Congressional Affairs (Prepared September 4, 2009)
(Thanks to Anne Houser of NIH/OLPA for the bulk of this information)
As of the beginning of the August recess, the FY2010 Appropriations action for NIH is as follows: the House passed its bill, H.R. 3293, on July 24. The Senate companion, bearing the same number, was reported from the Senate Appropriations Committee on July 30. Floor action in the Senate will occur after the recess.
- The House bill would appropriate $31,258,788,000 to NIH, which is $941,764,000 above the comparable FY2009 level and $500,000,000 above the President's budget request; rather than provide a specific funding level for cancer and autism as requested in the President's budget, recommends a funding level which provides "a comparable inflationary adjustment to the fiscal year 2009 levels for each institute and center to offset biomedical research inflation." The House bill would also provide a 2 percent stipend increase for research training grants; $534,066,000 for the Common Fund; $194,400,000 for the National Children's Study [NCS]; and $5,000,000 for the new bioethics research and training initiative. The House bill allocates $1,069,583,000 to NIDA, an increase of $36,824,000, or approximately 3.5%, over the FY 2009 level.
- The Senate bill would appropriate $30,758,788,000 to NIH, an increase of $441,764,000 over the level in the FY 2009 health appropriations bill, and equal to the President's budget request. This bill rejects the administration's proposals to earmark an increase of $268,000,000 for research on cancer and an increase of $19,000,000 for research on autism; would provide $549,066,000 for the Common Fund, the same amount as the budget request; did not provide a specific amount of funding for the NCS, stating that a decision about specific funding level, if any, for the NCS would be decided at conference. The Senate bill allocates $1,050,091,000 to NIDA, an increase of 17,332,000, or approximately 1.7%, over the FY 2009 level.
NOTE: (text from NIH) For the House bill, the rule under which debate occurred permitted five amendments to the bill, two of which pertain in some way to NIDA.
- Issa (R-CA)--Accepted without vote--Would defund three National Institutes of Health grants that support behavioral research on preventing the transmission of HIV/AIDS. The grants focus on: (1) the factors that put Thai prostitutes at special risk of HIV (a NIDA grant); (2) decreasing high-risk HIV behaviors among Russian alcoholics; and (3) an intervention program targeting HIV risk and alcohol use among Chinese prostitutes. (The Senate bill does not include this language. Final resolution will occur when the House and Senate "conference" their respective bills.
- Souder (R-IN)--Defeated--Would have prohibited funding in the Act from being used to carry out needle exchange programs. Mr. Obey mentioned that many prominent scientific and public health leaders have endorsed needle exchange programs as an effective public health intervention, based on scientific research, to reduce the incidence of HIV and other diseases, including Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases; Thomas Frieden, the Director of the CDC; former NIH Director Harold Varmus; former Surgeons General C. Everett Koop and David Satcher; and former HHS Secretary, Dr. Louis Sullivan. Dr. Fauci, who is one of the world's leading experts on HIV/AIDS very succinctly stated in Congressional testimony in 2008, "Clearly needle exchange programs work. There is no doubt about that." The underlying bill permits Federal funds to be used for needle exchange programs, provided that such programs are NOT located within 1,000 feet of a day care center, school, college or university, or any public swimming pool, park, playground, video arcade, or youth center, or an event sponsored by any such entity."
Transition - Executive Branch
The Senate has confirmed:
- Dr. Francis S. Collins to be Director, National Institutes of Health
- Gil Kerlikowske to be Director, Office of National Drug Control Policy
- Dr. A. Thomas McLellan to be Deputy Director, Office of National Drug Control Policy
Legislation of Particular Interest
Health Reform - This topic has recently trumped most others in the current Congress. Future Reports to Council will include more detail specific to issues of particular relevance to the substance abuse and addiction field. Text below is provided by NIH/OLPA:
H.R. 3200 - On July 31, the House Committee on Energy and Commerce approved, by a vote of 31 - 28, an amendment in the nature of a substitute to H.R. 3200, the America's Affordable Health Choices Act of 2009, after multiple mark-up sessions and after many amendments were adopted. H.R. 3200 was approved by the House Committees on Ways and Means and Education and Labor on July 17th. NIH provisions are as follows:
- Division B, Title IV, Subtitle A contains comparative effectiveness research (CER) provisions which would establish a Center for CER within AHRQ, a CER Commission to oversee and evaluate the Center's activities, and a trust fund to pay for the research the Center would support. The following three CER amendments were adopted by voice vote which would:
- prohibit research conducted, supported, or developed by the Center, the Commission, or the Federal Coordinating Council for Comparative Effectiveness Research (established by ARRA-NIH has representatives on this Council) from being used to deny or ration care. [Offered by Representative Mike Rogers (R-MI)].
