107th Congress

Appropriations for the National Institutes of Health, Fiscal Year 2003

S. 2776, Senate Report 107-216

Background

The President's fiscal year (FY) 2003 budget proposal for the National Institutes of Health (NIH), which was released on February 4, 2002, requested $27.335 billion for NIH, an increase of $3.902 billion, or 16.7 percent, over the FY 2002 estimate. This would be an increase of $3.712 billion, or 15.8 percent, when including the FY 2002 Emergency Response Fund (ERF). The budget would complete the doubling of the FY 1998 appropriation level in 5 years. Of this amount, $76 million was requested from the Senate Appropriations Subcommittees on Veterans Administration (VA), on Housing and Urban Development (HUD), and on Independent Agencies for Superfund research activities. The President's budget request to the Senate Appropriations Subcommittee on Labor, Health and Human Services (HHS) and Education for NIH was $27.259 billion.

On July 18, 2002, the Senate Appropriations Subcommittee on Labor, HHS, and Education reported out S. 2776, appropriations for the Departments of Labor, HHS, and Education for the fiscal year ending September 30, 2003. The bill included a total of $27,192,926,000 for NIH. This represented an increase of $3,737,083,000 over the FY 2002 level and $25,000,000 over the President's budget request, a 15.9 percent increase. This appropriation would complete the 5-year effort to double the funding for NIH. However, the bill was not brought to the Senate floor for a vote before the 107th Congress adjourned. On September 4, Representative C. W. "Bill" Young (R-FL), Chairman, House Appropriations Committee, introduced H.R. 5320, the Department of Labor, HHS, and Education Appropriations, FY 2003. This "place-holder" bill was the President's budget request for these agencies. No further action occurred on that measure, and differences between the House leadership, appropriations committees, and Administration stalled any appropriations action in the House for the remainder of the 107th Congress. As a result, only 2 of the 13 regular FY 2003 appropriations bills were enacted before the 107th Congress adjourned, neither affecting NIH funding. The Senate bill that would have funded NIH died at the end of that Congress. NIH has been provided funding for FY 2003 through a series of continuing resolutions, the most recent of which, a fifth continuing resolution, provides funding through January 11, 2003, at the current rate of spending for FY 2002.

Cancer-related research also would be a priority under the President's proposal. Cancer-related spending would increase from $4.9 billion in FY 2002 to $5.5 billion in FY 2003, an increase of nearly 13 percent, which is similar to the increase in cancer-related spending in FY 2002.

Hearings

The House Appropriations Subcommittee on Labor, HHS and Education (Representative Ralph Regula [R-OH], Chairman) held seven hearings relative to NIH: one for the NIH Budget Overview, four theme hearings, a hearing on bioterrorism at which NIH was one of several witnesses, and an October "overview hearing." The budget overview hearing was held on March 13, 2002, with Ruth L. Kirschstein, Acting Director of NIH, accompanied by NIH Institute and Center (IC) Directors. The theme hearings were as follows:

• March 14, 2002: "From Bench to Bedside and Beyond." ICs participating were the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Cancer Institute (NCI), the National Institute on Aging, the National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Allergy and Infectious Diseases (NIAID).
• March 19, 2002: "Fundamental Research: Biomedical Science in the Future." ICs participating were the National Institute of General Medical Sciences, the National Institute on Deafness and Other Communication Disorders, the National Institute of Mental Health, the National Institute on Drug Abuse, the National Center for Research Resources (NCRR), the Center for Scientific Review, and the Office of Research Services for Building and Facilities (B&#F).
• April 9, 2002: "Collaborations in Research." ICs participating were the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Center for Complementary and Alternative Medicine, the National Center on Minority Health and Health Disparities (NCMHD), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the Fogarty International Center (FIC).
• April 16, 2002: "Disease Prevention and Health Promotion." ICs participating were the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Dental and Craniofacial Research, the National Eye Institute, the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Nursing Research, the National Human Genome Research Institute, and the National Library of Medicine (NLM).
• May 1, 2002: "Bioterrorism." Participants included NIH, other U.S. Department of Health and Human Services (DHHS) agencies involved in bioterrorism-related research activities, and a witness from the Office of the Secretary (OS).
• October 9, 2002: "Overview." This hearing examined how NIH is using its resources, how NIH has spent funding received through the doubling efforts and the results NIH can document from the spending, and how NIH is planning for the "post-doubling" era. Elias Zerhouni, Director of NIH, compared the current burden of illness to what the burden might have been if the Nation failed to invest public funds in medical research. He then provided examples of new and expanded initiatives that were possible only because of the doubling effort, and discussed his "road map" for the future.

