[Federal Register Volume 71, Number 190 (Monday, October 2, 2006)]
[Notices]
[Pages 57955-57966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Surveillance and Response to Highly Pathogenic Avian and Pandemic 
Influenza in the Libyan Arab Jamahiriya

AGENCY: Office of Global Health Affairs, Office of the Secretary, DHHS.

ACTION: Notice.

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    Announcement Type: Single Eligibility--FY 2006 Initial 
Announcement.
    Funding Opportunity Number: OGHA 06-025.
    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: Application due by 5 p.m. ET.
    October 27, 2006: Award date.

SUMMARY: An influenza pandemic has greater potential than any other 
naturally occurring infectious disease to cause large and rapid global 
and domestic increases in death and serious illness. Preparedness is 
the key to substantially reducing the health, social, and economic 
impacts of an influenza pandemic and other public-health emergencies.
    On November 1, 2005, President George W. Bush announced the U.S. 
National Strategy for Pandemic Influenza and the following day, 
Secretary Michael O. Leavitt released the HHS Pandemic Influenza Plan. 
One of the primary objectives of both documents 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 the clear goals of ensuring the rapid 
reporting of outbreaks and containing outbreaks beyond the borders of 
the United States, by taking the following actions:
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    \1\ National Stragegy for Pandemic Influenza, p. 2.
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     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 
the rapid reporting of highly pathogenic avian and human influenza 
cases;
     Supporting the development of the proper scientific and 
epidemiological expertise in affected regions to ensure the early 
recognition of changes in the pattern of highly pathogenic avian or 
human influenza outbreaks;
     Supporting the development and maintenance 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 containment efforts, that 
is, actions to limit the spread of an influenza with pandemic potential 
beyond where it is first located; and,
     Providing guidance to all levels of Government in affected 
nations on the range of options for risk-communication, infection-
control, and containment.
    We rely upon our international partnerships, with the United 
Nations (UN); international organizations; and private and non-profit 
organizations, to amplify our efforts, and will engage them on 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 
could play a determining role in the severity of a pandemic.
    The International Partnership on Avian and Pandemic Influenza, 
launched by President Bush at the UN General Assembly in September 
2005, stands in support of multinational organizations and national 
Governments. Members of the Partnership have agreed that the following 
ten 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, 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, so 
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 WHO, 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 domestic 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.
    Following the President's National Strategy, this announcement 
seeks to support selected foreign Governments through their Ministries 
of Health or other responsible Ministries for human-health or public-
health emergency preparedness.
    Proposals may only include program elements that fall within 
designated areas under the Three Pillars of the U.S. National Strategy 
assigned to the U.S. Department of Health and Human Services (HHS) as 
described below. This support is meant to enhance, and not to supplant, 
current influenza-surveillance activities. Proposals should build upon 
infrastructure already in place. Preference will go to countries with 
limited resources, where influenza surveillance is not well-
established, and

[[Page 57956]]

which have experienced outbreaks of H5N1 influenza in animals or humans 
or are judged at-risk of such outbreaks by HHS and the WHO Secretariat. 
Only the Ministry of Health of the Great Socialist People's Libyan Arab 
Jamahiriya is eligible under this announcement.
    The term ``containment'' as used in this announcement, warrants 
special consideration. ``Containment'' here refers to efforts to 
control the emergence of a new influenza virus with pandemic potential 
and high pathogenicity that is, a new influenza strain efficiently 
transmitted among humans and causes severe disease in a high proportion 
of infected persons. The goal of containment would be to identify the 
first outbreak with such a strain, and to apply a coordinated, 
integrated, intensive public-health response to interrupt transmission 
among humans. (Severe Acute Respiratory Syndrome, for example, was 
ultimately contained after it spread to a number of countries.) A 
principle intent of this announcement is to assist partner countries to 
build capacity for identification, investigation and containment of 
such a strain.

Pillar I. Preparedness and Communication

    1. National Government Public-Health Preparedness Plans, Policy, 
and Coordination; and,
    2. Communications:
    (a) Targeting health care workers (HCW); and,
    (b) National Government spokespersons and risk messages.

Pillar II. Surveillance and Detection

    1. Laboratory capacity and infrastructure for virologic 
surveillance;
    2. Epidemiology capacity and infrastructure for disease 
surveillance;
    3. Sentinel, laboratory-based surveillance for influenza-like 
illness (ILI) and/or hospital-based surveillance for severe disease; 
development or enhancement of an in-country integrated (lab and epi) 
surveillance network for influenza; and
    4. Comprehensive, territory-wide surveillance for cases and 
clusters of suspicious respiratory and febrile illness that could 
represent emerging new pandemics.

    Note: Components 3 and 4 have distinct operational requirements, 
but awardees must fully integrate them into one overall, multi-
disciplinary surveillance network for influenza.

