International Development of H5N1 Influenza Vaccines; Funding Opportunity, 54482-54488 [E6-15325]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 179 (Friday, September 15, 2006)]
[Notices]
[Pages 54482-54488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15325]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


International Development of H5N1 Influenza Vaccines; Funding 
Opportunity

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

ACTION: Notice.

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    Funding Opportunity Title: International Development of H5N1 
Influenza Vaccines.
    Announcement Type: Single-Source Cooperative Agreement.
    Catalog of Federal Domestic Assistance Number: The Office of 
Management and Budget (OMB) Catalog of Federal Domestic Assistance 
number is 93.019.
SUMMARY: The objective of this project is to mitigate any potential 
global shortage of influenza vaccines and the manufacturing of this 
vaccine in the event of an influenza pandemic. The Office of Public 
Health Emergency Preparedness (OPHEP) requires the World Health 
Organization (WHO) to perform activities related to pandemic influenza 
preparedness and planning, particularly in the international 
development of H5N1 human vaccines (and other pandemic influenza 
vaccine candidates) and influenza vaccine manufacturing infrastructure 
building in countries where resources for vaccine acquisition and 
manufacturing may be limited. The specific countries in which the WHO 
Secretariat will carry out these activities are Argentina, Brazil, 
India, Indonesia, Mexico, Romania, Russia, South Africa, and Tunisia. 
Activities include pre-clinical safety and immunogenicity testing, 
toxicology testing, clinical vaccine lot manufacturing, scale-up and 
process development, analytical lot release assay development and 
validation, and clinical immunogencity assay development and 
validation.

DATES: To receive consideration, applications must be received no later 
than 5 p.m., Eastern Time, on September 29, 2006.

ADDRESSES: The Office of Grants Management within the Office of Public 
Health and Science of the U.S. Department of Health and Human Services, 
located at 1101 Wootten Parkway, Rockville, MD 20857, must receive all 
applications.

SUPPLEMENTARY INFORMATION: In the last century, three influenza 
pandemics have struck the United States and the world, and viruses from 
birds contributed to all of them. In 1918, the first pandemic infected 
one-third of the U.S. population, killed over half a million Americans, 
reduced American life expectancy by 13 years, and killed more than 20 
million people worldwide. Following the 1918 outbreak, influenza 
pandemics in 1957 and 1968 also killed tens of thousands of Americans 
and millions across the world. The recent limited outbreak of Severe 
Acute Respiratory Syndrome (SARS) in 2003 suggests the danger that a 
modern pandemic would present.
    The H5N1 strain of avian influenza has become the most threatening 
influenza virus in the world, and any large scale outbreak of this 
disease among humans would have grave consequences for global public 
health. Influenza experts have warned that the reassortment of 
different H5N1 viruses over the past seven years greatly increases the 
potential for the viruses to be transmitted more easily from person to 
person. Medical practitioners have also discovered several other, new 
avian viruses that can be transmitted to humans.
    The U.S. Government is concerned that a new influenza virus could 
become efficiently transmissible among humans. Now spreading through 
bird populations across Asia, reaching into Europe, the Middle East 
and, most recently, Africa, the H5N1 strain has infected domesticated 
birds, such as ducks and chickens, and long range migratory birds. In 
1997, the first recorded H5N1 outbreak in humans took place in Hong 
Kong. H5N1 struck again in late 2003, and has, as of August 17, 2006, 
resulted in 239 confirmed cases and 140 deaths world-wide, a 59 percent 
mortality rate. As of now, the H5N1 avian influenza is primarily an 
animal disease; H5N1 infection in humans has been the result of contact 
with sick poultry. Unless people come

[[Page 54483]]

