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Code · REGISTER · 2006-03-16 · Health Resources and Services Administration, HHS · Notices

Notices. Notice

7,532 words·~34 min read·/register/2006/03/16/06-2538

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-01-C DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration
(HRSA)is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (“the Program”), as required by Section 2112(b)(2) of the Public Health Service
(PHS)Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place, NW., Washington, DC 20005,
(202)357-6400. For information on HRSA's role in the Program, contact the Acting Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857;
(301)443-6593. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 *et seq.* , provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated his responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at Section 2114 of the PHS Act or as set forth at 42 CFR 100.3, as applicable. This Table lists for each covered childhood vaccine the conditions which may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that the Secretary publish in the **Federal Register** a notice of each petition filed. Set forth below is a list of petitions received by HRSA on October 1, 2005, through December 31, 2005. Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following: 1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and 2. Any allegation in a petition that the petitioner either:
(a)“Sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Table but which was caused by” one of the vaccines referred to in the Table, or
(b)“Sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table. This notice will also serve as the special master's invitation to all interested persons to submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three
(3)copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading FOR FURTHER INFORMATION CONTACT ), with a copy to HRSA addressed to Acting Director, Division of Vaccine Injury Compensation Program, Healthcare Systems Bureau, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program. List of Petitions 1. Anna and Robert Perkins on behalf of Jason Perkins, Chicago, Illinois, Court of Federal Claims No: 05-1057V. 2. Ingrid Bianco on behalf of Frank John Bianco, Somers Point, New Jersey, Court of Federal Claims No: 05-1059V. 3. Patricia and Chris Riggle on behalf of Joseph William Riggle, Greenland, New Hampshire, Court of Federal Claims No: 05-1062V. 4. Barbara and John Murphy on behalf of Michael Murphy, West Friendship, Maryland, Court of Federal Claims No: 05-1063V. 5. Alisha Shepperson on behalf of Jordan Taylor Shepperson, Fort Walton Beach, Florida, Court of Federal Claims No: 05-1064V. 6. Darren McDonough on behalf of Garrett Patrick McDonough, Greensboro, North Carolina, Court of Federal Claims No: 05-1077V. 7. Mary and Michael Schoeppner on behalf of Mary Schoeppner, Tampa, Florida, Court of Federal Claims No: 05-1080V. 8. Suzanne and John Davis on behalf of Spencer Davis, Lewiston, Maine, Court of Federal Claims No: 05-1084V. 9. Leslie Wilson and Akira Ueno on behalf of Nathan Ueno, Portland, Oregon Court of Federal Claims No: 05-1102V. 10. Melissa and John Wallace on behalf of Madilyn Wallace, Boston, Massachusetts, Court of Federal Claims No: 05-1104V. 11. Jestine Lachapelle on behalf of Joshua Lachapelle, Deceased, Dover, Delaware, Court of Federal Claims No: 05-1106V. 12. Stephen Lieurance, Andover, Kansas, Court of Federal Claims No: 05-1107V. 13. Pamela and Ronald Smith on behalf of Takashi Jesse Smith, San Jose, California, Court of Federal Claims No: 05-1108V. 14. Asa and Leondra McMahon on behalf of Asa McMahon, Ithaca, New York, Court of Federal Claims No: 05-1110V. 15. James Grassman, Deceased Rancho Mirage, California, Court of Federal Claims No: 05-1114V. 16. Jorge Alberto Carcamo, Simi Valley, California, Court of Federal Claims No: 05-1116V. 17. Kristi and Scott Getson on behalf of Edward Matthew Getson, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1117V. 18. Nicole Schwartz on behalf of Alexander Schwartz, Somers Point, New Jersey, Court of Federal Claims No: 05-1118V. 19. Scott Berger, Commack, New York, Court of Federal Claims No: 05-1120V. 20. Sonali and Darryl Tang on behalf of Arman Sebastian Tang, La Mesa, California, Court of Federal Claims No: 05-1122V. 21. Roger Siekbert on behalf of Chloe Siekbert, Blue Creek, Ohio, Court of Federal Claims No: 05-1124V. 22. Julie Clinton on behalf of John Clinton, Memphis, Tennessee, Court of Federal Claims No: 05-1126V. 23. Yanitza and Joel Jimenez on behalf of Jeilynne Jimenez, Somers Point, New Jersey, Court of Federal Claims No: 05-1127V. 24. Andrea and Mitchell Mitchell on behalf of Jack Mitchell, Carmel, Indiana, Court of Federal Claims No: 05-1128V. 25. William Taylor on behalf of Joseph Taylor, Boston, Massachusetts, Court of Federal Claims No: 05-1133V. 26. Sheri and Steven Zettle on behalf of Quaid Zettle, Boston, Massachusetts, Court of Federal Claims No: 05-1134V. 27. Marcia and Joseph Ferraro on behalf of Anthony Ferraro, Boston, Massachusetts, Court of Federal Claims No: 05-1135V. 28. Kerrie