ip11-1102 foa final amendment i 04.19.11.doc

AMENDMENT I: April 19, 2011

TO PUBLISHED FOA IP11-1102

· Page 32, last paragraph, sentences 1 and 2. Replace “objective” with “technical”.

· Page 33, mid-page. Strike sentence discussing rankings under “Application Selection Process” and replace with “Not Applicable.”

The purpose of these amendments is to make clear that this sole-source award will be reviewed by a technical panel rather than a full objective panel.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC) “Integrated Economic, Dynamic Disease, Risk and Decision Analytic Modeling of Global and Domestic Policy Issues for Polio”

I. AUTHORIZATION AND INTENT

Announcement Type:

· New – Type 1 Funding Opportunity Number: CDC-RFA-IP11-1102 Catalog of Federal Domestic Assistance Number: 93.185 Key Dates:

Application Deadline Date: April 25, 2011, 5:00pm Eastern Standard Time Authority:

This program is authorized under Section 307 of the Public Health Service Act, as amended, 42 U.S.C. 242l, and section 104 of the Foreign Assistance Act of 1961, 22 U.S.C. 2151b.

Background:

In 1988, when the World Health Assembly committed to the eradication of wild polioviruses, these viruses (types 1, 2, and 3) paralyzed over an estimated 350,000 children per year globally. After investing approximately $7.5 billion to date, the Global Polio Eradication Initiative (GPEI) has succeeded in eradicating type 2 wild polioviruses and reducing the number of cases of paralytic polio to less than 1,000 cases annually in 2010. The success of the GPEI contributes to its demise. The perception of polio no longer representing a major health threat due to the decreased disease burden makes obtaining funding to finish eradication a challenge for the GPEI, particularly given numerous competing demands for resources.

Kid Risk, Inc. and its predecessor (the Harvard Kids Risk Project) collaborated with researchers at CDC to develop mathematical models to support national and global policy makers as they explore options for managing the risks of polioviruses, both domestically and internationally. The existing differential equation based (DEB) dynamic disease model for polio (1) and polio individual-based model (developed with support from the WHO Polio Research Committee) represent important tools to support policy analyses. However, significant opportunities exist to improve the DEB model by addressing some important limitations identified in the original publication (e.g., improved treatment of secondary oral polio vaccine (OPV) and evolution of circulating vaccine-derived polioviruses (cVDPVs). In addition, the evolution of vaccine tools and discussions about the potential role of inactivated polio vaccine (IPV) for global routine use necessitate that we expand and update the existing DEB model so that we can accurately model new global options for managing risks during the pre-eradication, transition, and post-eradication periods (e.g., consideration of different IPV dosing regimens, characterization of serotype specificity to consider the implications of making different vaccine types for pre-eradication immunization, and consideration of the impact of evolving population immunity in different settings).

Numerous challenges continue to arise with respect eradicating wild polioviruses and developing policies for managing the risks of polioviruses during and after eradication for which mathematical modeling offers the opportunity for important insights. Following up directly on previously developed economic, dynamic disease, risk and decision analytic modeling tools, this work will support the development and analysis of policies related to managing the risks of polioviruses after successful eradication of wild polioviruses (i.e., post-eradication).

In addition, given delays in achieving global eradication, GPEI partners now seek the same types of analytical tools to address pre-eradication and transition period issues and the prior post-eradication analyses will need to be updated to account for changes that have and will continue to occur up through the achievement of eradication including new vaccination options, current efforts to develop potential antivirals for polio. In spite of a potentially large opportunity associated with the development of polio antivirals, currently the strategic case for their development remains a significant gap in the literature.

Efforts are needed to iterate on the differential equation based (DEB) model using an expanded set of immunity states based on the information provided by an expert review. Updated modeling will also quantify the role of secondary OPV exposure for different serotypes in providing population immunity in settings with very frequent supplemental immunization activities (SIAs) (e.g., northern India) or very low population immunity (e.g. northern Nigeria). This modeling will help to characterize the importance of SIAs as a pre-eradication strategy, and combined with additional modeling will demonstrate the importance of maintaining high levels of population immunity, at least up until the time of OPV cessation, with respect to managing the risks associated with cVDPVs.

