and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD) |
|
Funding Opportunity Title |
NIH/PEPFAR Collaboration for Advancing Implementation Science in Prevention of Maternal-Child HIV Transmission (PMTCT) (R01) |
Activity Code |
R01 Research Project Grant |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-HD-12-210 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.865, 93.989 |
FOA Purpose |
The NIH, in collaboration with the Office of the Global AIDS Coordinator, invites applications for implementation science projects that will inform the President’s Emergency Plan for AIDS Relief (PEPFAR) as they develop more efficient and cost-effective methods to deliver proven interventions for prevention of maternal-child HIV transmission (PMTCT). |
Posted Date |
September 6, 2011 |
Open Date (Earliest Submission Date) |
January 28, 2012 |
Letter of Intent Due Date |
January 28, 2012 |
Application Due Date(s) |
February 28, 2012, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
June/July 2012 |
Advisory Council Review |
August 2012 |
Earliest Start Date(s) |
December 2012 |
Expiration Date |
February 29, 2012 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (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). 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
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The NIH, in collaboration with the Office of the Global AIDS Coordinator, invites applications for implementation science projects that will inform the President’s Emergency Plan for AIDS Relief (PEPFAR) as they develop more efficient and cost-effective methods to deliver proven interventions for prevention of maternal-child HIV transmission (PMTCT).
Globally, over 1,000 children are newly infected with HIV each day, the majority in sub-Saharan Africa; the primary mode of HIV acquisition for infants is through mother-to-child transmission (MTCT) during pregnancy, childbirth or breastfeeding. One of the great successes in HIV research has been the development of highly effective interventions to prevent MTCT (PMTCT). Clinical trials have identified simple, less expensive, effective antiretroviral prophylaxis regimens capable of being implemented in resource-limited settings, including interventions to reduce HIV transmission through breastfeeding. Although great strides have been made in implementing PMTCT programs in low- and middle-income countries, there remain significant bottlenecks and challenges in developing and carrying out PMTCT programs in these settings. While the pace of expansion of PMTCT program coverage has been accelerating, it has been slowed by limited availability and access to family planning and antenatal services, low rates of HIV testing among pregnant women, and lack of integration of CD4 testing and antiretroviral treatment services into the antenatal setting, compounded by human and fiscal resource constraints and a lack of political will to prioritize maternal and child health and prevention of MTCT.
PEPFAR has committed to a goal of eliminating new pediatric infections by 2015, a commitment that depends heavily upon successful implementation of efficacious PMTCT interventions. Although there remains debate regarding the optimal antiretroviral intervention to reduce MTCT, and results from ongoing and new clinical trials are eagerly awaited, there is no doubt that we have in hand today the tools to significantly reduce the rate of new HIV infections in children. The ability to implement PMTCT programs is less tied to financing the purchase of the drug regimens or choice of regimen than to the development and support of the maternal-child health infrastructure required for implementation of such programs.
Structural factors within country health systems are one of the largest challenges to implementing effective PMTCT programs. At the country level, maternal, newborn and child health services, where PMTCT programs are targeted, are usually separate from programs, laboratories, and services for HIV treatment and care. PEPFAR has provided guidance on integrating PMTCT programs in HIV, Maternal, neonatal and child health and pediatric HIV services (See http://www.pepfar.gov/guidance/pmtct). However, many antepartum and postpartum care systems are still not equipped to test all women for HIV, conduct CD4 and other laboratory testing to stage disease of HIV-infected women, and provide antiretroviral treatment to women who need it and antiretroviral prophylaxis to the others. On the other hand, programs that have implemented these essential services offer important models and experience for developing implementation strategies that can be tested, evaluated and optimized when used on a larger scale. The success in resource-rich countries in perinatal prevention lies not just in what antiretroviral regimen is provided for PMTCT but the integration of the entire array of services needed for identification, care and treatment of the HIV-infected woman and her infant into the antepartum obstetric and child health infrastructure. Implementation of PMTCT in resource-limited countries offers a unique opportunity to link prevention and treatment efforts, rather than viewing these as competing efforts.
Particularly in rural areas of resource-limited countries, health services remain hard to access or are too expensive. Despite having effective prevention regimens that can be implemented even in settings where women may have only limited antenatal care or present to the health care system for the first time in labor, women must be able to access the health care system to be able to receive such interventions, which may be difficult in rural settings where many deliveries occur at home using traditional birth attendants. While some programs have developed innovative delivery systems for provision of preventive regimens in such settings, there is a need for evaluation and further development of such systems and to test such promising delivery systems in pilot programs and then in regional and national scale-up of services.