into direct, sustained contact with infected birds, it is unlikely they 
will contract the disease. The concern is that the virus will acquire 
the ability for sustained transmission among humans.
    Equally alarming is that the global influenza vaccine manufacturing 
capacity of 400-500 million doses of vaccine per year is far short of 
the needed 4-8 billion doses that may be needed to protect the global 
population. Influenza vaccine manufacturers are located primarily in 
industrialized countries and provide vaccine to these countries. 
However, other countries lack the resources to procure influenza 
vaccine from the commercial providers and/or are devoid of the 
necessary vaccine manufacturing infrastructure needed to produce 
pandemic influenza vaccine in-country.
    In November, 2005, U.S. President George W. Bush directed all 
relevant Federal Departments and agencies to 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.
    One of the primary objectives of the U.S. Government's 
international efforts on avian and pandemic influenza preparations is 
to pursue and develop 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. These efforts include goals of ensuring the rapid reporting of 
outbreaks and containing such outbreaks beyond the borders of the 
United States, by taking the following actions:
     Work through multilateral health organizations such as the 
World Health Organization (WHO), the United Nation's Food and 
Agriculture Organization (FAO), the World Organization for Animal 
Health (OIE), and regional organizations such as the Asia-Pacific 
Economic Cooperation (APEC) forum, as well as through bilateral and 
multilateral contacts, to do the following:
     Support the development and exercising of avian-influenza 
and pandemic-response plans;
     Expand in-country medical, veterinary and scientific 
capacity to respond to an outbreak;
     Educate populations at home and abroad about high-risk 
practices that increase the likelihood of virus transmission between 
species;
     Encourage nations to develop production capacity and 
stockpiles to support their response needs, to include the pooling of 
efforts to create regional capacity;
     Ensure that there is maximal sharing of scientific 
information about influenza viruses between Governments, scientific 
entities and the private sector;
     Work with our international partners to ensure we are all 
leveraging the most advanced technological approaches available for 
vaccine production;
     Work through the International Partnership on Avian and 
Pandemic Influenza to develop a coalition of strong partners to 
coordinate actions to limit the spread of a virus with pandemic 
potential beyond the location where it is first recognized to protect 
U.S. interests abroad; and
     Where appropriate, offer and coordinate assistance from 
the United States and other members of the International Partnership.
    Through such partnerships other bilateral and multilateral 
initiatives, we will promote these principles and support the 
development of an international capacity to prepare, detect and respond 
to an influenza pandemic. For example, the WHO global action plan 
promotes increased capacity for production of human influenza pandemic 
vaccines to reduce the anticipated gap between the potential vaccine 
demand and supply during an influenza pandemic.
    This announcement seeks to support increased access to vaccines by 
stimulating influenza vaccine development and manufacturing 
infrastructure building by institutions in foreign countries as they 
develop sustainable programs for vaccines to prevent avian H5N1 or 
other influenza viruses in humans.
    Within the U.S. Department of Health and Human Services (HHS), the 
Office of Public Health Emergency Preparedness (OPHEP) intends to award 
to the WHO Secretariat a maximum grant award of $10,000,000. OPHEP may 
award subsequent grants or cooperative agreements in future fiscal 
years for international development of H5N1 vaccine (or other pandemic 
vaccine candidates), in the event OPHEP receives congressional 
authority and funding.
    Only the Secretariat of the World Health Organization is eligible 
to submit an application for this funding opportunity.
    Other funds the WHO Secretariat chooses to provide for such 
efforts, within the WHO Pandemic Influenza Framework may support 
similar program efforts in other, additional countries or complementary 
activities in the same countries.

I. Funding Opportunity Description

    Authority: The Department of Defense, Emergency Supplemental 
Appropriations to Address Hurricanes in the Gulf of Mexico and 
Pandemic Influenza Act, 2006, Pub. L. 109-148 119 Stat. 2680, 2786 
(2005).

    Purpose: The purposes of the award are to do the following:
     Support the production of candidate vaccines, in the 
countries specified, to prevent the H5N1 strain of influenza in humans, 
under proper biosafety and quality conditions, for clinical trials;
     Provide funding for the development and manufacturing of 
human vaccine candidates against the H5N1 strain of highly pathogenic 
avian influenza and the establishment of pilot production and 
commercial-scale vaccine manufacturing processes for non-(pre)clinical 
safety and immunogenicity testing that could lead to regulatory 
approval or licensure of a human H5N1 vaccine by national regulatory 
authorities in the specified countries for the prevention of H5N1 
influenza virus infection in humans; and
     Develop inactivated H5N1 vaccines by using eggs or 
qualified cells or cell lines and a virus reassortant qualified by the 
WHO that contains HA and NA genes derived from a recent human H5N1 
influenza strain.

Measurable Outcomes

    Measurable outcomes of the program will be in alignment with the 
U.S. President's National Strategy for Pandemic Influenza 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 U.S. President's initiative on pandemic-influenza 
preparedness:
     Prevent and contain an incipient epidemic through capacity 
building and in-country collaboration with international partners;
     Work in a manner complementary to and supportive of 
expanded cooperation with and appropriate

[[Page 54484]]

support of key multilateral organizations (including the WHO, the FAO 
and the OIE);
     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; and/or
     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 actions based on the best available science.

