109th Congress

Appropriations for the National Institutes of Health, Fiscal Year 2006

P.L. 109-149 (H.R. 3010), P.L. 109-148 (H.R. 2863)

Background

On December 30, 2005, the President signed into law the revised conference report accompanying H.R. 3010, the fiscal year (FY) 2006 appropriations bill for the Departments of Labor, Health and Human Services (HHS), and Education, and related agencies as P.L. 109-149. The Senate cleared the bill by a voice vote on December 21; the House adopted the conference report by a vote of 215 to 213 on December 14. Since September 30, the National Institutes of Health (NIH) had been funded for FY 2006 through a series of continuing resolutions.

The revised conference report is nearly identical to the one approved by conferees on November 16, which was rejected by the House on November 17 by a vote of 224 to 209. A day after the House unexpectedly defeated the conference report on the FY 2006 Labor-HHS-Education appropriations bill, the Senate voted to send its conferees for the bill back to the negotiating table with instructions to seek extra funding for low-income energy subsidies and medical research. By a vote of 58 to 36, the Senate instructed its conferees to seek an additional $797 million for NIH in the bill, bringing the overall total for the Agency to the Senate-passed level of $29.4 billion. Senator Richard J. Durbin (D-IL), Minority Whip, offered that motion to instruct. The failure of the House to pass the conference report forced the conferees to reconvene to produce another measure that the House and Senate both would approve. The only changes in the second edition of the conference report involved adding additional funds for rural health programs and correcting a Medicare coverage issue. The revised conference report appropriates $28.6 billion for NIH, an increase of $10.7 million over the FY 2006 request and an increase of $206 million over the comparable FY 2005 budget. However, $100 million of that appropriation will be transferred to the Global HIV/AIDS account.

Provisions of the Legislation/Impact on NIH

The bill continues a number of provisions that have been included in previous years, such as transfer authorities for the Director of NIH, specific authorities for the NIH Roadmap and flexible research authority, a prohibition on human embryo research (with a technical correction in a code citation), continuation of the extramural salary cap at Executive Level I, and continuation of bill language that requires that requests for information on scientific research or any other matter prepared by Government researchers and scientists be transmitted to the Committees on Appropriations "in a prompt professional manner and within the time frame specified in the request, uncensored and without delay."

The bill also includes several new provisions, such as $97 million for biodefense countermeasures not included in either the House or Senate bill; new language not included in the House and Senate bills permitting the Office of AIDS Research (OAR) to use its funding to make grants for the construction or renovation of facilities in order to expand a breeding colony that will serve as a new national resource to breed nonhuman primates for AIDS research; and a general provision as proposed by the Senate pertaining to appointments to a scientific advisory committee, instead of a similar provision included in the House bill. This last provision, similar to the Waxman amendment included in the House action, provides that a candidate for appointment to a Federal scientific advisory committee cannot be required to disclose political affiliation or voting history or the position held with respect to political issues not directly related to, and necessary for, the work of the committee involved. None of the appropriated funds can be used to disseminate scientific information that is deliberately false or misleading.

Eliminated from the bill was an amendment added by Representative Randy Neugebauer (R-TX), which would have prohibited funding for two National Institute of Mental Health grants. The conference agreement does not include bill language granting full-scope authority for the contracting of construction for the first and second phases of the John E. Porter Neurosciences Building, and no funding is provided for extramural facilities construction grants for the National Center for Research Resources (NCRR).

DEPARTMENT OF DEFENSE (DOD) APPROPRIATIONS

At the conclusion of the first session of the 109th Congress, the two appropriations bills left for passage were the Labor-HHS-Education appropriations bill and the DOD appropriations bill. Initially, it was thought that the Labor-HHS-Education bill might be included in the DOD legislation because of unresolved issues such as pandemic influenza and hurricane relief and that pandemic influenza funding would be included in this measure. However, the House leadership wanted all bills passed without consolidation. When the DOD appropriations bill was finally passed, it became the Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006 (P.L. 109-148) and included $3.8 billion for avian influenza preparedness, funding roughly the FY 2006 portion of the Administration's request. These funds include:

• $3.3 billion for the Public Health and Social Services Emergency Fund (PHSSEF) to improve pandemic preparedness. Within that amount, $350 million is provided for upgrading State and local response capacity; $241 million is provided for international activities, disease surveillance, vaccine registries, research, and clinical trials; and $50 million is provided to increase laboratory capacity through the Centers for Disease Control and Prevention (CDC).
• The Department of Health and Human Services is provided with flexibility to use the balance of the funds to support other core preparedness activities, such as expanding the domestic production capacity of influenza vaccine, developing and stockpiling of pandemic vaccines, and stockpiling of antivirals and other supplies for the Strategic National Stockpile necessary for protecting and preserving lives in the event of an outbreak of pandemic influenza.
• The remainder of the funds are provided for international assistance, monitoring and tracking, and research and development.

