NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from single institutions and consortia of institutions to participate in the Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP-MBP). The objective of the IPCP-MBP is to support integrated and iterative multi-project, multi-disciplinary preclinical/nonclinical development efforts and exploratory clinical studies with the goal of advancing a non-vaccine biomedical prevention (nBP) product or strategy. Products and strategies eligible for support can be characterized as microbicides, topical or systemic PreExposure Prophylaxis (PrEP), or Multipurpose Prevention Technologies (MPT) to prevent HIV acquisition/transmission in the male and/or female genital or gastrointestinal (GI) tracts.

Non-vaccine based Biomedical Prevention (nBP) approaches can take many forms such as single and/or combination products composed of small molecules or biologics that prevent HIV transmission/ acquisition through interaction with well described or novel anti-HIV targets (gp120, gp41, reverse transcriptase, integrase, etc.) or cellular targets, (CD4, CCR5, etc.). Strategies can also employ modulation and/or induction of innate, inflammatory and/or adaptive immune processes, alone or in combination with a small molecule or biologic. In the case of MPT strategies, small molecules or biologics can be paired with licensed contraceptives and/or inhibitors of Sexually Transmitted Infections (STIs) associated with increased transmission of HIV.

The proof of efficacy concepts obtained from 2010 to 2013 for nBP-mediated topical microbicides and PrEP trials have established that antiretroviral-based strategies can prevent HIV acquisition/transmission in women, discordant partners, and men who have sex with men (MSM). The NIAID Division of AIDS (DAIDS) Integrated Preclinical/Clinical Program (IPCP) has a history of supporting and creating integrated platforms that promote the transition of nBP candidates from early discovery to initial clinical testing. For the purposes of this FOA, nBP candidates are identified as chemically defined small molecules or biologics which can result in the inhibition of HIV acquisition/transmission in the female or male genital and/or gastrointestinal (GI) tract.

The results of the NIAID sponsored Phase III Vaginal and Oral Interventions to Control the Epidemic (VOICE) clinical trial of Tenofovir gel and oral Tenofovir and Truvada has shown that daily use and adherence to prevention products can be problematic. Thus, this FOA will put additional emphasis on developing products whose use provides sustained, rather than on-demand protection. Therefore, this FOA will not support the development of additional vaginal, on-demand/coital products or strategies, but will focus on the development of products and strategies that cover two windows of protection from HIV infection.

• A one week, (7) day window of protection: These products or strategies will provide a window of protection from HIV infection for at least 7 days following a single application/dose. The term non-coital product or strategy will be used to identify this window of protection products or strategies.
• One month (30 days) or greater window of protection: These products or strategies will provide protection from HIV infection for a period of 30 days or more following either a single dose or with use of a sustained Drug Delivery System (DDS), such as an Intravaginal Ring (IVR). This window of protection will be identified as sustained release products or strategies.

Thus, the focus on non-coital and sustained release nBP studies which address pharmacokinetics (PK) and pharmacodynamics (PD) safety and efficacy relationships and inform on product attributes and methods to monitor product adherence and their impact ( forgiveness of a drug regime) are of significant interest.

The scientific and nBP development objectives of the IPCP-MBP are to:

• Support development of novel single and combination nBPs and DDS for sustained and non-coital HIV prevention in the male and female genital and GI tracts,
• Support translation of innovative nBP candidates from preclinical development to Pre-phase I clinical trials, and
• Facilitate entry of new methods and expertise into the nBP field, such as:
• Behavioral and user product perception research into the early stages of product development. Examples include baseline behavioral studies, using prototype or product surrogates (OTC lubricants), etc., to determine user perception of a product(s) attributes and promote adherence and acceptability.
• Understand the molecular and cellular mechanisms of the mucosal environment that are altered by an nBP and/or how the alteration may impact the safety, efficacy, adherence or acceptability of an nBP product or strategy.
• Development and validation of new and existing technologies for measuring and tracking nBP safety, efficacy, PK/PD in tissue and secretions, acceptability and adherence, and
• Development of innovative biomedical technologies or strategies to quantify adherence to nBP products and or their placebos.