Work is also needed to update the overall economic and policy analysis models for post-eradication (Thompson et al., 2008; Duintjer Tebbens et al., 2008) and to expand on the modeling tools to allow evaluation of specific questions for all three time periods: pre-eradication, transition, and post-eradication. The post-eradication options will require reassessment as IPV options continue to evolve with dose-sparing, adjuvants, and alternative delivery devices. In addition, conditions continue to change associated with the delays in achieving eradication, and the implications of these changes as they relate to assumptions made about population immunity and risks warrant reassessment. GPEI decision makers will demand additional economic analyses to help them understand the trade-offs associated with various options, and it will be essential to update the estimates of the risks, costs, and benefits to reflect the actual set of post-eradication options. In addition, economic analyses are also needed to support policies during the transition period. Notably, questions have already been raised about the potential and expected economics (incremental cost-effectiveness and incremental net benefits) associated with using IPV during the OPV cessation transition period (i.e., assuming transitional use of IPV for various lengths of time after successful disruption of wild polioviruses but prior to and for various points of time after OPV cessation).

Given the importance of maintaining high quality surveillance through the transition period and into post-eradication period, when OPV cessation will occur and one or more outbreaks from cVDPVs are expected to require response, the cooperative agreement efforts will continue to explore issues related to surveillance and anticipated use of the global vaccine stockpile. Specifically, the cooperative agreement includes characterization of the value of information from surveillance during the transition period, quantification of the consequences of possible reductions in surveillance sensitivity, and exploration of the role that environmental surveillance could play in early detection of circulating live viruses. The efforts also include developing and exploring scenarios related to characterization of the consequences of unmet vaccine needs from the proposed stockpile of monovalent oral polio vaccine (mOPV) to be used during the OPV cessation period to control potential cVDPVs.

Domestically, although the US maintains very high levels of coverage through routine immunization, important sources of heterogeneity exist in the population. Additional modeling offers an important opportunity to help domestic policy makers explore the potential need for vaccine and outbreak response strategies for at-risk sub-populations (i.e., different types of populations of vaccine exemptors). Specifically, prior work identified the need for domestic modeling efforts focused on two specific, identified types of populations (i.e., a large community with a relatively high proportion of parents who seek Personal Belief Exemptions [PBEs] for their children [reflecting recent trends], and a distributed network of connected un[der]immunized small communities with known [historical] objections to vaccines). Work is needed to assess the US polio vaccine stockpile needs for these 2 specific types of communities and explore the larger implications related to resource considerations for preparedness.

The specific aims of this cooperative agreement are the following:

A. Develop appropriate new and modified models and appropriate inputs required to achieve all of the other specific aims and document technical assumptions in detail to support review of the work.

B. Characterize the risks of cVDPV outbreaks during the transition and OPV cessation periods reflecting updated current and projected vaccination trends to assess population immunity and demonstrate the importance of continued investments in vaccination to achieve high coverage rates (with either OPV or IPV) up until OPV cessation (at which point IPV will be the only option).

C. Characterize the value of information of monitoring and activities to ensure data quality during the pre-eradication, transition, and post-eradication period, qualitatively characterize the consequences of poor quality data about vaccine coverage rates for both routine and supplemental immunization activities, and quantify the trade-offs associated with poor quality data for routine immunization and/or supplemental immunization activities for some specific examples.

D. Model two populations of interest with respect to the potential for domestic (US) outbreaks and potential demand for polio vaccines from the stockpile: (1) a large urban community with a relatively high proportion of parents who seek Personal Belief Exemptions (PBEs) for their children (reflecting recent trends), and (2) a distributed network of connected un(der)immunized small communities with known (historical) objections to vaccines.

E. Discuss the implications of delayed eradication with respect to the changing population immunity profile and the potential role of older children and adults in the transmission of infection, and review the conditions that led to the accumulation of susceptibility and outbreaks in previously polio-free countries (including development of case studies of outbreaks to demonstrate the impacts of the various conditions).

F. Characterize the value of information from surveillance during the transition period, quantify the consequences of possible reductions in surveillance, and explore the role that environmental surveillance could play in early detection of circulating live viruses.

