October 16, 2001
Sheraton Premiere at Tysons Corner
Vienna, VA
Summary Minutes
The National Children's Study is led by a consortium of federal agency partners: the U.S. Department of Health and Human Services (including the National Institute of Child Health and Human Development [NICHD] and the National Institute of Environmental Health Sciences [NIEHS], two parts of the National Institutes of Health, and the Centers for Disease Control and Prevention [CDC]) and the U.S. Environmental Protection Agency (EPA).
I. Welcome
Duane Alexander, M.D., director of the NICHD and chair of the meeting, welcomed those present to the first meeting of the NCS Federal Consortium.
II. Discussion of the NCS
The meeting began with an overview presentation about the NCS and its current status.In addition, it was noted that the NCS was to be an undertaking of a consortium of all federal agencies that had a stake or interest in study-related issues, with the participation of non-federal organizations and scientists/researchers, such as the March of Dimes, environmental health organizations, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and so on, via extensive public-private partnerships.
It was explained that children were known to have an increased vulnerability to environmental exposures, as evidenced in early exposure to lead, fetal alcohol syndrome, and levels of pesticides in their blood. In spite of the documented risks, no studies had yet been able to identify the presence or absence of effects. The NCS would address these issues.
Participants learned about the size, length, and anticipated types of samples collected for the NCS.It was noted that, because the NCS was an extremely comprehensive study, the challenge would be to keep it from being overly comprehensive; that is, the NCS would not be able to answer every question put to it.
It was added that the NCS structure allowed for extensive involvement of both non-federal and federal scientists in the planning; Working Groups would focus on specific research areas and would operate under the guidance of an advisory committee. A charter for a specific advisory committee for this study had recently been drafted.
Because of the charge to involve many federal agencies, it was decided that those with a stake in the study would present their interests, priorities, and needs to those responsible for the NCS. For this purpose, the Federal Consortium was incorporated into the structure of the NCS, following language in the Children’s Health Act of 2000. It was added that the Federal Consortium would be chaired by the director of NICHD, Dr. Duane Alexander, who was responsible to congress for the conduct of the study.
III. Structure and Role of the Federal Consortium
It was explained that the primary purpose of the Federal Consortium was to provide a forum for the various federal agencies that had an interest and involvement, if not a stake, in the NCS. Study planners were attempting to include agencies in the Working Groups involved in the detailed work of planning, designing, and developing the study. It was added that all federal agency representatives would come together to express their organizations’ views at the twice-yearly Federal Consortium meetings.
Attendees learned that Consortium meetings would be opportunities to learn about the progress of the study, and to hear federal agencies voice their concerns, beliefs, and ideas about the study’s content, conduct, plans, and design among their counterparts from other agencies.
Participants also heard that the NIH, CDC, and EPA were assigned lead responsibility by congress for developing and implementing the NCS, but that congress also called for the involvement of a broad consortium of federal agencies. With that in mind, it was explained that many organizations were invited to attend the meeting. The following agencies had expressed clear interest in the NCS:the Departments of Transportation, Agriculture, Labor, and Defense.Members also learned that the Consortium would likely expand over time to give other agencies opportunities to contribute to the study. Dr. Alexander explained that every idea put forth seriously by an agency would be considered, fairly received, and reviewed, but noted that it would not be possible to include all proposed ideas in the study. He added that some discussion of ideas would take place outside the formality of the Consortium, during planning meetings and Working Group meetings, and in other forums.
It was also explained that the NCS manual described the Consortium and established a standing agenda for its meetings. The Consortium would likely meet twice a year, in conjunction with the Study Assembly meetings and at other times, as necessary. It was added that this forum would enable the NCS to handle administrative issues for the respective agencies, especially with regard to space, priorities, and funding.