- prohibit CMS from using Federally-funded CER data to make coverage determinations on the basis of cost. [Offered by Representative Phil Gingrey (R-GA)].
- require that, in developing best practices, the Commission or Center consult with "specialty colleges and academies of medicine." Any recommendations made or best practices developed by the Commission or Center must be based upon evidence-based medicine and must not violate standards and protocols of clinical excellence of the specialty colleges and academies. [Offered by Representative Tim Murphy (R-PA)]
- Division C, Title III, would require CDC, NIH, and other HHS agencies conducting or supporting prevention and wellness research to take into consideration the "National Prevention and Wellness Strategy" report also required under the bill as well as take into consideration recommendations of the Task Force on Clinical Preventive Services and the Task Force on Community Preventive Services.
- The substitute amendment contains new language in Division C that NCMHD be represented on both these task forces.
- An amendment offered by Representative Mike Doyle (D-PA) and agreed to by voice vote, adds a new subtitle to Division C that would require the Secretary of HHS, in consultation with the Interagency Autism Coordinating Committee, to award national training initiative supplemental grants to University Centers for Excellence in Developmental Disabilities.
- An Amendment En Bloc offered by Representative by Pallone, agreed to by voice vote, would add the following pain and postpartum depression research provisions to Division C, Title V:
- Subtitle M of Division C, as added by this amendment, would amend the PHS Act to encourage the Director of NIH to continue and expand, through the Pain Consortium, an aggressive research program on the causes of and potential treatments for pain. The Pain Consortium, in consultation with DPCPSI, would be required to make recommendations on pain research initiatives that could be paid for by the Common Fund. In addition, the Secretary would be required to hold a conference and to establish an interagency pain research consortium and be required to establish a pain research national education outreach and awareness campaign.
- Subtitle N contains a sense of the Congress that the Director of NIMH may conduct a longitudinal study on the relative mental health consequences for women of resolving a pregnancy in various ways. Provisions in this subtitle also would encourage the Secretary to continue research to expand the understanding of the causes of, and treatments for, postpartum conditions and require the Secretary to conduct a study on the benefits of screening for postpartum conditions.
Bills of Interest
[For the full text and additional information about any bill, go to the Library of Congress website at http://thomas.loc.gov].
H.R. 2354 - On May 12, Representative Janice Schakowsky (D-IL) introduced the Health Promotion Funding Integrated Research, Synthesis, and Training Act or the Health Promotion FIRST Act. Provisions relevant to NIH would require the Director of NIH, acting through OBSSR, to develop a plan on how best to develop the science of health promotion at the agency. The plan must provide for the allocation of resources for the research. The bill would also require the Director of NIH, acting through OBSSR, to conduct or support early research programs and research training regarding health promotion. The bill was referred to the House Committee on Energy and Commerce. See S. 1001
H.R. 2369 - On May 12, Representative Patrick Kennedy (D-RI) introduced the Improving the Quality of Mental and Substance Use Health Care Act of 2009, to improve mental and substance use health care. The bill was referred to the Energy and Commerce Committee.
H.R. 2502 - On May 19, Representative Kurt Schrader (D-OR) introduced the Comparative Effectiveness Research (CER) Act of 2009. The bill would establish a nonprofit corporation called the Health Care Comparative Effectiveness Research Institute to contract with appropriate Federal agencies or the private sector to conduct comparative effectiveness research. The Institute would be responsible for (1) establishing and carrying out a research project agenda [in carrying out a research agenda, Institute is authorized to enter into contracts with Federal government agencies with experience in conducting CER], (2) establishing a methodology committee to develop scientifically-based methodological standards for comparative clinical effectiveness research [would be required to consult or contract with IOM, AHRQ, NIH (can contract with one or more) in developing and updating standards], and (3) ensuring that there is a process for peer-review of the research [Institute would be authorized to use existing peer-review processes used by entities with which the Institute contracts]. Provisions would also establish a Board of Governors comprising 21 members, including the Secretary of HHS, the Director of AHRQ and the Director of NIH, to over-see the Institute's activities. The legislation would create the Comparative Effectiveness Research Trust Fund in the U.S. Treasury. The Trust Fund would be financed through fees on Medicare and private health insurance plans, in addition to transferring CER funds in ARRA (P.L. 111-5) not already obligated or expended. Funding for the Institute would sunset after 10 years. H.R. 2502 was jointly referred to the House Committees on Energy and Commerce and Ways and Means.