G. Develop the strategic (economic and scientific) case for investment in the development of antivirals and model the impact of the future risk of reintroduction of a live poliovirus from an immunodeficiency-related vaccine-derived poliovirus ( iVDPV) effectively treated with one or more polio antiviral.

H. Update the analyses of the expected economics (incremental cost-effectiveness and incremental net benefits) associated with the post-eradication options.

I. Develop and explore scenarios related to characterization of the consequences of unmet vaccine needs from the proposed stockpile of mOPV during the OPV cessation period to control potential cVDPVs to provide additional analytical support for the design and optimization of the stockpile.

J. Communicate the lessons learned from integrated modeling and the global polio eradication experience to promote knowledge transfer that will assist other potential global disease eradication efforts.

Purpose:

The purpose of the program is to support the US Government endorsed Global Polio Eradication Initiative (GPEI). This program addresses the “Healthy People 2020” focus areas of “Global Health” and “Immunization and Infectious Diseases.”

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD) and the Center for Global Health (CGH):

· Long Term Objective 13.B.1: Help domestic and international partners achieve World Health Organization's goal of global polio eradication.

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

II. PROGRAM IMPLEMENTATION

Recipient Activities:

Year 1 Tasks and Milestones

· Task 1: Iteration on the expanded DEB model with the expanded immunity states based on the information discussed in the expert review completed in CDC Phase I and development of appropriate new and modified models and appropriate inputs required to achieve all of the other specific aims. This task highlights the importance of continued model development and iteration throughout the entire Cooperative Agreement, with the expectation that this task will cover efforts required to document technical assumptions in detail to support review of the work. The specific questions addressed in all of the other tasks will lead to the development of new and/or modified model components as the work proceeds, and the collaborators anticipate that over the course of the efforts, completion of this task will lead to one or more reports (potentially publishable in the technical literature) that provide technical modeling details by Month 36 (Months 1-36).

· Task 2: Review updated current and projected vaccination trends to assess population immunity for all time periods (i.e., pre-eradication, transition, and post-eradication). Review the current data related to the risks of circulating vaccine-derived polioviruses (cVDPVs) and build on the PRC-related modeling of the evolution of OPV viruses to quantitatively estimate the risks of cVDPV outbreaks during the pre-eradication, transition, and post-eradication time periods (Months 1-10).

· Task 3: Review the available data related to monitoring and data quality, and qualitatively discuss the consequences of poor quality data about vaccine coverage rates for both routine and supplemental immunization activities by month 15 (Months 1-15).

· Task 4: Select and characterize the specific large US community with relatively high proportion of parents who seek Personal Belief Exemptions (PBEs) for their children (e.g., San Diego) for modeling. This characterization should include analysis of the current and expected future population immunity profile based on analysis of available vaccine coverage data with respect to polio in this community based on the best available population and vaccination history information and on different potential forecasts of future vaccine acceptance. Consider the potential role of transients, including illegal aliens, and identify all groups that may represent sources of heterogeneity in the population with respect to polio immunity (Months 1-4).

· Task 5: Select and characterize the distributed network of connected small communities in the US with historical vaccine objectors (e.g., the Amish). Obtain and synthesize all available data needed to model the network (Months 1-4).

· Task 6: Characterize the heterogeneity in population immunity in the large US community that could imply the existence of pockets of susceptibles (e.g., related to exemptor populations) and present these to the CDC collaborators for discussion about model inputs (Months 5-9).

· Task 7: Build a geographical information system (GIS) model to mathematically characterize the connectivity of the network of US communities and present this model to CDC collaborators for discussion about model inputs (Months 5-9).

· Task 8: Review the conditions that led to the accumulation of susceptibility and outbreaks in Tajikistan and other previously polio-free countries, prepare a case study of one or more outbreaks to demonstrate the impacts of the various conditions, and develop an assessment of the risks associated with national population immunity profiles to complement CDC’s on-going risk assessment efforts by month 15 (Months 6-15).

· Task 9: Review the conditions that led to the accumulation of susceptibility and outbreaks in Tajikistan and other previously polio-free countries, prepare a case study of one or more outbreaks to demonstrate the impacts of the various conditions, and develop an assessment of the risks associated with national population immunity profiles to complement CDC’s on-going risk assessment efforts by month 15 (Months 6-15).

