107th Congress

Appropriations for the National Institutes of Health, Fiscal Year 2002

P.L. 107-116 (H.R. 3061/H. Rept. 107-229, S. 1536/ S. Rept. 107-84, and Conference Report, H. Rept. 107-342), P.L. 107-117 (Conference Report, H. Rept. 107-350), P.L. 107-73 (Conference Report, H. Rept. 107-272)

Impact of Public Law

Public Law (P.L.) 107-116, the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2002, which was signed on January 10, 2002, provides funding for the U.S. Departments of Labor, Health and Human Services, and Education, including the National Institutes of Health (NIH).

For NIH, P.L. 107-116 provides an appropriation of $23.285 billion, an even split between the budget authority provided by the House and Senate and $2.990 billion (14.7 percent) above fiscal year (FY) 2001. The program level is $22.888 billion (a 14.4-percent increase) once a $100 million transfer to the global AIDS fund and evaluation taps are taken into account. Specific provisions of the law are as follows:

• Maintains transfer authorities consistent with FY 2001 appropriation language.
• Provides $110 million for extramural facilities construction grants, including a $5 million earmark for the Chimp Sanctuary as authorized in P.L. 106-551.
• Deletes provision to provide $500,000 for the NIH Foundation.
• Earmarks $160 million for the National Center for Research Resources' (NCRR) Institutional Development Award (IDeA) program and $271.58 million for NCRR's General Clinical Research Centers.
• Provides $26 million for the John Edward Porter Neuroscience Research Center within Buildings and Facilities (B&F). The Director of NIH may transfer up to $75 million from B&F to International Assistance Programs—"Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis." These funds will remain available until expended.
• Clarifies that the Acting Director of NIH may continue to serve using this title, rather than Principal Deputy Director, until a new Director of NIH is confirmed by the Senate.
• Maintains the salary cap for extramural investigators at Level I as provided in FY 2001.
• Limits the transfer authority of the Secretary of Health and Human Services (HHS) to transferring 1 percent of the total appropriated to the U.S. Department of Health and Human Services (DHHS), and specifies that no individual appropriation can be increased by more than 3 percent, unless the House and Senate approve, in which case the transfer can be increased by an additional 2 percent.
• Allows for a 1.25 percent evaluation tap by the Secretary of HHS.
• Maintains human embryo research prohibition identical to FY 2001.
• The conference agreement includes $1 million to launch a public awareness campaign to inform Americans about the existence of spare embryos and options for couples to adopt an embryo or embryos in order to bear children, as proposed by the Senate. The House had no similar provision. The conferees further direct that the Secretary of HHS prepare and submit a report to the Committees on Appropriations by April 1, 2002, outlining the Department's plans and timeline to launch this campaign.
• Includes an across-the-board administrative and related expenses reduction of $25 million across three cabinet departments included in this bill (does not apply to the Food and Drug Administration and the Indian Health Service).

P.L. 107-117, the Department of Defense Appropriations Act, 2002, which was signed on January 10, 2002, also provides funding for NIH. This measure is composed of two parts: funding for the U.S. Department of Defense and the Emergency Supplemental Act, 2002. Bioterrorism funding for NIH is included in the supplemental section. As described in the conference report, $85 million is provided for bioterrorism-related research, including next generation vaccine research at the National Institute of Allergy and Infectious Diseases (NIAID). The "conferees encourage NIAID to conduct research on safer alternatives to the existing smallpox vaccine, such as an inactivated smallpox virus." In addition, $70 million is provided for the construction of a level-4 biosafety laboratory and related infrastructure costs at NIAID and $71 million for improving laboratory security at the Centers for Disease Control and Prevention (CDC) and NIH. The bill also includes $10.5 million for the National Institute of Environmental Health Sciences (NIEHS) "for carrying out under current authorities, worker training, research, and education activities" which "shall remain available until expended" in response to the September 11 terrorist attacks.