and Paul Ferrara on behalf of Paul Ferrara, Boston, Massachusetts, Court of Federal Claims No: 05-1136V. 29. Ishrat and Ahmad Ahsan on behalf of Ariana Ahsan, Boston, Massachusetts, Court of Federal Claims No: 05-1137V. 30. Nicole and Bret Cochran on behalf of Jake Cochran, Boston, Massachusetts, Court of Federal Claims No: 05-1138V. 31. Lisa and James Glover on behalf of Chloe Glover, Boston, Massachusetts, Court of Federal Claims No: 05-1139V. 32. Paula Kelley, Clairton, Pennsylvania, Court of Federal Claims No: 05-1140V. 33. Renda Sue Mace and Billy Oliphant on behalf of Renda Sue Mace, Clinton, Oklahoma, Court of Federal Claims No: 05-1146V. 34. Heidi and Roderick Conner on behalf of Maryah M. Conner, Twin Falls, Idaho, Court of Federal Claims No: 05-1149V. 35. Louise Habakus on behalf of Nicholas Habakus, Red Bank, New Jersey, Court of Federal Claims No: 05-1150V. 36. Marlo Thomas, Goldsboro, North Carolina, Court of Federal Claims No: 05-1151V. 37. Marcy Miles on behalf of Sean Miles, Norwich, New York, Court of Federal Claims No: 05-1152V. 38. Jerry Fridley, Fontana, California, Court of Federal Claims No: 05-1153V. 39. Janelle and M. Thomas Jones on behalf of Benjamin Jones, Ft. Wayne, Indiana, Court of Federal Claims No: 05-1154V. 40. Linda Burton on behalf of Evan Burton, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1155V. 41. Luke James Lewis, Lackland, Texas, Court of Federal Claims No: 05-1160V. 42. Michelle and Trever Anderson on behalf of Aidan Bae Schulte Anderson, Augusta, Georgia, Court of Federal Claims No: 05-1162V. 43. Pamela Haynes on behalf of John Haynes, Boston, Massachusetts, Court of Federal Claims No: 05-1164V. 44. Theresa Lux on behalf of Katharine Lux, Boston, Massachusetts, Court of Federal Claims No: 05-1165V. 45. Christine and Cody Bielawa on behalf of Matthew Bielawa, New York, New York, Court of Federal Claims No: 05-1168V. 46. Joyce and Carl Schwenk on behalf of Justin Schwenk, Lansdale, Pennsylvania, Court of Federal Claims No: 05-1169V. 47. Don Kostenbader, Pottsville, Pennsylvania, Court of Federal Claims No: 05-1171V. 48. Theresa Cangialosi on behalf of Alexandra Coen, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1174V. 49. Kimberly and Kieran Bastible on behalf of Luke Xavier Bastible, Lake Success, New York, Court of Federal Claims No: 05-1176V. 50. Lesley Ann Jones on behalf of Jade Christine Dollar, Morton, Illinois, Court of Federal Claims No: 05-1178V. 51. Ann and Keith Dronen on behalf of Anastasia C. Dronen, Wimette, Illinois, Court of Federal Claims No: 05-1181V. 52. Joseph Demko, Sherman, Texas, Court of Federal Claims No: 05-1190V. 53. Shirley and Clarence McKinnon on behalf of Deontay Perry, Baltimore, Maryland, Court of Federal Claims No: 05-1194V. 54. Stacey and David Lavely on behalf of Jagger Lavely, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1195V. 55. Kevin Wayne Stead, Fort Bragg, North Carolina, Court of Federal Claims No: 05-1196V. 56. Lorraine and Gregory Sissons on behalf of Lauren Sissons, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1197V. 57. Tammi Halvorson on behalf of Patrick Halvorson, Boston, Massachusetts, Court of Federal Claims No: 05-1198V. 58. Roseann Havers on behalf of Mikayla Havers, Boston, Massachusetts, Court of Federal Claims No: 05-1199V. 59. Michelle Mouille on behalf of Maurice Lamkin, San Antonio, Texas, Court of Federal Claims No: 05-1204V. 60. Philip Carter, Costa Mesa, California, Court of Federal Claims No: 05-1206V. 61. Lori Bedrio on behalf of Samantha Bedrio, La Mesa, California, Court of Federal Claims No: 05-1207V. 62. Jeffrey House on behalf of Logan House, Boston, Massachusetts, Court of Federal Claims No: 05-1210V. 63. Nanette and Jeff Cunningham on behalf of Zoe Rose Cunningham, Sulphur Springs, Texas, Court of Federal Claims No: 05-1212V. 64. Charlene French, Tacoma, Washington, Court of Federal Claims No: 05-1213V. 65. Linda Reno on behalf of Connor Reno, Boston, Massachusetts, Court of Federal Claims No: 05-1214V. 66. Jenny and Glenn Hess on behalf of Jackson Connor Hess, Flint, Michigan, Court of Federal Claims No: 05-1216V. 67. Lauren and Louis Matto on behalf of Louis Matto, IV, Somers Point, New Jersey, Court of Federal Claims No: 05-1221V. 68. Carrie Ruth Brake on behalf of Stephen Joseph Brake, Winchester, Kentucky, Court of Federal Claims No: 05-1228V. 69. Brenda Deiuliis on behalf of Anthony N. Deiuliis, Pittsburgh, Pennsylvania, Court of Federal Claims No: 05-1230V. 70. Robert Smith, Dickinson, Texas, Court of Federal Claims No: 05-1231V. 71. Carrie Ruth Brake on behalf of Phillip Brake, Winchester, Kentucky, Court of Federal Claims No: 05-1233V. 72. Pamela and Greg Giacchi on behalf of Anthony Giacchi, Pompton, New Jersey, Court of Federal Claims No: 05-1235V. 73. Laurie and John M. Lupo on behalf of Jonathan David Lupo, Basking Ridge, New Jersey, Court of Federal Claims No: 05-1238V. 74. Jonathan Corneil, Wahpeton, North Dakota, Court of Federal Claims No: 05-1239V. 75. Tina L. Goodlock, Adrian, Michigan, Court of Federal Claims No: 05-1240V. 76. Lydia Cisneros and Alejandro Rodriguez on behalf of Britney Rodriguez Cisneros, Deceased, Los Angeles, California, Court