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

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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, 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.

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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.

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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 Start Printed Page 11662ducks 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 http://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:

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 Start Printed Page 11663Human 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

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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:

End Authority

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; Start Printed 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 Start Printed Page 11665Influenza 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:

ActivityCurrent year fundingYear 2 fundingYear 3 fundingTotal funding per activity
Enhanced communications (matching funds)$200,000$200,000
Maintenance of communications systems (matching funds)10,000$10,000$10,00030,000
Security and biosecurity enhancements (matching funds)50,00050,000
International biosafety/biosecurity technical advisor (matching funds)100,000100,000200,000
Enhancement of laboratory capacity at IPC435,000435,000
Virology laboratory training85,00085,000
H5N1 avian influenza animal and human surveillance (including virology technical advisor for Laos)225,000175,000175,000575,000
Enhancement of laboratory diagnostic capabilities in African nations (matching funds)250,000250,000250,000750,000
Grand Total1,455,000635,000535,0002,625,000

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 Start Printed Page 11666to 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 Start Printed Page 11667and 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. Start Printed 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, http://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 Start Printed Page 11669firm 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 Start Printed Page 11670dollar 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.

Start Signature

Dated: March 2, 2006.

Stewart Simonson,

Assistant Secretary for Public Health Emergency Preparedness, Department of Health and Human Services.

End Signature End Supplemental Information

Footnotes

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

Back to Citation

[FR Doc. E6-3251 Filed 3-7-06; 8:45 am]

BILLING CODE 4150-37-P