· Task 10: Review the literature and qualitatively discuss the different types of surveillance and the choices that influence the quality of surveillance information obtained (Months 6-15).

· Task 11: Estimate the number of potential cases and consider the potential observation of “clustering” that could be occur if live polioviruses were introduced into a large US urban population and infections spread due to heterogeneity in immunity (Months 8-10).

· Task 12: Estimate the number of potential cases and consider the potential for geographic spread prior to detection of a case that could be occur if live polioviruses were introduced into the distributed network of un(der)immunized small populations in the US (Months 8-10).

· Task 13: Demonstrate the importance of continued investments in vaccination to achieve high coverage rates (with either OPV or IPV) up until OPV cessation (at which point IPV will be the only option) as a critical management strategy for reducing the risks of cVDPVs now and in the future (Months 8-13).

· Task 14: Estimate the potential demands for vaccine in the large US community given an outbreak in the context of a range of assumptions about vaccine acceptance and identify important issues for surveillance and communication, including communication to other nearby large communities that may also include large numbers of PBEs (Months 10-11).

· Task 15: Estimate the potential demands for vaccine in the distributed US network given an outbreak in the context of a range of assumptions about vaccine acceptance and identify important issues for surveillance and communication, including communication to other nearby large urban areas (Months 10-11).

· Task 16: Write and revise a report (in the form of a draft manuscript for potential publication) related to the strategic case for the development of antivirals with completion of a report will be submitted by the end of Year 2 (Months 11-24).

Year 2 Tasks and Milestones:

· Task 17: Write and revise a report (in the form of a draft manuscript for potential publication) that describes the work and insights from modeling the potential of an outbreak in a large US community with submission of the report by Month 14 (Months 12-14).

· Task 18:

Write and revise a report (in the form of a draft manuscript for potential publication) that describes the work and insights from modeling the distributed US network of un(der)immunized small communities with submission of the report by Month 14 (Months 12-14).

· Task 19: Write and revise a report (in the form of a draft manuscript for potential publication) related to characterizing the risks of cVDPVs during all time periods and the importance of continued investments in vaccination to achieve high coverage rates (with either OPV or IPV) up until OPV cessation (at which point IPV will be the only option) with submission of the report by the end of Month 18 (Months 12-18).

· Task 20: Write and revise a report related to the potential impact of eliminating or reducing the future risk of reintroduction of a live poliovirus from an immunodeficient vaccine-derived poliovirus (iVDPV) excretors, and quantify the potential benefits of antivirals (Months 12-16).

· Task 21: Develop models to assess the value of information from monitoring and activities to ensure data quality and quantify the trade-offs associated with poor quality data for routine immunization and/or supplemental immunization activities for some specific examples (Months 15-24).

· Task 22: Write and revise a report (in the form of a draft manuscript for potential publication) related to the implications of delayed eradication with respect to the changing population immunity profile and the potential role of older children and adults in the transmission of infection, and link this to the need for active management of population immunity in polio-free countries at risk for outbreaks by month 26 (Months 15-26).

· Task 23: Develop models to assess the value of information from surveillance during the transition period, quantify the consequences of possible reductions in surveillance, and explore the role that environmental surveillance could play in early detection of circulating live viruses (Months 16-28).

· Task 24: Develop scenarios to characterize the consequences of unmet vaccine needs from the stockpile in terms of costs and polio cases and to explore optimal stockpile and procurement and filling strategies for different outbreak response tools (i.e., mOPV serotypes, IPV, and antivirals) (Months 22-30).

Year 3 Tasks and Milestones:

· Task 25: Write and revise a report (in the form of a draft manuscript for potential publication) related to the value of information from monitoring and activities to ensure data quality and quantify the trade-offs associated with poor quality data for routine immunization and/or supplemental immunization activities for some specific examples by month 28 (Months 24-28).

· Task 26: Develop an economic model to characterize the expected economics (incremental cost-effectiveness and incremental net benefits) associated with the post-eradication options by extending the original analyses presented by Thompson et al. (2008) and Duintjer Tebbens et al. (2008) and addressing the key limitations identified in those analyses with respect to evolution of IPV options (i.e., including the possibility of dose-sparing, adjuvants, and alternative delivery devices) (Months 24-30).

