114 S1537 IS: Border Health Security Act of 2015
U.S. Senate
2015-06-10
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II114th CONGRESS1st SessionS. 1537IN THE SENATE OF THE UNITED STATESJune 10, 2015Mr. Udall (for himself, Mr. Heinrich, and Mrs. Gillibrand) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo establish grant programs to improve the health of border area residents and for all hazards
			 preparedness in the border area including bioterrorism, infectious
			 disease, and noncommunicable emerging threats, and for other purposes.

 1.Short titleThis Act may be cited as the Border Health Security Act of 2015.
 2.FindingsCongress makes the following findings:
 (1)The United States-Mexico border is an interdependent and dynamic region of more than 15,000,000 people with significant and unique public health challenges.
 (2)These challenges include low rates of health insurance coverage, poor access to health care services, high unemployment rates, low educational attainment, and high rates of dangerous diseases, such as tuberculosis, diabetes, obesity, and other non-communicable diseases.
 (3)As the 2009 novel influenza A (H1N1) pandemic illustrated, diseases do not respect international boundaries, and a strong public health effort at and along the borders is crucial to not only protect and improve the health of Americans but also to help secure the country against threats to biosecurity and other emerging threats.
 (4)For 11 years, the United States-Mexico Border Health Commission has served as a crucial binational institution to address these unique and truly cross-border health issues.
 (5)More than 75 percent of Canadians live within 100 miles of the United States border. The 2003 epidemic of severe acute respiratory syndrome caused more than 250 illnesses in the Greater Toronto Area, just 80 miles from New York.
			3.United States-Mexico
 Border Health Commission Act amendmentsThe United States-Mexico Border Health Commission Act (22 U.S.C. 290n et seq.) is amended—
 (1)in section 3—
 (A)in paragraph (1), by striking ; and and inserting ;;
 (B)in paragraph (2), by striking the period and inserting a semicolon; and
 (C)by adding at the end the following:

 (3)to cooperate with the Canada-United States Pan-Border Public Health Preparedness Council (referred to in this Act as the Council), as appropriate; and
 (4)to serve as an independent and objective body to both recommend and implement initiatives that solve border health issues.;
 (2)in section 5—
 (A)in subsection (b), by striking should be the leader and inserting shall be the Chair; and
 (B)by adding at the end the following:

						(d)Providing
 advice and recommendationsMembers of the Commission and the Council may at any time provide advice or recommendations to the Secretary, Congress, or any Member of Congress concerning issues that are considered by the Commission or Council. Such advice or recommendations may be provided regardless of whether a request for such is made and regardless of whether the member or individual is authorized to provide such advice or recommendations by the Commission or Council or any other Federal official.;
 (3)by redesignating section 8 as section 12;
 (4)by striking section 7 and inserting the following:

					7.Border health
				grants
						(a)Eligible entity
 definedIn this section, the term eligible entity means a State, public institution of higher education, local government, Indian tribe, tribal organization, urban Indian organization, nonprofit health organization, trauma center, critical access hospital or other hospital that serves rural or other vulnerable communities and populations, faith-based entity, or community health center receiving assistance under section 330 of the Public Health Service Act (42 U.S.C. 254b), that is located in the United States-Mexico border area or the United States-Canada border area.
 (b)AuthorizationFrom amounts appropriated under section 11, the Secretary, in consultation with members of the Commission and Council and in coordination with the Office of Global Affairs, shall award grants to eligible entities to address priorities and recommendations outlined by the strategic plan and operational work plan of the Commission and the Council, as authorized under section 9, to improve the health of United States-Mexico border area and United States-Canada border area residents.
 (c)ApplicationAn eligible entity that desires a grant under subsection (b) shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
						(d)Use of
 fundsAn eligible entity that receives a grant under subsection (b) shall use the grant funds for any of the following:
 (1)Programs relating to any one or more of the following:
 (A)Maternal and child health. (B)Primary care and preventative health.
 (C)Infectious disease testing, monitoring, and surveillance.
 (D)Public health and public health infrastructure.
 (E)Health promotion. (F)Oral health.
 (G)Behavioral and mental health. (H)Substance abuse prevention and harm reduction.
 (I)Health conditions that have a high prevalence in the United States-Mexico border area or United States-Canada border area.
 (J)Medical and health services research.
 (K)Workforce training and development. (L)Community health workers and promotoras.
 (M)Health care infrastructure problems in the United States-Mexico border area or United States-Canada border area (including planning and construction grants).
 (N)Health disparities in the United States-Mexico border area or United States-Canada border area.
 (O)Environmental health. (P)Health education.
 (Q)Outreach and enrollment services with respect to Federal programs (including programs authorized under titles XIX and XXI of the Social Security Act (42 U.S.C. 1396 et seq. and 1397aa et seq.)).
 (R)Trauma care. (S)Health research with an emphasis on infectious disease and pressing issues related to noncommunicable diseases.
 (T)Epidemiology and health research.
 (U)Cross-border health surveillance coordinated with Mexican Health Authorities or Canadian Health Authorities.
 (V)Obesity, particularly childhood obesity.
 (W)Crisis communication, domestic violence, health literacy, or cancer.
 (X)Community-based participatory research on border health issues.
 (Y)Violence prevention.
 (Z)Cross-border public health preparedness.
 (2)Other programs determined appropriate by the Secretary.
							(e)Supplement, not
 supplantAmounts provided to an eligible entity awarded a grant under subsection (b) shall be used to supplement and not supplant other funds available to the eligible entity to carry out the activities described in subsection (d).
						8.Grants for Early
				Warning Infectious Disease Surveillance (EWIDS) in the border area
						(a)Eligible entity
 definedIn this section, the term eligible entity means a State, local government, Indian tribe, tribal organization, urban Indian organization, trauma center, regional trauma center coordinating entity, or public health entity.
 (b)AuthorizationFrom funds appropriated under section 11, the Secretary shall award grants for Early Warning Infectious Disease Surveillance (EWIDS) to eligible entities for infectious disease surveillance activities in the United States-Mexico border area or United States-Canada border area.
 (c)ApplicationAn eligible entity that desires a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
						(d)Uses of
 fundsAn eligible entity that receives a grant under subsection (b) shall use the grant funds, in coordination with State and local all hazards programs, to—
 (1)develop and implement infectious disease surveillance plans and networks and public health emergency and readiness assessments and preparedness plans, and purchase items necessary for such plans;
 (2)coordinate infectious disease surveillance planning and interjurisdictional risk assessments in the region with appropriate United States-based agencies and organizations and appropriate authorities in Mexico or Canada;
 (3)improve infrastructure, including surge capacity, syndromic surveillance, and isolation/decontamination capacity, and policy preparedness, including for mutual assistance and for the sharing of information and resources;
 (4)improve laboratory capacity, in order to maintain and enhance capability and capacity to detect potential infectious disease, whether naturally occurring or the result of terrorism;
 (5)create and maintain a health alert network, including risk communication and information dissemination that is culturally competent and takes into account the needs of at-risk populations, including individuals with disabilities;
 (6)educate and train clinicians, epidemiologists, laboratories, and emergency management personnel;
 (7)implement electronic data and infrastructure inventory systems to coordinate the triage, transportation, and treatment of multicasualty incident victims;
 (8)provide infectious disease testing in the United States-Mexico border area or United States-Canada border area; and
 (9)carry out such other activities identified by the Secretary, members of the Commission, members of the Council, State or local public health authorities, representatives of border health offices, or authorities at the United States-Mexico or United States-Canada borders.
							9.Plans, reports,
				audits, and by-laws
						(a)Strategic
				plan
							(1)In
 generalNot later than 2 years after the date of enactment of this section, and every 5 years thereafter, the Commission (including the participation of members representing both the United States and Mexican sections) and the Council (including the participation of members representing both the United States and Canada) shall each prepare a binational strategic plan to guide the operations of the Commission and the Council and submit such plan to the Secretary and Congress.
 (2)RequirementsThe binational strategic plan under paragraph (1) shall include—
 (A)health-related priority areas determined most important by the full membership of the Commission or Council, as applicable;
 (B)recommendations for goals, objectives, strategies, and actions designed to address such priority areas; and
 (C)a proposed evaluation framework with output and outcome indicators appropriate to gauge progress toward meeting the objectives and priorities of the Commission or Council, as applicable.
								(b)Work
 planNot later than January 1, 2017, and every 2 years thereafter, the Commission and the Council shall develop and approve an operational work plan and budget based on the strategic plan under subsection (a).
						(c)GAO
 reviewNot later than January 1, 2018, and every 2 years thereafter, the Comptroller General of the United States shall conduct an evaluation of the activities conducted by the Commission and the Council based on the operational work plans described in subsection (b) for the previous year and the output and outcome indicators included in the strategic plan described in subsection (a). The evaluation shall include a request for written evaluations from members of the Commission and the Council about barriers and facilitators to executing successfully the work plans of the Commission and the Council.
 (d)Biannual reportingThe Commission and Council shall each issue a biannual report to the Secretary that provides independent policy recommendations related to border health issues. Not later than 3 months following receipt of each such biannual report, the Secretary shall provide to Congress the report and any studies or other materials produced independently by the Commission and Council.
 (e)AuditsThe Secretary shall annually prepare an audited financial report to account for all appropriated assets expended by the Commission and Council to address both the strategic and operational work plans for the year involved.
 (f)By-LawsNot later than 6 months after the date of enactment of this section, the Commission and Council shall develop and approve bylaws to provide fully for compliance with the requirements of this section.
						(g)Transmittal to
 congressThe Commission and Council shall submit copies of the operational work plan and by-laws to Congress. The Comptroller General of the United States shall submit a copy of each evaluation completed under subsection (c) to Congress.
						10.Coordination
						(a)In
 generalTo the extent practicable and appropriate, plans, systems, and activities to be funded (or supported) under this Act for all hazard preparedness, and general border health, shall be coordinated with Federal, State, and local authorities in Mexico, Canada, and the United States.
						(b)Coordination of
 health services and surveillanceThe Secretary, acting through the Assistant Secretary for Preparedness and Response, when appropriate, may coordinate with the Secretary of Homeland Security in establishing a health alert system that—
 (1)alerts clinicians and public health officials of emerging disease clusters and syndromes along the United States-Mexico border area and United States-Canada border area; and
 (2)warns of health threats, extreme weather conditions, disasters of mass scale, bioterrorism, and other emerging threats along the United States-Mexico border area and United States-Canada border area.
							11.Authorization
 of appropriationsThere is authorized to be appropriated to carry out this Act $7,000,000 for fiscal year 2017 and each succeeding year, subject to the availability of appropriations for such purpose, of which $4,650,000 shall be made available to fund operationally feasible functions, activities, and grants with respect to the United States-Mexico border and the border health activities under cooperative agreements with the border health offices of the States of California, Arizona, New Mexico, and Texas, and $2,350,000 shall be allocated for the administration of United States activities under this Act on the United States-Canada border and the border health authorities, acting through the Canada-United States Pan-Border Public Health Preparedness Council.;
				and
 (5)in section 12 (as so redesignated)—
 (A)by redesignating paragraphs (3) and (4) as paragraphs (4) and (6), respectively;
 (B)by inserting after paragraph (2), the following:

						(3)Indians; indian
 tribe; tribal organization; urban indian organizationThe terms Indian, Indian tribe, tribal organization, and urban Indian organization have the meanings given such terms in section 4 of the Indian Health Care Improvement Act (25 U.S.C. 1603).;
				and
 (C)by inserting after paragraph (4), as so redesignated, the following:

						(5)United
 States-Canada border areaThe term United States-Canada border area means the area located in the United States and Canada within 100 kilometers of the border between the United States and Canada..


115 S1774 IS: Employee Rights Act
U.S. Senate
2017-09-07
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II115th CONGRESS1st SessionS. 1774IN THE SENATE OF THE UNITED STATESSeptember 7, 2017Mr. Hatch (for himself, Mr. Alexander, Mr. Cornyn, Mr. Cruz, Mr. Roberts, Mr. Young, Mr. Lankford, Mr. Scott, Mr. Heller, Mr. Rubio, Mr. Shelby, Mr. Perdue, Mr. Sasse, Mr. Isakson, and Mr. Risch) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo provide protections for workers with respect to their right to select or refrain from selecting
			 representation by a labor organization.

		1.Short
 titleThis Act may be cited as the Employee Rights Act.
		2.Amendments to
			 the National Labor Relations Act
			(a)Unfair labor
 practicesSection 8(b)(1) of the National Labor Relations Act (29 U.S.C. 158(b)(1)) is amended by striking restrain or and inserting interfere with, restrain, or.
			(b)Representatives
 and electionsSection 9 of the National Labor Relations Act (29 U.S.C. 159) is amended—
 (1)in subsection (a)—
 (A)by striking designated or selected for the purposes of collective bargaining and inserting for the purposes of collective bargaining selected by secret ballot in an election conducted by the Board,; and
 (B)by inserting before the period the following: : Provided further, That, for purposes of determining the majority of the employees in a secret ballot election in a unit, the term majority shall mean the majority of all the employees in the unit, and not the majority of employees voting in the election; and
 (2)in subsection (e), by adding at the end the following:

 (3)Whenever any certified or voluntarily recognized bargaining unit existing on or after the date of enactment of the Employee Rights Act experiences turnover, expansion, or alteration by merger of unit represented employees exceeding 50 percent of the bargaining unit on such date and (A) the unit represented employees are covered by a negotiated and agreed-upon collective bargaining agreement in effect between a labor organization representative and an employer, the Board shall conduct a secret paper ballot election among the represented employees in the bargaining unit between the 120th day and 110th day prior to the collective bargaining agreement’s expiration or prior to the conclusion of three years, whichever occurs earlier, or (B) there is no negotiated collective bargaining agreement then in effect between a labor organization and an employer, the Board shall conduct a secret paper ballot election among the represented employees in the bargaining unit within 30 days. Thereafter, a secret ballot election shall again be conducted under the same conditions and procedures whenever the recognized bargaining unit experiences turnover, expansion, or alteration by merger of unit represented employees exceeding 50 percent of the bargaining unit then in existence at the time of the preceding secret paper ballot election. The election shall be conducted without regard to the pendency of any unfair labor practice charge against the employer or the labor organization representative and the Board shall rule on any objections to the election pursuant to its established timeframes for resolving such matters. If a majority of the votes cast in a valid election reject the continuing representation by the labor organization, the Board shall withdraw the labor organization’s certification, the labor organization shall cease representation of employees in the bargaining unit, and any obligations to or on behalf of the labor organization in a collectively bargained contract then in effect shall terminate..
				(c)Fair
 representation in electionsSection 9 of the National Labor Relations Act (29 U.S.C. 159) is amended—
 (1)in subsection (b), by inserting prior to an election after in each case; and
 (2)in subsection (c)—
 (A)in the flush matter following paragraph (1)(B)—
 (i)by inserting of 14 days in advance after appropriate hearing upon due notice;
 (ii)by inserting , and a review of post-hearing appeals, after the record of such hearing; and
 (iii)by adding at the end the following: The employer shall provide the Board a list consisting only of employee names and home addresses of all eligible voters within 7 days following the Board’s determination of the appropriate unit or following any agreement between the employer and the labor organization regarding the eligible voters. Any employee may elect to be excluded from such list by notifying the employer in writing.; and
 (B)by adding at the end the following:

 (6)(A)No election shall take place after the filing of any petition unless and until—
 (i)a hearing is conducted before a qualified hearing officer in accordance with due process on any and all material, factual issues regarding jurisdiction, statutory coverage, appropriate unit, unit inclusion or exclusion, or eligibility of individuals; and
 (ii)the issues are resolved by a Regional Director, subject to appeal and review, or by the Board.
 (B)No election results shall be final and no labor organization shall be certified as the bargaining representative of the employees in an appropriate unit unless and until the Board has ruled on—
 (i)each pre-election issue not resolved before the election; and
 (ii)the Board conducts a hearing in accordance with due process and resolves each issue pertaining to the conduct or results of the election..
 (d)PenaltiesSection 10 of the National Labor Relations Act (29 U.S.C. 160) is amended by inserting after the second sentence following the second proviso, the following: Any labor organization found to have interfered with, restrained, or coerced employees in the exercise of their rights under section 7 to form or join a labor organization or to refrain therefrom, including the filing of a decertification petition, shall be liable for wages lost and labor organization dues or fees collected unlawfully, if any, and an additional amount as liquidated damages. Any labor organization found to have interfered with, restrained, or coerced an employee in connection with the filing of a decertification petition shall be prohibited from filing objections to an election held pursuant to such petition..
			3.Amendments to
			 the Labor-Management Reporting and Disclosure Act of 1959
 (a)DefinitionSection 3(k) of the Labor-Management Reporting and Disclosure Act of 1959 (29 U.S.C. 402(k)) is amended by striking ballot, voting machine, or otherwise, but and inserting paper ballot, voting machine, or electronic ballot cast in the privacy of a voting booth and.
			(b)Rights of
 membersSection 101(a)(1) of the Labor-Management Reporting and Disclosure Act of 1959 (29 U.S.C. 411(a)(1)) is amended by adding at the end the following: Every employee in a bargaining unit represented by a labor organization, regardless of membership status in the labor organization, shall have the same right as members to vote by secret ballot regarding whether to ratify a collective bargaining agreement with, or to engage in a strike or refusal to work of any kind against, their employer..
			(c)Right not To
 subsidize labor organization nonrepresentational activitiesTitle I of the Labor-Management Reporting and Disclosure Act of 1959 (29 U.S.C. 411 et seq.) is amended by adding at the end the following:

					106.Right not to
 subsidize labor organization nonrepresentational activitiesNo employee’s labor organization dues, fees, or assessments or other contributions shall be used or contributed to any person, organization, or entity for any purpose not directly related to the labor organization’s collective bargaining or contract administration functions on behalf of the represented unit employee unless the employee member, or nonmember required to make such payments as a condition of employment, authorizes such expenditure in writing, after a notice period of not less than 35 days. An initial authorization provided by an employee under the preceding sentence shall expire not later than 1 year after the date on which such authorization is signed by the employee. There shall be no automatic renewal of an authorization under this section..
 (d)LimitationsSection 101(a) of the Labor-Management Reporting and Disclosure Act of 1959 (29 U.S.C. 411(a)) is amended by adding at the end the following:

 (6)LimitationNo strike shall commence without the consent of a majority of all represented unit employees affected, determined by a secret ballot vote conducted by a neutral, private organization chosen by agreement between the employer and the labor organization involved. In any case in which the employer involved has made an offer for a collective bargaining agreement, the represented unit employees involved shall be provided the opportunity for a secret ballot vote on such offer prior to any vote relating to the commencement of a strike. The cost of any such election shall be borne by the labor organization..
			(e)Reporting by
 labor organizationsSection 201(c) of the Labor-Management Reporting and Disclosure Act of 1959 (29 U.S.C. 431(c)) is amended—
 (1)by inserting and the independently verified annual audit report of the labor organization’s financial condition and operations after required to be contained in such report;
 (2)by inserting and represented unit nonmembers after members;
 (3)by inserting and represented unit nonmember after any member;
 (4)by inserting and represented unit nonmember after such member; (5)by striking and after any books, records,; and
 (6)by inserting , and independently verified annual audit report of the labor organization’s financial condition and operations before necessary to verify such report..
				(f)Acts of
 violenceSection 610 of the Labor-Management Reporting and Disclosure Act of 1959 (29 U.S.C. 530) is amended—
 (1)by striking It shall and inserting (a) It shall; and
 (2)by adding at the end the following:

 (b)It shall be unlawful for any person, through the use of force or violence, or threat of the use of force or violence, to restrain, coerce, or intimidate, or attempt to restrain, coerce, or intimidate any person for the purpose of obtaining from any person any right to represent employees or any compensation or other term or condition of employment. Any person who willfully violates this subsection shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.
 (c)The lawfulness of a labor organization’s objectives shall not remove or exempt from the definition of extortion, as defined in section 1951(b)(2) of title 18, United States Code, conduct by the labor organization or its agents that otherwise constitutes extortion as defined in such section..


		I
		112th CONGRESS
		2d Session
		H. R. 5368
		IN THE HOUSE OF REPRESENTATIVES

			May 7, 2012
			Mr. Duncan of South
			 Carolina introduced the following bill; which was referred to the
			 Committee on Ways and
			 Means

		A BILL
		To reduce temporarily the rate of duty on certain
		  machinery for molding unvulcanized rubber for tubeless radial
		  tires.

		1.Certain machinery for molding
			 unvulcanized rubber for tubeless radial tires
			(a)In
			 generalSubchapter II of chapter 99 of the Harmonized Tariff
			 Schedule of the United States is amended by inserting in numerical sequence the
			 following new heading:

								9902.01.00Numerically controlled machinery for molding or otherwise
						forming uncured, unvulcanized rubber to be used in production of tubeless
						radial tires designed for off-the-highway earthmover (haulage) use, with
						section widths measuring 68.86 cm or more but not greater than 149.9 cm and rim
						diameters measuring 124.4 cm but not greater than 160.02 cm, such tires of a
						type classified in subheading 4011.94.40, and parts of such machinery (provided
						for in subheading 8477.90.85)FreeNo changeNo changeOn or before 12/31/2015

					.
			(b)Effective
			 dateThe amendment made by subsection (a) applies to articles
			 entered, or withdrawn from warehouse for consumption, on or after the 15th day
			 after the date of the enactment of this Act.


		II
		111th CONGRESS
		1st Session
		S. 1213
		IN THE SENATE OF THE UNITED STATES

			June 9, 2009
			Mr. Baucus (for himself
			 and Mr. Conrad) introduced the following
			 bill; which was read twice and referred to the
			 Committee on
			 Finance

		A BILL
		To amend title XI of the Social Security Act to provide
		  for the conduct of comparative effectiveness research and to amend the Internal
		  Revenue Code of 1986 to establish a Patient-Centered Outcomes Research Trust
		  Fund, and for other purposes.

		1.Short
			 titleThis Act may be cited as
			 the Patient-Centered Outcomes Research
			 Act of 2009.
		2.Comparative
			 effectiveness research
			(a)In
			 generalTitle XI of the
			 Social Security Act (42 U.S.C. 1301 et seq.) is amended by adding at the end
			 the following new part:

					DComparative
				effectiveness research
						1181.Comparative effectiveness
		  research(a)DefinitionsIn
				this section:
								(1)BoardThe
				term Board means the Board of Governors established under
				subsection (f).
								(2)Comparative
				clinical effectiveness research
									(A)In
				generalThe term comparative clinical effectiveness
				research means research evaluating and comparing the clinical
				effectiveness, risks, and benefits of 2 or more medical treatments, services,
				and items described in subparagraph (B).
									(B)Medical
				treatments, services, and items describedThe medical treatments,
				services, and items described in this subparagraph are health care
				interventions, protocols for treatment, care management, and delivery,
				procedures, medical devices, diagnostic tools, pharmaceuticals (including drugs
				and biologicals), and any other strategies or items being used in the
				treatment, management, and diagnosis of, or prevention of illness or injury in,
				patients.
									(3)Comparative
				effectiveness researchThe term comparative effectiveness
				research means research evaluating and comparing the implications and
				outcomes of 2 or more health care strategies to address a particular medical
				condition for specific patient populations.
								(4)Conflicts of
				interestThe term conflicts of interest means
				associations, including financial and personal, that may be reasonably assumed
				to have the potential to bias an individual’s decisions in matters related to
				the Institute or the conduct of activities under this section.
								(5)InstituteThe
				term Institute means the Patient-Centered Outcomes Research
				Institute established under subsection (b)(1).
								(b)Patient-Centered
				Outcomes Research Institute
								(1)EstablishmentThere is authorized to be established a
				nonprofit corporation, to be known as the Patient-Centered Outcomes
				Research Institute which is neither an agency nor establishment of the
				United States Government.
								(2)Application of
				provisionsThe Institute
				shall be subject to the provisions of this section, and, to the extent
				consistent with this section, to the District of Columbia Nonprofit Corporation
				Act.
								(3)Funding of comparative effectiveness
				researchFor fiscal year 2010
				and each subsequent fiscal year, amounts in the Patient-Centered Outcomes
				Research Trust Fund (referred to in this section as the PCORTF)
				under section
				9511 of the Internal Revenue Code of 1986 shall be available,
				without further appropriation, to the Institute to carry out this
				section.
								(c)PurposeThe purpose of the Institute is to assist
				patients, clinicians, purchasers, and policy makers in making informed health
				decisions by advancing the quality and relevance of evidence concerning the
				manner in which diseases, disorders, and other health conditions can
				effectively and appropriately be prevented, diagnosed, treated, monitored, and
				managed through research and evidence synthesis that considers variations in
				patient subpopulations, and the dissemination of research findings with respect
				to the relative clinical outcomes, clinical effectiveness, and appropriateness
				of the medical treatments, services, and items described in subsection
				(a)(2)(B).
							(d)Duties
								(1)Identifying
				research priorities and establishing research project agenda
									(A)Identifying
				research prioritiesThe Institute shall identify national
				priorities for comparative clinical effectiveness research, taking into account
				factors, including—
										(i)disease
				incidence, prevalence, and burden in the United States;
										(ii)evidence gaps in
				terms of clinical outcomes;
										(iii)practice
				variations, including variations in delivery and outcomes by geography,
				treatment site, provider type, and patient subgroup;
										(iv)the potential
				for new evidence concerning certain categories of health care services or
				treatments to improve patient health and well-being, and the quality of
				care;
										(v)the effect or
				potential for an effect on health expenditures associated with a health
				condition or the use of a particular medical treatment, service, or
				item;
										(vi)the effect or
				potential for an effect on patient needs, outcomes, and preferences, including
				quality of life; and
										(vii)the relevance
				to assisting patients and clinicians in making informed health
				decisions.
										(B)Establishing
				research project agenda
										(i)In
				generalThe Institute shall establish and update a research
				project agenda for comparative clinical effectiveness research to address the
				priorities identified under subparagraph (A), taking into consideration the
				types of such research that might address each priority and the relative value
				(determined based on the cost of conducting such research compared to the
				potential usefulness of the information produced by such research) associated
				with the different types of research, and such other factors as the Institute
				determines appropriate.
										(ii)Consideration
				of need to conduct a systematic reviewIn establishing and
				updating the research project agenda under clause (i), the Institute shall
				consider the need to conduct a systematic review of existing research before
				providing for the conduct of new research under paragraph (2)(A).
										(2)Carrying out
				research project agenda
									(A)Comparative
				clinical effectiveness researchIn carrying out the research
				project agenda established under paragraph (1)(B), the Institute shall provide
				for the conduct of appropriate research and the synthesis of evidence, in
				accordance with the methodological standards adopted under paragraph (10),
				using methods, including the following:
										(i)Systematic
				reviews and assessments of existing research and evidence.
										(ii)Primary
				research, such as randomized clinical trials, molecularly informed trials, and
				observational studies.
										(iii)Any other
				methodologies recommended by the methodology committee established under
				paragraph (7) that are adopted by the Board under paragraph (10).
										(B)Contracts for
				the management and conduct of research
										(i)In
				generalThe Institute may enter into contracts for the management
				and conduct of research in accordance with the research project agenda
				established under paragraph (1)(B) with the following:
											(I)Agencies and
				instrumentalities of the Federal Government that have experience in conducting
				comparative clinical effectiveness research, such as the Agency for Healthcare
				Research and Quality, to the extent that such contracts are authorized under
				the governing statutes of such agencies and instrumentalities.
											(II)Appropriate
				private sector research or study-conducting entities that have demonstrated the
				experience and capacity to achieve the goals of comparative effectiveness
				research.
											(ii)Conditions for
				contractsA contract entered into under this subparagraph shall
				require that the agency, instrumentality, or other entity—
											(I)abide by the
				transparency and conflicts of interest requirements that apply to the Institute
				with respect to the research managed or conducted under such contract;
											(II)comply with the
				methodological standards adopted under paragraph (10) with respect to such
				research;
											(III)take into
				consideration public comments on the study design that are transmitted by the
				Institute to the agency, instrumentality, or other entity under subsection
				(i)(1)(B) during the finalization of the study design and transmit responses to
				such comments to the Institute, which will publish such comments, responses,
				and finalized study design in accordance with subsection (i)(3)(A)(iii) prior
				to the conduct of such research; and
											(IV)in the case
				where the agency, instrumentality, or other entity is managing or conducting a
				comparative effectiveness research study for a rare disease, consult with the
				expert advisory panel for rare disease appointed under paragraph (5)(A)(iii)
				with respect to such research study.
											(iii)Coverage of
				copayments or coinsuranceA contract entered into under this
				subparagraph may allow for the coverage of copayments or co-insurance, or allow
				for other appropriate measures, to the extent that such coverage or other
				measures are necessary to preserve the validity of a research project, such as
				in the case where the research project must be blinded.
										(C)Review and
				update of evidenceThe Institute shall review and update evidence
				on a periodic basis, in order to take into account new research, evolving
				evidence, advances in medical technology, and changes in the standard of care
				as they become available, as appropriate.
									(D)Taking into
				account potential differencesResearch shall—
										(i)be designed, as
				appropriate, to take into account the potential for differences in the
				effectiveness of health care treatments, services, and items as used with
				various subpopulations, such as racial and ethnic minorities, women, age, and
				groups of individuals with different comorbidities, genetic and molecular
				sub-types, or quality of life preferences; and
										(ii)include members
				of such subpopulations as subjects in the research as feasible and
				appropriate.
										(E)Differences in
				treatment modalitiesResearch shall be designed, as appropriate,
				to take into account different characteristics of treatment modalities that may
				affect research outcomes, such as the phase of the treatment modality in the
				innovation cycle and the impact of the skill of the operator of the treatment
				modality.
									(3)Study and
				report on feasibility of conducting research in-house
									(A)StudyThe
				Institute shall conduct a study on the feasibility of conducting research
				in-house.
									(B)ReportNot
				later than 5 years after the date of enactment of this section, the Institute
				shall submit a report to Congress containing the results of the study conducted
				under subparagraph (A).
									(4)Data
				collection
									(A)In
				generalThe Secretary shall, with appropriate safeguards for
				privacy, make available to the Institute such data collected by the Centers for
				Medicare & Medicaid Services under the programs under titles XVIII, XIX,
				and XXI as the Institute may require to carry out this section. The Institute
				may also request and, if such request is granted, obtain data from Federal,
				State, or private entities, including data from clinical databases and
				registries.
									(B)Use of
				dataThe Institute shall only use data provided to the Institute
				under subparagraph (A) in accordance with laws and regulations governing the
				release and use of such data, including applicable confidentiality and privacy
				standards.
									(5)Appointing
				expert advisory panels
									(A)Appointment
										(i)In
				generalThe Institute shall, as appropriate, appoint expert
				advisory panels to assist in identifying research priorities and establishing
				the research project agenda under paragraph (1). Panels shall advise the
				Institute in matters such as identifying gaps in and updating medical evidence
				in order to ensure that the information produced from such research is
				clinically relevant to decisions made by clinicians and patients at the point
				of care.
										(ii)Expert
				advisory panels for primary researchThe Institute shall appoint
				expert advisory panels in carrying out the research project agenda under
				paragraph (2)(A)(ii). Such expert advisory panels shall, upon request, advise
				the Institute and the agency, instrumentality, or entity conducting the
				research on the research question involved and the research design or protocol,
				including the appropriate comparator technologies, important patient subgroups,
				and other parameters of the research, as necessary. Upon the request of such
				agency, instrumentality, or entity, such panels shall be available as a
				resource for technical questions that may arise during the conduct of such
				research.
										(iii)Expert
				advisory panel for rare diseaseIn the case of a comparative
				effectiveness research study for rare disease, the Institute shall appoint an
				expert advisory panel for purposes of assisting in the design of such research
				study and determining the relative value and feasibility of conducting such
				research study.
										(B)Composition
										(i)In
				generalAn expert advisory panel appointed under subparagraph (A)
				shall include individuals who have experience in the relevant topic, project,
				or category for which the panel is established, including—
											(I)practicing and
				research clinicians (including relevant specialists and subspecialists),
				patients, and representatives of patients; and
											(II)experts in
				scientific and health services research, health services delivery, and
				evidence-based medicine.
											(ii)Inclusion of
				representatives of manufacturers of medical technologyAn expert
				advisory panel appointed under subparagraph (A) may include a representative of
				each manufacturer of each medical technology that is included under the
				relevant topic, project, or category for which the panel is established.
										(6)Supporting
				Patient and consumer RepresentativesThe Institute shall provide
				support and resources to help patient and consumer representatives on the Board
				and expert advisory panels appointed by the Institute under paragraph (5) to
				effectively participate in technical discussions regarding complex research
				topics. Such support shall include initial and continuing education to
				facilitate effective engagement in activities undertaken by the Institute and
				may include regular and ongoing opportunities for patient and consumer
				representatives to interact with each other and to exchange information and
				support regarding their involvement in the Institute’s activities. The
				Institute shall provide per diem and other appropriate compensation to patient
				and consumer representatives for their time spent participating in the
				activities of the Institute under this paragraph.
								(7)Establishing
				methodology committee
									(A)In
				generalThe Institute shall establish a standing methodology
				committee to carry out the functions described in subparagraph (C).
									(B)Appointment and
				compositionThe methodology committee established under
				subparagraph (A) shall be composed of not more than 17 members appointed by the
				Comptroller General of the United States. Members appointed to the methodology
				committee shall be experts in their scientific field, such as health services
				research, clinical research, comparative effectiveness research, biostatistics,
				genomics, and research methodologies. Stakeholders with such expertise may be
				appointed to the methodology committee.
									(C)FunctionsSubject
				to subparagraph (D), the methodology committee shall work to develop and
				improve the science and methods of comparative effectiveness research by
				undertaking, directly or through subcontract, the following activities:
										(i)Not later than 2
				years after the date on which the members of the methodology committee are
				appointed under subparagraph (B), developing and periodically updating the
				following:
											(I)Establish and
				maintain methodological standards for comparative clinical effectiveness
				research on major categories of interventions to prevent, diagnose, or treat a
				clinical condition or improve the delivery of care. Such methodological
				standards shall provide specific criteria for internal validity,
				generalizability, feasibility, and timeliness of such research and for clinical
				outcomes measures, risk adjustment, and other relevant aspects of research and
				assessment with respect to the design of such research. Any methodological
				standards developed and updated under this subclause shall be scientifically
				based and include methods by which new information, data, or advances in
				technology are considered and incorporated into ongoing research projects by