of Federal Claims No: 05-1241V. 77. Joanne Arnoult on behalf of Jordan Arnoult, Marrero, Louisiana, Court of Federal Claims No: 05-1247V. 78. Janice Crabtree and Jeffery Ambroziak on behalf of William Ambroziak, Boston, Massachusetts, Court of Federal Claims No: 05-1256V. 79. Pamela and David Goggins on behalf of Allston Goggins, Boston, Massachusetts, Court of Federal Claims No: 05-1257V. 80. Michael Peace on behalf of Anaya Shanelle Peace, Dallas, Texas, Court of Federal Claims No: 05-1258V. 81. Lujene and Alan Clarke on behalf of Devon Chandler Clarke, Lake Success, New York, Court of Federal Claims No: 05-1260V. 82. Francis Perez on behalf of Mario Perez, Deceased, Willingboro, New Jersey, Court of Federal Claims No: 05-1261V. 83. Theodore W. Porada, Middleburg Heights, Ohio, Court of Federal Claims No: 05-1262V. 84. Shawnte Ayalew on behalf of Sydney Jones, Redwood City, California, Court of Federal Claims No: 05-1266V. 85. Frederick and Betty Brady on behalf of Frederick Brady Ashville, North Carolina, Court of Federal Claims No: 05-1267V. 86. Khudeza Begum on behalf of Mehabub Bhuiyan, New York, New York, Court of Federal Claims No: 05-1269V. 87. Natasha Malone on behalf of Jazmon Malone, Dallas, Texas, Court of Federal Claims No: 05-1270V. 88. Liz Warren on behalf of Milo Zada, San Francisco, California, Court of Federal Claims No: 05-1271V. 89. Alexandra and Donald Mazziotti on behalf of Gabriella Mazziotti, Portland, Oregon, Court of Federal Claims No: 05-1274V. 90. Leilani and Gary Gross on behalf of Talia Gross, Huntington Beach, California, Court of Federal Claims No: 05-1275V. 91. Mary and Joseph Hostetler on behalf of Matthew Hostetler, Apple Creek, Ohio, Court of Federal Claims No: 05-1276V. 92. John Crouch on behalf of Cody Crouch Boston, Massachusetts, Court of Federal Claims No: 05-1279V. 93. David Dearinger on behalf of George Dearinger, Everett, Washington, Court of Federal Claims No: 05-1280V. 94. Karrie and Len Jennings on behalf of Tristin Robert Jennings, Minneapolis, Minnesota, Court of Federal Claims No: 05-1283V. 95. Latricia Hewings on behalf of Miles Lee Williams, Deceased, Milwaukee, Wisconsin, Court of Federal Claims No: 05-1292V. 96. David Dearinger on behalf of Jack Dearinger, Everett, Washington, Court of Federal Claims No: 05-1293V. 97. Maloree McDonough, Little Rock, Arkansas, Court of Federal Claims No: 05-1294V. 98. Frederick James Vondrak, III on behalf of Frederick James Vondrak, IV, Novi, Michigan, Court of Federal Claims No: 05-1310V. 99. Andrew Collier on behalf of Michael Collier, Brookfield, Missouri, Court of Federal Claims No: 05-1314V. 100. Donna and Ed Iarrapino on behalf of Joseph Andrew Iarrapino, Lake Success, New York, Court of Federal Claims No: 05-1350V. 101. Denise and Michael Smith on behalf of Alexander Hunter Smith, Lake Success, New York, Court of Federal Claims No: 05-1351V. 102. Alan Peltes St. Louis, Missouri, Court of Federal Claims No: 05-1352V. 103. Jeannine and Dominic Pernice on behalf of Nicholas Pernice, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1358V. 104. Amy Sauter on behalf of Jack Sauter, Philadelphia, Pennsylvania, Court of Federal Claims No: 05-1359V. 105. Michael W. Collier, Sr. on behalf of Benjamin D. Collier, Lake Success, New York, Court of Federal Claims No: 05-1370V. 106. Melissa Steinberg, Frenchtown, New Jersey, Court of Federal Claims No: 05-1377V. 107. Karen Dola-Fein and Gregory Fein on behalf of Daniel Fein, West Hills, California, Court of Federal Claims No: 05-1379V. 108. Renee and Brendon Deyo on behalf of Bryan Deyo, Washington, DC, Court of Federal Claims No: 05-1385V. 109. Melissa Guffey on behalf of Kimberly Warfle, Paris, Tennessee, Court of Federal Claims No: 05-1399V. 110. Kimberly and Stephen Benson on behalf of Mackenzie Benson, Doyleston, Pennsylvania, Court of Federal Claims No: 05-1400V. 111. Tresa and Steven Kinzer on behalf of Samuel Kinzer, Cleveland, Tennessee, Court of Federal Claims No: 05-1401V. Dated: March 9, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-3791 Filed 3-15-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Organ Procurement and Transplantation Network Status of Living Donor Guidelines AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notification of Review and Access of Public Comments. SUMMARY: **Federal Register** Notice (volume 71, number 14, pp 3519-3520) published on January 23, 2006, inadvertently omitted information on the review and access of the material received in response to the solicitation of comments to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network
(OPTN)concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies. *Docket:* For access to the docket to read background documents or comments received, go to the Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 12C-06, Rockville, Maryland 20857 weekdays (Federal holidays excepted) between the hours of 8:30 a.m. and 5 p.m. To schedule an appointment to view public comments, phone
(301)443-7757. FOR FURTHER INFORMATION CONTACT: Jim Burdick, M.D. at the above address; telephone number
