Support, Training and Capacity Building for Infectious Disease Surveillance Networks in Affected Countries in Southeast Asia, Africa and Other Regions of the World, 11661-11670 [E6-3251]

Download as PDF Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices purposes, administrative or judicial proceedings). Even in those limited contexts, however, the Commission’s rules may afford protections to the submitter, such as advance notice to seek a protective order in litigation. See 15 U.S.C. 57b–2; 16 CFR 4.9–4.11. Finally, the information presented in the study will not reveal companyspecific data. See 15 U.S.C. 57b– 2(d)(1)(B). Rather, the Commission anticipates providing information on an anonymous or aggregated basis, in a manner sufficient to protect individual companies’ confidential information, to provide a factual summary of how the alcohol industry self-regulation has operated for the specified period. 2. Estimated Hours Burden The FTC staff’s estimate of the hours burden is based on the time required to respond to each information request. Because beverage alcohol companies vary in size, the number of products that they sell, and the extent and variety of their advertising and promotion efforts, the FTC staff has provided a range of the estimated hours burden. As noted above, each company will receive information requests pertaining to four categories. Based upon its knowledge of the industry, the staff estimates, on average, that the time required to gather, organize, format, and produce responses to each of the four information categories will range between 15 and 120 hours for most companies, but that the largest companies could require as many as 280 hours for the most timeconsuming category, that is, placement information. The total estimated burden per company is based on the following: erjones on PROD1PC68 with NOTICES Identify, obtain and organize sales information, prepare response: 15–35 hours. Identify, obtain, and organize information on advertising and marketing expenditures, prepare response: 25–65 hours. Identify, obtain, and organize placement information, prepare response: 120–280 hours. Identify, obtain, and organize information regarding compliance review, prepare response: 10–20 hours. FTC staff anticipates that the cumulative hours burden to respond to the information requests will be between 170 hours and 400 hours per company. Nonetheless, in order to be conservative, the FTC estimates that the burden per company for each of up to twelve intended recipients will be 400 hours. Accordingly, staff’s estimate of the total burden is 4,800 hours. These estimates include any time spent by separately incorporated subsidiaries and other entities affiliated with the ultimate VerDate Aug<31>2005 15:53 Mar 07, 2006 Jkt 208001 parent company that has received the information requests. 3. Estimated Cost Burden It is difficult to calculate with precision the labor costs associated with this data production, as they entail varying compensation levels of management and/or support staff among companies of different sizes. Although financial, marketing, legal, and clerical personnel may be involved in the information collection process, FTC staff has assumed that mid-management personnel and outside legal counsel will handle most of the tasks involved in gathering and producing responsive information and has applied an average hourly wage of $250/hour for their labor. FTC staff anticipates that the labor costs per company will range between $42,500 (170 hours × $250/ hour) and $100,000 (400 hours × $250/ hour). Nonetheless, in order to be conservative, the FTC estimates that the total labor costs per company will be $100,000. FTC staff estimates that the capital or other non-labor costs associated with the information requests are minimal. Although the information requests may necessitate that industry members maintain the requested information provided to the Commission, they should already have in place the means to compile and maintain business records. William Blumenthal, General Counsel. [FR Doc. E6–3244 Filed 3–7–06; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Support, Training and Capacity Building for Infectious Disease Surveillance Networks in Affected Countries in Southeast Asia, Africa and Other Regions of the World AGENCY: Office of the Secretary, Office of Public Health Emergency Preparedness, HHS. ACTION: Notice. Announcement Type: Single Source, Cooperative Agreement. Funding Opportunity Number: Not applicable. Catalog Of Federal Domestic Assistance Number: The OMB Catalog of Federal Domestic Assistance number is pending. SUMMARY: This is a project to enhance the surveillance, epidemiological investigation and laboratory diagnostic capabilities in countries in S.E. Asia, PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 11661 Africa and other regions of the world that are at risk for an avian influenza (H5N1) outbreak or where such an outbreak has already occurred. Such enhancements will help establish an early warning system that could prevent and contain the spread of an avian influenza pandemic to the United States. DATES: To receive consideration, applications must be received no later than 5 p.m. Eastern Time on April 7, 2006. ADDRESSES: Applications must be received by the Office of Grants Management, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootten Parkway, Rockville, MD 20857. FOR FURTHER INFORMATION, CONTACT: Lily O. Engstrom, Senior Policy Advisor to the Assistant Secretary for Public Health Emergency Preparedness, Office of Public Health Emergency Preparedness, Department of Health and Human Services at (202) 205–2882. SUPPLEMENTARY INFORMATION: In the last century, three influenza pandemics have struck the United States and the world, and viruses from birds contributed to all of them. In 1918, the first pandemic killed over half-a-million Americans and more than 20 million people worldwide. One-third of the U.S. population was infected, and American life expectancy was reduced by 13 years. Following the 1918 outbreak, influenza pandemics in 1957 and 1968 killed tens of thousands of Americans and millions across the world. The recent limited outbreak of Severe Acute Respiratory Syndrome (SARS) suggests the danger that a modern pandemic would present. The H5N1 strain of avian flu has become the most threatening influenza virus in the world, and any large-scale outbreak of this disease among humans would have grave consequences for global public health. Influenza experts have warned that the re-assortment of different H5N1 viruses over the past seven years greatly increases the potential for the viruses to be transmitted more easily from person to person. Medical practitioners have also discovered several other, new avian viruses that can be transmitted to humans. The U.S. Government is concerned that a new influenza virus could become efficiently transmissible among humans. Now spreading through bird populations across Asia, reaching into Europe, the Middle East and, most recently, Africa, the H5N1 strain has infected domesticated birds such as E:\FR\FM\08MRN1.SGM 08MRN1 erjones on PROD1PC68 with NOTICES 11662 Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices ducks and chickens and long-range migratory birds. In 1997, the first recorded H5N1 outbreak in humans took place in Hong Kong. H5N1 struck again in late 2003 and has, as of March 1, 2006, resulted in 174 confirmed cases and 92 deaths world-wide, a 53 percent mortality rate. As of now, the H5N1 avian flu is primarily an animal disease; H5N1 infection in humans has been the result of contact with sick poultry. Unless people come into direct, sustained contact with infected birds, it is unlikely they will contract the disease. The concern is that the virus will acquire the ability for sustained transmission among humans. In the fight against avian and pandemic flu, early detection is the first line of defense. A pandemic is like a forest fire. If caught early, it might be extinguished with limited damage. But if left undetected, it can grow into an inferno that spreads quickly. The President has charged the Federal Government to take immediate steps to ensure early warning of an avian flu outbreak among animals and humans anywhere in the world. It is in the interest of the U.S. Government to help establish early warning surveillance systems and laboratory capabilities in various regions of the world that would enable early detection, reporting, identification and investigation of any H5N1 outbreaks. The development of such capabilities could make a significant difference in preventing and containing the spread of an avian influenza pandemic to the United States. On November 1, 2005, President Bush announced the National Strategy for Pandemic Influenza, and the following day Secretary Michael O. Leavitt released the HHS Pandemic Influenza Plan. The President directed all relevant Federal departments and agencies to take steps to address the threat of avian and pandemic flu. Drawing on the combined efforts of Government officials and the public health, medical, veterinary, and law-enforcement communities, as well as the private sector, this strategy is designed to meet three critical goals: detecting human or animal outbreaks that occur anywhere in the world; protecting the American people by stockpiling vaccines and antiviral drugs, while improving the capacity to produce new vaccines; and preparing to respond at the Federal, State, and local levels in the event an avian or pandemic influenza reaches the United States. The U.S. National Strategy for Pandemic Influenza can be found at https://www.pandemicflu.gov. One of the primary objectives of both the National Strategy and the HHS VerDate Aug<31>2005 15:53 Mar 07, 2006 Jkt 208001 Pandemic Influenza Plan is to leverage global partnerships to increase preparedness and response capabilities around the world ‘‘with the intent of stopping, slowing or otherwise limiting the spread of a pandemic to the United States.’’ 1 Pillars Two and Three of the National Strategy set out clear goals of ensuring rapid reporting of outbreaks and containing such outbreaks beyond the borders of the United States, by taking the following actions: Working through the International Partnership on Avian and Pandemic Influenza, as well as through other political and diplomatic channels, such as the United Nations and the AsiaPacific Economic Cooperation Forum, to ensure transparency, scientific cooperation and rapid reporting of avian and human influenza cases; Supporting the development of the proper scientific and epidemiological expertise in affected regions to ensure early recognition of changes in the pattern of avian or human influenza outbreaks; Supporting the development and sustainment of sufficient host-country laboratory capacities and diagnostic reagents in affected regions, to provide rapid confirmation of cases of influenza in animals and humans; Working through the International Partnership to develop a coalition of strong partners to coordinate actions to limit the spread of an influenza virus with pandemic potential beyond the location where it is first detected; and Providing guidance to all levels of government in affected nations on the range of options for infection-control and containment. We rely upon our international partnerships with the United Nations, international organizations and private non-profit organizations to amplify our efforts and will engage them on both a multilateral and bilateral basis. Our international effort to contain and mitigate the effects of an outbreak of pandemic influenza is a central component of our overall strategy. In many ways, the character and quality of the U.S. response and that of our international partners may play a determining role in the magnitude and severity of a pandemic. The International Partnership on Avian and Pandemic Influenza stands in support of multinational organizations. Members of the Partnership have agreed that the following 10 principles will guide their efforts: 1. International cooperation to protect the lives and health of our people; 1 National PO 00000 Strategy for Pandemic Influenza, p. 2. Frm 00090 Fmt 4703 Sfmt 4703 2. Timely and sustained high-level global political leadership to combat avian and pandemic influenza; 3. Transparency in reporting of influenza cases in humans and in animals caused by virus strains that have pandemic potential, to increase understanding and preparedness, especially to ensure rapid and timely response to potential outbreaks; 4. Immediate sharing of epidemiological data and samples with the World Health Organization (WHO) and the international community to detect and characterize the nature and evolution of any outbreaks as quickly as possible by utilizing, where appropriate, existing networks and mechanisms; 5. Rapid reaction to address the first signs of accelerated transmission of H5N1 and other highly pathogenic influenza strains so that appropriate international and national resources can be brought to bear; 6. Prevention and containment of an incipient epidemic through capacity building and in-country collaboration with international partners; 7. Working in a manner complementary to and supportive of expanded cooperation with and appropriate support of key multilateral organizations (including the WHO, Food and Agriculture Organization and World Organization for Animal Health); 8. Timely coordination of bilateral and multilateral resource allocations; dedication of domestic resources (human and financial); improvements in public awareness; and development of economic and trade contingency plans; 9. Increased coordination and harmonization of preparedness, prevention, response and containment activities among nations, complementing domestic and regional preparedness initiatives and encouraging, where appropriate, the development of strategic regional initiatives; and 10. Actions taken based on the best available science. Through the Partnership and other bilateral and multilateral initiatives, we will promote these principles and support the development of an international capacity to prepare, detect and respond to an influenza pandemic. In support of the President’s National Strategy and consistent with the principles of the International Partnership, this cooperative agreement, while contemplating a global approach, will begin in this first phase with a focus on countries in Southeast Asia and Africa. The program funded by this cooperative agreement intends to combine the efforts and the resources of the U.S. Department of Health and E:\FR\FM\08MRN1.SGM 08MRN1 erjones on PROD1PC68 with NOTICES Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices Human Services (HHS) and the Reseau International des Instituts Pasteur (RIIP) network of research and surveillance to enhance outbreak surveillance and investigation capacity beginning in Southeast Asia and Africa. The Institut Pasteur—Cambodia (IPC) in its capacity as the National Influenza Reference Center, in agreement with the Cambodian Ministry of Health, the Cambodian Ministry of Agriculture, the World Health Organization (WHO) and the United Nations Food and Agriculture Organization (FAO), has initiated an outbreak surveillance and investigation system supported by rigorous laboratory identification of genotype Z of avian influenza virus H5N1. This cooperative agreement will enhance laboratory capacity at IPC to enable it to support the Cambodian Ministry of Health’s Influenza-LikeIllness (ILI) surveillance program. IPC currently provides all laboratory testing services required for ILI surveillance, both for animal and human specimens. This service is conducted for and on behalf of the Cambodian Ministry of Health and the Cambodian Ministry of Agriculture, Forestry and Fisheries, both of which are fully informed of all testing results. Under this cooperative agreement, it is anticipated that there will be a gradual but progressive shift to include National Institute of Public Health (NIPH) staff in the cataloguing of specimens and ultimately, when capacity is adequate, actual testing of samples in the NIPH laboratory. To achieve enhanced laboratory capacity at IPC in support of ILI surveillance, this cooperative agreement will fund the following: Costs connected with the testing of ILI surveillance samples from both Cambodia and Laos at IPC; A portion of annual maintenance costs for the newly built Biosafety-Level (BSL)–3 laboratory at IPC; Installation of appropriate enhancements of physical security at the IPC campus to ensure that only authorized persons have access to the BSL–3 suite and to safeguard the equipment and collections of virus samples kept in the laboratory; and Costs for IPC to undertake human and animal surveillance for H5N1 avian influenza in both Cambodia and Laos. This component of the agreement will include building field-investigation as well as laboratory capacity. This cooperative agreement also contemplates funding other activities in support of ILI surveillance programs in Cambodia and Laos, including technical assistance to the respective Ministries of VerDate Aug<31>2005 15:53 Mar 07, 2006 Jkt 208001 Health to implement and expand their surveillance programs. This cooperative agreement will also support capacity building at