International Research in Infectious Diseases, including AIDS

International Research in Infectious Diseases, including AIDS is sponsored by National Institutes of Health (NIH), U.S. Department of Health and Human Services (DHHS). This Funding Opportunity Announcement encourages applications from organizations/institutions in eligible foreign countries, including Bangladesh, that propose research related to infectious diseases that are of interest/importance to that country, including AIDS.

Expired RFA-AI-14-002: International Collaborations in Infectious Diseases Research (U19) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title International Collaborations in Infectious Diseases Research (U19) U19 Research Program Cooperative Agreements Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-AI-14-001 , U 01 Research Project Cooperative Agreements Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from U.S. institutions and collaborating foreign (non-U.S.) institutions to study infectious diseases (excluding HIV/AIDS) of great public health significance in resource-constrained countries.

The collaboration must include, at a minimum, one U.S. institution and one eligible foreign institution. Eligible foreign countries are defined as low-income economies, lower-middle-income economies, and upper-middle-income economies, as defined by the World Bank.

This work is expected to increase scientific knowledge on public health related issues, enhance relevant research experience for U.S. and foreign investigators, promote the development of research capacity, and encourage future collaborative Open Date (Earliest Submission Date) Letter of Intent Due Date(s) March 7, 2014, by 5:00 PM local time of applicant Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) ** ELECTRONIC APPLICATION SUBMISSION REQUIRED** NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants. gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted.

ASSIST replaces the Grants. gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ) and where instructions in the Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement I. Funding Opportunity Description The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. The NIAID has a long-standing interest in and commitment to global health and international research on infectious diseases.

A solid foundation of international research and collaborations enhances the U.S. capacity for infectious disease research and the ability to respond to newly emergent disease threats.

Moreover, the availability of NIAID-sponsored overseas study sites for field research advances our global public health agenda and allows for research that might not be possible in the U.S. The International Collaborations in Infectious Disease Research (ICIDR) Program, initiated in 1980, makes awards to institutions in the US and/or foreign countries to engage in substantial international collaborations in infectious disease research (excluding HIV/AIDS).

The goals of the ICIDR program are to: support high-quality, collaborative research that will lead to or result in detection, prevention, amelioration, and/or improved treatment of infectious diseases; increase relevant and collaborative research experience for both U.S. and foreign investigators; and facilitate and enhance scientific linkages between U.S. and foreign investigators to enhance the independent research capacity of the collaborating foreign institutions and foster further international collaborative research projects.

This FOA invites applications from U.S. institutions or institutions in eligible, resource-limited foreign countries proposing collaborative research focused on infectious diseases that disproportionately affect the health of people living in resource-limited countries. The collaboration must include, at a minimum, one US institution and one eligible foreign institution.

However, additional collaborations may be included with other developed countries, and/or with more than one eligible foreign country. Both the U.S. and eligible foreign institutions must have a lead investigator identified as key personnel; each lead investigator (U.S. and foreign) must have a primary appointment at the collaborating institution.

Both the U.S. and foreign lead investigators must have a significant role in the design, implementation, monitoring, and administrative management of the research projects. Eligible foreign countries are defined as low-income economies, lower-middle-income economies, and upper-middle-income economies, as defined by the World Bank. (See Section III.

1 Eligible applicants). Applicants may choose to submit single project applications (U01 see companion RFA-AI-14-001) or multiple project applications (U19). Specific Areas of Research Interest The ICIDR program supports research requiring access to populations of infected human and/or other mammalian hosts, parasites, and/or vectors limited or unavailable in the U.S. and other developed countries.

majority of research supported under the ICIDR program must be conducted at one or more foreign sites with an emphasis on field and clinical studies of endemic Characteristics of the proposed research should include the Research on infectious diseases (except HIV/AIDS), including emerging infections, that are of importance and/or interest to the foreign collaborating country, including one or more of the following: Research addressing infectious diseases of significant public health importance within the collaborating foreign country that cannot be addressed in the U.

