Grants and cooperative agreements; availability, etc.: Emerging infectious diseases in Asia-Pacific region; detection, monitoring, and response; training and capacity-building,

[Federal Register: October 2, 2006 (Volume 71, Number 190)]

[Notices]

[Page 57946-57955]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr02oc06-66]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Training and Capacity-Building for the Detection and Monitoring of, and Response to, Emerging Infectious Diseases in the Asia-Pacific Region

AGENCY: Office of Public Health Emergency Preparedness and the Office of Global Health Affairs, Office of the Secretary, DHHS.

ACTION: Notice.

Announcement Type: Single Eligibility--FY 2006 Initial Announcement.

Funding Opportunity Number: OGHA 05-019.

GSA Catalog of Federal Domestic Assistance: 93.283.

DATES: October 2, 2006.

Application Availability.

October 10, 2006.

Optional Letter of Intent due by 5 p.m. ET.

October 17, 2006--Applications due by 5 p.m. ET

October 27, 2006--Award date.

SUMMARY: The Office of Public Health Emergency Preparedness (OPHEP) and the Office of Global Health Affairs (OGHA) within the U.S. Department of Health and Human Services (HHS) announces that up to $2,100,000 in fiscal year (FY) 2006 funds is available for a cooperative agreement to provide support to develop a cadre of in-country trainers who can improve their ongoing hospital infection-control programs to achieve better adherence by health-care workers to infection-control and case- management principles and practices.

This effort is an undertaking by the Department of Health and Human Services (HHS). The project will be approved for up to a program period of three (3) years with a budget period of one-year for a total of $2,100,000.

Under certain circumstances especially in support of HHS International efforts, OGHA and OPHEP are required to collaborate on programs, issues and initiatives regarding international public health (i.e. Avian Influenza, disease surveillance, etc.). Normally, OGHA is often tasked as to devise, award, and administer international Federal assistance actions (grants, cooperative agreements, IAA's, etc.). When emergency preparedness issues are to be addressed as part of the program plan, OGHA partners with OPHEP to provide assistance in ensuring risks mitigation and emergency preparedness elements are included.

The Regional Emerging Diseases Intervention (REDI) Center in Singapore will design the program around mentorship principles so trainers can gain advice and support for their efforts in teaching infection-control and case-management practices in local languages.

While there is no current pandemic influenza outbreak, there is still reason to be concerned about the spread of the H5N1 virus from Southeast Asia to countries in Europe, the Middle East, and Africa. In the last century, three influenza pandemics have affected the United States, and viruses from birds contributed to all of them. Medical practitioners have also discovered several other, new, avian viruses human beings can transmit among one another. Although the H5N1 virus has primarily infected domesticated birds and long-range migratory birds, the virus has demonstrated the ability to infect and produce fatal illness in humans. Influenza experts believe an avian virus could become efficiently transmissible between humans, and result in a worldwide outbreak, which would overwhelm health and medical capabilities. Furthermore, an influenza pandemic could result in hundreds of thousands of deaths, millions of hospitalizations, and hundreds of billions of dollars in direct costs in the United States alone.

On November 1, 2005, President Bush announced the National Strategy on Pandemic Influenza, and the following day Secretary Michael O. Leavitt released the HHS Pandemic Influenza Plan. Building on these efforts, President Bush released the Implementation Plan for the National Strategy for Pandemic Influenza on May 3, 2006, which describes more than 300 critical actions to address the threat of pandemic influenza. All relevant Federal Departments and agencies must take steps to address the threat of avian and pandemic influenza. 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. HHS technical expertise in applied epidemiology, rapid laboratory diagnostics, infection control, virology research, vaccine delivery, and other areas is a critical component of both the domestic and the international

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response to the threat of pandemic influenza.

One of the primary objectives of both the National Strategy and the HHS Pandemic 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\ The U.S. cannot mount an effective response to an influenza pandemic without effective worldwide partnerships. As such, we are working bilaterally with partner countries, with multilateral organizations, and with private, non-profit organizations, to amplify our efforts. 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 could play a determining role in the severity of a pandemic. Pillars Two and Three of the National Strategy set out clear goals for ensuring the rapid reporting of outbreaks and containing outbreaks beyond the borders of the U.S. by taking the following actions:

\1\ National Strategy for Academic 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 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 with pandemic potential beyond the location where it is first located; and,

Providing guidance to all levels of Government in affected nations on the range of options for infection control and containment.

The International Partnership on Avian and Pandemic Influenza, launched by President Bush at the United Nations (UN) General Assembly in September 2005, stands in support of multinational organizations and National Governments. Members of the Partnership have agreed the following 10 principles will guide their efforts:

1. International cooperation to protect the lives and health of our people;

2. Timely, 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 viruses strains that have pandemic potential, to increase understanding and preparedness and 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 using, 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, that appropriate international and national resources can be brought to bear;

6. Prevent and contain an incipient epidemic through capacity- building and in-country collaboration with international partners;

7. Work in a manner complementary to and supportive of expanded cooperation with and appropriate support of key multilateral organizations (including the WHO, the UN Food and Agriculture Organization and the 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 domestics, and regional preparedness initiatives, and encouraging (where appropriate) the development of strategic regional initiatives; and,

10. Actions 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 for, detect, and respond to an influenza pandemic.

    An important international resource for minimizing the global impact of avian-influenza and human-influenza pandemics is the REDI Center. Announced in 2003 by President Bush and Singaporean Prime Minister Goh under the auspices of the Asia-Pacific Economic Cooperation forum, the REDI Center is an international organization based in Singapore and jointly supported by HHS and the Singaporean Ministry of Health. The primary goal of the REDI Center is to establish a regional outpost for the United States to improve the detection of and the response to new and emerging infectious diseases threats by strengthening regional capabilities. These goals are directly related to the goals of the President's National Strategy and the HHS Pandemic Plan. With funding from this grant, the REDI Center will help extend the perimeter of defense for emerging infectious diseases, such as the H5N1 strain of avian influenza; increase international collaborative research; and translate the findings of research into improved public health in the Asia-Pacific region.