				the Institute, as appropriate. The process for developing and updating such
				standards shall include input from relevant experts, stakeholders, and decision
				makers, and shall provide opportunities for public comment. Such standards
				shall also include methods by which patient subpopulations can be accounted for
				and evaluated in different types of research. As appropriate, such standards
				shall build on existing work on methodological standards for defined categories
				of health interventions and for each of the major categories of comparative
				effectiveness research methods (determined as of the date of enactment of the
				Patient-Centered Outcomes Research Act of
				2009).
											(II)A translation
				table that is designed to provide guidance and act as a reference for the Board
				to determine research methods that are most likely to address each specific
				comparative clinical effectiveness research question.
											(ii)Not later than 3
				years after such date, examining the following:
											(I)Methods by which
				various aspects of the health care delivery system (such as benefit design and
				performance, and health services organization, management, information
				communication, and delivery) could be assessed and compared for their relative
				effectiveness, benefits, risks, advantages, and disadvantages in a
				scientifically valid and standardized way.
											(II)Methods by which
				efficiency and value (including the full range of harms and benefits, such as
				quality of life) could be assessed in a scientifically valid and standardized
				way.
											(D)Consultation
				and conduct of examinations
										(i)In
				generalSubject to clause (iii), in undertaking the activities
				described in subparagraph (C), the methodology committee shall—
											(I)consult or
				contract with 1 or more of the entities described in clause (ii); and
											(II)consult with
				stakeholders and other entities knowledgeable in relevant fields, as
				appropriate.
											(ii)Entities
				describedThe following entities are described in this
				clause:
											(I)The Institute of
				Medicine of the National Academies.
											(II)The Agency for
				Healthcare Research and Quality.
											(III)The National
				Institutes of Health.
											(IV)Academic,
				non-profit, or other private entities with relevant expertise.
											(iii)Conduct of
				examinationsThe methodology committee shall contract with the
				Institute of Medicine of the National Academies for the conduct of the
				examinations described in subclauses (I) and (II) of subparagraph
				(C)(ii).
										(E)ReportsThe
				methodology committee shall submit reports to the Board on the committee’s
				performance of the functions described in subparagraph (C). Reports submitted
				under the preceding sentence with respect to the functions described in clause
				(i) of such subparagraph shall contain recommendations—
										(i)for the Institute
				to adopt methodological standards developed and updated by the methodology
				committee under such subparagraph; and
										(ii)for such other
				action as the methodology committee determines is necessary to comply with such
				methodological standards.
										(8)Providing for a
				peer-review process for primary research
									(A)In
				generalThe Institute shall ensure that there is a process for
				peer review of the research conducted under paragraph (2)(A)(ii). Under such
				process—
										(i)evidence from
				research conducted under such paragraph shall be reviewed to assess scientific
				integrity and adherence to methodological standards adopted under paragraph
				(10); and
										(ii)a list of the
				names of individuals contributing to any peer-review process during the
				preceding year or years shall be made public and included in annual reports in
				accordance with paragraph (12)(D).
										(B)CompositionSuch
				peer-review process shall be designed in a manner so as to avoid bias and
				conflicts of interest on the part of the reviewers and shall be composed of
				experts in the scientific field relevant to the research under review.
									(C)Use of existing
				processes
										(i)Processes of
				another entityIn the case where the Institute enters into a
				contract or other agreement with another entity for the conduct or management
				of research under this section, the Institute may utilize the peer-review
				process of such entity if such process meets the requirements under
				subparagraphs (A) and (B).
										(ii)Processes of
				appropriate medical journalsThe Institute may utilize the
				peer-review process of appropriate medical journals if such process meets the
				requirements under subparagraphs (A) and (B).
										(9)Dissemination
				of research findings
									(A)In
				generalThe Institute shall disseminate research findings to
				clinicians, patients, and the general public in accordance with the
				dissemination protocols and strategies adopted under paragraph (10). Research
				findings disseminated—
										(i)shall convey
				findings of research so that they are comprehensible and useful to patients and
				providers in making health care decisions;
										(ii)shall discuss
				findings and other considerations specific to certain subpopulations, risk
				factors, and comorbidities, as appropriate;
										(iii)shall include
				considerations such as limitations of research and what further research may be
				needed, as appropriate;
										(iv)shall not
				include practice guidelines, coverage recommendations, or policy
				recommendations; and
										(v)shall not include
				any data the dissemination of which would violate the privacy of research
				participants or violate any confidentiality agreements made with respect to the
				use of data under this section.
										(B)Dissemination
				protocols and strategiesThe Institute shall develop protocols
				and strategies for the appropriate dissemination of research findings in order
				to ensure effective communication of such findings and the use and
				incorporation of such findings into relevant activities for the purpose of
				informing higher quality and more effective and timely decisions regarding
				medical treatments, services, and items. In developing and adopting such
				protocols and strategies, the Institute shall consult with stakeholders,
				including practicing clinicians and patients, concerning the types of
				dissemination that will be most useful to the end users of the information and
				may provide for the utilization of multiple formats for conveying findings to
				different audiences.
									(C)Definition of
				research findingsIn this paragraph, the term research
				findings means the results of a study or assessment.
									(10)AdoptionSubject
				to subsection (i)(1)(A)(i), the Institute shall adopt the national priorities
				identified under paragraph (1)(A), the research project agenda established
				under paragraph (1)(B), the methodological standards developed and updated by
				the methodology committee under paragraph (7)(C)(i), any peer-review process
				provided under paragraph (8), and dissemination protocols and strategies
				developed under paragraph (9)(B) by majority vote. In the case where the
				Institute does not adopt such national priorities, research project agenda,
				methodological standards, peer-review process, or dissemination protocols and
				strategies in accordance with the preceding sentence, the national priorities,
				research project agenda, methodological standards, peer-review process, or
				dissemination protocols and strategies shall be referred to the appropriate
				staff or entity within the Institute (or, in the case of the methodological
				standards, the methodology committee) for further review.
								(11)Coordination
				of research and resources and building capacity for research
									(A)Coordination of
				research and resourcesThe Institute shall coordinate research
				conducted, commissioned, or otherwise funded under this section with
				comparative clinical effectiveness and other relevant research and related
				efforts conducted by public and private agencies and organizations in order to
				ensure the most efficient use of the Institute's resources and that research is
				not duplicated unnecessarily.
									(B)Building
				capacity for researchThe Institute may build capacity for
				comparative clinical effectiveness research and methodologies, including
				research training and development of data resources (such as clinical
				registries), through appropriate activities, including using up to 20 percent
				of the amounts appropriated or credited to the PCORTF under section 9511(b) of
				the Internal Revenue Code of 1986 with respect to a fiscal year to fund
				extramural efforts of organizations such as the Cochrane Collaboration (or a
				successor organization) and other organizations that develop and maintain a
				data network to collect, link, and analyze data on outcomes and effectiveness
				from multiple sources, including electronic health records.
									(C)Inclusion in
				annual reportsThe Institute shall report on any coordination and
				capacity building conducted under this paragraph in annual reports in
				accordance with paragraph (12)(E).
									(12)Annual
				reportsThe Institute shall submit an annual report to Congress
				and the President, and shall make the annual report available to the public.
				Such report shall contain—
									(A)a description of
				the activities conducted under this section during the preceding year,
				including the use of amounts appropriated or credited to the PCORTF under
				section
				9511(b) of the Internal Revenue Code of 1986 to carry out this
				section, research projects completed and underway, and a summary of the
				findings of such projects;
									(B)the research
				project agenda and budget of the Institute for the following year;
									(C)a description of
				research priorities identified under paragraph (1)(A), dissemination protocols
				and strategies developed by the Institute under paragraph (9)(B), and
				methodological standards developed and updated by the methodology committee
				under paragraph (7)(C)(i) that are adopted under paragraph (10) during the
				preceding year;
									(D)the names of
				individuals contributing to any peer-review process provided under paragraph
				(8) during the preceding year or years, in a manner such that those individuals
				cannot be identified with a particular research project; and
									(E)a description of
				efforts by the Institute under paragraph (11) to—
										(i)coordinate the
				research conducted, commissioned, or otherwise funded under this section and
				the resources of the Institute with research and related efforts conducted by
				other private and public entities; and
										(ii)build capacity
				for comparative clinical effectiveness research and other relevant research and
				related efforts through appropriate activities.
										(F)any other
				relevant information (including information on the membership of the Board,
				expert advisory panels appointed under paragraph (5), the methodology committee
				established under paragraph (7), and the executive staff of the Institute, any
				conflicts of interest with respect to the members of such Board, expert
				advisory panels, and methodology committee, or with respect to any individuals
				selected for employment as executive staff of the Institute, and any bylaws
				adopted by the Board during the preceding year).
									(e)Administration
								(1)In
				generalSubject to paragraph (2), the Board shall carry out the
				duties of the Institute.
								(2)Nondelegable
				dutiesThe activities described in subsections (b)(3)(D), (d)(1),
				and (d)(10) are nondelegable.
								(f)Board of
				governors
								(1)In
				generalThe Institute shall
				have a Board of Governors, which shall consist of the following members:
									(A)The Secretary of
				Health and Human Services (or the Secretary's designee).
									(B)The Director of
				the Agency for Healthcare Research and Quality (or the Director’s
				designee).
									(C)The Director of
				the National Institutes of Health (or the Director’s designee).
									(D)18 members
				appointed by the Comptroller General of the United States not later than 6
				months after the date of enactment of this section, as follows:
										(i)3
				members representing patients and health care consumers.
										(ii)3 members
				representing practicing physicians, including surgeons.
										(iii)3 members
				representing agencies that administer public programs, as follows:
											(I)1 member
				representing the Centers for Medicare & Medicaid Services who has
				experience in administering the program under title XVIII.
											(II)1 member
				representing agencies that administer State health programs (who may represent
				the Centers for Medicare & Medicaid Services and have experience in
				administering the program under title XIX or the program under title XXI or be
				a governor of a State).
											(III)1 member
				representing agencies that administer other Federal health programs (such as a
				health program of the Department of Defense under chapter 55 of title 10,
				United States Code, the Federal employees health benefits program under chapter
				89 of title 5 of such Code, a health program of the Department of Veterans
				Affairs under chapter 17 of title 38 of such Code, or a medical care program of
				the Indian Health Service or of a tribal organization).
											(iv)3 members
				representing private payers, of whom at least 1 member shall represent health
				insurance issuers and at least 1 member shall represent employers who
				self-insure employee benefits.
										(v)3
				members representing pharmaceutical, device, and diagnostic manufacturers or
				developers.
										(vi)1 member
				representing nonprofit organizations involved in health services
				research.
										(vii)1 member
				representing organizations that focus on quality measurement and improvement or
				decision support.
										(viii)1 member
				representing independent health services researchers.
										(2)Qualifications
									(A)Diverse
				representation of perspectivesThe Board shall represent a broad
				range of perspectives and collectively have scientific expertise in clinical
				health sciences research, including epidemiology, decisions sciences, health
				economics, and statistics.
									(B)Conflicts of
				interest
										(i)In
				generalIn appointing members
				of the Board under paragraph (1)(D), the Comptroller General of the United
				States shall take into consideration any conflicts of interest of potential
				appointees. Any conflicts of interest of members appointed to the Board under
				paragraph (1) shall be disclosed in accordance with subsection
				(i)(4)(B).
										(ii)RecusalA member of the Board shall be recused from
				participating with respect to a particular research project or other matter
				considered by the Board in carrying out its research project agenda under
				subsection (d)(2) in the case where the member (or an immediate family member
				of such member) has a financial or personal interest directly related to the
				research project or the matter that could affect or be affected by such
				participation.
										(3)Terms
									(A)In
				generalA member of the Board
				appointed under paragraph (1)(D) shall be appointed for a term of 6 years,
				except with respect to the members first appointed under such paragraph—
										(i)6
				shall be appointed for a term of 6 years;
										(ii)6 shall be
				appointed for a term of 4 years; and
										(iii)6 shall be
				appointed for a term of 2 years.
										(B)LimitationNo
				individual shall be appointed to the Board under paragraph (1)(D) for more than
				2 terms.
									(C)Expiration of
				termAny member of the Board whose term has expired may serve
				until such member’s successor has taken office, or until the end of the
				calendar year in which such member’s term has expired, whichever is
				earlier.
									(D)Vacancies
										(i)In
				generalAny member appointed to fill a vacancy prior to the
				expiration of the term for which such member’s predecessor was appointed shall
				be appointed for the remainder of such term.
										(ii)Vacancies not