Optimal nBP development platforms consist of a synergistic mixture of projects and cores that add value to the proposed nBP strategy by supporting assessment of their safety, efficacy and potential acceptability. The IPCP application allows applicants to address a wide range of potential product development concerns, such as: preclinical virology, nonclinical safety and toxicological studies, regulatory requirements [Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)], and Good Clinical Practice (GCP) requirements. The cumulative effort of the individual Research Projects and/or Scientific Cores can furthermore lead to innovation that can have significant impact on the nBP field and associated prevention pipelines. A minimal IPCP application that can accomplish this objective is envisioned to have 2 research projects, an Administrative Core and involvement of a private sector for-profit or not-for-profit company in one or more of the Projects or Cores. The proposed nBP development program is not required to include a Pre-phase I clinical trial.

Applicants are strongly encouraged to identify milestones, Go/No-Go criteria, Gantt charts, time lines and selection algorithms to assist the IPCP-MBP team, assigned NIAID staff and their Scientific Advisory Board in making informed development decisions for the thematic nBP product. Additionally, applicants may, if applicable, consider developing a Targeted Product Profile (TPP) to describe the desired and minimally acceptable properties of the nBP product and/or DDS.

IPCP-MBP Research Scopes:

The overall success of a proposed IPCP-MBP program will be a function of how the individual projects and cores establish an integrated effort to advance the product to clinical testing. Of equal value is the knowledge added to the nBP field as IPCP-MBP projects and cores address scientific and developmental barriers to advancement or elucidate biological and behavioral influences that inform on the potential safety, efficacy and acceptability of the nBP product. Based on these research scopes, potential development efforts can fall into four project areas:

1. nBP field enhancement: Although the overarching goal of the IPCP-MBP is to advance prevention products and candidates to clinical evaluation, hypothesis driven projects with a broader impact on nBP science can play an important role in a proposed program. Examples of nBP field enhancement projects include:

• How nBPs alter the vaginal/rectal microenvironment, as well as how mucosal factors or conditions alter nBP efficacy. For example: sexual trauma (from normal sexual activity or sexual violence), biofilms, age, hormonal states, exogenous hormone use, mucus, vaginal fluid factors, semen/seminal plasma, etc.
• The role of the immune system and product pharmacology in the safety and efficacy of proposed products and DDS, including:
• adaptive or innate immune responses (i.e. understanding the molecular mechanism surrounding vaginal or rectal immune responses, leukocyte trafficking and homing, the inflammatory response and the inflammasome activation) following nBP delivery,
• pharmacology and pharmacometric studies to understand drug uptake and metabolism,
• the fate of virus after a nBP has prevented acquisition/transmission.
• Additionally, nBP field enhancement can take the form of the development and validation of new technologies, i.e. novel non-coital or sustained release formulation/delivery strategies, electronic or other methods of monitoring or quantifying product adherence, and novel animal model and/or human safety assessment techniques.

2. Preclinical Development: These projects focus on preclinical development of nBP candidate(s), strategies and/or DDS. Their objective is to provide support for: (1) the feasibility of the product/strategy as an nBP, and (2) meeting the minimal requirements for preclinical virology as identified by the Food and Drug Administration (FDA): http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328842.pdf. These objectives include establishing:

• In vitro efficacy in cell lines and primary cells with minimal or no cytotoxicity
• No toxicity to beneficial microbiome organisms, e.g. Lactobacilli sp
• Lack of toxicity (single and/or multiple dose) in relevant animal models

Preclinical projects may also be designed to assist in the down-selection to the best nBP product for IPCP-MBP development. Applicants are encouraged, but not required to develop and implement a Targeted Product Profile (TPP) that identifies target product and/or DDS properties that will be used by the applicant to assist in identifying the optimal product and/or DDS for development.

3. IND-enabling Critical Path Project: The objective of an IND-enabling critical path project is to enable regulatory approval for clinical studies by meeting US Food and Drug Administration (FDA) requirements for an Investigational New Drug (IND), Investigational Device Evaluation (IDE) and/or New Device Exception (NDE) application. The IND-enabling critical path project can be implemented for a total of three years at any time during the IPCP-MBP application. The IND-enabling critical path project can have one of two objectives. The first is the development of a regulatory package that will support clinical testing without advancing to clinical testing within the IPCP-MBP application. The second is to meet the regulatory requirements for performing clinical testing within the IPCP-MBP application.

