109th Congress

Appropriations for the National Institutes of Health, Fiscal Year 2007

H.R. 5647, H. Rept. 109-515, S. 3708, S. Rept. 109-287; P.L. 109-289; P.L. 109-369; P.L. 109-383

Background

On February 6, 2006, the President released the fiscal year (FY) 2007 budget with the program level for the National Institutes of Health (NIH) proposed at $28.587 billion, the same as the FY 2006 program level. NIH’s President’s budget authority request to the Appropriations Subcommittee on Labor, Health and Human Services (HHS), Education and Related Agencies was $28.350 billion. The budget authority request to the Appropriations Subcommittee on Interior, Environment and Related Agencies was $78 million for the National Institute of Environmental Health Sciences (NIEHS) Superfund research program. The NIH program level also includes $150 million for the Type I Diabetes Initiative, appropriated by P.L. 107-360.

The 2006 election marked a dramatic change in a Congress that has been in place for more than a decade. The Democrats accomplished their takeover of both chambers of Congress by netting the six Senate seats needed for a 51 to 49 majority, including Democratic-aligned Vermont Independent Bernard Sanders and Independent Democrat Joseph I. Lieberman of Connecticut, and by nearly doubling the 15-seat net gain they needed to claim control of the House, with a projected ratio of 231 Democrats to 204 Republicans. The November election changed the landscape for further appropriations action, resulting in the passage of a second continuing resolution immediately following the election, followed by a third continuing resolution after the Thanksgiving recess that will provide funding for the agencies without enacted appropriations through February 15, 2007, and into the 110th Congress, when the Democrats will take over the leadership in the House and Senate.

CONTINUING RESOLUTIONS

1. Continuing Resolution (through 11/17/06)       P.L. 109-289, 9/29/06
2. Continuing Resolution (through 12/8/06)       P.L. 109-369, 11/17/06
3. Continuing Resolution (through 2/15/07)       P.L. 109-383, 12/09/06

HOUSE ACTION

On June 13, 2006, the House Committee on Appropriations marked up and reported out H.R. 5647, the House Appropriations Subcommittee on Labor, HHS, Education and Related Agencies appropriations bill for FY 2007, without change to the Subcommittee-reported version, which was marked up on June 7. NIH would receive an appropriation of $28.350 billion, which is equal to NIH’s President’s budget authority request. House floor action was scheduled for June 21; however, the bill was pulled, in large part because the Minority Whip, Representative Steny H. Hoyer (D-MD), successfully offered an amendment to the bill that would raise the minimum wage by $2.10, to $7.25, over 2 years, and was not brought to the House floor before the close of the 109th Congress.

The House FY 2007 appropriations bill included language from last year’s bill identifying a maximum of $332 million that may be transferred from NIH Institutes and Centers (ICs) to the Common Fund; earmarks of $159.5 million for the advanced development of biodefense countermeasures and $96.030 million for activities related to countering potential nuclear, radiological, and chemical threats; an earmark of $69 million for the National Institute of Child Health and Human Development (NICHD) for the continuation of the National Children’s Study (NCS); and language that would require all investigators funded by NIH to “submit an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication to the NIH National Library of Medicine’s PubMed Central as soon as practicable but no later than 12 months after the official date of publication.”

SENATE ACTION

On July 20, the Senate Committee on Appropriations marked up and reported out S. 3708, the Senate Appropriations Subcommittee on Labor, HHS, Education and Related Agencies appropriations bill for FY 2007, without change to the Subcommittee-reported version, which was marked up on July 18. The bill included $28.5 billion for NIH, an increase of approximately $200 million over the President’s request and the House-reported level, excluding the Global HIV/AIDS Fund transfer. The bill did not reach the Senate floor before the November elections, nor before adjournment.

The Senate FY 2007 appropriations bill included a maximum of $332 million that may be transferred from ICs to the Common Fund; earmarks of $159.5 million for the advanced development of biodefense countermeasures and $96.030 million for activities related to countering potential nuclear, radiological, and chemical threats; $100 million that may be made available from the National Institute of Allergy and Infectious Diseases (NIAID) for the International Assistance Programs Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis; new bill language permitting funds appropriated to ICs to be expended for improvements and repairs of facilities, not to exceed $2.5 million per project; and report language stating that “the Committee supports full and timely implementation of the Study [NCS] and has included funds within the Office of the Director to continue the study...the leadership of the NCS is urged to bring in additional objective scientific expertise to assess the scientific merit of the study components. The Committee further urged the NIH to coordinate the involvement of the Departments, the lead Federal partners and other interested institutes, agencies and non-Federal partners conducting research on children’s environmental health and development, such that this study is ready for the field by no later than 2007.”

