Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Allergy and Infectious Diseases (NIAID) National Cancer Institute (NCI) National Institute on Alcohol Abuse and Alcoholism (NIAAA) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH)
Funding Opportunity Title	NIH/PEPFAR Collaboration for Implementation Science and Impact Evaluation (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	June 7, 2011 - See Notice NOT-AI-11-048 This Notice announces the activation of a Q&A website.
Funding Opportunity Announcement (FOA) Number	RFA-AI-11-003
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.855, 93.856, 93.394, 93.865, 93.279, 93.273, 93.242
FOA Purpose	The NIH, in collaboration with the Office of the Global AIDS Coordinator, is soliciting applications for support 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 HIV prevention, treatment, and care on a large scale.

Posted Date	April 5, 2011
Open Date (Earliest Submission Date)	May 7, 2011
Letter of Intent Due Date	June 7, 2011
Application Due Date(s)	July 7, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	November, 2011
Advisory Council Review	January, 2012
Earliest Start Date(s)	April, 2012
Expiration Date	July 8, 2011
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 President’s Emergency Plan for AIDS Relief (PEPFAR) is a global health initiative launched in 2003 with the goal of comprehensively combating the devastation due to HIV/AIDS around the world. Implementation science is the study of methods to improve the uptake, implementation, and translation of research findings into routine and common practices (the "know-do" or "evidence to program" gap). The scope of implementation science is broader than typical biomedical research; it seeks to improve program effectiveness and optimize efficiency, including the effective transfer of interventions from one setting to another. The methods of implementation science facilitate making evidence-based choices between competing or combined interventions and improving the delivery of effective and cost-effective programs. A rigorous implementation science research agenda is needed to improve program delivery in PEPFAR and to increase the global impact of proven HIV/AIDS modalities in prevention, treatment, and care. While scientific knowledge to prevent and treat HIV/AIDS has expanded substantially, scientific advances regarding the implementation of effective interventions have not kept pace. There is an unmet need for implementation science research to inform approaches and investments for public health programming and policy making. For example, research is needed to improve the dissemination and uptake of effective interventions, to deliver effective interventions most efficiently, to improve the transfer of interventions from one setting or population to another, to test the effectiveness of at scale combination prevention interventions, and to conduct comparative effectiveness studies to better inform choices between competing interventions. The answers to these questions should improve the operations and efficiency of a proven prevention, treatment or care intervention, and should be applicable across a broader range of targets, strategies, settings, and populations.

There is substantial expertise in the scientific community to address implementation science research questions, including questions in the fields of operations research, epidemiology, sociology, health economics, health services research, anthropology, statistics, political science, policy analysis, and ethics.

The intent of this Funding Opportunity Announcement (FOA) is to solicit implementation science research relevant to programs supported by the PEPFAR. Studies should address the challenges that PEPFAR encounters in the implementation of HIV/AIDS prevention, treatment, and care programs in resource-limited countries. Studies should reflect the needs and priorities of the countries or regions in which they are to be conducted, but also produce results that are quantifiable, relate to scaled-up service delivery, and can be generalized across PEPFAR programs. Studies that address program effectiveness and cost efficiency are particularly important to meeting PEPFAR program goals. Studies that are designed specifically to improve prevention, care and treatment outcomes in most-at-risk populations and those marginalized by gender inequities are high priorities for PEPFAR. Research applications must use data from PEPFAR implementation site(s) and investigators are expected to demonstrate the collaborations necessary to do the proposed study. In addition, to assist in the building of in country expertise, applicants are strongly encouraged to include host country investigators as integral parts of the study team.

The list below provides examples of priority research areas that would be considered responsive to this FOA. The topics were identified in consultations with multiple stakeholders and selected because they reflect urgent needs in countries where PEPFAR is active and seeks to optimize service delivery. It is not an exhaustive list, nor is this list intended to limit studies to these areas of investigation. However, Investigators who submit applications outside of these areas of emphasis should demonstrate the importance of their research and how the results will inform delivery of HIV prevention, care, and treatment in PEPFAR-funded sites.

NOTE: Applicants must include a letter of support from the executive authority of the PEPFAR implementation site(s) involved in the collaboration. This document must be in PDF format. If appropriate letter(s) are not provided the application will be considered nonresponsive and will not be reviewed.

Priority research areas include but are not limited to:

• Role of nutrition and nutritional status in prevention, treatment and care of HIV/AIDS.
• Prevention of mother-to-child HIV transmission (PMTCT).
• Engagement and retention of individuals (adults, adolescents, and children) in HIV care and treatment.
• Integration of primary health care, HIV/AIDS services and treatment of common co-morbidities.
• Scale-up of male circumcision to prevent HIV acquisition.
• Social/behavioral approaches that prevent HIV transmission.

