Answer. The research that is conducted under these Cooperative Agreements has a high probability of supplying information that will lead to our ability to predict which infants are likely to suffer from breathing dysfunctions that are life-threatening to the infants. The infants will be evaluated extensively in the hospital at entry, and during the course of the study to look for breathing dysfunctions that are not monitored in the home, but we know are more common in infants who die of SIDS. This information will be correlated with episodes of apnea, slowed heart rate, and reduced oxygenation that are recorded in the home, and with their clinical outcome; e.g., do they require resuscitation, or do they recover normal breathing on their own? It is hoped that we will be able to identify characteristics that will distinguish between those infants who are destined for severe breathing dysfunction from those who are not.

INFERTILITY AND REPRODUCTIVE RESEARCH CENTERS

Question. We've all heard a lot about NORPLANT, the most recent breakthrough in contraceptive implant devices. So, I'm interested to know how the Institute's own contraception research, as well as research in the area of infertility, is progressing. With funds added by the Senate last year, I understand that you are establishing 2 infertility research centers and 3 contraceptive research centers. What is the status of these centers and what will each of these have as a specific research focus?

Answer. Regarding the infertility research centers, the NICHD has designed and obtained NIH approval for a Cooperative Specialized Research Center Program to be represented by two centers composed of multiple, interactive projects. These Centers will serve as national resources for the conduct of high priority infertility research and also as sites promoting the career development of young scientists selecting careers in infertility research. The national competition for these Centers was announced in a Request for Applications by the NIH on March 8, 1991. Potential applicants are presently being provided with requested items of information. The application deadline is June 17, 1991. Following initial scientific peer review, the applications will receive a secondary review by the National Advisory Child Health and Human Development Council, before funding of the selected Centers in September, 1991. The selected Centers are expected to become operational shortly thereafter. The research of the selected Centers will address topics such as the development of new approaches to the treatment of endometriosis, ovulatory dysfunction, uterine fibroid impairment of fertility status, or male factor-based infertility.

Regarding the contraceptive research centers, a Request for Applications (RFA) was issued on March 8, 1991, describing the research program in broad terms and requesting scientists to focus on specific steps of the research process. This RFA also had a deadline of June 17, 1991 for receipt of applications. From the letters and telephone calls that we have received, we expect a very enthusiastic response from our scientific community. We anticipate receipt of applications that will address fertility regulation in both men and women. While the specifics of these applications are not available to us at the present time, we are confident that they will include research on new drugs, potential vaccines, barrier contraceptives and new approaches to sterilization. The Institute

will work very closely with the scientific community to move the centers program forward.

CHILD HEALTH RESEARCH CENTERS

Question. The Committee is certainly aware that a strong basic scientific research program is critical if we are going to transfer this knowledge to clinical applications in order to help children. Along that line, what is the current status of the Child Health Research Centers?

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. The FY 1991 Appropriation provides funds to support a total of 11 centers, four of them new in FY 1991. A Request for Applications for the new Centers was published on January 25, with a receipt date of April 9, 1991. It is expected that there will be 40-50 applications received, with the initial review scheduled for June 11-13 and funding before the end of the fiscal year.

INFANT DAY CARE

Question. Doctor Alexander, I'm sure you know the success we had during the last Congress in establishing and funding the new child care program. The Committee is certainly interested in the Institute's work on the effect of various early child care arrangements on an infant's later development. I understand that research is under way at 10 different sites tracking about 1,200 children from birth to age 3 to learn more about the effects on the child's development of different child care arrangements. What are the different child care arrangements that will be studied?

Answer. The NICHD Study of Early Child Care will provide information on the various child care arrangements utilized in the United States in the 1990s and will examine the effects of these child care arrangements on child development through the first three years of life. The study is in the process of recruiting both families with mothers who plan to go to work outside of the home before their child's first birthday and families with mothers who plan to stay at home.

There are numerous child care arrangements, as infants may be cared for by others in their own home or receive care in someone else's home or a child care facility. In some cases, a relative such as a father, grandfather, or an aunt may provide care, but in many instances the provider is unrelated to the child's family. Other variables include the number of hours per week the child is in day care and the quality of the day care program. At times, the same infant is placed in multiple care arrangements each week and many infants are switched from one child care arrangement to another as months go by. The NICHD Study of Early Child Care will collect information about the number, type and quality of the arrangements that the children experience. The study will follow the same children over the first three years of their life.

The study will provide information about child care

arrangements and their influence on the development of thinking and

language skills; social and emotional development of infants and toddlers; the effects of child care arrangements in the first year of life on the developmental progress of children two and three years old; and child care conditions that lead to favorable developmental outcomes as well as those conditions that lead to poor outcomes at 15, 24, and 36 months of age. Such information will be useful to parents when they consider child care arrangements and could also lead policy makers to require that providers of care for infants meet standards shown by this study to be important.

Question. Will following these children to age 3 be long

enough?

Answer. Following the children through the age of three will provide useful and scientifically important information. Since developmental milestones and goals change with the child's age, additional knowledge could be gained by following the development of these children beyond age 3. For example, it would be interesting to find out to what extent their early experiences hinder or enhance their ability to master age appropriate developmental challenges such as the ability to make friends and to maintain friendships, the ability to reach goals through harmonious interactions with others, and the ability to acquire reading and math skills. At this time, however, no decision has been made to follow the children for a longer time period. NICHD would like to progress further along into the current study before making any further plans.