· Task 27: Write and revise a report (in the form of a draft manuscript for potential publication) that reviews the conditions that led to the accumulation of susceptibility and outbreaks in previously polio-free countries, presents one or more case studies of outbreaks that demonstrate the impacts of the various conditions, and identifies countries currently at risk by month 36 (Months 26-36).

· Task 28: Write and revise a report (in the form of a draft manuscript for potential publication) related to the expected economics (incremental cost-effectiveness and incremental net benefits) of post-eradication policies with expected submission of manuscript for clearance by end of Month 36 (Months 28-36).

· Task 29: Write and revise a report (in the form of a draft manuscript for potential publication) to characterize the value of information from surveillance during the transition period, quantify the consequences of possible reductions in surveillance, and explore the role that environmental surveillance could play in early detection of circulating live viruses with submission of the report by Month 36 (Months 28-36).

· Task 30: Write and revise a report (in the form of a draft manuscript for potential publication) related to characterization of the consequences of unmet vaccine needs from the stockpile in terms of costs and polio cases and to exploration of optimal stockpile and procurement and filling strategies for outbreak response tools (i.e., different mOPV serotypes, IPV, and antivirals) with expected submission of manuscript for clearance by end of Month 36 (Months 28-36).

· Task 31: Write and revise a report (in the form of a draft manuscript for potential publication) related to the technical innovations of the modeling tools developed by Month 36 (Months 35-36).

· Task 32: Write and revise a report (in the form of a draft manuscript for potential publication) related to communication of lessons learned from performing integrated polio modeling. The manuscript will address common myths and misperceptions that people may hold with respect to polio eradication and post-eradication issues (i.e., it would address issues related to mistaken assumptions about the risks being equivalent in all countries if they all use the same vaccine, inconsistent assumptions related to coverage given a switch of vaccines, etc.) with completion of the manuscript by Month 24. This task involves mainly writing, and it is mentioned here because some of the work may be started during Year 2, but most (if not all) of the effort is expected and the report will be submitted by the end of Year 3 (Months 24-36).

· Task 33: Write and revise a report (in the form of a draft manuscript for potential publication) related to updates of the Cost paper (Duintjer Tebbens et al., 2006a) and Risk paper (Duintjer Tebbens et al., 2006b) if needed to support Task 27 with expected submission of the report by Month 36 (Months 33-36).

· Task 34: Write and revise a final summary on factors to consider in the economic implications of disease eradication and preliminary lessons learned from polio eradication to assist other potential global disease eradication efforts. (Months 33-36).

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities:

· Provide technical assistance to Kid Risk, Inc. in support of the activities implemented under this agreement. Specific assistance activities include:

· Engagement in interactive discussions of model assumptions and supporting data,

· Provision of required technical data (laboratory and epidemiological) for model inputs and additional information and expert judgments about critical sources of uncertainty to be used to characterize probability distributions for model inputs, iteration on preliminary results of data analyses and model development activities to support model validation activities,

· Participation in discussions related to written and oral communications of insights based on CDC staff’s in-depth field and laboratory expertise. This participation is expected to be at the level that warrants co-authorship on all of the reports identified as deliverables (and subsequent publication in appropriate peer-reviewed journals to the extent possible).

· Provide a forum for information exchange by arranging in-person meetings (estimated twice per year) and monthly conference calls with Kid Risk, Inc. staff, CDC polio eradication staff, WHO polio eradication initiative staff, Bill & Melinda Gates Foundation, and other partners as appropriate, in order to provide appropriate information and to agree on model modifications and strategies for cost-effectiveness data collection and presentation.

· Arrange, in collaboration with WHO, in-kind staff assistance to aid with data collection and model review activities.

· Arrange access to other partners involved in the GPEI, including WHO, regional WHO offices, UNICEF, Rotary International, National Health leaders in polio endemic countries, and Task Force for Global Health.

· Promote effective communication of collaborative insights within CDC and with CDC’s partners in polio eradication efforts.