Pillar III. Response and Containment

    1. Local rapid-response teams; and,
    2. Infection control in public health-care settings.

Pillar One

    Pandemic influenza presents a massive communications challenge to 
all levels of a nation's Government as well as its society, economy, 
and critical infrastructure. The uncertainty of the course of a 
pandemic and unknown scientific factors, as well as unforeseen and 
unintended outcomes with respect to Governmental actions and statements 
make this a communications-management issue of formidable proportion. 
The economic and societal effects of such a pandemic could have a 
significant detrimental impact on a nation and its people.
    A critical component of national preparedness for an influenza 
pandemic is informing the public about this potential threat and 
providing a solid foundation of information upon which to base future 
actions. To be effective, Governments should base these strategies on 
scientifically derived risk-communications principles that are critical 
before, during, and after an influenza pandemic. Effective 
communication guides the public, the news media, health-care providers, 
and other groups in responding appropriately to outbreak situations and 
adhering to public-health measures. These guidelines must be an 
integral part of a national pandemic plan as developed and coordinated 
by a nation's appropriate agencies, such as Ministries of Health, 
Agriculture, Trade, Information, and Tourism.
    Public-health and health-care workers will be the first to observe 
and report suspicious clusters of respiratory disease, and could also 
be the most trusted resources of information for the populations they 
serve. Therefore, these audiences must be a specific target for health-
communications marketing and strategy. Communication strategies should 
include formative evaluation, message development and testing, and 
summative evaluation.
    In addition, these critical audiences will be integral to any 
national response. Yet, worksite restrictions may hamper efforts to 
receive and provide validated up-to-date information (lack of 
computers, Internet access, quarantining, etc.). A mechanism for the 
rapid dissemination of information both to national and District or 
Provincial health-response units and international partners is 
necessary.
    To build trust and assure that information flows through common 
channels of communication, coordination of media messages, training of 
journalists and development of credible national Government 
spokespeople is also recommended.

Pillar Two

    One component of pandemic preparedness involves understanding the 
impact annual epidemics of influenza have on a population. Data 
regarding impact are critical to the development of prevention and 
control measures, such as vaccination policies. Vaccination efforts are 
the cornerstone of influenza prevention, and will be the primary means 
of mitigating the impact of an influenza pandemic, when we have a 
vaccine proven safe and effective against the pandemic strain. Another 
critical area for preparedness is the ability to identify potential 
human cases of novel influenza strains, so national Governments and the 
international community can launch early efforts to attempt to stop 
outbreaks.
    The systematic collection of influenza-surveillance data over time 
is necessary to monitor and track the activity of influenza virus and 
disease, and is essential to understanding the impact influenza has on 
a country's population. Developing influenza-surveillance networks is 
critical for the rapid detection of new variants, including those with 
pandemic potential, to contribute to the global disease-surveillance 
system. Global collaboration, under the coordination of the Secretariat 
of the World Health Organization (WHO), is a key feature of influenza 
surveillance.
    The WHO established an international laboratory-based surveillance 
network for influenza in 1948, which currently consists of 113 National 
Influenza Center (NIC) laboratories in 84 countries, and four WHO 
Collaborating Centers for Reference and Research of Influenza 
(including one located at the HHS Centers for Disease Control and 
Prevention [CDC]). The primary purposes of the WHO network are to 
detect the emergence and spread of new antigenic variants of influenza, 
to use this information to update the formulation of annual human 
influenza vaccine, and to provide as much warning as possible about the 
next pandemic. This system provides the foundation of worldwide 
influenza prevention and control, and is a critical contribution to 
preserving global health security.
    Monitoring of human and animal influenza viruses and providing 
contributions to the global disease-surveillance system, including the 
sharing of appropriate specimens and viral isolates, will assure the 
data used in the WHO Secretariat's annual vaccine recommendations are 
relevant to each country that participates. Increased participation in 
the global surveillance system for influenza viruses will enhance each 
country's ability to monitor severe respiratory illness, to develop 
vaccine policy for influenza, and to help build global and regional 
strategies for the prevention and control

[[Page 57957]]

of influenza in animals and humans. Monitoring the disease activity of 
influenza is important to facilitate planning for the allocation of 
resources, appropriate and clear communications with the public, 
containment and response interventions, and outbreak investigations.

Pillar Three

    In the absence of available vaccine or specific antiviral 
treatment, infection control and related non-pharmaceutical public-
health interventions are the mainstay of reducing the spread and impact 
of an influenza pandemic. Correct and consistent infection-control 
practices should be a part of routine health-care delivery, an active 
consideration in planning for pandemic influenza and other infectious- 
disease outbreaks, and an integral part of outbreak response and 
control. The dual goals of providing safe health-care to patients and 
protecting health-care personnel while they work are critical to 
maintaining a functional health-care system. Elements of health-care 
related infection-control also influence community guidance for self-
protection and the prevention of infection.
    The principal intent of this assistance is to support surveillance 
and response, to allow for the containment of a highly pathogenic virus 
transmissible among humans. A second intent is to support the 
development of epidemiologic, laboratory, and related capacity to 
detect, respond to, and monitor shifts in influenza viruses, as well as 
in severe respiratory illness syndromes. A third intent is to help 
strengthen the connection of national institutions, especially National 
Influenza Centers, to more fully participate in the WHO Influenza 
Program, and be more capable of sharing specimens and quality data of 
the circulation of influenza viruses from throughout the country.
    Measurable outcomes of the program will be in alignment with the 
three Pillars of the HHS Pandemic Influenza Operational Plan and the 
Pillars of the President's National Strategy for Pandemic Influenza, 
the principles of the International Partnership on Avian and Pandemic 
Influenza, and the following performance goal(s) for the Office of 
Global Health Affairs (OGHA).
    This announcement is only for non-research activities supported by 
HHS, including OGHA. If an applicant proposes research activities, HHS 
will not review the application. For the definition of ``research,'' 
please see the HHS/CDC Web site at the following Internet address: 
http://www.cdc.gov/od/ads/opspoll1.htm.