P.L. 107-73, the Departments of Veterans Affairs and Housing and Urban Development and Independent Agencies Appropriations Act, 2002, provides funding for NIEHS. On November 27, 2001, the President signed H.R. 2620, providing $70.228 million for the Institute. Of the appropriated amount, $45.8 million is to support research and $24.4 million is to fund worker training activities. Prior to FY 2001, NIEHS received funding for these activities through a transfer from the Hazardous Substance Superfund account within the Environmental Protection Agency budget via an interagency agreement. (See article entitled Veterans Affairs and Housing and Urban Development and Independent Agencies Appropriations Act of 2002.)

Legislative History of P.L. 107-116

On February 27, 2001, President Bush presented a skeletal budget to Congress (in anticipation of a later, complete President's Budget request). The document noted specifically that the President's Budget continues the effort to double the NIH's 1998 funding level in 5 years by increasing NIH's funding by $2.8 billion over 2001, for a total of $23.1 billion in 2002. On April 9, the President released his FY 2002 President's Budget. This proposal matched his February submission to Congress. The President's Budget request stated the Administration's commitment to continue the 5-year plan to double the NIH budget by FY 2003, with FY 2002 representing the fourth installment in this plan.

In a break from the tradition of previous years, the House Appropriations Subcommittee on Labor, HHS, and Education held theme hearings for NIH, two of which preceded the release of the President's Budget. The subject of the first hearing, held on March 28, 2001, was chronic diseases. The second hearing, held on April 4, had two panels: lifespan, and special populations and health disparities. The subcommittee held the NIH budget hearing (similar to the NIH overview hearing held in previous years) on May 16, followed by the final theme hearing entitled "Research and Infrastructure" on May 17. The Senate held its NIH budget hearing on May 23, 2001.

On October 9, 2001, the House Committee on Appropriations reported H.R. 3061, which would have appropriated $22.564 billion to NIH, an increase of $2.462 billion, or 12 percent, over the previous year's level. On October 11, the House passed the FY 2002 Labor, HHS, and Education Appropriations bill, H.R. 3061, with one amendment added on the floor that was of interest to NIH. This amendment, offered by Representative Bernard Sanders (I-VT), was intended to reduce the cost of prescription drugs. This amendment is similar to others he has offered each year since 1996. The text of the amendment is as follows, "None of the funds made available in this Act for the Department of Health and Human Services may be used to grant an exclusive or partially exclusive license pursuant to chapter 18 of title 35, United States Code, except in accORDance with section 209 of such title (relating to the availability to the public of an invention and its benefits on reasonable terms)."

On October 11, the Senate Appropriations Committee reported its bill, S. 1536, which would have provided a $3.4 billion increase for NIH, for a total of $23.7 billion. On November 6, the Senate passed its version of the bill. In the interim, from September 30, 2001, until such time as the final appropriations measure for FY 2002 was signed, a total of eight continuing resolutions were passed and signed, the last extended funding through January 10, 2002. The conference report for H.R. 3061 was approved in the House on December 19 and in the Senate on December 20.

Comparison of Major Provisions from House and Senate Labor, HHS, and Education Appropriations Bills as Reported and the Conference Action

Senate Amendments from Floor Debate

Stem Cell Research: Continued a provision to prohibit the use of funds in the act concerning research involving human embryos, but would have added a new section to it as follows: "(c) Subject to the provisions in section 510 (a) and (b), Federal dollars are permitted, at the discretion of the President, solely for the purpose of stem cell research, on embryos that have been created in excess of clinical need and will be discarded, and donated with the written consent of the progenitors." The new section was deleted in Senate floor action.

Conference Bill and Report Language

National Institutes of Health
Highlights of the FY 2002 Appropriations Conference Bill

The Conference agreement provides $23.285 billion for NIH, an even split between the budget authority provided by the House and Senate and $2,990 million (14.7 percent) above FY 2001. The program level is $22.888 billion (a 14.4-percent increase) once a $100 million transfer to the global AIDS fund and evaluation taps are taken into account.

