April 8, 2002
Sheraton Premiere at Tysons Corner
Vienna, VA
Summary Minutes
I. Welcome
Duane Alexander, M.D., the chair of the Federal Consortium and the director of the NICHD, welcomed those present to the second Federal Consortium meeting for the NCS.
II. Overview of the NCS
Mark Klebanoff, M.D., M.P.H., director of the Division of Epidemiology, Statistics, and Prevention Research at the NICHD, outlined the components of the NCS and reviewed the organizational structure of the study, planning phase activities, cross-cutting integrative Working Groups, hypotheses-generating Working Groups, pilot studies, and core hypotheses. He noted that, at the time of the meeting, 275 members from 62 different agencies were serving on 22 Working Groups, while the NCS Study Assembly had more than 1,000 members. The collaborative interagency relationship between the NICHD, EPA, CDC, and the NIEHS was also reviewed.
Following his presentation, Dr. Klebanoff conducted a question/answer session. The following items were discussed:
- Once the study was in progress, the Interagency Coordinating Committee (ICC) would consider another solicitation for ancillary studies.
- Federal Consortium members voiced interest in generating support for the NCS from their respective agencies. Targeting center/agency/institute heads in regard to providing assistance was discussed. It was decided that Federal Consortium members could begin to pitch the idea of supporting the NCS to their individual agencies for fiscal year 2004.
- It was decided that study results would be reported as the study progressed, rather than solely at the end of the study. The NCS would have outcomes of interest early on; those involved hoped to start the initial analysis very early in the study.
- It was noted that health care costs were being considered in through the Health Services Working Group.
- The current size of the study was set for more than 100,000 families, with follow-up four-to-five years until the child turned 21. Follow-up would take place at infancy, preschool, elementary age, middle school age, high adolescence age, and age 21.
- It was confirmed that all hypotheses would go to the Study Design Working Group, which would decide how to package the hypotheses to pass on to the NCS Advisory Committee (NCSAC) and the ICC for review. The NCSAC would review the findings with the ICC, the ICC would make recommendations to the NICHD director, and the NICHD director would use the Federal Consortium members for additional advice regarding hypotheses and findings. It was noted that the NCSAC would discuss how to compare alternatives and make findings in its April 8, 2002, meeting. It was explained that the NCSAC would make recommendations, while the Working Groups would contribute findings.
- It was confirmed that Working Groups would report directly to the NCSAC. Working Groups were authorized to meet and work by the National Advisory Child Health and Human Development Council, which served as advisory council to the study before the NCSAC was formed.
- It was added that Web-based portal/e-rooms had been established for Working Groups to share information/hypotheses. Most communication was between the chairs of the Working Groups. Listservs had also been established for each Working Group to provide an additional line of communication.
III. Funding Status of the NCS
The following items were noted about the funding status of the NCS. Please note that the figures provided were estimates.
- Funding needs for the life course of the NCS would be approximately $2 billion.
- For fiscal year 2001, the cost of the NCS was $3.2 million.
- For fiscal year 2002, the estimated cost was $10 million, with the NIH contributing $2.5 million, NIEHS contributing $1 million, the CDC contributing $1 million, and the EPA contributing $1.5 million.
- For fiscal year 2003, the NICHD’s budget request for the NCS was $6 million. The estimated overall cost was $13 million.
It was noted that Dr. Alexander had met with Dr. Ruth Kirschstein, the acting director of NIH, to discuss the NCS. It was anticipated that Dr. Kirschstein (or the NIH director) would address the NCS to the Office of Management and Budget (OMB), with help from the staff at the DHHS and the EPA. In May 2002, the DHHS, CDC, and EPA were scheduled to meet with key people at OMB to discuss the fiscal year 2004 budget. At the time of the consortium meeting, the fiscal year 2003 budget was already set.
It was also noted that Woodie Kessel, M.D., M.P.H., senior child health science advisor in the DHHS Office of the Secretary (DHHSOS), met with the DHHS Assistant Secretary for Health and a representative from the DHHS Budget Office to generate further support of the study.