				to affect power of boardA vacancy on the Board shall not affect
				its powers, but shall be filled in the same manner as the original appointment
				was made.
										(4)Chairperson and
				vice-chairperson
									(A)In
				generalThe Comptroller
				General of the United States shall designate a Chairperson and Vice-Chairperson
				of the Board from among the members of the Board appointed under paragraph
				(1)(D).
									(B)TermThe
				members so designated shall serve as Chairperson and Vice-Chairperson of the
				Board for a period of 3 years.
									(5)Compensation
									(A)In
				generalA member of the Board
				shall be entitled to compensation at the per diem equivalent of the rate
				provided for level IV of the Executive Schedule under section 5315 of title 5,
				United States Code.
									(B)Travel
				expensesWhile away from home
				or regular place of business in the performance of duties for the Board, each
				member of the Board may receive reasonable travel, subsistence, and other
				necessary expenses.
									(6)Director and
				staff; experts and consultantsThe Board may—
									(A)employ and fix
				the compensation of an executive director and such other personnel as may be
				necessary to carry out the duties of the Institute;
									(B)seek such
				assistance and support as may be required in the performance of the duties of
				the Institute from appropriate departments and agencies of the Federal
				Government;
									(C)enter into
				contracts or make other arrangements and make such payments as may be necessary
				for performance of the duties of the Institute;
									(D)provide travel,
				subsistence, and per diem compensation for individuals performing the duties of
				the Institute, including members of any expert advisory panel appointed under
				subsection (d)(5), members of the methodology committee established under
				subsection (d)(7), and individuals selected to contribute to any peer-review
				process under subsection (d)(8); and
									(E)prescribe such
				rules, regulations, and bylaws as the Board determines necessary with respect
				to the internal organization and operation of the Institute.
									(7)Meetings and
				hearingsThe Board shall meet and hold hearings at the call of
				the Chairperson or a majority of its members. In the case where the Board is
				meeting on matters not related to personnel, Board meetings shall be open to
				the public and advertised through public notice at least 7 days prior to the
				meeting.
								(8)QuorumA
				majority of the members of the Board shall constitute a quorum for purposes of
				conducting the duties of the Institute, but a lesser number of members may meet
				and hold hearings.
								(g)Financial
				oversight
								(1)Contract for
				auditThe Institute shall provide for the conduct of financial
				audits of the Institute on an annual basis by a private entity with expertise
				in conducting financial audits.
								(2)Review of audit
				and report to CongressThe Comptroller General of the United
				States shall—
									(A)review the
				results of the audits conducted under paragraph (1); and
									(B)submit a report
				to Congress containing the results of such audits and review.
									(h)Governmental
				oversight
								(1)Review and
				reports
									(A)In
				generalThe Comptroller General of the United States shall review
				the following:
										(i)Processes
				established by the Institute, including those with respect to the
				identification of research priorities under subsection (d)(1)(A) and the
				conduct of research projects under this section. Such review shall determine
				whether information produced by such research projects—
											(I)is objective and
				credible;
											(II)is produced in a
				manner consistent with the requirements under this section; and
											(III)is developed
				through a transparent process.
											(ii)The overall
				effect of the Institute and the effectiveness of activities conducted under
				this section, including an assessment of—
											(I)the utilization
				of the findings of research conducted under this section by health care
				decision makers; and
											(II)the effect of
				the Institute and such activities on innovation and on the health economy of
				the United States.
											(B)ReportsNot
				later than 5 years after the date of enactment of this section, and not less
				frequently than every 5 years thereafter, the Comptroller General of the United
				States shall submit a report to Congress containing the results of the review
				conducted under subparagraph (A), together with recommendations for such
				legislation and administrative action as the Comptroller General determines
				appropriate.
									(2)Funding
				assessment
									(A)In
				generalThe Comptroller General of the United States shall assess
				the adequacy and use of funding for the Institute and activities conducted
				under this section under the PCORTF under section 9511 of the Internal Revenue
				Code of 1986. Such assessment shall include a determination as to whether,
				based on the utilization of findings by public and private payers, each of the
				following are appropriate sources of funding for the Institute, including a
				determination of whether such sources of funding should be continued or
				adjusted, or whether other sources of funding not described in clauses (i)
				through (iii) would be appropriate:
										(i)The transfer of
				funds from the Federal Hospital Insurance Trust Fund under section 1817 and the
				Federal Supplementary Medical Insurance Trust Fund under section 1841 to the
				PCORTF under section 1183.
										(ii)The amounts
				appropriated under subparagraphs (A), (B), (C), (D)(ii), and (E)(ii) of
				subsection (b)(1) of such section 9511.
										(iii)Private sector
				contributions under subparagraphs (D)(i) and (E)(i) of such subsection
				(b)(1).
										(B)ReportNot
				later than 8 years after the date of enactment of this section, the Comptroller
				General of the United States shall submit a report to Congress containing the
				results of the assessment conducted under subparagraph (A), together with
				recommendations for such legislation and administrative action as the
				Comptroller General determines appropriate.
									(i)Ensuring
				transparency, credibility, and accessThe Institute shall
				establish procedures to ensure that the following requirements for ensuring
				transparency, credibility, and access are met:
								(1)Public comment
				periods
									(A)In
				generalThe Institute shall provide for a public comment period
				of not less than 45 and not more than 60 days at the following times:
										(i)Prior to the
				adoption of the national priorities identified under subsection (d)(1)(A), the
				research project agenda established under subsection (d)(1)(B), the
				methodological standards developed and updated by the methodology committee
				under subsection (d)(7)(C)(i), the peer-review process generally provided under
				subsection (d)(8), and dissemination protocols and strategies developed by the
				Institute under subsection (d)(9)(B) in accordance with subsection
				(d)(10).
										(ii)Prior to the
				finalization of individual study designs.
										(iii)After the
				release of draft findings with respect to a systematic review and assessment of
				existing research and evidence under subsection (d)(2)(A)(i).
										(B)Transmission of
				public comments on study designThe Institute shall transmit
				public comments submitted during the public comment period described in
				subparagraph (A)(ii) to the entity conducting research with respect to which
				the individual study design is being finalized.
									(2)Additional
				forumsThe Institute shall, in addition to the public comment
				periods described in paragraph (1)(A), support forums to increase public
				awareness and obtain and incorporate public input and feedback through media
				(such as an Internet website) on the following:
									(A)The
				identification of research priorities, including research topics, and the
				establishment of the research project agenda under subparagraphs (A) and (B),
				respectively, of subsection (d)(1).
									(B)Research
				findings.
									(C)Any other duties,
				activities, or processes the Institute determines appropriate.
									(3)Public
				availabilityThe Institute shall make available to the public and
				disclose through the official public Internet website of the Institute, and
				through other forums and media the Institute determines appropriate, the
				following:
									(A)The process and
				methods for the conduct of research under this section, including—
										(i)the identity of
				the entity conducting such research;
										(ii)any links the
				entity has to industry (including such links that are not directly tied to the
				particular research being conducted under this section);
										(iii)draft study
				designs (including research questions and the finalized study design, together
				with public comments on such study design and responses to such
				comments);
										(iv)research
				protocols (including measures taken, methods of research, methods of analysis,
				research results, and such other information as the Institute determines
				appropriate) with respect to each medical treatment, service, and item
				described in subsection (a)(2)(B);
										(v)any key decisions
				made by the Institute and any appropriate committees of the Institute;
										(vi)the identity of
				investigators conducting such research and any conflicts of interest of such
				investigators; and
										(vii)any progress
				reports the Institute determines appropriate.
										(B)Notice of each of
				the public comment periods under paragraph (1)(A), including deadlines for
				public comments for such periods.
									(C)Public comments
				submitted during each of the public comment periods under paragraph (1)(A),
				including such public comments submitted on draft findings under clause (iii)
				of such paragraph.
									(D)Bylaws,
				processes, and proceedings of the Institute, to the extent practicable and as
				the Institute determines appropriate.
									(E)Not later than 90
				days after receipt by the Institute of a relevant report or research findings,
				appropriate information contained in such report or findings.
									(4)Conflicts of
				interestThe Institute shall—
									(A)in appointing
				members to an expert advisory panel under subsection (d)(5) and the methodology
				committee under subsection (d)(7), and in selecting individuals to contribute
				to any peer-review process under subsection (d)(8) and for employment as
				executive staff of the Institute, take into consideration any conflicts of
				interest of potential appointees, participants, and staff; and
									(B)include a
				description of any such conflicts of interest and conflicts of interest of
				Board members in the annual report under subsection (d)(12), except that, in
				the case of individuals contributing to any such peer review process, such
				description shall be in a manner such that those individuals cannot be
				identified with a particular research project.
									(j)Rules
								(1)GiftsThe
				Institute, or the Board and staff of the Institute acting on behalf of the
				Institute, may not accept gifts, bequeaths, or donations of services or
				property.
								(2)Establishment
				and prohibition on accepting outside funding or contributionsThe
				Institute may not—
									(A)establish a
				corporation other than as provided under this section; or
									(B)accept any funds
				or contributions other than as provided under this part.
									(k)Rules of
				construction
								(1)CoverageNothing
				in this section shall be construed—
									(A)to permit the
				Institute to mandate coverage, reimbursement, or other policies for any public
				or private payer; or
									(B)as preventing the
				Secretary from covering the routine costs of clinical care received by an
				individual entitled to, or enrolled for, benefits under title XVIII, XIX, or
				XXI in the case where such individual is participating in a clinical trial and
				such costs would otherwise be covered under such title with respect to the
				beneficiary.
									(2)Reports and
				findingsNone of the reports submitted under this section or
				research findings disseminated by the Institute shall be construed as mandates,
				guidelines, or recommendations for payment, coverage, or treatment.
								1182.Limitations on use of comparative
		  effectiveness research by the secretaryThe Secretary
				may only use evidence and findings from comparative effectiveness research
				conducted under section 1181 to make a determination regarding coverage under
				title XVIII if such use is through an iterative and transparent process which
				meets the following requirements:
							(1)Stakeholders and
				other individuals have the opportunity to provide informed and relevant
				information with respect to the determination.
							(2)Stakeholders and
				other individuals have the opportunity to review draft proposals of the
				determination and submit public comments with respect to such draft
				proposals.
							(3)In making the
				determination, the Secretary considers—
								(A)all other
				relevant evidence, studies, and research in addition to such comparative
				effectiveness research; and
								(B)evidence and
				research that demonstrates or suggests a benefit of coverage with respect to a
				specific subpopulation of individuals, even if the evidence and findings from
				the comparative effectiveness research demonstrates or suggests that, on
				average, with respect to the general population the benefits of coverage do not
				exceed the harm.
								1183.Trust fund transfers to
		  Patient-Centered Outcomes Research Trust fund(a)In
				generalThe Secretary shall provide for the transfer, from the
				Federal Hospital Insurance Trust Fund under section 1817 and the Federal
				Supplementary Medical Insurance Trust Fund under section 1841, in proportion
				(as estimated by the Secretary) to the total expenditures during such fiscal
				year that are made under title XVIII from the respective trust fund, to the
				Patient-Centered Outcomes Research Trust Fund (referred to in this section as
				the PCORTF) under section 9511 of the Internal Revenue Code of
				1986, the following:
								(1)For fiscal year
				2013, an amount equal to $1 multiplied by the average number of individuals
				entitled to benefits under part A, or enrolled under part B, of title XVIII
				during such fiscal year.
								(2)For each of
				fiscal years 2014, 2015, 2016, 2017, 2018, and 2019, an amount equal to $2
				multiplied by the average number of individuals entitled to benefits under part
				A, or enrolled under part B, of title XVIII during such fiscal year.
								(b)Adjustments for
				increases in health care spendingIn the case of any fiscal year
				beginning after September 30, 2014, the dollar amount in effect under
				subsection (a)(2) for such fiscal year shall be equal to the sum of such dollar
				amount for the previous fiscal year (determined after the application of this
				subsection), plus an amount equal to the product of—
								(1)such dollar
				amount for the previous fiscal year, multiplied by
								(2)the percentage
				increase in the projected per capita amount of National Health Expenditures
				from the calendar year in which the previous fiscal year ends to the calendar
				year in which the fiscal year involved ends, as most recently published by the
				Secretary before the beginning of the fiscal
				year.
								.
			(b)Coordination
			 with provider education and technical assistanceSection 1889(a)
			 of the Social Security Act (42 U.S.C. 1395zz(a)) is amended by inserting
			 and to enhance the understanding of and utilization by providers of
			 services and suppliers of research findings disseminated by the
			 Patient-Centered Outcomes Research Institute established under section
			 1181 before the period at the end.
			(c)Patient-Centered
			 Outcomes Research Trust Fund; financing for trust fund
				(1)Establishment of
			 trust fund
					(A)In
			 generalSubchapter A of chapter 98 of the Internal Revenue Code
			 of 1986 (relating to establishment of trust funds) is amended by adding at the
			 end the following new section:

							9511.Patient-Centered
				Outcomes Research Trust Fund
								(a)Creation of
				Trust FundThere is established in the Treasury of the United
				States a trust fund to be known as the Patient-Centered Outcomes
				Research Trust Fund (hereafter in this section referred to as the
				PCORTF), consisting of such amounts as may be appropriated or
				credited to such Trust Fund as provided in this section and section
				9602(b).
								(b)Transfers to
				Fund
									(1)AppropriationThere
				are hereby appropriated to the Trust Fund the following:
										(A)For fiscal year
				2010, $10,000,000.
										(B)For fiscal year
				2011, $50,000,000.
										(C)For fiscal year
				2012, $150,000,000.
										(D)For fiscal year
				2013—
											(i)an amount
				equivalent to the net revenues received in the Treasury from the fees imposed
				under subchapter B of chapter 34 (relating to fees on health insurance and
				self-insured plans) for such fiscal year; and
											(ii)$150,000,000.
											(E)For each of
				fiscal years 2014, 2015, 2016, 2017, 2018, and 2019—
											(i)an amount
				equivalent to the net revenues received in the Treasury from the fees imposed
				under subchapter B of chapter 34 (relating to fees on health insurance and
				self-insured plans) for such fiscal year; and
											(ii)$150,000,000.
											The
				amounts appropriated under subparagraphs (A), (B), (C), (D)(ii), and (E)(ii)
				shall be transferred from the general fund of the Treasury, from funds not
				otherwise appropriated.(2)Trust fund
				transfersIn addition to the amounts appropriated under paragraph
				(1), there shall be credited to the PCORTF the amounts transferred under
				section 1183 of the Social Security Act.
									(3)American
				Recovery and reinvestment fundsIn addition to the amounts
				appropriated under paragraph (1) and the amounts credited under paragraph (2),
				of amounts appropriated for comparative effectiveness research to be allocated
				at the discretion of the Secretary of Health and Human Services under the
				heading Agency for Healthcare Research and Quality under the heading Department
				of Health and Human Services under title VIII of Division A of the American
				Recovery and Reinvestment Act of 2009 (Public Law 111–5), $10,000,000 shall be
				transferred to the Trust Fund.
									(4)Limitation on
				transfers to PCORTFNo amount may be appropriated or transferred
				to the PCORTF on and after the date of any expenditure from the PCORTF which is
				not an expenditure permitted under this section. The determination of whether
				an expenditure is so permitted shall be made without regard to—
										(A)any provision of
				law which is not contained or referenced in this chapter or in a revenue Act,
				and
										(B)whether such
				provision of law is a subsequently enacted provision or directly or indirectly
				seeks to waive the application of this paragraph.
										(c)TrusteeThe
				Secretary of Health and Human Services shall be a trustee of the PCORTF.
								(d)Expenditures
				From FundAmounts in the PCORTF are available, without further
				appropriation, to the Patient-Centered Outcomes Research Institute established
				by section 2(a) of the Patient-Centered
				Outcomes Research Act of 2009 for carrying out part D of title XI
				of the Social Security Act (as in effect on the date of enactment of the
				Patient-Centered Outcomes Research Act of
				2009).
								(e)Net
				RevenuesFor purposes of this section, the term net
				revenues means the amount estimated by the Secretary of the Treasury
				based on the excess of—
									(1)the fees received
				in the Treasury under subchapter B of chapter 34, over
									(2)the decrease in
				the tax imposed by chapter 1 resulting from the fees imposed by such
				subchapter.
									(f)TerminationNo
				amounts shall be available for expenditure from the PCORTF after September 30,
				2019, and any amounts in such Trust Fund after such date shall be transferred
				to the general fund of the Treasury.
								.