A comparison chart of House and Senate provisions is provided below. Summaries of the House and Senate hearings and a more complete description of major features of the House and Senate appropriations bills can be found in the attachments.

Status and Outlook

On June 13, 2006, the House Committee on Appropriations marked up and reported out H.R. 5647, the House Appropriations Subcommittee on Labor, HHS, Education and Related Agencies appropriations bill for FY 2007. On July 20, the Senate Committee on Appropriations marked up and reported out S. 3708, its FY 2007 appropriations bill. In the absence of enacted appropriations, Congress has passed three continuing resolutions (CRs) to provide funding for NIH and other agencies. Floor action did not occur on either H.R. 5647 or S. 3708, and final action on the FY 2007 Labor, HHS, Education and Related Agencies appropriations now will not occur until the 110th Congress convenes. On December 11, Senator Robert C. Byrd (D-WV) and Representative David R. Obey (D-WI), who will lead the Senate and House Appropriations Committees, respectively, when the new Congress convenes, issued a joint statement indicating that they plan to pass a year-long continuing resolution.

COMPARISON OF HOUSE AND SENATE PROVISIONS IN FY 2007 BILLS

¹ Text of Section 216 (Flexible Research Authority):

“SEC. 216. (a) AUTHORITY—Notwithstanding any other provision of law, the Director of the National Institutes of Health may use funds available under section 402(i) of the Public Health Service Act (42 U.S.C. 282(i)) to enter into transactions (other than contracts, cooperative agreements, or grants) to carry out research in support of the NIH Roadmap for Medical Research.

(b) PEER REVIEW—In entering into transactions under subsection (a), the Director of the National Institutes of Health may utilize such peer review procedures (including consultation with appropriate scientific experts) as the Director determines to be appropriate to obtain assessments of scientific and technical merit. Such procedures shall apply to such transactions in lieu of the peer review and advisory council review procedures that would otherwise be required under sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and 494 of the Public Health Service Act (42 U.S.C. 241, 284(b)(1)(B), 284(b)(2), 284a(a)(3)(A), 289a, and 289c).”

ATTACHMENT 1

FY 2007 Hearings

House Appropriations Hearing, April 6, 2006

The April 6 hearing, chaired by Representative Ralph Regula (R-OH), was attended by 5 of the 10 Republican members and all the Democratic members. All Members but Representatives Regula and Anne M. Northup (R-KY) spoke in favor of an increase for NIH but acknowledged the limitations faced by the Chair, given the pending House Budget Resolution, which was on the floor at the time of the hearing.

Dr. Elias Zerhouni testified about the remarkable improvements in medical treatment over the past 30 years as a result of the investment of Congress in NIH. He emphasized that the doubling period, in particular, had accelerated research to the point that we are poised to use NIH-supported discoveries to transform the medical treatment paradigm in the 21st century from one that responds to symptoms to one that predicts disease, personalizes treatment, and preempts disease, striking disease before it strikes the patient.

Aside from the budget, major issues from the hearing were the absence in the budget of funding for the NCS; Representative Dave Weldon’s (R-FL) concerns about the possible link between the vaccine preservative thimerosal and increasing autism rates and his support for the current relevant NIEHS and NIAID studies; declining support for the IDeA program; support for public access and the need for a mandatory program; status of the Specialized Programs of Research Excellence in Ovarian Cancer; and a question from Representative Patrick J. Kennedy (D-RI), who asked whether NIH supports legislation to prevent genetic discrimination against patients whose medical records contain information about their genetic predispositions.

Senate Appropriations Hearing, May 19, 2006

Senator Arlen Specter (R-PA) presided over a 45-minute hearing on May 19 with NIH witnesses, followed by 1 hour of 90-second statements by 20 witnesses representing many of the major organizations supportive of NIH research. Senators Specter, Tom Harkin (D-IA), and Richard C. Shelby (R-AL) each decried the flat budget proposed for FY 2007, with Senator Specter stating that the NIH budget has already been cut by 10.4 percent in the last 2 years. Senator Shelby twice said, “I’m going to do everything I can as a member of the Appropriations Committee to help fund, properly fund, medical research through NIH.”

