References (continued)

100. PHEMCE is the inter-agency body responsible for coordinating the research, development, regulation, procurement, stockpiling, and deployment of MCM. U.S. Department of Health and Human Services, "Project BioShield," https://www.medicalcountermeasures.gov/BARDA/bioshield/bioshield.aspx.

101. Theresa Wizemann, Clare Stroud, and Bruce Altevogt, Innovative Strategies to Enhance Products from Discovery Through Approval, ed. Institute of Medicine (Washington, DC: National Academies Press, 2010), 24, http://books.nap.edu/openbook.php?record_id=12856&page=R1.

102. Under Section 505A of the Food and Drug Administration Modernization Act of 1997(i.e., the "Pediatric Rule"), FDA can request pediatric testing from investigators and manufacturers of a product. The reward for such testing is a 6-month period of marketing exclusivity to develop patents and intellectual property related to the product. U.S. Department of Health and Human Services, Food and Drug Administration, "Frequently Asked Questions on Pediatric Exclusivity (505A), the Pediatric Rule, and Their Interaction," http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm077915.htm.

103. Theresa Wizemann, Clare Stroud, and Bruce Altevogt, Innovative Strategies to Enhance Products from Discovery Through Approval, 40-41.

104. U.S. Department of Health and Human Services, Memorandum to the National Commission on Children and Disasters: Response to the National Commission on Children and Disasters Interim Report, March 18, 2010, 17, Washington, DC.

105. FDA reported to the Commission that "exposure [of children] to toxic substances for the purpose of a controlled trial is not ethical, and so the FDA must utilize data from sources other than the gold standard randomized, controlled, clinical trial. In addition, pediatric patients are not capable of providing legal informed consent, and cannot volunteer for studies, especially if there is not direct benefit to the subject. Pediatric product development is challenging and unique, and requires a rational approach that leverages existing data to obtain sufficient evidence of safety and effectiveness in the pediatric population." Ibid., 21.

106. Secretary Kathleen Sebelius, "Address to the American Medical Association Third National Congress on Health System Readiness," (Washington, DC: AMA, December 1, 2009), 3, http://www.newfluwiki2.com/upload/sebeliusdec1speech.pdf.

107. U.S. Department of Health and Human Services Assistant Secretary for Preparedness and Response, The Public Health Emergency Medical Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long- Range National Needs, (Washington, DC: HHS, August 2010).

108. Public Law (P.L.) 108-276(2004).

109. Stuart Nightingale, Joanna Prasher, and Stewart Simonson, Emergency Use Authorization (EUA) to Enable Use of Needed Products in Civilian and Military Emergencies, ed. Centers for Disease Control and Prevention (Atlanta, GA: CDC, 2007), 1046, http://www.ncbi.nlm.nih.gov/pubmed/18214177.

110. The 2009 H1N1. outbreak provided examples of the use of EUAs. EUAs were used to approve the use of Tamiflu and/or Relenza on children under 1. year of age. EUAs were also issued for use of certain personal protective equipment during the H1N1. outbreak. Centers for Disease Control and Prevention, "Termination of the Emergency Use Authorization of Medical Products and Devices," http://www.cdc.gov/h1n1flu/eua/.

111. National Commission on Children and Disasters, Interim Report, (Washington, DC: NCCD, October 14, 2009), 15, http://www.childrenanddisasters.acf.hhs.gov/20091014_508IR_partII.pdf .

112. P.L. 109-417(2006).

113. National Commission on Children and Disasters, Interim Report, 16.

114. U.S. Department of Health and Human Services Assistant Secretary for Preparedness and Response, The Public Health Emergency Medical Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long- Range National Needs, 16.

115. DMAT is "a group of professional and para-professional medical personnel (supported by a cadre of logistical and administrative staff) designed to provide medical care during a disaster or other event." Office of the Assistant Secretary for Preparedness and Response, "Disaster Medical Assistance Team (DMAT)," http://www.phe.gov/Preparedness/responders/ndms/teams/Pages/dmat.aspx.

116. Office of the Assistant Secretary for Preparedness and Response, "National Disaster Medical System," http://www.phe.gov/Preparedness/responders/ndms/Pages/default.aspx.