H.R. 2835 - On June 11, Representative Barney Frank (D-MA) introduced the Medical Marijuana Patient Protection Act, to provide for the medical use of marijuana in accordance with the laws of the various States. The bill was referred to the Energy and Commerce Committee.
H.R. 2818 - On June 11, Representative Jerry McNerney (D-CA) introduced the Methamphetamine Education, Treatment, and Hope Act of 2009, to amend the Public Health Service Act to provide for the establishment of a drug-free workplace information clearinghouse, to support residential methamphetamine treatment programs for pregnant and parenting women, to improve the prevention and treatment of methamphetamine addiction, and for other purposes. The bill was referred to the Energy and Commerce Committee.
H.R. 2906 - On June 16, Representative Jim Moran (D-VA) introduced the Comprehensive Problem Gambling Act of 2009, to amend the Public Health Service Act to specifically include problem and pathological gambling in programs of the Substance Abuse and Mental Health Services Administration and to establish a national program to address the harmful consequences of problem gambling. The bill was referred to the Energy and Commerce Committee.
H.R. 2943 - On June 18, Representative Barney Frank (D-MA) introduced the Personal Use of Marijuana by Responsible Adults Act of 2009, to, eliminate most federal penalties for possession of marijuana for personal use, and for other purposes. The bill was referred to the Judiciary and Energy and Commerce Committees.
H.R. 2965 - On July 8, by a vote of 386-41, the House passed H.R. 2965, the Enhancing Small Business Research and Innovation Act of 2009, which was introduced by Representative Jason Altmire (D-PA). The House adopted 5 amendments to the reported bill, which included the Manager's Amendments (to give priority to rural businesses, renewable energy, water conservation technology, places hardest hit by the economic downturn, and improve oversight of the SBIR program). Other amendments adopted would (1) require GAO to examine and report to Congress on the effect that venture capital (VC) ownership restrictions in the bill (VC operating companies investment in small businesses) have on eligibility and participation under this act (Rep. Brown-Waite); (2) require agencies with space shuttle activities to help small businesses (Rep. Kosmas); (3) give preference to organizations that are located in underrepresented states and regions, or are owned by women, minorities, or disabled veterans when awarding grants for SBA outreach efforts (Rep. Reichert); and (4) add medical technology to the list of topics that deserve special consideration as SBIR research topics (Rep. Paulson).
As reported from the House Committee on Small Business and the House Committee on Science and Technology, the bill would permit VC capital-backed small businesses to receive funding from the SBIR and Small Business Technology Research (STTR) programs. The bill does not include any set-aside increases as does the Senate reauthorization bill, S. 1233. H.R. 2965 contains a short time-limited reauthorization for the SBIR and STTR programs, only through Fiscal Year 2011 (the current extension of the SBIR/STTR programs expired July 30, 2009). As reported, the bill would increase small business award levels as follows: $250,000 from $100,000 for participation in the Phase I level and $2 million from $750,000 for participation in Phase II. The bill would also allow small businesses to receive more than one Phase II award and require that in order to receive a Phase II award, the business must have already received a Phase I award. Additionally, the agency would have to engage with small business awardees that received multiple Phase I awards, but no Phase II awards, in order to develop performance measures with respect to progression in the SBIR program. Other features include the following:
- Eligibility Requirements for Venture Capital. The bill would provide that for determining eligibility for SBIR and STTR programs, the following must apply:
- A business cannot have more than 500 employees.
- Venture capital operating company (VCOC) backed small businesses would qualify for the program only if the VCOC does not own more than 50 percent of the small business or employees of that VCOC do not constitute a majority of the board of directors for that business.
- If the VCOC is controlled by a business with more than 500 employees, the small business would be eligible to receive funds if no more than two such VCOC's (that have more than 500 employees) back that small business and those VCOC's do not control more than 20 percent of the small business.
- The bill would provide special consideration for small business projects that include energy-related research, rare disease-related research, transportation and infrastructure research and research related to nanotechnology.