Dr. Zerhouni testified about the remarkable improvements in medical treatment over the past 30 years as a result of the investment of Congress in NIH. He emphasized that the doubling period, in particular, had accelerated research to the point that we are poised to use NIH-supported discoveries to transform the medical treatment paradigm in the 21st century from one that responds to symptoms to one that predicts disease, personalizes treatment, and preempts disease, striking disease before it strikes the patient. Dr. Zerhouni provided a passionate portrayal of the Agency’s past successes and a vision for the future of medicine. He testified that the per capita investment by Americans in NIH was relatively small in comparison with the achievements of medical research and the rising cost of health care.

Major issues from the hearing included the proposed budget and its ramifications for NIH programs, with the first question from the Chair asking Dr. Zerhouni how he will “continue to deliver when you’ve had more than a 10-percent decrease considering inflation, which amounts to about $3 billion.” Dr. Zerhouni responded that it is difficult to support research without a sustained investment over time, and the consequence is that if you “lose purchasing power, the most important impact on the research is loss of scientists.” Senator Specter also asked about the adequacy of funding for the development of a vaccine in the event of pandemic influenza and whether the current funding would permit the cancer genomics initiative to go forward. Senator Harkin asked pointed questions about the lack of funding for the NCS, its priority among other programs, and whether it is really important. Senator Shelby also pressed on the status of research on lupus and treatments for lupus, noting that his wife suffers from lupus.

ATTACHMENT 2

Major Features of the FY 2007 House Appropriations Bill (H.R. 5647) and Report (H. Rept.109-515)

Funding Level: The Committee recommends an appropriation of $28,250,003,000 for NIH, which yields a total program level of $28,258,203,000. This program level is equal to the President’s request, when adjusted for the Global HIV/AIDS Fund transfer.

HOUSE BILL LANGUAGE

• Common Fund: The bill includes language from last year’s bill identifying a maximum of $332 million that may be transferred from ICs to the Common Fund. The language would also require the Director of NIH to report to the House and Senate Committees on Appropriations every 6 months, detailing all deposits to and expenditures from the Common Fund.
• Earmarks: $159.5 million shall be for expenses necessary to support activities related to the advanced development of biodefense countermeasures; $96.030 million for activities related to countering potential nuclear, radiological, and chemical threats to civilian populations; and $14 million for the flexible research authority (FRA).
• NCS: A $69-million earmark in NICHD for continuation of the NCS
• Public Access: “The Director of the National Institutes of Health (NIH) shall require that all investigators funded by the NIH submit an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication to the NIH National Library of Medicine’s PubMed Central as soon as practicable but no later than 12 months after the official date of publication.”
• Human Embryo Research (HER): Continuation of the HER prohibition
• Foundation: $500,000 for the NIH Foundation
• Construction: $25 million for extramural facilities construction for the National Center for Research Resources (NCRR)
• Transfer Authorities: Continuation of transfer authorities for the Director of NIH and Director of the Office of AIDS Research (OAR)
• Transfer Authorities: Continuation of authority for OAR to spend up to $4 million to make grants for construction or renovation of facilities as provided for in Section 2354(a)(5)(B) of the Public Health Service Act
• Extramural Salary Support Limitation: Limitation that the salary of an individual, through a grant or other extramural mechanism, be capped at Executive Level II. (As proposed by the Administration; the conference report for FY 2006 capped salaries at Executive Level I.)
• Evaluation: Limitation that not more than 1 percent of any amounts appropriated for programs authorized under Section 241(a) of the Public Health Service Act shall be made available for the evaluation (directly or by grants or contracts) of the implementation and effectiveness of such programs. (The conference report for FY 2006 permitted up to 2.4 percent.)
• FRA: Continuation of authority for FRA for support of research for the NIH Roadmap
• Scientific Advisory Committees: Continuation of language that none of the funds appropriated can be used to ask a candidate for appointment to a Federal scientific advisory committee to disclose his or her political affiliation or voting history or the position that the candidate holds with respect to political issues not directly related to and necessary for the work of the committee involved and that none of the funds made available in this Act may be used to disseminate scientific information that is deliberately false or misleading
• E-Gov: No funds provided in this Act shall be reprogrammed or transferred from the accounts, object classes, or original purposes for which the funds were provided to the Governmentwide E-Gov Initiative without an approved reprogramming request from the Committees on Appropriations. (New provision)
• Program Assessment Rating Tool (PART): Unless specifically exempted, no funds are provided in this Act to conduct or participate in the conduct of a PART analysis or study unless the House and Senate Committees on Appropriations have approved the study, inclusive of the data on which the analysis will be based, methodology to be employed, and relative weight of each of the four factors that will be assigned to the study in determining a final score. (New provision)