the three Institut Pasteur—affiliated laboratories in Viet Nam (National Institute of Hygiene and Epidemiology [NIHE]— Hanoi, Institut Pasteur—Ho Chi Minh City, and Institut Pasteur—Nha Trang). Specifically, this agreement will fund the following: Enhanced interoperable communications among the three RIIPaffiliated laboratories in Viet Nam and between them and HHS agencies as well as the WHO Secretariat and Regional Office for the Western Pacific; and placement of a qualified international biosafety/biosecurity technical advisor for two years at the newly constructed BSL–3 laboratory at NIHE. This cooperative agreement will also fund the enhancement of capacity in RIIP affiliated laboratories in Africa. Such enhanced capacity will be directed at improving human and animal surveillance for H5N1 and other infectious respiratory diseases. Finally, this cooperative agreement will fund the creation of one postdoctoral position for U.S. citizens in the Influenza Laboratory at Institut Pasteur—Paris to focus exclusively on influenza surveillance in Southeast Asia, Africa and other parts of the world impacted by H5N1. No funds provided under this cooperative agreement may be used to support any activity that duplicates another activity supported by any component of HHS. All funded activities must be coordinated with the Office of Public Health Emergency Preparedness (HHS), with in-country Centers for Disease Control and Prevention (CDC) offices, and with the respective Ministries of Health. I. Funding Opportunity Description Authority: Sections 301, 307, 1701 and 2811 of the Public Health Service Act, 42 U.S.C. 241, 242l, 300u, 300hh–11. Purpose: The purposes of the program are to: Enhance cooperation between the HHS and RIIP institutes to support and increase influenza outbreakinvestigation, surveillance, and training capacity in Southeast Asia; Enhance laboratory capacities for H5N1 diagnosis in the Cambodian Ministry of Health’s Influenza-Like Illness (ILI) surveillance program; Enhance and expand IPC’s capacity to conduct human and animal surveillance activities in Cambodia and Laos; Enhance and expand the training capacity for H5N1 avian influenza surveillance and epidemiology within PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 11663 the RIIP network in Cambodia, Laos and Viet Nam, as well as provide and expand biosafety and biosecurity training for BSL–3 facilities in this region; Enhance communications and interoperable connectivity among the three RIIP-affiliated laboratories in Vietnam; Enhance security at the BSL–3 laboratory suite and related physical plant for Institut Pasteur—Cambodia; and Enhance laboratory capacities in African countries that are at risk for an H5N1 outbreak or where there has already been an H5N1 outbreak in order to strengthen early detection and diagnosis of influenzas in animals and humans. Measurable outcomes of the program will be in alignment with the President’s National Strategy and the principles of the International Partnership on Avian and Pandemic Influenza, and one (or more) of the following performance goal(s) for the agency pursuant to the President’s initiative on pandemic influenza preparedness: To detect animal and human outbreaks before they spread around the world; To take immediate steps to ensure early warning of an avian flu outbreak among animals or humans in affected regions; and To strengthen a new international partnership on avian influenza. Grantee Activities Grantee activities for this program are as follows: Enhance laboratory capacities for H5N1 diagnosis in the National Influenza Reference Center (virology unit, IPC) in support of the Cambodian Ministry of Health’s ILI surveillance program, based on the enhancement of diagnostic test sensitivity, on testing an increased number of Cambodian and Laotian samples as well as on development of a valid serological test (microneutralization test) for human influenza infection; Enhance and expand training capacity for H5N1 surveillance and epidemiology in Cambodia, Laos and Viet Nam; Support surveillance for influenzalike illness (ILI), severe pneumonia and other respiratory diseases, to be carried out through and/or on behalf of the respective Ministries of Health in outpatient departments of Provincial hospitals in Cambodia and Laos; Strengthen the capacity for early detection and early warning of avian influenza outbreaks in Cambodia, Laos and Viet Nam; E:\FR\FM\08MRN1.SGM 08MRN1 erjones on PROD1PC68 with NOTICES 11664 Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices Provide support (financial and technical) to systematic, extensive epidemiological and viral investigations following any confirmed H5N1 human or animal cases in Cambodia and Laos; Enhance laboratory capabilities in affected and at-risk nations in Africa to perform surveillance and diagnosis of H5N1 in humans and animals; and Coordinate activities that are conducted under this cooperative agreement with other relevant institutes (members) of the RIIP. All influenza virus information obtained or developed as a result of the foregoing activities or other activities funded under this cooperative agreement shall be shared with HHS as well as within the WHO Global influenza network and WHO Collaborating Centers of Influenza. As part of its proposal, RIIP shall submit a plan for ensuring that such information is shared in a timely, accurate, thorough and reliable manner with HHS and WHO. Such plan will also address the sharing with HHS of specimen and other viral material obtained by RIIP as a result of activities funded under this cooperative agreement. In addition, this cooperative agreement will provide limited and specific funding, as detailed below, for the following activities: Security Enhancements to BSL–3 laboratory suite and related physical plant for IPC. A BSL–3 laboratory at IPC will substantially enhance capacity in Cambodia to isolate and work with the A/H5N1 virus and other emerging infectious diseases. It is essential that the physical security (including biosecurity and entry-control systems) for the BSL–3 suite be sufficient to ensure the integrity of the laboratory and prevent unauthorized access. Funding for this activity will match, on a one-time basis, investments by Institut Pasteur up to $50,000 USD for costs connected with acquiring and installing entry-control systems and other physical-security enhancements (including vehicular barriers, cameras, monitors and locking devices) for the BSL–3 suite and related physical plant. Enhanced communications and interoperable connectivity among the three RIIP affiliated laboratories in Viet Nam (NIHE—Hanoi, Institut Pasteur— Ho Chi Minh City, and Institut Pasteur—Nha Trang) and between them and HHS agencies as well as the WHO Secretariat and Regional Office for the Western Pacific. The occurrence of A/H5N1 avian influenza in Viet Nam highlights the need to build critical public health capacity in that country. The three VerDate Aug<31>2005 15:53 Mar 07, 2006 Jkt 208001 Institut Pasteur network laboratories (i.e., NIHE—Hanoi, Institut Pasteur—Ho Chi Minh City, and Institut Pasteur— Nha Trang) are at the very core of Viet Nam’s public health response to avian influenza and other emerging diseases. It is essential that these laboratories have the capacity to communicate (by voice, data and video) with each other, the WHO Secretariat, HHS (including both the Centers for Disease Control and Prevention [CDC] and the National Institutes of Health [NIH]) and the Paris headquarters of Institut Pasteur in real time and at high speed. This enhanced capability will enable the laboratories to consult with scientific experts around the world and provide important disease surveillance data in a timely manner. Advancements in the understanding of A/H5N1 and other emerging diseases is heavily dependent on communications technology—so common in the developed world yet in need of substantial and accelerated enhancements in Viet Nam. Funding for this activity will match, on a one-time basis, investments made by the Institut Pasteur in the three laboratories up to a total of $200,000 USD for costs associated with hardware, software and installation required to develop this interoperable connectivity. Funding will also match Institut Pasteur’s investments in maintenance of this communications system at the three laboratories, up to a total of $10,000 USD per year for three years. Support for an international biosafety/ biosecurity technical advisor for the new BSL–3 laboratory suite at NIHE, a member laboratory of the Institut Pasteur Network located in Hanoi, Viet Nam, as well as support for a short-term virologist to lead the virology laboratory in Laos. A BSL–3 laboratory at NIHE will enhance capacity in Viet Nam to isolate and work with A/H5N1 avian influenza and other emerging infectious diseases. Since BSL–3 biosafety/biosecurity practices are complicated and require 100 percent compliance at all times that the laboratory is operational, it is essential that NIHE and its employees have on-site access to an international technical advisor with substantial biosafety/biosecurity experience. This will ensure the safe and efficient operation of the laboratory and provide critically important on-the-job training to NIHE scientists and technicians who work in the BSL–3 suite. Funding for this activity will match costs incurred by Institut Pasteur related to assigning an experienced, full-time international BSL–3 biosafety/ biosecurity technical advisor to NIHE, PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 up to $100,000 USD per year for two years. Human and animal surveillance and training capacity building in Cambodia and Laos. A/H5N1 is an avian disease, which makes animal sampling essential to any meaningful surveillance program. IPC operates a state-of-the-art laboratory in Phnom Penh, Cambodia, and has an established working relationship with the appropriate health and agriculture authorities in the national Governments of Cambodia and Laos. IPC is, therefore, uniquely qualified to undertake animal and human disease surveillance in these countries. IPC is also an important training asset in the region and can leverage existing and new programs to maximize animal surveillance training for Cambodian and Laotian nationals. At the invitation of the Ministry of Health, Institut Pasteur is in the process of establishing a presence in Laos to support disease surveillance and other public health activities. There is a critical need to enhance virology laboratory capacity in Laos. Such augmented capacity will be essential to the success of any meaningful surveillance program targeted at influenza and other respiratory diseases. The cooperative agreement will support the placement of a technical advisor in Laos to assist with virology capacity building. Funding for animal and human surveillance and training capacity building will be up to $225,000 for the first year (to include support for the technical advisor in virology) and up to $175,000 USD for the second and third year of this agreement. Human and animal surveillance and training capacity building in Africa. H5N1 has spread to Africa and RIIP has several laboratories uniquely positioned to assist with surveillance activities on this continent. It is essential that investments in capacity building at these laboratories be made as soon as practicable so that a foundation for early infectious disease warning in Africa will be established in time to track the spread of H5N1 in animals and humans. This cooperative agreement will match investments made by Institut Pasteur in such capacity building in Africa up to $250,000 for each year of this agreement. The Influenza Laboratory at Institut Pasteur—Paris will support a number of the activities undertaken pursuant to this cooperative agreement. Additional capacity is required to ensure that this laboratory is capable of responding in a timely manner to developments in the field. This cooperative agreement will support the creation of a post-doctoral position in the Institut Pasteur—Paris E:\FR\FM\08MRN1.SGM 08MRN1 11665 Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices Influenza Laboratory. Candidates for this position must be U.S. citizens not presently studying or working in France at the time of application. Funding for this activity, which will include salary and any necessary equipment and supplies, will be $100,000 USD for each year of the agreement. HHS, particularly the Office of Public Health Emergency Preparedness, will be substantially involved with the design and implementation of the described grantee activities. HHS staff activities for this program are as follows: Provide expert assistance in the design, implementation and delivery of instruction to individuals selected for epidemiology training and laboratorysupport training; Provide liaison through HHS employees at U.S. Embassies in host countries with local Ministries of Health and Agriculture and other host-nation organizations, as appropriate and as relevant to the achievement of the purposes of this cooperative agreement; and Provide oversight of activities that are supported by funds awarded through this cooperative agreement. II. Award Information This project will be supported through the cooperative agreement mechanism. OPHEP anticipates making only one award. The anticipated start date is approximately May 1, 2006, and the anticipated period of performance is Current year funding Activity approximately May 1, 2006, through April 30, 2009. OPHEP anticipates that approximately $1,455,000 will be available for the first 12-month budget period. The total amount that may be requested by the Pasteur Foundation is $2,625,000 for three years. Indirect costs will not be covered by the funds in this cooperative agreement. Approximate Current Fiscal Year Funding: $1,455,000. Approximate Total Project Period Funding: $2,625,000. Funds under this cooperative agreement shall not be applied to indirect costs. Funding Breakdown: Year 2 funding Year 3 funding Total funding per activity Enhanced communications (matching funds) .................................................. Maintenance of communications systems (matching funds) ........................... Security and biosecurity enhancements (matching funds) .............................. International biosafety/biosecurity technical advisor (matching funds) ........... Enhancement of laboratory capacity at IPC .................................................... Virology laboratory training .............................................................................. H5N1 avian influenza animal and human surveillance (including virology technical advisor for Laos) ........................................................................... Influenza Post-Doctoral position ...................................................................... Enhancement of laboratory diagnostic capabilities in African nations (matching funds) ..................................................................................................... $200,000 10,000 50,000 100,000 435,000 85,000 ........................ $10,000 ........................ 100,000 ........................ ........................ ........................ $10,000 ........................ ........................ ........................ ........................ $200,000 30,000 50,000 200,000 435,000 85,000 225,000 100,000 175,000 100,000 175,000 100,000 575,000 300,000 250,000 250,000 250,000 750,000 Grand Total ............................................................................................... 