Grantee Activities

    Grantee activities for this award are as follows:
     Perform activities related to pandemic influenza 
preparedness and planning, particularly in the international 
development of H5N1 human vaccines (and other pandemic influenza 
vaccine candidates) and influenza vaccine manufacturing infrastructure 
building in countries where resources for vaccine acquisition and 
manufacturing may be limited. The specific countries in which the WHO 
Secretariat will carry out these activities are Argentina, Brazil, 
India, Indonesia, Mexico, Romania, Russia, South Africa, and Tunisia. 
Activities include pre-clinical safety and immunogenicity testing, 
toxicology testing, clinical vaccine lot manufacturing, scale-up and 
process development, analytical lot release assay development and 
validation, and clinical immunogencity assay development and 
validation. All procurement transactions or contracts entered into by 
the WHO shall be conducted in a manner to provide, to the maximum 
extent practical, open and free competition for public sector and 
private sector entities in the target countries. The recipient shall be 
alert to organizational conflicts of interest as well as noncompetitive 
practices among contractors that may restrict or eliminate competition 
or otherwise restrain trade.
     Undertake relevant activities to develop standard methods 
and reagents;
     Conduct periodic, site visits, with international experts;
     Ensure work supported by these grants complies with WHO 
biosafety guidelines for pandemic-influenza vaccine manufacturing and 
acceptable to the relevant national regulatory agency;
     Provide H5N1 virus reference vaccine strains from WHO 
influenza virus reference laboratories; and
     Provide WHO potency reagent standards, including virus 
reference antigen and antiserum, for lot-release testing of human 
vaccines against the H5N1 strain.
    Activities not eligible for funding include the following:
     Study design, implementation, and analysis of clinical 
trials; and
     Preparation of vaccine candidates for licensure by a 
country's national regulatory agency.
    HHS Activities for this program are as follows:
    1. Participate in an orientation meeting with the grantee on 
expectations, regulations and key management requirements, as well as 
reporting requirements and formats and contents. The orientation could 
include staff from HHS agencies and the Office of the Special 
Representative for Avian and Pandemic Influenza at the U.S. Department 
of State.
    2. Provide the WHO Secretariat with the necessary resources and 
expert assistance in specialized training areas.
    All influenza virus information obtained or developed as a result 
of the foregoing activities or other activities funded under this 
cooperative agreement shall be shared with HHS, the WHO Global 
Influenza Network, and WHO Collaborating Centers of Influenza, and 
placed in the public domain, worldwide. If the WHO Secretariat enters 
into contracts or other agreements to accomplish the requirements of 
this cooperative agreement, WHO shall include language in such 
contracts and agreements stating that any information obtained or 
developed as a result of the foregoing activities or other activities 
funded under this cooperative agreement shall be shared with HHS, the 
WHO Global Influenza Network, and WHO Collaborating Centers of 
Influenza and placed within the public domain, worldwide. The WHO 
Secretariat shall also include language in said contracts or agreements 
that makes the United States Federal Government a third-party 
beneficiary to any information obtained or developed as a result of the 
foregoing activities or other activities funded under this cooperative 
agreement.

II. Award Information

    This project will be supported through the cooperative agreement 
mechanism. HHS anticipates making only one award. The period of 
performance is September 15, 2006 through September 14, 2007.
    Approximate Current Fiscal Year Funding: $10,000,000.

III. Eligibility Information

1. Eligible Applicant

    The WHO Secretariat is the only worldwide organization with the 
experience and scientific standing to accomplish the goals set forth in 
this RFA. It is the recognized world health authority within the United 
Nations system. It has over 40 years of experience in establishing and 
monitoring vaccine programs. The WHO has established a pandemic 
influenza program that includes disease-surveillance, assistance with 
vaccine production, and through its unique system of WHO Collaborating 
Laboratories, the technical expertise to recommend and supply unique 
and relevant reagents necessary for the production and characterization 
of pandemic influenza vaccines. There is no other organization with 
this history and capability.
    Program efforts in other and additional countries may be supported 
by other funds the WHO Secretariat chooses to provide for such efforts, 
within the WHO Pandemic Influenza Framework.

2. Cost-sharing or Matching Funds

    Matching funds are not required for this program. Although matching 
funds are not required, preference may go to organizations that can 
leverage additional funds to contribute to program goals.