The success of this project and its ability to deliver its desired endpoint (either a product ready for pre-clinical testing or clinical testing) will depend on proposing appropriate studies, complying with regulatory requirements, and timing studies carefully during the development pathway. The types of studies that may be found in this project are highly structured and controlled studies designed to meet the code of federal regulations (CFR) and/or International Conference on Harmonization (ICH) requirements governing nonclinical and clinical testing. IND-enabling activities can include: acute and chronic toxicology in rodent and non-rodent models, pharmacokinetic (PK) studies [absorption, distribution, metabolism and excretion (ADME)], pharmacodynamic (PD) studies, toxicokinetic (TK) studies, development of a clinical dosage form (formulation), ISO 10993 compliant extractable/leachable studies, reproductive toxicology, genotoxicity, analytical method development/validation and studies to address Chemistry, Manufacturing and Control (CMC) requirements for a proposed API and its delivery vehicle.

4. Pre-phase I Exploratory Clinical Trial: Unlike a traditional Phase I dose-escalation, safety and tolerance study, Pre-phase I clinical trials may only be performed at U.S.-clinical sites, involve limited human exposure to products (not more than 20 participants per arm) and involve limited participant risk. Because of the size restriction, Pre-phase I clinical trials are not meant to provide definitive powered statistical assessments of the nBP candidate.

Although determination of safety of a nBP product or strategy is always a primary objective of the Pre-phase I clinical trial, secondary and other exploratory objectives can address hypotheses whose results will inform on product design and characteristics to meet this FOA’s non-coital and sustained release windows for HIV prevention, and/or be a test-bed for piloting and developing new safety, efficacy, acceptability or adherence models and measurement technologies. Often these trials include:

• Identification, measurement and validation of potential surrogate markers for safety, efficacy, immune impact, inflammation, acceptability and/or adherence.
• Testing the ability of new DDS to deliver prevention products systemically and/or to mucosal surfaces in genital and/or GI tract.
• PK assessments to establish safety and/or PK/PD relationships in tissues, secretions and HIV target cells.
• Qualitative assessments of baseline health conditions or practices that could modify prevention product and/or DDS safety, efficacy, acceptability and/or adherence.

Applicants are encouraged to consider incorporating HIV positive cohorts and specific at-risk populations, such as adolescents, post-menopausal women, Black and/or Hispanic men who have sex with men (MSM), other specific at risk ethnicities/races, intravenous drug users (IDUs) and alcohol users and abusers when scientifically appropriate and within the described scope of a Pre-phase I clinical trial.

Administrative Core:

The Administrative Core is a resource for the multi-component application, providing for the overall short and long-term management, coordination, and supervision of the IPCP-MBP. Potential duties of the administrative core may be: management and organization of group and annual meetings, website development, management of teleconferences and other communications, coordination of IPCP-MBP scientific meeting presentations and publication of data, management of internal data and reagent sharing, shipping of reagents, tracking IPCP-MBP project and core progress, dispute resolution, management of the participation of the Scientific Advisory Panel (SAP) and NIAID, development of contingency plans for PD(s)/PI(s) replacement and meeting NIH reporting requirements for the award.

Scientific Core(s):

Scientific Cores provide broad-based support for routine activities that individual projects may need to facilitate their development activities. Examples of Scientific Core roles include performance of in vitro and in vivo screening/testing algorithms, and statistical and data management. In addition, applicants with IND-enabling critical path projects and Pre-phase I clinical trials are encouraged to create a Regulatory Core. This type of core may be used to assist in meeting FDA GLP/GMP regulatory requirements and the NIAID/DAIDS clinical trial research policies. Creation of Scientific Cores solely to oversee contract research organizations (CRO) and fee-for-service activities to support product development are strongly discouraged.