    In direct support of the President's National Strategy, this grant will finance the REDI Center. Funding support for activities supported by the REDI Center is fully consistent with the international component of the Fiscal Year 2006 Pandemic Influenza Plan. One of the overarching goals of the National Strategy and the HHS Pandemic Plan is to stop, slow or limit the spread of disease. Early in a pandemic, before a vaccine is available, the ability to limit transmission and delay the spread of a pandemic will rely primarily on the appropriate and thorough application of infection-control measures in health-care facilities, the work place, and community and among individuals at home. The education and training of health-care workers in infection- control measures is imperative for both their protection and for limiting the transmission of virus.

    The Implementation Plan directs HHS to educate health-care workers in priority countries, and to provide guidance on the range of options for infection-control and containment. Current HHS infection-control guidance for influenza is based on our knowledge of the routes of influenza transmission, the pathogenesis of the virus, and the effects of influenza-control measures used for past pandemics and inter- pandemic periods. Infection-control precautions during patient care in health-care settings (e.g., hospitals, nursing homes, outpatient offices, emergency transport vehicles) also apply to health-care personnel who go into the homes of patients.

    Funding from this grant will focus on hospital infection-control training in Indonesia. As of August 22, 2006, 58

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    cases of human infection with the H5N1 avian influenza virus, of which 39 have been fatal. The H5N1 avian influenza virus is now endemic in poultry populations throughout Indonesia, and there continues to be close contact between humans and poultry across that country. A portion of the available funding will support an innovative, integrated animal and human disease-control and surveillance pilot project in Tangerang, jointly supported by the Governments of Singapore, Indonesia, and the United States.

    The National Strategy for Pandemic Influenza and the HHS Pandemic Influenza Strategic Plan are available at the following Internet address: http://www.pandemicflu.gov.

    1. Funding Opportunity Description

       Authority: Sections 301(a) and 307 of the Public Health Service Act (42 U.S.C. 241(a) and 42 U.S.C. 2421).

       Purpose of the Agreement

       Enhance cooperation between the United States, Singapore, and Indonesia, to support and increase influenza-preparedness;

       Provide assistance to the REDI Center for the expansion of in- country training programs in local languages in infection control and case management in Indonesia;

       Institute infection-control procedures in the approximately 40 infectious disease hospitals throughout Indonesia;

       Develop a cadre of Indonesian trainers who can train additional health-care workers, by designing and implementing courses in local languages that follow a train-the-trainer model;

       Provide support for a trilateral collaboration between the United States, Singapore, and Indonesia, on an innovative and integrated disease-control and surveillance pilot program in the Tangerang District of Indonesia.

       The program will encourage participants to assess the condition of their designated health-care facilities to handle large volumes of influenza patients and assess the effectiveness of their current training efforts and quality-assurance systems in hospital infection control. The goal is to develop a cadre of Indonesian trainers who can improve their ongoing hospital infection-control programs to achieve better adherence by health-care workers to infection-control and case- management principles and practices. The REDI Center will design the program around mentorship principles so trainers can gain advice and support for their efforts in teaching infection-control and case- management practices in local languages.

       Activities: Awardee activities for this program are as follows:

       Identify infectious-disease hospitals likely to receive influenza patients in Indonesia, and conduct needs assessments on current hospital infection-control and influenza case-management practices.

       Provide technical support and training for staff who are implementing in-country reviews of current hospital infection-control and influenza case-management practices in Indonesia.

       Develop and implement local-language training curricula and workshops by using a train-the-trainer model. Serve as an ongoing technical resource and mentor for trainers and health-care workers in Indonesia.

       Develop and implement demonstration projects and table-top exercises to complement classroom teaching.

       Providing support to epidemiological investigations and case management following confirmed human or animal influenza cases in Indonesia.

       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 HHS pursuant to the President's initiative on pandemic-influenza preparedness:

       To detect outbreaks in the Asia/Pacific region before they spread to the United States and around the world;

       To educate health-care workers in priority countries, and provide guidance on the range of options for infection-control and containment.

       To take immediate steps to ensure early warning of an avian influenza outbreak among animals or humans in affected regions; and

       To strengthen a new international partnership on avian influenza.

    2. Award Information

       The administrative and funding instrument for this program will be the cooperative agreement, in which HHS/OGHA will have scientific and/ or programmatic involvement is anticipated during the performance of the project. Under the cooperative agreement, HHS/OGHA will support and/or stimulate activities of the awardee by working with it in a non- directive partnership role. HHS staff is substantially involved in the program activities, above and beyond routine monitoring. Through this cooperative agreement, HHS will collaborate in an advisory capacity with the award recipient, especially during the development and implementation of a mutually agreed-upon work plan. HHS will actively participate in periodic progress reviews and in a final evaluation of the program.