ACROSS THE BOARD

Since the bill included no new net spending for hurricane disaster assistance and avian influenza preparedness, additional expenditures were offset by a 1-percent across-the-board reduction applied to all FY 2006 discretionary spending with the exemption of Veterans Administration funding, reallocating previously appropriated funds in the Federal Emergency Management Agency's Disaster Relief Fund, and rescissions of unobligated balances. Therefore, there is a 1-percent across-the-board reduction for the NIH total.

Legislative History

CONTINUING RESOLUTIONS

The Federal agencies without enacted FY 2006 appropriations bills, including NIH, operated under a series of Continuing Resolutions:
1) Continuing Resolution (through 11/18/05)       P.L. 109-77, 9/30/05
2) Continuing Resolution (through 12/17/05)       P.L. 109-105, 11/19/05
3) Continuing Resolution (through 12/30/05)       P.L. 109-128, 12/18/05

ADMINISTRATION BUDGET

The President's FY 2006 budget was released on February 7, 2005. The FY 2006 program level for NIH as proposed in this request was $28.845 million, an increase of $196 million or 0.7 percent over the FY 2005 appropriation. The NIH's President's budget authority request to the Appropriations Subcommittee on Labor, HHS, Education and Related Agencies was $28.510 million, an increase of $145 million or 0.5 percent over the FY 2005 level. The budget authority request for the National Institute of Environmental Health Sciences Superfund research program was $80.3 million. This program was previously funded under the House Appropriations Subcommittee on VA-HUD; upon the reorganization of the House and Senate Appropriations Subcommittees, which occurred at the beginning of the 109th Congress, it is now funded by the House Appropriations Subcommittee on Interior, Environment and Related Agencies and the Senate Appropriations Subcommittee on Interior and Related Agencies. The NIH program level also included $150 million for the Type I Diabetes Initiative appropriated by P.L. 107-360. Of this program total, $97.1 million was included in the budget authority request for PHSSEF for research on radiological, nuclear, and chemical threat countermeasures.

House Action

On June 24, 2005, the House passed H.R. 3010, the bill making appropriations for the Departments of Labor, HHS, and Education, and related agencies for the fiscal year ending September 30, 2006, by a vote of 250 to 151. This includes $28,506,805,000 for NIH, which is $142,290,000 above the FY 2005 comparable level. The funding falls $2,929,000 below the President's budget request for NIH for FY 2006, which was $28.5 billion (an increase of $145 million or 0.5 percent over the FY 2005 level). The bill was reported out by the House Appropriations Subcommittee on Labor, HHS, Education and Related Agencies on June 9 and by the full House Committee on Appropriations on June 16. An amendment offered by Representative Dave Weldon (R-FL) in the full Committee markup was narrowly defeated by a vote of 29 yeas to 36 nays. The amendment would have prohibited any entity or institution, private or public, from receiving NIH funds if the entity engaged in human cloning for research or reproductive purposes.

During House floor debate on the bill, two NIH-related amendments passed by a voice vote as part of an en bloc set of amendments offered by Representative Ralph Regula (R-OH), Chair, and agreed to by Representative David R. Obey (D-WI), the Ranking Minority Member. The Neugebauer amendment was removed in conference, but an amendment similar to the Waxman amendment survived conference, as described below.

• The Neugebauer Amendment, sponsored by Representative Neugebauer, reads: "SEC. 5__. None of the funds made available in this Act may be used by the National Institute of Mental Health for any of the following grants: (1) Grant number MH060105 (Perceived Regard and Relationship Resilience in Newlyweds). (2) Grant number MH047313 (Perceptual Bases of Visual Concepts in Pigeons)."
• The Waxman Amendment, sponsored by Representative Henry A. Waxman (D-CA), reads: "SEC. 5__. None of the funds made available in this Act may be used by the Department of Health and Human Services to appoint an individual to a Federal advisory committee on the basis of political affiliation, unless required by Federal statute."

Another amendment, which was withdrawn but on which a colloquy occurred, was offered by Representative Ted Poe (R-TX) and would have defunded NIH and CDC programs related to the "Milk Matters" campaign. In the colloquy between Representatives Poe and Regula, Representative Poe asked, "Mr. Chairman, would the gentleman be willing to work with me and other fiscally responsible colleagues to protect taxpayer money from wasteful spending at the NIH and the CDC, and work with us to ensure that NIH and the CDC spend the money in the way it is appropriated in fiscal year 2006?" The Chair agreed to do so. (Representative Poe subsequently wrote a letter to NIH regarding his concerns and asked for a response.)

There was also a colloquy between Representatives Dennis J. Kucinich (D-OH) and Regula about Gulf War illness. Representative Kucinich wanted to require NIH to study Gulf War illness, and Representative Regula agreed to work with him on this request.

Senate Action

On July 12, 2005, the Senate Appropriations Subcommittee on Labor, HHS, Education and Related Agencies marked up H.R. 3010. The marked-up bill includes $29.415 billion for NIH, an increase of $1.050 billion over the FY 2005 appropriation and $905 million over the President's budget request. On July 14, the Senate Appropriations Committee reported out H.R. 3010 with funding for NIH at the Subcommittee-approved level. The bill was passed by the Senate on October 27.

