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‘‘(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 eligi-
ble 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 evalu-
ated, including plant, equipment, or services. 
Amounts provided by the Federal Government, or 
services assisted or subsidized to any significant ex-
tent by the Federal Government, may not be in-
cluded in determining the amount of such non-Fed-
eral contributions. 
‘‘(f) PRIORITY.—The Secretary shall give priority for 
the award of the contracts or grants described in sub-
section (a) to any eligible entity that serves a medically 
underserved population (as defined in section 330(b)(3)). 
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‘‘(g) REPORT.—Not later than 90 days after the com-
pletion of a demonstration program under subsection (a), 
the recipient of such contract or grant described in such 
subsection shall submit to the Secretary a report con-
taining the results of an evaluation of the program, includ-
ing 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 finan-
cial 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 
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the demonstration programs funded under subsection (a), 
including an evaluation of— 
‘‘(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 
appropriated to carry out this section $12,000,000 
for each of fiscal years 2011 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. 2554. 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 
medical 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 
emergency 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 
satisfaction that the State has a shortage of emergency 
medical technicians. 
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‘‘(d) REPORT.—The Secretary shall submit to the 
Congress an annual report on the program under this sec-
tion. 
‘‘(e) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated such sums as may be necessary for each of fiscal 
years 2011 through 2015.’’. 
(b) GAO STUDY AND REPORT.—The Comptroller 
General 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 re-
port on the results of such study, including rec-
ommendations on whether the program established 
under section 315A of the Public Health Service 
Act, as added by subsection (a), should be expanded 
to assist veterans seeking to become licensed or cer-
tified in a State as health providers other than emer-
gency medical technicians. 
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(c) CHIEF MEDICAL OFFICER.—Paragraph (5) of 
section 516(c) of the Homeland Security Act of 2002 (6 
U.S.C. 321e(c)) is amended by striking ‘‘medical commu-
nity’’ and inserting ‘‘medical and dental communities’’. 
PART 4—PAIN CARE AND MANAGEMENT 
PROGRAMS 
SEC. 2561. INSTITUTE OF MEDICINE CONFERENCE ON PAIN. 
(a) CONVENING.—Not later than June 30, 2011, the 
Secretary of Health and Human Services shall seek to 
enter into an agreement with the Institute of Medicine of 
the National 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 identi-
fied 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 
applicable 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 Con-
ference’s findings and recommendations shall be sub-
mitted to the Congress not later than June 30, 2012. 
(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 2011 
and 2012. 
SEC. 2562. 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 
clinical research on the causes of and potential treat-
ments for pain. 
‘‘(2) ANNUAL
RECOMMENDATIONS.—Not less 
than annually, the Pain Consortium, in consultation 
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with the Division of Program Coordination, Plan-
ning, 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 initiatives. 
‘‘(3) DEFINITION.—In this subsection, the term 
‘Pain Consortium’ means the Pain Consortium of 
the National Institutes of Health or a similar trans- 
National Institutes of Health coordinating entity 
designated 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 
enactment of this section and as necessary maintain 
a committee, to be known as the Interagency Pain 
Research Coordinating Committee (in this section 
referred to as the ‘Committee’), to coordinate all ef-
forts within the Department of Health and Human 
Services and other Federal agencies that relate to 
pain research. 
‘‘(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 Na-
tional Institutes of Health and the di-
rectors of such national research insti-
tutes and national centers as the Sec-
retary determines 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 treat-
ment, including the Department of 
Defense and the Department of Vet-
erans Affairs. 
‘‘(ii) Twelve additional voting mem-
bers appointed 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) Six 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. 
‘‘(ii) Six members shall be appointed 
from members of the general public, who 
are representatives of leading research, ad-
vocacy, and service organizations for indi-
viduals 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 subject 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, 
prevention, 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 Department of Defense and the Department 
of Veteran Affairs, are free of unnecessary du-
plication of effort; 
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‘‘(D) make recommendations on how best 
to disseminate information on pain care; and 
‘‘(E) make recommendations on how to ex-
pand partnerships between public entities, in-
cluding Federal agencies, and private entities to 
expand collaborative, crosscutting research. 
‘‘(6) REVIEW.—The Secretary shall review the 
necessity of the Committee at least once every 2 
years.’’. 
SEC. 2563. 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 12 months 
after the date of the enactment of this section, the Sec-
retary 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 edu-
cate consumers, patients, their families, and other care-
givers with respect to— 
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‘‘(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 
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 in-
formation, services, and resources for consumers, 
employers, third-party payors, patients, their fami-
lies, 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 
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‘‘(7) other issues the Secretary deems appro-
priate. 