HOUSE REPORT LANGUAGE

• Office of the Director (OD): The Committee recommends a substantial increase to OD for activities that benefit multiple ICs under the Roadmap initiative and recommends corresponding reductions in the budget of each IC as proposed in the budget request.
• Congressional Justification (CJ) Material: The Committee is troubled by the lack of program-level detail displayed for each IC. Therefore, the Committee directs NIH to include additional information for each IC for which funding is requested in its FY 2008 budget submission (specifics are listed in the report).
• Director’s Discretionary Fund (DDF): $120.7 million for the DDF, which is the same as the request and $28.63 million above the FY 2006 appropriation
• Biodefense: $159.5 million to OD for the advanced development of biodefense countermeasures
• Representational Expenses: $10,000, as requested by the Administration for representation allowances when specifically approved by the Director of NIH
• Office of Portfolio Analysis and Strategic Initiatives (OPASI): $3 million for OPASI, as requested by the Administration. “The Committee believes that OPASI is a critical mechanism to review the NIH research portfolio as a whole, to address the issues raised by external groups about the coding of diseases for funding reporting, and, most importantly, as a tool to help direct future research efforts in order to maximize the significant public investment in biomedical research to cure disease.”
• Priority Setting: Each IC is directed to develop a report, to be submitted no later than February 15, 2007, that identifies, by IC, measures to be taken to ensure that awards made via the peer-review process in FY 2007 and beyond reflect the strategic plans that have been published by each IC in conjunction with the extramural community.
• Autism and Vaccines: The Committee encourages NIH to dedicate significant resources to pursue the recommended research initiatives outlined in the Institute of Medicine’s Immunization Review. These reports have identified the research needed to better understand why a number of children suffer severe adverse reactions to childhood vaccines.
• Lymphatic Research and Lymphatic Diseases: In light of the transformational impact of lymphatic biology and disease research, which requires the participation of multiple ICs, the Committee encourages the Director of NIH to give careful consideration to the development of an initiative for lymphatic biology and disease under the auspices of OPASI.
• Microbicides: The Committee encourages greater emphasis on microbicide research and development at NIH. The Committee has long advocated that NIH establish a dedicated microbicide unit with clearly identified leadership, funding, and staffing to accelerate and coordinate NIH-supported microbicide research.
• Parkinson’s Disease (PD): The Committee continues to encourage NIH to develop a strategic plan for future investments in PD research, based on the findings of a planning conference tasked with identifying the current shortcomings and future opportunities for more effective treatments and potential cures for the disease, and a clearly defined budget for achieving those objectives.
• Study of Gender Differences: Recent findings have demonstrated that significant differences between men and women exist in health and disease, and one of the fields where such differences are most pronounced is neuroscience. The Committee encourages each of the 15 Institutes involved in the NIH Neuroscience Blueprint to carefully analyze the entire NIH Neuroscience Blueprint research portfolio to ensure that gender is included as a variable, when appropriate, and to require that all reported results include gender-specific analysis. The Committee requests a written report from the Director of NIH that includes information on the progress of these efforts by all 15 NIH Neuroscience Blueprint Institutes prior to the FY 2008 hearings.
• NIAID: The Committee did not include bill language requested by the Administration to permit the transfer of $100 million to the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Instead the Committee recommends an increase of $130 million above the FY 2006 appropriation for the Health Resources and Services Administration and Centers for Disease Control and Prevention (CDC) domestic HIV/AIDS programs and has provided $121.952 million for global HIV/AIDS activities at CDC. The Committee recommendation does not include bill language that would provide $25 million for the construction of extramural facilities for research on infectious agents and countermeasures. The Committee understands that these funds are intended to support new facilities rather than the completion of laboratories that are already partially constructed; therefore, the Committee has provided the requested $25 million to NCRR for open competition among all institutions, rather than a competition specifically aimed at infectious agents.
• NICHD: Report language expressed disappointment that the proposed elimination of funding for the NCS is mentioned only in passing in the Items of Significant Interest section and nowhere else in NIH’s FY 2007 justification material. As a result, “the Committee has included bill language directing NICHD to dedicate $69,000,000 from within funds provided to continue the National Children’s Study, including funding all Vanguard Centers and any other activities that were planned for fiscal year 2007. If NIH wishes to request that Congress discontinue the study in future fiscal years, the Committee directs that a complete justification of the reasons for terminating the study accompany the budget request, rather than one sentence tucked away in response to prior year report language.”
• NCRR/General Clinical Research Centers (GCRCs)/Clinical and Translational Science Awards (CTSAs): Supportive language for this venture is included, and a report on progress is requested. A total of $215.938 million is provided for the Institutional Development Award (IDeA) program, which is the same as the budget request. “The Committee recognizes the importance of the Centers of Biomedical Research Excellence (COBRE) and the IDeA Networks of Biomedical Research Excellence (INBRE) programs, and expects funding for COBRE to be at a level of at least $130,000,000 and INBRE funding to be at least $85,000,000.”

