costs, as well as scientific merit; and funding an array of mechanisms to achieve the overall average. Noncompeting grants will be computed by providing on average no more than a four percent increase for future years with a limit on indirect costs to the rate in effect at the time of the competing award. In this fashion, we will provide stability and predictability to both NIEHS and the investigator. Mr. Early: Does the NIEHS plan to make greater use of "out of order" funding to achieve a lower cost per award? Dr. Hoel: As proposed in the financial management plan, "funding out of order" is not intended expressly as a means of achieving a lower average grant cost but as one of several techniques for containing the overall costs of NIH research awards. Such a funding policy will be applied only to those grant applications near the payline that are still applications of a very high quality. Thus the peer review system will not be compromised in our efforts to manage costs. Mr. Early: What has been the reaction of your Institute's study sections to the Financial Management Plan, and limiting the overall increase in the cost of a grant? Dr. Hoel: Our one Institute Study Section has been briefed on the outlines of the draft Financial Management Plan and the importance of close scrutiny of budgets at their level. To date there has been no reaction and limited opportunity for staff to observe any changes in behavior. The extramural community is understandably guarded in its reaction to this proposal. However, once NIH demonstrates that this policy will have no adverse impact, i.e., funding of high quality science will not be compromised, both scientists and administrators will be more reassured. Mr. Early: What impact will limiting the average increase in the cost per award have for your Institute, particularly with respect to the National Toxicology Program and clinical research? Dr. Hoel: Limiting the average increase in the cost per award may have peculiar effects on the NIEHS. It may very well have an impact on the nature of science in our portfolio. While we support no clinical trials and little clinical research per se, there are some critical needs in environmental epidemiology. These studies are quite expensive and may be difficult to initiate under the anticipated limitations. Care will have to be taken that the sometimes unique demands for resources in these projects are not unduly effected by the overall management scheme. Since the work of the National Toxicology Program is done primarily through contracts, the limits would have little effect on this. Mr. Early: In general, Doctor, what do you see as the "down side" of using the BRDPI, out of order funding, and shortening the average length of a grant? Dr. Hoel: The BRDPI is a relatively accurate measure of the change in costs from one year to the next in biomedical research. To make sure that the pool of competing grants does not exceed this index, staff must control such dynamics as the number of competing renewals versus new projects and the mix of mechanisms. However, it will provide more predictability than we have had in the past. Of course, the real down side may be if the rate of inflation is ever as high as it was in the late 1970s and we cannot afford to match that rate in our budget. NIH funding components currently exercise flexibility in the selection of awards with the advice of Advisory Councils and staff. This discretion is essential to maintain program balance. We do not expect there will be a significantly different practice in the future, even as we implement the financial management plan. The four year average will not jeopardize the stability of funding for investigators. It is important to maintain the proper balance between effect on the NIH commitment base, the frequency of re-review, and the stability of support. Mr. Early: In your professional judgment, given the unique aspects of some of your Institute's activities, do you believe some exception from the Financial Management Plan may be warranted? Dr. Hoel: Yes, and I have already referred to some of these situations. In the case of program projects for a small Institute, we may need to have some accommodation as to the impact of adding one or two of these to the portfolio. While they adversely affect our numbers as currently calculated, this mechanism presents the opportunity to fund the kind of interdisciplinary, cross-cutting research that is needed in environmental health sciences. The same is true for epidemiological studies, especially those that bring the new tools of biomarkers of exposure and effect into the realm of traditional epidemiology. OTHER BUDGET Mr. Early: What was the NIEHS professional judgment budget and how does it differ from the request before us? Dr. Hoel: The FY 1992 professional judgment budget was $310 million, $56 million more than the request level. The professional judgment budget includes funding for 200 competing research project grants, nearly double the number of such grants in the request. The additional funding would also provide for two new environmental health sciences centers, focusing on reproductive toxicology and respiratory toxicology, five additional Environmental/Occupational Medicine Academic Awards, 20 other research grants, 97 additional training positions, 41 additional research and