					(B)Clerical
			 AmendmentThe table of sections for subchapter A of chapter 98 of
			 such Code is amended by adding at the end the following new item:

								Sec. 9511. Patient-Centered Outcomes
				Research Trust
				Fund.

							.
					(2)Financing for
			 Fund from fees on insured and self-insured health plans
					(A)General
			 RuleChapter 34 of the Internal
			 Revenue Code of 1986 is amended by adding at the end the following new
			 subchapter:

							BInsured and
				Self-Insured Health Plans

									Sec. 4375. Health insurance.
									Sec. 4376. Self-insured health
				  plans.
									Sec. 4377. Definitions and special
				  rules.

								4375.Health
				insurance
									(a)Imposition of
				FeeThere is hereby imposed
				on each specified health insurance policy for each policy year ending after
				September 30, 2012, a fee equal to the product of $2 ($1 in the case of policy
				years ending during fiscal year 2013) multiplied by the average number of lives
				covered under the policy.
									(b)Liability for
				FeeThe fee imposed by subsection (a) shall be paid by the issuer
				of the policy.
									(c)Specified Health
				Insurance PolicyFor purposes of this section:
										(1)In
				generalExcept as otherwise provided in this section, the term
				specified health insurance policy means any accident or health
				insurance policy (including a policy under a group health plan) issued with
				respect to individuals residing in the United States.
										(2)Exemption for
				certain policiesThe term specified health insurance
				policy does not include any insurance if substantially all of its
				coverage is of excepted benefits described in section 9832(c).
										(3)Treatment of
				prepaid health coverage arrangements
											(A)In
				generalIn the case of any arrangement described in subparagraph
				(B)—
												(i)such arrangement
				shall be treated as a specified health insurance policy, and
												(ii)the person
				referred to in such subparagraph shall be treated as the issuer.
												(B)Description of
				arrangementsAn arrangement is described in this subparagraph if
				under such arrangement fixed payments or premiums are received as consideration
				for any person’s agreement to provide or arrange for the provision of accident
				or health coverage to residents of the United States, regardless of how such
				coverage is provided or arranged to be provided.
											(d)Adjustments for
				increases in health care spendingIn the case of any policy year
				ending in any fiscal year beginning after September 30, 2014, the dollar amount
				in effect under subsection (a) for such policy year shall be equal to the sum
				of such dollar amount for policy years ending in the previous fiscal year
				(determined after the application of this subsection), plus an amount equal to
				the product of—
										(1)such dollar
				amount for policy years ending in the previous fiscal year, multiplied
				by
										(2)the percentage
				increase in the projected per capita amount of National Health Expenditures
				from the calendar year in which the previous fiscal year ends to the calendar
				year in which the fiscal year involved ends, as most recently published by the
				Secretary of Health and Human Services before the beginning of the fiscal
				year.
										(e)TerminationThis
				section shall not apply to policy years ending after September 30, 2019.
									4376.Self-Insured
				health plans
									(a)Imposition of
				FeeIn the case of any
				applicable self-insured health plan for each plan year ending after September
				30, 2012, there is hereby imposed a fee equal to $2 ($1 in the case of plan
				years ending during fiscal year 2013) multiplied by the average number of lives
				covered under the plan.
									(b)Liability for
				Fee
										(1)In
				generalThe fee imposed by subsection (a) shall be paid by the
				plan sponsor.
										(2)Plan
				sponsorFor purposes of paragraph (1) the term plan
				sponsor means—
											(A)the employer in
				the case of a plan established or maintained by a single employer,
											(B)the employee
				organization in the case of a plan established or maintained by an employee
				organization,
											(C)in the case
				of—
												(i)a plan established
				or maintained by 2 or more employers or jointly by 1 or more employers and 1 or
				more employee organizations,
												(ii)a multiple
				employer welfare arrangement, or
												(iii)a voluntary
				employees’ beneficiary association described in section 501(c)(9),
												the association, committee, joint
				board of trustees, or other similar group of representatives of the parties who
				establish or maintain the plan, or(D)the cooperative or
				association described in subsection (c)(2)(F) in the case of a plan established
				or maintained by such a cooperative or association.
											(c)Applicable
				Self-Insured Health PlanFor purposes of this section, the term
				applicable self-insured health plan means any plan for providing
				accident or health coverage if—
										(1)any portion of
				such coverage is provided other than through an insurance policy, and
										(2)such plan is
				established or maintained—
											(A)by one or more
				employers for the benefit of their employees or former employees,
											(B)by one or more
				employee organizations for the benefit of their members or former
				members,
											(C)jointly by 1 or
				more employers and 1 or more employee organizations for the benefit of
				employees or former employees,
											(D)by a voluntary
				employees’ beneficiary association described in section 501(c)(9),
											(E)by any
				organization described in section 501(c)(6), or
											(F)in the case of a
				plan not described in the preceding subparagraphs, by a multiple employer
				welfare arrangement (as defined in section 3(40) of
				Employee Retirement Income Security Act of
				1974), a rural electric cooperative (as defined in section
				3(40)(B)(iv) of such Act), or a rural telephone cooperative association (as
				defined in section 3(40)(B)(v) of such Act).
											(d)Adjustments for
				increases in health care spendingIn the case of any plan year
				ending in any fiscal year beginning after September 30, 2014, the dollar amount
				in effect under subsection (a) for such plan year shall be equal to the sum of
				such dollar amount for plan years ending in the previous fiscal year
				(determined after the application of this subsection), plus an amount equal to
				the product of—
										(1)such dollar
				amount for plan years ending in the previous fiscal year, multiplied by
										(2)the percentage
				increase in the projected per capita amount of National Health Expenditures
				from the calendar year in which the previous fiscal year ends to the calendar
				year in which the fiscal year involved ends, as most recently published by the
				Secretary of Health and Human Services before the beginning of the fiscal
				year.
										(e)TerminationThis
				section shall not apply to plan years ending after September 30, 2019.
									4377.Definitions
				and special rules
									(a)DefinitionsFor
				purposes of this subchapter—
										(1)Accident and
				health coverageThe term accident and health
				coverage means any coverage which, if provided by an insurance policy,
				would cause such policy to be a specified health insurance policy (as defined
				in section 4375(c)).
										(2)Insurance
				policyThe term insurance policy means any policy or
				other instrument whereby a contract of insurance is issued, renewed, or
				extended.
										(3)United
				StatesThe term United States includes any
				possession of the United States.
										(b)Treatment of
				Governmental Entities
										(1)In
				generalFor purposes of this subchapter—
											(A)the term
				person includes any governmental entity, and
											(B)notwithstanding
				any other law or rule of law, governmental entities shall not be exempt from
				the fees imposed by this subchapter except as provided in paragraph (2).
											(2)Treatment of
				exempt governmental programsIn the case of an exempt governmental
				program, no fee shall be imposed under section 4375 or section 4376 on any
				covered life under such program.
										(3)Exempt
				governmental program definedFor purposes of this subchapter, the
				term exempt governmental program means—
											(A)any insurance
				program established under title XVIII of the Social Security Act,
											(B)the medical
				assistance program established by title XIX or XXI of the
				Social Security Act,
											(C)any program
				established by Federal law for providing medical care (other than through
				insurance policies) to individuals (or the spouses and dependents thereof) by
				reason of such individuals being—
												(i)members of the
				Armed Forces of the United States, or
												(ii)veterans,
				and
												(D)any program
				established by Federal law for providing medical care (other than through
				insurance policies) to members of Indian tribes (as defined in section 4(d) of
				the Indian Health Care Improvement
				Act).
											(c)Treatment as
				TaxFor purposes of subtitle F, the fees imposed by this
				subchapter shall be treated as if they were taxes.
									(d)No Cover Over to
				PossessionsNotwithstanding any other provision of law, no amount
				collected under this subchapter shall be covered over to any possession of the
				United
				States.
									.
					(B)Clerical
			 Amendments
						(i)Chapter 34 of such
			 Code is amended by striking the chapter heading and inserting the
			 following:

								34TAXES ON CERTAIN
				INSURANCE POLICIES

										Subchapter A. Policies issued by
				  foreign insurers
										Subchapter B. Insured and
				  self-insured health plans

									APolicies Issued By
				Foreign
				Insurers
									.
						(ii)The
			 table of chapters for subtitle D of such Code is amended by striking the item
			 relating to chapter 34 and inserting the following new item:

									Chapter 34—Taxes on Certain Insurance
				Policies

								.
						3.Coordination
			 with Federal coordinating council for comparative effectiveness
			 researchSection 804 of
			 Division A of the American Recovery and Reinvestment Act of 2009 (42 U.S.C.
			 299b–8) is amended—
			(1)in subsection
			 (c)—
				(A)in paragraph (1),
			 by striking and at the end;
				(B)in paragraph (2),
			 by striking the period at the end and inserting ; and;
			 and
				(C)by adding at the
			 end the following new paragraph:

						(3)provide support
				to the Patient-Centered Outcomes Research Institute established under section
				1181(b)(1) of the Social Security Act (referred to in this section as the
				Institute).
						;
				(2)in subsection
			 (d)(2)—
				(A)by redesignating
			 subparagraph (B) as subparagraph (C); and
				(B)by inserting
			 after subparagraph (A) the following new subparagraph:

						(B)Inclusion of
				chairperson of the board of governors of the Patient-Centered Outcomes research
				instituteIn the case where the Chairperson of the Board of
				Governors of the Patient-Centered Outcomes Research Institute established under
				section 1181(f) of the Social Security Act is a senior Federal officer or
				employee with responsibility for a health-related program, the members of the
				council shall include such
				Chairperson.
						.
				(3)in subsection
			 (e)(2), by striking regarding its activities and all that
			 follows through the period at the end and inserting “containing—

					(A)an inventory of
				its activities with respect to comparative effectiveness research conducted by
				relevant Federal departments and agencies; and
					(B)recommendations
				concerning better coordination of comparative effectiveness research by such
				departments and
				agencies.
					;
			(4)by redesignating
			 subsection (g) as subsection (h); and
			(5)by inserting
			 after subsection (f) the following new subsection:

					(g)Coordination
				with the Patient-Centered Outcomes Research InstituteThe Council
				shall coordinate with the Institute in carrying out its duties under this
				section.
					.
			4.GAO report on
			 national coverage determinations processNot later than 18 months after the date of
			 enactment of this Act, the Comptroller General of the United States shall
			 submit a report to Congress on the process for making national coverage
			 determinations (as defined in section 1869(f)(1)(B) of the Social Security Act
			 (42 U.S.C. 1395ff(f)(1)(B))) under the Medicare program under title XVIII of
			 the Social Security Act. Such report shall include a determination whether, in
			 initiating and conducting such process, the Secretary of Health and Human
			 Services has complied with applicable law and regulations, including
			 requirements for consultation with appropriate outside experts, providing
			 appropriate notice and comment opportunities to the public, and making
			 information and data (other than proprietary data) considered in making such
			 determinations available to the public and to nonvoting members of any advisory
			 committees established to advise the Secretary with respect to such
			 determinations.