Conference Bill Language

NIAID: Gives the NIH Director authority to transfer $25 million to the International Assistance Programs, Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis, as proposed by the House.

National Institute of Biomedical Imaging and Bioengineering (NIBIB): Conference provides separate appropriation of $112 million and adjusts the FY 2001 base to reflect the transfers comparably.

NCRR: Conference provides $110 million for extramural facilities construction grants, including a $5 million earmark for the Chimp Sanctuary as authorized in P.L. 106-551.

Office of the Director (OD):

• Retains Director's 1-percent transfer authority.
• Retains language for third party payment.
• Does not include Foundation funding.
• Earmarks $53.5 million for the Office of AIDS Research (OAR).
• DHHS, Public Health and Social Services Emergency Fund: This agreement includes $243 million for the Public Health and Social Services Emergency Fund, none of which is designated for NIH.

B&F:

• Provides $26 million for John Edward Porter Neuroscience Research Center and full-scope language for first and second phases of the Center construction.
• Allows the Director of NIH discretion to transfer up to $75 million to International Assistance Programs, Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis.

Office of the Secretary: Provides $22 million for an IT security and innovation fund.

General Provisions:

• Retains Executive Level I Salary Cap.
• Allows for a 1.25-percent evaluation tap.
• The conferees identified a total of $297 million for evaluation.
• The Secretary of HHS may transfer not more than 3 percent between appropriations; however, with House and Senate approval, an appropriation can increase by an additional 2 percent.
• The Directors of NIH and OAR retain authority to transfer up to 3 percent between Institute and Centers (ICs) for AIDS research.
• Does not include any delayed obligations as proposed by the House.
• Reduces $25 million across the board for administrative and related expenses across three cabinet departments.
• Retains provision that the current Director retain the title of Acting Director until a new Director is confirmed by the Senate.
• Retains identical human embryo language from FY 2001 Labor, HHS Education Appropriations bill.

Conference Report Language

NIBIB: Conferees expressed concern that the number of research grants to be transferred to NIBIB is inconsistent with previous assessments of NIH support for basic biomedical imaging and bioengineering. Conferees support the creation of a joint NIH extramural task force to reevaluate the transfer of additional grants to the new Institute.

NCRR: Provides, within appropriated funds, a total of $160 million for the IDeA program and $272 million is provided for GCRCs.

Office of the Director (OD):

Allocates, within appropriated funds, $10.3 million for the Office of Rare Diseases and $17 million for the Office of Dietary Supplements.

The conferees note that proposed funding levels in the House and Senate for specific diseases are intended only to express relative priority and are not funding earmarks.

For institutions affected by the Houston flood, NIH is strongly encouraged, to the extent practical, to provide 1-year extensions to the investigators at these institutions.

NIH is to submit a written progress report to the House and Senate Committees on Appropriations on efforts to expand the National Disease Research Interchange Program.

Office of the Secretary:

Conferees provide $1 million to launch a public awareness campaign regarding the availability of spare embryos for couples to adopt.

The Secretary of HHS is encouraged to develop a national strategy that encourages collaborative research entrepreneurship. The Secretary is further urged to consider the scientific expertise at NIBIB to execute a strategy to consider the establishment of a center for tissue engineering and regenerative medicine through the extramural research program.

DHHS, Public Health and Social Services Emergency Fund

As described in the conference report H.R. 3338, the U.S. Department of Defense Appropriations Act, 2002, provides $2.504 billion for the DHHS, Public Health and Social Services Emergency Fund, of which $85 million is for bioterrorism-related research and development at NIAID, $70 million for construction of biosafety laboratories at NIAID, and $71 million for improving laboratory security at NIH and CDC. The bill also includes $10.5 million for NIEHS "for carrying out under current authorities, worker training, research, and education activities," which "shall remain available until expended" in response to the September 11 terrorist attacks. [Note: H.R. 3338 was signed into law on January 10, 2002, as P.L. 107-117.]