S or other developed countries, such as (but not limited to): dengue, tuberculosis, trachoma, Nipah, and malaria. Research may also include studies of vector-borne pathogens for which the vector is not endemic to the U.S. and/or colonies are not available in U.S. labs.

Research addressing neglected or understudied infectious diseases where little may be known about the impact on public health in areas outside developed countries, and where there is reason to believe that these infections contribute to the disease burden in the foreign country, including recently emerging diseases, such as MERS-CoV.

Research on infectious diseases in special populations or in the setting of co-infections that are particular to the eligible country/countries. Examples include but are not limited to: pertussis, pneumonia, and diarrhea in infants.

For diseases that can be studied within U.S. populations, research must focus on aspects of disease or on populations that are not available in the U.S. Examples include but are not limited to: vector-pathogen-reservoir interactions, regional epidemiology, Chagas disease, congenital syphilis, influenza in tropical areas and hepatitis.

Also included are emerging and unique diseases that are rare in the US, such as those caused by the viral hemorrhagic fever viruses. Research may focus on more than one organism/infectious disease (e.g. diarrheal or respiratory diseases), including co-infections and microbiome studies, provided a strong rationale is given.

Within the guidelines above, studies may be proposed on any aspect of infectious diseases, including, but not limited to: the epidemiology, natural history of disease, pathogenesis, and immunopathogenesis; epidemiologic or natural history studies to define the incidence, clinical presentations, time course, and outcomes of diseases; studies of correlates of immunity to infectious diseases in patients with little or no disease; identification of resistance patterns; identification of biomarkers that can be used to develop diagnostics, targets for therapy or vaccines; characterization of susceptible cohorts for a particular pathogen; and pilot or feasibility studies in preparation for larger studies.

Development and/or evaluation of point-of-care or improved diagnostics is encouraged. Evaluation of new diagnostics is allowed as long treatment/care is determined by standard, accepted procedures and results of the evaluated diagnostic for an individual are not reported back to the treating physician and do not impact care. Routine diagnosis, treatment, and care must be provided outside of the proposed research project.

Development of immunological, microbiological, biostatistical, epidemiological, data management and clinical research capacity at the endemic sites is strongly encouraged.

Multidisciplinary collaborations are encouraged to ensure the appropriate breadth of scientific expertise in contributing fields, including but not limited to infectious diseases, biochemistry, immunology, genetics, pharmacology, molecular biology, microbiology, zoology, and medical entomology. Annual Programmatic Meetings will be held to facilitate communication and collaboration among funded ICIDRs.

Responsibilities associated with organizing and attending these meetings are detailed in the cooperative agreement terms and conditions of award below. The following areas of research are not responsive to this FOA and will NOT Research focused on HIV/AIDS, the interaction of HIV/AIDS and an infectious organism/disease or other disease/condition, or the study of interventions intended to treat or prevent HIV/AIDS.

Research limited to sample collection at a foreign site for detailed sample evaluation in developed/high economy [U.S. and non-U.S.] Research proposing clinical trials of interventions in humans. Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards NIAID intends to commit $5 million in FY 2015 to fund 5 - 8 cooperative agreements.

Direct costs are limited to $500,000 per year excluding The scope of the proposed project should determine the project period. The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Eligible countries are defined as low-income economies, lower-middle-income economies, and upper-middle-income economies by World Bank definition: http://siteresources. worldbank.

org/DATASTATISTICS/Resources/CLASS. XLS . The application must include a collaborative arrangement between the U.S. and one or more established institutions (e.g. university, research institute, federal or state health department, hospital) located in one or more eligible foreign (non-U.S.) countries.

Non-domestic (non-U.S.) components of U.S. organizations are NOT eligible to apply as the foreign institution, but are eligible to apply as However, organizational components (e.g., branches, posts) of institutions headquartered in the U.S. and other upper income economies that are physically located in an otherwise eligible country will not be eligible as the foreign country institution; they may apply as an additional collaborator.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) The PD(s)/PI(s) must hold a primary appointment at either a U.S. institution or at an institution in an eligible country.