(301)443-7577. Dated: March 9, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-3790 Filed 3-15-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service [Funding Announcement Number: HHS-2006-IHS-EPI-0001] Division of Epidemiology and Disease Prevention; Epidemiology Program for American Indians/Alaska Natives and Urban Indian Communities; Announcement Type: Competing Renewal Catalog of Federal Domestic Assistance Numbers: 93.231 *Dates:* Key Dates: *Application Deadline Date:* June 30, 2006; *Anticipated Application Review:* August 16, 2006; *Application Notification:* September 1, 2006; *Anticipated Start Date:* September 16, 2006. I. Funding Opportunity Description The Department of Health and Human Services
(HHS)Indian Health Service
(IHS)announces that competitive cooperative agreement applications are now being accepted by the Division of Epidemiology and Disease Prevention for American Indians/Alaska Natives (AI/AN) and Urban Indian Communities for Tribal Epidemiology Centers. This program is authorized under section 214(b)(1) of the Indian Health Care Improvement Act, 25 U.S.C. 1621(m), Public Law 94-437, as amended by Public Law 102-573. This program is described in section 93.231 in the Catalog of Federal Domestic Assistance. There will be only one funding cycle during Fiscal Year
(FY)2006. These cooperative agreements will be awarded and administered in accordance with this announcement, Department of Health and Human Service
(HHS)at 45 CFR part 92, HHS Uniform Administrative Requirements for Grants and Cooperative Agreements to State, local, and Tribal governments, or 45 CFR part 74, Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Non-profit Organizations and Commercial Organizations; the Public Health Service
(PHS)Grant Policy Statement; and applicable Office of Management and Budget Circulars. The PHS urges applicants submitting an application to address specific objectives of *Healthy People 2010.* Interested applicants may obtain a copy of *Healthy People 2010 in print* (Summary Report; Stock No. 017-001-00547-9) or on CD-ROM (Stock No. 107-001-00549-5) through the Superintendent of Documents, Government Printing Office, P.O. Box 371954-7945, or
(202)512-1800. You may access this information via the Internet at the following Web site: *http://www.health.gov/healthypeople/publications.* The purpose of this cooperative agreement program is to develop and support Tribal Epidemiology Centers
(TEC)and public health infrastructure through the augmentation of existing programs with expertise in epidemiology and a history of regional support. Activities should include, but are not limited to, enhancement of surveillance for disease conditions; epidemiologic analysis, interpretation, and dissemination of surveillance data; investigation of disease outbreaks; developments and implementation of epidemiologic studies; development and implementation of disease control and prevention programs; and coordination of activities of other public health authorities in the region. Proposed activities are encouraged to cover large populations and/or geographical areas that do not necessarily correspond with current IHS administrative areas. To achieve the purpose of this program, the recipient will be responsible for the activities under item number *1. Recipient Activities* and IHS will be responsible for conducting activities under item number *2. IHS Activities.* 1. Recipient Activities
(a)Assist and facilitate AI/AN communities, Tribal organizations, and urban Indian organizations in implementing and enhancing disease surveillance systems, identifying their highest priority health status objectives based on epidemiologic data, and monitoring progress toward meeting each of the health status objectives of IHS, the AI/AN communities, Tribal and urban Indian organizations in the region. Assist and facilitate reporting of nationally notifiable disease conditions to public health authorities in the region.
(b)Provide health specific data and community health profiles for Tribal entities their respective catchment areas.
(c)Participate in the development of systems for sharing, improving, and disseminating aggregate health data at a national level for purposes of advocacy for AI/AN communities, Government Performance and Results Act (GPRA), Healthy People 2010, and other national-level activities.
(d)Collaborate with national DHHS programs in the development of standardized health profiles, surveillance and data monitoring methods and data sets.
(e)Support responses to public health emergencies in collaboration with the IHS, Division of Epidemiology and Disease Prevention (DEDP), state, local, Tribal, and other Federal health authorities.
(f)Support the IHS Director's HP/DP Initiatives & Performance Contract. You may access this information via the Internet at the following Web site: *http://www.ihs.gov/.* At the IHS Web site, click on Go to IHS.gov Main-Page, on the right side, under *Special Announcement* , you will find the Director's Initiative.
(g)Develop and implement epidemiologic studies that have practical application in improving the health status of constituent communities. Studies may require Institutional Review Board approval if human subjects are involved.