Potential applicants are encouraged to contact the NIH Scientific/Research Contacts listed in this FOA for clarifications on the scope of this initiative, PEPFAR priorities, or other questions related to the application or review process.

Role of Nutrition and Nutritional Status in Prevention, Treatment and Care of HIV/AIDS

The severe nutritional consequence of HIV infection has been recognized for decades, yet there remain significant gaps in our knowledge of how to design and implement the best programs to prevent and treat HIV-associated malnutrition. In 2009, WHO issued Guidelines for an Integrated Approach to the Nutritional Care of HIV-Infected Children (6 months-14 years). Guidelines for adults and adolescents are forthcoming. Household food insecurity challenges the success of PEPFAR treatment and prevention programs in many ways: malnutrition increases HIV-mortality, forces patients to spend considerable time and effort to secure food for their household at the expense of their HIV care, and drives patients to consider risky transactional sex to obtain food. HIV-infected children are particularly vulnerable as they have high nutrient needs to ensure growth and development and are dependent upon adults for care. Prevention of wasting and under-nutrition in those with HIV requires food security in the community and in the home, and an emphasis on nutrition within the health system. The delivery of appropriate nutritional care has been compromised by over-burdened service providers, a lack of training, weak health care systems, and vertical isolation of HIV programs, which reduces synergy across service delivery programs. Implementation research addressing nutrition and HIV/AIDS within PEPFAR is needed to develop optimal cross-cutting nutrition activities. Implementation science in this area includes the evaluation of delivery systems and integration of PEPFAR activities with other nutrition and food support programs as well as the assessment of effectiveness and cost-efficiency of specific nutrition interventions related to PEPFAR programs.

Examples of priority research areas in nutrition include:

• How current WHO guidelines for nutrition can be implemented and what impacts they have on health outcomes for HIV- infected children and adults.
• What minimal elements are needed in a nutritional package for adults in HIV care settings, and how the package will differ for pregnant/lactating women and for children.
• How to effectively integrate programs in nutrition, food supply, primary health care and HIV clinics as nutritional assessment/support services are scaled up, and what approaches are best for monitoring these programs for outcomes.
• What the benefits are to integrating a combination package of nutritional assessment, counseling, clean water, and macro- and/or micronutrient supplementation with other HIV interventions and whether a combined package can be cost-effective.
• To what degree individual- or household-level approaches to improving nutrition lead to better health outcomes for HIV-infected adults and children.

Prevention of Mother-to-Child Transmission of HIV (PMTCT)

Successful prevention of mother to child transmission (PMTCT) is attained through a cascade of interventions, culminating in successful prevention of HIV transmission from mother to infant and survival of the mother/infant pair. These interventions include access to antenatal care; counseling and HIV testing; assessing the therapeutic needs of the mother; provision of antiretrovirals (ARV) as therapy or prophylaxis; safe obstetrical practices; provision of optimal infant feeding and nutrition; testing of the infant to determine HIV infection status; and postnatal services to ensure optimization of maternal health, treatment of infected infants, and effective family planning. The concept of a cascade breaks down the overall PMTCT 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 this cascade of antenatal, PMTCT, and postnatal interventions.

Maternal and infant health are inextricably linked. The majority of maternal deaths and perinatal transmissions occur in women who meet criteria to initiate ARV therapy. Thus, identifying pregnant or lactating HIV-infected women who meet treatment criteria and starting ARV could make substantial impacts on maternal mortality and MTCT. However, clinical services for mothers, newborn and older children may be separate from those for HIV treatment and care. Antenatal and postpartum care systems may be ill-equipped to test all women for HIV infection, conduct CD4 testing to identify disease stage, and provide ARV treatment to women who need it and prophylaxis to the others.

Since the risk of HIV acquisition may be increased in women during pregnancy and acute HIV infection during pregnancy increases the risk of MTCT, preventing HIV acquisition in women testing HIV negative during pregnancy is an important step in preventing HIV infection in children. Repeat HIV testing in late pregnancy or labor (and during the breastfeeding period) may identify acute maternal HIV infection, allow PMTCT interventions, and allow for appropriate care for these women.

Prevention of unintended pregnancy among HIV-infected women may be the most cost-effective way to prevent HIV infection in children. Globally, 80 million of the 211 million pregnancies each year are unintended, and rates of unintended pregnancy among HIV-infected women are higher than in the general population. Capacity for family planning needs to be built into programs delivering clinical services to HIV-infected women.