1,455,000 635,000 535,000 2,625,000 Approximate Number of Awards: 1. Ceiling of Individual Award Range: Maximum dollar amount for the first 12month budget period is $1,455,000, and will not include payment of any indirect costs. Throughout the project period, the commitment of HHS to the continuation of funding will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), demonstrated commitment of the recipient to the principles of the International Partnership on Avian and Pandemic Influenza, and the determination that continued funding is in the best interest of the Federal Government and continues to meet the goals of the U.S. National Strategy for Pandemic Influenza. erjones on PROD1PC68 with NOTICES III. Eligibility Information 1. Eligible Applicants The only eligible applicant that can apply for this funding opportunity is the Pasteur Foundation, a U.S. not-for-profit affiliate of the Institut Pasteur. In making this award, HHS will be able to capitalize on Pasteur’s existing Reseau International des Instituts Pasteur (RIIP), a worldwide network of research and VerDate Aug<31>2005 17:23 Mar 07, 2006 Jkt 208001 surveillance institutes. Since its creation, the Institut Pasteur has had an international calling, and from its earliest days Pasteur scientists have traveled around the world to study and combat epidemics. The first Institut Pasteur outside of France was created in 1891 in Saigon. The RIIP is made up of 29 institutions spread out across five continents, and unites 8,800 people, most of whom the institutions recruit locally. With regard to Southeast Asia, the RIIP is strategically positioned to study the natural history of A/H5N1 avian influenza virus. The RIIP network in Asia has undertaken a number of research and surveillance programs that focus on acute respiratory infections, of both viral and bacterial origin in Viet Nam, Cambodia and Laos. The network is also engaged in surveillance activities in other regions of the world, including Africa. The RIIP Institutes in Southeast Asia have been providing a beneficial service in the region by working with the local Ministries of Health in their epidemiological investigations, and by providing laboratory diagnosis of both human and animal influenza samples. One RIIP program is specifically looking PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 at the natural history and circulation of the A/H5N1 virus in and around the locations where it has previously emerged in human or avian populations. RIIP active and current involvement in the region includes the following: In 2004, NIHE in Hanoi and the Pasteur Institute collected throat swabs and serum samples from family members and contacts of victims, as well as from random poultry workers. Through the first months of 2004, NIHE collected several hundred samples in northern Viet Nam; Pasteur got several dozen more in the south. In addition to patients, their contacts and poultry workers were tested by using the RT– PCR assay; the results were overwhelmingly negative. The two institutes were unable to check for antibodies to the virus in blood samples, a sign of past infection, because the most sensitive procedure, the microneutralization assay, requires a BSL–3 laboratory. Consequently, they shipped the samples to HHS/CDC in Atlanta, Georgia, where tests confirmed the negative findings. In New Caledonia, the Pasteur Institute aimed to evaluate the annual incidence of influenza and to identify the circulating viral types and subtypes E:\FR\FM\08MRN1.SGM 08MRN1 11666 Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices to gather information for the local vaccination program and regional influenza surveillance. In 1999, the Institute set up a surveillance network that included sentinel practitioners in Noumea and the virology department of the Pasteur Institute. Influenza circulated in New Caledonia every year, regularly during the Southern Hemisphere winter, and occasionally during March–May. Isolates were generally consistent with world surveillance, except in 1999, when a new A/H5N1 variant was identified. This study emphasizes the need for regular influenza surveillance, even when performed on a limited scale. The study also identified the optimal time for local vaccination to be in December or January of each year. RIIP has a long history of making important public health and biomedical science contributions in Africa. The RIIP network in Africa includes laboratories in Algeria, Cameroon, the Ivory Coast, Madagascar, Niger, the Central African Republic, Senegal, Morocco and Tunis. These facilities provide a unique, existing capability that can be leveraged to enhance H5N1 surveillance and disease detection in the region. 2. Cost-Sharing or Matching Funds Matching funds are required for this program. HHS will pay $2,625,000 or 68 percent of the total costs of $3,855,000 while the Pasteur Foundation will provide $1,230,000 or 32 percent of total costs. erjones on PROD1PC68 with NOTICES 3. Other If an applicant requests a funding amount greater than the ceiling of the award range, HHS will consider the application non-responsive, and the application will not enter into the review process. HHS will notify the applicant that the application did not meet the submission requirements. Special Requirements If the application is incomplete or non-responsive to the special requirements listed in this section, the application will not enter into the review process. HHS will notify the applicant that the application did not meet submission requirements. HHS will consider late applications non-responsive. Please see section on ‘‘Submission Dates and Times.’’ Title 2 of the United States Code Section 1611 states that ‘‘an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.’’ VerDate Aug<31>2005 15:53 Mar 07, 2006 Jkt 208001 IV. Application and Submission Information 1. Address To Request Application Package Application kits may be requested by calling (240) 453–8822 or writing to the Office of Grants Management, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootten Parkway, Suite 550, Rockville, MD 20852. Applicants may also fax a written request to the OPHS Office of Grants Management at (240) 453–8823 to obtain a hard copy of the application kit. Applications must be prepared using Form OPHS–1. 2. Content and Form of Submission Application: Applicants must submit a project narrative in English, along with the application forms, in the following format: Maximum number of pages: 50. If your narrative exceeds the page limit, HHS will only review the first 50 pages within the page limit; Font size: 12-point, unreduced; Single-spaced; Paper size: 8.5 by 11 inches; Page-margin size: One inch; Number all pages of the application sequentially from page one (Application Face Page) to the end of the application, including charts, figures, tables, and appendices; Print only on one side of page; Hold application together only by rubber bands or metal clips, and o not bind it in any other way. The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed: Understanding of the requirements. The application shall include a discussion of your organization’s understanding of the need, purpose and requirements of this cooperative agreement, as well as the President’s National Strategy and the principles of the International Partnership on Avian and Pandemic Influenza. The discussion shall be sufficiently specific, detailed and complete to clearly and fully demonstrate that the applicant has a thorough understanding of all the technical requirements of this announcement. A Project Plan. The project plan must demonstrate that the organization has the technical expertise to carry out the work/task requirements of this announcement. The plan must contain sufficient detail to clearly describe the proposed means for conducting the ‘‘Grantee Activities’’ described in Section I, and shall include a complete explanation of the methods and PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 procedures the applicant will use. The project plan shall include discussions of the following elements: • Objectives; • Methods to accomplish the purposes of the cooperative agreement and the ‘‘Grantee Activities’’; • Detailed time line for accomplishment of each activity; • Ability to respond to emergencies; • Ability to respond to situations on weekends and after hours; and • Coordination with HHS, the WHO Secretariat and Regional Office, the FAO, and the World Organization for Animal Health (OIE). Staffing and Management Plan. The applicant must provide a project staffing and management plan, which must include time lines and sufficient detail to ensure that it can meet the Federal Government’s requirements in a timely and efficient manner. • The applicant must provide resumes that identify the educational and experience level of any individual(s) who will perform in a key position and other qualifications to show the key individuals’ ability to comply with the minimum requirements of this announcement. • The applicant must provide a summary of the qualifications of nonkey personnel. Resumes must be limited to three pages per person. • The proposed staffing plan must demonstrate the applicant’s ability to recruit/retain/replace personnel who have the knowledge, experience, locallanguage skills, training and technical expertise commensurate with the requirements of this announcement. The plan must demonstrate the applicant’s ability to provide bi-lingual personnel to train and mentor host-country participants. Performance Measures. The applicant must provide measures of effectiveness that will demonstrate accomplishment of the objectives of this cooperative agreement and progress toward the goals of the President’s National Strategy. Measures of effectiveness must relate to the performance goals stated in the ‘‘Purpose’’ section of this announcement. Measures must be objective and quantitative, and must measure the intended outcomes. The applicant must submit a section on measures of effectiveness with its application, and they will be an element for evaluation. In addition, the applicant shall insert the following as measures of applicant’s performance: • Number of new epidemiologists actually trained and employed from each designated country; • Number of new laboratorians actually trained in virologic techniques E:\FR\FM\08MRN1.SGM 08MRN1 erjones on PROD1PC68 with NOTICES Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices and employed in each designated country; • Whether the RIIP institutes in Cambodia and Viet Nam establish formal and reliable communication links with the WHO Global Outbreak Alert and Response Network (GOARN), the WHO Global Influenza Surveillance Network, and the equivalent animal disease surveillance networks at the FAO and OIE; • The number, accuracy, thoroughness and timeliness of reports to the WHO Global Influenza Surveillance Network from the RIIP laboratories receiving funding under this agreement; • The number, accuracy, thoroughness, and timeliness of other notifications submitted to the WHO Secretariat and HHS regarding potential or actual outbreaks of ILI or other respiratory diseases anywhere in the world; and • The timely and successful appointment of a candidate for the postdoctoral position funded under this agreement. Budget Justification. The budget justification, which will be limited to 10 pages, will count against the overall 50page limit. This justification must comply with the criteria for applications. The applicant must submit, at a minimum, a cost proposal fully supported by information adequate to establish the reasonableness of the proposed amount. The applicant may include additional information in the application appendices, which will not count toward the narrative page limit. This additional information includes the following: Curricula Vitae, Resumes, Organizational Charts, Letters of Support, etc. An agency or organization is required to have a Dun and Bradstreet Data Universal Numbering System (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 no charge. To obtain a DUNS number, access www.dunandbradstreet.com, or call 1– 866–705–5711. Additional requirements that could require submission of additional documentation with the application appear in section ‘‘VI.2. Administrative and National Policy Requirements.’’ 3. Submission Dates and Times To be considered for review, applications must be received by the Office of Grants Management, Office of VerDate Aug<31>2005 15:53 Mar 07, 2006 Jkt 208001 11667 Public Health and Science, by 5 p.m. Eastern Time on April 7, 2006. Applications will be considered as meeting the deadline if they are received on or before the deadline date. The application due date in this announcement supercedes the instructions in the OPHS–1. The applicant is encouraged to initiate electronic applications early in the application development process, and to submit prior to or early on the due date. This will allow sufficient time to address any problems with electronic submissions prior to the application deadline. Submission Mechanisms The Office of Public Health and Science (OPHS), which is serving as the awarding agency for the Office of Public Health Emergency Preparedness, provides multiple mechanisms for the submission of applications, as described in the following sections. Applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of applications submitted using any of these mechanisms. Applications submitted to the OPHS Office of Grants Management after the deadlines identified below will not be accepted for review. Applications which do not conform to the requirements of the cooperative agreement announcement will not be accepted for review and will be returned to the applicant. Applications may be submitted electronically only via the electronic submission mechanisms specified below. Any applications submitted via any other means of electronic communication, including facsimile or electronic mail, will not be accepted for review. While applications are accepted in hard copy, the use of the electronic application submission capabilities provided by the OPHS eGrants system or the www.Grants.gov Web site Portal is encouraged. Electronic grant application submissions must be submitted no later than 5 p.m. Eastern Time on the deadline date specified in the ‘‘Submission Dates and Times’’ section of this announcement using one of the electronic submission mechanisms specified below. All required hard copy original signatures and mail-in items must be received by the OPHS Office of Grants Management no later than 5 p.m. Eastern Time on the next business day after the deadline date specified in the ‘‘Submission Dates and Times’’ section of this announcement. Applications will not be considered valid until all electronic application components, hard copy original signatures, and mail-in items are received by the OPHS Office of Grants Management according to the deadlines specified above. Application submissions that do not adhere to the due date requirements will be considered late and will be deemed ineligible. Electronic Submissions via the OPHS eGrants System The OPHS electronic grants management system, eGrants, provides for applications to be submitted electronically. Information about this system is available on the OPHS eGrants website, https:// egrants.osophs.dhhs.gov, or may be requested from the OPHS Office of Grants Management at (240) 453–8822. When submitting applications via the OPHS eGrants system, applicants are required to submit a hard copy of the application face page (Standard Form 424) with the original signature of an individual authorized to act for the applicant agency and assume the obligations imposed by the terms and conditions of the grant award. If required, applicants will also need to submit a hard copy of the Standard Form LLL and/or certain Program related forms (e.g., Program Certifications) with the original signature of an individual authorized to act for the applicant agency. Electronic applications submitted via the OPHS eGrants system must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. The applicant may identify specific mail-in items to be sent to the Office of Grants Management separate from the electronic submission; however, these mail-in items must be entered on the eGrants Application Checklist at the time of electronic submission, and must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation. Upon completion of a successful electronic application submission, the OPHS eGrants system will provide the applicant with a confirmation page indicating the date and time (Eastern Time) of the electronic application submission. This confirmation page will also provide a listing of all items that constitute the final application submission, including all electronic application components, required hard copy original signatures, and mail-in items, as well as the mailing address of the OPHS Office of Grants Management where all required hard copy materials must be submitted. PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\08MRN1.SGM 08MRN1 11668 Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices erjones on PROD1PC68 with NOTICES As items are received by the OPHS Office of Grants Management, the electronic application status will be updated to reflect the receipt of mail-in items. It is recommended that the applicant monitor the status of its application in the OPHS eGrants system to ensure that all signatures and mail-in items are received. Electronic Submissions via the www.Grants.gov Web Site Portal The Grants.gov Web site Portal provides organizations with the ability to submit applications for OPHS grant opportunities. Organizations must successfully complete the necessary registration processes in order to submit an application. Information about this system is available on the Grants.gov Web site, https://www.grants.gov. In addition to electronically submitted materials, applicants may be required to submit hard copy signatures for certain Program related forms, or original materials as required by the announcement. It is imperative that the applicant review both the cooperative agreement announcement as well as the application guidance provided within the Grants.gov application package to determine such requirements. Any required hard copy materials or documents that require a signature must be submitted separately via mail to the OPHS Office of Grants Management and, if required, must contain the original signature of an individual authorized to act for the applicant agency and to assume the obligations imposed by the terms and conditions of the cooperative agreement award. Electronic applications submitted via the Grants.gov Web site Portal must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. All required mail-in items must be received by the due date specified above. MailIn items may only include publications, resumes or organizational documentation. Upon completion of a successful electronic application submission via the