117. Katherine A. Gnauck, Kevin E. Nufer, Jonathon M. LaValley, Cameron S. Crandall, Frances W. Craig, and Gina B. Wilson-Ramirez, "Do Pediatric and Adult Disaster Victims Differ? A Descriptive Analysis of Clinical Encounters from Four Natural Disaster DMAT Deployments," Prehospital and Disaster Medicine 22, no. 1(2007):67, http://pdm.medicine.wisc.edu/Volume_22/issue_1/nufer.pdf.

118. PSTs are specialty DMATs, composed of "individuals specifically trained in the care of children and pediatric-specific equipment, supplies, and pharmaceuticals." Debra Weiner, Shannon Manzi, Mark Waltzman, Michele Morin, Anne Meginniss, and Gary Fleisher, "FEMA's Organized Response with a Pediatric Subspecialty Team: The National Disaster Medical System Response: A Pediatric Perspective," Pediatrics 117, no.5(2006): S406, http://pediatrics.aappublications.org/cgi/reprint/117/5/S2/S405.

119. Nicole Lurie, Testimony of Nicole Lurie before the U.S. Senate, Committee on Homeland Security and Governmental Affairs, Ad Hoc Subcommittee on Disaster Recovery, "Children and Disasters: The Role of HHS in Evacuation Planning and Mental Health Recovery," Washington, DC, August 4, 2009, http://hsgac.senate.gov/public/index.cfm?FuseAction=Hearings.Hearing&Hearing_ID=aa8241f6-6f0e-41a5-87c3- 07c9a58ecbfa.

120. National Commission on Children and Disasters, "Summary Report: Field Visit, Miami, Florida," (Washington, DC: NCCD, 2010), 2, http://www.childrenanddisasters.acf.hhs.gov/Summary_FLFieldVisit_FINAL.pdf .

121. National Commission on Children and Disasters, Interim Report, 18-19.

122. NDMS uses individuals with specific expertise in medical or public health services, emergency management, forensic sciences, and other related fields. These individuals must meet prerequisite training requirements applicable to their positions before being eligible to participate on an NDMS team and be available for interstate deployment. If accepted, individuals become intermittent Federal employees, compensated when deployed on an NDMS mission. Office of the Assistant Secretary for Preparedness and Response, "Recruitment Information: National Disaster Medical System," http://www.phe.gov/Preparedness/responders/ndms/teams/Pages/recruitment.aspx.

123. U.S. Department of Health and Human Services, Memorandum to the National Commission on Children and Disasters: Response to the National Commission on Children and Disasters Interim Report, 27-28.

124. National Commission on Children and Disasters, personal communication with the American Academy of Pediatrics, July 15, 2010.

125. Federally funded medical response teams include DMATs, Public Health Service Commissioned Corps teams, DoD teams, and Medical Reserve Corps teams.

126. OFRD's teams include Rapid Deployment Force Teams and Mental Health Teams, as well as recently developed Services Access Teams, which are specifically designed to assist those affected by a disaster, including children and youth, by connecting them with local service providers. United States Public Health Service, "Office of Force Readiness and Deployment," http://ccrf.hhs.gov/ccrf/.

127. U.S. Department of Health and Human Services, Memorandum to the National Commission on Children and Disasters: Response to the National Commission on Children and Disasters Interim Report, 27.

128. Daniel Green, "Public Comment at the National Commission on Children and Disasters Public Meeting, February 2, 2010," 4-6, http://www.childrenanddisasters.acf.hhs.gov/20100202_PublicComment_DGreen.pdf .

129. Elizabeth Ablah, Annie M. Tinius, and Kurt Konda, "Pediatric Emergency Preparedness Training: Are We on a Path toward National Dissemination?," The Journal of Trauma 67, no. 2(2009):S156.

130. While 68. percent of the clinical practitioners comprising DMATs have pediatric-specific training, only 5.6 percent have formal subspecialty training in pediatrics (e.g., pediatricians, pediatric nurse practitioners, pediatric emergency medicine, and pediatric critical care), and 47. percent have formal training specific to pregnant women. "Pediatric-specific training" refers to boarded or licensed providers who have received formalized training in pediatric care as well as training for other age groups (e.g., Emergency Medicine and Family Medicine). "Subspecialty training in pediatrics" refers to physicians and nurse practitioners who have received formalized training limited to pediatrics. Allen Dobbs, Chief Medical Officer, NDMS, personal communication to Christopher Revere, August 19, 2009.