Recipient Activities

    The proposal may include activities under all three Pillars. 
However, the application all of those activities should prioritize the 
principal intent of rapidly building epidemiologic, laboratory, and 
response capabilities to contain an emergent, highly pathogenic virus 
transmissible among humans. Applicants should allocate a minimum of 70 
percent of resources to Pillar Two activities unless they present 
strong evidence that the key capacities represented in Pillar Two are 
already well-established in the country, or can be made such with less 
than 70 percent of the resources for which applicants have applied. 
Applicants can select activities other than Pillar Two based on the 
National Pandemic Plan. If applicants do not propose any activities for 
one or more Pillars, they must describe a brief plan for how they will 
address those activities, and must describe the funding sources to 
underwrite those activities, whether national resources or financing 
from an alternate partner or funding source.
    Activities recipients may perform under this program are as 
follows:

Pillar I Preparedness and Communication

1.1 Preparedness Plans, Policy, and Coordination

     Developing a high-level, Inter-Ministerial Task Force or 
working group for influenza that meets regularly with representation 
from both the human- and animal-health sectors, Government Ministries, 
businesses, and non-governmental organizations (NGOs); to determine 
ways to improve national influenza surveillance; develop prevention and 
control measures such as vaccine policy; and work on national pandemic 
preparedness.
     Adhering to the core principles of the International 
Partnership on Avian and Pandemic Influenza (http://www.state.gov/r/pa/prs/ps/2005/53865.htm), including transparency and rapid reporting of 
cases.
     Establishing a national plan, based on scientifically 
valid information, for containing influenza in animals with human 
pandemic potential, and for responding to a human pandemic.
     Testing and executing those plans.
     Committing to the timely coordination of bilateral and 
multilateral resource allocations, the dedication of domestic resources 
(human and financial), and the development of contingency plans.

1.2 Communications

     Establishing a communications component as part of a 
National Pandemic Plan, coordinated by the Ministries of Health, 
Agriculture, Information, Trade, Tourism, etc., as appropriate to 
accomplish the following:
     Establishing a communications strategy to coordinate the 
development, testing and evaluation of health information among 
involved Ministries and bilateral/multilateral agencies that are 
providing assistance.
     Prepare public-health messages in local languages to ask 
medical and public-health workers to report unusual cases of 
respiratory disease to local authorities, by emphasizing that a cluster 
of severe pneumonia of unknown origin anywhere in the world constitutes 
a potential international emergency.
     Prompt reporting of cases and clusters of human infection 
with avian influenza A (H5N1) by doing the following:
    [cir] Providing technical support for local-language public-health 
education and outreach efforts by Ministries of Health and Agriculture, 
the World Health Organization (WHO)/Headquarters, and the relevant WHO 
Regional Offices;
    [cir] Providing local-language training for health-care providers 
in identifying patients with risk factors for disease caused by highly 
pathogenic avian influenza A (H5N1); and,
    [cir] Supporting public-sector field staff in Districts and 
Provinces in detecting and reporting suspected cases of highly 
pathogenic avian influenza.
     Develop public-health materials in local languages for use 
in community-based educational campaigns that inform people about 
infection control and public-health containment (or ``social 
distancing'') measures (e.g., quarantine, school closures, travel 
restrictions) that can control outbreaks of pandemic influenza. These 
materials will also provide information about the use of proper and 
safe antiviral drugs and vaccines.
    [cir] Ensure these activities and messages fit together and are 
consistent with inter-Ministerial Governmental social- mobilization 
efforts and similar efforts funded by the U.S. Agency for International 
Development (USAID) and other donors.
     Develop local-language mass-media and community-outreach 
programs that promote AI awareness and behavior change, if other 
partners are not addressing this area consistent with the national 
pandemic response plan.

[[Page 57958]]

     Identify and train credible national Government 
spokespeople.
     Partner early with media editors and journalists, if other 
partners are not addressing this area, consistent with the national 
pandemic response plan, to:
    [cir] Provide valid training on avian influenza to journalists and 
editors.
     Develop public-health materials in local languages that 
inform health-care workers about infection-control measures that can 
control the spread of pandemic influenza in health-care facilities and 
in the workplace. These materials will also provide information about 
antiviral use.
     Develop health-promotion and education activities in local 
languages to increase professional awareness of the need to detect each 
and every case and cluster of human respiratory infection (family, 
health care, or institutional) during the pandemic-alert period.
     Work with the WHO Secretariat and other multilateral 
organizations, existing bilateral programs, and private-sector partners 
to develop workplace, community- and hospital-based health prevention, 
promotion, and education activities.

Pillar II. Surveillance and Detection

2.1 Laboratory Capacity and Infrastructure

     Train laboratory scientists and technicians in proper 
laboratory techniques for influenza detection, typing, and sub-typing.
     Install and maintain laboratory equipment and 
infrastructure needed to carry out the functions of WHO-certified 
National Influenza Center, if possible, or work towards the capacity to 
carry out those functions.
     Maintain and assure biosafety and biosecurity of targeted 
laboratories according to national and international standards.
     Install and maintain information-management equipment for 
reporting of results from influenza laboratory work, back to the sites 
providing specimens, to national leaders, and to the WHO Secretariat 
and other international partners.

2.2 Epidemiology Capacity and Infrastructure

     Train epidemiologists at appropriate levels and sufficient 
scale to be able to support multiple surveillance, outbreak 
investigation and response, and disease-control activities involved in 
avian and pandemic preparedness.
     Establish needed information and data-management capacity 
and telecommunications capacity needed for surveillance, outbreak 
response, and disease control, including containment of a suspect 
pandemic virus.
     Establish other needed infrastructure critical to 
supporting outbreak detection, response, and containment efforts.

2.3 Sentinel, Laboratory-Based Surveillance for Influenza-Like 
Illnesses and/or Hospital-Based Surveillance for Severe Disease