Grants.gov Web site Portal, the applicant will be provided with a confirmation page from Grants.gov indicating the date and time (Eastern Time) of the electronic application submission as well as the Grants.gov Receipt Number. It is critical that the applicant print and retain this confirmation as well as a copy of the entire application package for its records. All applications submitted via the Grants.gov Web site Portal will be validated by Grants.gov. Any applications deemed ‘‘Invalid’’ by the VerDate Aug<31>2005 15:53 Mar 07, 2006 Jkt 208001 Grants.gov Web site Portal will not be transferred to the OPHS eGrants system, and OPHS has no responsibility for any application that is not validated and transferred to OPHS from the Grants.gov Web site Portal. Grants.gov will notify the applicant regarding the application validation status. Once the application is successfully validated by the Grants.gov Web site Portal, applicants should immediately mail all required hard copy materials to the OPHS Office of Grants Management to be received by the deadlines specified above. It is critical that the applicant clearly identify the Organization name and Grants.gov Application Receipt Number on all hard copy materials. Once the application is validated by Grants.gov, it will be electronically transferred to the OPHS eGrants system for processing. Upon receipt of both the electronic application from the Grants.gov Web site Portal, and the required hard copy mail-in items, applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of the application submitted using the Grants.gov Web site Portal. Applicants should contact Grants.gov regarding any questions or concerns about the electronic application process used by the Grants.gov Web site Portal. Mailed or Hand-Delivered Hard Copy Applications Applicants who submit applications in hard copy (via mail or handdelivered) are required to submit an original and two copies of the application. The original application must be signed by an individual authorized to act for the applicant agency or organization and to assume for the organization the obligations imposed by the terms and conditions of the grant award. Mailed or hand-delivered applications will be considered as meeting the deadline if they are received by the OPHS Office of Grant Management on or before 5 p.m. Eastern Time on the deadline date specified in the ‘‘Submission Dates and Times’’ section of this announcement. The application deadline date requirement specified in this announcement supersedes the instructions in the OPHS–1. Applications that do not meet the deadline will be returned to the applicant unread. 4. Intergovernmental Review of Applications Executive Order 12372 does not apply to this program. PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 5. Funding Restrictions Restrictions, which applicants must take into account while preparing the budget, are as follows: Alterations and renovations (A&R) are prohibited on grants/cooperative agreements to foreign recipients. Alterations and renovations are defined as work that changes the interior arrangements or other physical characteristics of an existing facility or of installed equipment so that it can be used more effectively for its currently designated purpose or adapted to an alternative use to meet a programmatic requirement. Recipients may not use funds for A&R (including modernization, remodeling, or improvement) of an existing building. Recipients may not use funds for planning, organizing or convening conferences. Reimbursement of preaward costs is not allowed. Recipients may spend funds for reasonable program purposes, including personnel, travel, supplies, and services. Recipients may purchase equipment if deemed necessary to accomplish program objectives; however, they must request prior approval in writing from HHS/ OPHEP officials for any equipment whose purchase price exceeds $10,000 USD. The costs generally allowable in grants/cooperative agreements to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut and the WHO Secretariat, HHS will not pay indirect costs (either directly or through sub-award) to organizations located outside the territorial limits of the United States, or to international organizations, regardless of their location. Recipients may contract with other organizations under this program; however, the applicant must perform a substantial portion of the project activities (including program management and operations) for which it is requesting funds. Contracts will require prior approval in writing from HHS/OPHEP. Recipients may not use funds awarded under this cooperative agreement to support any activity that duplicates another activity supported by any component of HHS. Applicants shall state all requests for funds in the budget in U.S. dollars. Once HHS makes an award, HHS will not compensate foreign recipients for currency-exchange fluctuations through the issuance of supplemental awards. The funding recipient must obtain annual audits of these funds (programspecific audit) by a U.S.-based audit E:\FR\FM\08MRN1.SGM 08MRN1 Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by HHS. A fiscal Recipient Capability Assessment may be required, prior to or post award, to review the applicant’s business management and fiscal capabilities regarding the handling of U.S. Federal funds. 6. Other Submission Requirements None. V. Application Review Information 1. Criteria HHS will evaluate applications against the following factors: erjones on PROD1PC68 with NOTICES Factor 1: Project Plan (35 Points) HHS will evaluate the extent to which the proposal demonstrates that the organization has the technical expertise to carry out the work/task requirements described in this announcement. HHS will evaluate the applicant’s project plan to determine the extent to which it provides a clear, logical and feasible technical approach to meeting the goals of this announcement in terms of workflow, resources, communications and reporting requirements for accomplishing work in each of the operational task areas, which HHS will evaluate as equally weighted subfactors, as follows: Design and implementation of a recruitment program that identifies potential participants for training in epidemiology and laboratory procedures with specific focus on influenza and other acute respiratory infections; Work with HHS to design and implement a process that identifies local individuals who have experience, training or education relevant to conducting epidemiological surveys or laboratory procedures, recruits those individuals to participate in RIIP training, and creates a pool of highly qualified candidates for positions within the host-country Ministries of Health or Agriculture; Design and implement a training program that assigns selected participants to work under the tutelage of senior RIIP scientists in support of ILI research, disease surveillance and public health activities; Train a minimum of one local person in epidemiology each year in each RIIP institute in Cambodia and Viet Nam (a total of four), and a minimum of one local person as a laboratorian skilled in influenza diagnostics each year in each RIIP institute in Cambodia and Viet Nam (a total of four); VerDate Aug<31>2005 15:53 Mar 07, 2006 Jkt 208001 11669 Provide real-time notification of possible outbreaks of influenza in humans or animals from any RIIP institute anywhere in the world, but especially from RIIP institutes in Southeast Asia and Africa, and submit notification to HHS, the WHO Secretariat and Regional Office, FAO, and OIE; and Provide enhanced reporting of ILI and animal influenza information through its worldwide network of institutions engaged with and linked to the WHO Global Outbreak Alert and Response Network (GOARN), the WHO Global Influenza Surveillance Network, and the relevant disease surveillance networks at the FAO and OIE. political and economic factors that could affect successful implementation of this cooperative agreement. The applicant’s proposal must also demonstrate understanding of the functions, capabilities and operating procedures of host-country Ministries of Health and Agriculture and international organizations such as the WHO and FAO, and describe the applicant’s ability to work with and within those organizations. The applicant must also demonstrate an understanding of the U.S. National Strategy for Pandemic Influenza and a commitment to the principles of the International Partnership on Avian and Pandemic Influenza. Factor 2. Staffing and Management Plan. (30 Points) (a) Personnel. HHS will evaluate the relevant educational and/or work experience qualifications of key personnel, senior project staff, and subject-matter specialists to determine the extent to which they meet the requirements listed in this announcement. (b) Staffing Plan. HHS will evaluate the staffing plan to determine the extent to which the applicant’s proposed organizational chart reflects proper staffing to accomplish the work described in this announcement, and the extent of the applicant’s ability to recruit/retain/replace personnel who have the knowledge, experience, locallanguage skills, training and technical expertise to meet requirements of the positions. 2. Review and Selection Process Factor 3. Performance Measures (20 Points) HHS will evaluate the applicant’s description of performance measures, including measures of effectiveness, to determine the extent to which the applicant proposes objective and quantitative measures that relate to the performance goals stated in the ‘‘Purpose’’ section of this announcement, including the goals of the President’s National Strategy, and whether the proposed measures will accurately measure the intended outcomes. Factor 4: Understanding of the Requirements (15 Points) HHS will evaluate the extent of the applicant’s understanding of the operational tasks identified in this announcement to ensure successful performance of the work in this project. Because the focus of the work will be on countries in Southeast Asia and Africa, the applicant must demonstrate an understanding of the cultural, ethnic, PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 HHS/OPHEP will review applications for completeness. An incomplete application or an application that is non-responsive to the eligibility criteria will not advance through the review process. HHS will notify applicants if their applications did not meet submission requirements. An objective review panel, which could include both Federal employees and non-Federal members, will evaluate complete and responsive applications according to the criteria listed in the ‘‘V.1. Criteria’’ section above. The objective review process will follow the policy requirements as stated in the GPD 2.04 VI. Award Administration Information 1. Award Notices The successful applicant will receive a Notice of Award (NoA). The NoA shall be the only binding, authorizing document between the recipient and HHS. An authorized Grants Management Officer will sign the NoA, and mail it to the recipient fiscal officer identified in the application. Unsuccessful applicants will receive notification of the results of the application review by mail. 2. Administrative and National Policy Requirements A successful applicant must comply with the administrative requirements outlined in 45 CFR part 74 and part 92 as appropriate. The FY 2006 Appropriations Act requires that when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money, the issuance shall clearly state the percentage and dollar amount of the total costs of the program or project that will be financed with Federal money and the percentage and E:\FR\FM\08MRN1.SGM 08MRN1 11670 Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Notices dollar amount of the total costs of the project or program that will be financed by non-governmental sources. DEPARTMENT OF HEALTH AND HUMAN SERVICES 3. Reporting Requirements Agency for Healthcare Research and Quality The applicant must provide HHS with an original, plus two hard copies, as well as an electronic copy of the following reports in English: 1. A quarterly progress report, due no less than 30 days after the end of each quarter of the budget period. The progress report for the third quarter of the year will serve as the non-competing continuation application. The quarterly progress report must contain the following elements: a. Activities and Objectives for the Current Budget Period; b. Financial Progress for the Current Budget Period; c. Proposed Activity Objectives for the New Budget Period; d. Budget; e. Measures of Effectiveness; and f. Additional Requested Information. 2. An annual progress report, due 90 days after the end of the budget period, which must contain a detailed summary of the elements required in the quarterly progress report; 3. Final performance reports, due no more than 90 days after the end of the project period; and 4. A Financial Status Report (FSR) SF–269 is due 90 days after the close of each 12-month budget period. Recipients must mail the reports to the Grants Management Specialist listed in the ‘‘Agency Contacts’’ section of this announcement. VII. Agency Contacts erjones on PROD1PC68 with NOTICES For program technical assistance, contact: Lily O. Engstrom, Senior Policy Advisor to the Assistant Secretary for Public Health Emergency Preparedness, Office of Public Health Emergency Preparedness, OS, HHS, Telephone: 202.205.4727, E-mail: lily.engstrom@hhs.gov. For financial, grants management, or budget assistance, contact: Grants Management Specialist, Office of Grants Management, Office of Public Health and Science, 11101 Wootten Parkway, Suite 550, Rockville, MD 20857, Telephone: (240) 453–8822, E-mail Address: kcampbell@osophs.dhhs.gov. Dated: March 2, 2006. Stewart Simonson, Assistant Secretary for Public Health Emergency Preparedness, Department of Health and Human Services. [FR Doc. E6–3251 Filed 3–7–06; 8:45 am] BILLING CODE 4150–37–P VerDate Aug<31>2005 15:53 Mar 07, 2006 Jkt 208001 Meeting of the National Advisory Council for Healthcare Research and Quality Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of public meeting. AGENCY: SUMMARY: In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality. DATES: The meeting will be held on Friday, April 7, 2006, from 8:30 a.m. to 4 p.m. and is open to the public. ADDRESSES: The meeting will be held in Room 800, the Department of Health and Human Services, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: Deborah Queenan, Coordinator of the Advisory Council, at the Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, Maryland, 20850, (301) 427–1330. For press-related information, please contact Karen Migdail at (301) 427–1855. If sign language interpretation or other reasonable accommodation for a disability is needed, please contact Mr. Donald L. Inniss, Director, Office of Equal Employment Opportunity Program, Program Support Center, on (301) 443–1144 no later than March 24, 2006. Agenda, roster, and minutes from previous council meetings are available from Ms. Bonnie Campbell, Committee Management Officer, Agency for Healthcare Quality and Research, 540 Gaither Road, Rockville, Maryland, 20850. Ms. Campbell’s phone number is (301) 427–1554. SUPPLEMENTARY INFORMATION: I. Purpose Section 921 of the Public Health Service Act (42 U.S.C. 299c) established the National Advisory Council for Healthcare Research and Quality. In accordance with its statutory mandate, the Council is to advise the Secretary of the Department of Health and Human Services and the Director, Agency for Healthcare Research and Quality (AHRQ), on matters related to actions of the Agency to enhance the quality, improve the outcomes, reduce the costs of health care services, improve access to such services through scientific research, and to promote improvements in clinical practice and in the PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 organization, financing, and delivery of health care services. The Council is composed of members of the public appointed by the Secretary, and Federal ex-officio members. II. Agenda On Friday, April 7, 2006, the meeting will convene at 8:30 a.m. with the call to order by the Council Chair. The agenda will include the Director’s update on the status of the Agency’s current research, programs, and initiatives; a discussion of ambulatory care safety; and the findings on breast cancer from AHRQ’s Effective Healthcare initiative. The official agenda will be available on AHRQ’s Web site at https://www.ahrq.gov no later than March 31, 2006. The meeting will adjourn at 4 p.m. Dated: February 27, 2006. Carolyn M. Clancy, Director. [FR Doc. 06–2189 Filed 3–7–06; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92– 463) of October 6, 1972, that the Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention, of the Department of Health and Human Services, has been renewed for a 2-year period extending through February 19, 2008. For further information, contact Robert Martin, M.D., Executive Secretary, Centers for Disease Control and Prevention, Department of Health and Human Services, 4470 Buford Highway, M/S G–25, Chamblee, Georgia 30341, telephone 770–488–8295 or fax 7770–488–8282. The Director, Management and Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. E:\FR\FM\08MRN1.SGM 08MRN1