IV. Funding Status
Participants learned that, to date, congress had not set aside any funds for the NCS. Although the Children’s Health Act of 2000 authorized $18 million for planning purposes and such sums as necessary after that, no appropriations had been made specifically for the study. It was explained that the NICHD had identified funds set aside for this study in its fiscal year 2001 and fiscal year 2002 budgets. In addition, the EPA and CDC identified funds from their budgets to contribute in fiscal year 2001 and fiscal year 2002, while the NIEHS indicated it would contribute funds in fiscal year 2002, and continue doing so through the duration of the study. It was noted that no other federal or outside funds had been contributed so far.
Estimated funds required for fiscal year 2002 ranged from $5 to $6 million, although the staff had already identified $10 to $12 million for projects, activities, pilot studies, and other needs of the NCS. Federal Consortium members learned that their organizations would be asked to invest in the planning phase.
Further, the agencies involved in the NCS planned to approach the Office of Management and Budget (OMB) for funding in fiscal year 2003. Dr. Alexander described possible ways that OMB may fund the study, explaining that existing funds could not be used because the expected cost of $150 million per year exceeded the dollar amount that could come out of regular agency budgets. Agency representatives described enthusiasm for the NCS on the part of the secretary of DHHS, the EPA administrator, and other high-level staff members.
V. The NCS Decision-Making Process
Participants heard that, when issues were of sufficient importance, decisions regarding the NCS would be made in the Interagency Coordinating Committee (ICC) in conjunction with the NICHD director. It was explained that decision-making for the NCS involved extensive mechanisms informed by the Working Groups, the NCS Advisory Committee (NCSAC), and the Federal Consortium. It was added that only with input from those entities and with data informed by these processes would decisions be made.
VI. Conclusion and Next Meeting
Dr. Alexander called the meeting to a close and noted that the next meeting would probably be held within six months.
Attendees
Duane Alexander, M.D., NICHD, NIH, DHHS— Chair
Robert Amler, Agency for Toxic Substances and Disease Registry (ASTDR), DHHS
Peter Ashley, U.S. Department of Housing and Urban Development (HUD)
Lisa Begg, Office of Research on Women’s Health, NIH, DHHS
Coleen Boyle, National Center on Birth Defects and Developmental Disabilities (NCBDDD), CDC, DHHS
Scott Campbell Brown, U.S. Department of Education
George Curlin, National Institute on Allergy and Infectious Diseases, NIH, DHHS
Alan Dellapenna, Indian Health Service, DHHS
Robert Dobie, Nation Institute on Deafness and Other Communication Disorders, NIH, DHHS
Denise Dougherty, Agency on Health Research Quality, DHHS
Vivian Faden, National Institute on Alcoholism and Alcohol Abuse, NIH, DHHS
William Farland, EPA
Warren Friedman, HUD
Val G. Hemming, Uniformed Services University of the Health Sciences, Department of Defense
Edward Hunter, National Center for Health Statistics (NCHS), CDC, DHHS
Elizabeth Lee Hofmann, EPA
Shelly Jackson, U.S. Department of Justice
Peter Kaufmann, National Heart, Lung, and Blood Institute, NIH, DHHS
Woodie Kessel, Office of Disease Prevention and Health Promotion, CDC, DHHS
Carole Kimmel, EPA
Mark Klebanoff, NICHD, NIH, DHHS
Doreen Koretz, National Institute of Mental Health, NIH, DHHS
Matt Longnecker, NIEHS, NIH, DHHS
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 Diseases, NIH, DHHS
Claudia Moy, National Institute of Neurological Disorders and Stroke, NIH, DHHS
Mary Overpeck, Maternal and Child Health Bureau, Health Resources and Services Administration, DHHS
Peter Scheidt, NICHD, NIH, DHHS
Richard Schieber, National Center for Injury Prevention and Control, CDC, DHHS
Ken Schoendorf, NCHS, CDC, DHHS
Sherry Selevan, EPA
Vincent Smeriglio, National Institute of Drug Abuse, NIH, DHHS
David Thomasson, U.S. Department of Energy
Vanessa Vu, EPA
Rich Waxweiler, CDC, DHHS
Deborah Winn, National Cancer Institute, NIH, DHHS
Marshalyn Yeargin-Allsopp, NCBDDD, CDC, DHHS
Joey Zhou, HUD