     Develop a nationwide system to collect virologic and 
epidemiologic data for influenza, including appropriate samples and 
viral isolates, by establishing three or more sites with good 
geographic distribution throughout the country. Each site will consist 
of a local laboratory and one or more public or private clinics or 
hospitals from which to collect data. Each site should do the 
following:
    [cir] Conduct virologic and epidemiologic surveillance for 
influenza by collecting information, including appropriate samples and 
specimens for virus isolation year-round;
    [cir] Have lab capacity for performing the isolation and typing of 
influenza viruses; or at least molecular technology for identification;
    [cir] Collect information on influenza-like illnesses and/or severe 
respiratory disease at each site by building on information already 
available. Possible sources of information are the following: (1) 
Recording visits by patients with influenza-like-illness to physicians 
or public or private primary-care clinics or hospitals, based on a 
standard case definition; (2) Monitoring hospital admissions for severe 
respiratory illness and pneumonia, based on a standard case definition. 
The sites should collect patient information, such as age, patient 
history and other relevant information;
    [cir] Collect a subset of at least 10 (and preferably up to 25) 
specimens from the patient populations under surveillance that exhibit 
febrile, acute upper-respiratory illness weekly during the period of 
surveillance by using a standard case definition (preferably one 
established by the WHO Secretariat) and submit them to the local 
laboratory for the site;
    [cir] During unusual outbreaks of influenza, such as outbreaks with 
unusual epidemiologic characteristics, or those related to infections 
by highly pathogenic avian or other animal influenza viruses; collect 
epidemiologic information to characterize the outbreak; and collect 
additional samples for viral isolation, including tissue samples, if 
appropriate; and submittal to the site laboratory. Report the outbreak 
to the National Influenza Center for further transmittal to one or more 
of the WHO-designated Collaborating Centers for Influenza;
    [cir] Prepare and provide regular weekly reports on the 
epidemiologic information collected (influenza-like-illness and/or 
severe respiratory illness) to the local laboratory and to the National 
Influenza Center for further transmittal to one or more of the WHO-
designated Collaborating Centers for Influenza;
    [cir] If proper biosafety conditions exist, perform viral isolation 
for influenza viruses, either in tissue culture or in eggs, type 
positive isolates for influenza A and B, and, if possible, subtype 
influenza viruses;
    [cir] Store original clinical materials at -70 degrees celsius, 
until the beginning of the next influenza season; and,
    [cir] Submit viral isolates to the National Influenza Center within 
the country on at least a monthly basis for more complete analysis.
     Each WHO-certified National Influenza Center also will be 
responsible for and commit to performing the following activities:
    [cir] Performing preliminary antigenic and, if possible, genetic 
characterization on the virus isolates submitted from the laboratories 
in the surveillance sites (including those isolates grown at the NIC);
    [cir] Send, as quickly as possible, representative influenza virus 
isolates to one of the four WHO Collaborating Centers for Influenza, 
including any low-reacting viruses, as tested by using the WHO reagent 
kit, each month during the period of surveillance and more frequently, 
if possible;
    [cir] If any viruses are unsubtypable as tested by using the WHO 
kit, alert the WHO Secretariat and send the virus isolate to one of the 
four WHO Collaborating Centers for Influenza immediately;
    [cir] During the period of surveillance, provide weekly influenza-
surveillance information, preferably electronically to the WHO 
Secretariat through FluNet;
    [cir] Provide an annual national summary on influenza activity, 
virological information, and other relevant information on influenza to 
the WHO Secretariat and the WHO Collaborating Center for Influenza at 
HHS/CDC;
    [cir] Provide technical expertise and training to support the 
surveillance sites and laboratories in the national network in 
developing the capacity to type and subtype viruses and when feasible 
to identify avian influenza viruses by molecular techniques; and 
provide reagents to national public-health laboratories as able;

[[Page 57959]]

    [cir] Establish the capacity to identify avian influenza viruses in 
specimens collected from suspect cases using molecular diagnostic 
techniques;
    [cir] Provide support for human-health diagnostic laboratories in 
your network by giving assistance in the development and implementation 
of rapid laboratory diagnostics protocols and methods, and to establish 
objectives for rapid screening; and,
    [cir] Establish linkages with surveillance systems that detect 
influenza viruses in animal populations and with national Government 
authorities responsible for animal health.
     Foreign Governments that apply for funding through this 
announcement should play a substantial role in the development and 
support of the influenza-surveillance network in their countries, by 
committing to the following:
    [cir] Timely and sustained high-level political leadership to 
combat avian and novel influenza strains;
    [cir] Complete transparency in the reporting of influenza cases in 
humans and animals caused by virus strains that have pandemic 
potential;
    [cir] Timely sharing of influenza-surveillance information with the 
WHO Global Influenza Surveillance network by facilitating the regular 
exchange of information and virus samples with one of the four WHO 
Collaborating Centers for Influenza; and,
    [cir] Providing continued support for influenza activities within 
the country and developing a plan for increased participation in the 
global influenza surveillance network over a five-year period.

2.4 Comprehensive, National Surveillance for Clusters and Cases of 
Severe Respiratory and Febrile Syndromes That Might Represent Emergent 
Cases From a Highly Pathogenic Influenza Virus of Pandemic Potential

     Establish early-warning networks, adapt international case 
definitions, and implement standards for laboratory diagnostics of 
human and animal samples.
     Strengthen early-warning systems for reporting human cases 
of infection with influenza A (H5N1) by:
    [cir] Initiating or enhancing Participation in the WHO Global 
Outbreak Alert and Response Network (GOARN) to report possible 
outbreaks of highly pathogenic avian influenza in humans and the WHO 
Global Influenza Surveillance Network to share specimens and viruses.
     Develop and establish village-based public-sector alert-
and-response surveillance systems for human cases of influenza. By 
providing health education at the community level and to providers and 
setting up a system for reporting of suspect cases based on a standard 
case definition.
     Develop a system that rapidly notifies National Government 
authorities of suspect avian influenza cases and provides appropriate 
samples for testing at the national level if the capacity does not 
exist at a country's network site.
     Establish a system to monitor for severe cases of 
respiratory illness for a possible case or cluster of the H5N1 virus or 
other respiratory diseases that pose a global threat.
     Develop protocols and tools to investigate cases and 
clusters, including the widespread dissemination of specimen collection 
and transport materials, to allow rapid diagnosis.