Human resource limitations are also a significant constraint toward implementation of PMTCT programs. Task shifting from professional health workers to non-professionals could help facilitate scale-up of prevention services. Donor investment in health systems strengthening and expansion of human resource capacity is critical not just for PMTCT programs but to prepare treatment programs for increased number of people who need treatment, as treatment guidelines move toward earlier initiation of therapy.
Systematic evaluation of program effectiveness is important for measuring the impact of PMTCT programs and to determine best practices, and much work has already been done on this by PEPFAR and the Interagency Task Force. Data on the traditional PMTCT cascade (antenatal attendance, uptake of HIV testing, and use of any antiretroviral drugs in pregnancy) are inadequate to address the true impact of PMTCT programs. Data on numbers of women who have had clinical staging, CD4 cell counts, and viral load testing, and who require and receive antiretroviral treatment, as well as the antiretroviral prophylaxis regimens that are given to women not receiving treatment, are needed. Data on the impact of PMTCT services on HIV transmission to the infant, and more importantly, HIV-free child survival should be considered the gold standard metric to measure the effectiveness of PMTCT programs.
In addition to a better understanding of clinic delivery systems, research is needed on reasons why women do not access such services. Stigma, discrimination, and violence remain realities in the lives of many HIV-infected women and are another barrier to uptake of services. Even in settings where HIV counseling and testing services are available, the impact and nature of social stigma associated with HIV infection that may inhibit women from accessing services to learn their HIV infection status, and, therefore, from taking steps to prevent transmission of HIV to their infant need to be more fully assessed and characterized. Further research in this area is needed, including potential ameliorating interventions.
The limited availability of family planning services in resource-limited countries is also a major challenge. Provision of safe and effective family planning to women who desire to space or limit their childbearing is a key element of perinatal prevention, and capacity for family planning needs to be built within programs caring for HIV-infected women.
Priorities in PMTC/Pediatric/Maternal HIV Care Operational/Implementation Science Research
While there have been improvements in implementation of PMTCT programs in resource-limited countries, in 2009 only 21% of the estimated number of pregnant women living in low resource settings were tested for HIV. Although 45% of HIV-infected pregnant women in these countries received some antiretroviral drugs for PMTCT, most received only single-dose nevirapine for PMTCT and were not evaluated for treatment for their own health (UNICEF Children and AIDS Fourth Stocktaking Report, 2009).
Significant improvement in the effectiveness of PMTCT programs (including treatment of pregnant HIV-infected women who require treatment for their own health) is a high priority. Implementation science is critical to provide strong, evidence-based, scalable interventions to address current barriers to effective PMTCT programs to advance the field and achieve the goal of global elimination of pediatric HIV infection and optimize survival of HIV-infected mothers and their children. Successful operational and implementation science research are studies whose results will change policy or practice and/or improve program and health system performance.
The multiple services/interventions within PMTCT can be viewed as a cascade of interventions, culminating in successful prevention of HIV transmission from mother to infant and survival of the HIV-infected mother/infant pair from assuring that women are able to space and time their childbearing; to accessing antenatal care in general; to counseling and HIV testing; assessing maternal need for therapy for her own health; antiretroviral therapy or prophylaxis delivery; safe delivery practices; provision of optimal infant feeding and nutrition (including to the breastfeeding mother); diagnostic testing of the infant to determine HIV infection status; and postnatal services to ensure optimization of maternal health and provide family planning. The concept of a cascade breaks down the intervention into smaller, incremental components, each of which presents particular challenges and for which different implementation strategies may be most effective. Implementation science research is needed to determine how to best recruit and retain women and their infants at each point of the cascade of antenatal, PMTCT, and postnatal services. Implementation science is also needed to maximize functionality and to compare impact and effectiveness of alternative approaches to PMTCT and maternal/child health interventions that have been effective on a smaller scale.
A number of organizations have recently had consultations on operational research priorities in PMTCT and maternal/pediatric HIV care. These include an Expert Consultation on Operational Research on PMTCT and Pediatric HIV Care and Treatment held by UNICEF, WHO, UNAIDS in collaboration with George Washington University and Elizabeth Glaser Pediatric AIDS Foundation held on September 9-11, 2009; the International AIDS Society/Industry Liaison Forum expert consultation and final report on HIV research priorities for women and children in November 2009; and the Office of AIDS Expert Consultation on Implementation Science Research held on July 23-24, 2009.
