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their impact on contraceptive practice and health. The guiding principle that we have followed is that utilization of any method should be voluntary.
CHILD HEALTH RESEARCH CENTERS
Question. Dr. Alexander, for the last two fiscal years, the Subcommittee has encouraged the Institute to establish a Child Health Research Center program and has provided the Institute with funds to accomplish that goal. Would you please update the Subcommittee on the status of the center grant program?
Answer. The Child Health Research Centers Program is intended to increase the ability of pediatric institutions to develop basic science investigative capacities for application to pediatric clinical problems. Seven centers were established in FY 1990.
Question. Do you plan to expand the program in fiscal years 1991 and 1992? If so, how much do you anticipate will be spent in this fiscal year and how much will be necessary to fund the program in fiscal year 1992?
Answer. In FY 1991, the Institute will support four additional centers. A Request for Applications for these additional centers was published on January 25, with a receipt date of April 9, 1991. Initial review of applications is for June 11-13. Grant awards will be made prior to the end of FY 1991. NICHD funding for the 11 centers in FY 1991 is estimated at $3.5 million. The FY 1992 Budget Request provides $3.6 million to continue these 11 centers. No expansion of the program in FY 1992 is included in the request.
QUESTIONS SUBMITTTED BY SENATOR MARK O. HATFIELD
SUDDEN INFANT DEATH SYNDROME (SIDS)
Question. Dr. Alexander, to what extent is Sudden Infant Death Syndrome (SIDS) a factor in our nation's infant mortality problem?
Answer. SIDS is the leading cause of infant mortality between the ages of one month and one year of life. Between 6,000 and 7,000 infants die with this diagnosis each year, with an incidence of one to two deaths per thousand live births.
Question. What is the present status on the implementation of the 5-year Sudden Infant Death Syndrome Research Plan?
Answer. The Institute is currently in the second year of the five-year plan and we are on schedule for our objectives this fiscal year.
The NICHD has issued a request for contract proposals, "Brain and Tissue Bank for Developmental Disorders", to set up a repository to collect, store, and distribute specimens from "unaffected" infants and children, and those with neurodevelopmental disorders. Sudden Infant Death Syndrome is specifically designated as a developmental disorder targeted by this repository. Once established, tissues from the repository will be made available to
qualified investigators to support and facilitate research that will lead to improved understanding of the etiology, pathology, pathogenesis, and clinico-pathological correlations of conditions associated with SIDS, mental retardation, and learning and behavioral deficits. The review process for applications is near completion, and one or two awards will be made in FY 1991.
The criteria for animal models relevant to SIDS, and the research approaches and areas that should be expanded, were explored at the "Animal Models of SIDS Workshop" convened by the NICHD in October, 1990. In addition to providing research recommendations, this workshop served to stimulate new scientists from the areas of neuroscience, thermoregulation, and behavioral biology to consider the scientific problems in SIDS.
The recommendations from this workshop were incorporated into a request for grant applications (RFA), "Animal Models for SIDS," published in February 1991, with a May 1991, receipt date for applications. Up to eight awards are planned for this fiscal year. The objective of the RFA is to stimulate research on animal models that explore some aspect of the SIDS phenotype, to identify and understand possible etiologies and physiologic mechanisms responsible for sudden death in infancy.
A meeting of neonatologists, pulmonary and sleep physiologists, behavioral psychologists, and neurologists was held on January 16, 1990 to provide recommendations for research on cardiorespiratory deficits in future SIDS victims, and the usefulness of apnea monitors. The following priorities were identified: (1) clinical studies of documented monitoring in the home of high-risk infants; (2) prospective clinical studies to identify behavioral, neurologic, and other physiologic risk factors in the first month of life that are predictive of SIDS; (3) development of home monitors for obstructive apnea and oxygen desaturation; and, (4) when the studies outlined above are completed, a randomized trial of appropriate monitors to prevent SIDS deaths would be conducted.
The request for applications for grants to address the first priority, "Event Recordings of High Risk Infants on Apnea Monitors," was issued in March, 1991. Six awards are planned for FY 1991. purposes of the initiative are to determine whether home apnea monitors employing event recordings of respiratory, cardiac, and oxygenation parameters are effective in identifying clinically relevant episodes, and to determine the conditions that optimize the use of apnea monitors in these infants.
Biomedical research, surveillance, and health service delivery regarding SIDS are under the auspices of several components within the Public Health Service, with related responsibilities in other parts of the Federal Government. The Interagency Panel on SIDS was re-established to exchange information on SIDS activities, enhance productivity through collaboration and coordination, and develop new strategies to understand and combat SIDS. Three meetings of the panel, which included staff from six Public Health Service agencies, were held to share current activities and to discuss difficulties in diagnosing and reporting SIDS.
The five-year research plan called for collaboration between NICHD and other agencies of the Public Health Service to develop and implement epidemiologic studies of SIDS. NICHD is working with CDC and the Indian Health Service to investigate infant deaths among the American Indians of the Aberdeen Reservation. They have an annual SIDS rate three times that of the remaining population in North and South Dakota, making it the highest in the nation. It is important to gain more information on these deaths to (1) determine whether some are not SIDS, and may be preventable through public health efforts, and (2) to learn more about causes of SIDS. The joint project will establish a surveillance network for infant deaths on the Aberdeen reservation, and a pilot protocol to investigate the causes. We plan to fund these efforts through interagency agreements in FY 1991.