    Note: The WHO-certified National Influenza Center (NIC) within a 
country can be one of the surveillance sites, and, as such, conduct 
all the activities listed above under components 2.3 and 2.4. 
However, component 2.4 is often the responsibility of units of 
Ministries of Health other than the laboratory unit that serves as 
the National Influenza Center, and Governments might need to share 
resources across units and establish protocols to fulfill the 
requirements of components 2.3 and 2.4. If there are two or more 
NICs within a country, each NIC could participate as a site; 
however, NICs within a single country should work together and place 
emphasis on the addition of new surveillance sites. In addition, the 
NIC(s) should act as the focal point and authority within the 
country on influenza surveillance, and be the main point of 
communication with the WHO Secretariat and WHO Collaborating Centers 
for the rapid submittal of virus isolates and information into the 
global influenza surveillance system.

Pillar III. Response and Containment

3.1 Local Rapid-Response Teams (RRT)

     Develop and adopt rapid-response protocols for use in 
responding quickly to credible reports of human-to-human transmission 
that could indicate the beginnings of an influenza pandemic. Awardees 
may carry out this action in conjunction with HHS, USAID, the WHO 
Secretariat, and other donor countries.
     Develop and train in-country rapid-response teams to 
assess and report quickly on possible outbreaks of avian and human 
influenza at the village level by accomplishing the following:
    [cir] Developing national and regional rapid-response teams 
deployable within 24 hours; and,
    [cir] Working with GOARN to train members of response teams and 
staff from Ministries of Health and Agriculture. Training topics should 
include outbreak investigations, cluster investigations, case-control 
investigations, and case-cohort investigations.

3.2 Infection Control

     Develop local-language public-health materials, in 
cooperation with HHS that inform local health-care workers and hospital 
administrators in priority counties about infection-control measures to 
control the spread of pandemic influenza in health-care facilities and 
in workplace health facilities. The information should include guidance 
about the appropriate use of antiviral drugs and vaccines.
     Develop and/or field-test and evaluate culturally and 
economically appropriate standards for infection-control practices and 
infrastructure for international health-care settings.
     Develop economical and culturally acceptable standardized 
preventive practices for the routine delivery of health-care that will 
be effective in prevention of health-care-associated influenza 
transmission during a pandemic. (e.g., routine management standards for 
febrile respiratory illnesses).
     Develop and/or field-test and evaluate culturally and 
economically feasible community-based practices for the prevention of 
infection in community settings.
     Develop a costed national plan for delivering basic 
infection-control materials to and maintaining them in District and 
Provincial hospitals, with guidance for distribution and use in 
preparation for and during the anticipated disruptions caused by a 
pandemic of influenza.
     Develop, in partnership with international public-health 
agencies, instructional material for print or broadcast to target 
infection-control and nursing personnel in local languages to train 
them in appropriate cohorting, cleaning, worker protection and the use 
of protective equipment (e.g., gloves, gowns, masks, etc.).

I. 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).

II. Award Information

    The administrative and funding instrument to be used for this 
program will be the cooperative agreement in which substantial OGHA/HHS 
scientific and/or programmatic involvement is anticipated during the 
performance of the project. Under the cooperative

[[Page 57960]]

agreement, OGHA/HHS will support and/or stimulate awardee activities by 
working with them 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 a final evaluation of the program.
    Approximately $1,000,000.00 in fiscal year (FY) 2006 funds is 
available to support the 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 single award made from this announcement. The project period for 
this agreement is for three (3) years with a budget period of 12 
months.
    The award recipient must comply with all HHS management 
requirements for meeting participation and progress and financial 
reporting for this cooperative agreement. (Please see HHS Activities 
and Program Evaluation sections below.)
    HHS/OS/OGHA activities for this program are as follows:

Pillar One

     Organize an orientation meeting with the award recipient 
to brief them on applicable U.S. Government expectations, regulations, 
policies and key management requirements, as well as report formats and 
contents.
     Review and approve the process used by the grantee to 
select key personnel and/or post-award subcontractors and/or sub 
grantees to be involved in the activities performed under this 
agreement.
     Review and approve the grantees' annual work plan and 
detailed budget.
     Review and approve the grantees' monitoring and evaluation 
plan, including for compliance with the performance management metrics 
and systems developed for U.S. Government and HHS assistance related to 
avian and pandemic influenza.
     Meet or teleconference on a regular basis, as necessary, 
with the grantee to assess quarterly technical and financial progress 
reports and modify plans as necessary.
     Meet on an annual basis with the grantee to review annual 
progress report for each U.S. Government fiscal year, and to review 
annual work plans and budgets for subsequent year.
     Provide technical assistance, as mutually agreed upon, and 
revise annually during validation of the first and subsequent annual 
work plans. This could include expert technical assistance and targeted 
training activities in specialized areas relevant to influenza pandemic 
preparedness, containment, and mitigation.

Pillar Two

     Provide technical assistance on techniques and reagents 
for the identification of influenza viruses. Annually provide the WHO 
reagent kit, produced and distributed by the WHO Collaborating Center 
for Influenza at HHS/OGHA;
     Providing epidemiological and laboratory training;
     Providing technical consultation on the development of in-
country influenza-surveillance networks;
     Providing confirmation of antigenic analysis and more 
detailed characterization information on the influenza virus isolates 
submitted to HHS/OGHA, with written reports back to the National 
Influenza Center; and,
     Providing technical advice on the conduct of local and 
regional epidemiologic outbreak investigations.

Pillar Three

     Providing technical advice and training in the development 
of local rapid-response teams;
     Providing technical advice for the development of policies 
and capabilities for rapidly mobilizing materials from stockpiles of 
pharmaceuticals and commodities to the site of an outbreak; and,
     Providing technical advice and training in developing 
plans for infection control.