Examples of priority research areas in PMTCT include:

• How sequential steps in the PMTCT care cascade can be improved.
• How provision of antenatal and obstetrical care by trained providers minimizes drop-off at steps in this cascade.
• The integrated models of antenatal care and ARV treatment that can lead to improved PMTCT.
• How missed opportunities in ARV clinic systems to prevent MTCT can be addressed.
• The approaches for preventing (or detecting early) incident maternal infection during pregnancy and lactation that work best.
• The best approaches to integration of family planning services.
• Approaches by which ARV clinic systems to prevent unintended pregnancies can be addressed.

Engagement and Retention of Individuals (Adults, Adolescents and Children) in HIV Care and Treatment

Engaging HIV-infected individuals in care and treatment on an early and consistent basis is critical to the success of PEPFAR programs. Late treatment initiation, poor adherence, and loss to follow-up threaten the goals of ARV treatment programs. Treatment failure causes significant morbidity for the individual and the community. Late initiation of ARV increases the risks of early mortality, evolution of ARV resistance and treatment failure.

Continuing the scale-up of PEPFAR treatment services within budget constraints requires an effort to ensure efficiency and effectiveness for care and treatment services. Implementation science methodology can help to identify and evaluate innovative practices that will lead to the early diagnosis of HIV-infected individuals, improve the speed of enrollment in care and initiation of appropriate HIV treatment, and maximize adherence and long term follow-up.

Research is needed to identify and strengthen linkages between testing and care services for patients with newly diagnosed HIV; to improve the capacity, effectiveness, and cost effectiveness in providing care to HIV-infected patients prior to eligibility for ARV therapy; and to guide PEPFAR in promoting smooth transitions into treatment programs while maintaining consistency of care and effectively managing the diseases that commonly jeopardize outcomes for HIV-positive individuals (e.g., TB, malaria, liver disease, cervical dysplasia).

Studies are needed to evaluate approaches to improve the effectiveness of treatment programs in retaining patients, reducing morbidity, and minimizing ARV toxicity while maximizing the durability of first-line regimens. Comparative efficiency studies or other types of effectiveness studies are also needed to determine the optimal use of resources for monitoring viral suppression, to monitor and prevent HIV drug resistance, and to evaluate the impact of HIV drug resistance.

Recent data demonstrate high rates of loss-to-follow-up among individuals during care and treatment. Reports indicate that switching treatment sites, dropping out of HIV care and high mortality all contribute to loss-to-follow-up. Sample-based approaches have been developed for tracking and estimating true mortality. However, methods for accurately predicting those at risk of dropping out of care, tracking and facilitating continuity of care for those who switch care sites, and developing programs to reduce loss-to-follow-up across the spectrum of HIV prevention, testing, care, and treatment services have not been tested but are essential to the success of PEPFAR.

Examples of priority research areas in Engagement and Retention include:

• How waiting times for ARV’s can be reduced through streamlined identification of eligible patients and initiation of therapy.
• The practices that improve retention in care and adherence to ARV across most-at risk populations and in specific age groups.
• How clinic visits and lab testing (CD4 and/or HIV viral load) should be spaced to support a durable response to first-line ARV therapies.
• The monitoring strategies that will detect regimen failure early.
• The most cost effective strategies for clinical and laboratory monitoring of adverse events related to ARVs.

Integration of Primary Health Care, HIV/AIDS Services and Treatment of Common Co-Morbidities

As PEPFAR evolves from an emergency plan to a sustainable component of a strengthened health care infrastructure -- consistent with the goals of the Global Health Initiative -- it will become even more important to coordinate and integrate health care services. Integration of HIV/AIDS prevention, care, and treatment services across all tiers of a country’s health care system is an essential next step to ensure that gains from primary HIV care are not lost due to lack of care for serious HIV co-morbidities.

Service integration may benefit both the general health care system and HIV/AIDS services. Collective strengthening of primary care services and HIV services could improve access to primary care through HIV care delivery sites. Expansion of HIV care services could use a family care approach model that also addresses nutrition; maternal and child health; safe water; malaria and other infectious diseases, including tuberculosis (TB); and that maximizes integrated HIV/TB co-infection treatment services. Implementation science approaches can provide information about whether addressing HIV disease and common co-morbidities in primary care facilities compromises the quality of either HIV care or primary health care. In addition, serious co-infections, such as tuberculosis, and co-morbidities (e.g., cancer, liver disease, alcohol or drug use, and mental health conditions) often are not addressed in ARV clinics. Implementation science could address practical questions related to the integration at scale of these services into HIV care.