       Approximately $2,100,000 in FY 2006 funds is available to support this agreement under the Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006 which provides funds to combat a potential influenza pandemic both domestically and internationally.

       The anticipated start date is October 27, 2006. There will only be one (1), single award made from this announcement. The program period is three (3) years for this agreement and the budget period is for 12 months.

       Although the financial plans of HHS/OGHA provide for this program, the award pursuant to this Request for Applications (RFA) is contingent upon the availability of funds for this purpose.

       The award recipient must comply with all HHS management requirements for meeting progress against milestones and for financial reporting for this cooperative agreement. (Please see HHS Activities and Program Evaluation sections below.)

       HHS/OGHA activities for this program are as follows:

       Organize an orientation meeting with the award recipient after the award is made to brief it on applicable U.S. Government expectations, regulations, policies and key management requirements, as well as report formats and contents.

       Review and approve the award recipient's annual work plan and detailed budget.

       Review and approve the award recipient's monitoring-and- evaluation plan.

       Conference on a monthly basis with the award recipient to assess monthly expenditures in relation to the approved work plan, and modify plans as necessary.

       Meet on an annual basis with the award recipient to review its annual progress report for each U.S. Government Fiscal Year, and to review annual work plans and budgets for the subsequent year.

       Assure experienced HHS or other subject-matter experts from other relevant U.S. Government Departments and agencies will participate in the planning, development, implementation, and evaluation of all phases of this project.

       Assist in establishing and maintaining U.S. Government, Singaporean and Indonesian

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       Governments, and non-governmental organizations (NGOs) contracts and agreements necessary to carry out the program.

       Program Evaluation Criteria: The application must have a comprehensive evaluation plan consistent with the scope, stated goals and objectives and funding level of the project. The evaluation plan should include both a process evaluation to track the implementation of project activities and outcome evaluation criteria.

       In addition to conducting internal evaluations, successful applicants must be prepared to participate in external evaluations supported by Singaporean and Indonesian Governments and HHS.

       In addition to routine communications with the Ministry of Health of Singapore and HHS within 30 days following the end of each quarter, the grantee will submit a written quarterly performance and financial status report of no more than ten pages in length to the Ministry of Health and HHS. At a minimum, quarterly performance reports will include the following:

       A concise summary of the most significant achievements and problems encountered during the reporting period, e.g. a comparison of work progress with objectives established for the quarter against the award recipient's implementation schedule. Where the awardee did not meet objectives were not met, the report must include a statement of cause and a summary of corrective actions.

       Specific action(s) HHS and/or the Singaporean and/or Indonesian Governments need to undertake to alleviate obstacles to progress.

       Other pertinent information that will permit oversight and evaluation of project operations.

       Within 90 days following the end of the project period the awardee must submit a final report that contain all required information and data to HHS and the Singaporean Ministry of Health. At minimum, the report will contain the following:

       A summary of the major activities supported under the grant; and the major accomplishments that resulted from activities to improve performance.

       An analysis of the project, based on the challenges described in the ``Background'' Section of the RFA performed prior to or during the project period, including a description of the specific objectives stated in the grant application and the accomplishments and failures that resulted from activities during the grant agreement period. Awardees should place emphasis on indicators and measures of operational efficiency and effectiveness.

    3. Eligibility Information

1. Eligible Applicants: This is a single-source, cooperative agreement with the Regional Emerging Diseases Intervention (REDI) Center for approximately a total of $2,100,000 in FY 2006 funds for a project period of three years with the anticipated start date of October 27, 2006. The REDI Center is a joint venture by the United States and the Republic of Singapore, announced under the auspices of the Asia-Pacific Economic Cooperation forum and incorporated in Singapore as an International Organization. Senior political and scientific leadership in the United States and Singapore, the World Health Organization, countries in the Asia-Pacific region, and other partners support the REDI center's objectives and mission. The REDI Center is specifically designed to serve as a base of training for regional public-health officials, researchers, clinicians and other health professionals, with an emphasis on the surveillance of and rapid response to emerging disease threats, such as a human pandemic influenza.

   There is no other organization in the Asia-Pacific region with the REDI Center's unique ability to serve as a regional center of excellence for influenza-related training in public health, biomedical research, and public-health emergency preparedness. The REDI Center is already working to catalyze regional collaboration in research into and surveillance of infectious diseases, including the H5N1 strain of avian influenza and other diseases directly relevant to the security of the United States and the Asia-Pacific region. The REDI Center is uniquely positioned to leverage existing networks, training infrastructure, and scientific expertise for influenza preparedness and response activities.

   The REDI Center has and will continue to carry out activities in Southeast Asia of high relevance to the U.S. Government's planning and preparedness for a potential human influenza pandemic. The REDI Center is organizing in-country training of hospital workers throughout Southeast Asia in infection control and case management of influenza, has organized training courses in infectious disease epidemiology and in public-health emergency preparedness for trainees from throughout the region, and has as facilitated international research collaborations in influenza and related illnesses. The REDI Center has demonstrated experience in organizing committees of world-renowned infectious-disease experts from HHS, Singaporean centers of excellence, and other leading public-health and medical-research institutions.

