders associated with pain; 
‘‘(B) identify critical gaps in basic and 
clinical research on the symptoms and causes of 
pain; 
‘‘(C) make recommendations to ensure that 
the activities of the National Institutes of Health 
and other Federal agencies, including the De-
partment of Defense and the Department of Vet-
eran Affairs, are free of unnecessary duplication 
of effort; 
‘‘(D) make recommendations on how best to 
disseminate information on pain care; and 
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‘‘(E) make recommendations on how to ex-
pand partnerships between public entities, in-
cluding Federal agencies, and private entities to 
expand collaborative, cross-cutting research. 
‘‘(6) REVIEW.—The Secretary shall review the 
necessity of the Committee at least once every 2 
years.’’. 
SEC. 2553. PUBLIC AWARENESS CAMPAIGN ON PAIN MAN-
AGEMENT. 
Part B of title II (42 U.S.C. 238 et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 249. NATIONAL EDUCATION OUTREACH AND AWARE-
NESS CAMPAIGN ON PAIN MANAGEMENT. 
‘‘(a) ESTABLISHMENT.—Not later than June 30, 2010, 
the Secretary shall establish and implement a national pain 
care education outreach and awareness campaign described 
in subsection (b). 
‘‘(b) REQUIREMENTS.—The Secretary shall design the 
public awareness campaign under this section to educate 
consumers, patients, their families, and other caregivers 
with respect to— 
‘‘(1) the incidence and importance of pain as a 
national public health problem; 
‘‘(2) the adverse physical, psychological, emo-
tional, societal, and financial consequences that can 
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result if pain is not appropriately assessed, diag-
nosed, treated, or managed; 
‘‘(3) the availability, benefits, and risks of all 
pain treatment and management options; 
‘‘(4) having pain promptly assessed, appro-
priately diagnosed, treated, and managed, and regu-
larly reassessed with treatment adjusted as needed; 
‘‘(5) the role of credentialed pain management 
specialists and subspecialists, and of comprehensive 
interdisciplinary centers of treatment expertise; 
‘‘(6) the availability in the public, nonprofit, 
and private sectors of pain management-related infor-
mation, services, and resources for consumers, em-
ployers, third-party payors, patients, their families, 
and caregivers, including information on— 
‘‘(A) appropriate assessment, diagnosis, 
treatment, and management options for all types 
of pain and pain-related symptoms; and 
‘‘(B) conditions for which no treatment op-
tions are yet recognized; and 
‘‘(7) other issues the Secretary deems appro-
priate. 
‘‘(c) CONSULTATION.—In designing and implementing 
the public awareness campaign required by this section, the 
Secretary shall consult with organizations representing pa-
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tients in pain and other consumers, employers, physicians 
including physicians specializing in pain care, other pain 
management professionals, medical device manufacturers, 
and pharmaceutical companies. 
‘‘(d) COORDINATION.— 
‘‘(1) LEAD OFFICIAL.—The Secretary shall des-
ignate one official in the Department of Health and 
Human Services to oversee the campaign established 
under this section. 
‘‘(2) AGENCY
COORDINATION.—The Secretary 
shall ensure the involvement in the public awareness 
campaign under this section of the Surgeon General 
of the Public Health Service, the Director of the Cen-
ters for Disease Control and Prevention, and such 
other representatives of offices and agencies of the De-
partment of Health and Human Services as the Sec-
retary determines appropriate. 
‘‘(e) UNDERSERVED AREAS AND POPULATIONS.—In 
designing the public awareness campaign under this sec-
tion, the Secretary shall— 
‘‘(1) take into account the special needs of geo-
graphic areas and racial, ethnic, gender, age, and 
other demographic groups that are currently under-
served; and 
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‘‘(2) provide resources that will reduce dispari-
ties in access to appropriate diagnosis, assessment, 
and treatment. 
‘‘(f) GRANTS AND CONTRACTS.—The Secretary may 
make awards of grants, cooperative agreements, and con-
tracts to public agencies and private nonprofit organiza-
tions to assist with the development and implementation 
of the public awareness campaign under this section. 
‘‘(g) EVALUATION AND REPORT.—Not later than the 
end of fiscal year 2012, the Secretary shall prepare and 
submit to the Congress a report evaluating the effectiveness 
of the public awareness campaign under this section in edu-
cating the general public with respect to the matters de-
scribed in subsection (b). 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For pur-
poses of carrying out this section, there are authorized to 
be appropriated $2,000,000 for fiscal year 2010 and 
$4,000,000 for each of fiscal years 2011 and 2012.’’. 
Subtitle C—Food and Drug 
Administration 
PART 1—IN GENERAL 
SEC. 2561. NATIONAL MEDICAL DEVICE REGISTRY. 
(a) REGISTRY.— 
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(1) IN GENERAL.—Section 519 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is 
amended— 
(A) by redesignating subsection (g) as sub-
section (h); and 
(B) by inserting after subsection (f) the fol-
lowing: 
‘‘National Medical Device Registry 
‘‘(g)(1) The Secretary shall establish a national med-
ical device registry (in this subsection referred to as the ‘reg-
istry’) to facilitate analysis of postmarket safety and out-
comes data on each device that— 
‘‘(A) is or has been used in or on a patient; and 
‘‘(B) is— 
‘‘(i) a class III device; or 
‘‘(ii) a class II device that is implantable, 
life-supporting, or life-sustaining. 
‘‘(2) In developing the registry, the Secretary shall, in 
consultation with the Commissioner of Food and Drugs, the 
Administrator of the Centers for Medicare & Medicaid Serv-
ices, the head of the Office of the National Coordinator for 
Health Information Technology, and the Secretary of Vet-
erans Affairs, determine the best methods for— 
‘‘(A) including in the registry, in a manner con-
sistent with subsection (f), appropriate information to 
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identify each device described in paragraph (1) by 
type, model, and serial number or other unique iden-
tifier; 
‘‘(B) validating methods for analyzing patient 
safety and outcomes data from multiple sources and 
for linking such data with the information included 
in the registry as described in subparagraph (A), in-
cluding, to the extent feasible, use of— 
‘‘(i) data provided to the Secretary under 
other provisions of this chapter; and 
‘‘(ii) information from public and private 
sources identified under paragraph (3); 
‘‘(C) integrating the activities described in this 
subsection with— 
‘‘(i) activities under paragraph (3) of sec-
tion 505(k) (relating to active postmarket risk 
identification); 
‘‘(ii) activities under paragraph (4) of sec-
tion 505(k) (relating to advanced analysis of 
drug safety data); and 
‘‘(iii) other postmarket device surveillance 
activities of the Secretary authorized by this 
chapter; and 
‘‘(D) providing public access to the data and 
analysis collected or developed through the registry in 
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a manner and form that protects patient privacy and 
proprietary information and is comprehensive, useful, 
and not misleading to patients, physicians, and sci-
entists. 