OTHER ISSUES OF CONCERN IN THE HOUSE AND SENATE REPORTS

House Report

Public Access: The Committee expressed support for NIH's implementation of its public access policy, calling it a "first step toward providing free and timely access to the published results of all NIH-funded biomedical research," but expressed concern that the final policy may not achieve the desired goals. NIH was directed to prepare and submit a detailed report to the Committee and to develop an aggressive education and outreach initiative aimed at informing grant recipients about the policy in an effort to maximize full and prompt participation.

Stem Cell Research: Report language urged NIH to place a high priority on investigating the plasticity and expansion of adult stem cells using more recently discovered multipotent adult stem cells from fat, dental pulp, heart, umbilical cord blood, and olfactory neurons. Furthermore, the Director of NIH, through the new Office of Portfolio Analysis and Strategic Initiatives (OPASI), was urged to consider the distinctions between the various types of adult stem cell research as tools are developed to more accurately categorize and assess expenditures on stem cell research as a whole and to prepare a report compiling the complete range of diseases being treated with all adult stem cells, including umbilical cord blood cells.

PubChem: The report included language stating that "NIH is replicating scientific information services that already exist in the private sector. In order to properly focus PubChem, the Committee urges NIH to work with private sector providers to avoid unnecessary duplication and competition with private sector chemical databases."

Clinical and Translational Science Awards (CTSAs): The report included supportive language for NIH's proposal to address the translation of clinical research and create an academic home to advance the new intellectual discipline of clinical and translational sciences.

National Library of Medicine (NLM) Infrastructure: Now that the preliminary work has been completed, the Committee encouraged the Secretary of HHS to consider the commitment of necessary resources to begin construction of new physical facilities for NLM in order to enable it to keep pace with the rapid increase in medical publishing and biotechnology information research and development.

Stem Cell Research (Section 509): The report stated that the bill continues a provision to prohibit the use of funds for research involving human embryos. "However, this language 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."

Senate Report

Biomedical Research and Development Price Index: The report stated that the Committee has included sufficient funding to enable NIH to fully pay the committed levels on its grants and expressed disappointment that the "budget request's proposed average cost assumptions would keep NIH from purchasing the same amount of research as in fiscal year 2005 with its new research project grants (RPGs), when biomedical inflation, as measured by the Department of Commerce's Biomedical Research and Development Price Index (BRDPI), is taken into account. The funding level recommended by the Committee will permit the average cost of new and competing RPGs to rise by the BRDPI inflator, or 3.2 percent, instead of being held flat, as proposed in the budget request."

CTSAs: "The Committee supports NIH's efforts to integrate NIH's General Clinical Research Centers (GCRCs) and other relevant clinical mechanisms into a new and more efficient single application that results in awards that combine clinical science support with clinical career development and training." The report further requested that NIH'submit a report describing its new award for clinical and translational sciences, which NIH expects to fund in FY 2006; the expected costs in FYs 2006 and 2007; and the specific components of the program and plans for transition from the current funding mechanisms to the new awards. The report "included $327,000,000 for clinical research supported by the GCRCs and the CTSAs combined. The Committee expects the total number of awards for this combined program to remain at 79 in fiscal year 2006."

Human Embryonic Stem Cell Research: The report included language expressing concern that "the current administration policy relating to human embryonic stem cell research is so narrow that it is stifling the pace of stem cell research . . . that with the proper safeguards in place, this field of investigation ought to be widened." Citing the number of stem cell lines available under the current policy, the report stated that 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." It further urged NIH to 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, and to "commit a substantial amount of resources to all methods of human embryonic stem cell research."

Public Access: The report requested a progress report that contains the following information: 1) the total number of peer-reviewed articles deposited in PubMed Central since the May 2, 2005, implementation date and the distribution of chosen delay periods, 2) an assessment of the extent to which the implemented policy has led to improved public access, 3) an assessment of the impact of the policy on the peer-review system, and 4) the cost of operating the database.

PubChem: "The Committee is aware of the development of PubChem, the informatics component of the Molecular Libraries project of the NIH Roadmap for Medical Research. The Committee understands that the purpose of PubChem is to create a database of chemical structures and their biological activities. PubChem will house both data from the new NIH molecular libraries screening center network and compound information from the scientific literature. The Committee expects the NIH to work with private sector chemical information providers, with a primary goal of maximizing progress in science while avoiding unnecessary duplication and competition with private sector databases."

COMPARISON OF HOUSE, SENATE, AND CONFERENCE PROVISIONS IN P.L. 109-149

National Institutes of Health
FY 2006 Appropriation, by Institute and Center
Includes 1-Percent Government-Wide Rescission (P.L. 109-148)
(dollars in thousands)

¹ Text of Section 217 (Flexible Research Authority):

"SEC. 217. (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)."

² Text of Section 509 (Human Embryo Research Prohibition), as corrected:

"SEC. 509. (a) None of the funds made available in this Act may be used for-
(1) the creation of a human embryo or embryos for research purposes; or
(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).
b) For purposes of this section, the term 'human embryo or embryos' includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells."

³ Includes $150 million for type 1 diabetes

⁴ Gross Conference includes Department of Interior recission of -$382,000.