2. Cost-Sharing or Matching: Although cost-sharing, matching funds, and cost participation are not a requirement of this agreement, preference may go to organizations that can leverage additional funds to contribute to program goals. If applicants receive funding from other sources to underwrite the same or similar activities, or anticipate receiving such funding in the next 12 months, they must detail how the disparate streams of financing complement each other.

3. Other--(If Applicable): If an applicant requests a funding amount greater than the ceiling of the award range, HHS will consider the application non-responsive, and it will not enter into the review process. HHS will notify the applicant that the application did not meet the submission requirements.

   4. Application and Submission Information

1. Address to Request Application Package:

   This Cooperative Agreement project uses the Application Form HHS/ OPHS-1, Revised 8/2004, enclosed in the application packet. Many different programs funded through the HHS Public Health Service (PHS) use this generic form. Some parts of it are not required; applicants must fill out other sections in a fashion specific to the program. Instructions for filling out HHS OPHS-1, Revised 8/2004 will accompany the application packet. Applicants may also obtain these forms by downloading them from the following Internet address: https://egrants.osophs.dhhs.gov and clicking on Grant Announcements; from

   http://www.grants.gov/; or by writing to Ms. Karen Campbell, Director,

   Office of Grants Management, Office of Public Health and Science, U.S. Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Suite 550, Rockville, MD 20852; or contact the HHS/OPHS/Office of Grants Management, at (240) 453-8822. Please specify the HHS/OGHA program(s) for which you are requesting an application kit.

   ADDRESSES: Application kits may be requested from, and submit to: Ms. Karen Campbell, Director, Office of Grants Management, Office of Public Health and Science, Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Suite 550, Rockville, MD 20852.

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2. Content and Form of Application Submission:

   Application Materials:

   A separate budget page is required for each budget year. Applicant must submit with their proposal a line-item budget (SF 424A) with coinciding justification to support each of the budget years. These forms will represent the full project period of Federal assistance requested. HHS/OGHA will reject proposals submitted without a budget and justification for each budget year requested in the application.

   All applicants must include in their applications by a Project Abstract, submitted on a 3.5-inch floppy disk. The abstract must be typed, single-spaced, and not exceed two pages. Reviewers and staff will refer frequently to the information contained in the abstract, and therefore it should contain substantive information about the proposed projects in summary form. A list of suggested keywords and a format sheet for your use in preparing the abstract will accompany the application packet.

   All applicants must include a Project Narrative in their grant applications. Format requirements are the same as for the ``Project Abstract'' Section; margins should be one-inch at the top and one-inch at the bottom and both sides; and typeset must be no smaller than 12 cpi, unreduced. Applicants should type biographical sketches either on the appropriate form or on plain paper and they should not exceed two pages; list only with publications directly relevant to this project.

   Application Format Requirements

   If an applicant is applying on paper, the entire application may not exceed 80 pages in length, including the abstract, project and budget narratives, face page, attachments, any appendices and letters of commitment and support. Applicants must number pages consecutively. a. Number of Copies

   If submitting in hard-copy, please submit one (1) original and two (2) unbound copies of the application. Please do not bind or staple the application. Application must be single-sided. b. Font

   Please use an easily readable serif typeface, such as Times Roman, Courier, or CG Times. Applicants must submit the text and table portions of the application in not less than 12-point and 1.0 line spacing. HHS/OGHA will return applications that do not adhere to 12- point font requirements. c. Paper Size and Margins

   For scanning purposes, please submit the application on 8\1/2\ x 11 white paper. Margins must be at least one (1) inch at the top, bottom, left and right of the paper. Please left-align text. d. Numbering

   Please number the pages of the application sequentially from page one (face page) to the end of the application, including charts, figures, tables, and appendices. e. Names

   Please include the name of the applicant on each page. f. Section Headings

   Please put all section headings flush left in bold type.

   Application Format: An application for funding must consist of the following documents, in the following order:

   i. Application Face Page. HHS/PHS Application Form HHS/OPHS-1, provided with the application package. Prepare this page according to instructions provided in the form itself.

   DUNS Number

   An applicant organization must have a Data Universal Numbering System (DUNS) number to apply for a grant from the Federal Government. The DUNS number is a unique, nine-character identification number provided by the commercial company Dun and Bradstreet. There is no charge to obtain a DUNS number. Information about obtaining a DUNS number is available at the following Internet address: https://www.dnb.com/product/eupdate/requestOptions.html or by calling 1-866-

   705-5711. Please include the DUNS number next to the Office of Management and Budget (OMB) Approval Number on the application face page. HHS/OGHA will not review an application that does not have a DUNS number.

   Additionally, the applicant organization must register with the Federal Government's Central Contractor Registry (CCR) to do electronic business with the Federal Government. Information about registering with the CCR is available at the following Internet address: http://www.hrsa.gov/grants/ccr.htm .

   Finally, applicants that are applying electronically through Grants.gov must register with the Credential Provider for Grants.gov. Information about this requirement is available at the following Internet address: http://www.grants.gov/CredentialProvider.