‘‘(3)(A) To facilitate analyses of postmarket safety and 
patient outcomes for devices described in paragraph (1), the 
Secretary shall, in collaboration with public, academic, and 
private entities, develop methods to— 
‘‘(i) obtain access to disparate sources of patient 
safety and outcomes data, including— 
‘‘(I) Federal health-related electronic data 
(such as data from the Medicare program under 
title XVIII of the Social Security Act or from the 
health systems of the Department of Veterans Af-
fairs); 
‘‘(II) private sector health-related electronic 
data (such as pharmaceutical purchase data and 
health insurance claims data); and 
‘‘(III) other data as the Secretary deems 
necessary to permit postmarket assessment of de-
vice safety and effectiveness; and 
‘‘(ii) link data obtained under clause (i) with in-
formation in the registry. 
‘‘(B) In this paragraph, the term ‘data’ refers to infor-
mation respecting a device described in paragraph (1), in-
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cluding claims data, patient survey data, standardized 
analytic files that allow for the pooling and analysis of data 
from disparate data environments, electronic health records, 
and any other data deemed appropriate by the Secretary. 
‘‘(4) Not later than 36 months after the date of the 
enactment of this subsection, the Secretary shall promulgate 
regulations for establishment and operation of the registry 
under paragraph (1). Such regulations— 
‘‘(A)(i) in the case of devices that are described 
in paragraph (1) and sold on or after the date of the 
enactment of this subsection, shall require manufac-
turers of such devices to submit information to the 
registry, including, for each such device, the type, 
model, and serial number or, if required under sub-
section (f), other unique device identifier; and 
‘‘(ii) in the case of devices that are described in 
paragraph (1) and sold before such date, may require 
manufacturers of such devices to submit such infor-
mation to the registry, if deemed necessary by the 
Secretary to protect the public health; 
‘‘(B) shall establish procedures— 
‘‘(i) to permit linkage of information sub-
mitted pursuant to subparagraph (A) with pa-
tient safety and outcomes data obtained under 
paragraph (3); and 
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‘‘(ii) to permit analyses of linked data; 
‘‘(C) may require device manufacturers to sub-
mit such other information as is necessary to facili-
tate postmarket assessments of device safety and effec-
tiveness and notification of device risks; 
‘‘(D) shall establish requirements for regular and 
timely reports to the Secretary, which shall be in-
cluded in the registry, concerning adverse event 
trends, adverse event patterns, incidence and preva-
lence of adverse events, and other information the Sec-
retary determines appropriate, which may include 
data on comparative safety and outcomes trends; and 
‘‘(E) shall establish procedures to permit public 
access to the information in the registry in a manner 
and form that protects patient privacy and propri-
etary information and is comprehensive, useful, and 
not misleading to patients, physicians, and scientists. 
‘‘(5) To carry out this subsection, there are authorized 
to be appropriated such sums as may be necessary for fiscal 
years 2010 and 2011.’’. 
(2) EFFECTIVE DATE.—The Secretary of Health 
and Human Services shall establish and begin imple-
mentation of the registry under section 519(g) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
paragraph (1), by not later than the date that is 36 
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months after the date of the enactment of this Act, 
without regard to whether or not final regulations to 
establish and operate the registry have been promul-
gated by such date. 
(3) 
CONFORMING
AMENDMENT.—Section 
303(f)(1)(B)(ii) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amended by 
striking ‘‘519(g)’’ and inserting ‘‘519(h)’’. 
(b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED 
ELECTRONIC HEALTH RECORDS OF UNIQUE DEVICE IDEN-
TIFIERS.— 
(1) RECOMMENDATIONS.—The HIT Policy Com-
mittee established under section 3002 of the Public 
Health Service Act (42 U.S.C. 300jj–12) shall rec-
ommend to the head of the Office of the National Co-
ordinator for Health Information Technology stand-
ards, implementation specifications, and certification 
criteria for the electronic exchange and use in cer-
tified electronic health records of a unique device 
identifier for each device described in section 
519(g)(1) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a). 
(2) STANDARDS, 
IMPLEMENTATION
CRITERIA, 
AND CERTIFICATION CRITERIA.—The Secretary of the 
Health Human Services, acting through the head of 
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the Office of the National Coordinator for Health In-
formation Technology, shall adopt standards, imple-
mentation specifications, and certification criteria for 
the electronic exchange and use in certified electronic 
health records of a unique device identifier for each 
device described in paragraph (1), if such an identi-
fier is required by section 519(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the 
device. 
SEC. 2562. NUTRITION LABELING OF STANDARD MENU 
ITEMS AT CHAIN RESTAURANTS AND OF ARTI-
CLES OF FOOD SOLD FROM VENDING MA-
CHINES. 
(a) TECHNICAL AMENDMENTS.—Section 403(q)(5)(A) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(q)(5)(A)) is amended— 
(1) in subclause (i), by inserting ‘‘except as pro-
vided in clause (H)(ii)(III),’’ after ‘‘(i)’’ ; and 
(2) in subclause (ii), by inserting ‘‘except as pro-
vided in clause (H)(ii)(III),’’ after ‘‘(ii)’’. 
(b) LABELING REQUIREMENTS.—Section 403(q)(5) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(q)(5)) is amended by adding at the end the following: 
‘‘(H) RESTAURANTS, RETAIL FOOD ESTABLISHMENTS, 
AND VENDING MACHINES.— 
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‘‘(i) 
GENERAL
REQUIREMENTS
FOR
RES-
TAURANTS
AND
SIMILAR
RETAIL
FOOD
ESTABLISH-
MENTS.—Except for food described in subclause (vii), 
in the case of food that is a standard menu item that 
is offered for sale in a restaurant or similar retail 
food establishment that is part of a chain with 20 or 
more locations doing business under the same name 
(regardless of the type of ownership of the locations) 
and offering for sale substantially the same menu 
items, the restaurant or similar retail food establish-
ment shall disclose the information described in sub-
clauses (ii) and (iii). 
‘‘(ii) INFORMATION REQUIRED TO BE DISCLOSED 
BY
RESTAURANTS
AND
RETAIL
FOOD
ESTABLISH-
MENTS.—Except as provided in subclause (vii), the 
restaurant or similar retail food establishment shall 
disclose in a clear and conspicuous manner— 
‘‘(I)(aa) in a nutrient content disclosure 
statement adjacent to the name of the standard 
menu item, so as to be clearly associated with the 
standard menu item, on the menu listing the 
item for sale, the number of calories contained in 
the standard menu item, as usually prepared 
and offered for sale; and 
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‘‘(bb) a succinct statement concerning sug-
gested daily caloric intake, as specified by the 
Secretary by regulation and posted prominently 
on the menu and designed to enable the public 
to understand, in the context of a total daily 
diet, the significance of the caloric information 
that is provided on the menu; 
‘‘(II)(aa) in a nutrient content disclosure 
statement adjacent to the name of the standard 
menu item, so as to be clearly associated with the 
standard menu item, on the menu board, includ-
ing a drive-through menu board, the number of 
calories contained in the standard menu item, as 
usually prepared and offered for sale; and 
‘‘(bb) a succinct statement concerning sug-
gested daily caloric intake, as specified by the 
Secretary by regulation and posted prominently 
on the menu board, designed to enable the public 
to understand, in the context of a total daily 
diet, the significance of the nutrition informa-
tion that is provided on the menu board; 
‘‘(III) in a written form, available on the 
premises of the restaurant or similar retail es-
tablishment and to the consumer upon request, 
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the nutrition information required under clauses 
(C) and (D) of subparagraph (1); and 
‘‘(IV) on the menu or menu board, a promi-
nent, clear, and conspicuous statement regarding 
the availability of the information described in 
item (III). 