Examples of priority research areas in the Integration of Health Care, Services and Treatment include:

• How HIV prevention can be optimally integrated with treatment and care services.
• The strategies for addressing HIV and common co-morbidities that are most effective in primary care facilities.
• The models for integrated TB/HIV services that support early detection of TB, effective TB/HIV treatment, and TB prevention among those with HIV.
• The diagnostic algorithms for common clinical syndromes (e.g., HIV co-morbidities) that best achieve economic efficiencies.
• The best system-level approaches for the management of complex HIV-associated co-morbidities (such as treatment of HIV-associated malignancy, palliative care, mental health or substance abuse disorders) when specialty care is not accessible at primary HIV clinics.
• How HIV care or integrated HIV/primary care can utilize cancer care resources (screening, prevention, education) to reduce mortality and morbidity due to HIV-associated cancers.
• How palliative care can be effectively integrated into PEPFAR clinics when curative therapies for serious HIV-related co-infections are not possible.
• How routinely collected data (e.g. clinical, behavioral, and biological datasets) and coordinated data systems can strengthen and improve health care delivery.
• How communication technology can be applied in rural/peripheral areas to improve data collection and health impact.

Scale up of Male Circumcision to Prevent HIV Acquisition

Randomized controlled trials have conclusively shown that medical adult male circumcision (MC) can reduce the risk of HIV acquisition by men from women by 50-60%. MC also reduces transmission of Human Papilloma Virus and Herpes Simplex Virus and has other health benefits. Programs to increase the availability, awareness, acceptability and uptake of MC in countries with a high prevalence of HIV and a low prevalence of circumcision could have a major impact on curtailing HIV spread. However, MC must be part of a combination prevention program and, to optimize their effectiveness at the national level, circumcision programs should be integrated with other prevention programs. Implementation science approaches are needed to understand how to best promote MC uptake, integrate MC into combination prevention approaches, and roll-out MC services efficiently and safely at levels that meet demands.

There is high importance in addressing those immediately at risk, namely young men nearing sexual debut or early in their sexually active years. However, four years after the conclusion of the circumcision trials, it is clear that the cost and complexity of future programs that focus on adults can be significantly reduced by developing neonatal circumcision activities now. Neonatal circumcision can be performed more easily, with lower risk in the newborn and at a lower cost than MC in older childhood/adult males. The impact of neonatal circumcision on later acquisition of HIV has not been studied in clinical trials, but many observational studies have shown a reduced HIV prevalence among men who were circumcised as infants or in childhood/adolescence compared to uncircumcised men. Thus, neonatal circumcision programs may provide cost-effective, long-term population-based benefits in slowing the HIV epidemic for future generations. Implementation science is needed to develop the safest, most acceptable, and most cost-effective way to scale up sustainable programs.

Examples of priority research areas in the scale up of MC include:

• How newborn infant male circumcision can be safely and effectively integrated into newborn care visits.
• How mass communication strategies or other behavioral or structural interventions improve demand and uptake of circumcision among adolescents and adult men.
• How communication strategies may be developed to inform the attitudes and beliefs of men, their partners, new parents or other key decision-makers, about the role of medical male circumcision in a combination prevention strategy.
• How to test various approaches to the rollout of medical male circumcision: centralized or distributed delivery; fixed facility or mobile unit based; continually offered or through mass campaigns; offered to all ages or limited to those at highest risk of infection.

HIV Prevention: Social/Behavioral Approaches

There are significant science-to-practice gaps in the area of social/behavioral interventions for HIV prevention. A wide range of implementation science studies are needed, particularly in the areas of dissemination, adoption, fidelity/adaptation, and sustainability of interventions. These studies may include innovative methods for evaluating the effectiveness and added value of incorporating promising but less tested interventions into a combination prevention package. Translating effective prevention interventions from selected populations under controlled conditions into a variety of real world settings and scaling up these interventions also requires an understanding of the elements of the intervention that are essential for efficacy and those elements that allow some flexibility for a specific target population. A critical question is how best to combine efficacious interventions for specific populations and settings.