(h)Develop and implement disease control and prevention programs in cooperation with other public health entities. Make recommendations for targeting of public health services needed by constituents.
(i)Establish a required broad-based advisory council that consists of technical experts in epidemiology and public health, community members, health care providers, and others who can provide overall program direction and guidance.
(j)Provide a mid-year report and an annual report (no more than 10 pages respectively) at the end of each project year. 2. IHS Activities
(a)Convene a Tribal Epidemiology Centers
(TECs)workshop/conference of funded organizations every year for information sharing and problem solving.
(b)Provide funded TECs with ongoing consultation and technical assistance to plan, implement, and evaluate each component of the comprehensive program as described under *Recipient Activities* above. Consultation and technical assistance will include, but not be limited to, the following areas:
(1)Interpretation of current scientific literature related to epidemiology, statistics, surveillance, Health People 2010 Objectives, and other disease control activities;
(2)Design and implementation of each program component (surveillance, epidemiologic analysis, outbreak investigation, development of epidemiologic studies, development of disease control programs, and coordination of activities; and
(3)Overall operational planning and program management.
(c)Provide opportunities for training fellowship at the the DEDP and other programs in IHS, if funds permit.
(d)Conduct site visits to TECs to assess program progress and mutually resolve problems, as needed, and/or coordinate reverse site visits to IHS in Albuquerque, New Mexico.
(e)Assign Federal personnel to TECs in lieu of a portion of the financial assistance, if available.
(f)Coordinate all epidemiologic activities on a national scope.
(g)DEDP will increase funding as additional funds become available. II. Award Information *Type of Awards:* Cooperative Agreement. *Estimated Funds Available:* up to $6,000,000. The total amount of funds available for fiscal year 2006 is up to $6,000,000. The awards are for 12 months in duration and can be reviewed during the 5-year project period. The average award is approximately $150,000 to $1,000,000 depending on the applicant's score. Awards under this announcement are subject to the availability of funds. Additional funds may become available from other HHS Operating Divisions for distribution to successful applicants within the Epidemiology Program to support the shared program objectives. If funds become available, they will be distributed on a limited competition basis. *Anticipated Number of Awards:* 12. *Project Period:* September 16, 2006 to September 15, 2011. *Award Amount:* $150,000 and up to $1,000,000 per year**. *Funding Information:* As part of an effort to establish TECs throughout the nation, these funds will be used to support activities on a regional basis. Collaborative efforts among Tribal, local, state, Federal, and university health organizations are encouraged. It is anticipated that funding will be available ranging from $150,000 and up to $1,000,000 per year to fund each award. Applicants are encouraged to apply for sums up to $1,000,000. Awardees who were originally funded at levels lower than requested may receive additional funding, if additional funds become available in subsequent years. The awarding office has no obligation to provide future funding. • Funding will be based on scoring levels of the review process. An example is outlined below. Score Funding up to amount ** 90-100 $300,000-$1,000,000. 80-89 $250,000. 70-79 $200,000. 60-69 $150,000. 59-below Not funded. ** Varies depending on scores and funds available. Applicants may be eligible for consideration later in the fiscal year without further review if funds are available. At the request of the applicant, Federal personnel, if available, may be assigned to a project in lieu of a portion of the financial assistance. • Only one project cooperative agreement will be funded per Indian Tribe or Indian health organization. • Cooperative Agreements will be funded annually during the project period of five years, dependent upon the scope of work, and yearly continuation applications are required to be renewed. Renewals of cooperative agreements will be base don the following: —Satisfactory progress. —Availability of funds. —Continuing need of IHS for the program. • Awardees will be required to submit the Standard Form 424 and semi annual Progress and Financial Reports. • Forms are available at the following Web site *http://www.grants.gov.* The progress report should provide information about changes in the program and a summary report of any evaluations. These semi-annual progress reports and financial reports will be closely monitored by the IHS Staff to ensure that the program is achieving the goals of the Divisions of the Epidemiology and Disease prevention. • Limitations—Only one cooperative agreement project will be awarded per Tribe, Tribal or Indian organization, or intertribal consortia. • Period of support—The project under this announcement will be awarded as a cooperative agreement for a five-year period. Due to the nature of these projects, collaboration with the DEDP is necessary to conduct the following:
(a)Coordinate activities;
(b)Participate in projects, investigations, or studies of national scope; and
(c)Share surveillance and other data collected, in compliance with the Federal Privacy Act Health Insurance Portability & Accountability Act, or similar Tribal laws. The IHS will, therefore, have substantial programmatic involvement in these projects (see *IHS Activities* above). Programmatic Involvement: See *IHS Activities.* III. Eligibility Information 1. Eligible Applicants. AI/AN Tribes, Tribal organizations, and eligible intertribal consortia or Indian organizations may be eligible for a cooperative agreement. Such entities must represent or serve a population of at least 60,000 AI/AN to be eligible. An intertribal consortium or AI/AN organization is eligible to receive a cooperative agreement if it is incorporated for the primary purpose of improving AI/AN health, and represents the Tribes, AN villages, or urban Indian communities in which it is located. Collaborations with regional IHS, CDC, State, or a academic or other organizations are encouraged (letter of support and collaboration should be included in the application). The following documentation is required:
(a)Tribal Resolution. 1. A signed and dated resolution supportive of the epidemiology cooperative agreement proposal from the Indian Tribes(s) served by the project must accompany the application. 2. Application by Tribal organizations will not require a specific Tribal resolution(s) if the current blanket Tribal resolution(s) under which they operate would encompass the proposed activities and project type.