‘‘(c) CONSULTATION.—In designing and imple-
menting the public awareness campaign required by this 
section, the Secretary shall consult with organizations rep-
resenting patients in pain and other consumers, employ-
ers, 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 
Centers for Disease Control and Prevention, and 
such other representatives of offices and agencies of 
the Department of Health and Human Services as 
the Secretary determines appropriate. 
‘‘(e) UNDERSERVED AREAS AND POPULATIONS.—In 
designing the public awareness campaign under this sec-
tion, the Secretary shall— 
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‘‘(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 
‘‘(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 effective-
ness of the public awareness campaign under this section 
in educating the general public with respect to the matters 
described in subsection (b). 
‘‘(h) AUTHORIZATION
OF APPROPRIATIONS.—For 
purposes of carrying out this section, there are authorized 
to be appropriated $2,000,000 for fiscal year 2011 and 
$4,000,000 for each of fiscal years 2012 and 2015.’’. 
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Subtitle C—Food and Drug 
Administration 
PART 1—IN GENERAL 
SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY. 
(a) REGISTRY.— 
(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 
following: 
‘‘National Medical Device Registry 
‘‘(g)(1)(A) The Secretary shall establish a national 
medical device registry (in this subsection referred to as 
the ‘registry’) to facilitate analysis of postmarket safety 
and outcomes data on each covered device. 
‘‘(B) In this subsection, the term ‘covered device’— 
‘‘(i) shall include each class III device; and 
‘‘(ii) may include, as the Secretary determines 
appropriate and specifies in regulation, a class II de-
vice that is life-supporting or life-sustaining. 
‘‘(C) Notwithstanding subparagraph (B)(i), the Sec-
retary may by order exempt a class III device from the 
provisions of this subsection if the Secretary concludes 
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that inclusion of information on the device in the registry 
will not provide useful information on safety or effective-
ness. 
‘‘(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 
Services, the Administrator of the Agency for Healthcare 
Research and Quality, the head of the Office of the Na-
tional Coordinator for Health Information Technology, 
and the Secretary of Veterans Affairs, determine the best 
methods for— 
‘‘(A) including in the registry, in a manner con-
sistent with subsection (f), appropriate information 
to identify each covered device by type, model, and 
serial number or other unique identifier; 
‘‘(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); 
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‘‘(C) integrating the activities described in this 
subsection (so as to avoid duplication) 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); 
‘‘(iii) other postmarket device surveillance 
activities of the Secretary authorized by this 
chapter; and 
‘‘(iv) registries carried out by or for the 
Agency for Healthcare Research and Quality; 
and 
‘‘(D) providing public access to the data and 
analysis collected or developed through the registry 
in a manner and form that protects patient privacy 
and proprietary information and is comprehensive, 
useful, and not misleading to patients, physicians, 
and scientists. 
‘‘(3)(A) To facilitate analyses of postmarket safety 
and patient outcomes for covered devices, the Secretary 
shall, in collaboration with public, academic, and private 
entities, develop methods to— 
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‘‘(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 pro-
gram under title XVIII of the Social Secu-
rity Act or from the health systems of the 
Department of Veterans Affairs); 
‘‘(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 as-
sessment of device safety and effectiveness; 
and 
‘‘(ii) link data obtained under clause (i) 
with information in the registry. 
‘‘(B) In this paragraph, the term ‘data’ refers to in-
formation respecting a covered device, including 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. 
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‘‘(4) The Secretary shall promulgate regulations for 
establishment and operation of the registry under para-
graph (1). Such regulations— 
‘‘(A)(i) in the case of covered devices that are 
sold on or after the date of the enactment of this 
subsection, shall require manufacturers of such de-
vices to submit information to the registry, includ-
ing, for each such device, the type, model, and serial 
number or, if required under subsection (f), other 
unique device identifier; and 
‘‘(ii) in the case of covered devices that are sold 
before such date, may require manufacturers of such 
devices to submit such information 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 
‘‘(ii) to permit analyses of linked data; 
‘‘(C) may require covered device manufacturers 
to submit such other information as is necessary to 
facilitate postmarket assessments of device safety 
and effectiveness and notification of device risks; 
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‘‘(D) shall establish requirements for regular 
and timely reports to the Secretary, which shall be 
included in the registry, concerning adverse event 
trends, adverse event patterns, incidence and preva-
lence of adverse events, and other information the 
Secretary 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 sci-
entists. 