House Bill and Report Language

House Appropriations Action

Major highlights of the FY 2002 House Labor, HHS, and Education Appropriations bill, H.R. 3061, and accompanying House Report 107-229 are as follows:

National Institutes of Health
Highlights of the FY 2002 House Bill

House Bill Language

Transfer Authorities: Transfer authorities would remain consistent with FY 2001 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 OAR may transfer up to 3 percent of funds identified as HIV/AIDS.

AIDS: As has been done for the past several years, there is no separate AIDS allocation by IC.

Delayed Obligations for FY 2002: "Of the funds appropriated for the National Institutes of Health for Fiscal Year 2002, $2,875,000,000 shall not be available for obligation until September 30, 2002."

Foundation: No funds are provided for the Foundation for NIH.

Salary Cap: Modifies the limitation on the extramural salary cap by changing the Executive Level I included in FY 2001 to Executive Level II.

Global AIDS: The Director of NIH is authorized to "transfer up to $25,000,000 to International Assistance Programs, 'Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis,' to remain available until expended," which will come from NIAID. The Director of NIH is also authorized to "transfer up to $75,000,000 to International Assistance Programs, ‘Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis,' to remain available until expended," which will come from B&F.

Extramural Construction: NCRR extramural construction is earmarked at $97 million, $22 million above the FY 2001 level. Of the $97 million, $5 million is earmarked for beginning construction of facilities for a Chimp Sanctuary system as authorized in Public Law 106-551.

Buildings and Facilities (B&F): Full-scope contracting authority language is included for the neurosciences construction project; would provide $26 million for the John Edward Porter Neuroscience Research Center.

Evaluation: Continues a provision to prohibit the Secretary of HHS from using evaluation set-aside funds until the Committee receives a report detailing the planned use of such funds.

Secretary's Transfer Authority: Modifies a provision included in last year's bill to provide the Secretary of HHS with 1-percent transfer authority of discretionary funds but changes the amount an appropriation can be increased to 10 percent.

Human Embryo Prohibition/Stem Cell: Continues a provision to prohibit the use of funds in the act concerning research involving human embryos; includes report language to clarify that the HER prohibition "should not be construed to limit federal support for research involving human embryonic stem cells listed on an NIH registry and carried out in accORDance with policy outlined by the President."

House Report Language

No Disease-Specific Earmarks: The Committee maintained its policy of resisting disease-specific earmarks in the bill and report but noted that "NIH has testified that its allocation will allow increases above the overall NIH level for research related to Parkinson's disease, Alzheimer's disease, diabetes and cardiovascular disease, among others."

Rejection of Set-Aside Increase: The budget proposed to increase the Public Health Service evaluation tap from 1 to 2 percent. The Committee did not agree to this proposal but rather adjusted the appropriation for each IC based on a 1-percent evaluation tap amount and provides each IC with the same program level as requested by the President.

Pay Increase: Within the funds provided, the Committee assumes a 4.6-percent pay increase.

Behavioral Research: The Committee requests NIH to report back with a plan for a coordinated system of increased training in basic and applied behavioral and social research.

Bayh-Dole Act: The Committee supports the principles of the Bayh-Dole Act with respect to the utilization, commercialization, and public availability of Government-funded inventions. The Committee encourages NIH to offer guidance to both funding recipients and their commercial sponsors to find the appropriate balance between these potentially competing interests of availability of scientific information and the need to protect legitimate proprietary interests and to preserve incentives for commercial development.

Loan Repayment: The Committee has provided funds for the Loan Repayment Program and requests data on the number of applications as of May 1, 2002, as well as the number and size of awards made as of September 1, 2002.