Agencies

[Federal Register Volume 71, Number 45 (Wednesday, March 8, 2006)]
[Notices]
[Pages 11661-11670]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Support, Training and Capacity Building for Infectious Disease 
Surveillance Networks in Affected Countries in Southeast Asia, Africa 
and Other Regions of the World

AGENCY: Office of the Secretary, Office of Public Health Emergency 
Preparedness, HHS.

ACTION: Notice.

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    Announcement Type: Single Source, Cooperative Agreement.
    Funding Opportunity Number: Not applicable.

Catalog Of Federal Domestic Assistance Number: The OMB Catalog of 
Federal Domestic Assistance number is pending.

SUMMARY: This is a project to enhance the surveillance, epidemiological 
investigation and laboratory diagnostic capabilities in countries in 
S.E. Asia, Africa and other regions of the world that are at risk for 
an avian influenza (H5N1) outbreak or where such an outbreak has 
already occurred. Such enhancements will help establish an early 
warning system that could prevent and contain the spread of an avian 
influenza pandemic to the United States.

DATES: To receive consideration, applications must be received no later 
than 5 p.m. Eastern Time on April 7, 2006.

ADDRESSES: Applications must be received by the Office of Grants 
Management, Office of Public Health and Science, Department of Health 
and Human Services, 1101 Wootten Parkway, Rockville, MD 20857.

FOR FURTHER INFORMATION, CONTACT: Lily O. Engstrom, Senior Policy 
Advisor to the Assistant Secretary for Public Health Emergency 
Preparedness, Office of Public Health Emergency Preparedness, 
Department of Health and Human Services at (202) 205-2882.

SUPPLEMENTARY INFORMATION: In the last century, three influenza 
pandemics have struck the United States and the world, and viruses from 
birds contributed to all of them. In 1918, the first pandemic killed 
over half-a-million Americans and more than 20 million people 
worldwide. One-third of the U.S. population was infected, and American 
life expectancy was reduced by 13 years. Following the 1918 outbreak, 
influenza pandemics in 1957 and 1968 killed tens of thousands of 
Americans and millions across the world. The recent limited outbreak of 
Severe Acute Respiratory Syndrome (SARS) suggests the danger that a 
modern pandemic would present.
    The H5N1 strain of avian flu has become the most threatening 
influenza virus in the world, and any large-scale outbreak of this 
disease among humans would have grave consequences for global public 
health. Influenza experts have warned that the re-assortment of 
different H5N1 viruses over the past seven years greatly increases the 
potential for the viruses to be transmitted more easily from person to 
person. Medical practitioners have also discovered several other, new 
avian viruses that can be transmitted to humans.
    The U.S. Government is concerned that a new influenza virus could 
become efficiently transmissible among humans. Now spreading through 
bird populations across Asia, reaching into Europe, the Middle East 
and, most recently, Africa, the H5N1 strain has infected domesticated 
birds such as

[[Page 11662]]

ducks and chickens and long-range migratory birds. In 1997, the first 
recorded H5N1 outbreak in humans took place in Hong Kong. H5N1 struck 
again in late 2003 and has, as of March 1, 2006, resulted in 174 
confirmed cases and 92 deaths world-wide, a 53 percent mortality rate. 
As of now, the H5N1 avian flu is primarily an animal disease; H5N1 
infection in humans has been the result of contact with sick poultry. 
Unless people come into direct, sustained contact with infected birds, 
it is unlikely they will contract the disease. The concern is that the 
virus will acquire the ability for sustained transmission among humans.
    In the fight against avian and pandemic flu, early detection is the 
first line of defense. A pandemic is like a forest fire. If caught 
early, it might be extinguished with limited damage. But if left 
undetected, it can grow into an inferno that spreads quickly. The 
President has charged the Federal Government to take immediate steps to 
ensure early warning of an avian flu outbreak among animals and humans 
anywhere in the world. It is in the interest of the U.S. Government to 
help establish early warning surveillance systems and laboratory 
capabilities in various regions of the world that would enable early 
detection, reporting, identification and investigation of any H5N1 
outbreaks. The development of such capabilities could make a 
significant difference in preventing and containing the spread of an 
avian influenza pandemic to the United States.
    On November 1, 2005, President Bush announced the National Strategy 
for Pandemic Influenza, and the following day Secretary Michael O. 
Leavitt released the HHS Pandemic Influenza Plan. The President 
directed all relevant Federal departments and agencies to take steps to 
address the threat of avian and pandemic flu. Drawing on the combined 
efforts of Government officials and the public health, medical, 
veterinary, and law-enforcement communities, as well as the private 
sector, this strategy is designed to meet three critical goals: 
detecting human or animal outbreaks that occur anywhere in the world; 
protecting the American people by stockpiling vaccines and antiviral 
drugs, while improving the capacity to produce new vaccines; and 
preparing to respond at the Federal, State, and local levels in the 
event an avian or pandemic influenza reaches the United States. The 
U.S. National Strategy for Pandemic Influenza can be found at https://
www.pandemicflu.gov.
    One of the primary objectives of both the National Strategy and the 
HHS Pandemic Influenza Plan is to leverage global partnerships to 
increase preparedness and response capabilities around the world ``with 
the intent of stopping, slowing or otherwise limiting the spread of a 
pandemic to the United States.'' \1\ Pillars Two and Three of the 
National Strategy set out clear goals of ensuring rapid reporting of 
outbreaks and containing such outbreaks beyond the borders of the 
United States, by taking the following actions:
---------------------------------------------------------------------------

    \1\ National Strategy for Pandemic Influenza, p. 2.
---------------------------------------------------------------------------

    Working through the International Partnership on Avian and Pandemic 
Influenza, as well as through other political and diplomatic channels, 
such as the United Nations and the Asia-Pacific Economic Cooperation 
Forum, to ensure transparency, scientific cooperation and rapid 
reporting of avian and human influenza cases;
    Supporting the development of the proper scientific and 
epidemiological expertise in affected regions to ensure early 
recognition of changes in the pattern of avian or human influenza 
outbreaks;
    Supporting the development and sustainment of sufficient host-
country laboratory capacities and diagnostic reagents in affected 
regions, to provide rapid confirmation of cases of influenza in animals 
and humans;
    Working through the International Partnership to develop a 
coalition of strong partners to coordinate actions to limit the spread 
of an influenza virus with pandemic potential beyond the location where 
it is first detected; and
    Providing guidance to all levels of government in affected nations 
on the range of options for infection-control and containment.
    We rely upon our international partnerships with the United 
Nations, international organizations and private non-profit 
organizations to amplify our efforts and will engage them on both a 
multilateral and bilateral basis. Our international effort to contain 
and mitigate the effects of an outbreak of pandemic influenza is a 
central component of our overall strategy. In many ways, the character 
and quality of the U.S. response and that of our international partners 
may play a determining role in the magnitude and severity of a 
pandemic.
    The International Partnership on Avian and Pandemic Influenza 
stands in support of multinational organizations. Members of the 
Partnership have agreed that the following 10 principles will guide 
their efforts:
    1. International cooperation to protect the lives and health of our 
people;
    2. Timely and sustained high-level global political leadership to 
combat avian and pandemic influenza;
    3. Transparency in reporting of influenza cases in humans and in 
animals caused by virus strains that have pandemic potential, to 
increase understanding and preparedness, especially to ensure rapid and 
timely response to potential outbreaks;
    4. Immediate sharing of epidemiological data and samples with the 
World Health Organization (WHO) and the international community to 
detect and characterize the nature and evolution of any outbreaks as 
quickly as possible by utilizing, where appropriate, existing networks 
and mechanisms;
    5. Rapid reaction to address the first signs of accelerated 
transmission of H5N1 and other highly pathogenic influenza strains so 
that appropriate international and national resources can be brought to 
bear;
    6. Prevention and containment of an incipient epidemic through 
capacity building and in-country collaboration with international 
partners;
    7. Working in a manner complementary to and supportive of expanded 
cooperation with and appropriate support of key multilateral 
organizations (including the WHO, Food and Agriculture Organization and 
World Organization for Animal Health);
    8. Timely coordination of bilateral and multilateral resource 
allocations; dedication of domestic resources (human and financial); 
improvements in public awareness; and development of economic and trade 
contingency plans;
    9. Increased coordination and harmonization of preparedness, 
prevention, response and containment activities among nations, 
complementing domestic and regional preparedness initiatives and 
encouraging, where appropriate, the development of strategic regional 
initiatives; and
    10. Actions taken based on the best available science.
    Through the Partnership and other bilateral and multilateral 
initiatives, we will promote these principles and support the 
development of an international capacity to prepare, detect and respond 
to an influenza pandemic.
    In support of the President's National Strategy and consistent with 
the principles of the International Partnership, this cooperative 
agreement, while contemplating a global approach, will begin in this 
first phase with a focus on countries in Southeast Asia and Africa. The 
program funded by this cooperative agreement intends to combine the 
efforts and the resources of the U.S. Department of Health and

[[Page 11663]]

Human Services (HHS) and the Reseau International des Instituts Pasteur 
(RIIP) network of research and surveillance to enhance outbreak 
surveillance and investigation capacity beginning in Southeast Asia and 
Africa. The Institut Pasteur--Cambodia (IPC) in its capacity as the 
National Influenza Reference Center, in agreement with the Cambodian 
Ministry of Health, the Cambodian Ministry of Agriculture, the World 
Health Organization (WHO) and the United Nations Food and Agriculture 
Organization (FAO), has initiated an outbreak surveillance and 
investigation system supported by rigorous laboratory identification of 
genotype Z of avian influenza virus H5N1.
    This cooperative agreement will enhance laboratory capacity at IPC 
to enable it to support the Cambodian Ministry of Health's Influenza-
Like-Illness (ILI) surveillance program. IPC currently provides all 
laboratory testing services required for ILI surveillance, both for 
animal and human specimens. This service is conducted for and on behalf 
of the Cambodian Ministry of Health and the Cambodian Ministry of 
Agriculture, Forestry and Fisheries, both of which are fully informed 
of all testing results. Under this cooperative agreement, it is 
anticipated that there will be a gradual but progressive shift to 
include National Institute of Public Health (NIPH) staff in the 
cataloguing of specimens and ultimately, when capacity is adequate, 
actual testing of samples in the NIPH laboratory.
    To achieve enhanced laboratory capacity at IPC in support of ILI 
surveillance, this cooperative agreement will fund the following:
    Costs connected with the testing of ILI surveillance samples from 
both Cambodia and Laos at IPC;
    A portion of annual maintenance costs for the newly built 
Biosafety-Level (BSL)-3 laboratory at IPC;
    Installation of appropriate enhancements of physical security at 
the IPC campus to ensure that only authorized persons have access to 
the BSL-3 suite and to safeguard the equipment and collections of virus 
samples kept in the laboratory; and Costs for IPC to undertake human 
and animal surveillance for H5N1 avian influenza in both Cambodia and 
Laos. This component of the agreement will include building field-
investigation as well as laboratory capacity.
    This cooperative agreement also contemplates funding other 
activities in support of ILI surveillance programs in Cambodia and 
Laos, including technical assistance to the respective Ministries of 
Health to implement and expand their surveillance programs.
    This cooperative agreement will also support capacity building at 
the three Institut Pasteur--affiliated laboratories in Viet Nam 
(National Institute of Hygiene and Epidemiology [NIHE]--Hanoi, Institut 
Pasteur--Ho Chi Minh City, and Institut Pasteur--Nha Trang). 
Specifically, this agreement will fund the following:
    Enhanced interoperable communications among the three RIIP-
affiliated laboratories in Viet Nam and between them and HHS agencies 
as well as the WHO Secretariat and Regional Office for the Western 
Pacific; and placement of a qualified international biosafety/
biosecurity technical advisor for two years at the newly constructed 
BSL-3 laboratory at NIHE.
    This cooperative agreement will also fund the enhancement of 
capacity in RIIP affiliated laboratories in Africa. Such enhanced 
capacity will be directed at improving human and animal surveillance 
for H5N1 and other infectious respiratory diseases.
    Finally, this cooperative agreement will fund the creation of one 
post-doctoral position for U.S. citizens in the Influenza Laboratory at 
Institut Pasteur--Paris to focus exclusively on influenza surveillance 
in Southeast Asia, Africa and other parts of the world impacted by 
H5N1.
    No funds provided under this cooperative agreement may be used to 
support any activity that duplicates another activity supported by any 
component of HHS. All funded activities must be coordinated with the 
Office of Public Health Emergency Preparedness (HHS), with in-country 
Centers for Disease Control and Prevention (CDC) offices, and with the 
respective Ministries of Health.