‘‘(5)(A) The Secretary shall promulgate final regula-
tions under paragraph (4) not later than 36 months after 
the date of the enactment of this subsection. 
‘‘(B) Before issuing the notice of proposed rule-
making preceding the final regulations described in sub-
paragraph (A), the Secretary shall hold a public hearing 
before an advisory committee on the issue of which class 
II devices to include in the definition of covered devices. 
‘‘(C) The Secretary shall include in any regulation 
under this subsection an explanation demonstrating that 
the requirements of such regulation— 
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‘‘(i) do not duplicate other Federal require-
ments; and 
‘‘(ii) do not impose an undue burden on device 
manufacturers. 
‘‘(6) With respect to any entity that submits or is 
required to submit a safety report or other information 
in connection with the safety of a device under this section 
(and any release by the Secretary of that report or infor-
mation), such report or information shall not be construed 
to reflect necessarily a conclusion by the entity or the Sec-
retary that the report or information constitutes an admis-
sion that the product involved malfunctioned, caused or 
contributed to an adverse experience, or otherwise caused 
or contributed to a death, serious injury, or serious illness. 
Such an entity need not admit, and may deny, that the 
report or information submitted by the entity constitutes 
an admission that the product involved malfunctioned, 
caused or contributed to an adverse experience, or caused 
or contributed to a death, serious injury, or serious illness. 
‘‘(7) To carry out this subsection, there are author-
ized to be appropriated such sums as may be necessary 
for each of fiscal years 2011 and 2012.’’. 
(2) 
EFFECTIVE
DATE.—The 
Secretary 
of 
Health and Human Services shall establish and 
begin implementation of the registry under section 
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519(g) of the Federal Food, Drug, and Cosmetic 
Act, as added by paragraph (1), by not later than 
the date that is 36 months after the date of the en-
actment of this Act, without regard to whether or 
not final regulations to establish and operate the 
registry have been promulgated by such date. 
(3) 
CONFORMING
AMENDMENT.—Section 
303(f)(1)(B)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amend-
ed by striking ‘‘519(g)’’ and inserting ‘‘519(h)’’. 
(b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED 
ELECTRONIC HEALTH RECORDS
OF UNIQUE DEVICE 
IDENTIFIERS.— 
(1) 
RECOMMENDATIONS.—The 
HIT 
Policy 
Committee established under section 3002 of the 
Public Health Service Act (42 U.S.C. 300jj–12) 
shall recommend to the head of the Office of the Na-
tional Coordinator for Health Information Tech-
nology standards, implementation specifications, and 
certification criteria for the electronic exchange and 
use in certified electronic health records of a unique 
device identifier for each covered device (as defined 
under section 519(g)(1)(B) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection 
(a)). 
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(2) STANDARDS, IMPLEMENTATION
CRITERIA, 
AND
CERTIFICATION
CRITERIA.—The Secretary of 
Health and Human Services, acting through the 
head of the Office of the National Coordinator for 
Health Information Technology, shall adopt 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 covered device referred to in para-
graph (1), if such an identifier is required by section 
519(f) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360i(f)) for the device. 
(c) UNIQUE DEVICE IDENTIFICATION SYSTEM.—The 
Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall issue proposed 
regulations to implement section 519(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not 
later than 6 months after the date of the enactment of 
this Act. 
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SEC. 2572. NUTRITION LABELING OF STANDARD MENU 
ITEMS AT CHAIN RESTAURANTS AND OF AR-
TICLES 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 
provided 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 ESTABLISH-
MENTS, AND VENDING MACHINES.— 
‘‘(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 simi-
lar 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 
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food establishment shall disclose the information de-
scribed in subclauses (ii) and (iii). 
‘‘(ii) INFORMATION
REQUIRED
TO
BE
DIS-
CLOSED BY RESTAURANTS AND RETAIL FOOD ES-
TABLISHMENTS.—Except as provided in subclause 
(vii), the restaurant or similar retail food establish-
ment shall disclose in a clear and conspicuous man-
ner— 
‘‘(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 con-
tained 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 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 
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the standard menu item, on the menu board, 
including 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 pub-
lic 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, 
the 
nutrition 
information 
required 
under 
clauses (C) and (D) of subparagraph (1); and 
‘‘(IV) on the menu or menu board, a 
prominent, clear, and conspicuous statement re-
garding the availability of the information de-
scribed 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-serv-
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ice beverages or food that is on display and that is 
visible to customers, a restaurant or similar retail 
food establishment 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 nutri-
ent 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 regu-
lation) or in a related guidance of the Food and 
Drug Administration. 