The following questions are examples of implementation science questions related to PMTCT and maternal/pediatric HIV care that could be considered for this FOA:
Providing opportunities for enhanced communication and collaboration between implementation scientists and program implementers can help to facilitate better utilization of scientific evidence in programming while simultaneously helping to ensure that research is country-driven and responsive to the local context. The Center for Global Health Studies (based at the Fogarty International Center) will provide a forum for a network ofPD/PIs, key collaborators and PMTCT implementers, to enable cross-fertilization of ideas, insights and experiences as the research progresses. To this end and in partnership with NICHD, CGHS will convene one meeting on the NIH campus each year and two regional meetings each year. Funds should be budgeted in the application to allow PD/PIs and key collaborators to attend annual meetings at NIH and one regional meeting each year.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. The participating NIH institutes and the Office of Global AIDS Coordinator intend to commit a total of $3,350,000 to support 4-8 awards in FY2012. Of that amount, NICHD intends to commit $1,000,000 for fiscal year 2012. Future year amounts will depend on annual appropriations. |
Award Budget |
Total costs of up to $500,000 per year and project duration of up to two years for a maximum of $1,000,000 total costs over a two-year project period. Funds should be budgeted in the application to allow PD/PIs and key collaborators to attend annual meetings at NIH and one regional meeting each year. A minimum of 80% of awarded funds must be spent in the PEPFAR country where the research is taking place. |
Award Project Period |
The scope of the proposed project should determine the project period. The maximum project period is 2 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
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.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations
are strongly encouraged to start the registration process at least four (4)
weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.
At least one of the investigators (which may be the PD/PI) with substantial involvement in the application must have their primary affiliation with an institution based in the PEPFAR country where the proposed research will be conducted.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Applicants must download 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.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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 review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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 plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
George K. Siberry, MD, MPH
Medical Officer
Pediatric, Adolescent, and Maternal AIDS (PAMA)
Branch
Eunice
Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
National Institutes of Health
6100 Executive Boulevard, Room 4B11H
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service;
non-USPS service)
Phone: 301-496-7350
Fax: 301-496-8678
Email: siberryg@mail.nih.gov
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource 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.
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.
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
The PMTCT implementation research applications submitted in response to this FOA must be performed in collaboration with PEPFAR-affiliated programs. Therefore, all applications must include evidence (e.g., letter of support) that one or more PEPFAR-affiliated programs support the conduct of the proposed study in their country.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
How does the study address a priority research area for improving implementation of one or more PMTCT interventions? Are the studies likely to result in substantial and meaningful changes in the approaches and interventions that make up PEPFAR programs? How will answering the operational research question be useful for improving the response to the epidemic and/or the survival of the population of interest? Can the proposed research, if successful, be generalized to PMTCT in different PEPFAR settings? Will the answers to the research question be relevant, useful, and generalizable to the global efforts to scale up PMTCT and/or maternal/child HIV care services? How will investigation of this implementation science research question lead to promotion of health of HIV-women and their children through better PMTCT? If successful, how feasible will it be to rapidly and widely implement the results of the operational research study needed to address the research question (logistically, financially, and in a timely manner)?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the research team have the established collaborations in the PEPFAR country (or countries) necessary to conduct the study and do they present a convincing plan for collaboration for the proposed study? Does the research team include host country investigators as integral parts of the study team? Will at least one of the investigators (which may be the PD/PI) with substantial involvement in the application have their primary affiliation with an institution based in the PEPFAR country where the proposed research will be conducted?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the project challenge existing paradigms or programmatic practice; or address an innovative hypothesis or critical barrier to success of PMTCT in PEPFAR programs? Does the project incorporate new approaches to answer questions related to program design and incorporation of scientific advances in program implementation of PMTCT interventions? Will answering the research question add significantly to the knowledge base related to PMTCT and/or maternal/child HIV care?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed? Can the question proposed be answered through well-designed and conducted operational research? Is
the operational research that is proposed to answer the question feasible
within the current ethical, population and financial environment (is it
logistically feasible, financially doable, and will it give timely results)?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Is there a letter of support and/or other documentation that provides convincing evidence that one or more PEPFAR-affiliated programs support the conduct of the proposed study in their country, and that they are a collaborating partner with the PD/PI? Do the letters of support from other collaborating institutions adequately demonstrate a strong collaboration that will benefit the studies?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NICHD , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
George K. Siberry, MD, MPH
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301.496.7350
Email: siberryg@mail.nih.gov
Nalini Anand, JD, MPH
Fogarty International Center (FIC)
Telephone: 301-496-1491
Email: nalini.anand@nih.gov
Ed Handelsman, MD
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-402-3221
Email: ed.handelsman@nih.gov
Susannah Allison, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3952
Email: allisonsu@mail.nih.gov
Sherry Dupere, PhD
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov
Bryan Clark, MBA
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov
Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: bruce.butrum@nih.gov
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