‘‘(iii) SELF-SERVICE FOOD AND FOOD ON DIS-
PLAY.—Except as provided in subclause (vii), in the 
case of food sold at a salad bar, buffet line, cafeteria 
line, or similar self-service facility, and for self-service 
beverages or food that is on display and that is visible 
to customers, a restaurant or similar retail food es-
tablishment shall place adjacent to each food offered 
a sign that lists calories per displayed food item or 
per serving. 
‘‘(iv) REASONABLE BASIS.—For the purposes of 
this clause, a restaurant or similar retail food estab-
lishment shall have a reasonable basis for its nutrient 
content disclosures, including nutrient databases, 
cookbooks, laboratory analyses, and other reasonable 
means, as described in section 101.10 of title 21, Code 
of Federal Regulations (or any successor regulation) 
or in a related guidance of the Food and Drug Ad-
ministration. 
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‘‘(v) MENU
VARIABILITY
AND
COMBINATION 
MEALS.—The Secretary shall establish by regulation 
standards for determining and disclosing the nutrient 
content for standard menu items that come in dif-
ferent flavors, varieties, or combinations, but which 
are listed as a single menu item, such as soft drinks, 
ice cream, pizza, doughnuts, or children’s combina-
tion meals, through means determined by the Sec-
retary, including ranges, averages, or other methods. 
‘‘(vi) ADDITIONAL
INFORMATION.—If the Sec-
retary determines that a nutrient, other than a nutri-
ent required under subclause (ii)(III), should be dis-
closed for the purpose of providing information to as-
sist consumers in maintaining healthy dietary prac-
tices, the Secretary may require, by regulation, disclo-
sure of such nutrient in the written form required 
under subclause (ii)(III). 
‘‘(vii) NONAPPLICABILITY TO CERTAIN FOOD.— 
‘‘(I) IN GENERAL.—Subclauses (i) through 
(vi) do not apply to— 
‘‘(aa) items that are not listed on a 
menu or menu board (such as condiments 
and other items placed on the table or 
counter for general use); 
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‘‘(bb) daily specials, temporary menu 
items appearing on the menu for less than 
60 days per calendar year, or custom or-
ders; or 
‘‘(cc) such other food that is part of a 
customary market test appearing on the 
menu for less than 90 days, under terms 
and conditions established by the Secretary. 
‘‘(II) WRITTEN
FORMS.—Clause (C) shall 
apply to any regulations promulgated under sub-
clauses (ii)(III) and (vi). 
‘‘(viii) VENDING MACHINES.—In the case of an 
article of food sold from a vending machine that— 
‘‘(I) does not permit a prospective pur-
chaser to examine the Nutrition Facts Panel be-
fore purchasing the article or does not otherwise 
provide visible nutrition information at the 
point of purchase; and 
‘‘(II) is operated by a person who is en-
gaged in the business of owning or operating 20 
or more vending machines, 
the vending machine operator shall provide a sign in 
close proximity to each article of food or the selection 
button that includes a clear and conspicuous state-
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ment disclosing the number of calories contained in 
the article. 
‘‘(ix) VOLUNTARY PROVISION OF NUTRITION IN-
FORMATION.— 
‘‘(I) IN GENERAL.—An authorized official of 
any restaurant or similar retail food establish-
ment or vending machine operator not subject to 
the requirements of this clause may elect to be 
subject to the requirements of such clause, by reg-
istering biannually the name and address of 
such restaurant or similar retail food establish-
ment or vending machine operator with the Sec-
retary, as specified by the Secretary by regula-
tion. 
‘‘(II) REGISTRATION.—Within 120 days of 
the enactment of this clause, the Secretary shall 
publish a notice in the Federal Register speci-
fying the terms and conditions for implementa-
tion of item (I), pending promulgation of regula-
tions. 
‘‘(III) RULE OF CONSTRUCTION.—Nothing 
in this subclause shall be construed to authorize 
the Secretary to require an application, review, 
or licensing process for any entity to register 
with the Secretary, as described in such item. 
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‘‘(x) REGULATIONS.— 
‘‘(I) PROPOSED
REGULATION.—Not later 
than 1 year after the date of the enactment of 
this clause, the Secretary shall promulgate pro-
posed regulations to carry out this clause. 
‘‘(II) CONTENTS.—In promulgating regula-
tions, the Secretary shall— 
‘‘(aa) consider standardization of rec-
ipes and methods of preparation, reasonable 
variation in serving size and formulation of 
menu items, space on menus and menu 
boards, inadvertent human error, training 
of food service workers, variations in ingre-
dients, and other factors, as the Secretary 
determines; and 
‘‘(bb) specify the format and manner of 
the nutrient content disclosure requirements 
under this subclause. 
‘‘(III) REPORTING.—The Secretary shall 
submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives a quarterly report that describes 
the Secretary’s progress toward promulgating 
final regulations under this subparagraph. 
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‘‘(xi) DEFINITION.—In this clause, the term 
‘menu’ or ‘menu board’ means the primary writing of 
the restaurant or other similar retail food establish-
ment from which a consumer makes an order selec-
tion.’’. 
(c) NATIONAL UNIFORMITY.—Section 403A(a)(4) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343– 
1(a)(4)) is amended by striking ‘‘except a requirement for 
nutrition labeling of food which is exempt under subclause 
(i) or (ii) of section 403(q)(5)(A)’’ and inserting ‘‘except 
that this paragraph does not apply to food that is offered 
for sale in a restaurant or similar retail food establishment 
that is not part of a chain with 20 or more locations doing 
business under the same name (regardless of the type of 
ownership of the locations) and offering for sale substan-
tially the same menu items unless such restaurant or simi-
lar retail food establishment complies with the voluntary 
provision of nutrition information requirements under sec-
tion 403(q)(5)(H)(ix)’’. 
(d) RULE OF CONSTRUCTION.—Nothing in the amend-
ments made by this section shall be construed— 
(1) to preempt any provision of State or local 
law, unless such provision establishes or continues 
into effect nutrient content disclosures of the type re-
quired under section 403(q)(5)(H) of the Federal 
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Food, Drug, and Cosmetic Act (as added by sub-
section (b)) and is expressly preempted under section 
403A(a)(4) of such Act; 
(2) to apply to any State or local requirement 
respecting a statement in the labeling of food that 
provides for a warning concerning the safety of the 
food or component of the food; or 
(3) 
except 
as 
provided 
in 
section 
403(q)(5)(H)(ix) of the Federal Food, Drug, and Cos-
metic Act (as added by subsection (b)), to apply to 
any restaurant or similar retail food establishment 
other than a restaurant or similar retail food estab-
lishment described in section 403(q)(5)(H)(i) of such 
Act. 