Major Features of the FY 2007 Senate Bill (S. 3708) and Report (S. Rept. 109-287)

Funding Level: The Committee recommends an appropriation of $28,550,667,000 for NIH. This amount is $220.820 million above the FY 2006 appropriation and $200.664 million over the budget request.

SENATE BILL LANGUAGE

• Common Fund: The Committee includes bill language from last year’s bill identifying a maximum of $332 million that may be transferred from ICs to the Common Fund, which supports activities that are of benefit to multiple ICs. The language also requires the Director of NIH to report to the House and Senate Committees on Appropriations every 6 months, detailing all deposits to and expenditures from the Common Fund. (Same as the House bill)
• Earmarks: $159.5 million shall be for expenses necessary to support activities related to the advanced development of biodefense countermeasures; $96.030 million for activities related to countering potential nuclear, radiological, and chemical threats to civilian populations; $14 million for FRA; and $10,000 as requested by the Administration for representation allowances when specifically approved by the Director of NIH. (Same as the House bill)
• NIAID: $100 million “may be made available to International Assistance Programs, the Global Fund to Fight HIV/AIDS, Malaria, and Tuberculosis, to remain available until expended.” (Not included in the House bill)
• NCS: Instead of bill language, report language stating that “The Committee supports full and timely implementation of the Study [NCS] and has included funds within the Office of the Director to continue the study . . . the leadership of the NCS is urged to bring in additional objective scientific expertise to assess the scientific merit of the study components. The Committee further urges the NIH to coordinate the involvement of the Departments, the lead Federal partners and other interested institutes, agencies and non-Federal partners conducting research on children’s environmental health and development, such that this study is ready for the field by no later than 2007.” (The House bill language includes a $69-million earmark within NICHD for the study.)
• Public Access: No bill or report language. (The House bill would require that “the Director of the National Institutes of Health (NIH) shall require that all investigators funded by the NIH submit an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication to the NIH National Library of Medicine’s PubMed Central as soon as practicable but no later than 12 months after the official date of publication.”)
• HER: Continuation of the HER prohibition (Same as the House bill)
• Foundation: $500,000 for the NIH Foundation (Same as the House bill)
• Construction: $25 million for extramural facilities construction for NIAID “to enhance the Nation’s capability to do research on biological and other agents.” (The House bill proposes to transfer $25 million from NIAID to NCRR.)
• Transfer Authorities: Continuation of transfer authorities for the Director of NIH and Director of OAR (Same as the House bill)
• Transfer Authorities: Continuation of authority for OAR to spend up to $4 million on grants for construction or renovation of facilities as provided for in Section 2354(a)(5)(B) of the Public Health Service Act (Same as the House bill)
• Extramural Salary: Limitation that the salary of an individual, through a grant or other extramural mechanism, be capped at Executive Level I. (The House bill proposes Executive Level II, as proposed by the Administration; the conference report for FY 2006 capped salaries at Executive Level I.)
• Improvements and Repairs: Funds appropriated by this Act to NIH ICs may be expended for improvements and repairs of facilities, as necessary for the proper and efficient conduct of the activities authorized herein, not to exceed $2.5 million per project. (New provision, not included in the House bill)
• Evaluation: Limitation that not more than 2.4 percent of any amounts appropriated for programs authorized under Section 241(a) of the Public Health Service Act shall be made available for the evaluation (directly or by grants or contracts) of the implementation and effectiveness of such programs. (The House bill would limit the evaluation tap to 1 percent; the conference report for FY 2006 permitted up to 2.4 percent.)
• FRA: Continuation of authority for FRA for support of research for the NIH Roadmap (Same as the House bill)
• Scientific Information: Continuation of language for the Office of the Secretary, General Departmental Management, requiring that “scientific information requested by the Committees on Appropriations and prepared by government researchers and scientists shall be transmitted to the Committees on Appropriations, uncensored and without delay” (Included in the FY 2006 Conference-reported measure but not in the FY 2007 House bill)
• Scientific Advisory Committees: Continuation of language that none of the funds appropriated can be used to ask a candidate for appointment to a Federal scientific advisory committee to disclose his or her political affiliation or voting history or the position that the candidate holds with respect to political issues not directly related to and necessary for the work of the committee involved and that none of the funds made available in this Act may be used to disseminate scientific information that is deliberately false or misleading (Same as the House bill)