The Senate Subcommittee on Labor, HHS and Education (Senator Tom Harkin [D-IA], Chairman) held its NIH overview hearing on March 21, 2002, with Dr. Kirschstein accompanied by NIH IC Directors.

Provisions of the Legislation/Impact on NIH

Major highlights of the FY 2003 Senate Labor, HHS, and Education Appropriation bill, S. 2766, and accompanying Senate Report 107-216 are included in the appendix.

Status and Outlook

The 108th Congress will have to address FY 2003 NIH appropriations and appropriations for FY 2004 when it convenes in January. At this time, it is anticipated that there will be an "omnibus" bill to fund all agencies without enacted appropriations for the remainder of FY 2003.

It is hoped by supporters of NIH that whatever measure emerges, NIH will see the completion of its 5-year doubling in the FY 2003 bill. It is not known, however, whether this will be possible within the context of the overall discretionary spending compromise between the House-approved level and the Senate-reported level.

Procedurally, the Senate would have to amend one of the House-passed bills with the language of the omnibus bill in order to maintain the constitutional requirement that money bills originate in the House. The aim would be to complete the action by the Senate of the Union Address, in the last week of January.

Appendix

Major highlights of the FY 2003 Senate Labor, HHS, and Education Appropriation bill, S. 2766, and accompanying Senate Report 107-216 are as follows:

Senate Bill Language:

• NIBIB: Transfer of $150 million from ICs to NIBIB is included in the total
• Transfer Authorities: Continues transfer authorities, consistent with FY 2002 appropriation language. The Director of NIH may transfer up to 1 percent of any appropriation, but may not increase any single appropriation by more than 3 percent. The Director of the Office of AIDS Research (OAR) may transfer up to 3 percent of funds identified for HIV/AIDS.
• AIDS: As has been done for the past several years, there is no separate AIDS allocation by IC.
• Foundation: Provides up to $500,000 for the Foundation.
• Salary Cap: Retains the extramural salary cap at the Executive Level I included in FY 2002.
• Global AIDS (from NIAID): (from NIAID): "$100 million may be made available to International Assistance Programs, "Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis," to remain available until expended. Provided further, up to $150 million shall be for extramural facilities construction grants to enhance the Nation's capability to do research on biological and other agents."
• NCRR:
  Extramural Construction: NCRR extramural construction is earmarked at $125 million, an increase of $15 million over the FY 2002 appropriation and $48 million over the budget request, "consistent with the requirements of section 481A of the Public Health Service Act, which allocates 25 percent of the total funding to institutions of emerging excellence."
  General Clinical Research Center (GCRC) Indirect Costs: No NCRR funds are to be used to pay recipients of the general research support grants program any amount for indirect expenses in connection with such grants. Allocations for GCRCs and Institutional Development Award (IDeA) Program found in report language.
• B&F: Full scope contracting authority language is included for the neurosciences construction project.
• Evaluation: Continues a provision to allow for not more than a 1.25 percent evaluation cap.
• Secretary's Transfer Authority: Continues the Secretary's 1 percent transfer authority, to no more than 1 percent of the total discretionary appropriation for DHHS and limits the amount an appropriation can be increased by a transfer to not more than 3 percent. However, an appropriation may be increased by up to an additional 2 percent subject to approval by the House and Senate Committees on Appropriations, provided that the Appropriations Committees of both Houses of Congress are notified at least 15 days in advance of any transfer.
• Morris K. Udall Centers: Includes new provision to lift ceiling (currently limited to 10 centers) on number of designated Morris K. Udall Centers for Research on Parkinson's Disease.
• Human Embryo Prohibition/Stem Cell: Continues a provision to prohibit the use of funds in the Act concerning research involving human embryos.