Dr. Kessel explained that the NCS grew out of the President’s Task Force on Environmental Health Risks & Safety Risks to Children, and that the Task Force focused on the following items: asthma, lead, injuries, schools, environmental health, and use of land and resources.
IV. Lead Agency Presentations
A. National Institute of Environmental Health Sciences (NIEHS), NIH Sheila Newton, director of the Office of Policy, Planning, and Evaluation, NIEHS, noted that the Institute had contributed two ICC members and one full-time employee to the NCS. She added that the Institute also contributed $1 million to the NCS for fiscal year 2002. It was explained that the NIEHS was particularly interested in autism, and in the environmental role in development of type I diabetes. She concluded by noting that Ken Olden, director of the NIEHS, was very enthusiastic about the study.
B. Centers for Disease Control and Prevention (CDC)
Jose Cordero, M.D., M.P.H., director of the National Center for Birth Defects and Developmental Disabilities (NCBDDD), CDC, indicated that the CDC would support the study in its effort to address issues longitudinally, which may lead to prevention and intervention opportunities. He noted that the CDC had contributed four ICC members and $1 million (as of April 5, 2002) to the NCS for fiscal year 2002. It was added that, on March 29, 2002, when approximately 50 CDC employees met to discuss the coordination of all activities at CDC centers, the NCS was discussed, and the study received a positive response from all attendees. The CDC will continue to provide resources to the NCS.
C. U.S. Environmental Protection Agency (EPA)
William Farland, Ph.D, acting deputy assistant administrator for science in the Office of Research and Development, EPA, attended the Federal Consortium meeting on behalf of Dr. Paul Gilman, the assistant administrator of that office. Dr. Gilman had been briefed on the NCS and was very enthusiastic about the study. The EPA had contributed four ICC members, 19 staff members for the NCS Working Groups, and additional staff to work on pilot studies. For fiscal year 2002 and fiscal year 2003, the EPA had $500,000 available for pilot studies and other support, as well as $1 million for grant funds each year. Dr. Farland discussed how low-level exposures and effects on outcomes, an issue of importance to the EPA, could only be studied through a mechanism like the NCS.
Dr. Alexander stated that, while no organization outside of the lead agencies directly involved with the NCS at this time had been approached for funding, additional money or staff was welcome from any contributor.
Dr. Alexander indicated that Canada and Mexico had made preliminary inquiries about enrolling their own cohorts, which would make any combined analyses more powerful. He stressed, however, that these were very preliminary discussions.
V. Introduction of Federal Consortium Member Agencies
Representatives from the Agency for Toxic Substances and Disease Registry (ATSDR) noted that the organization would focus on health problems near hazardous waste sites. It was noted that the ASTDR currently had 96 percent to 99 percent success in enrolling counties for eight- to 10-year registries.
Representatives from the Uniformed Services University at the Department of Defense (DOD) noted that the University could try to obtain broader, high-level DOD involvement in the Federal Consortium. It was noted that the University could enroll 1 million to 1.5 million dependent American children located world-wide, who could represent diverse populations of generally underserved children, but who had care by virtue of military coverage (i.e., they moved frequently, but health care was seamless). It was added that the DOD could provide access to a group of special needs children through its school system.
Representatives from the CDC indicated that the agency had definitions and measurements of child neglect that may be of interest to the NCS.
Based on experience relative to the Superfund, EPA representatives indicated that the agency may be able to provide insight regarding community outreach and performance measures. They also provided information about an upcoming collaboration on children’s health and the environment in North America.
Representatives from the Agency for Children and Families (ACF), DHHS, mentioned a conference on children to be held in New York in May 2002, and a National Youth Summit in Washington, D.C., in June 2002.
VI. Structure of Planning Process
It was noted that Working Groups were not permitted to report to Federal Consortium members; only the NCSAC could report to federal officials. It was explained that the membership of the NCSAC would pass on Working Group recommendations to the ICC, who would then pass on the recommendations to the NICHD director for review with the Federal Consortium.