131. MAJ Julie Carpenter, Medical Operations Officer, National Guard Bureau, personal communication to Commissioner Michael Anderson, July 23, 2010.

132. FETIG is an advisory group with representatives from Federal agencies, academia, and the private sector that coordinates public health, medical disaster preparedness, and response core curricula, training standards, and education for use by Federal agencies and non-governmental organizations. Office of the Assistant Secretary for Preparedness and Response, Charter for the Federal Education and Training Interagency Group, (Washington, DC: HHS, March 13, 2008), 1-3.

133. ESF #8, Public Health and Medical Services, coordinates all Federal assistance in support of State, local, tribal, and regional response to public health and medical disasters, incidents requiring a coordinated Federal public health or medical response, and developing public health or medical emergencies. U.S. Department of Homeland Security, Federal Emergency Management Agency, "National Response Framework, Emergency Support Function #8—Public Health and Medical Services Annex," http://www.fema.gov/pdf/emergency/nrf/nrf-esf-08.pdf .

134. National Commission on Children and Disasters, Interim Report, 19-20.

135. U.S. Department of Health and Human Services, National Health Security Strategy of the United States of America, (Washington, DC: HHS, 2009), 8, http://www.phe.gov/Preparedness/planning/authority/nhss/strategy/Documents/nhss-final.pdf .

136. Ibid., 9.

137. U.S. Department of Health and Human Services, Interim Implementation Guide for the National Health Security Strategy of the United States of America, (Washington, DC: HHS, 2009), 4, http://www.phe.gov/Preparedness/planning/authority/nhss/implementationguide/Documents/iig-final.pdf .

138. American Academy of Pediatrics, American College of Emergency Physicians, and Emergency Nurses Association, "Joint Policy Statement: Guidelines for Care in the Emergency Department," Pediatrics 124, no. 4 (2009): 1233-43, http://aappolicy.aappublications.org/cgi/reprint/pediatrics;124/4/1233.pdf .

139. Committee on the Future of Emergency Care in the United States Health System, Board on Health Care Services, Emergency Care for Children: Growing Pains. Executive Summary, ed. Institute of Medicine (Washington, DC: National Academies Press, 2007), 4, http://www.nap.edu/nap-cgi/report.cgi?record_id=11655&type=pdfxsum.

140. Monica E. Kleinman, "Regionalization of Critical Care: Not Just for Kids," Critical Care Medicine 37, no. 7(2009):2149-2154.

141. Murray Pollack, Steven Alexander, Nancy Clarke, Urs Ruttiman, Helen Tesselaar, and Antoinet Bachulis, "Improved Outcomes from Tertiary Center Pediatric Intensive Care: A Statewide Comparison of Tertiary and Nontertiary Care Facilities," Critical Care Medicine 19, no. 2(1991):150-159.

142. ASPR's ECCC was established to promote and support Federal programs that will enhance emergency care and its delivery systems; to advance regional partnerships; and to support State, local, and regional preparedness and response capability. Office of the Assistant Secretary for Preparedness and Response, "ECCC Frequently Asked Questions," http://www.phe.gov/Preparedness/planning/eccc/Pages/faqs.aspx.

143. P.L. 111-5(2009).

144. P.L. 111-148(2010).

145. P.L. 111-148, Sec. 1204.

146. National Association of Children's Hospitals and Related Institutions (NACHRI), "History of Children's Hospitals," http://www.childrenshospitals.net/AM/Template.cfm?Section=+History+of+Children%E2%80%99s+Hospitals&TE MPLATE=/CM/ContentDisplay.cfm&CONTENTID=12693.

147. Agency for Healthcare Research and Quality, "Preparation by General Health Care Facilities for a Surge of Critically Ill Children," U.S. Department of Health and Human Services, http://www.ahrq.gov/prep/pedhospital/pedhospital6.htm.

148. American Academy of Pediatrics, American College of Emergency Physicians, and Emergency Nurses Association, "Joint Policy Statement: Guidelines for Care in the Emergency Department," 1234.