(b)Non-profit organization—A copy of 501(c)(3) non profit certificate. 2. Cost Sharing or Matching—The Division of Epidemiology and Disease Prevention does not require matching funds or cost sharing. IV. Application and Submission Information 1. Address and Web Site To Request Application The entire application kit can be found in Grants.gov Web site, *http://www.grants.gov.* Information regarding the electronic application process may be obtained from either of the following persons: Selina Keryte, Project Officer, Division of Epidemiology and Disease, Prevention, 5300 Homestead Road NE., Albuquerque, NM 87110. Phone:
(505)248-4132. Fax:
(505)248-4393. E-mail: *selina.Keryte@ihs.gov.* Martha Redhouse, Division of Grants Operations, Indian Health Service, Twinbrook Metro Plaza, Suite 360, 801 Thompson Ave., Rockville, Maryland 20852. Phone:
(301)443-5204. Fax:
(301)443-9602. E-mail: *martha.redhouse@ihs.gov.* The preferred method is to submit the application using Grants.gov. For some reason if you are unable to use Grants.gov, please request an application package kit including the required PHS 5161-1 (Rev. 7/00) (OMB Approval No. 0348-0043) and the U.S. Government Standard forms (SF-424 and SF-424B) from the following person, Martha Redhouse. The telephone number is not a toll-free number. 2. Content and Form of Application Submission Requirements All applications must be double-spaced, typewritten, and have consecutively numbered pages using black type not smaller than 12 characters per one inch, with conventional one-inch border margins, on only one side of standard size 8.5 x 11 paper that can be photocopied. The application narrative (not including Abstract, Tribal Resolution, Standard Forms, Table of Contents or the Attachments must not exceed 25 typed pages as described above. Contain a narrative that does not exceed 7 typed pages including other submission below. The 7 page narrative does not include the work plan, standard forms, Tribal resolutions (if necessary), table of contents, budget, budget justifications, and/or other appendix items. Public Policy Requirements: All Federal-wide public policies apply to IHS grants with exception of Lobbying and Discrimination. All applications must include the following in the order presented: • Tribal Resolution(s) and documentation. • Standard Form 424, Application for Federal Assistance. • Standard Form 424A, Budget Information—Non-Construction Programs, Pages 1 and 2. • Standard Form 424B, Assurances—Non-Construction Programs (front and back). • Certification (pages 17-19). • Checklist (pages 25-26). Note: Each standard form and checklist is contained in the PHS Grant Application, Form PHS 5161-1 (Revised 7/00). • A one-page project Executive Summary. • Table of Contents. • Introduction and Need for Assistance. • Project Objective(s) to include a spreadsheet with Objective Time-Line, Approach, and Results & Benefits. • Project Evaluation Plan. • Applicant's organizational capabilities addressing *Recipient's Activities* refer to Item #1. *Recipient Activities.* • Multi-year Narratives and Budget Justifications. • Attachments to include: • Resume of key staff or biosketches. • Position descriptions for key staff. • Organizational chart. • All letters of support from potential collaborators. • Copy of current negotiated indirect cost rate agreement (required) in order to receive IDC. • A map of the areas to benefit from the project. • If applicable, application Receipt Card, IHS-815-1A. 3. Submission Dates and Times Applications must be submitted electronically through Grants.gov by the close of business on Friday, June 30, 2006. If technical issues arise and the applicant is unable to successfully complete the electronic application process, the applicant must contact Grants Policy Staff fifteen days prior to the application deadline. At that time, it will be determined whether you may submit a paper application. As appropriate, paper applications are due by the date referenced above. Paper applications (original and 1 copy) shall be considered as meeting the deadline if they are received on the appropriate deadline date or postmarked on or before the deadline date. Applicants should request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks will not be acceptable as proof of timely mailing and will not be considered for funding. Late applications will not be accepted for processing and will be returned to the applicant and will not be considered for funding. Use the following address to send the paper application by the close of business on Friday, June 30, 2006: Division of Grants Operations, Twinbrook Metro Plaza, Suite 360, 801 Thompson Avenue, Rockville, Maryland, 20852. 4. Intergovernmental Review Executive Order 12372 requiring intergovernmental review is not applicable to this program. 5. Funding Restriction Applications may request total costs from $150,000 to $1,000,000 annually for a period of 5 years.
(a)Pre-award costs are not allowable.
(b)The available funds are inclusive of direct and indirect costs.