III. AWARD INFORMATION AND REQUIREMENTS

Type of Award: Cooperative Agreement. CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism: U66: Immunization Projects – Cooperative Agreements Fiscal Year Funds: 2011 Approximate Current Fiscal Year Funding: $ 319,100 (Includes direct and indirect costs.)

Approximate Total Project Period Funding: $ 1,150,000 (This amount is an estimate, and is subject to availability of funds. It includes direct and indirect costs.)

Approximate Number of Awards: 1 Approximate Average Award: $ 319,100 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

Floor of Individual Award Range: None.

Ceiling of Individual Award Range: None. (This ceiling is for the first 12-month budget period, and includes direct and indirect costs.)

Anticipated Award Date: June 1, 2011 Budget Period Length: 12 Months Project Period Length: 3 years Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

IV. ELIGIBILITY

Kid Risk, Inc is the only qualified agency to provide the services specified under this acquisition because:

A. Kid Risk, Inc has developed the only available integrated dynamic global model of polio risks and costs, a process that involved 6 years of extensive literature review, data-gathering and model development and iteration, with extensive collaboration with CDC, WHO, and other international polio experts. CDC has been a major partner in polio eradication since 1991. The program is aware of, and works closely with, all the partners who are involved in this enormous public health project. Nevertheless, as the program did before the first sole-sourced cooperative agreement with Kid Risk, the program consulted its extensive literature search library (updated monthly) to be sure that no one else was conducting research that could potentially be related to the kind of tools we needed developed as we move closer to the post-wild-poliovirus-interruption phase of eradication. The search turned up nothing, especially since Kid Risk owns all the intellectual property upon which the cooperative agreement will be based.

B. Kid Risk, Inc staff has developed, in the last 6 years, extensive knowledge and expertise about the GPEI and has collected data relative to polio risks and costs, which will be critical for the necessary timely completion of the project.

C. Kid Risk, Inc project has established collaborative, respected relationships with the World Health Organization (WHO) and other polio eradication initiative partners. This will be essential for the collection of unpublished information about historic vaccination costs and for the collaborative effort with WHO to develop and conduct proposed data collection efforts.

D. Kid Risk, Inc started as the Kids Risk Project at the Harvard School of Public Health. Harvard spun the Kids Risk Project into Kid Risk, Inc. The Principal Investigator became President of an independent non-profit organization called Kid Risk, Inc. which is endowed with the same personnel, and the same intellectual property of the former Kids Risk Project. CDC’s National Immunization Program (and subsequently the National Center for Immunization and Respiratory Diseases) had cooperative agreements with Harvard’s Kids Risk Project for 5 years, under which the Polio Eradication Branch collaborated extensively and Global Immunization Division and the Division of Viral Diseases worked directly with the Kids Risk Project staff. During the previous cooperative agreement, Harvard subcontracted the work to Kid Risk, Inc., which developed complex dynamic models to assess the risks and costs of polio outbreaks and the cost-effectiveness of different strategies to prevent and control polio, all of which now belongs to Kid Risk, Inc. The work under the cooperative agreements resulted in 12 peer-reviewed papers written collaboratively with CDC scientists on polio eradication issues specifically relevant to cost-effectiveness and policy options of polio eradication strategies.

E. Kid Risk, Inc., as a project under the Harvard School of Public Health and now as a non-profit organization, has established fully collaborative, respected relationships with the World Health Organization (WHO) and other GPEI partners, has also performed other polio policy assessments for WHO and the Bill and Melinda Gates Foundation. Further partner collaboration will be essential for the collection of unpublished information about historic and projected program costs and for the collaborative effort with WHO to work with specific country representatives.

F. NCIRD had a contract with Kid Risk, Inc in 2010 to determine the model inputs and uncertainty distributions for the second generation of the differential equation based (DEB) dynamic disease model and toto examination of the role of intestinal immunity in poliovirus transmission, and have a current contract to further modify the existing tools for more complex analyses. This includes specifically developing models for India and Nigeria that we anticipate will be needed to support efforts to address key pre-eradication policy questions relevant to those countries. The deliverables for these contracts developed as expected.

G. The proposed agreement supports and is directly related to the achievement of CDC objectives for the control and prevention of vaccine preventable diseases and one of the CDC Director’s Winnable Battles in Global Health, polio eradication.