SEC. 2563. PROTECTING CONSUMER ACCESS TO GENERIC 
DRUGS. 
(a) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following: 
‘‘(w) PROTECTING CONSUMER ACCESS TO GENERIC 
DRUGS.— 
‘‘(1) UNFAIR AND DECEPTIVE ACTS AND PRAC-
TICES RELATED TO NEW DRUG APPLICATIONS.— 
‘‘(A) CONDUCT
PROHIBITED.—It shall be 
unlawful for any person to directly or indirectly 
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be a party to any agreement resolving or settling 
a patent infringement claim in which— 
‘‘(i) an ANDA filer receives anything 
of value; and 
‘‘(ii) the ANDA filer agrees to limit or 
forego 
research, 
development, 
manufac-
turing, marketing, or sales, for any period 
of time, of the drug that is to be manufac-
tured under the ANDA involved and is the 
subject of the patent infringement claim. 
‘‘(B) EXCEPTIONS.—Notwithstanding sub-
paragraph (A)(i), subparagraph (A) does not 
prohibit a resolution or settlement of a patent 
infringement claim in which the value received 
by the ANDA filer includes no more than— 
‘‘(i) the right to market the drug that 
is to be manufactured under the ANDA in-
volved and is the subject of the patent in-
fringement claim, before the expiration of— 
‘‘(I) the patent that is the basis 
for the patent infringement claim; or 
‘‘(II) any other statutory exclu-
sivity that would prevent the mar-
keting of such drug; and 
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any allegation made to an ANDA filer, 
whether or not included in a complaint 
filed with a court of law, that its ANDA or 
drug to be manufactured under such ANDA 
may infringe any patent. 
‘‘(2) FTC RULEMAKING.—The Federal Trade 
Commission may, by rule promulgated under section 
553 of title 5, United States Code, exempt certain 
agreements described in paragraph (1) from the re-
quirements of this subsection if the Commission finds 
such agreements to be in furtherance of market com-
petition and for the benefit of consumers. Consistent 
with the authority of the Commission, such rules may 
include interpretive rules and general statements of 
policy with respect to the practices prohibited under 
paragraph (1).’’. 
(b) NOTICE AND CERTIFICATION OF AGREEMENTS.— 
(1) NOTICE
OF
ALL
AGREEMENTS.—Section 
1112(c)(2) of the Medicare Prescription Drug, Im-
provement, and Modernization Act of 2003 (21 U.S.C. 
3155 note) is amended by— 
(A) striking ‘‘the Commission the’’ and in-
serting the following: ‘‘the Commission— 
‘‘(A) the’’; 
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(B) striking the period at the end and in-
serting ‘‘; and’’; and 
(C) adding at the end the following: 
‘‘(B) any other agreement the parties enter 
into within 30 days of entering into an agree-
ment covered by subsection (a) or (b).’’. 
(2) CERTIFICATION
OF
AGREEMENTS.—Section 
1112 of such Act is amended by adding at the end the 
following: 
‘‘(d) CERTIFICATION.—The chief executive officer or 
the company official responsible for negotiating any agree-
ment required to be filed under subsection (a), (b), or (c) 
shall execute and file with the Assistant Attorney General 
and the Commission a certification as follows: ‘I declare 
under penalty of perjury that the following is true and cor-
rect: The materials filed with the Federal Trade Commis-
sion and the Department of Justice under section 1112 of 
subtitle B of title XI of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003, with respect 
to the agreement referenced in this certification: (1) rep-
resent the complete, final, and exclusive agreement between 
the parties; (2) include any ancillary agreements that are 
contingent upon, provide a contingent condition for, or are 
otherwise related to, the referenced agreement; and (3) in-
clude written descriptions of any oral agreements, represen-
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tations, commitments, or promises between the parties that 
are responsive to subsection (a) or (b) of such section 1112 
and have not been reduced to writing.’.’’. 
(c) GAO STUDY.— 
(1) STUDY.—Beginning 2 years after the date of 
enactment of this Act, and each year for a period of 
4 years thereafter, the Comptroller General shall con-
duct a study on the litigation in United States courts 
during the period beginning years prior to the date 
of enactment of this Act relating to patent infringe-
ment claims involving generic drugs, the number of 
patent challenges initiated by manufacturers of ge-
neric drugs, and the number of settlements of such 
litigation. The Comptroller General shall transmit to 
Congress a report of the findings of such a study and 
an analysis of the effect of the amendments made by 
subsections (a) and (b) on such litigation, whether 
such amendments have had an effect on the number 
and frequency of claims settled, and whether such 
amendments resulted in earlier or delayed entry of ge-
neric drugs to market, including whether any harm 
or benefits to consumers has resulted. 
(2) DISCLOSURE
OF
AGREEMENTS.—Notwith-
standing any other law, agreements filed under sec-
tion 1112 of the Medicare Prescription Drug, Im-
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provement, and Modernization Act of 2003 (21 U.S.C. 
355 note), or unaggregated information from such 
agreements, shall be disclosed to the Comptroller Gen-
eral for purposes of the study under paragraph (1) 
within 30 days of a request by the Comptroller Gen-
eral. 
PART 2—BIOSIMILARS 
SEC. 2565. LICENSURE 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.— 
‘‘(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 ap-
plication submitted under this subsection 
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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 notwithstanding 
minor differences in clinically in-
active 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 
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 
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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 suggested 
in the proposed labeling, but only to 
the extent the mechanism or mecha-
nisms of action are known for the ref-
erence product; 
‘‘(III) the condition or conditions 
of use prescribed, recommended, or sug-
gested in the labeling proposed for the 
biological product have been previously 
approved for the reference product; 
‘‘(IV) the route of administration, 
the dosage form, and the 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 standards 
designed to assure that the biological 
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product continues to be safe, pure, and 
potent. 
‘‘(ii) 
DETERMINATION
BY
SEC-
RETARY.—The Secretary may determine, in 
the Secretary’s discretion, that an element 
described in clause (i)(I) is unnecessary in 
an application submitted under this sub-
section. 
‘‘(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-
tion, including publicly available in-
formation 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-
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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). 
‘‘(D) RESTRICTIONS ON BIOLOGICAL PROD-
UCTS CONTAINING DANGEROUS INGREDIENTS.—If 
information in an application submitted under 
this subsection, in a supplement to such an ap-
plication, or otherwise available to the Secretary 
shows that a biological product— 
‘‘(i) is, bears, or contains a select agent 
or toxin listed in section 73.3 or 73.4 of 
title 42, section 121.3 or 121.4 of title 9, or 
section 331.3 of title 7, Code of Federal Reg-
ulations (or any successor regulations); or 
‘‘(ii) is, bears, or contains a controlled 
substance in schedule I or II of section 202 
of the Controlled Substances Act, as listed 
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in part 1308 of title 21, Code of Federal 
Regulations (or any successor regulations); 
the Secretary shall not license the biological 
product under this subsection unless the Sec-
retary determines, after consultation with appro-
priate national security and drug enforcement 
agencies, that there would be no increased risk to 
the security or health of the public from licensing 
such biological product under this subsection. 
‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE 
BIOLOGICAL PRODUCT.—Upon review of an applica-
tion submitted under this subsection relying on the 
same reference product for which a prior biological 
product has received a determination of interchange-
ability for any condition of use, the Secretary shall 
not make a determination under paragraph (4) that 
the second or subsequent biological product is inter-
changeable for any condition of use until the earlier 
of— 
‘‘(A) 1 year after the first commercial mar-
keting of the first interchangeable biosimilar bio-
logical product to be approved as interchangeable 
for that reference product; 
‘‘(B) 18 months after— 
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‘‘(i) a final court decision on all pat-
ents in suit in an action instituted under 
subsection (l)(5) 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)(5) 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 product if 
the applicant that submitted such application 
has been sued under subsection (l)(5) 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)(5). 
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 
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Supreme Court for a writ of certiorari) has been or 
can be taken. 
‘‘(7) EXCLUSIVITY FOR REFERENCE PRODUCT.— 
‘‘(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 prod-
uct 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). 
‘‘(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 bi-
ological product that is the reference prod-
uct (or a licensor, predecessor in interest, or 
other related entity) for— 
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‘‘(I) a change (not including a 
modification to the structure of the bio-
logical 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, pu-
rity, or potency. 
‘‘(8) PEDIATRIC STUDIES.— 
‘‘(A) EXCLUSIVITY.—If, before or after li-
censure of the reference product under subsection 
(a) of this section, the Secretary determines that 
information relating to the use of such product 
in the pediatric population may produce health 
benefits in that population, the Secretary makes 
a written request for pediatric studies (which 
shall include a timeframe for completing such 
studies), the applicant or holder of the approved 
application agrees to the request, such studies are 
completed using appropriate formulations for 
each age group for which the study is requested 
within any such timeframe, and the reports 
thereof are submitted and accepted in accordance 
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with section 505A(d)(3) of the Federal Food, 
Drug, and Cosmetic Act the period referred to in 
paragraph (7)(A) of this subsection is deemed to 
be 12 years and 6 months rather than 12 years. 
‘‘(B) EXCEPTION.—The Secretary shall not 
extend the period referred to in subparagraph 
(A) of this paragraph if the determination under 
section 505A(d)(3) of the Federal Food, Drug, 
and Cosmetic Act is made later than 9 months 
prior to the expiration of such period. 
‘‘(C) APPLICATION
OF
CERTAIN
PROVI-
SIONS.—The provisions of subsections (a), (d), 
(e), (f), (h), (j), (k), and (l) of section 505A of 
the Federal Food, Drug, and Cosmetic Act shall 
apply with respect to the extension of a period 
under subparagraph (A) of this paragraph to the 
same extent and in the same manner as such 
provisions apply with respect to the extension of 
a period under subsection (b) or (c) of section 
505A of the Federal Food, Drug, and Cosmetic 
Act. 
‘‘(9) GUIDANCE DOCUMENTS.— 
‘‘(A) IN
GENERAL.—The Secretary may, 
after opportunity for public comment, issue 
guidance in accordance, except as provided in 
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subparagraph (B)(i), with section 701(h) of the 
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 com-
ment 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-
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graph (A), such guidance shall include a descrip-
tion of— 
‘‘(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 guid-
ance document under subparagraph (A) to 
modify or reverse a guidance document 
under clause (i). 
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‘‘(iii) NO EFFECT ON ABILITY TO DENY 
LICENSE.—Clause (i) shall not be construed 
to require the Secretary to approve a prod-
uct with respect to which the Secretary has 
not indicated in a guidance document that 
the science and experience, as described in 
clause (i), does not allow approval of such 
an application. 
‘‘(10) NAMING.—The Secretary shall ensure that 
the labeling and packaging of each biological product 
licensed under this subsection bears a name that 
uniquely identifies the biological product and distin-
guishes it from the reference product and any other 
biological products licensed under this subsection fol-
lowing evaluation against such reference product. 
‘‘(l) PATENT NOTICES; RELATIONSHIP TO FINAL AP-
PROVAL.— 
‘‘(1) DEFINITIONS.—For the purposes of this 
subsection, the term— 
‘‘(A) ‘biosimilar product’ means the biologi-
cal product that is the subject of the application 
under subsection (k); 
‘‘(B) ‘relevant patent’ means a patent 
that— 
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‘‘(i) expires after the date specified in 
subsection (k)(7)(A) that applies to the ref-
erence product; and 
‘‘(ii) could reasonably be asserted 
against the applicant due to the unauthor-
ized making, use, sale, or offer for sale with-
in the United States, or the importation 
into the United States of the biosimilar 
product, or materials used in the manufac-
ture of the biosimilar product, or due to a 
use of the biosimilar product in a method of 
treatment that is indicated in the applica-
tion; 
‘‘(C) ‘reference product sponsor’ means the 
holder of an approved application or license for 
the reference product; and 
‘‘(D) ‘interested third party’ means a per-
son other than the reference product sponsor that 
owns a relevant patent, or has the right to com-
mence or participate in an action for infringe-
ment of a relevant patent. 
‘‘(2) HANDLING
OF
CONFIDENTIAL
INFORMA-
TION.—Any entity receiving confidential information 
pursuant to this subsection shall designate one or 
more individuals to receive such information. Each 
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individual so designated shall execute an agreement 
in accordance with regulations promulgated by the 
Secretary. The regulations shall require each such in-
dividual to take reasonable steps to maintain the con-
fidentiality of information received pursuant to this 
subsection and use the information solely for purposes 
authorized by this subsection. The obligations imposed 
on an individual who has received confidential infor-
mation pursuant to this subsection shall continue 
until the individual returns or destroys the confiden-
tial information, a court imposes a protective order 
that governs the use or handling of the confidential 
information, or the party providing the confidential 
information agrees to other terms or conditions re-
garding the handling or use of the confidential infor-
mation. 
‘‘(3) PUBLIC NOTICE BY SECRETARY.—Within 30 
days of acceptance by the Secretary of an application 
filed under subsection (k), the Secretary shall publish 
a notice identifying— 
‘‘(A) the reference product identified in the 
application; and 
‘‘(B) the name and address of an agent des-
ignated by the applicant to receive notices pursu-
ant to paragraph (4)(B). 
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‘‘(4) EXCHANGES CONCERNING PATENTS.— 
‘‘(A) EXCHANGES WITH REFERENCE PROD-
UCT SPONSOR.— 
‘‘(i) Within 30 days of the date of ac-
ceptance of the application by the Sec-
retary, the applicant shall provide the ref-
erence product sponsor with a copy of the 
application and information concerning the 
biosimilar product and its production. This 
information shall include a detailed de-
scription of the biosimilar product, its 
method of manufacture, and the materials 
used in the manufacture of the product. 