III. Eligibility Information

1. Eligible Applicants

    This is a single source, cooperative agreement with the Ministry of 
Health of the Great Socialist People's Libyan Arab Jamahiriya (Libya). 
On November 1, 2005, President George W. Bush announced the U.S. 
National Strategy for Pandemic Influenza, and the following day 
Secretary Michael O. Leavitt released the HHS Pandemic Influenza Plan. 
One of the primary objectives of both documents 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 the clear goals of ensuring the 
rapid reporting of outbreaks and containing outbreaks beyond the 
borders of the United States.
---------------------------------------------------------------------------

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

    We rely upon our international partnerships, with the United 
Nations (UN); international organizations; and private, non-profit 
organizations, to amplify our efforts, and will engage them on 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 
could play a determining role in the severity of a pandemic.
    The International Partnership on Avian and Pandemic Influenza, 
launched by President Bush at the UN General Assembly in September 
2005, stands in support of multinational organizations and national 
Governments. Members of the Partnership have agreed that the following 
ten 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 viruses trains 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, so 
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, Food

[[Page 57961]]

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. Based on an overall public health 
analysis for pandemic flu, Libya requires assistance in detection, 
surveillance and other areas to manage and identify Avian Influenza.
    Avian Influenza is a significant burden on neighboring countries of 
Libya. Egypt, for example, has consistently identified the H5N1 virus 
in poultry and humans resulting in human fatalities and the near 
decimation of its poultry industry. Other countries proximate to Libya 
which have reported human cases of H5N1 include Turkey, Iraq, and 
Azerbaijan. Sharing the same bird fly-ways and trading goods daily with 
many of its neighboring countries already affected by H5N1, Libya is at 
heightened risk. For these reasons, eligibility for this cooperative 
agreement is limited to the country of Libya.
    Twenty-two years of sanctions has isolated Libya from the rest of 
the world and exacerbated the seriousness of the situation within 
Libya. The sanctions have prevented Libya from experiencing the 
benefits of medical training in state-of-the art practice and 
scientific collaborations leaving Libya vulnerable to an influenza 
pandemic.
    Libya recently appointed its first Minister of Health and is in the 
early stages of developing a Ministry of Health. Previously, under the 
General People's Committee for Health and Environment of the Great 
Socialist People's Libyan Arab Jamahiriya, public health services did 
not in exist. With the control and governance of public health services 
now delegated to Libya's Ministry of Health, the Ministry of Health 
assumes responsibility for developing and building the capacity of the 
public health care system. Therefore, in accordance with the guidance 
presented here, and the demand to seek Ministers of Health of countries 
affected, the only eligible source for any efforts in building the 
capacity of the public health care system in the country of Libya is 
the Minister of Health.

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.

IV. Application and Submission Information

1. Address To Request Application Package:

    This Cooperative Agreement project uses the Application Form HHS 
Office of Public Health and Science (OPHS) 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 
OPHS-1, Revised 8/2004 will be included in the application packet. 
These forms are also available from the following sites by downloading 
from https://egrants.osophs.dhhs.gov and clicking on Grant 
Announcements, or 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 by 
contacting the HHS/OPHS Office of Grants Management, at 1-(240) 453-
8822. Please specify the HHS program(s) for which you are requesting an 
application kit.

ADDRESSES: Application kits may be requested from, and applications 
submitted to Karen Campbell, Director, Office of Grants Management, 
Office of Public Health and Science (OPHS), Department of Health and 
Human Services, 1101 Wootton Parkway, Suite 550, Rockville, MD 20852.

2. Content and Form of Application Submission

Application Materials
    A separate budget page is required for the budget year requested. 
Applicants must submit with the 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 will not favorably consider proposals 
submitted without a budget and justification for each budget year 
requested in the application. Specific instructions for submitting a 
detailed budget for this application appear in the application packet. 
If additional information and/or clarification are necessary, please 
contact the HHS/OPHS Office of Grants Management identified in Section 
VII of this announcement.
    A Project Abstract submitted on 3.5 inch floppy disk must accompany 
all applications. 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 be included in the application packet.
    A Project Narrative must accompany all grant applications. In 
addition to the instructions provided in OPHS-1 (Rev 8/2004) for 
project narrative, the specific guidelines for the project narrative 
appear in the program guidelines. 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, and not reduced. Applicants should type 
biographical sketches either on the appropriate form or on plain paper, 
and should not exceed two pages, with publications listed limited only 
to those that are directly relevant to this project.
Application Format Requirements
    If applying on paper, the entire application may not exceed 80 
pages in length, including theabstract, project and budget narratives, 
face page,

[[Page 57962]]