Examples of priority research areas in Social/Behavioral Approaches include:

• The prevention interventions that have the highest levels of acceptability and adherence in different populations at high risk of HIV infection. For example, discordant couples in sub-Saharan Africa, adolescents in urban South African setting, men who have sex with men (MSM) in East Africa, illicit drug users, etc.
• Approaches that increase the acceptability of and adherence to prevention interventions of known efficacy.
• Factors influencing impact of efficacious interventions after transfer into broader community and clinic-based settings.
• How target audiences for prevention interventions are defined, how evidence is packaged for various audiences, and how message framing can enhance uptake.
• How individuals can manage the implementation process and whether mentoring can enhance adoption of interventions.
• The essential elements for success of effective interventions in real world settings, including interventions to prevent high risk sexual exposure.
• How the financing of organizations affect intervention adoption, effectiveness, and sustainability.

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 following NIH components and the Office of Global AIDS Coordinator intend to commit the following amounts in FY 2012: NIAID and the Office of Global AIDS Coordinator $10,000,000, number of awards 10-15.
Award Budget	Two types of awards will be considered: 1. Total costs of up to $250,000 per year and project duration of up to three years for a maximum of $750,000 total costs over a three-year project period. 2. Total costs of up to $1,000,000 per year and project duration of up to three years for a maximum of $3,000,000 total costs over a three-year project period.
Award Project Period	The scope of the proposed project should determine the project period. The maximum project period is 3 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:

• 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

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• 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
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign (non-U.S.) components of U.S. Organizations 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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.

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.

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:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service; non-USPS mail)
Telephone: (301) 496-8426
Email: pjackson@niaid.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 application submission. 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) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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.

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.

NOTE: Applicants must include a letter of support from the executive authority of the PEPFAR implementation site(s) involved in the collaboration. This letter must be provided in PDF. Format. These documents should be placed in the Letters of Support section of the PHS 398 Research Plan. If appropriate letter(s) are not provided the application will be considered nonresponsive and 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? If the study does not address one of the identified priority research areas for PEPFAR programs, has the applicant provided strong justification that this is an important implementation science gap in PEPFAR HIV/AIDS prevention, care, and treatment programs? Will the studies have a significant impact on the applications, methods, technologies, treatments, services, or preventative interventions that make up PEPFAR programs? Can the proposed research, if successful, be generalized to different PEPFAR settings that are scaling up HIV prevention, treatment, and care services? How significant an impact will this implementation science research question have on the HIV epidemic profile or the survival of the population of interest? If successful, can the results of the proposed studies be rapidly and widely implemented?

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?

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? For example: Does the project challenge existing paradigms or programmatic practice; or address an innovative hypothesis or critical barrier to success of PEPFAR programs? Does the project incorporate new approaches to answer questions related to program design and incorporation of scientific advances in program implementation?

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?

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? Does the letter of support from the executive authority of the PEPFAR implementation site(s) that will be involved in the collaboration adequately state that the agency receives PEPFAR resources, and that they are a collaborating partner with the project PI/PD? 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) NIAID led Peer Review Group, 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

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 l. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Programmatic balance regarding the relevance to a variety of PEPFAR regions.

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 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons 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

Emily Erbelding, M.D., M.P.H.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 4133, MSC-7620
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 496-0545
Email: emily.erbelding@nih.gov

Geraldina Dominguez, Ph.D.
Office of HIV and AIDS Malignancy
National Cancer Institute (NCI)
Building 31, Room 3A/33, MSC-2440
31 Center Drive
Bethesda, MD 20892-2440
Telephone: (301) 496-3204
Email: domingug@mail.nih.gov

Lynne M. Mofenson, M.D.
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Room 4B11, MSC-7510
6100 Executive Boulevard
Rockville, MD 20852-7510
Telephone: (301) 435-6870
Email: Lynne.Mofenson@nih.hhs.gov

Katherine Davenny, Ph.D.
AIDS Research Program
National Institute on Drug Abuse (NIDA)
Room 4215, MSC-9589
6001 Executive Boulevard
Bethesda, MD 20892-9589
Telephone: (301) 443-2146
Email: kd25h@nih.gov

Christopher Gordon, Ph.D.
Division of AIDS Research
National Institute of Mental Health (NIMH)
Room 6199, MSC-9619
6001 Executive Boulevard
Bethesda, MD 20892-9619
Phone: (301) 443-1613
Email: cgordon1@mail.nih.gov

Kendall J. Bryant, Ph.D.
Alcohol and HIV/AIDS
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Room 2069, MSC-9304
5635 Fishers Lane
Rockville MD 20892-9304
Telephone: (301) 402-9389
Email: KBryant@mail.nih.gov

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express/courier service; non-USPS mail)
Telephone: (301) 496-8426
Email: pjackson@niaid.nih.gov

Ann Devine
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 2114, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5601
Email ADevine@niaid.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.