"(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.

"(d) REPORT.-The Secretary shall submit to the Congress 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 General of the United States shall

(1) conduct a study on the barriers experienced by veterans who received training as medical personnel 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 recommendations 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 certified in a State as health providers other than emergency medical technicians.

SEC. 2545. DENTAL EMERGENCY RESPONDERS: PUBLIC HEALTH AND MEDICAL RESPONSE. (a) NATIONAL HEALTH SECURITY STRATEGY.-Section 2802(b)(3) (42 U.S.C. 300hh1(b)(3)) is amended

(1) in the matter preceding subparagraph (A), by inserting "dental and" before "mental health facilities"; and

(2) in subparagraph (D), by inserting "and dental" after "medical".

(b) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL RESPONSE CURRICULA AND TRAINING.-Section 319F(a)(5)(B) (42 U.S.C. 247d-6(a)(5)(B)) is amended by striking "public health or medical" and inserting "public health, medical, or dental".

SEC. 2546. DENTAL EMERGENCY RESPONDERS: HOMELAND SECURITY.

(a) NATIONAL RESPONSE FRAMEWORK.-Paragraph (6) of section 2 of the Homeland Security Act of 2002 (6 U.S.C. 101) is amended by inserting “and dental” after "emergency medical".

(b) NATIONAL PREPAREDNESS SYSTEM.-Subparagraph (B) of section 653(b)(4) of the Post-Katrina Emergency Management Reform Act of 2006 (6 U.S.C. 753(b)(4)) is amended by striking "public health and medical" and inserting "public health, medical, and dental".

(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 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 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 significant public health problem in the United States;

(2) evaluate the adequacy of assessment, diagnosis, treatment, and management of acute and chronic pain in the general population, and in identified racial, ethnic, gender, age, and other demographic groups that may be disproportionately affected by inadequacies in the assessment, diagnosis, treatment, and management of pain;

(3) identify barriers to appropriate pain care, including—

(A) lack of understanding and education among employers, patients, health care providers, regulators, and third-party payors;

(B) barriers to access to care at the primary, specialty, and tertiary care levels, including 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 improve pain care; and

(4) establish an agenda for action in both the public and private sectors that will reduce such barriers and significantly improve the state of pain care research, education, and clinical care in the United States.

(c) OTHER APPROPRIATE ENTITY.-If the Institute of Medicine declines to enter into an agreement under subsection (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 encouraged to continue and expand, through the Pain Consortium, an aggressive program of basic and clinical research on the causes of and potential treatments for pain.

“(2) ANNUAL RECOMMENDATIONS.-Not less than annually, the Pain Consortium, in consultation with 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 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 subsection.

"(b) INTERAGENCY PAIN RESEARCH COORDINATING COMMITTEE.

"(1) ESTABLISHMENT.-The Secretary shall establish 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 efforts within the Department of Health and Human Services and other Federal agencies that relate to pain research.

"(2) MEMBERSHIP.

“(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 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 support pain care research and treatment, including the Department of Defense and the Department of Veterans Affairs. "(ii) 12 additional voting members appointed under subparagraph (B).

"(B) ADDITIONAL MEMBERS.-The Committee 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 disciplines, including clinical, basic, and public health sciences;

"(III) represent different geographical regions of the United States; and

"(IV) are from practice settings, academia, manufacturers, or other research settings; and

“(ii) 6 members shall be appointed from members of the general public, who are representatives of leading research, advocacy, and service organizations for individuals with pain-related conditions.

"(C) NONVOTING MEMBERS.-The Committee shall include such nonvoting members as the Secretary determines to be appropriate.

"(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 duplication of effort;

"(D) make recommendations on how best to disseminate information on pain care; and

"(E) make recommendations on how to expand partnerships between public entities, including 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 MANAGEMENT.

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 AWARENESS 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, emotional, societal, and financial consequences that can result if pain is not appropriately assessed, diagnosed, treated, or managed;

"(3) the availability, benefits, and risks of all pain treatment and management options;

"(4) having pain promptly assessed, appropriately diagnosed, treated, and managed, and regularly 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 information, services, and resources for consumers, employers, 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 options are yet recognized; and "(7) other issues the Secretary deems appropriate.

"(c) CONSULTATION.-In designing and implementing the public awareness campaign required by this section, the Secretary shall consult with organizations representing patients 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 designate 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 section, the Secretary shall

"(1) take into account the special needs of geographic areas and racial, ethnic, gender, age, and other demographic groups that are currently underserved; and "(2) provide resources that will reduce disparities in access to appropriate diagnosis, assessment, and treatment.

"(f) GRANTS AND CONTRACTS.-The Secretary may make awards of grants, cooperative agreements, and contracts to public agencies and private nonprofit organizations 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 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 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.

(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 subsection (h); and

(B) by inserting after subsection (f) the following:

"National Medical Device Registry

"(g)(1) 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 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 Services, the head of the Office of the National Coordinator for Health Information Technology, and the Secretary of Veterans Affairs, determine the best methods for

“(A) including in the registry, in a manner consistent with subsection (f), appropriate information to identify each device described in paragraph (1) 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), including, 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 section 505(k) (relating to active postmarket risk identification);

“(ii) activities under paragraph (4) of section 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 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 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 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 assessment 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 information respecting a device described in paragraph (1), 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.

"(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 manufacturers of such devices to submit information to the registry, including, 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 devices that are described in paragraph (1) and 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 submitted pursuant to subparagraph (A) with patient safety and outcomes data obtained under paragraph (3); and

"(ii) to permit analyses of linked data;

"(C) may require device manufacturers to submit such other information as is necessary to facilitate postmarket assessments of device safety and effectiveness and notification of device risks;

"(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 prevalence 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 proprietary 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 implementation 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 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 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 amended 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 National Coordinator for Health Information Technology standards, implementation 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 section 519(g)(1) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).