149. Office of the Assistant Secretary for Preparedness and Response, "Hospital Preparedness Program," http://www.phe.gov/preparedness/planning/hpp/pages/default.aspx.

150. U.S. Department of Health and Human Services, Memorandum to the National Commission on Children and Disasters: Response to the National Commission on Children and Disasters Interim Report, March 18, 2010, 8, Washington, DC.

151. The Joint Commission, "About the Joint Commission," http://www.jointcommission.org/AboutUs/.

152. P.L. 93-288, as amended, 42. U.S.C. 5121-5207(1988).

153. Suk-fong Tank, Profile of Pediatric Visits, ed. American Academy of Pediatrics (Elk Grove, IL: AAP, 2007), 2, http://practice.aap.org/public/ProfileOfPediatricVisits.pdf .

154. Gary Peck, Testimony of Gary Peck before the U.S. Senate, Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, "Post-Katrina Health Care in the New Orleans Region: Progress and Continuing Concerns," Washington, DC, August 1, 2007, 4, http://www.aap.org/advocacy/washing/Testimonies-Statements-Petitions/08-01-07-NOLA-Providers-Testimony.pdf .

155. U.S. Department of Health and Human Services, National Health Security Strategy of the United States of America, 15.

156. A "medical home" is defined as a source of primary care that is accessible, continuous, comprehensive, family-centered, coordinated, compassionate, and culturally effective. Stephen E. Edwards, "Foreword," Pediatrics: Supplement: The Medical Home 113, no. 5(2004): 1471.

157. National Commission on Children and Disasters, Interim Report, 6.

158. Louisiana Department of Health and Hospitals, "News Release: Orleans Parish Declared as Health Professional Shortage Area," http://www.dhh.louisiana.gov/news.asp?ID=1&Detail=857&Arch=2006#.

159. Gary Peck, "Post-Katrina Health Care in the New Orleans Region: Progress and Continuing Concerns," 6.

160. CPT is "the most widely accepted medical nomenclature used to report medical procedures and services under public and private health insurance programs." CPT® is registered trademark of the American Medical Association. American Medical Association, "About CPT," http://www.ama-assn.org/ama/pub/physicianresources/ solutions-managing-your-practice/coding-billing-insurance/cpt/about-cpt.shtml.

161. CPT is "maintained by the CPT Editorial Panel, which meets three times a year to discuss issues associated with new and emerging technologies as well as difficulties encountered with procedures and services and their relation to CPT codes." Ibid.

162. Philip Landrigan, Paul Lioy, George Thurston, Gertrud Berkowitz, L.C. Chen, Steven Chillrud, Stephen Gavett, Panos Georgopoulos, Alison Geyh, Stephen Levin, Frederica Perera, Stephen Rappaport, Christopher Small, and the NIEHS World Trade Center Working Group, "Health and Environmental Consequences of the World Trade Center Disaster," Environmental Health Perspectives 112, no. 6(2004): 738, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1241968/pdf/ehp0112-000731.pdf .

163. Pauline Thomas, Robert Brackbill, Lisa Thalji, Laura DiGrande, Sharon Campolucci, Lorna Thorpe, and Kelly Henning, "Respiratory and Other Health Effects Reported in Children Exposed to the World Trade Center Disaster of 11. September 2001," Environmental Health Perspectives 116, no. 10 (2008): 1386, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2569099/pdf/ehp-116-1383.pdf .

164. David Abramson, Irwin Redlener, Tasha Stehling-Ariza, Jonathan Sury, Akilah Banister, and Yoon Soo Park, Impact on Children and Families of the Deepwater Horizon Oil Spill: Preliminary Findings of the Coastal Population Impact Study, Research Brief 2010-8, ed. National Center for Disaster Preparedness, Columbia University Mailman School of Public Health (New York. NY, August 3, 2010), 4, 7, http://www.ncdp.mailman.columbia.edu/files/NCDP_Oil_Impact_Report.pdf .