Human Stem Cell Research: "It is the Committee's intent that the NIH move ahead expeditiously to implement the President's policy concerning support of scientifically meritorious research involving both adult and human embryonic stem cells. The Committee commends the NIH for moving quickly to negotiate material transfer agreements with holders of existing embryonic cell lines. The Director is requested to keep the Committee apprised of program initiatives as well as research progress concerning both adult and embryonic stem cells."

Parkinson's Disease: The Committee strongly urges the Director to work toward the implementation of the 5-year Parkinson's disease research agenda.

Pediatric Research: Within the total provided to NIH, the Committee believes adequate funds are available to continue implementing this activity.

Research to Improve Efficiency and Reduce Costs of Health Care: The Committee urges NIH to work with the Agency for Healthcare Research and Quality (AHRQ) to find the methods of evaluation and treatment that will reduce health care costs without sacrificing quality.

Veterans Administration (VA) Cooperation: The Committee urges NIH to explore ways to increase cooperative research efforts with the VA.

Senate Bill and Report Language

Senate Appropriations Action

Major highlights of the FY 2002 Senate Labor, HHS, Education Appropriations bill, S. 1536, and accompanying Senate Report 107-84 are as follows:

National Institutes of Health
Highlights of the FY 2002 Senate Bill and Report Language

Senate Bill Language

NIBIB: Substantial difference in appropriation levels between House and Senate (House: $39.896 million; Senate: $140 million).

Transfer Authorities: Transfer authorities would remain consistent with FY 2001 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 OAR may transfer up to 3 percent of funds identified as HIV/AIDS.

AIDS: As has been done for the past several years, there is no separate AIDS allocation by IC.

Delayed Obligations for FY 2002: No delayed obligations as included by the House.

Foundation: The Foundation is provided $500,000.

Salary Cap: Retains extramural salary cap at the Executive Level I included in FY 2001.

Global AIDS: For Global AIDS, $25 million is to be transferred from NIAID and $70 million is to be transferred from NIH's B&F account for "Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis." The remaining $5 million would be taken from DHHS General Departmental Management.

NCRR:

Extramural Construction: NCRR extramural construction is earmarked at $125 million, $28 million above the House passed level and an increase of $50 million over the FY 2001 appropriation.

GCRCs: The Committee has provided $275 million for the GCRC program.

IDeA Grants: The Committee has provided $200 million for the IDeA program.

B&F: Full-scope contracting authority language is included for the neurosciences construction project; would provide $26 million for the John Edward Porter Neuroscience Research Center, and $53 million is earmarked for the animal vivarium.

Embryo Adoption Awareness (Office of the Secretary/General Departmental Management): "The Committee directs the Department to launch a public awareness campaign to educate Americans about the existence of these spare embryos and adoption options. The Committee has provided $1,000,000 for this purpose."

Evaluation: Continues a provision to prohibit the Secretary of HHS from using evaluation set-aside funds until the Committee receives a report detailing the planned use of such funds, and limits the amount that can be used to 2 percent of any amounts appropriated for programs authorized for the evaluation. (This represents an increase in the statutory limit for the policy evaluation set-aside from 1 to 2 percent, but no specific bill language amounts designated for PE in AHRQ or CDC. Budget authority is provided for AHRQ instead.)

NIH Director Title: Continues a provision allowing the Acting Director of NIH to remain in that position until a new Director is confirmed (using the title of Acting Director, NIH).

Secretary's Transfer Authority: Continues the Secretary's 1-percent transfer authority, such that no appropriation may be decreased by more than 1 percent nor increased by more than 3 percent.

Human Embryo Prohibition/Stem Cell: Continues a provision to prohibit the use of funds in the act concerning research involving human embryos, but adds a new section to it as follows: "(c) Subject to the provisions in section 510 (a) and (b), Federal dollars are permitted, at the discretion of the President, solely for the purpose of stem cell research, on embryos that have been created in excess of clinical need and will be discarded, and donated with the written consent of the progenitors."