There is no language about E-Gov or PART in the Senate bill, as is included in the House bill.

SENATE REPORT LANGUAGE

• OD: The Committee recommends a substantial increase to OD for activities that benefit multiple ICs under the Roadmap initiative and recommends corresponding reductions to the budget of each IC as proposed in the budget request.
• CJ Material: An important tool in the oversight process is the justification material submitted to the Committee. Prior to the development of next year’s budget justifications, the Committee expects to work with NIH officials to develop a more consistent format that affords increased transparency for NIH research activities, both ongoing and proposed, and provides greater accountability for research dollars. (Similar but more explicit language is included in the House report.)
• Mission Statements: The Committee has eliminated any references in this report to the mission of individual ICs. Moreover, the Committee expects that research will not be discouraged, nor will collaboration be hampered, by artificial barriers. (No similar language in the House report)
• Biomedical Research and Development Price Index: The Committee believes that, to the extent that resources allow, NIH should follow its cost management plan principles, which will help NIH continue to maintain the purchasing power of the research in which it invests.
• Human Embryonic Stem Cell Research: “The Committee strongly urges the administration to modify the current embryonic stem cell policy so that it provides this area of research the greatest opportunity to lead to the treatments and cures for which we are all hoping . . . The Committee also strongly urges that the NIH explore all avenues of stem cell research including adult stem cells and alternative methods of establishing human embryonic stem cell lines that do not involve the destruction of an embryo . . . The Committee strongly urges the NIH to commit a substantial amount of resources to all methods of human embryonic stem cell research. Finally, the Committee expects the NIH to provide detailed reporting on funding for all forms of stem cell research in future congressional budget justifications.” (No similar language in the House report)
• NIH Common Fund: The Committee included bill language requested in the President’s Budget to provide additional transfer authority for the NIH Common Fund. “The Committee believes that the amounts transferred from the Institutes and Centers to the NIH Common Fund should reflect a uniform percentage of the transfer amount.”
• Ombudsman: “The Committee understands that, with the exception of a limited number of topics such as the treatment of human subjects, neither the NIH nor the Department has a structure in place to process and address complaints by investigators and others about the ways in which NIH-funded research activities are conducted. In an agency with an annual appropriation of more than $28,000,000,000, this is not acceptable. The Committee strongly urges the NIH to put in place a structure in which complaints about NIH-funded grants and other activities can be evaluated objectively.” (No similar language in the House report)
• Clinical Research Databases: The Committee is aware that NIH is establishing large, validated databases to measure patient-reported outcomes from clinical trials that cover a wide range of chronic diseases and demographic characteristics. NIH is urged to create databases to measure and track outcomes for surgical procedures in order to establish common data standards and facilitate comparisons among surgical clinical research studies. A report on the development of these surgical databases is expected in the FY 2008 congressional budget justifications.
• Gene Therapy Research: In 2005, the Committee urged the Director of NIH to assess the prospects for the most promising areas for breakthroughs in this field and develop an aggressive program to focus resources on those areas. A meeting was convened on the topic, but the Committee believes that more focused and aggressive action is needed. NIH is strongly urged to develop a plan for assessing the prospects for success in Cooley’s anemia and a broad range of diseases, with the goal of curing a single gene disorder in the shortest possible time through the use of gene therapy.
• Biodefense: $159.5 million to OD for the advanced development of biodefense countermeasures