NATIONAL CENTER ON MEDICAL REHABILITATION RESEARCH

Question. Dr. Alexander, the budget for the new National Center on Medical Rehabilitation Research for persons with physical disabilities has $3.8 million for grants and I understand another $1.2 million for intramural activity and staffing. Since the Center is now established and can be in full gear in 1992, is that enough money given the immense needs for improved medical rehabilitation and technology for persons with disabilities? What is your professional judgment about a budget level to meet the needs in this field?

Answer. The FY 1992 budget request for the National Center on Medical Rehabilitation Research (NCMRR) will establish a broad-based research program that will include research project grants, research career awards, research training and R&D contracts. Subsequent to the passage of legislation in November, 1990, establishing the NCMRR, a budget request for FY 1992 was presented by NICHD to NIH in the amount of $14 million, which included extramural and intramural research on medical rehabilitation, as well as administrative costs.

MENTAL RETARDATION RESEARCH CENTERS

Question. Dr. Alexander, last year the Senate Appropriations Committee provided $1.5 million for the limitation of negotiated reductions at 14 Mental Retardation Research Centers supported by NICHD. Please describe how you complied with that congressional directive.

Answer. Although the Senate Committee provided funds for additional Mental Retardation Research Centers and relief of inflationary pressures in FY 1991, the appropriation included an

increase of funds only for additional centers. Thus, the NICHD will award grants for two additional centers for a total of 14 in

FY 1991, and continuation awards for existing centers will be at approximately the same level as in FY 1990.

FETAL ALCOHOL SYNDROME

Question. How is the Institute addressing the fetal alcohol syndrome (FAS) problem?

Answer. Research on alcohol and pregnancy, including Fetal Alcohol Syndrome (FAS), is part of the mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Research supported by NIAAA first led to the identification and description of FAS in the 1970s, and found that heavy maternal drinking was a clear health risk to the infant.

Question. Is money being allotted for research in this area for FY 1992?

Answer. NIAAA support for alcohol and pregnancy research in FY 1992 is estimated at $11,500,000. The NICHD does not conduct research on Fetal Alcohol Syndrome.

Question. Does your Institute coordinate or plan to coordinate FAS research with the Indian Health Service?

Answer. As the focal point for FAS research in the Public Health Service, the NIAAA actively coordinates its FAS research with the Indian Health Service, and with the Centers for Disease Control and the Office of Substance Abuse Prevention.

RU-486 RESEARCH

Question. Is your Institute currently funding projects using the drug RU-486? If so please explain the objectives of these studies.

Answer. At the present time the NICHD is supporting one extramural grant and conducting one intramural study using the drug RU-486. The extramural grant is seeking to increase our understanding of the cellular mechanisms underlying preterm labor, which is a major cause of infant mortality and morbidity in the United States. Data obtained from this research grant should help provide a fundamental basis for the development of new preventive therapies and risk assessments for preterm labor. The intramural study currently being conducted by the NICHD is designed to evaluate the effects of a small daily dose of RU-486 on the endometrium, the lining of the uterus. Utilizing its ability to block the action of progesterone, this low dosage of the drug may prevent the normal development of the secretory endometrium and thereby prevent pregnancy. Further research, based on the findings of the current study, holds the potential of the development of RU-486 as a new, safe and effective means of preventing pregnancy.

QUESTIONS SUBMITTTED BY SENATOR DALE BUMPERS

INJURY PREVENTION

Question. The President's budget quotes the publication "Costs of Injury Prevention: a Report to Congress," noting that the potential savings from reducing injuries is in the billions of dollars. What types of injuries do we know the least about preventing, and do you have plans to expand the program of injury prevention research at NICHD in FY 92?

Answer. Of the major types of injuries, we know the least about preventing injuries to pedestrians, suicide, homicide, drowning in minorities, and all injuries to adolescents. The NICHD plans to expand its support of studies on these subjects, as part of a five year initiative in childhood injury prevention research. Specific plans include solicitation of research proposals on alternative methods to study life threatening injuries; interventions based on new understanding of the mechanisms of injuries; and injury prevention in adolescents.

ADOLESCENT STUDIES

Question. I've heard a lot recently about the need for more research on the adolescent population, since it's considered an under-studied population. Does NICHD plan to expand its portfolio on adolescent studies?

Answer. Yes, the NICHD does plan a significant expansion in this area. We have long considered adolescence a critical period of development, and there has been longstanding support for research on the entry of adolescents into sexual activity and then subsequent fertility-related behavior. We plan to support a major, integrative study of adolescent behavior that examines peer and family influences on adolescent behavior. Additionally, this study would investigate how adolescent development may be affected by different contexts--social, economic and school. Researchers have long considered how these aspects of adolescents' lives fit together, and this will be a major new study to address them in a coherent manner. We view this as the beginning of a new generation of research on adolescent behavior. Another feature of this initiative is the concern about understanding the diversity of the teen population. Given the different rates at which white and black teens experience early childbearing or poor educational outcomes, it is important that studies be designed so that we can separate the effects of race and ethnicity from those of economic conditions. This project could provide information that is critical to our understanding of how adolescents traverse these difficult years successfully and our ability to intervene when the process is not going well.

Research on adolescent sexual behavior and fertility will be expanded to encompass the risk of AIDS for the adolescent population, as part of our broader effort to understand the role of risk-taking in a more general sense. While much of the concern about adolescents revolves around social and behavioral issues, there are many questions about the processes of puberty and control of growth that are also high on our agenda of ongoing and expanded research efforts.