3. Special Requirements

    If the application is incomplete or non responsive to the special 
requirements listed in this section, the application will not enter 
into the review process. HHS will notify the applicant that the 
application did not meet submission requirements.
     HHS will consider a late application to be nonresponsive. 
Please see section on Submission Dates and Times.
     Section 503, Departments of Labor, Health and Human 
Services, Education and related agencies, Appropriations Act, 2006, 
Pub. L. 109-149, 119 Stat. 2833, which states that appropriated funds 
under the Act shall not be used for lobbying activities, applies.

IV. Application and Submission Information

1. Address To Request Application Package

    Applicants may request application kits by calling 1-(240) 453 
8822, or by writing to the Office of Grants

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Management, Office of Public Health and Science, U.S. Department of 
Health and Human Services, 1101 Wootten Parkway, Suite 550, Rockville, 
MD 20852. Applicants may also fax a written request to the HHS/OPHS 
Office of Grants Management at 1-(240) 453 8823 to obtain a hard copy 
of the application kit. Applicants must prepare their applications by 
using Form OPHS 1.

2. Content and Form of Submission

    Application: Applicants must submit a project narrative in English, 
along with the application forms, in the following format:
     Maximum number of pages: 50. If your narrative exceeds the 
page limit, HHS will only review the first 50 pages within the page 
limit;
     Font size: 12-point, unreduced;
     Single-spaced;
     Paper size: 8.5 by 11 inches;
     Page margin size: One inch;
     Number all pages of the application sequentially from page 
one (i.e., the Application Face Page) to the end of the application, 
including charts, figures, tables, and appendices;
     Print only on one side of page; and
     Hold application together only by rubber bands or metal 
clips, and do not bind it in any way.
    The narrative should address activities over the entire project 
period, and must include the following items, in the order listed:
A. Understanding of the Requirements.
    The application shall include a discussion of your organization's 
understanding of the need, purpose and requirements of this cooperative 
agreement, as well as the U.S. President's National Strategy and the 
principles of the International Partnership on Avian and Pandemic 
Influenza. The discussion shall be sufficiently specific, detailed and 
complete to clearly and fully demonstrate that the applicant has a 
thorough understanding of all the technical requirements of this 
announcement.
    The applicant must describe how it will perform the requirements 
(meet the goals) in this RFA. The applicant must include a description 
of what standards will be used to measure the effectiveness and 
accomplishments of the requirements in the cooperative agreement. 
Measures must be objective and quantitative, and must measure the 
intended outcomes. The applicant must submit a section on measures of 
effectiveness with its application, and they will be an element for 
evaluation.
B. Project Plan
    Background and Significance:
     Describe the background and justify the need for the 
proposed project to enhance or expand the development and manufacturing 
of human candidate vaccines against the H5N1 strain of influenza in the 
targeted countries.
     Applicants must provide timelines, milestones (as 
appropriate) and address specific areas of risk, such as scientific, 
facility, regulatory and mitigation plans to ensure timely completion 
of the project.
C. Staffing and Management Plan
    The applicant must provide a project staffing and management plan, 
which must include time lines and sufficient detail to ensure that it 
can meet the Federal Government's requirements in a timely and 
efficient manner. The applicant must provide r[eacute]sum[eacute]s that 
identify the educational and experience level of any individual(s) who 
will perform in a key position and other qualifications to show the key 
individuals' ability to comply with the minimum requirements of this 
announcement. The applicant must provide a summary of the 
qualifications of non key personnel. R[eacute]sum[eacute]s must be 
limited to three pages per person.
    The proposed staffing plan must demonstrate the applicant's ability 
to recruit, retain, and replace personnel who have the knowledge, 
experience, local language skills, training and technical expertise 
commensurate with the requirements of this announcement. The plan must 
demonstrate the applicant's ability to provide bilingual personnel to 
train and mentor host country participants.
D. Budget Justification
    The budget justification, limited to 10 pages, will count against 
the overall 50-page application limit. This justification must comply 
with the criteria for applications. The applicant must submit, at a 
minimum, a cost proposal fully supported by information adequate to 
establish the reasonableness of the proposed amount.
    The applicant may include additional information in the application 
appendices, which will not count toward the narrative page limit. This 
additional information may include Curricula Vitae, 
R[eacute]sum[eacute]s, Organizational Charts, Letters of Support, etc.
    An agency or organization must have a Dun and Bradstreet Data 
Universal Numbering System (DUNS) number to apply for a grant or 
cooperative agreement from the Federal Government. The DUNS number is a 
nine digit identification number, which uniquely identifies business 
entities. Obtaining a DUNS number is easy, and there is no charge. To 
obtain a DUNS number, access the following Internet address, https://
www.dunandbradstreet.com, or call 1 866 705 5711.
    Additional requirements that could require submission of additional 
documentation with the application appear in Section VI.2, 
``Administrative and National Policy Requirements.''