NICHD defines research priorities for future years of the fiveyear research plan by convening workshops. On March 25, 1991, NICHD brought together all the researchers that are studying fetal hemoglobin to critically examine the available scientific information, and determine the potential of fetal hemoglobin kinetics to identify infants at risk for SIDS. In the fourth year, we will be conducting a study to evaluate biochemical and metabolic screening technologies for SIDS risk. One of the biochemical markers that may be worth pursuing is fetal hemoglobin. During the first two months of life, infants stop producing the oxygen carrying blood protein they used in utero, called fetal hemoglobin, and produce the adult type of hemoglobin. There is controversy in the scientific literature whether elevated fetal hemoglobin levels in a proportion of SIDS victims discriminate them from other infants. Since there are no defined prognostic tests for SIDS risk at this time, it is important to pursue this biochemical finding for infant screening.
Question. How much does the Institute estimate will be spent on SIDS specific research in FY 1991? How much on SIDS related research?
Answer. The NICHD revised estimate for funding SIDS specific research in FY 1991 is $5,500,000; the amount for SIDS related research, $33,000,000.
Question. How much is provided in the President's budget request for SIDS research in fiscal year 1992? Is this sufficient to fully implement the 3rd year of the five-year plan? If not, how much more is necessary to fully implement the 3rd year?
Answer. The FY 1992 President's budget request includes a total of $41,500,000 for SIDS research. Of that amount, $6,100,000 is for activities that relate to the third year of the five-year plan. Full cost for the third year would require an additional $4,400,000 over the budget request, for a total of $10,500,000.
Senator HARKIN. Thank you very much. The subcommittee will stand in recess to reconvene at 1:35 p.m. to hear the rest of the Institutes.
[Whereupon, at 12:34 p.m., Thursday, March 14, the subcommittee was recessed, to reconvene at 1:35 p.m. the same day.]
(AFTERNOON SESSION, 1:43 P.M., THURSDAY, MARCH 14, 1991)
The subcommittee met at 1:43 p.m., in room SD-192, Dirksen Senate Office Building, Hon. Tom Harkin (chairman) presiding. Present: Senators Harkin, Hatfield, and Specter.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
STATEMENT OF DR. DAVID HOEL, ACTING DIRECTOR
OPENING STATEMENT OF SENATOR HARKIN
Senator HARKIN. Thank you very much. The subcommittee will resume its sitting.
Dr. Hoel, I want to welcome you before the committee in your first appearance representing the National Institute of Environmental Health Sciences.
We have your budget that totals $254.4 million, which is about 5.6 percent more than last year.
I know the Institute has been interested for a number of years in getting underway on the construction of a new building in Research Triangle Park, NC, where the Institute is located. We will have a chance to talk about that and other issues.
At this time, I would be pleased if you would proceed with any opening statement that you care to make.
Dr. HOEL. Thank you very much, Mr. Chairman. It is, indeed, a pleasure to be here.
Before beginning, I would like to acknowledge Dr. David Rall, who retired last fall after 20 years as the director of NIEHS. During his tenure, he built both the Institute and the National Toxicology Program for which everyone in the environmental health area is indeed indebted.
This afternoon I would like to briefly describe two areas of the many things that NIEHS is involved in, and the first is—and it has already been mentioned-the problems with metal toxicity. I believe that NIEHS has been a leader in the research on metal toxicity and understanding the human health aspects of these toxicants.
In particular, we are thinking these days about lead, mercury, and manganese. There are programs now with regard to lead abatement that a number of the areas of the government are involved with. Our research is continuing with Dr. Needleman of the University of Pittsburgh who is looking at the possible apparent
permanent effects of low-level lead exposure on intellectual and psychobehavioral functions.
Also, clinical studies are being carried out to find better drugs to treat lead poisoned children. We are also quite interested, through the contracts mechanism, in the lead transfer from the mother to the fetus, whether this is from bone or diet or just what. We are developing that work.
We finished a major conference on the health effects of lead and, in fact, I have the new publication in Environmental Health Perspectives that came out last November.
In the area of mercury, Dr. Löe has already mentioned the dental amalgams issue aired on the "60 Minutes" TV program. We have begun through one of our research centers-Tom Clarkson at Rochester-a very interesting epidemiological study in the Seychelles Islands where individuals there are exposed to low-level mercury through consumption of fish. We hope to develop a better understanding of the low end of the dose response curve with regard to human exposures.
In the area of manganese, we had a conference earlier this week. This is quite important to the EPA because it is being proposed that manganese be used as a gasoline octane booster in this country. We have to discover what are possible information gaps on health effects. We do not want to create another situation as we had with lead.
So, I think in this area we need both the epidemiological clinical work, exposure understandings, and, in particular, basic work in mechanism so that we can concentrate on the effects of neurobiology and fetal exposure.
INTERPRETATION OF TOXICOLOGICAL TEST DATA
The second area of interest is in interpretation of toxicological test data. Through the National Toxicology Program, NIEHS is involved with generating this for the Federal Government. And what we want to do is to improve the methods for estimating the lowdose effects to man based on the findings in high-dose toxicological studies. And here we are concentrating on generating supplemental information on oncogene activation, pharmacokinetics, receptor binding, cell proliferation, and so forth. The regulatory agencies will be able to incorporate this data with our toxicological findings so that they could do a better job in terms of estimating human health risk from these studies.
We are also quite interested in research in biomarkers for measuring both environmental exposures and molecular effects in people. We see also an important future research area in terms of genetic susceptibility to toxicants.
In these areas, a couple of examples would be the issue of dioxin and the effects at low levels and the idea that it is a receptor mediated effect and what effect this might have with regard to risk assessments in setting low-dose levels. I think we will see some of this during this year. There is quite a concentrated research effort here.
And also with asbestos and the controversies about abatement of asbestos in buildings. Here the argument is concerning the toxi