It was explained that most agencies represented on the Federal Consortium had employees who were active members on various Working Groups.
In addition, many requests were noted for an Oral Health Working Group, but it was decided that no additional Working Groups would be added to the NCS at this point. Instead, it was confirmed that oral health issues would be incorporated into existing Working Groups.
Dr. Alexander was scheduled to address the House Appropriations Committee on April 9, 2002, to discuss issues related to the NICHD; he indicated that he would discuss the NCS and highlight its importance as a major collaborative effort.
VII. Discussion of Issues
Participants noted that no study currently existed in the U.S. where families were followed, which would be one of the primary benefits of the NCS.
Members clarified that federal agencies needed to support the NCS through budget process and/or policy development process, and to pass study information onto all center, agency, institute directors.
In addition, members were called upon to increase appreciation in the community for how many agencies were involved in the NCS, recognize the comprehensive potential of the NCS, and understand that successful completion of the NCS would be a major contribution for all families.
Dr. Alexander added that he would keep Federal Consortium members informed of funding for the NCS as it developed.
VIII. Conclusion
Dr. Alexander concluded the meeting by noting that the next meeting of the Federal Consortium would be in early fiscal year 2003.
Meeting Attendees
Duane Alexander, M.D., NICHD, NIH, DHHS— Chair
Catherine Allen, EPA
Robert Amler, ATSDR, DHHS
Gloria Beckles, National Center for Chronic Disease Prevention and Health Promotion, CDC, DHHS
Yvonne Bryan, National Institute of Nursing Research, NIH, DHHS
Gwen Collman, NIEHS, NIH, DHHS
Jose Cordero, NCBDDD, CDC, DHHS
Mary Ann Danello, Consumer Product Safety Commission
Martin Dannenfelser, ACF, DHHS
Robert Dobie, National Institute on Deafness and Other Communication Disorders, NIH, DHHS
Lynda Doll, National Center for Injury Prevention and Control, CDC, DHHS
Denise Dougherty, Agency for Healthcare Research Quality (AHRQ) , DHHS
Marguerite Evans, National Center for Complimentary and Alternative Medicine, NIH, DHHS
William Farland, EPA
Susan Farrell, National Institute of Alcoholism and Alcohol Abuse, NIH, DHHS
Val G. Hemming, Uniformed Services University of the Health Sciences (USUHS), Department of Defense (DOD)
Deborah Hirtz, National Institute of Neurological Disorders and Stroke, NIH, DHHS
Elizabeth Lee Hofmann, EPA
Christine Johnson, USUHS, DOD
Jeanellen Kallevang, NICHD, NIH, DHHS
Woodie Kessel, Office of Disease Prevention and Health Promotion, CDC, DHHS
Carole Kimmel, EPA
Mark Klebanoff, NICHD, NIH, DHHS
Michael Kogan, Maternal and Child Health Bureau (MCHB), Health Resources and Services Administration (HRSA), DHHS
Doreen Koretz, National Institute of Mental Health, NIH, DHHS
Arnold Kuzmack, EPA
Amal Mahfouz, EPA
Saul Malozowski, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, DHHS
Ricardo Martinez, National Institute of Dental and Craniofacial Research, NIH, DHHS
Margaret Miller, U.S. Food and Drug Administration, DHHS
Alan Moshell, National Institute of Arthritis and Musculoskeletal Disorders, NIH, DHHS
Sheila Newton, NIEHS, NIH, DHHS
Mary Overpeck, MCHB, HRSA, DHHS
Roger Rosa, National Institute for Occupational Safety and Health, CDC, DHHS
Ken Schoendorf, National Center for Health Statistics (NCHS), CDC, DHHS
Lisa Simpson, AHRQ, DHHS
Vincent Smeriglio, National Institute of Drug Abuse, NIH, DHHS Ed Sondik, NCHS, CDC, DHHS
Vanessa Vu, EPA
Marshalyn Yeargin-Allsopp, NCBDDD, CDC, DHHS