3. Submission Dates and Times

    To be considered for review, applications must be received by the 
HHS/OPHS Office of Grants Management by 5 p.m., Eastern Time on the 
date specified in the dates section of the announcement. HHS will 
consider applications as having met the deadline if we receive them on 
or before the deadline date. The application due date in this 
announcement supersedes the instructions in the OPHS 1.
Submission Mechanisms
    HHS/OPHS, which is serving as the awarding agency for HHS/OPHEP, 
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 the receipt of applications submitted by using any of these 
mechanisms. HHS will not accept applications submitted to the HHS/OPHS 
Office of Grants Management after the deadlines identified below. HHS 
will not accept for review applications that do not conform to the 
requirements of the cooperative agreement announcement, and will return 
such applications to the applicant.
    Applicants may submit electronically only via the electronic 
submission mechanisms specified below. HHS will not accept 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 https://www.Grants.gov Web site Portal.
    Applicants must submit electronic grant applications no later than 
5 p.m., Eastern Time, on the deadline date specified in the 
``Submission Dates and Times'' section of this announcement, by using 
one of the electronic submission mechanisms specified below. The HHS/
OPHS Office of Grants Management must receive all required

[[Page 54486]]

hard-copy original signatures and mail in items by no later than 5 
p.m., Eastern Time, on the next business day after the deadline date 
specified in the ``Submission Dates and Times'' section of this 
announcement.
    HHS will not consider applications as 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 as late application 
submissions that do not adhere to the due date requirements, and will 
consider them ineligible.
    HHS encourages applicants to initiate electronic applications early 
in the application development process, and to submit prior to or early 
on the due date. This will allow sufficient time to address any 
problems with electronic submissions prior to the application deadline.
Electronic Submissions via the HHS/OPHS eGrants System
    The HHS/OPHS electronic grants-management system, eGrants, provides 
for the electronic submission of applications. Information about this 
system is available on the OPHS eGrants Web site, at the following 
Internet address: https://egrants.osophs.dhhs.gov; or interested 
parties may request it from the HHS/OPHS Office of Grants Management at 
1-(240) 453B8822.
    When submitting applications via the HHS/OPHS eGrants system, 
applicants must 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/OPHS must receive them 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, 
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 the HHS/OPHS Office of Grants Management receives items, it will 
update the electronic application status 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 we have received 
all signatures and mail in items.
Electronic Submissions via the https://www.Grants.gov Web site Portal
    The Grants.gov Web site Portal provides organizations with the 
ability to submit applications for HHS/OPHS grant opportunities. 
Organizations must successfully complete the necessary registration 
processes to submit an application. Information about this system is 
available on the Grants.gov Web site, at the following Internet 
address: https://www.grants.gov.
    In addition to electronically submitted materials, applicants may 
be required to submit hard-copy signatures for certain program-related 
forms, or original materials as required by the announcement. 
Applicants must review both the cooperative agreement announcement as 
well as the application guidance provided within the Grants.gov 
application package to determine such requirements. Applicants must 
submit separately any required hard-copy materials or documents that 
require a signature via mail to the HHS/OPHS Office of Grants 
Management, and which, if required, must contain the original signature 
of an individual authorized to act for the applicant agency and to 
assume the obligations imposed by the terms and conditions of the 
cooperative agreement award.
    Electronic applications submitted via the Grants.gov Web site 
Portal must contain all completed online forms required by the 
application kit, the Program Narrative, Budget Narrative and any 
appendices or exhibits. HHS must receive all required mail in items by 
the due date 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. It is critical that the applicant print and 
retain this confirmation, as well as a copy of the entire application 
package for its records. 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 be transferred to 
the HHS/OPHS eGrants system, and HHS/OPHS has no responsibility for any 
application 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 an application, applicants 
should immediately mail all required hard-copy materials to the HHS/
OPHS Office of Grants Management by the deadlines specified above. It 
is critical the applicant clearly identify the Organization name and 
Grants.gov Application Receipt Number on all hard-copy materials.
    Once Grants.gov has validated an application, it will be proceed 
electronically 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 through 
the Grants.gov Web site Portal.
    Applicants should contact Grants.gov regarding any questions or 
concerns about the electronic application process used by the 
Grants.gov Web site Portal.
Mailed or Hand-Delivered Hard-Copy Applications
    Applicants who submit applications in hard copy (via mail or hand 
delivered) 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.