I. Funding Opportunity Description

    Authority: Sections 301, 307, 1701 and 2811 of the Public Health 
Service Act, 42 U.S.C. 241, 242l, 300u, 300hh-11.
    Purpose: The purposes of the program are to:
    Enhance cooperation between the HHS and RIIP institutes to support 
and increase influenza outbreak-investigation, surveillance, and 
training capacity in Southeast Asia; Enhance laboratory capacities for 
H5N1 diagnosis in the Cambodian Ministry of Health's Influenza-Like 
Illness (ILI) surveillance program;
    Enhance and expand IPC's capacity to conduct human and animal 
surveillance activities in Cambodia and Laos;
    Enhance and expand the training capacity for H5N1 avian influenza 
surveillance and epidemiology within the RIIP network in Cambodia, Laos 
and Viet Nam, as well as provide and expand biosafety and biosecurity 
training for BSL-3 facilities in this region;
    Enhance communications and interoperable connectivity among the 
three RIIP-affiliated laboratories in Vietnam;
    Enhance security at the BSL-3 laboratory suite and related physical 
plant for Institut Pasteur--Cambodia; and
    Enhance laboratory capacities in African countries that are at risk 
for an H5N1 outbreak or where there has already been an H5N1 outbreak 
in order to strengthen early detection and diagnosis of influenzas in 
animals and humans.
    Measurable outcomes of the program will be in alignment with the 
President's National Strategy and the principles of the International 
Partnership on Avian and Pandemic Influenza, and one (or more) of the 
following performance goal(s) for the agency pursuant to the 
President's initiative on pandemic influenza preparedness:

To detect animal and human outbreaks before they spread around the 
world;
To take immediate steps to ensure early warning of an avian flu 
outbreak among animals or humans in affected regions; and
To strengthen a new international partnership on avian influenza.

Grantee Activities

    Grantee activities for this program are as follows:
    Enhance laboratory capacities for H5N1 diagnosis in the National 
Influenza Reference Center (virology unit, IPC) in support of the 
Cambodian Ministry of Health's ILI surveillance program, based on the 
enhancement of diagnostic test sensitivity, on testing an increased 
number of Cambodian and Laotian samples as well as on development of a 
valid serological test (microneutralization test) for human influenza 
infection;
    Enhance and expand training capacity for H5N1 surveillance and 
epidemiology in Cambodia, Laos and Viet Nam;
    Support surveillance for influenza-like illness (ILI), severe 
pneumonia and other respiratory diseases, to be carried out through 
and/or on behalf of the respective Ministries of Health in outpatient 
departments of Provincial hospitals in Cambodia and Laos;
    Strengthen the capacity for early detection and early warning of 
avian influenza outbreaks in Cambodia, Laos and Viet Nam;

[[Page 11664]]

    Provide support (financial and technical) to systematic, extensive 
epidemiological and viral investigations following any confirmed H5N1 
human or animal cases in Cambodia and Laos;
    Enhance laboratory capabilities in affected and at-risk nations in 
Africa to perform surveillance and diagnosis of H5N1 in humans and 
animals; and
    Coordinate activities that are conducted under this cooperative 
agreement with other relevant institutes (members) of the RIIP.
    All influenza virus information obtained or developed as a result 
of the foregoing activities or other activities funded under this 
cooperative agreement shall be shared with HHS as well as within the 
WHO Global influenza network and WHO Collaborating Centers of 
Influenza. As part of its proposal, RIIP shall submit a plan for 
ensuring that such information is shared in a timely, accurate, 
thorough and reliable manner with HHS and WHO. Such plan will also 
address the sharing with HHS of specimen and other viral material 
obtained by RIIP as a result of activities funded under this 
cooperative agreement.
    In addition, this cooperative agreement will provide limited and 
specific funding, as detailed below, for the following activities:
    Security Enhancements to BSL-3 laboratory suite and related 
physical plant for IPC.
    A BSL-3 laboratory at IPC will substantially enhance capacity in 
Cambodia to isolate and work with the A/H5N1 virus and other emerging 
infectious diseases. It is essential that the physical security 
(including biosecurity and entry-control systems) for the BSL-3 suite 
be sufficient to ensure the integrity of the laboratory and prevent 
unauthorized access.
    Funding for this activity will match, on a one-time basis, 
investments by Institut Pasteur up to $50,000 USD for costs connected 
with acquiring and installing entry-control systems and other physical-
security enhancements (including vehicular barriers, cameras, monitors 
and locking devices) for the BSL-3 suite and related physical plant.
    Enhanced communications and interoperable connectivity among the 
three RIIP affiliated laboratories in Viet Nam (NIHE--Hanoi, Institut 
Pasteur--Ho Chi Minh City, and Institut Pasteur--Nha Trang) and between 
them and HHS agencies as well as the WHO Secretariat and Regional 
Office for the Western Pacific.
    The occurrence of A/H5N1 avian influenza in Viet Nam highlights the 
need to build critical public health capacity in that country. The 
three Institut Pasteur network laboratories (i.e., NIHE--Hanoi, 
Institut Pasteur--Ho Chi Minh City, and Institut Pasteur--Nha Trang) 
are at the very core of Viet Nam's public health response to avian 
influenza and other emerging diseases. It is essential that these 
laboratories have the capacity to communicate (by voice, data and 
video) with each other, the WHO Secretariat, HHS (including both the 
Centers for Disease Control and Prevention [CDC] and the National 
Institutes of Health [NIH]) and the Paris headquarters of Institut 
Pasteur in real time and at high speed. This enhanced capability will 
enable the laboratories to consult with scientific experts around the 
world and provide important disease surveillance data in a timely 
manner. Advancements in the understanding of A/H5N1 and other emerging 
diseases is heavily dependent on communications technology--so common 
in the developed world yet in need of substantial and accelerated 
enhancements in Viet Nam.
    Funding for this activity will match, on a one-time basis, 
investments made by the Institut Pasteur in the three laboratories up 
to a total of $200,000 USD for costs associated with hardware, software 
and installation required to develop this interoperable connectivity. 
Funding will also match Institut Pasteur's investments in maintenance 
of this communications system at the three laboratories, up to a total 
of $10,000 USD per year for three years.
    Support for an international biosafety/biosecurity technical 
advisor for the new BSL-3 laboratory suite at NIHE, a member laboratory 
of the Institut Pasteur Network located in Hanoi, Viet Nam, as well as 
support for a short-term virologist to lead the virology laboratory in 
Laos.
    A BSL-3 laboratory at NIHE will enhance capacity in Viet Nam to 
isolate and work with A/H5N1 avian influenza and other emerging 
infectious diseases. Since BSL-3 biosafety/biosecurity practices are 
complicated and require 100 percent compliance at all times that the 
laboratory is operational, it is essential that NIHE and its employees 
have on-site access to an international technical advisor with 
substantial biosafety/biosecurity experience. This will ensure the safe 
and efficient operation of the laboratory and provide critically 
important on-the-job training to NIHE scientists and technicians who 
work in the BSL-3 suite.
    Funding for this activity will match costs incurred by Institut 
Pasteur related to assigning an experienced, full-time international 
BSL-3 biosafety/biosecurity technical advisor to NIHE, up to $100,000 
USD per year for two years.
    Human and animal surveillance and training capacity building in 
Cambodia and Laos. A/H5N1 is an avian disease, which makes animal 
sampling essential to any meaningful surveillance program. IPC operates 
a state-of-the-art laboratory in Phnom Penh, Cambodia, and has an 
established working relationship with the appropriate health and 
agriculture authorities in the national Governments of Cambodia and 
Laos. IPC is, therefore, uniquely qualified to undertake animal and 
human disease surveillance in these countries. IPC is also an important 
training asset in the region and can leverage existing and new programs 
to maximize animal surveillance training for Cambodian and Laotian 
nationals.
    At the invitation of the Ministry of Health, Institut Pasteur is in 
the process of establishing a presence in Laos to support disease 
surveillance and other public health activities. There is a critical 
need to enhance virology laboratory capacity in Laos. Such augmented 
capacity will be essential to the success of any meaningful 
surveillance program targeted at influenza and other respiratory 
diseases. The cooperative agreement will support the placement of a 
technical advisor in Laos to assist with virology capacity building.
    Funding for animal and human surveillance and training capacity 
building will be up to $225,000 for the first year (to include support 
for the technical advisor in virology) and up to $175,000 USD for the 
second and third year of this agreement.
    Human and animal surveillance and training capacity building in 
Africa. H5N1 has spread to Africa and RIIP has several laboratories 
uniquely positioned to assist with surveillance activities on this 
continent. It is essential that investments in capacity building at 
these laboratories be made as soon as practicable so that a foundation 
for early infectious disease warning in Africa will be established in 
time to track the spread of H5N1 in animals and humans. This 
cooperative agreement will match investments made by Institut Pasteur 
in such capacity building in Africa up to $250,000 for each year of 
this agreement.
    The Influenza Laboratory at Institut Pasteur--Paris will support a 
number of the activities undertaken pursuant to this cooperative 
agreement. Additional capacity is required to ensure that this 
laboratory is capable of responding in a timely manner to developments 
in the field. This cooperative agreement will support the creation of a 
post-doctoral position in the Institut Pasteur--Paris

[[Page 11665]]

Influenza Laboratory. Candidates for this position must be U.S. 
citizens not presently studying or working in France at the time of 
application. Funding for this activity, which will include salary and 
any necessary equipment and supplies, will be $100,000 USD for each 
year of the agreement.
    HHS, particularly the Office of Public Health Emergency 
Preparedness, will be substantially involved with the design and 
implementation of the described grantee activities. HHS staff 
activities for this program are as follows:
    Provide expert assistance in the design, implementation and 
delivery of instruction to individuals selected for epidemiology 
training and laboratory-support training;
    Provide liaison through HHS employees at U.S. Embassies in host 
countries with local Ministries of Health and Agriculture and other 
host-nation organizations, as appropriate and as relevant to the 
achievement of the purposes of this cooperative agreement; and
    Provide oversight of activities that are supported by funds awarded 
through this cooperative agreement.

II. Award Information

    This project will be supported through the cooperative agreement 
mechanism. OPHEP anticipates making only one award. The anticipated 
start date is approximately May 1, 2006, and the anticipated period of 
performance is approximately May 1, 2006, through April 30, 2009. OPHEP 
anticipates that approximately $1,455,000 will be available for the 
first 12-month budget period. The total amount that may be requested by 
the Pasteur Foundation is $2,625,000 for three years. Indirect costs 
will not be covered by the funds in this cooperative agreement.
    Approximate Current Fiscal Year Funding: $1,455,000.
    Approximate Total Project Period Funding: $2,625,000.
    Funds under this cooperative agreement shall not be applied to 
indirect costs.
    Funding Breakdown:

----------------------------------------------------------------------------------------------------------------
                                                   Current year                                    Total funding
                    Activity                          funding     Year 2 funding  Year 3 funding   per activity
----------------------------------------------------------------------------------------------------------------
Enhanced communications (matching funds)........        $200,000  ..............  ..............        $200,000
Maintenance of communications systems (matching           10,000         $10,000         $10,000          30,000
 funds).........................................
Security and biosecurity enhancements (matching           50,000  ..............  ..............          50,000
 funds).........................................
International biosafety/biosecurity technical            100,000         100,000  ..............         200,000
 advisor (matching funds).......................
Enhancement of laboratory capacity at IPC.......         435,000  ..............  ..............         435,000
Virology laboratory training....................          85,000  ..............  ..............          85,000
H5N1 avian influenza animal and human                    225,000         175,000         175,000         575,000
 surveillance (including virology technical
 advisor for Laos)..............................
Influenza Post-Doctoral position................         100,000         100,000         100,000         300,000
Enhancement of laboratory diagnostic                     250,000         250,000         250,000         750,000
 capabilities in African nations (matching
 funds).........................................
                                                 ---------------------------------------------------------------
    Grand Total.................................       1,455,000         635,000         535,000       2,625,000
----------------------------------------------------------------------------------------------------------------

    Approximate Number of Awards: 1.
    Ceiling of Individual Award Range: Maximum dollar amount for the 
first 12-month budget period is $1,455,000, and will not include 
payment of any indirect costs.
    Throughout the project period, the commitment of HHS to the 
continuation of funding will depend on the availability of funds, 
evidence of satisfactory progress by the recipient (as documented in 
required reports), demonstrated commitment of the recipient to the 
principles of the International Partnership on Avian and Pandemic 
Influenza, and the determination that continued funding is in the best 
interest of the Federal Government and continues to meet the goals of 
the U.S. National Strategy for Pandemic Influenza.