   Applicants that are applying electronically through the HHS/OPHS E- Grants System must register with the provider. Information about this requirement is available at the following Internet address: https://egrants.osophs.dhhs.gov .

   ii. Table of Contents. Provide a Table of Contents for the remainder of the application (including appendices), with page numbers.

   iii. Application Checklist. Application Form HHS/OPHS-1, provided with the application package.

   iv. Budget. Application Form HHS/OPHS-1, provided with the application package.

   v. Budget Justification. Applicants must enter the amount of financial support (direct costs) they are requesting from the Federal granting agency for the first year on the Face Sheet of Application Form HHS/PHS 5161-1, Line 15a. The application should include funds for electronic-mail capability, unless access to the Internet is already available. The amount of financial support (direct costs) entered on the SF 424 is the amount an applicant is requesting from the Federal granting agency for the project year.

   Personnel Costs: Applicants should explain their personnel costs by listing each staff member supported from Federal funds, name (if possible), position title, percent full-time equivalency, annual salary, and the exact amount requested.

   Fringe Benefits: List the components that comprise the fringe benefit rate, for example, health insurance, taxes, unemployment insurance, life insurance, retirement plan, and tuition reimbursement. The fringe benefits should be directly proportional to that portion of personnel costs allocated for the project.

   Travel: Applicants must list travel costs according to local and long-distance travel. For local travel, the applicants should outline the mileage rate, number of miles, reason for the travel and the staff member/consumers who will be completing the travel. The budget should also reflect the travel expenses associated with participating in meetings and other proposed training or workshops.

   Equipment: Applicants must list equipment costs, and provide justification for the need of the equipment to carry out the program's goals. Applicants must provide an extensive justification and a detailed status of current equipment when they request funds for the purchase of computers and furniture items.

   Supplies: Applicants must list the items the project will use. In this

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   category, separate office supplies from medical and educational purchases. ``Office supplies'' could include paper, pencils, and the like; ``medical supplies'' are syringes, blood tubes, plastic gloves, etc., and ``educational supplies'' can be pamphlets and educational videotapes. Applicants must list these categories separately.

   Subcontracts: To the extent possible, applicants should standardize all subcontract budgets and justifications, and should present contract budgets by using the same object-class categories contained in the Standard Form 424A. Applicants must provide a clear explanation as to the purpose of each contract, how organization estimated the costs, and the specific contract deliverables.

   Other: Applicants must put all costs that do not fit into any other category into this category, and provide an explanation of each cost in this category. In some cases, grantee rent, utilities and insurance fall under this category if they are not included in an approved indirect cost rate.)

   vi. Staffing Plan and Personnel Requirements. Applicants must present a staffing plan, and provide a justification for the plan that includes education and experience qualifications and the rationale for the amount of time being requested for each staff position. Applicants must include in Appendix B position descriptions that include the roles, responsibilities, and qualifications of proposed project staff. Applicants must include in Appendix C copies of biographical sketches for any key employed personnel that will be assigned to work on the proposed project.

   vii. Project Abstract. Applicants must provide a summary of the application. Because HHS/OGHA often distributes the abstract to provide information to the American public and to the U.S. Congress, applicants should prepare this so it is clear, accurate, concise, and without reference to other parts of the application. It must include a brief description of the proposed grant project, including the needs addressed, the proposed work, and the population group(s) served.

   Applicants must place the following at the top of the abstract:

   Project Title;

   Applicant Name;

   Address;

   Contact Phone Numbers (Voice, Fax);

   E-Mail Address; and

   Web Site Address, if applicable

   The project abstract must be single-spaced and limited to two pages in length.

   viii. Program Narrative. This section provides a comprehensive framework and description of all aspects of the proposed program. It should be succinct, self-explanatory and well-organized, so reviewers can understand the proposed project.

   Applicants should use the following section headers for the Narrative:

   Introduction

   This section should briefly describe the purpose of the proposed project.

   Work Plan

   Applicants should describe the activities or steps to achieve each of the activities proposed in the methodology section and use a time line that includes each activity and identifies responsible staff.

   Resolution of Challenges

   Applicants should discuss likely challenges in designing and implementing the activities described in the Work Plan, and approaches to resolve such challenges.

   Evaluation and Technical Support Capacity

   Applicants should describe their current experience, skills, and knowledge, including individuals on staff, materials published, and previous work of a similar nature.

   Organizational Information

   Applicants should provide information on their current mission and structure, scope of current activities, and an organizational chart, and describe how these all contribute to the ability of the organization to conduct the program requirements and meet program expectations.

   ix. Appendices. Applicants must provide the following items to complete the content of their application(s). Please note that these are supplementary in nature, and are not a continuation of the project narrative. Applicants should label each appendix clearly.

   (1) Appendix A: Tables, Charts, etc.

   To give further details about the proposal.

   (2) Appendix B: Job Descriptions for Key Personnel

   Applicants should keep each to one page in length as much as possible. Item 6 in the Program Narrative Section of the HHS/PHS 5161-1 Form provides some guidance on items to include in a job description.

   (3) Appendix C: Biographical Sketches of Key Personnel

   Applicants should include biographical sketches for persons who are occupying the key positions described in Appendix B, not to exceed two pages in length. In the event an applicant includes a biographical sketch for an identified individual who is not yet hired, it must include a letter of commitment from that person with the biographical sketch.

   (4) Appendix D: Letters of Agreement and/or Description(s) of Proposed/Existing Contracts (project specific). Applicants must provide any documents that describe working relationships between the applicant agency and other agencies and programs cited in the proposal. Documents that confirm actual or pending contractual agreements should clearly describe the roles of the subcontractors and any deliverable. Letters of agreement must be dated.