As stated above, Kid Risk, Inc is the only organization that can uniquely provide an integrated economic, dynamic disease, risk and decision analytic model of global and domestic policy issues to meet all of the GPEI program requirements including cost and time constraints.

SPECIAL ELIGIBILITY CRITERIA: Licensing/Credential/Permits

Cost Sharing or Matching

Cost sharing or matching funds are not required for this program.

Maintenance of Effort

Maintenance of Effort is not required for this program.

Special Requirements:

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.

Intergovernmental Review of Applications

Executive Order 12372 does not apply to this program.

V. Application Content

CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm Other Requirements

Letter of Intent (LOI):

A letter of intent is not applicable to this funding opportunity announcement.

A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

A Project Narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format:

· Maximum number of pages: 20. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

· Font size: 12 point unreduced, Times New Roman

· Double spaced

· Page margin size: One inch

· Number all narrative pages; not to exceed the maximum number of pages.

The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:

1. Plan

2. Short-Term (1 year) Objectives

3. Long-Term Objectives

4. Method

5. Staff

6. Evaluation and Performance Measures

7. Budget Justification. The budget justification will not be counted in the stated page limit. (If funds for indirect costs are requested, the applicant must include a current, approved indirect cost rate agreement with the application)

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit.

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:

· Curriculum Vitas, Resumes, Organizational Charts, Letters of Support, etc.

Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named:

· Curriculum vitae, Letters of Support, Indirect Cost Rate Agreement, etc.

No more than 25 electronic attachments should be uploaded per application.

Additional requirements for additional documentation with the application are listed in Section VII. Award Administration Information, subsection entitled “Administrative and National Policy Requirements.”

APPLICATION SUBMISSION

Registering your organization through www.Grants.gov, the official agency-wide E-grant website, is the first step in submitting an application online. Registration information is located on the “Get Registered” screen of www.Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, the Grants.gov registration process also requires that you register your organization with the Central Contractor Registry (CCR) annually. The CCR registration can require an additional one to two days to complete.

Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC Procurement and Grant Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 for further instruction.

Note: Application submission is not concluded until successful completion of the validation process.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. Applicants are strongly encouraged check the status of their application to ensure submission of their application package is complete and no submission errors exists. To guarantee that you comply with the application deadline published in the Funding Opportunity Announcement, applicants are also strongly encouraged to allocate additional days prior to the published deadline to file their application. Non-validated applications will not be accepted after the published application deadline date.

In the event that you do not receive a “validation” email within two (2) business days of application submission, please contact Grants.gov. Refer to the email message generated at the time of application submission for instructions on how to track your application or the Application User Guide, Version 3.0 page 57.

Dun and Bradstreet Universal Number (DUNS)

The applicant is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) identifier to apply for grants or cooperative agreements from the Federal government. The DUNS is a nine-digit number which uniquely identifies business entities. There is no charge associated with obtaining a DUNS number. Applicants may obtain a DUNS number by accessing the Dun and Bradstreet website or by calling 1-866-705-5711. International registrants can confirm by sending an e-mail to ccrhelp@dnb.com, including Company Name, D-U-N-S Number, and Physical Address, and Country.

Electronic Submission of Application:

Applications must be submitted electronically at www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully made available to CDC for processing from Grants.gov on the deadline date. The application package can be downloaded from www.Grants.gov. Applicants can complete the application package off-line, and then upload and submit the application via the Grants.gov Web site. The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than PDF may result in the file being unreadable by staff.

Applications submitted through Grants.gov (http://www.grants.gov), are electronically time/date stamped and assigned a tracking number. The AOR (Authorized Organization Representative) will receive an e-mail notice of receipt when Grants.gov receives the application. The tracking number serves to document submission and initiate the electronic validation process before the application is made available to CDC for processing.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

Organizations that encounter technical difficulties in using www.Grants.gov to submit their application must attempt to overcome those difficulties by contacting the Grants.gov Support Center (1-800-518-4726, support@grants.gov). After consulting with the Grants.gov Support Center, if the technical difficulties remain unresolved and electronic submission is not possible to meet the established deadline, organizations may submit a request prior to the application deadline by email to GMO/GMS for permission to submit a paper application. An organization's request for permission must: (a) include the Grants.gov case number assigned to the inquiry, (b) describe the difficulties that prevent electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to the GMO/GMS at least 3 calendar days prior to the application deadline. Paper applications submitted without prior approval will not be considered.