III. Eligibility Information

1. Eligible Applicants

    The only eligible applicant that can apply for this funding 
opportunity is the Pasteur Foundation, a U.S. not-for-profit affiliate 
of the Institut Pasteur. In making this award, HHS will be able to 
capitalize on Pasteur's existing Reseau International des Instituts 
Pasteur (RIIP), a worldwide network of research and surveillance 
institutes. Since its creation, the Institut Pasteur has had an 
international calling, and from its earliest days Pasteur scientists 
have traveled around the world to study and combat epidemics. The first 
Institut Pasteur outside of France was created in 1891 in Saigon. The 
RIIP is made up of 29 institutions spread out across five continents, 
and unites 8,800 people, most of whom the institutions recruit locally.
    With regard to Southeast Asia, the RIIP is strategically positioned 
to study the natural history of A/H5N1 avian influenza virus. The RIIP 
network in Asia has undertaken a number of research and surveillance 
programs that focus on acute respiratory infections, of both viral and 
bacterial origin in Viet Nam, Cambodia and Laos. The network is also 
engaged in surveillance activities in other regions of the world, 
including Africa.
    The RIIP Institutes in Southeast Asia have been providing a 
beneficial service in the region by working with the local Ministries 
of Health in their epidemiological investigations, and by providing 
laboratory diagnosis of both human and animal influenza samples. One 
RIIP program is specifically looking at the natural history and 
circulation of the A/H5N1 virus in and around the locations where it 
has previously emerged in human or avian populations. RIIP active and 
current involvement in the region includes the following:
    In 2004, NIHE in Hanoi and the Pasteur Institute collected throat 
swabs and serum samples from family members and contacts of victims, as 
well as from random poultry workers. Through the first months of 2004, 
NIHE collected several hundred samples in northern Viet Nam; Pasteur 
got several dozen more in the south. In addition to patients, their 
contacts and poultry workers were tested by using the RT-PCR assay; the 
results were overwhelmingly negative. The two institutes were unable to 
check for antibodies to the virus in blood samples, a sign of past 
infection, because the most sensitive procedure, the micro-
neutralization assay, requires a BSL-3 laboratory. Consequently, they 
shipped the samples to HHS/CDC in Atlanta, Georgia, where tests 
confirmed the negative findings.
    In New Caledonia, the Pasteur Institute aimed to evaluate the 
annual incidence of influenza and to identify the circulating viral 
types and subtypes

[[Page 11666]]

to gather information for the local vaccination program and regional 
influenza surveillance. In 1999, the Institute set up a surveillance 
network that included sentinel practitioners in Noumea and the virology 
department of the Pasteur Institute. Influenza circulated in New 
Caledonia every year, regularly during the Southern Hemisphere winter, 
and occasionally during March-May. Isolates were generally consistent 
with world surveillance, except in 1999, when a new A/H5N1 variant was 
identified. This study emphasizes the need for regular influenza 
surveillance, even when performed on a limited scale. The study also 
identified the optimal time for local vaccination to be in December or 
January of each year.
    RIIP has a long history of making important public health and 
biomedical science contributions in Africa. The RIIP network in Africa 
includes laboratories in Algeria, Cameroon, the Ivory Coast, 
Madagascar, Niger, the Central African Republic, Senegal, Morocco and 
Tunis. These facilities provide a unique, existing capability that can 
be leveraged to enhance H5N1 surveillance and disease detection in the 
region.

2. Cost-Sharing or Matching Funds

    Matching funds are required for this program. HHS will pay 
$2,625,000 or 68 percent of the total costs of $3,855,000 while the 
Pasteur Foundation will provide $1,230,000 or 32 percent of total 
costs.

3. Other

    If an applicant requests a funding amount greater than the ceiling 
of the award range, HHS will consider the application non-responsive, 
and the application will not enter into the review process. HHS will 
notify the applicant that the application did not meet the submission 
requirements.
Special Requirements
    If the application is incomplete or non-responsive to the special 
requirements listed in this section, the application will not enter 
into the review process. HHS will notify the applicant that the 
application did not meet submission requirements.
    HHS will consider late applications non-responsive. Please see 
section on ``Submission Dates and Times.''
    Title 2 of the United States Code Section 1611 states that ``an 
organization described in Section 501(c)(4) of the Internal Revenue 
Code that engages in lobbying activities is not eligible to receive 
Federal funds constituting a grant, loan, or an award.''

IV. Application and Submission Information

1. Address To Request Application Package

    Application kits may be requested by calling (240) 453-8822 or 
writing to the Office of Grants Management, Office of Public Health and 
Science, Department of Health and Human Services, 1101 Wootten Parkway, 
Suite 550, Rockville, MD 20852. Applicants may also fax a written 
request to the OPHS Office of Grants Management at (240) 453-8823 to 
obtain a hard copy of the application kit. Applications must be 
prepared using Form OPHS-1.

2. Content and Form of Submission

    Application: Applicants must submit a project narrative in English, 
along with the application forms, in the following format:
    Maximum number of pages: 50. If your narrative exceeds the page 
limit, HHS will only review the first 50 pages within the page limit;
    Font size: 12-point, unreduced;
    Single-spaced;
    Paper size: 8.5 by 11 inches;
    Page-margin size: One inch;
    Number all pages of the application sequentially from page one 
(Application Face Page) to the end of the application, including 
charts, figures, tables, and appendices;
    Print only on one side of page;
    Hold application together only by rubber bands or metal clips, and 
o not bind it in any other way.
    The narrative should address activities to be conducted over the 
entire project period and must include the following items in the order 
listed:
    Understanding of the requirements. The application shall include a 
discussion of your organization's understanding of the need, purpose 
and requirements of this cooperative agreement, as well as the 
President's National Strategy and the principles of the International 
Partnership on Avian and Pandemic Influenza. The discussion shall be 
sufficiently specific, detailed and complete to clearly and fully 
demonstrate that the applicant has a thorough understanding of all the 
technical requirements of this announcement.
    A Project Plan. The project plan must demonstrate that the 
organization has the technical expertise to carry out the work/task 
requirements of this announcement. The plan must contain sufficient 
detail to clearly describe the proposed means for conducting the 
``Grantee Activities'' described in Section I, and shall include a 
complete explanation of the methods and procedures the applicant will 
use. The project plan shall include discussions of the following 
elements:
     Objectives;
     Methods to accomplish the purposes of the cooperative 
agreement and the ``Grantee Activities'';
     Detailed time line for accomplishment of each activity;
     Ability to respond to emergencies;
     Ability to respond to situations on weekends and after 
hours; and
     Coordination with HHS, the WHO Secretariat and Regional 
Office, the FAO, and the World Organization for Animal Health (OIE).
    Staffing and Management Plan. The applicant must provide a project 
staffing and management plan, which must include time lines and 
sufficient detail to ensure that it can meet the Federal Government's 
requirements in a timely and efficient manner.
     The applicant must provide resumes that identify the 
educational and experience level of any individual(s) who will perform 
in a key position and other qualifications to show the key individuals' 
ability to comply with the minimum requirements of this announcement.
     The applicant must provide a summary of the qualifications 
of non-key personnel. Resumes must be limited to three pages per 
person.
     The proposed staffing plan must demonstrate the 
applicant's ability to recruit/retain/replace personnel who have the 
knowledge, experience, local-language skills, training and technical 
expertise commensurate with the requirements of this announcement. The 
plan must demonstrate the applicant's ability to provide bi-lingual 
personnel to train and mentor host-country participants.
    Performance Measures. The applicant must provide measures of 
effectiveness that will demonstrate accomplishment of the objectives of 
this cooperative agreement and progress toward the goals of the 
President's National Strategy. Measures of effectiveness must relate to 
the performance goals stated in the ``Purpose'' section of this 
announcement. Measures must be objective and quantitative, and must 
measure the intended outcomes. The applicant must submit a section on 
measures of effectiveness with its application, and they will be an 
element for evaluation. In addition, the applicant shall insert the 
following as measures of applicant's performance:
     Number of new epidemiologists actually trained and 
employed from each designated country;
     Number of new laboratorians actually trained in virologic 
techniques

[[Page 11667]]

and employed in each designated country;
     Whether the RIIP institutes in Cambodia and Viet Nam 
establish formal and reliable communication links with the WHO Global 
Outbreak Alert and Response Network (GOARN), the WHO Global Influenza 
Surveillance Network, and the equivalent animal disease surveillance 
networks at the FAO and OIE;
     The number, accuracy, thoroughness and timeliness of 
reports to the WHO Global Influenza Surveillance Network from the RIIP 
laboratories receiving funding under this agreement;
     The number, accuracy, thoroughness, and timeliness of 
other notifications submitted to the WHO Secretariat and HHS regarding 
potential or actual outbreaks of ILI or other respiratory diseases 
anywhere in the world; and
     The timely and successful appointment of a candidate for 
the post-doctoral position funded under this agreement.
    Budget Justification. The budget justification, which will be 
limited to 10 pages, will count against the overall 50-page limit. This 
justification must comply with the criteria for applications. The 
applicant must submit, at a minimum, a cost proposal fully supported by 
information adequate to establish the reasonableness of the proposed 
amount.
    The applicant may include additional information in the application 
appendices, which will not count toward the narrative page limit. This 
additional information includes the following: Curricula Vitae, 
Resumes, Organizational Charts, Letters of Support, etc.
    An agency or organization is required to have a Dun and Bradstreet 
Data Universal Numbering System (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 no charge. To 
obtain a DUNS number, access www.dunandbradstreet.com, or call 1-866-
705-5711.
    Additional requirements that could require submission of additional 
documentation with the application appear in section ``VI.2. 
Administrative and National Policy Requirements.''

3. Submission Dates and Times

    To be considered for review, applications must be received by the 
Office of Grants Management, Office of Public Health and Science, by 5 
p.m. Eastern Time on April 7, 2006. Applications will be considered as 
meeting the deadline if they are received on or before the deadline 
date. The application due date in this announcement supercedes the 
instructions in the OPHS-1.
Submission Mechanisms
    The Office of Public Health and Science (OPHS), which is serving as 
the awarding agency for the Office of Public Health Emergency 
Preparedness, provides multiple mechanisms for the submission of 
applications, as described in the following sections. Applicants will 
receive notification via mail from the OPHS Office of Grants Management 
confirming the receipt of applications submitted using any of these 
mechanisms. Applications submitted to the OPHS Office of Grants 
Management after the deadlines identified below will not be accepted 
for review. Applications which do not conform to the requirements of 
the cooperative agreement announcement will not be accepted for review 
and will be returned to the applicant.
    Applications may be submitted electronically only via the 
electronic submission mechanisms specified below. Any applications 
submitted via any other means of electronic communication, including 
facsimile or electronic mail, will not be accepted for review. While 
applications are accepted in hard copy, the use of the electronic 
application submission capabilities provided by the OPHS eGrants system 
or the www.Grants.gov Web site Portal is encouraged.
    Electronic grant application submissions must be submitted no later 
than 5 p.m. Eastern Time on the deadline date specified in the 
``Submission Dates and Times'' section of this announcement using one 
of the electronic submission mechanisms specified below. All required 
hard copy original signatures and mail-in items must be received by the 
OPHS Office of Grants Management no later than 5 p.m. Eastern Time on 
the next business day after the deadline date specified in the 
``Submission Dates and Times'' section of this announcement.
    Applications will not be considered valid until all electronic 
application components, hard copy original signatures, and mail-in 
items are received by the OPHS Office of Grants Management according to 
the deadlines specified above. Application submissions that do not 
adhere to the due date requirements will be considered late and will be 
deemed ineligible.
    The applicant is encouraged to initiate electronic applications 
early in the application development process, and to submit prior to or 
early on the due date. This will allow sufficient time to address any 
problems with electronic submissions prior to the application deadline.
Electronic Submissions via the OPHS eGrants System
    The OPHS electronic grants management system, eGrants, provides for 
applications to be submitted electronically. Information about this 
system is available on the OPHS eGrants website, https://
egrants.osophs.dhhs.gov, or may be requested from the OPHS Office of 
Grants Management at (240) 453-8822.
    When submitting applications via the OPHS eGrants system, 
applicants are required to submit a hard copy of the application face 
page (Standard Form 424) with the original signature of an individual 
authorized to act for the applicant agency and assume the obligations 
imposed by the terms and conditions of the grant award. If required, 
applicants will also need to submit a hard copy of the Standard Form 
LLL and/or certain Program related forms (e.g., Program Certifications) 
with the original signature of an individual authorized to act for the 
applicant agency.
    Electronic applications submitted via the OPHS eGrants system must 
contain all completed online forms required by the application kit, the 
Program Narrative, Budget Narrative and any appendices or exhibits. The 
applicant may identify specific mail-in items to be sent to the Office 
of Grants Management separate from the electronic submission; however, 
these mail-in items must be entered on the eGrants Application 
Checklist at the time of electronic submission, and must be received by 
the due date requirements specified above. Mail-In items may only 
include publications, resumes, or organizational documentation.
    Upon completion of a successful electronic application submission, 
the OPHS eGrants system will provide the applicant with a confirmation 
page indicating the date and time (Eastern Time) of the electronic 
application submission. This confirmation page will also provide a 
listing of all items that constitute the final application submission, 
including all electronic application components, required hard copy 
original signatures, and mail-in items, as well as the mailing address 
of the OPHS Office of Grants Management where all required hard copy 
materials must be submitted.