attachments, any appendices and letters of commitment and support. 
Applicants must number pages consecutively.
    HHS/OGHA will deem as non-compliant applications submitted 
electronically that exceed 80 pages when printed and will return all 
non-compliant applications to the applicant without further 
consideration.
    (a) Number of Copies: 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 might 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: Public Health Service (PHS) Application 
Form OPHS-1, provided with the application package. Prepare this page 
according to instructions provided in the form itself.
DUNS Number
    An applicant organization is required to have a Data Universal 
Numbering System (DUNS) number in order 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 can be found at https://www.dnb.com/product/eupdate/requestOptions.html or call 1-866-705-5711. Please 
include the DUNS number next to the OMB Approval Number on the 
application face page. An application will not be reviewed without a 
DUNS number.
    Additionally, the applicant organization will be required to 
register with the Federal Government's Central Contractor Registry 
(CCR) in order to do electronic business with the Federal Government. 
Information about registering with the CCR can be found at http://www.hrsa.gov/grants/ccr.htm.
    Finally, an applicant applying electronically through Grants.gov is 
required to register with the Credential Provider for Grants.gov. 
Information about this requirement is available at http://www.grants.gov/CredentialProvider
    An applicant applying electronically through the OPHS E-Grants 
System is required to register with the provider. Information about 
this requirement is available at 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 OPHS-1, provided with 
the application package.
    iv. Budget: Application Form OPHS-1, provided with the application 
package.
    v. Budget Justification: The amount of financial support (direct 
costs) that an applicant is requesting from the Federal granting agency 
for the first year is to be entered on the Face Sheet of Application 
Form PHS 5161-1, Line 15a. The application should include funds for 
electronic mail capability unless access by 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: Personnel costs should be explained by listing 
each staff member who will be supported from 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, tuition reimbursement. The 
fringe benefits should be directly proportional to that portion of 
personnel costs that are allocated for the project.
    Travel: List travel costs according to local and long distance 
travel. For local travel, the mileage rate, number of miles, reason for 
travel and staff member/consumers completing the travel should be 
outlined. The budget should also reflect the travel expenses associated 
with participating in meetings and other proposed trainings or 
workshops.
    Equipment: List equipment costs and provide justification for the 
need of the equipment to carry out the programs goals. Extensive 
justification and a detailed status of current equipment must be 
provided when requesting funds for the purchase of computers and 
furniture items.
    Supplies: List the items that the project will use. In this 
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 may be pamphlets and educational videotapes. 
Remember, they must be listed separately.
    Subcontracts: To the extent possible, all subcontract budgets and 
justifications should be standardized, and contract budgets should be 
presented by using the same object class categories contained in the 
Standard Form 424A. Provide a clear explanation as to thepurpose of 
each contract, how the costs were estimated, and the specific contract 
deliverables.
    Other: 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: An applicant must 
present a staffing plan and provide a justification for the plan that 
includes education and experience qualifications and rationale for the 
amount of time being requested for each staff position. Position 
descriptions that include the roles, responsibilities, and 
qualifications of proposed project staff must be included in Appendix 
B. Copies of biographical sketches for any key employed personnel that 
will be assigned to work on the proposed project must be included in 
Appendix C.
    vii. Project Abstract: Provide a summary of the application. 
Because the abstract is often distributed to provide information to the 
public and Congress, please prepare this so that 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 to be addressed, the proposed services, and the 
population group(s) to be served.
    Please place the following at the top of the abstract:
     Project Title;
     Applicant Name;
     Address;

[[Page 57963]]

     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 that 
reviewers can understand the proposed project.
    Use the following section headers for the Narrative:

Introduction

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

Work Plan

    Describe the activities or steps that will be used to achieve each 
of the activities proposed in the methodology section. Use a time line 
that includes each activity and identifies responsible staff.

Resolution of Challenges

    Discuss challenges that are likely to be encountered in designing 
and implementing the activities described in the Work Plan, and 
approaches that will be used to resolve such challenges.

Evaluation and Technical Support Capacity

    Describe current experience, skills, and knowledge, including 
individuals on staff, materials published, and previous work of a 
similar nature.

Organizational Information

    Provide information on the applicant agency's 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: Please provide the following items to complete the 
content of the application. Please note that these are supplementary in 
nature, and are not intended to be a continuation of the project 
narrative. Be sure each appendix is clearly labeled.
    1. Appendix A: Tables, Charts, etc.
    To give further details about the proposal.
    2. Appendix B: Job Descriptions for Key Personnel.
    Keep each to one page in length as much as is possible. Item 6 in 
the Program Narrative section of the PHS 5161-1 Form provides some 
guidance on items to include in a job description.
    3. Appendix C: Biographical Sketches of Key Personnel.
    Include biographical sketches for persons occupying the key 
positions described in Appendix B, not to exceed two pages in length. 
In the event that a biographical sketch is included for an identified 
individual who is not yet hired, please 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). 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 agreements must be dated.
    5. Appendix E: Project Organizational Chart.
    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.
    Include here any other documents that are relevant to the 
application, including letters of supports. Letters of support must be 
dated.

3. Submission Dates & Times

    The Office of Public Health and Science (OPHS) 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 
described below will not be accepted for review. Applications which do 
not conform to the requirements of the grant announcement will not be 
accepted for review and will be returned to the applicant.
    Applications may only be submitted electronically 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 Grants.gov Web site Portal is encouraged.
    Electronic grant application submissions must be submitted no later 
than 5:00 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. All required hard-copy original signatures 
and mail-in items must be received by the OPHS Office of Grants 
Management no later that 5 p.m. Eastern Time on the next business day 
after the deadline date specified in the DATES section of the 
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.
    Applicants are encouraged to initiate electronic applications early 
in the application development process, and to submit early on the due 
date or before. This will 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 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 grant 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 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. All

[[Page 57964]]

required mail-in items must 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 
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 for their records, as well as a copy of the 
entire application package.
    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 
Website 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 regarding the electronic application process conducted through 
the Grants.gov Web site Portal.
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 Web site, 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 completedonline 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 hardcopy 
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. 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 their application in the OPHS eGrants 
system to ensure that all signatures and mail-in items are received.
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 DATES section of the 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. Applicants should submit 
their applications to the following address: Director, Office of Grants 
Management, Office of Public Health and Science, U.S. 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 that may be charged are outlined 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 on the Internet at the following address: 
http://www.whitehouse.gov/omb. No pre-award costs are allowed.

6. Other Submission Requirements

    N/A.