   (5) Appendix E: Organizational Chart for the Project. Applicants must provide a one-page figure that depicts the organizational structure of the project, including subcontractors and other significant collaborators.

   (6) Appendix F: Other Relevant Documents. Applicants should include here any other documents relevant to the application, including letters of support. Letters of support must be dated.

3. Submission Dates and Times: Application Submission.

   HHS/OPHS provides multiple mechanisms for the submission of applications, as described in the following sections. Applicants will receive notification via mail from the HHS/OPHS Office of Grants Management to confirm receipt of applications submitted by using any of these mechanisms. The HHS/OPHS Office of Grants Management will not accept for review applications submitted after the deadlines described below. HHS will not accept for review applications that do not conform to the requirements of the grant announcement and will return them to the applicant.

   Applicants may only submit electronically via the electronic submission mechanisms specified below. HHS will accept for review any applications submitted via any other means of electronic communication, including facsimile or electronic mail. While HHS will accept applications in hard copy, we encourage the use of the electronic application submission capabilities provided by the HHS/OPHS eGrants system or the Grants.gov Web site Portal.

   Applicants must submit electronic grant application submissions no later than 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement using one of the electronic submission mechanisms specified below. The HHS/OPHS Office of Grants Management must receive all required hardcopy original signatures and mail-in items no

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   later than 5 p.m. Eastern Time on the next business day after the deadline date specified in the DATES section of the announcement.

   HHS will not consider applications valid until the HHS/OPHS Office of Grants Management has received all electronic application components, hard-copy original signatures, and mail-in items according to the deadlines specified above. HHS will consider application submissions that do not adhere to the due date requirements and will deem them ineligible.

   Applicants should initiate electronic applications early in the application development process and should submit early on the due date or before to aid in addressing any problems with submissions prior to the application deadline.

   Electronic Submissions via the Grants.gov Web site Portal. The Grants.gov Web site Portal provides organizations with the ability to submit applications for HHS 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 at the following Internet address: 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. Applicants must review both the grant announcement, as well as the application guidance provided within the Grants.gov application package, to determine such requirements. Applicants must submit any required hard-copy materials, or documents that require a signature, separately via mail to the HHS/OPHS Office of Grants Management, which, if required, must contain the original signature of an individual authorized to act for the applicant agency and the obligations imposed by the terms and conditions of the grant 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. HHS must receive all required mail-in items by the due date requirements specified above. Mail-in items may only include publications, r[eacute]sum[eacute]s, or organizational documentation.

   Upon completion of a successful electronic application submission via the Grants.gov Web site Portal the applicant will receive a confirmation page from Grants.gov to indicate the date and time (Eastern Time) of the electronic application submission, as well as the Grants.gov Receipt Number. Applicants must print and retain this confirmation for their records, as well as a copy of the entire application package.

   Grants.gov will validate all applications submitted via the Grants.gov Web site Portal. Any applications deemed ``Invalid'' by the Grants.gov Web site Portal will not proceed to the HHS/OPHS eGrants system, and HHS/OPHS has no responsibility for any application that is not validated and transferred to HHS/OPHS from the Grants.gov Web site Portal. Grants.gov will notify the applicant regarding the application validation status. Once the Grants.gov Web site Portal has successfully validated the application, applicants should immediately mail all required hard-copy materials to the HHS/OPHS Office of Grants Management by the deadlines specified above. Applicants must clearly identify their Organization's name and Grants.gov Application Receipt Number on all hard-copy materials.

   Once the Grants.gov has validated an application, it will electronically proceed to the HHS/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 HHS/OPHS Office of Grants Management to confirm the receipt of the application submitted by using the Grants.gov Web site Portal.

   Applicants should contact Grants.gov regarding any questions or concerns regarding the electronic application process conducted through the Grants.gov Web site Portal.

   Electronic Submissions via the HHS/OPHS eGrants System. The HHS/ OPHS electronic grants management system, eGrants, provides for applications to be submitted electronically. Information about this system is available on the HHS/OPHS eGrants Web site, https://egrants.osophs.dhhs.gov , or may be requested from the HHS/OPHS Office

   of Grants Management at (240) 453-8822.

   When submitting applications via the HHS/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 HHS/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 send to the HHS/OPHS Office of Grants Management separate from the electronic submission; however, applicants must enter these mail-in items on the eGrants Application Checklist at the time of electronic submission, and HHS must receive them 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 HHS/OPHS eGrants system will provide the applicant with a confirmation page to indicate 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 HHS/OPHS Office of Grants Management, to which applicants must submit all required hard copy materials.

   As items the HHS/OPHS Office of Grants Management receives items, the electronic application status will be updated to reflect the receipt of mail-in items. We recommend applicants monitor the status of their applications in the HHS/OPHS eGrants system to ensure that the receipt of all signatures and mail-in items.

   Mailed or Hand-Delivered Hard-Copy Applications. Applicants who submit applications in hard copy (via mail or hand-delivered) must submit an original and two copies of the application. 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 must sign the original application.

   HHS will consider mailed or hand-delivered applications as having met the deadline if the HHS/OPHS Office of Grant Management receives them on or before 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement. The application deadline date requirement specified in this announcement supersedes the instructions in the HHS/OPHS-1. HHS will return unread

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   applications that do not meet the deadline.