Senate Report Language:

• National Institutes of Health: A total of $27,192,926,000 is recommended to fund biomedical research at the 27 ICs that comprise NIH. This represents an increase of $3,737,083,000 over the FY 2002 level and $25 million over the budget request. This appropriation completes the historic 5-year effort to double the funding for NIH.
• NHLBI: The Committee encourages NHLBI, in conjunction with the Walter Reed Army Medical Center, to conduct a controlled, prospective, randomized trial to compare the outcomes of following a demanding vegetarian diet versus a more liberal diet that would also include lipid-lowering drugs, and the impact of relaxation response-based stress management programs. Such a trial could take place over an extended period of time to allow for a long-term assessment of outcomes.
• GCRCs: For FY 2003, "the Committee has provided $312 million, an increase of $40 million over the FY 2002 level, for the GCRC program as authorized by Section 481C of the Public Health Service Act."
• IDeA Grants: "The Committee has provided $220 million for the IDeA Program. This is a $60 million increase over FY 2002. Within the total provided, $90 million is for the Biomedical Research Infrastructure Network (BRIN) initiative, and $130 million is for the Centers of Biomedical Research Excellence (COBRE) initiative."
• Federal Loan Guarantee Program: "The Committee understands that the Administration has been considering a program that would guarantee loans for construction of research facilities at institutions conducting NIH-supported biomedical research. The Committee is very interested in a Federal loan guarantee program that has the potential to address the huge requirement for new and upgraded research facilities that has been generated by the doubling of the NIH budget. The Committee requests a report, to be submitted by June 1, 2003, describing how such a program would work, the potential benefits and costs both to the Federal Government and to the institution, and how a loan guarantee program would be integrated with the current grant program."
• NLM: "The Congress believes that if the National Center for Biotechnology Information is to make its maximum contribution to our fight against disease, its facilities must soon be expanded. The Committee provided funds necessary for the design of such facilities, and it desires that the design, when completed, be rapidly moved into the construction phase. The Committee, therefore, requests a report from NIH by April 1, 2003, that delineates the features of this new facility, its size, and its expected cost, based upon a fast-track schedule."
• Clinical Research: "The Committee encourages the Director of NIH to reinstitute the advisory panel on clinical research and to consider creating an office of clinical research to oversee and coordinate activities across NIH. In addition, the Committee strongly urges NIH to accelerate its ongoing clinical research training program. The Committee requests a report by April 1, 2003, outlining the status of clinical research activities currently underway as well as activities planned for the future."
• Graduate Training in Clinical Investigation Awards: "The Committee is concerned that NIH has not moved forward with implementation of the Graduate Training in Clinical Investigation Awards authorized by the Clinical Research Enhancement Act. The Committee believes that the Graduate Training in Clinical Investigation Awards may be necessary to replenish the supply of well-trained clinical investigators."
• Laboratory Animals: "The Committee is concerned about allegations that several institutions receiving NIH funding may not be in full compliance with the Public Health Service policy on humane care and use of laboratory animals. The Committee encourages NIH to determine the extent and scope of any such allegations and to notify the Committee of its findings."
• Minority Health Professions Infrastructure: "The Committee continues to be pleased with the implementation by the Director of NIH of various programs focused on developing research infrastructure at minority health professions institutions, including Research Centers at Minority Institutions, Extramural Biomedical Research Facilities, and NCMHD. Because there are a number of new competitive mechanisms through which NIH can work with these research institutions, the Committee recommends that the Director of NIH work closely with the Director of NCMHD to coordinate these various mechanisms."
• Office of Dietary Supplements (ODS)/Ephedra: "The Committee is pleased that ODS has followed through on its recommendation to begin a major research initiative on the safety and efficacy of products containing ephedra, and it urges the Office to ensure that the work is reviewed in an unbiased manner before it is finalized. The results of this research should be evaluated by the Food and Drug Administration (FDA) to ensure that any regulatory action taken on products containing ephedrine alkaloids is based on sound science."
• Parkinson's Disease Research Agenda: "The Committee is aware that the Parkinson's Disease Research Agenda developed by NIH in 2000 included professional judgment funding projections that totaled an additional $1 billion over 5 years. It is the clear intent of the Committee that NIH, which has received substantial funding increases in recent years, come as close as possible to fulfilling that agenda while maintaining the standards of peer review. The Committee strongly urges NIH to devote additional resources to Parkinson's research using all available mechanisms, including Requests for Applications (RFAs) and further support of NIEHS initiatives. The Committee expects NIH to report to Congress by April 1, 2003, on the steps it is taking to fulfill the Parkinson's Disease Research Agenda."
• Pediatric Drug Studies: "The Committee is aware that many generic drugs have not been studied for use in pediatric patients. Therefore, the Committee encourages NIH to take actions necessary to fully implement the new section 409I of the Public Health Service Act to study the safety and efficacy of off-patent/off-exclusivity drugs in pediatric patients. The Committee requests a report by February 1, 2004."