(c)Only one cooperative agreement will be awarded per applicant. 6. Other Submission Requirements (See Below) Beginning October 1, 2003, applicants were required to have a Dun and Bradstreet
(DUNS)number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is simple to obtain and there is not charge. DUNS Number Applicants are required to have a Dun and Bradstreet
(DUNS)number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine-digit identification number which uniquely identifies business entities. Obtaining a DUNS number is easy and there is not charge. To obtain a DUNS number, access *http://www.dunandbradstreet.com* or call 1-866-705-5711. Interested parties may wish to obtain their DUNS number by phone to expedite the process. Applications submitted electronically must also be registered with the Central Contractor Registry (CCR). A DUNS number is required before CCR registration can be completed. Many organizations may already have a DUNS number. Please use the number listed above to investigate whether or not your organization has a DUNS number. Registration with the CCR is free of charge. Applicants may register by calling 1-888-227-2423. Please review and complete the CCR “Registration Worksheet” located on *http://www.grants.gov/CCR Register.* More detailed information regarding these registration processes can be found at *http://www.grants.gov.* *Electronic Submission:* The preferred method of receipt of applications is electronic submission through Grants.gov. However, should any technical problems arise regarding the submission, please contact Grants.gov Customer Support at 1-800-518-4726 or *support@grants.gov.* The Contact Center hours of operation are Monday-Friday from 7 a.m. to 9 p.m. (Eastern Standard Time). If you required additional assistance please contact IHS Grants Policy Staff at
(301)443-6528 at least fifteen days prior to the application deadline. To submit an application electronically, please use the *http://www.Grants.gov* application site. Download a copy of the application package on the Grants.gov Web site, complete it offline and then upload and submit the application via the Grants.gov site. Do not e-mail an electronic copy of a grant application to DEDP. Please note the following:
(a)Under the new IHS requirements, paper applications are not the preferred method. However, if you have technical problems submitted your application on-line, please contact Grants.gov Customer Support at: *http://www.grants.gov/CustomerSupport.* If you are still unable to successfully submit your application on-line, please contact Grants Policy Staff fifteen days prior to the application deadline and advise them of the difficulties you are having submitting your application on-line. At that time, it will be determined whether you may submit a paper application. At that point you have to download the application package from Grants.gov, and send it directly to the Division of Grants Operations, 801 Thompson Avenue, TMP 360, Rockville, MD 20852 by the due date, Friday, June 30, 2006.
(b)When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation. We strongly recommend that you do not wait until the deadline date to begin the application process through Grants.gov.
(c)To use Grants.gov, you, as the applicant, must have DUNS Number and register in the Central Contractor Registry (CCR). You should allow a minimum of ten days to complete CCR registration. You may access this information via the Internet at the following Web site. CCR Registration: *http://www.ccr.gov,* DUNS Number: *http://www.dunandbrastreet.com.*
(d)You must submit all documents electronically, including all information typically included on the SF-424 and all necessary assurances and certifications.
(e)Your application must comply with any page limitation requirements described in the program announcement.
(f)After you electronically submit your application, you will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number. The Indian Health Service will retrieve your application from Grants.gov.
(g)You may access the electronic application for this program at *http://www.grants.gov.*
(h)You must search for the downloadable application kit by CFDA number.
(i)To receive an application package, the applicant must provide the Funding Opportunity Number: [HHS-2006-IHS-EPI-0001]. E-mail applications will not be accepted under this announcement. V. Application Review Information 1. Criteria Introduction, Current Capacity, and Need for Assistance (10 Points)
(a)Describe the applicant's current public health activities including whether the applicant has an adequate health department, how long it has been operating, what programs or services are currently provided, and interactions with other public health authorities in the regions (State, local, or Tribal), how long it has been operating, and what programs or services are currently provided. Specifically describe current epidemiologic capacity and history of support for such activities.
(b)Provide a physical location of the TEC and area to be served by the proposed project including a map (include the map in the attachments).
(c)Describe the relationship between this program and other funded work planned, anticipated, or underway.
(d)If applicable, identify the past three years of grants with current Tribal Management Grants including past awarded cooperative agreements from the DEDP, dates of funding, and project accomplishments (do not include copies of reports). Project Objective(s) (30 Points) Approach, Results and Benefits, for the Entire 5-year Funding Period By Year
(a)State in measurable and realistic terms the objectives and appropriate activities to achieve each objective for the projects as listed in the *Recipient Activities* .
(b)Identify the expected results, benefits, and outcomes or products to be derived from each objective of the project.
(c)Include a work plan for each objective that indicates when the objectives and major activities will be accomplished and who will conduct the activities on a calendar time line.
(d)Specify who will review and accept the work to be performed by consultants or contractors. Project Evaluation (20 Points)
(a)State how project objectives will be achieved.
(b)Define the criteria to be used to evaluate results.
(c)Explain the methodology that will be used to determine if the needs identified for the project are being met and if the outcomes identified are being achieved. Organization Capabilities and Qualifications (25 Points)
(a)Explain the management and administrative structure of the organization including documentation of current certified financial management systems from the BIA, IHS, or a Certified Public Accountant and an updated organization chart (include chart in the attachments).
(b)Describe the ability of the organization to manage a project of the proposed scope.
(c)Provide position descriptions and resumes/biosketch of key personnel, including those of consultants or contractors in the Appendix. Position descriptions should very clearly describe each position and its duties, indicating desired qualification and experience requirements related to the project. Resumes should indicate that the proposed staff is qualified to carry out the project activities. Budget (15 Points)
(a)Provide a detailed budget by line item and by each year.
(b)Provide a justification by line item in the budget including sufficient cost and other details to facilitate the determination of cost allowability and relevance of these costs to the proposed project. The funds requested should be appropriate and necessary for the scope of the project.
(c)Describe where the TEC will be housed, i.e., facilities and equipment available.
(d)If use of consultants or contractors are proposed or anticipated, provide a detailed scope of work that clearly defines the deliverables or outcomes anticipated.