   Applicants should submit their applications to the following address: Director, Office of Grants Management, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootten Parkway, Suite 550, Rockville, MD 20852

4. Intergovernmental Review: This program is not subject to the review requirements of Executive Order 12372, Intergovernmental Review of Federal Programs.

5. Funding Restrictions: Allowability, allocability, reasonableness, and necessity of direct costs applicants may charge appear in the following documents: OMB-21 (Institutes of Higher Education); OMB Circular A-122 (Nonprofit Organizations); and 45 CFR part 74, Appendix E (Hospitals). Copies of these circulars are available at the following Internet address: http://www.whitehouse.gov/omb. No pre-award costs are allowed.

6. Other Submission Requirements: N/A.

   5. Application Review Information

1. Criteria: HHS/OGHA staff will screen applications for completeness and for responsiveness to the program guidance. Applicant should pay strict attention to addressing these criteria, as they are the basis upon which the application will be judged. An application judged to be non-responsive or incomplete will be returned to the applicant without review.

   An application that is complete and responsive to the guidance will undergo an evaluation for scientific and technical merit by an appropriate peer-review group specifically convened for this solicitation and in accordance with HHS policies and procedures. The panel may contain both Federal and non-Federal representatives. As part of the initial merit review, the application will receive a written critique. The ad hoc peer review group will discuss fully all applications recommended for approval and will assign a priority score for funding. HHS/OGHA will assess an eligible application according the following criteria:

   (1) Technical Approach (40 points):

   The applicant's presentation of a sound and practical technical approach for executing the requirements with adequate explanation, substantiation and justification for methods for handling the projected needs of Indonesian health-care institutions.

   The successful applicant must demonstrate a clear understanding of the scope and objectives of the President's National Strategy and Implementation Plan and the HHS Pandemic Influenza Plan, a recognition of potential difficulties that could arise in performing the work required, and an understanding of the close coordination necessary between the Singaporean and Indonesian Governments, the U.S. Agency for International Development, and other organizations, such as the World Health Organization and the United Nations Children's Fund.

   Applicants must submit a strategic plan that outlines the schedule of activities and expected products of the Group's work, with benchmarks at months six and 12.

   (2) Personnel Qualifications and Experience (20 points):

   Project Leadership--For the technical and administrative leadership of the project requirements, successful applicants must demonstrate documented training, expertise, relevant experiences, local-language skills, leadership/management skills, and the availability of a suitable overall project manager and surrounding management structure to successfully plan and manage the project. The successful applicant will provide documented history of leadership in the establishment and management of training programs that involve training of health care professionals in countries other than the United States. Applicants should show documented managerial ability to achieve delivery or performance requirements as demonstrated by the proposed use of management and other personnel resources and to successfully manage the project, including subcontractor and/or consultant efforts, if applicable, as evidenced by the management plan and demonstrated by previous relevant experience.

   Partner Institutions and other Personnel-Applicants should provide documented evidence of the availability, training, qualifications, expertise, relevant experience, local-language skills, education and competence of the scientific, clinical, analytical, technical and administrative staff and any other proposed personnel (including from partner institutions, subcontractors and consultants), to perform the requirements of the work activities, as evidenced by r[eacute]sum[eacute]s, endorsements and explanations of previous efforts.

   Staffing Plan--Applicants should submit a staffing plan for the conduct of the project, including the appropriateness of the time commitment of all staff and partner institutions, the clarity and appropriateness of assigned roles, and lines of authority. Applicants should also provide an organizational chart for each partner institution named in the application to show the relationships among the key personnel.

   Administrative and Organizational Framework--Applicants must demonstrate the adequacy of their administrative and organizational framework, with lines of authority and responsibility clearly drawn, and the adequacy of the project plan, with a proposed time schedule for achieving the objectives and maintaining quality control over the implementation and operation of the project. Applicants must show the adequacy of back-up staffing and the evidence they will be able to function as a team. The framework should identify the institution that will assume legal and financial responsibility and accountability for the use and disposition of funds awarded on the basis of this RFA.

   (3) Experience and Capabilities of the Organization (30 Points):

   Applicants should submit documented relevant experience of their organization in managing projects of similar complexity and scope of activities in the developing world.

   Applicants should show the clarity and appropriateness of their lines of communication and authority for coordination and management of the project. Adequacy and feasibility of plans to ensure successful coordination of multiple-partner collaboration.

   Applicants must document their experience in recruiting qualified medical personnel for projects of similar complexity and scope in the developing world.

   (4) Facilities and Resources (10 Points):

   Applicants must document the availability and adequacy of facilities, equipment and resources necessary to carry out the activities specified under the ``Program Requirements'' Section of the announcement.

2. Review and Selection Process:

   A panel of peer reviewers will review the application. The reviewers will address and consider each of the above criteria will in assigning the overall score. The Deputy Director for Operations of the HHS/Office of Global Health Affairs will make the award on the basis of score, program relevance, and availability of funds.

   6. Award Administration Information

1. Award Notices: HHS/OGHA does not release information about individual applications during the review process until it has made final funding decisions. When HHS/OGHA has made these decisions, it will notify applicants by letter regarding the outcome of their

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   applications. The official document to notify an applicant HHS has approved and funded an application is the Notice of Award, which specifies to the awardee the amount of money awarded, the purpose of the agreement, the terms and conditions of the agreement, and the amount of funding, if any, by the awardee will contribute to the project costs.