Investigators at other U.S. or other high economy country institutions may be included as collaborators on the project(s). However, the majority of the research must be conducted in an eligible resource-limited This FOA does not require cost sharing as defined in the NIH Grants Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

and Submission Information 1. Requesting an Application Package Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants. gov .

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants. gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.

gov will also be accepted. It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Annie Walker-Abbey, Ph. D.

Division of Extramural Activities National Institute of Allergy and Infectious Diseases (NIAID) Zip Code for express couriers: 20817-1821 Types Available in ASSIST Strategy/Program Plan Page Limits Core (use for Scientific/Service/Resource Core) Project (use for Research Projects) Additional page limits described in the SF424 Application Page Limits must be followed.

Instructions for the Submission of Multi-Component The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components: Administrative Core: required Scientific/Service/Resource Core: optional, only 1 Core is Research Projects: 2 required, no maximum When preparing your application in ASSIST, use Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. Research & Related Other Project Follow standard instructions. Do not include Facilities & Other Resources or Equipment attachments to the Overall Component.

Instead, load separate attachments containing only the information relevant to each individual research Project Component and Core Component within that component section of Project/Performance Site Location(s) summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the Key personnel must be identified for both the U.S. and eligible foreign institution(s). If both U.S. and foreign PD(s)/PI(s) are not identified, then someone in key personnel must be identified as the major collaborator (MC).

The MC must have a primary appointment at the collaborating U.S. or foreign institution. The MC must participate in the design, implementation, monitoring, and administrative management of the proposed summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission. Aims: List in priority order, the broad, long-range objectives and goals of the proposed program.

Concisely and realistically describe the hypothesis or hypotheses to be tested. Strategy: This section summarizes the overall research strategy for the multi-component application. The multi-component application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another.

This is an important section, for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme.

Summarize the special features in the environment and/or resources that make this application strong Identify and describe the overall goals and objectives of the proposed ICIDR, the potential importance of the proposed research to the health and well-being of the population in the disease endemic country, the organization of the ICIDR, the role of the participating institutions, and the role of all consortium members.

Include the research question(s) to be addressed. Include a timeline for the planning, implementation, conduct and completion of all research project(s) proposed. of Support: A letter of support, signed by the institutional official must be included for each collaborating institution.

Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. When preparing your application in ASSIST, use Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Enter Human Embryonic Stem Cells in each relevant Research & Related Other Project Information (Administrative Core) Subjects: Answer only the Are Human Subjects Involved?

and 'Is the Project Exempt from Federal regulations? questions. Animals: Answer only the Are Vertebrate Animals Used?

Narrative: Do not complete. Project /Performance Site Location(s) List all performance sites that apply to the specific Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core) In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field. In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

For institutions/organizations proposing a single PD/PI, the PD/PI will serve as the Administrative Core Director. For institutions/organizations proposing multiple PD(s)/PI(s), one PD/PI must be selected to serve as the Administrative Core Director.

Through the required Administrative Core functions indicated below, the Administrative Core Director provides leadership and guidance in fulfilling the stated objectives of his or her ICIDR, and is responsible for creating within the Administrative Core an infrastructure that promotes cross-discipline interactions among all of the Research Projects and Core(s), and provides oversight and governance over fiscal and resource Budget (Administrative Core) Budget forms appropriate for the specific component will be included in the application package.

Include the committed level of effort of the administrative Applicants should request funds for the Annual Programmatic Meeting and Kick-Off Meeting in the budget. Annual Programmatic Meeting of all ICIDRs funded under this FOA are to start during the second year of award and should be attended by the PD(s)/PI(s), MC(s), and selected key personnel.

These individuals should also budget and plan to attend the kick-off meeting to be held within three months of award. Effort of ICIDR Personnel: It is expected that ICIDR scientists from the U.S. institution will travel to the foreign affiliate for long-term collaborations at the foreign site. It is anticipated that the U.S. PD(s)/PI(s) orMC will spend up to 2 months per year at the foreign site.