(e)If applicant is claiming IDC, applicants must submit a negotiated indirect cost rate agreement as an attachment. Attachments to include: • Attached resumes/biosketch and job descriptions for the key staff. • Current approved organizational chart. • A map of the area to benefit from the project. • Copy of the negotiated indirect cost rate agreement. • If applicable, Application Receipt card, #IHS 815-1A. • Letters of support/collaboration. 2. Review and Selection Process Applications submitted by the closing date and verified by electronic submission or the postmark under this program announcement will undergo a review to determine that:
(a)The applicant is eligible in accordance with the Eligibility Section of this application.
(b)Letters of support/collaboration are included.
(c)The application executive summary, forms and materials submitted are adequate to allow the review panel to undertake an in-depth evaluation.
(d)The application complies with this announcement; otherwise it will be returned without consideration. Competitive Review of Accepted Applications Applications meeting eligibility requirements that are complete, responsive, and conform to this program announcement will be reviewed for merit by an Ad Hoc Objective Review Committee
(ORC)appointed by the IHS to review and make recommendations on these applications. The reviews will be conducted in accordance with the IHS objectives review procedures. The technical review process ensures selection of quality projects in a national competition for limited funding. The ORC will include at least 60 percent non-IHS, Federal or non-Federal individuals. Applications will be evaluated and rated on the basis of the list above. These criteria are used to evaluate the quality of a proposal, to assign a numerical score to each application, and to determine the likelihood of its success. The comments from the ORC will be advisory only. 3. Result of the Review The results of the objective review are forwarded to the Director, Office of Public Health Support
(OPHS)for final review and considerations. The OPHS Director will make recommendations for approval and funding to the IHS Director who will then make the final decision on all applications, within approximately 30 days; applicants will be notified in writing of disapproval. A brief explanation of the reasons why the application was not approved will be provided along with the name of the IHS official to contact if more information is desired. Anticipated Announcement and Award Dates: • *Anticipated Announcement:* March 1, 2006. • *Award Date(s):* September 1, 2006. The IHS Director will make the final decision on all awards. VI. Award Administration Information 1. Award Notices Successful applicants will be notified through the official Notice of Award. The Notice of Award will state the amount of Federal funds to be awarded, the purpose of the cooperative agreement, the terms and conditions of the award, effective date, the project, and budget period. 2. Administrative Requirements and National Policy Requirements Cooperative agreement Administration Requirements: Cooperative agreements are administered in accordance with the following documents:
(a)45 CFR part 92, HHS Uniform Administrative Requirements for Grants and Cooperative agreements to State, local, Tribal governments or 45 CFR part 74, Uniform Administrative Requirements for Awards and Subawards to institutions of Higher Educations, Hospital, Other Tribal Nonprofit Organization, and Commercial Organizations.
(b)PHS Grants Policy Statement;
(c)Appropriate Cost Principals: OMB Circular A-87 “State and Local Governments,” or OMB Circular A-122 “Non-Profit Organization”; and
(d)OMB Circular A-133 “Audits of States, Local Governments, and Non-Profit Organizations.”
(e)A-102 Grants and Cooperative agreements with State and Local Governments.
(f)A-110 “Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organization. All Federal-wide public policies apply to IHS grants with the exception of Lobbying and Discrimination.” 3. Reporting Requirements
(a)Semi-annual and annual program progress reports are required. These reports will be no more than 10 pages in length and will be in accordance with a format provided by the DEDP.
(b)Financial Status Reports: The semi and annual financial status reports must be submitted within 30 days from the end of the half year. Final Financial Status Reports are due within 90 days of expiration of the budget/project period. Standard Form 269 (long form) will be used for Financial Status Report. Grantees are responsible and accountable for accurate reporting of the Progress Reports and Financial Status Reports which are generally due semi-annually. Financial Status Reports (SF-269) are due 90 days after each budget period and the final SF-269 must be verified from the grantee records on how the value was derived. Grantees must submit reports in a reasonable period of time. Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following:
(1)The imposition of special award provisions; and
(2)the non-funding or non-award of other eligible projects or activities. This applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports. VII. Agency Contact(s) Division of Epidemiology and Disease Prevention, Indian Health Service, Selina Keryte Project Officer ( *selina.keryte@ihs.gov* ), 5300 Homestead Road, NE., Albuquerque, NM 87110, Phone:
(505)248-4132. Fax:
(505)248-4393. Donald Reece ( *donald.reece@ihs.gov* ), James Cheek, M.D. ( *james.cheek@ihs.gov* ), Division of Grants Operations, Indian Health Service, Twinbrook Metro Plaza, Suite 360, 12300 Twinbrook Parkway, Rockville, Maryland 20852. Dated: March 9, 2006. Robert G. McSwain, Deputy Director, Indian Health Service. [FR Doc. 06-2538 Filed 3-15-06; 8:45 am]
Connectionstraces to 4
5 references not yet in our index
  • 42 CFR 100.3
  • Pub. L. 94-437
  • Pub. L. 102-573
  • 45 CFR 92
  • 45 CFR 74
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Cite42 CFR 100.3
Pub. L.Pub. L. 94-437
Pub. L.Pub. L. 102-573
Cite45 CFR 92
Cite45 CFR 74
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