2. Administrative and National Policy Requirements:

   The regulations set out at 45 CFR parts 74 and 92 are the HHS rules and requirements that govern the administration of grants. Part 74 is applicable to all recipients, except those covered by part 92, which governs awards to U.S. State and local Governments. Applicants funded under this announcement must be aware of and comply with these regulations. The CFR volume that includes parts 74 and 92 is available at the following Internet address: http://www.access.gpo.gov/nara/cfr/waisidx_03/45cfrv1_03.html .

3. Reporting: The projects must have an evaluation plan, consistent with the scope of the proposed project and funding level, that conforms to the project's stated goals and objectives. The evaluation plan should include both a process evaluation to track the implementation of project activities, and an outcome evaluation to measure changes in knowledge and skills attributable to the project. Project funds may support evaluation activities.

   In addition to conducting its own evaluation of projects, the successful applicant must be prepared to participate in an external evaluation, supported by HHS/OGHA and conducted by an independent entity, to assess the efficiency and effectiveness of the project funded under this announcement.

   Within 30 days following the end of each of quarter, awardees must submit a performance report no more than ten pages in length to HHS/ OGHA. HHS/OGHA will forward a sample monthly performance report will be provided at the time of notification of award. At a minimum, monthly performance reports should include the following:

   A concise summary of the most significant achievements and problems encountered during the reporting period, e.g., number of training courses held and number of trainees.

   A comparison of work progress with objectives established against the quarter using the grantee's implementation schedule, and where the grantee did not meet such objectives, a statement of why.

   Specific action(s) the grantee would like HHS/OGHA to undertake to alleviate a problem.

   Other pertinent information that will permit the monitoring and oversight of project operations.

   A quarterly financial report to describe the current financial status of the funds used under this award. The awardee and HHS/OGHA will agree at the time of award on the format of this portion of the report.

   Within 90 days following the end of the project period, the awardee must submit a final report containing information and data of interest to HHS, the U.S. Congress, and other countries. HHS/OGHA will send to successful applicants the specifics as to the format and content of the final report and the summary. At minimum, the report should contain the following:

   A summary of the major activities supported under the agreement and the major accomplishments resulting from activities to improve influenza preparedness in Indonesia.

   An analysis of the project based on the problem(s) described in the application and needs assessments, performed prior to or during the project period, including a description of the specific objectives stated in the grant application and the accomplishments and failures resulting from activities during the grant period.

   Awardees must submit quarterly performance reports and the final report may be submitted to: Mr. Dewayne Wynn, Grants Management Specialist, Office of Grants Management, HHS/OPHS, 1101 Wootton Parkway, Suite 550, Rockville, MD 20852, phone +1 (240) 453-8822.

   A Financial Status Report (FSR) SF-269 is due 90 days after the close of each 12-month budget period to HHS/OPHS Office of Grants Management.

   7. Agency Contacts

      For assistance on administrative and budgetary requirements, please contact: Mr. DeWayne Wynn, Grants Management Specialist, Office of Grants Management, HHS/OPHS, 1101 Wootton Parkway, Suite 550, Rockville, MD 20852, phone +1 (240) 453-8822.

      For assistance with questions regarding program requirements, please contact:Amar Bhat, PhD, Director, Office of Asia and the PacificOffice of Global Health Affairs,U.S. Department of Health and Human Services,5600 Fishers Lane, Suite 18-101,Rockville, MD 20857,Phone Number: 301-443-1774.

   8. Tips for Writing a Strong Application

      Include DUNS Number. You must include a DUNS Number to have your application reviewed. HHS will not review applications without a DUNS number. To obtain a DUNS number, go to http://www.dunandbradstreet.com or call

      1-866-705-5711. Please include the DUNS number next to the OMB Approval Number on the application face page.

      Keep your audience in mind. Reviewers will use only the information contained in the application to assess the application. Please be sure the application and responses to the program requirements and expectations are complete and clearly written. Do not assume reviewers are familiar with the applicant organization. Keep the review criteria in mind when writing the application.

      Start preparing the application early. Allow plenty of time to gather required information from various sources.

      Follow the instructions in this guidance carefully. Place all information in the order requested in the guidance. If you do not place the information in the requested order, you could receive a lower score.

      Be brief, concise, and clear. Make your points understandable. Provide accurate and honest information, including candid accounts of problems and realistic plans to address them. If you are omitting any required information or data, explain why. Make sure the information provided in each table, chart, attachment, etc., is consistent with the proposal narrative and information in other tables.

      Be organized and logical. Many applications fail to receive a high score because the reviewers cannot follow the thought process of the applicant, or because parts of the application do not fit together.

      Be careful in the use of appendices. Do not use the appendices for information required in the body of the application. Be sure to cross- reference all tables and attachments located in the appendices to the appropriate text in the application.

      Carefully proofread the application. Misspellings and grammatical errors will impede reviewers in understanding the application. Be sure pages are numbered (including appendices), and you follow page limits. Limit the use of abbreviations and acronyms, and define each one at its first use and periodically throughout application.

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      Dated: September 26, 2006. Sandra R. Manning, Deputy Director for Operations,Office of Global Health Affairs,U.S. Department of Health and Human Services.

      [FR Doc. E6-16178 Filed 9-29-06; 8:45 am]

      BILLING CODE 4150-38-P