If a paper application is authorized, the applicant will receive instructions from PGO TIMS to submit the original and two hard copies of the application by mail or express delivery service.

Submission Dates and Times

This announcement is the definitive guide on application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the applicant will be notified the application did not meet the submission requirements.

Application Deadline Date: April 25, 2011, 5:00pm Eastern Standard Time.

VI. Application Review Information

Eligible applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the CDC-RFA-IP11-1102. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

Evaluation Criteria Eligible applications will be evaluated against the following criteria:

1.

The extent to which the applicant plan is adequate, and to which short-term and long-term objectives are realistic, measurable, time-phased, and related to recipient activities. (20%)

2.

The ability and demonstrated knowledge and experience of the candidate to use dynamic mathematical modeling for the development of a global retrospective cost-effectiveness analysis for polio. (40%)

3.

The demonstrated ability of the candidate to collect unpublished data and information from global sources, including WHO. (20%)

4.

The ability of the candidate to produce work products, including written documents and oral presentations. (20%)

5.

The extent to which the budget request is clearly justified and consistent with the intended use of funds. (Reviewed, but not scored) Although the budget is not scored applicants should consider the following in development of their budget. Is the itemized budget for conducting the project, and justification reasonable and consistent with stated objectives and planned program activities? If the applicants requests indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

Funding Restrictions Restrictions, which must be taken into account while writing the budget, are as follows:

· Recipients may not use funds for research.

· Recipients may not use funds for clinical care.

· Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

· Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.

· The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

· Reimbursement of pre-award costs is not allowed.

The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:

http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

Application Review Process

All eligible applications will be initially reviewed for completeness by the Procurement and Grants Office (PGO) staff. In addition, eligible applications will be jointly reviewed for responsiveness by NCIRD and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified the application did not meet eligibility and/or published submission requirements.

A technical review panel will evaluate complete and responsive applications according to the criteria listed in Section VI. Application Review Information, subsection entitled “Evaluation Criteria”. The technical review process will follow the policy requirements as stated in the GPD 2.04 at http://198.102.218.46/doc/gpd204.doc. Applications will be reviewed objectively by a minimum of three CDC employees from outside of the funding center that will serve as independent reviewers. Reviewers will be sufficiently independent of the entities applying for assistance to ensure an objective and unbiased evaluation. Independent reviewers will be screened to ensure there is no Conflict of Interest prior to the review of applications. In the event that there is a Conflict of Interest, the reviewer will not participate or be present in the review. Independent reviewers will numerically score each application using only the criteria published in the program announcement.

Applications Selection Process

Not Applicable.

VII. Award Administration Information Award Notices

Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and e-mailed to the program director. A hard copy of the NoA will be mailed to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate. The following additional requirements apply to this project:

· AR-8

Public Health System Reporting Requirements

· AR-9

Paperwork Reduction Act Requirements

· AR-10

Smoke-Free Workplace Requirements

· AR-12

Lobbying Restrictions

· AR-14

Accounting System Requirements

· AR-15

Proof of Non-Profit Status

· AR-25

Release and Sharing of Data

· AR-29

Federal Leadership on Reducing Text Messaging while Driving Additional information on the requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

TERMS AND CONDITIONS

Reporting Requirements

Each funded applicant must provide CDC with an annual Interim Progress Report submitted via www.grants.gov:

1. The interim progress report is due no less than 90 days before the end of the budget period. The Interim Progress Report will serve as the non-competing continuation application, and must contain the following elements:

a. Standard Form (“SF”) 424S Form.

b. SF-424A Budget Information-Non-Construction Programs.

c. Budget Narrative.

d. Indirect Cost Rate Agreement.

e. Project Narrative.

Additionally, funded applicants must provide CDC with an original, plus two hard copies of the following reports:

2. Financial Status Report (SF 269) and annual progress report, no…