‘‘(ii) Within 60 days of the date of re-
ceipt of the information required to be pro-
vided under clause (i), the reference product 
sponsor shall provide to the applicant a list 
of relevant patents owned by the reference 
product sponsor, or in respect of which the 
reference product sponsor has the right to 
commence an action of infringement or oth-
erwise has an interest in the patent as such 
patent concerns the biosimilar product. 
‘‘(iii) If the reference product sponsor 
is issued or acquires an interest in a rel-
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clause (iii) or (iv) of subparagraph (B), the ref-
erence product sponsor or the interested third 
party, as applicable— 
‘‘(i) shall explain in writing why the 
sponsor or the interested third party believes 
the relevant patent would be infringed by 
the making, use, sale, or offer for sale with-
in the United States, or importation into 
the United States, of the biosimilar product 
or by a use of the biosimilar product in 
treatment that is indicated in the applica-
tion; 
‘‘(ii) may specify whether the relevant 
patent is available for licensing; and 
‘‘(iii) shall specify the number and 
date of expiration of the relevant patent. 
‘‘(D) CERTIFICATION
BY
APPLICANT
CON-
CERNING IDENTIFIED RELEVANT PATENTS.—Not 
later than 45 days after the date on which a pat-
ent is identified under clause (ii) or (iii) of sub-
paragraph (A) or under clause (iii) or (iv) of 
subparagraph (B), the applicant shall send a 
written statement regarding each identified pat-
ent to the party that identified the patent. Such 
statement shall either— 
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‘‘(i) state that the applicant will not 
commence marketing of the biosimilar prod-
uct and has requested the Secretary to not 
grant final approval of the application be-
fore the date of expiration of the noticed 
patent; or 
‘‘(ii) provide a detailed written expla-
nation setting forth the reasons why the ap-
plicant believes— 
‘‘(I) the making, use, sale, or offer 
for sale within the United States, or 
the importation into the United States, 
of the biosimilar product, or the use of 
the biosimilar product in a treatment 
indicated in the application, would not 
infringe the patent; or 
‘‘(II) the patent is invalid or un-
enforceable. 
‘‘(5) ACTION
FOR
INFRINGEMENT
INVOLVING 
REFERENCE PRODUCT SPONSOR.—If an action for in-
fringement concerning a relevant patent identified by 
the reference product sponsor under clause (ii) or (iii) 
of paragraph (4)(A), or by an interested third party 
under clause (iii) or (iv) of paragraph (4)(B), is 
brought within 60 days of the date of receipt of a 
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statement under paragraph (4)(D)(ii), and the court 
in which such action has been commenced determines 
the patent is infringed prior to the date applicable 
under subsection (k)(7)(A) or (k)(8), the Secretary 
shall make approval of the application effective on the 
day after the date of expiration of the patent that has 
been found to be infringed. If more than one such pat-
ent is found to be infringed by the court, the approval 
of the application shall be made effective on the day 
after the date that the last such patent expires.’’. 
(b) DEFINITIONS.—Section 351(i) of the Public Health 
Service Act (42 U.S.C. 262(i)) is amended— 
(1) by striking ‘‘In this section, the term ‘biologi-
cal product’ means’’ and inserting the following: ‘‘In 
this section: 
‘‘(1) The term ‘biological product’ means’’; 
(2) in paragraph (1), as so designated, by insert-
ing ‘‘protein (except any chemically synthesized 
polypeptide),’’ after ‘‘allergenic product,’’; and 
(3) by adding at the end the following: 
‘‘(2) The term ‘biosimilar’ or ‘biosimilarity’, in 
reference to a biological product that is the subject of 
an application under subsection (k), means— 
‘‘(A) that the biological product is highly 
similar to the reference product notwithstanding 
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minor differences in clinically inactive compo-
nents; and 
‘‘(B) there are no clinically meaningful dif-
ferences between the biological product and the 
reference product in terms of the safety, purity, 
and potency of the product. 
‘‘(3) The term ‘interchangeable’ or ‘interchange-
ability’, in reference to a biological product that is 
shown to meet the standards described in subsection 
(k)(4), means that the biological product may be sub-
stituted for the reference product without the interven-
tion of the health care provider who prescribed the 
reference product. 
‘‘(4) The term ‘reference product’ means the sin-
gle biological product licensed under subsection (a) 
against which a biological product is evaluated in an 
application submitted under subsection (k).’’. 
(c) PRODUCTS PREVIOUSLY APPROVED UNDER SEC-
TION 505.— 
(1) REQUIREMENT TO FOLLOW SECTION 351.— 
Except as provided in paragraph (2), an application 
for a biological product shall be submitted under sec-
tion 351 of the Public Health Service Act (42 U.S.C. 
262) (as amended by this Act). 
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(2) EXCEPTION.—An application for a biological 
product may be submitted under section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) if— 
(A) such biological product is in a product 
class for which a biological product in such 
product class is the subject of an application ap-
proved under such section 505 not later than the 
date of enactment of this Act; and 
(B) such application— 
(i) has been submitted to the Secretary 
of Health and Human Services (referred to 
in this Act as the ‘‘Secretary’’) before the 
date of enactment of this Act; or 
(ii) is submitted to the Secretary not 
later than the date that is 10 years after the 
date of enactment of this Act. 
(3) LIMITATION.—Notwithstanding paragraph 
(2), an application for a biological product may not 
be submitted under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) if there is 
another biological product approved under subsection 
(a) of section 351 of the Public Health Service Act 
that could be a reference product with respect to such 
application (within the meaning of such section 351) 
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if such application were submitted under subsection 
(k) of such section 351. 
(4) DEEMED APPROVED UNDER SECTION 351.— 
An approved application for a biological product 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) shall be deemed to be 
a license for the biological product under such section 
351 on the date that is 10 years after the date of en-
actment of this Act. 
(5) DEFINITIONS.—For purposes of this sub-
section, the term ‘‘biological product’’ has the mean-
ing given such term under section 351 of the Public 
Health Service Act (42 U.S.C. 262) (as amended by 
this Act). 
SEC. 2566. FEES RELATING TO BIOSIMILAR BIOLOGICAL 
PRODUCTS. 
Subparagraph (B) of section 735(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is 
amended by inserting ‘‘, including licensure of a biological 
product under section 351(k) of such Act’’ before the period 
at the end. 
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Subtitle D—Community Living 
Assistance Services and Supports 
SEC. 2571. ESTABLISHMENT OF NATIONAL VOLUNTARY IN-
SURANCE PROGRAM FOR PURCHASING COM-
MUNITY LIVING ASSISTANCE SERVICES AND 
SUPPORTS. 
(a) IN GENERAL.—The Public Health Service Act (42 
U.S.C. 201 et seq.), as amended, is amended by adding at 
the end the following: 
‘‘TITLE XXXII—COMMUNITY LIV-
ING 
ASSISTANCE 
SERVICES 
AND SUPPORTS 
‘‘SEC. 3201. IN GENERAL. 