Senate Report Language

Reprogramming Directive—General: "The Committee directs that the Departments and agencies funded through this bill make a written request to the chairman of the Committee prior to reprogramming of funds in excess of 10 percent, or $500,000, whichever is less, between programs, activities, or elements unless an alternate amount for the agency in question is specified elsewhere in this report. The Committee desires to have the requests for reprogramming actions which involve less than the above-mentioned amounts if such actions would have the effect of changing an agency's 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. The Committee directs that it be notified regarding reorganization of offices, programs, or activities prior to the planned implementation of such reorganizations. The Committee further directs that each agency under its jurisdiction submit to the Committee statements on the effect of this appropriation act within 60 days of final enactment of this act."

Reprogramming Directive—NIH: 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 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.

Transfer Authority: The Committee included bill language permitting transfers up to 1 percent between discretionary appropriations accounts, as long as no such appropriation is increased by more than 3 percent by such transfer; however, the Appropriations Committees of both Houses of Congress must be notified at least 15 days in advance of any transfer. (Similar bill language was carried in last year's bill for all three Departments.) Prior Committee notification is also required for actions requiring the use of general transfer authority unless otherwise provided for in this act. Such transfers specifically include taps, or other assessments, made between agencies or between offices within agencies. "Funds have been appropriated for each office funded by this Committee; it is not the intention of this Committee to augment those funding levels through the use of special assessments." This directive does not apply to working capital funds or other fee-for-service activities.

Doubling: The Committee reiterates its history of support for doubling and notes that the increase provided maintains the goal of doubling funding for NIH by FY 2003.

Autism: The Committee "wishes to see the meaningful implementation of the new Centers of Excellence" in autism research, mandated in the Children's Health Act of 2000.

Behavioral Science: The Committee also urges NIH to provide a detailed description of its ongoing work in the behavioral sciences, including a breakdown by Institute of funds within each Institute used for research and training activities included in NIH's behavioral and social science portfolio.

Clinical Research Loan Repayment: The Committee believes that this program should be made available to the largest possible number of health professionals who are pursuing structured training experience in clinical research, actively engaged in clinical research career development activities with the guidance of a mentor, or conducting clinical research with independent support from NIH.

Mississippi Delta: The Committee urges NIH to pursue a comprehensive medical research agenda with academic institutions in the Mississippi Delta that have partnered together to develop initiatives and research projects focusing on the disproportionate disease-risk factors and high rates of morbidity in this health-challenged region. The Committee requests a report by March 1, 2002, on what comprehensive study should be undertaken, when the research will begin, and with what institutions the NIH will partner.

Office of Dietary Supplements: The Committee expects the Office to allocate sufficient funds to expand the number of Botanical Research Centers, and it urges that hypericum and echinacea be studied at one of these new Centers.

Parkinson's Disease: The Committee states that a $143.5 million increase over the baseline year would be needed to implement Year 2 of the Parkinson's disease research agenda, and "the Committee has provided additional funds for that purpose." In addition, the Committee directs NIH to host a series of consortia in collaboration with the Parkinson's research-related Institutes and the extramural research community by February 15, 2002.

Embryo Adoption: The Committee has included $1 million for a public awareness campaign to educate Americans about the existence of spare embryos and adoption options.

Stem Cell Research: "The Committee urges NIH to move quickly to support all types of stem cell research, including embryonic, adult, and cORD blood, and to keep the Committee informed of the research progress. The Committee understands that it may take several years to translate research on these cells into therapies. Therefore, it directs the National Institutes of Health [NIH] to award grants for human embryonic stem cell research as quickly as possible, in strict compliance with ethical guidelines (from introductory section of report)."

Veterans Administration (VA) Cooperation: The Committee urges NIH to explore ways to increase cooperative research efforts with the VA.

Continuing Resolutions

List of FY 2002 Continuing Resolutions