• OPASI: $3 million for OPASI, as requested by the Administration. “The Committee believes that OPASI is a critical mechanism to review the NIH research portfolio as a whole, to address the issues raised by external groups about the coding of diseases for funding reporting, and, most importantly, as a tool to help direct future research efforts in order to maximize the significant public investment in biomedical research to cure disease.”
• Stroke and Women: “The Committee also encourages and supports NIH’s initiatives toward advancing the organization of stroke care in women, including post-stroke rehabilitation, and the identification of stroke treatment and research centers that would provide rapid, early, continuous 24-hour treatment to stroke victims, including the use of the clot-buster t-PA, when appropriate. Designated areas in medical facilities equipped with the resources and personnel for treating stroke would also promote the early evaluation of innovative stroke treatments. In addition, the Committee recommends all of these important initiatives be subsumed under an NIH mandate for a Women’s Agenda for Stroke Prevention, Diagnosis and Treatment.”
• Lymphatic Research and Lymphatic Diseases: In light of the transformational impact of lymphatic biology and disease research, which requires the participation of multiple ICs, the Committee encourages the Director of NIH to give careful consideration to the development of an initiative for lymphatic biology and disease under the auspices of OPASI. (Same as the House report)
• NCS: The Committee was very disappointed that the President’s Budget proposed to eliminate funding for the NCS. “The Committee supports full and timely implementation of the Study [NCS] and has included funds within the Office of the Director to continue the study. Now that the pilot phase of the project has gotten underway, the Committee believes it is timely to reconsider the scientific strategy to measure environmental exposures and genetic factors. Major scientific advances have occurred in several fields since the National Children’s Study was first authorized, and the leadership of the NCS is urged to bring in additional objective scientific expertise to assess the scientific merit of the study components. The Committee further urges the NIH to coordinate the involvement of the Departments, the lead Federal partners and other interested institutes, agencies and non-Federal partners conducting research on children’s environmental health and development, such that this study is ready for the field by no later than 2007.” (The House bill earmarked $69 million of the NICHD appropriation for the study.)
• PD: The Committee continues to encourage NIH to develop a strategic plan for future investments in PD research, based on the findings of a planning conference tasked with identifying the current shortcomings and future opportunities for more effective treatments and potential cures for the disease, and a clearly defined budget for achieving those objectives. (Same as the House report)
• Study of Gender Differences: Recent findings have demonstrated that significant differences between men and women exist in health and disease, and one of the fields where such differences are most pronounced is neuroscience. The Committee encourages each of the 15 Institutes involved in the NIH Neuroscience Blueprint to carefully analyze the entire NIH Neuroscience Blueprint research portfolio to ensure that gender is included as a variable, when appropriate, and to require that all reported results include gender-specific analysis. The Committee requests a written report from the Director of NIH that includes information on the progress of these efforts by all 15 NIH Neuroscience Blueprint Institutes prior to the FY 2008 hearings. (Same as the House report)
• NCRR/GCRCs/CTSAs: Directive language for this venture is included. “The Committee has included $361,200,000 for clinical research supported by the GCRCs and the CTSAs combined . . . The NIH is encouraged to fully fund up to 8 new CTSA awards rather than the 10 additional new CTSA awards proposed by the NCRR.” Two separate reports are requested. The following language is also included in the OD section: “While the Committee supports the goals of the CTSA, the initiative may result in a diminution of resources currently available to active clinical researchers. The Committee encourages the Director to take steps to ensure that the necessary clinical research infrastructure support is maintained for NIH-funded clinical investigators.” (Language unique to the Senate)
• IDeA: The Committee has provided $215.938 million, the same as the budget request for the IDeA program. (Same amount as the House report)