‘‘The Secretary shall establish a national voluntary in-
surance program to be known as the CLASS Independence 
Benefit Plan for purchasing community living assistance 
services and supports. Such program shall— 
‘‘(1) provide individuals who have functional 
limitations with tools that will allow them— 
‘‘(A) to maintain their personal and finan-
cial independence; and 
‘‘(B) to live in the community through a 
new financing strategy for community living as-
sistance services and supports; 
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‘‘(2) establish an infrastructure that will help 
address the Nation’s community living assistance 
services and supports needs; 
‘‘(3) alleviate burdens on family caregivers; and 
‘‘(4) address institutional bias by providing a fi-
nancing mechanism that supports personal choice and 
independence to live in the community. 
‘‘SEC. 3202. DEVELOPMENT AND MANAGEMENT OF PRO-
GRAM. 
‘‘The Secretary shall develop the CLASS Independence 
Benefit Plan in an actuarially sound manner and— 
‘‘(1) set criteria for participation in the CLASS 
Independence Benefit Plan that do not restrict eligi-
bility based on underwriting; 
‘‘(2) establish criteria for eligibility for benefits; 
‘‘(3) establish benefit levels; 
‘‘(4) establish mechanisms for collecting and dis-
tributing payments; 
‘‘(5) provide mechanisms to assist beneficiaries 
in the use of benefits; 
‘‘(6) promulgate such regulations as are nec-
essary to carry out the CLASS program in accord-
ance with this title; and 
‘‘(7) take any other action appropriate to de-
velop, manage, and maintain the CLASS Independ-
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ence Benefit Plan, including making adjustments to 
benefits paid out and premiums collected in order 
to— 
‘‘(A) maintain program solvency; and 
‘‘(B) ensure the program remains deficit 
neutral. 
‘‘SEC. 3203. REPORT. 
‘‘The Secretary shall submit to the Congress an annual 
report on the program under this title.’’. 
(b) EFFECTIVE DATE.—Title XXXII of the Public 
Health Service Act, as added by subsection (a), shall take 
effect on the effective date of a statute establishing a vol-
untary payroll deduction under the Internal Revenue Code 
of 1986 to support the program authorized by such title. 
Subtitle E—Miscellaneous 
SEC. 2581. STATES FAILING TO ADHERE TO CERTAIN EM-
PLOYMENT OBLIGATIONS. 
A State is eligible for Federal funds under the provi-
sions of the Public Health Service Act (42 U.S.C. 201 et 
seq.) only if the State— 
(1) agrees to be subject in its capacity as an em-
ployer to each obligation under division A of this Act 
and the amendments made by such division applica-
ble to persons in their capacity as an employer; and 
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(2) assures that all political subdivisions in the 
State will do the same. 
SEC. 2582. STUDY, REPORT, AND TERMINATION OF DUPLI-
CATIVE GRANT PROGRAMS. 
(a) STUDY.—The Secretary of Health and Human 
Services (in this section referred to as the ‘‘Secretary’’) shall 
conduct a study to determine if any grant program estab-
lished by this division, or any amendment made by this 
division, is duplicative of one or more other Federal grant 
programs under the authority of the Secretary in existence 
as of the date of the enactment of this Act. 
(b) REPORT.—Not later than 1 year after the date of 
the enactment of this Act, the Secretary shall submit to Con-
gress and make available to the public a report that con-
tains the results of the study required under subsection (a). 
(c) TERMINATION
OF
DUPLICATIVE
GRANT
PRO-
GRAMS.—If the Secretary determines under subsection (a) 
that any grant program established by this division, or any 
amendment made by this division, is duplicative of one or 
more other Federal grant programs under the authority of 
the Secretary, the Secretary shall, to maximum extent ap-
propriate, terminate such other Federal grant programs not 
later than 180 days after the date of the submission of the 
report under subsection (b). 
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SEC. 2583. HEALTH CENTERS UNDER PUBLIC HEALTH SERV-
ICE ACT; LIABILITY PROTECTIONS FOR VOL-
UNTEER PRACTITIONERS. 
(a) IN GENERAL.—Section 224 (42 U.S.C. 233) is 
amended— 
(1) in subsection (g)(1)(A)— 
(A) in the first sentence, by striking ‘‘or em-
ployee’’ and inserting ‘‘employee, or (subject to 
subsection (k)(4)) volunteer practitioner’’; and 
(B) in the second sentence, by inserting 
‘‘and subsection (k)(4)’’ after ‘‘subject to para-
graph (5)’’; and 
(2) in each of subsections (g), (i), (j), (l), and 
(m), by striking the term ‘‘employee, or contractor’’ 
each place such term appears and inserting ‘‘em-
ployee, volunteer practitioner, or contractor’’; 
(3) in subsection (g)(1)(H), by striking the term 
‘‘employee, and contractor’’ each place such term ap-
pears and inserting ‘‘employee, volunteer practitioner, 
and contractor’’; 
(4) in subsection (l), by striking the term ‘‘em-
ployee, or any contractor’’ and inserting ‘‘employee, 
volunteer practitioner, or contractor’’; and 
(5) in subsections (h)(3) and (k), by striking the 
term ‘‘employees, or contractors’’ each place such term 
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appears and inserting ‘‘employees, volunteer practi-
tioners, or contractors’’. 
(b) APPLICABILITY; DEFINITION.—Section 224(k) (42 
U.S.C. 233(k)) is amended by adding at the end the fol-
lowing paragraph: 
‘‘(4)(A) Subsections (g) through (m) apply with respect 
to volunteer practitioners beginning with the first fiscal 
year for which an appropriations Act provides that 
amounts in the fund under paragraph (2) are available 
with respect to such practitioners. 
‘‘(B) For purposes of subsections (g) through (m), the 
term ‘volunteer practitioner’ means a practitioner who, 
with respect to an entity described in subsection (g)(4), 
meets the following conditions: 
‘‘(i) The practitioner is a licensed physician, a 
licensed clinical psychologist, or other licensed or cer-
tified health care practitioner. 
‘‘(ii) At the request of such entity, the practi-
tioner provides services to patients of the entity, at a 
site at which the entity operates or at a site des-
ignated by the entity. The weekly number of hours of 
services provided to the patients by the practitioner is 
not a factor with respect to meeting conditions under 
this subparagraph. 
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‘‘(iii) The practitioner does not for the provision 
of such services receive any compensation from such 
patients, from the entity, or from third-party payors 
(including reimbursement under any insurance policy 
or health plan, or under any Federal or State health 
benefits program).’’. 
SEC. 2584. REPORT TO CONGRESS ON THE CURRENT STATE 
OF PARASITIC DISEASES THAT HAVE BEEN 
OVERLOOKED AMONG THE POOREST AMERI-
CANS. 
Not later than 12 months after the date of the enact-
ment of this Act, the Secretary of Health and Human Serv-
ices shall report to Congress on the epidemiology of, impact 
of, and appropriate funding required to address neglected 
diseases of poverty, including neglected parasitic diseases 
identified as Chagas Disease, cysticercosis, toxocariasis, tox-
oplasmosis, trichomoniasis, the soil-transmitted helminths, 
and others. The report should provide the information nec-
essary to enhance health policy to accurately evaluate and 
address the threat of these diseases. 