development contracts, and an expanded intramural program. Mr. Early: Will any significant new research initiatives or opportunities be lost or delayed by lack of funds in the FY 1992 budget request? Dr. Hoel: There are several. EPA and the states will need much more information about the health effects of air pollutants cited in the Clean Air Act Amendments of 1990. In addition, new provisions in the law regarding air toxics, alternative fuels, and protection of the ozone layer may have public health implications that could be identified and prevented. NIEHS could make major contributions in these areas. There are immediate research opportunities for new and improved toxicologic test methods and in methods to replace whole animals now used in toxicology studies. These opportunities must wait until the pressing demands for more toxicologic studies can be met. Finally, basic research in the environmental health sciences requires sophisticated laboratory instruments and large capacity, fast computers. NIEHS needs such equipment to remain at the cutting edge of this field. We have taken advantage of every opportunity to maximize NIEHS participation in sharing resources available through NIH in Bethesda and locally in the Research Triangle Park, Duke, and at the University of North Carolina, and North Carolina State, but we are beginning to lose ground as the costs of laboratory equipment and computers surpasses currently anticipated funding levels. Mr. Early: What priorities would the Institute pursue if additional resources were available and if an increase over the FY 1992 request is provided, how would you use these additional funds? Dr. Hoel: NIEHS shares the President's and the Congressional concerns about the quality of the Nations' air and its effect on human health. We give air pollution-related research very high priority and have every expectation that biomedical researchers in U.S. universities would respond with enthusiasm to this priority with a scientifically outstanding and highly relevant set of research proposals. Also, we must not lose sight of the potential for basic biomedical research at the molecular and cellular levels to provide the kinds of breakthroughs in the environmental health sciences necessary to move us forward in preventing environmental illnesses and reproductive and developmental disorders. We must continue to invest in basic studies, although there may not be any immediately obvious relationship between a particular study and a pressing environmental problem. toxicology and epidemiology combined with emerging tools and knowledge in basic biology now in use at NIEHS could significantly improve risk assessments. Advances in Finally, we are deeply concerned that poor men, women, and children of all racial and ethnic groups, but particularly minority racial groups, suffer an unconscionable burden of illness, disability, and premature death in this country. The environments in which these citizens live are a major factor as our research has demonstrated. We must direct even more of our research efforts to this American tragedy and must provide the kinds of innovative and broad educational and training opportunities needed to recruit young people from all of our diverse society into environmental and occupational medicine, environmental public health, and environmental health sciences research. Mr. Early: How much is in your FY 1992 budget request for the National Toxicology Program, and how much have you allocated for FY 1991? Dr. Hoel: The FY 1992 budget request is $81.8 million and the FY 1991 allocation is $79.0 million for NIEHS/NTP. Mr. Early: FY 1992? Dr. Hoel: How many substances will be tested in FY 1991 and For carcinogenicity, 13 additional substances in FY 1991 and 12 additional substances in FY 1992 will be studied. For short-term toxicity, 20 additional substances in FY 1991 and 14 additional substances in FY 1992 will be studied. Mr. Early: What are NIEHS' program plans for FY 1991 and FY 1992 in the area of validating new testing methodologies for nonanimal tests? Dr. Hoel: Program plans in FY 1991 and FY 1992 will be directed to specific projects that utilize computer assisted chemical analysis and the latest methods of gene manipulation to develop non-animal models. New efforts in research through computer assisted chemical analysis of the diverse chemical classes that have been assayed for cancer and other toxic endpoints, if proven to be diagnostic, could be used to reduce the necessity to test additional chemicals within a given class, thereby reducing numbers of animal studies needed. Another major effort enables researchers to transfer and direct the expression of genes into cells. As knowledge of the molecular aspects of cancer improves, it becomes increasingly possible to introduce and activate metabolically important genes in cultured cells so that individual cells can assume many of the functions found in intact tissues in animals. Among the advantages of these cells would be their ability to activate and detoxify chemical substances and their ability to exhibit easily measurable biochemical responses. While these efforts should reduce our dependence on animals, there is considerable scientific doubt about the prospects for total replacement of mammalian systems for toxicologic studies in the foreseeable future. |