165. PEHSUs are a network of pediatric environmental health specialists who provide information and outreach concerning protection of children's health from environmental hazards. PEHSUs conduct academic research, partner with local medical practices, and provide free clinical consultations of environmental exposures. Jerome Paulson, Catherine Karr, James Seltzer, Debra Cherry, Perry Sheffield, Enrique Cifuentes, Irena Buka, and Robert Amler, "Development of the Pediatric Environmental Health Specialty Unit Network in North America," American Journal of Pediatric Health 99, no. S3(2009): S511-512, http://ajph.aphapublications.org/cgi/reprint/99/S3/S511.

166. Federal Emergency Management Agency, "Planning Guidance for Protection and Recovery Following Radiological Dispersal Device (RDD) and Improvised Nuclear Device (IND) Incidents," Federal Register 73, no. 149 (2008): 45032, http://www.fema.gov/good_guidance/download/10260.

167. U.S. Department of Homeland Security and U.S. Environmental Protection Agency, Draft—Planning Guidance for Recovery Following Biological Incidents, (Washington, DC: DHS, 2009), 1, http://www.trivalleycares.org/comments/DHSDraftGuidance.pdf .

168. Peter Grevatt, Testimony of Peter Grevatt before the U.S. Senate, Committee on Environment and Public Works, Washington, DC, March 17, 2010, 4, http://epw.senate.gov/public/index.cfm?FuseAction=Files.View&FileStore_id=1e09573e-707b-4e69-95cbf4d80898b9c3.

169. U.S. Government Accountability Office, Environmental Health: High-Level Strategy and Leadership Needed to Continue Progress toward Protecting Children from Environmental Threats, GAO 10-205, (Washington, DC: GAO, 2010), 41-42, http://www.gao.gov/new.items/d10205.pdf .

170. National Commission on Children and Disasters, "Meeting Minutes of the Pediatric Medical Care Subcommittee," (Washington, DC: NCCD, March 22, 2010), 2, http://www.childrenanddisasters.acf.hhs.gov/NCCD%20Subcommittees/20100323_PMCSubcommitteeReport.pdf .

171. EMS is a system of public and private agencies and organizations providing treatment and transportation of patients to available emergency medical care.

172. U.S. Department of Health and Human Services, National Health Security Strategy of the United States of America, (Washington, DC: HHS, December 2009), 1, http://www.phe.gov/Preparedness/planning/authority/nhss/strategy/Documents/nhss-final.pdf .

173. FICEMS was established in 2005. to: ensure coordination among Federal agencies; identify the needs of State, local, tribal, and regional EMS systems; recommend programs, including grant programs; help establish priorities; and advise and make recommendations regarding the implementation of State EMS programs. Public Law (P.L.) 109-59, 119 Stat. 1933, (2005), http://ems.gov/pdf/ficems-bill.pdf .

174. The Office of EMS provides support to FICEMS in coordination with HHS and the Department of Homeland Security (DHS) and manages the EMS.gov Web site. National Highway Traffic Safety Administration, "The History of EMS at NHTSA," http://www.ems.gov/other/history.html.

175. The National EMS Advisory Council was established in April 2007. "as a nationally recognized council of EMS representatives and consumers to provide advice and recommendations regarding EMS to NHTSA." National Highway Traffic Safety Administration, "NEMSAC," http://www.ems.gov/nemsac/index.html.

176. Emergency Medical Services for Children National Resource Center, "EMSC: An Historical Perspective," Children's National Medical Center, http://www.childrensnational.org/files/PDF/EMSC/EMSC_An_Historical_Perspective.pdf .

177. ECCC was established to promote and support Federal programs that enhance emergency care and its delivery systems. Office of the Assistant Secretary for Preparedness and Response, "Emergency Care Coordination Center," http://www.phe.gov/Preparedness/planning/eccc/Pages/default.aspx.

178. P.L. 109-59, 119 Stat. 1933(2005).

179. Committee on the Future of Emergency Care in the United States Health System, Board on Health Care Services, Emergency Care for Children: Growing Pains, ed. Institute of Medicine (Washington, DC: National Academies Press, 2007), 6-7, http://books.nap.edu/catalog.php?record_id=11655.

180. Committee on the Future of Emergency Care in the United States Health System, Board on Health Care Services, Hospital-Based Emergency Care: At the Breaking Point, ed. Institute of Medicine (Washington, DC: National Academies Press, 2007), 368, http://www.nap.edu/openbook.php?record_id=11621.