‘‘(v) MENU
VARIABILITY
AND
COMBINATION 
MEALS.—The Secretary shall establish by regulation 
standards for determining and disclosing the nutri-
ent content for standard menu items that come in 
different flavors, varieties, or combinations, but 
which are listed as a single menu item, such as soft 
drinks, ice cream, pizza, doughnuts, or children’s 
combination meals, through means determined by 
the Secretary, including ranges, averages, or other 
methods. 
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‘‘(vi) ADDITIONAL INFORMATION.—If the Sec-
retary determines that a nutrient, other than a nu-
trient required under subclause (ii)(III), should be 
disclosed for the purpose of providing information to 
assist consumers in maintaining healthy dietary 
practices, the Secretary may require, by regulation, 
disclosure of such nutrient in the written form re-
quired 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); 
‘‘(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 Sec-
retary. 
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‘‘(II) WRITTEN FORMS.—Clause (C) shall 
apply to any regulations promulgated under 
subclauses (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 
before purchasing the article or does not other-
wise 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 selec-
tion button that includes a clear and conspicuous 
statement disclosing the number of calories con-
tained in the article. 
‘‘(ix) VOLUNTARY PROVISION OF NUTRITION IN-
FORMATION.— 
‘‘(I) IN GENERAL.—An authorized official 
of any restaurant or similar retail food estab-
lishment or vending machine operator not sub-
ject to the requirements of this clause may elect 
to be subject to the requirements of such 
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clause, by registering biannually the name and 
address of such restaurant or similar retail food 
establishment or vending machine operator with 
the Secretary, as specified by the Secretary by 
regulation. 
‘‘(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 regu-
lations. 
‘‘(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. 
‘‘(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, reason-
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able variation in serving size and formula-
tion of menu items, space on menus and 
menu boards, inadvertent human error, 
training of food service workers, variations 
in ingredients, and other factors, as the 
Secretary determines; and 
‘‘(bb) specify the format and manner 
of the nutrient content disclosure require-
ments under this subclause. 
‘‘(III) REPORTING.—The Secretary shall 
submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the 
House of Representatives a quarterly report 
that describes the Secretary’s progress toward 
promulgating final regulations under this sub-
paragraph. 
‘‘(xi) DEFINITION.—In this clause, the term 
‘menu’ or ‘menu board’ means the primary writing 
of the restaurant or other similar retail food estab-
lishment from which a consumer makes an order se-
lection.’’. 
(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 require-
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ment 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 substantially the same menu items unless such res-
taurant or similar retail food establishment complies with 
the voluntary provision of nutrition information require-
ments under section 403(q)(5)(H)(ix)’’. 
(d) RULE
OF
CONSTRUCTION.—Nothing in the 
amendments 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 
required under section 403(q)(5)(H) of the Federal 
Food, Drug, and Cosmetic Act (as added by sub-
section (b)) and is expressly preempted under sec-
tion 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 
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(3) 
except 
as 
provided 
in 
section 
403(q)(5)(H)(ix) of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (b)), to apply 
to any restaurant or similar retail food establish-
ment other than a restaurant or similar retail food 
establishment described in section 403(q)(5)(H)(i) of 
such Act. 
SEC. 2573. PROTECTING CONSUMER ACCESS TO GENERIC 
DRUGS. 
(a) FINDINGS; PURPOSE.— 
(1) FINDINGS.—The Congress finds the fol-
lowing: 
(A) In 1984, the Drug Price Competition 
and Patent Term Restoration Act (Public Law 
98–417; in this subsection referred to as the 
‘‘1984 Act’’) was enacted with the intent of fa-
cilitating the early entry of generic drugs while 
preserving incentives for innovation. 
(B) Prescription drugs make up 10 percent 
of national health care spending, but for the 
past decade have been one of the fastest grow-
ing segments of health care expenditures. 
(C) Until recently, the 1984 Act was suc-
cessful in facilitating generic competition to the 
benefit of consumers and health care payers— 
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although 67 percent of all prescriptions dis-
pensed in the United States are generic drugs, 
they account for only 20 percent of all expendi-
tures. 
(D) In recent years, the intent of the 1984 
Act has been subverted by certain settlement 
agreements between brand companies and their 
potential generic competitors that make reverse 
payments, i.e., payments by the brand company 
to the generic company. 