• Stem Cell Research: "The Committee requests that DHHS send the Subcommittee a report explaining how it plans to encourage more grant applications and what specific steps it plans to take to make more stem cell lines available, and the Committee encourages NIH to expand the registry to make it more useful to researchers by providing additional documentation regarding the stem cell lines. In addition, the Committee is aware of the exciting new developments in the field of umbilical cord stem cells. But more research needs to be undertaken to explore these issues, including the possible use of these cells to treat cancers, genetic diseases, muscular dystrophy, neurological disorders, and diabetes. The Committee urges NCI, NHLBI, NIAMS, NIDDK, and NINDS to actively pursue research in these areas in a manner consistent with the NIH tradition of strong peer-reviewed science."
• Training Award Stipends: "The Committee concurs with the policy adopted by NIH in March 2001 that provides for 10-percent increases in research training award stipends until appropriate stipend levels are achieved. The Committee strongly encourages NIH to apply this policy to the FY 2003 appropriation, just as it did with the training stipends funded by the FY 2002 appropriation."
• Clinical Center: "The Committee is extremely concerned about the cost of completing the Mark O. Hatfield Clinical Research Center. The Committee understands that small cost overruns are expected in most large construction projects; however, in this situation, $144,500,000 in unanticipated costs is totally unacceptable. Therefore, the Committee directs NIH, prior to requesting any further construction dollars, to do a thorough investigation of why the cost overrun occurred and to decide what steps NIH intends to take to ensure that future projects are better managed."
• Reprogramming: "The Committee directs the Director of NIH to make a written request to the Chairman of the Committee prior to any reprogramming of $1 million or more between programs, projects, activities, Institutes, Divisions, and Centers. The Committee also desires to have the requests for reprogramming actions that involve less than the above-mentioned amounts, if such actions would have the effect of changing funding requirements in future years, if programs or projects specifically cited in the Committee's reports are affected, or if the action can be considered to be the initiation of a new program."
• Department of Defense (DoD) Transfers: "The Committee has not approved the transfer of $49 million requested in the budget to fund the DoD medical free electronic laser research, HIV clinical trial research, and radiation exposure research. The Committee recommends that funding for defense-related science and technology initiatives should be handled by DoD."
• Distribution of Resources: Following the Institute of Medicine (IOM) study of the organization of NIH, the "Committee encourages NIH to contract with IOM to study the distribution of research resources across the Agency's ICs. An objective analysis may help inform the Committee on the wisest distribution of new funds as they become available."
• OS/Consolidation: "The Committee does not agree to the proposed consolidation of public affairs and legislative affairs functions in OS. For this reason the Committee's recommendation does not include the $27,793,000 requested to transfer staff from the operating divisions to OS. In addition, the Committee has denied the FY 2003 bill language request, proposed in the budget, to transfer funds from accounts of NIH and the Agency for Healthcare Research and Quality (AHRQ) within the Department for the purpose of consolidating all DHHS legislative and public affairs activities within OS. The Committee has taken this action because of the concern that information necessary to make timely decisions by the Congress and requests for information by the public may be delayed by this consolidation."
• OS/Information Requests: "The Committee directs that specific information requests from the Chairman and ranking member of the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, on scientific research or any other matter, shall be transmitted to the Committee on Appropriations in a prompt professional manner and within the time frame specified in the request. The Committee further directs that scientific information requested by the Committees on Appropriations and prepared by Government researchers and scientists be transmitted to the Committee on Appropriations, uncensored and without delay."
• OS/Chronic Fatigue: "The Committee is disappointed that the establishment of the Department's Chronic Fatigue Syndrome (CFS) Advisory Committee, announced in January 2001, has been delayed and that the Advisory Committee's predecessor, the Chronic Fatigue Syndrome Coordinating Committee, has not met since January 2001. The Committee urges the Department to approve the CFS Advisory Committee Charter, publish a call for nominations, install members, and hold one meeting, all prior to the end of calendar year 2002."
• OS/Complementary and Alternative Medicine Policy: "The Committee expects the Secretary to provide sufficient funds to establish an interagency coordinating unit to assist with the implementation of the White House Commission on Complementary and Alternative Medicine Policy's recommendations and expects to receive a briefing on the Department's progress in this area by March 30, 2003."
• OS/Health Disparities: "The Committee commends the Secretary for designating the elimination of health disparities as a major priority. The Committee expects the Office of Minority Health, along with NCMHD, to coordinate and monitor the implementation of the Department's elimination of health disparities strategic plans. The Committee expects the Secretary to report to Congress on the progress and implementation of the strategic plans during next year's appropriations hearings, and to include a progress update in the Department's Budget Justification."