[[Page 54487]]

    HHS will consider mailed or hand delivered applications will be 
considered 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 ``Submission Dates and Times'' section 
of this announcement. The application deadline date requirement 
specified in this announcement supersedes the instructions in the OPHS 
1. HHS will return to the applicant, unread, applications that do not 
meet the deadline.

4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

5. Funding Restrictions

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

6. Other Submission Requirements

    None.

V. Application Review Information

1. Criteria

    HHS will evaluate applications against the following factors:
    Factor 1: Does the application reflect a thorough understanding of 
the RFA and provide an acceptable plan for the accomplishment of these 
requirements including detailing the process for procurement 
transactions or contracts to ensure, to the maximum extent practical, 
open and free competition for public sector and private sector entities 
in the target countries? (50 points)
    Factor 2: Does the applicant have an established Pandemic Influenza 
program that includes disease surveillance, and assistance in vaccine 
production, and does it have the technical expertise to be able to 
recommend and supply relevant reagents? (25 points)
    Factor 3: Does the applicant have a successful history in working 
with the United States Government and the U.S. Department of Health and 
Human Services (HHS) on pandemic influenza issues? (25 points)

2. Review and Selection Process

    HHS/OPHEP will review applications for completeness. An incomplete 
application or an application that is non responsive to the eligibility 
criteria will not advance through the review process. HHS will notify 
applicants if their applications did not meet submission requirements.
    An objective review panel, which could include both Federal 
employees and non Federal members, will evaluate complete and 
responsive applications according to the criteria listed in Section 
V.1, ``Criteria,'' above.

VI. Award Administration Information

1. Award Notices

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

2. Administrative and National Policy Requirements

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

3. Reporting Requirements

    The applicant must provide The Grants Management Specialist at HHS 
listed in the ``Agency Contacts'' section of this announcement with an 
original, plus two hard copies, as well as an electronic copy of the 
following reports in English:
    1. A quarterly progress report, due no less than 30 days after the 
end of each quarter of the budget period. The quarterly progress report 
must contain the following elements:
    a. Activities and Objectives for the Current Budget Period;
    b. Financial Progress for the Current Budget Period;

[[Page 54488]]

    c. Proposed Activity Objectives for the New Budget Period;
    d. Budget;
    e. Measures of Effectiveness; and
    f. Additional Requested Information.
    2. An annual progress report, due 90 days after the end of the 
budget period, which must contain a detailed summary of the elements 
required in the quarterly progress report;
    3. Final performance reports, due no more than 90 days after the 
end of the project period; and
    4. A Financial Status Report (FSR) SF 269 is due 90 days after the 
close of each 12 month budget period.
    Recipients must mail the reports to the Grants Management 
Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    For program technical assistance, contact the following:
    Robin A. Robinson, Ph.D., Associate Director (Acting) for Medical 
Counter Measures Programs (Influenza), Office of Public Health 
Emergency Medical Countermeasures, Office of Public Health Emergency 
Preparedness, U.S. Department of Health and Human Services, 330 Switzer 
Bldg., Room 1512, 330 C Street, SW., Washington, DC 20201, (202) 205-
3931 office, (202) 205-3915 fax, e-mail: robin.robinson@hhs.gov.
    Andrew Robertson, Ph.D., Office of Public Health Emergency 
Preparedness, U.S. Department of Health and Human Services, 200 
Independence Avenue, SW., Room 638G, Washington, DC 20201, (202) 401-
5839, (202) 690-6512, e-mail: andrew.robertson@hhs.gov.
    For financial, grants management, or budget assistance, contact:
    DeWayne Wynn, Grants Management Specialist, Office of Grants 
Management, Office of Public Health and Science, Department of Health 
and Human Services, 1101 Wootten Parkway, Suite 550, Rockville, MD 
20857, telephone: (240) 453-8822, e-mail address: 
DeWayne.Wynn.os@hhs.gov.

    Dated: September 11, 2006.
W. Craig Vanderwagen,
Assistant Secretary for Public Health Emergency Preparedness, U.S. 
Department of Health and Human Services.
[FR Doc. E6-15325 Filed 9-14-06; 8:45 am]
BILLING CODE 4150-37-P