(E) These settlement agreements have un-
duly delayed the marketing of low-cost generic 
drugs contrary to free competition and the in-
terests of consumers. 
(F) The state of antitrust law relating to 
such settlement agreements is unsettled. 
(2) PURPOSE.—The purpose of this section is 
to provide an additional means to effectuate the in-
tent of the 1984 Act by enhancing competition in 
the pharmaceutical market by stopping agreements 
between brand name and generic drug manufactur-
ers that limit, delay, or otherwise prevent competi-
tion from generic drugs. 
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(b) 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 
be a party to any agreement resolving or set-
tling 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— 
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‘‘(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 
‘‘(ii) the waiver of a patent infringe-
ment claim for damages based on prior 
marketing of such drug. 
‘‘(C) ENFORCEMENT.— 
‘‘(i) IN GENERAL.—A violation of sub-
paragraph (A) shall be subject to enforce-
ment by the Federal Trade Commission in 
the same manner, by the same means, and 
with the same jurisdiction as would an un-
fair and deceptive act or practice in or af-
fecting interstate commerce or an unfair 
method of competition in or affecting inter-
state commerce prohibited under section 5 
of the Federal Trade Commission Act, as 
though all applicable terms and provisions 
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of the Federal Trade Commission Act were 
incorporated into and made a part of this 
subsection. 
‘‘(ii) 
INAPPLICABILITY.—Subchapter 
A of chapter VII shall not apply with re-
spect to this subsection. 
‘‘(D) DEFINITIONS.—In this subsection: 
‘‘(i) AGREEMENT.—The term ‘agree-
ment’ means anything that would con-
stitute an agreement under section 5 of the 
Federal Trade Commission Act. 
‘‘(ii) AGREEMENT RESOLVING OR SET-
TLING.—The term ‘agreement resolving or 
settling’, in reference to a patent infringe-
ment claim, includes any agreement that is 
contingent upon, provides a contingent 
condition for, or is otherwise related to the 
resolution or settlement of the claim. 
‘‘(iii) ANDA.—The term ‘ANDA’ 
means an abbreviated new drug application 
for the approval of a new drug under sec-
tion (j). 
‘‘(iv) 
ANDA 
FILER.—The 
term 
‘ANDA filer’ means a party that has filed 
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an ANDA with the Food and Drug Admin-
istration. 
‘‘(v) PATENT
INFRINGEMENT.—The 
term ‘patent infringement’ means infringe-
ment of any patent or of any filed patent 
application, extension, reissuance, renewal, 
division, continuation, continuation in part, 
reexamination, patent term restoration, 
patent of addition, or extension thereof. 
‘‘(vi) 
PATENT
INFRINGEMENT 
CLAIM.—The term ‘patent infringement 
claim’ means 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 for the benefit of con-
sumers. Consistent with the authority of the Com-
mission, such rules may include interpretive rules 
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and general statements of policy with respect to the 
practices prohibited under paragraph (1).’’. 
(c) 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’’; 
(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 
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correct: The materials filed with the Federal Trade Com-
mission 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 re-
spect to the agreement referenced in this certification: (1) 
represent the complete, final, and exclusive agreement be-
tween 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) include written descriptions of any oral agree-
ments, representations, commitments, or promises be-
tween the parties that are responsive to subsection (a) or 
(b) of such section 1112 and have not been reduced to 
writing.’.’’. 
(d) 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 
conduct a study on the litigation in United States 
courts during the period beginning 5 years prior to 
the date of enactment of this Act relating to patent 
infringement claims involving generic drugs, the 
number of patent challenges initiated by manufac-
turers of generic drugs, and the number of settle-
ments of such litigation. The Comptroller General 
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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 (b) and (c) on 
such litigation, whether such amendments have had 
an effect on the number and frequency of claims set-
tled, and whether such amendments resulted in ear-
lier or delayed entry of generic drugs to market, in-
cluding whether any harm or benefit 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-
provement, and Modernization Act of 2003 (21 
U.S.C. 355 note), or unaggregated information from 
such agreements, shall be disclosed to the Comp-
troller General for purposes of the study under para-
graph (1) within 30 days of a request by the Comp-
troller General. 
PART 2—BIOSIMILARS 
SEC. 2575. LICENSURE PATHWAY FOR BIOSIMILAR BIO-
LOGICAL 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— 
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(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 
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; 
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‘‘(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 
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; 
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‘‘(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 
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. 
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‘‘(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 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— 
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