V. Application Review Information

1. Criteria

    The application will be screened by OGHA staff for completeness and 
for responsiveness to the program guidance. The applicant should pay 
strict attention addressing these criteria, as they are the basis upon 
which applications 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 
be evaluated for scientific and technical merit by an appropriate peer 
review group specifically convened for this solicitation and in 
accordance with HHS policies and procedures. As part of the initial 
merit review, all applications will receive a written critique. All 
applications recommended for approval

[[Page 57965]]

will be discussed fully by the ad hoc peer review group and assigned a 
priority score for funding. Eligible applications will be assessed 
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 the partner institution.
     The successful applicant must demonstrate a clear 
understanding of the scope and objectives of the cooperative agreement, 
recognition of potential difficulties that could arise in performing 
the work required, presentation of adequate solutions, and 
understanding of the close coordination necessary between the HHS/OGHA, 
the International Partnership on Avian and Pandemic Influenza, United 
Nations agencies, and the WHO Secretariat.
     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. The strategic plan should specifically 
address the expected progress of the Quality of Care program.
(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, 
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. Expertise in 
maternal and child health care, including documented training, 
expertise, relevant experience, leadership skills, and medical 
expertise specific to maternal and child health. Documented managerial 
ability to achieve delivery or performance requirements as demonstrated 
by the proposed use of management and other personnel resources and to 
manage successfully the project, including subcontractor and/or 
consultant efforts, if applicable, as evidence by the management plan 
and demonstrated by previous relevant experience.
     Partner Institutions and other Personnel--Applicants 
should provide documented evidence of availability, training, 
qualifications, expertise, relevant experience, education and 
competence of the scientific, clinical, analytical, technical and 
administrative staff and any other proposed personnel (including 
partner institutions, subcontractors and consultants), to perform the 
requirements of the work activities as evidenced by resumes, 
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 showing relationships among the 
key personnel.
     Administrative and Organizational Framework--Adequacy of 
the administrative and organizational framework, with lines of 
authority and responsibility clearly demonstrated, and adequacy of the 
project plan, with proposed time schedule for achieving objectives and 
maintaining quality control over the implementation and operation of 
the project. Adequacy of back-up staffing and the evidence that 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)
     Applicant should submit documented relevant experience of 
the organization in managing projects of similar complexity and scope 
of the activities.
     Clarity and appropriateness of lines of communication and 
authority for coordination and management of the project. Adequacy and 
feasibility of plans to ensure successful coordination of a multiple-
partner collaboration.
     Documented experience recruiting qualified medical 
personnel for projects of similar complexity and scope of activities.
(4) Facilities and Resources (10 Points)
     Documented availability and adequacy of facilities, 
equipment and resources necessary to carry out the activities specified 
under Program Requirements.

VI. Award Administration Information

1. Award Notices

    HHS/OGHA does not release information about individual applications 
during the review process until we have made final funding decisions. 
When HHS/OGHA has made these decisions, we will notify applicants by 
letter regarding the outcome of their applications. The official 
document to notify an applicant HHS/OGHA has approved and funded an 
application is the Notice of Award, which specifies to the recipient 
the amount of money awarded, the purpose of the agreement, the terms 
and conditions of the agreement, and the amount of funding, if any, the 
recipient 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 U.S. 
Department of Health and Human Services (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 
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 are available from the following Internet 
address: http://www.access.gpo.gov/nara/cfr/waisidx_03/45cfrv1_03.html.

3. Reporting

    The projects is required to 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 that can be attributed to the project. Project 
funds may be used to support evaluation activities.
    In addition to conducting their own evaluation of projects, the 
successful applicant must be prepared to participate in an external 
evaluation, to be supported by OGHA/HHS and conducted by an independent 
entity, to assess efficiency and effectiveness for the project funded 
under this announcement.
    Within 30 days following the end of each of quarter, submit a 
performance report no more than ten pages in length must be submitted 
to OGHA/HHS. A sample quarterly performance report will be provided at 
the time of notification of award. At a minimum,

[[Page 57966]]

quarterly performance reports should include:
     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 
for the quarter using the grantee's implementation schedule, and where 
such objectives were not met, a statement of why they were not met.
     Specific action(s) that the grantee would like the OGHA/
HHS to undertake to alleviate a problem.
     Other pertinent information that will permit monitoring 
and overview of project operations.
     A quarterly financial report describing the current 
financial status of the funds used under this award. The awardee and 
OGHA will agree at the time of award for the format of this portion of 
the report.
    Within 90 days following the end of the project period a final 
report containing information and data of interest to the Department of 
Health and Human Services, Congress, and other countries must be 
submitted to OGHA/HHS. The specifics as to the format and content of 
the final report and the summary will be sent to successful applicants. 
At minimum, the report should contain:
     A summary of the major activities supported under the 
agreement and the major accomplishments resulting from activities to 
improve mortality in partner country.
     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.
    Quarterly performance reports and the final report may be submitted 
to: Mr. DeWayne Wynn, Grants Management Specialist, Office of Grants 
Management, Office of Public Health and Science, Department of Health 
and Human Services, 1101 Wootton Parkway, Suite 550, Rockville, MD 
20852, phone (240) 453-8822.
    A Financial Status Report (FSR) SF-269 is due 90 days after the 
close of each 12-month budget period and submitted to OPHS-Office of 
Grants Management.

VII. Agency Contacts

    For assistance on administrative and budgetary requirements, please 
contact: Mr. DeWayne Wynn, Grants Management Specialist, Office of 
Grants Management, Office of Public Health and Science, Department of 
Health and Human Services, 1101 Wootton Parkway, Suite 550, Rockville, 
MD 20852, phone (240) 453-8822.
    For assistance with questions regarding program requirements, 
please contact the following: David Smith, PhD, Office of Global Health 
Affairs, U.S. Department of Health and Human Services, 5600 Fishers 
Lane, Suite 18-101, Rockville, MD 20857; Phone Number: 1-301-443-1774.

VIII. Tips for Writing a Strong Application

    Include DUNS Number. You must include a DUNS Number to have your 
application reviewed. HHS/OGHA 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. 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 the applicant 
does not place information in the requested order, the application 
might 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 any required 
information or data is omitted, 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 that is 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 follow page limits. 
Limit the use of abbreviations and acronyms, and define each one at its 
first use and periodically throughout the application.

    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. E6-16181 Filed 9-29-06; 8:45 am]
BILLING CODE 4150-38-P