- The bill has a number of other provisions including new criteria for awards; a requirement for SBA to create by regulation a process in which each agency conducts at least two rounds of SBIR research solicitations per year and would render a decision on each proposal within 90 days; and new reports and databases, one of which would require that the government database of SBIR and STTR programs include information on the ownership structure of award recipients. It would require that small businesses participating in the program provide updated information on structure.
- An amendment offered in the Small Business mark up would incorporate an evaluation program within both the SBIR and STTR programs to measure performance and track development of individual agency programs.
H.R. 3001 - On June 23, Representative Tammy Baldwin (D-WI) introduced the Ending LGBT Health Disparities Act. H.R. 3001 would require the collection of sexual and gender minority data from each health related program operated by or that receives funding from the Department of Health and Human Services. The bill also would require the Secretary, acting through the Secretary of LGBT Health (a position that would be established by the bill), and the Directors of the Agency for Health Quality and Research and the NIH, to develop plans to expand existing research into health disparities to include those experienced by sexual and gender minority populations. H.R. 3001 was referred to the House Committees on Energy and Commerce, Armed Services, Judiciary, Ways and Means, Oversight and Government Reform, House Administration, Veterans' Affairs, Transportation and Infrastructure, Intelligence and Foreign Affairs.
H.R. 3002 - On June 23, Representative John Boehner (R-OH) introduced the Preserving Access to Targeted, Individualized, and Effective new Treatments and Services (PATIENTS) Act of 2009. The bill would prohibit the Secretary of HHS from using data obtained from comparative effectiveness research (CER), including CER research funded by P.L. 111-5, the American Recovery and Reinvestment Act (ARRA), to deny coverage under a Federal health care program. The Secretary would also be tasked with ensuring that CER conducted or supported by the Federal Government accounts for factors contributing to differences in the treatment response and treatment preferences of patients, including patient-reported outcomes, genomics and personalized medicine, the unique needs of health disparity populations, and indirect patient benefits. The bill was jointly referred to the House Committees on Energy and Commerce and Ways and Means. See S. 1259
H.R. 3065 - On June 26, Representative Jan Schakowsky introduced the Mental Illness Chronic Care Improvement Act of 2009, to establish a chronic care improvement demonstration program for Medicaid beneficiaries with severe mental illnesses, including co-occurring substance use disorders. The bill was referred to the Energy and Commerce Committee. See S.1136
H.R. 3075 - On June 26, Representative John Lewis (D-GA) introduced the National Parents Corps Act of 2009, to establish a National Parents Corps Program, and for other purposes. The bill was referred to the Education and Labor Committee.
H.R. 3245 - On July 16, Representative Bobby Scott (D-VA) introduced the Fairness in Cocaine Sentencing Act of 2009, to amend the Controlled Substances Act and the Controlled Substances Import and Export Act regarding penalties for cocaine offences. This bill would effectively equalize federal cocaine sentencing for crack vs. powdered cocaine. The bill was reported out by the Judiciary Committee and is pending in the Energy and Commerce Committee. See H.R. 1459
H.R. 3400 - On July 30, Representative Tom Price (R-GA) introduced the Empowering Patients First Act. Section 801 would (1) prohibit the Secretary of HHS from using data obtained from CER, including research conducted or supported using funds appropriated under ARRA, to deny coverage of an item or service under a Federal health care program; (2) require the Secretary to ensure that CER conducted or supported by the Federal Government accounts for factors contribu-ting to differences in the treatment response and treatment preferences of patients, including patient-reported outcomes, genomics and personalized medicine, the unique needs of health disparity populations, and indirect patient benefits; and (3) prohibit the Federal Coordinating Council for Comparative Effectiveness Research findings from being released in final form until after consulta-tion with and approval by relevant physician specialty organizations. H.R. 3400 was jointly referred to the House Committees on Energy and Commerce; Ways and Means; Education and Labor; Oversight and Government Reform; Judiciary; Rules; Budget; and Appropriations.
H.R. 3420 - On July 30, Representative Patrick Kennedy (D-RI) introduced the SUPPORT for Sub-stance Use Disorders Act, to improve and enhance substance use disorder programs for members of the armed forces, and for other purposes. The bill was referred to the Armed Services Committee.
H.R. 3475 - On July 31, Representative Randy Forbes (R-VA) introduced H.R. 3475, the Accelerate Cures for Patients Act of 2009. The bill would amend the PHS Act to authorize to be appropriated (in addition to amounts authorized to NIH under Section 402A of the PHS Act) an equal amount for medical research that has the greatest potential for near-term clinical benefit in human patients. H.R. 3475 was referred to the House Committee on Energy and Commerce.