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SEC. 2585. STUDY OF IMPACT OF OPTOMETRISTS ON AC-
CESS TO HEALTH CARE AND ON AVAIL-
ABILITY 
OF 
SUPPORT 
UNDER 
FEDERAL 
HEALTH PROGRAMS FOR OPTOMETRY. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’) shall conduct a study with respect to optometrists 
and optometry to determine— 
(1) whether there is a current and projected role 
for, and the impact of, optometrists in increasing ac-
cess to primary eye and vision care to underserved, 
rural, and senior populations; 
(2) the role and impact of optometrists in the 
early diagnosis and treatment of glaucoma, cataract, 
diabetes, and other conditions; 
(3) whether there is a need for optometrists to be 
recognized and supported as primary care providers; 
(4) whether there is an existence of, and the ex-
tent of, any barriers to recruitment and participation 
of underrepresented minorities in optometry, includ-
ing the potential role played by the lack of eligibility 
of optometrists, optometry students, and facilities for 
certain Federal health programs; and 
(5) the scope of Federal support for clinical opto-
metric education and options for enhancing that sup-
port— 
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(A) to address barriers to underrepresented 
minority recruitment and participation in op-
tometry; and 
(B) to improve access to primary eye and 
vision care, especially in underserved and rural 
areas. 
(b) COMMENT ON MATTERS STUDIED.—In carrying 
out the study under subsection (a), the Secretary shall seek 
the comments of appropriate public and private entities. 
(c) REPORT TO CONGRESS.—Not later than 18 months 
after the date of the enactment of this Act, the Secretary 
shall submit to the Congress a report containing— 
(1) the results of the study under subsection (a); 
(2) a summary of comments received from public 
and private entities under subsection (b); and 
(3) recommendations for such legislation and ad-
ministrative action as the Secretary determines to be 
appropriate regarding the issues studied under sub-
section (a). 
SECTION 1. SHORT TITLE; TABLE OF DIVISIONS, TITLES, 
AND SUBTITLES. 
(a) SHORT TITLE.—This Act may be cited as 
the ‘‘America’s Affordable Health Choices Act 
of 2009’’. 
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(b) TABLE OF DIVISIONS, TITLES, AND SUB-
TITLES.—This Act is divided into divisions, ti-
tles, and subtitles as follows: 
DIVISION A—AFFORDABLE HEALTH CARE CHOICES 
TITLE I—PROTECTIONS AND STANDARDS FOR QUALIFIED 
HEALTH BENEFITS PLANS 
Subtitle A—General Standards 
Subtitle B—Standards Guaranteeing Access to Affordable Cov-
erage 
Subtitle C—Standards Guaranteeing Access to Essential Bene-
fits 
Subtitle D—Additional Consumer Protections 
Subtitle E—Governance 
Subtitle F—Relation to other requirements; Miscellaneous 
Subtitle G—Early Investments 
TITLE II—HEALTH INSURANCE EXCHANGE AND RELATED 
PROVISIONS 
Subtitle A—Health Insurance Exchange 
Subtitle B—Public health insurance option 
Subtitle C—Individual Affordability Credits 
TITLE III—SHARED RESPONSIBILITY 
Subtitle A—Individual responsibility 
Subtitle B—Employer Responsibility 
TITLE IV—AMENDMENTS TO INTERNAL REVENUE CODE OF 
1986 
Subtitle A—Shared responsibility 
Subtitle B—Credit for small business employee health coverage 
expenses 
Subtitle C—Disclosures to carry out health insurance exchange 
subsidies 
Subtitle D—Other revenue provisions 
DIVISION B—MEDICARE AND MEDICAID IMPROVEMENTS 
TITLE I—IMPROVING HEALTH CARE VALUE 
Subtitle A—Provisions related to Medicare part A 
Subtitle B—Provisions Related to Part B 
Subtitle C—Provisions Related to Medicare Parts A and B 
Subtitle D—Medicare Advantage Reforms 
Subtitle E—Improvements to Medicare Part D 
Subtitle F—Medicare Rural Access Protections 
TITLE II—MEDICARE BENEFICIARY IMPROVEMENTS 
Subtitle A—Improving and Simplifying Financial Assistance for 
Low Income Medicare Beneficiaries 
Subtitle B—Reducing Health Disparities 
Subtitle C—Miscellaneous Improvements 
TITLE III—PROMOTING PRIMARY CARE, MENTAL HEALTH 
SERVICES, AND COORDINATED CARE 
TITLE IV—QUALITY 
Subtitle A—Comparative Effectiveness Research 
Subtitle B—Nursing Home Transparency 
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Subtitle C—Quality Measurements 
Subtitle D—Physician Payments Sunshine Provision 
Subtitle E—Public Reporting on Health Care-Associated Infec-
tions 
TITLE V—MEDICARE GRADUATE MEDICAL EDUCATION 
TITLE VI—PROGRAM INTEGRITY 
Subtitle A—Increased funding to fight waste, fraud, and abuse 
Subtitle B—Enhanced penalties for fraud and abuse 
Subtitle C—Enhanced Program and Provider Protections 
Subtitle D—Access to Information Needed to Prevent Fraud, 
Waste, and Abuse 
TITLE VII—MEDICAID AND CHIP 
Subtitle A—Medicaid and Health Reform 
Subtitle B—Prevention 
Subtitle C—Access 
Subtitle D—Coverage 
Subtitle E—Financing 
Subtitle F—Waste, Fraud, and Abuse 
Subtitle G—Puerto Rico and the Territories 
Subtitle H—Miscellaneous 
TITLE VIII—REVENUE-RELATED PROVISIONS 
TITLE IX—MISCELLANEOUS PROVISIONS 
DIVISION C—PUBLIC HEALTH AND WORKFORCE 
DEVELOPMENT 
TITLE I—COMMUNITY HEALTH CENTERS 
TITLE II—WORKFORCE 
Subtitle A—Primary care workforce 
Subtitle B—Nursing workforce 
Subtitle C—Public Health Workforce 
Subtitle D—Adapting workforce to evolving health system 
needs 
TITLE III—PREVENTION AND WELLNESS 
TITLE IV—QUALITY AND SURVEILLANCE 
TITLE V—OTHER PROVISIONS 
Subtitle A—Drug discount for rural and other hospitals 
Subtitle B—School-Based health clinics 
Subtitle C—National medical device registry 
Subtitle D—Grants for comprehensive programs To provide 
education to nurses and create a pipeline to nurs-
ing 
Subtitle E—States failing To adhere to certain employment ob-
ligations 
DIVISION A—AFFORDABLE 
HEALTH CARE CHOICES 
SEC. 100. PURPOSE; TABLE OF CONTENTS OF DIVISION; 
GENERAL DEFINITIONS. 
(a) PURPOSE.— 
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