Other U.S. ICIDR investigators may be expected to spend longer periods of time at the foreign site. The U.S. PD(s)/PI(s) or MC must expend at least 2. 4 person months effort on the ICIDR program.

The foreign PD(s)/PI(s) or MC must commit at least 3. 6 person months effort. The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries.

All other SF424 (R&R) PHS 398 Research Plan (Administrative Aims: Briefly describe the specific aims of the Administrative Strategy: Describe plans and procedures for establishing and managing an Administrative Core that provides the organizational capacity to: Coordinate, supervise and manage all ICIDR's activities Provide a supportive structure sufficient to ensure the accomplishment of all research objectives and projects Assist Research Project and Core Leaders with administrative aspects of their projects, such as gathering of progress reports and facilitating other communications with awardees and their mentors Promote collaboration and coordination among Research Project and Identify and describe quality control and analysis plans Foster infrastructure development and training at the collaborating foreign site(s) Communicate and interact with NIAID staff Plan : The Administrative Core should include a Management Plan that describes the organization of the proposed program and its management structure.

The Management Plan should include: the organization of the ICIDR and its management structure to form a cohesive, integrated and efficient unit that provides scientific and administrative oversight of Research Projects and Cores; and an overview of how the multiple Research Projects will be coordinated, integrated, and scientifically and technically managed to answer the scientific questions and hypotheses proposed within the application and within the scope of this FOA.

The Management Plan should also include a Staffing the structure and roles of administrative and scientific staff, the training and experience of proposed staff and the functions Management : A data management system, managed at the foreign site must be maintained for the ICIDR project.

Applicants must provide a description of the existing or planned data management system, including security features for controlled access to project data, tracking system for forms and activities, date and time stamps for all data records with electronic signatures, and audit trails to track all changes made to records. Training requirements for data managers and data entry personnel must be specified in the application.

It is recommended that data management systems be developed using U.S. Food and Drug Administration (FDA) guidelines on electronic records issued in 21 CFR part 11 ( http://www. biotechnicalservices. com/downloads/21CFRpart11.

pdf ). Biostatical support must be maintained for the ICIDR project. A description of how biostatistical support will be provided must be included in Arrangements: If the ICIDR award is made to a U.S. institution, research activities conducted at the foreign affiliate must be supported under a consortium agreement made with the U.S. institution.

If the ICIDR award is made to a foreign institution, research activities conducted at the U.S. institution must be supported under a consortium agreement made with the foreign institution. Capacity Building: The applicant should include for disseminating research findings to host country health leaders. This A summary of training needed by investigators and field staff to conduct the proposed research.

A summary of how capacity building and research and training objectives will be evaluated.

of Support: The applicant must include a countersigned letter of commitment from the non-applicant collaborating institution(s) indicating acceptance of the proposed research and documenting both foreign/U.S. investigators and the foreign/U.S. site to be used as the collaborating Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Planned Enrollment Report (Administrative When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core) When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. When preparing your application in ASSIST, use Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

A minimum of two individual research Projects is required. Each of the two or more individual Research Projects must present a unified approach to the overall goals of the ICIDR.

SF424 (R&R) Cover (Research Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Research Enter Human Embryonic Stem Cells in each relevant Research & Related Other Project Information (Research Projects) Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations?

questions. Animals: Answer only the Are Vertebrate Animals Used? Narrative: For each research project, succinctly outline the specific research goals and the Center’s plan for attaining these goals.

& Other Resources: For each individual Research Project, include the attachment Facilities & Other Resources to provide information on resources available for that project. If there are multiple performance sites, describe the resources available at each site.

Describe any special facilities used for working with biohazards or other potentially Equipment: For each individual Research Project, include the attachment Equipment to provide information on equipment available for that project. If there are multiple performance sites, describe the equipment available at each site. Describe any special equipment used for working with biohazards or other potentially dangerous substances.

Project /Performance Site Location(s) List all performance sites that apply to the specific Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries. Research &