[[Page 11668]]

    As items are received by the OPHS Office of Grants Management, the 
electronic application status will be updated to reflect the receipt of 
mail-in items. It is recommended that the applicant monitor the status 
of its application in the OPHS eGrants system to ensure that all 
signatures and mail-in items are received.
Electronic Submissions via the www.Grants.gov Web Site Portal
    The Grants.gov Web site Portal provides organizations with the 
ability to submit applications for OPHS grant opportunities. 
Organizations must successfully complete the necessary registration 
processes in order to submit an application. Information about this 
system is available on the Grants.gov Web site, https://www.grants.gov.
    In addition to electronically submitted materials, applicants may 
be required to submit hard copy signatures for certain Program related 
forms, or original materials as required by the announcement. It is 
imperative that the applicant review both the cooperative agreement 
announcement as well as the application guidance provided within the 
Grants.gov application package to determine such requirements. Any 
required hard copy materials or documents that require a signature must 
be submitted separately via mail to the OPHS Office of Grants 
Management and, if required, must contain the original signature of an 
individual authorized to act for the applicant agency and to assume the 
obligations imposed by the terms and conditions of the cooperative 
agreement award.
    Electronic applications submitted via the Grants.gov Web site 
Portal must contain all completed online forms required by the 
application kit, the Program Narrative, Budget Narrative and any 
appendices or exhibits. All required mail-in items must be received by 
the due date specified above. Mail-In items may only include 
publications, resumes or organizational documentation. Upon completion 
of a successful electronic application submission via the Grants.gov 
Web site Portal, the applicant will be provided with a confirmation 
page from Grants.gov indicating the date and time (Eastern Time) of the 
electronic application submission as well as the Grants.gov Receipt 
Number. It is critical that the applicant print and retain this 
confirmation as well as a copy of the entire application package for 
its records.
    All applications submitted via the Grants.gov Web site Portal will 
be validated by Grants.gov. Any applications deemed ``Invalid'' by the 
Grants.gov Web site Portal will not be transferred to the OPHS eGrants 
system, and OPHS has no responsibility for any application that is not 
validated and transferred to OPHS from the Grants.gov Web site Portal. 
Grants.gov will notify the applicant regarding the application 
validation status. Once the application is successfully validated by 
the Grants.gov Web site Portal, applicants should immediately mail all 
required hard copy materials to the OPHS Office of Grants Management to 
be received by the deadlines specified above. It is critical that the 
applicant clearly identify the Organization name and Grants.gov 
Application Receipt Number on all hard copy materials.
    Once the application is validated by Grants.gov, it will be 
electronically transferred to the OPHS eGrants system for processing. 
Upon receipt of both the electronic application from the Grants.gov Web 
site Portal, and the required hard copy mail-in items, applicants will 
receive notification via mail from the OPHS Office of Grants Management 
confirming the receipt of the application submitted using the 
Grants.gov Web site Portal.
    Applicants should contact Grants.gov regarding any questions or 
concerns about the electronic application process used by the 
Grants.gov Web site Portal.
Mailed or Hand-Delivered Hard Copy Applications
    Applicants who submit applications in hard copy (via mail or hand-
delivered) are required to submit an original and two copies of the 
application. The original application must be signed by an individual 
authorized to act for the applicant agency or organization and to 
assume for the organization the obligations imposed by the terms and 
conditions of the grant award.
    Mailed or hand-delivered applications will be considered as meeting 
the deadline if they are received by the OPHS Office of Grant 
Management on or before 5 p.m. Eastern Time on the deadline date 
specified in the ``Submission Dates and Times'' section of this 
announcement. The application deadline date requirement specified in 
this announcement supersedes the instructions in the OPHS-1. 
Applications that do not meet the deadline will be returned to the 
applicant unread.

4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

5. Funding Restrictions

    Restrictions, which applicants must take into account while 
preparing the budget, are as follows:
    Alterations and renovations (A&R) are prohibited on grants/
cooperative agreements to foreign recipients. Alterations and 
renovations are defined as work that changes the interior arrangements 
or other physical characteristics of an existing facility or of 
installed equipment so that it can be used more effectively for its 
currently designated purpose or adapted to an alternative use to meet a 
programmatic requirement. Recipients may not use funds for A&R 
(including modernization, remodeling, or improvement) of an existing 
building. Recipients may not use funds for planning, organizing or 
convening conferences. Reimbursement of pre-award costs is not allowed. 
Recipients may spend funds for reasonable program purposes, including 
personnel, travel, supplies, and services. Recipients may purchase 
equipment if deemed necessary to accomplish program objectives; 
however, they must request prior approval in writing from HHS/OPHEP 
officials for any equipment whose purchase price exceeds $10,000 USD.
    The costs generally allowable in grants/cooperative agreements to 
domestic organizations are allowable to foreign institutions and 
international organizations, with the following exception: With the 
exception of the American University, Beirut and the WHO Secretariat, 
HHS will not pay indirect costs (either directly or through sub-award) 
to organizations located outside the territorial limits of the United 
States, or to international organizations, regardless of their 
location. Recipients may contract with other organizations under this 
program; however, the applicant must perform a substantial portion of 
the project activities (including program management and operations) 
for which it is requesting funds. Contracts will require prior approval 
in writing from HHS/OPHEP. Recipients may not use funds awarded under 
this cooperative agreement to support any activity that duplicates 
another activity supported by any component of HHS.
    Applicants shall state all requests for funds in the budget in U.S. 
dollars. Once HHS makes an award, HHS will not compensate foreign 
recipients for currency-exchange fluctuations through the issuance of 
supplemental awards. The funding recipient must obtain annual audits of 
these funds (program-specific audit) by a U.S.-based audit

[[Page 11669]]

firm with international branches and current licensure/authority in-
country, and in accordance with International Accounting Standards or 
equivalent standard(s) approved in writing by HHS. A fiscal Recipient 
Capability Assessment may be required, prior to or post award, to 
review the applicant's business management and fiscal capabilities 
regarding the handling of U.S. Federal funds.

 6. Other Submission Requirements

    None.

V. Application Review Information

1. Criteria

    HHS will evaluate applications against the following factors:
Factor 1: Project Plan (35 Points)
    HHS will evaluate the extent to which the proposal demonstrates 
that the organization has the technical expertise to carry out the 
work/task requirements described in this announcement. HHS will 
evaluate the applicant's project plan to determine the extent to which 
it provides a clear, logical and feasible technical approach to meeting 
the goals of this announcement in terms of workflow, resources, 
communications and reporting requirements for accomplishing work in 
each of the operational task areas, which HHS will evaluate as equally 
weighted sub-factors, as follows:
    Design and implementation of a recruitment program that identifies 
potential participants for training in epidemiology and laboratory 
procedures with specific focus on influenza and other acute respiratory 
infections;
    Work with HHS to design and implement a process that identifies 
local individuals who have experience, training or education relevant 
to conducting epidemiological surveys or laboratory procedures, 
recruits those individuals to participate in RIIP training, and creates 
a pool of highly qualified candidates for positions within the host-
country Ministries of Health or Agriculture;
    Design and implement a training program that assigns selected 
participants to work under the tutelage of senior RIIP scientists in 
support of ILI research, disease surveillance and public health 
activities;
    Train a minimum of one local person in epidemiology each year in 
each RIIP institute in Cambodia and Viet Nam (a total of four), and a 
minimum of one local person as a laboratorian skilled in influenza 
diagnostics each year in each RIIP institute in Cambodia and Viet Nam 
(a total of four);
    Provide real-time notification of possible outbreaks of influenza 
in humans or animals from any RIIP institute anywhere in the world, but 
especially from RIIP institutes in Southeast Asia and Africa, and 
submit notification to HHS, the WHO Secretariat and Regional Office, 
FAO, and OIE; and
    Provide enhanced reporting of ILI and animal influenza information 
through its worldwide network of institutions engaged with and linked 
to the WHO Global Outbreak Alert and Response Network (GOARN), the WHO 
Global Influenza Surveillance Network, and the relevant disease 
surveillance networks at the FAO and OIE.
Factor 2. Staffing and Management Plan. (30 Points)
    (a) Personnel. HHS will evaluate the relevant educational and/or 
work experience qualifications of key personnel, senior project staff, 
and subject-matter specialists to determine the extent to which they 
meet the requirements listed in this announcement.
    (b) Staffing Plan. HHS will evaluate the staffing plan to determine 
the extent to which the applicant's proposed organizational chart 
reflects proper staffing to accomplish the work described in this 
announcement, and the extent of the applicant's ability to recruit/
retain/replace personnel who have the knowledge, experience, local-
language skills, training and technical expertise to meet requirements 
of the positions.
Factor 3. Performance Measures (20 Points)
    HHS will evaluate the applicant's description of performance 
measures, including measures of effectiveness, to determine the extent 
to which the applicant proposes objective and quantitative measures 
that relate to the performance goals stated in the ``Purpose'' section 
of this announcement, including the goals of the President's National 
Strategy, and whether the proposed measures will accurately measure the 
intended outcomes.
Factor 4: Understanding of the Requirements (15 Points)
    HHS will evaluate the extent of the applicant's understanding of 
the operational tasks identified in this announcement to ensure 
successful performance of the work in this project. Because the focus 
of the work will be on countries in Southeast Asia and Africa, the 
applicant must demonstrate an understanding of the cultural, ethnic, 
political and economic factors that could affect successful 
implementation of this cooperative agreement.
    The applicant's proposal must also demonstrate understanding of the 
functions, capabilities and operating procedures of host-country 
Ministries of Health and Agriculture and international organizations 
such as the WHO and FAO, and describe the applicant's ability to work 
with and within those organizations. The applicant must also 
demonstrate an understanding of the U.S. National Strategy for Pandemic 
Influenza and a commitment to the principles of the International 
Partnership on Avian and Pandemic Influenza.
2. Review and Selection Process
    HHS/OPHEP will review applications for completeness. An incomplete 
application or an application that is non-responsive to the eligibility 
criteria will not advance through the review process. HHS will notify 
applicants if their applications did not meet submission requirements.
    An objective review panel, which could include both Federal 
employees and non-Federal members, will evaluate complete and 
responsive applications according to the criteria listed in the ``V.1. 
Criteria'' section above. The objective review process will follow the 
policy requirements as stated in the GPD 2.04

VI. Award Administration Information

1. Award Notices

    The successful applicant will receive a Notice of Award (NoA). The 
NoA shall be the only binding, authorizing document between the 
recipient and HHS. An authorized Grants Management Officer will sign 
the NoA, and mail it to the recipient fiscal officer identified in the 
application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

2. Administrative and National Policy Requirements

    A successful applicant must comply with the administrative 
requirements outlined in 45 CFR part 74 and part 92 as appropriate. The 
FY 2006 Appropriations Act requires that when issuing statements, press 
releases, requests for proposals, bid solicitations, and other 
documents describing projects or programs funded in whole or in part 
with Federal money, the issuance shall clearly state the percentage and 
dollar amount of the total costs of the program or project that will be 
financed with Federal money and the percentage and

[[Page 11670]]

dollar amount of the total costs of the project or program that will be 
financed by non-governmental sources.

3. Reporting Requirements

    The applicant must provide HHS with an original, plus two hard 
copies, as well as an electronic copy of the following reports in 
English:
    1. A quarterly progress report, due no less than 30 days after the 
end of each quarter of the budget period. The progress report for the 
third quarter of the year will serve as the non-competing continuation 
application. The quarterly progress report must contain the following 
elements:
    a. Activities and Objectives for the Current Budget Period;
    b. Financial Progress for the Current Budget Period;
    c. Proposed Activity Objectives for the New Budget Period;
    d. Budget;
    e. Measures of Effectiveness; and
    f. Additional Requested Information.
    2. An annual progress report, due 90 days after the end of the 
budget period, which must contain a detailed summary of the elements 
required in the quarterly progress report;
    3. Final performance reports, due no more than 90 days after the 
end of the project period; and
    4. A Financial Status Report (FSR) SF-269 is due 90 days after the 
close of each 12-month budget period.
    Recipients must mail the reports to the Grants Management 
Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    For program technical assistance, contact: Lily O. Engstrom, Senior 
Policy Advisor to the Assistant Secretary for Public Health Emergency 
Preparedness, Office of Public Health Emergency Preparedness, OS, HHS, 
Telephone: 202.205.4727, E-mail: lily.engstrom@hhs.gov.
    For financial, grants management, or budget assistance, contact: 
Grants Management Specialist, Office of Grants Management, Office of 
Public Health and Science, 11101 Wootten Parkway, Suite 550, Rockville, 
MD 20857, Telephone: (240) 453-8822, E-mail Address: 
kcampbell@osophs.dhhs.gov.

    Dated: March 2, 2006.
Stewart Simonson,
Assistant Secretary for Public Health Emergency Preparedness, 
Department of Health and Human Services.
 [FR Doc. E6-3251 Filed 3-7-06; 8:45 am]
BILLING CODE 4150-37-P
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