181. National EMS Advisory Council, Position Statement adopted June 3, 2009, http://www.ems.gov/pdf/NEMSAC_PositionStatement_HealthcareReform.pdf .

182. National Association of State Emergency Medical Services Officials, State EMS Office Involvement in Domestic Preparedness Efforts: NASEMSO 2008. Addendum, (Falls Church, VA: NASEMSO, 2008), 5, http://www.nasemso.org/Projects/DomesticPreparedness/documents/08DPAddendumReport-2.pdf .

183. P.L.111-5(2009).

184. American College of Surgeons Committee on Trauma, American College of Emergency Physicians, National Association of EMS Physicians, Pediatric Equipment Guidelines Committee—Emergency Medical Services for Children Partnership for Children Stakeholder Group, and American Academy of Pediatrics, Equipment for Ambulances (Washington, DC: Children's National Medical Center, 2009): 2-5, http://www.childrensnational.org/files/PDF/EMSC/PubRes/Equipment_for_ambulances_FINAL.pdf .

185. Emergency Medical Services for Children National Resource Center, Children's National Medical Center, Gap Analysis of EMS Related Research: Report to the Federal Interagency Committee on EMS, (Washington, DC: EMSC, 2009), http://www.childrensnational.org/files/PDF/EMSC/NationalActivities/Gap_Analysis_of_EMS_Related_Research.pdf .

186. Committee on the Future of Emergency Care in the United States Health System, Board on Health Care Services, Emergency Care for Children: Growing Pains, 1-2.

187. Ibid., 6.

188. Ibid., 2.

189. Institute of Medicine, The National Emergency Care Enterprise: Advancing Care Through Collaboration: Workshop Summary, (Washington, DC: National Academies Press, 2009), http://books.nap.edu/catalog.php?record_id=12713.

190. The EMSC Program, administered by HRSA, "provides States grant money to help develop and institutionalize emergency medical services for critically ill and injured children" by enhancing existing EMS systems' pediatric capability. Emergency Medical Services for Children National Resource Center, "EMSC: An Historical Perspective."

191. National Commission on Children and Disasters, Interim Report, (Washington, DC: NCCD, October 14, 2009), 26, http://www.childrenanddisasters.acf.hhs.gov/20091014_508IR_partII.pdf .

192. Committee on the Future of Emergency Care in the United States Health System, Board on Health Care Services, Emergency Care for Children: Growing Pains, 14.

193. Medical direction protocols allow a paramedic or Emergency Medical Technician (EMT) to contact a physician from the field via radio or other means to obtain instructions on further care for a patient.

194. Emergency Medical Services for Children National Resource Center, EMSC Performance Measures: 2009- 2010 "Final" Edition, (Washington, DC: Children's National Medical Center, October 1, 2009), 14-92, http://www.childrensnational.org/files/PDF/EMSC/ForGrantees/PM_Implemenation_Manual_V2009.pdf .

195. The full list of EMSC performance measures is available on HRSA's Web site. Emergency Medical Services for Children, "Performance Measures," Health Resources and Services Administration, http://bolivia.hrsa.gov/emsc/PerformanceMeasures.aspx.

196. Centers for Medicare & Medicaid Services, "Ambulance Services Center," https://www.cms.gov/center/ambulance.asp.

197. American College of Surgeons Committee on Trauma, American College of Emergency Physicians, National Association of EMS Physicians, Pediatric Equipment Guidelines Committee—Emergency Medical Services for Children Partnership for Children Stakeholder Group, and American Academy of Pediatrics, Equipment for Ambulances, 2-5.

198. Diana Fendya, Sally Snow, and Tasmeen Singh Weik, "Using System Change as a Method of Performance / Quality Improvement for Emergency and Trauma Care of Severely Injured Children: Pediatric System Performance Improvement," Journal of Trauma Nursing 17, no. 1(2010):32.

199. Marianne Gausche-Hill, Charles Schmitz, and Roger Lewis, "Pediatric Preparedness of US Emergency Departments: A 2003. Survey," Pediatrics 120, no. 6(2007): 1230, http://pediatrics.aappublications.org/cgi/reprint/120/6/1229.

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