S. 1001 - On May 7, Senator Richard Lugar (R-IN) introduced the Health Promotion Funding Integrated Research, Synthesis, and Training Act or the Health Promotion FIRST Act. Provisions relevant to NIH would require the Director of NIH, acting through OBSSR, to develop a plan on how to best develop the science of health promotion at the agency. The plan must provide for the allocation of resources for the research. The bill would also require the Director of NIH, acting through OBSSR, to conduct or support early research programs and research training regarding health promotion. The bill was referred to the Senate HELP Committee.
S. 1058 - On May 14, Senator Mark Udall (D-CO) introduced the Brewers Excise and Economic Relief (BEER) Act of 2009, to amend the Internal Revenue Code of 1986 to reduce the tax on beer to its pre-1991 level, and for other purposes. The bill was referred to the Committee on Finance. See H.R. 836
S. 1136 - On May 21, Senator Debbie Stabenow (D-MI) introduced the Mental Illness Chronic Care Improvement Act of 2009, to establish a chronic care improvement demonstration program for Medicaid beneficiaries with severe mental illnesses, including co-occurring substance use disorders. The bill was referred to the Committee on Finance. See H.R. 3065.
S. 1188 - On June 4, Senator Jack Reed (D-RI) introduced the Community Mental Health Services Improvement Act, to amend the Public Health Service Act with respect to mental health services. The bill was referred to the Committee on Health, Education, Labor and Pensions. See H.R. 1011
S. 1233 - On July 23, the Senate passed S. 1390, the National Defense Authorization Act for Fiscal Year 2010, a bill to authorize appropriations for military activities of the Department of Defense, for military construction, and for defense activities of the Department of Energy, to prescribe military personnel strengths for such fiscal year. Included in this authorization bill, as an amendment, was the full text of the Senate passed bill S. 1233, the SBIR/STTR Reauthorization Act of 2009. This latter measure includes an increase of the SBIR set-aside from 2.5 to 3.5 percent and the increase of the STTR from 0.3 to 0.6, which would bring the total for the program to 4.1 percent. The House passed its version of the National Defense Authorization Act in June; its bill does not include setaside increases. See H.R. 2965
S 1259 - On June 15, Senator John Kyl (R-AZ) introduced the Preserving Access to Targeted, Individualized, and Effective new Treatments and Services (PATIENTS) Act of 2009. The bill would prohibit the Secretary of HHS from using data obtained from comparative effectiveness research (CER), including CER research funded by P.L. 111-5, the American Recovery and Reinvestment Act (ARRA), to deny coverage under a Federal health care program. The Secretary would also be tasked with ensuring that CER conducted or supported by the Federal Government accounts for factors contributing to differences in the treatment response and treatment preferences of patients, including patient-reported outcomes, genomics and personalized medicine, the unique needs of health disparity populations, and indirect patient benefits. The bill was referred to the Committee on Health, Education, Labor and Pensions. See H.R. 3002
S. 1373 - On June 25, Senators Joseph Lieberman (I-CT) and John Cornyn (R-TX) introduced the Federal Research Public Access Act (FRPAA), to require every federal department and agency with an annual extramural research budget of $100 million or more to make their research available to the public within six months of publication. Senators Cornyn and Lieberman first introduced this legislation in the 109th Congress. The NIH Public Access Policy was established statutorily with the passage of the Consolidated Appropriations Act of 2008, (P.L. 110-161), and became permanent upon passage of the Fiscal 2009 Omnibus Appropriations (P.L. 111-8). The NIH policy requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central (PMC) upon acceptance for publication, and be accessible to the public on PubMed Central no later than 12 months after publication.
Specifically, the FRPAA would:
- Require every researcher with an annual extramural research budget of $100 million or more, whether funded totally or partially by a government department or agency, to submit an electronic copy of the final manuscript that has been accepted for publication in a peer-reviewed journal.
- Ensure that the manuscript is preserved in a stable digital repository maintained by that agency or in another suitable repository that permits free public access, interoperability, and long-term preservation.
- Require that each taxpayer-funded manuscript be made available to the public online and without cost, no later than six months after the article has been published in a peer-reviewed journal. The bill has been referred to the Senate Committee on Homeland Security and Governmental Affairs.