Responsive Areas of Research

All examples of responsive areas assume that the identified activities are being conducted in the context of advancing the thematic IPCP-MBP product or strategy. Responsive areas include, but are not limited to:

• Development of new single or combination nBP agents/strategies for use in the male and female genital and GI tracts to prevent HIV transmission/acquisition. New combination nBP products using Tenofovir (TFV, PMPA, (R)-9-(2-Phosphonoylmethoxypropyl) adenine) or Tenofovir Disoproxil Fumarate (TDF or Viread ) may be considered if the new combination is strongly justified and is not currently being developed for HIV prevention.
• Development of coitally associated rectal microbicides or topical PrEP are allowed. Applicants are encouraged to also develop non-coital and sustained release rectal microbicides and topical PrEP approaches.
• Feasibility studies of a lead nBP candidate or delivery system. Applicants are encouraged to perform iterative state-of-the-art in vitro safety/toxicity and efficacy assessments designed to select the optimal or best candidate or drug delivery system.
• The role of the nBP in altering the mucosal environment or, conversely, mucosal biology and physiology in altering nBP efficacy, HIV susceptibility, or transmission. Areas of interest include: lymphocyte or myeloid cell trafficking, tissue-specific immune cells, innate lymphocytes and regulatory cells and their effector functions. Also of interest are mucosal pro- and anti-inflammatory responses in relation to infection or the nBP, such as activation of inflammasomes (in response to normal flora, altered microbiome or other HIV-associated STIs), as well as tissue/wound repair, changes in drug transporters, cellular metabolism, and hormone receptors and signaling cascades.
• Modulation of adaptive and/or innate immunity as a means of modifying susceptibility to transmission, either as a standalone nBP prevention strategy or in combination with other nBP approaches. Discovery and/or development of oral, injection or implant DDS with either single or combination nBP products that provide either 7 days or greater than 30 days HIV protection as identified above.
• Demonstration of the potential impact or superiority of the DDS in the application using PK, PD and TK determinations is encouraged. Applicants are also encouraged to incorporate target values for PK and/or PD outcomes into milestones, Go/ No-Go decision points. Applicants may wish to create a TPP to further describe the nBP product/ strategy being developed.
• MPT strategies, which incorporate contraceptives or inhibitors or drugs active against STIs may be proposed. Proposed combination strategies that include activity against an STI linked to HIV acquisition/transmission need to demonstrate and maintain antiviral activity and efficacy against HIV. Contraceptive MPT strategies must use a licensed contraceptive product, such as a hormone-based contraception or Intrauterine device (IUD). Non-licensed contraceptives are considered unresponsive.
• The use of nanotechnology approaches to solve specific problems related to nBP delivery, deployment, safety, efficacy, and adherence assessment and monitoring.
• Pre-phase I clinical trials to assess safety, acceptability, and PK endpoints. Secondary and exploratory endpoints to support and inform on the utility of the proposed nBP as a HIV prevention strategy and/or DDS. Inclusion of behavioral research methodology (e.g., qualitative research) to understand acceptability and user-experience is encouraged.
• Studies (animal and Pre-phase I clinical studies) to understand the long term effect(s) of nBP exposure on genital tract tissues such as; multiple dosing regimens, extended periods of intermittent or episodic exposure to the prevention product and/or DDS.
• Development of chemical, bioengineering and/or biomolecular methods to assess vaginal and rectal nBP product adherence. Responsive approaches may include, but are not limited to development of nano- or micro-scale detectors, use of co-formulated/delivered drugs or substances for detection and/or addition of product tags to monitor product use. Applicants are encouraged to assess their approach in a Pre-phase I clinical trial during the IPCP-MBP award period to demonstrate the safety, feasibility and reporting capacity of the adherence measurement method. Applicants may also want to consider such factors as cost to the participant, frequency of monitoring, format of results and additional burden to clinical trial conduct.
• Studies designed to optimize a prevention product’s rheological properties using specific tools or measures to quantify men’s and/or women s perception of the nBP’s properties (shape, size, composition, etc.) prior, during and after use.

Non-responsive Areas of Research

Applications focusing on or including the following areas will not be considered responsive and will not be reviewed:

• Phase I, II or III clinical trials or a Pre-phase I clinical trial which does not meet the requirements of this FOA for duration of nBP action, size and the reduction of risk requirements described above, conducted outside the continental United States or any clinical trial activity proposed to be conducted within a scientific core.
• Use of the IND-Enabling Critical Path Project to prepare for trials to be conducted outside the IPCP-MBP award or produce GMP products to support their conduct.
• Development of non-coital nBP products without a minimum of a one week, or sustained release product(s) with less than a 30 day window of protection from HIV infection. Coital dosing of rectal microbicide or PrEP nBPs products is responsive, as identified above.
• Proposed basic science research that is not part of or required for the development of the IPCP-MBP thematic nBP product, such as basic research into the mechanism of, or earliest events in, HIV/SIV transmission.
• Projects or cores proposing studies that will generate broadly descriptive results, such as biome characterization, genomic/proteomic analysis without a defined hypothesis that informs on the selection and/or optimization of the thematic nBP product or DDS.
• Applications proposing further development/optimization and/or creation of new coitally-dependent (as defined above) vaginal nBP products or DDS to prevent HIV transmission/acquisition. Coital products (as defined above) that are currently under development may be used as comparators or controls for development of FOA responsive nBP release strategies in animal and Pre-phase I clinical studies.
• Development of solely spermicidal products or mechanical and/or biologically-derived barriers (i.e. restoring beneficial bacterial populations) to prevent HIV infection. nBP or MPT strategies where condoms (male or female) or other barrier methods play a significant role in the overall projected efficacy of the nBP prevention strategy, including strategies designed to modify barrier methods to release a nBP product.
• Development of non-specific anti-HIV agents as nBP products or strategies. Non-specific agents for the purposes of this FOA are defined as agents that display broad anti-microbial activity in the absence of target specificity. These products are often characterized by broad nonspecific killing of viruses, parasites, yeast and bacteria, including beneficial Lactobacilli sp. Applicants proposing a new nBP candidate having chemical/biophysical properties that could be identified by peer review as constituting lack of specificity and/or having a broad potentially non-specific range of antimicrobial activity are strongly encouraged to include appropriate preliminary mechanistic data as well as safety data to justify development of the product as a specific agent.
• Applications proposing optimization of DDS, active pharmaceutical ingredient (APIs) or nBP products currently under development that do not involve a substantial modification of the DDS, API or nBP product. Examples are approaches that depend solely on changes in volume, delivered dose, device size and/or DDS drug content as a means to increase antiviral potency, duration of action, safety or adherence/acceptability.
• Further or new development of additional DDS or nBP product using the following products:
• Development of Tenofovir (TFV, PMPA, (R)-9-(2-Phosphonoylmethoxypropyl) adenine) or Tenofovir Disoproxil Fumarate (TDF or Viread ) as a single topical or systemic PrEP agent.
• Any nBP product demonstrated to have caused harm in nonclinical animal toxicology testing and/or clinical safety or efficacy trials. These products may be used as positive controls in preclinical studies and/or proposed Pre-phase I clinical studies where potential participant harm is managed by appropriate controls.
• N-9 (Nonoxynol-9).
• Development of new hormonal or non-hormonal contraceptive or spermicidal products.
• Development of sulfonated polysaccharides or other large molecular weight charged polyanions or polycations as a single nBP product.
• Over-the-counter products (OTC) or non-specific vaginal and/or female/male rectal health products for prevention of HIV transmission or STI infection.
• Random screening of chemical and/or natural product libraries or collections to identify new nBP products or prevention targets.
• Development of nBP products, e.g. complex natural product mixtures for which the composition of the drug product cannot meet FDA chemistry, manufacturing and control requirements for purity, identity and uniformity.
• Applications proposing any form of vaccine development (new mucosal vaccine, vector, insert, or delivery system).
• Studies of user product perception, in the absence of a prototype or product surrogate.
• Development of broad measures to assess nBP use, or generalized interventions to reduce HIV incidence. This includes community and stakeholder surveys and studies designed to assess acceptability at the community or population level of a nBP product or strategy.
• Studies of acceptability and/or adherence that are theoretically-based and are performed in the absence of individuals interacting with a product or delivery platform, which are designed to develop behavioral or social theories of acceptability or adherence.
• Studies or surveys designed to educate or survey a proposed stakeholder population in preparation for future clinical trials or product roll-out and implementation, including structural and/or behavioral interventions to enhance projected product use.
• Development of biomedical methods to quantify adherence that depend on the use of radioisotopes or dye applicator staining to quantify adherence.

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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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 Institutions)

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

An investigator may not serve concurrently as the PD/PI for more than one IPCP-HTM or IPCP-MBP application or award at any time, including awards in a No Cost Extension. However, a PD/PI may serve as a Project Leader and/or Scientific Core Leader on one or more applications provided the total effort does not exceed 12 person months and there is no scientific overlap.

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.

The NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for 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:

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

The letter of intent should be sent to:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3G20, MSC 9823
5601 Fishers Lane
Rockville, MD 20892-9823
Telephone: 240-669-5049
Email: pjackson@niaid.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core	6 pages
Core (use for Scientific Cores)	6 pages
Project (use for Research Projects)	12 pages

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Scientific Cores: optional no minimum or maximum but each Core must support at least two Research Projects
• Research Projects: 2 required, no maximum (Note: No more than one IND-enabling critical path project may be proposed)

When preparing your application in ASSIST, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: List in priority order the broad, long-range objectives and goals of the proposed Program. Concisely and realistically describe the hypothesis or hypotheses to be tested.

Research Strategy: This narrative section summarizes the overall research plan for the multi-component application. The multi-component application should be viewed as a confederation of a minimum of 2 required, interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another, with the required administrative core and proposed research core(s) providing infrastructure to assist in accomplishing the IPCP-MBP objectives. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the research problem. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.

At least one component (Research Project or Scientific Core) must be from a private sector for-profit or not-for-profit company. Applicants should describe the private sector involvement and expertise, activities, other resources and processes that would not otherwise be available to the investigators and how the private sector (industrial) component is integrated into the overall IPCP-MBP program.

The IPCP-MBP program is designed to allow applicants to develop an integrated and iterative research and development environment to support their proposed nBP product/DDS development. Applicants should describe in this section the required application overarching milestones, Go/ No-Go decision points and Gantt charts/timelines that will be used to monitor the IPCP-MBP research plan.

If a Targeted Product Profile (TPP), is included for the nBP product then the objectives, specific aims and milestones need to support the development of the nBP product or strategy described in the TPP.

Applicants are encouraged to involve new and Early Stage Investigators in the IPCP-MBP Program, and if applicable, describe how involvement in the IPCP-MPB Program will assist in the success of the investigator.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Requested funding for the overall administrative efforts should include secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses. Travel funds for the PD(s)/PI(s), Project Leaders, Scientific Core Leaders, other key IPCP-MBP personnel, and SAP members to attend an annual IPCP-MBP meeting should be included.

Applicants proposing Pre-phase I clinical trials where travel is required to coordinate activities among domestic clinical sites may request additional travel funds for clinical trial site oversight, if a regulatory core is not requested. If a regulatory core is requested then the travel budget should reside in that core. All such travel requests should be well justified.

Applicants are encouraged to budget for the appropriate IPCP-MBP administrative and operations support personnel. Inclusion of a Program Manager to assist leadership in management of the day-to-day business of the IPCP-MBP Program is strongly encouraged.

No travel funds may be requested for attendance of scientific meetings in the Administrative Core.

Administrative Core Leaders are requested to commit substantial time and effort to ensure success of the complex IPCP-MBP program. It is recommended that these individuals devote a minimum of 2.4 person months per year effort to the Program. This level of commitment can be all in one project/core or a total effort across several projects/cores within a single application. If leadership effort is devoted to multiple cores and/or individual research projects, the level of overall effort is expected to be commensurate with the direct involvement necessary to ensure adequate oversight of the Administrative Core and participation in any additional project(s) or core (s).

Budgets to support non-clinical research at foreign sites (non-U.S.) should not be requested for creation of new infrastructure (remodeling, etc.) or purchase of more than $30,000 in equipment or computers, and no more than 15% of a requested foreign site budget should be allotted for personnel training.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: List in priority order the broad, long-range objectives and goals of the proposed core. In addition, state the core’s relationship to the goals and how it relates to the individual research projects or other cores in the application.

Research Strategy: Describe the potential for the Administrative Core need to lead the IPCP-MBP program. Describe the processes and procedures and administrative plan that will be used for the short- and long-term management of the program by describing its administrative and business activities.

Describe how the Administrative Core will manage and organize group and annual meetings, electronic communication tools (e.g. websites, teleconferences, and communicate to the research team of action items and tasks arising from them), policy for presentation and publication of IPCP-MBP generated data and findings, management of internal data dissemination and reagent sharing, shipping of reagents, tracking IPCP-MBP project and core progress, internal dispute resolution, the participation of the Scientific Advisory Panel (SAP) and NIAID, development of contingency plans for PD(s)/PI(s) replacement and meeting NIH reporting requirements for the award. Discuss preparedness to deal with unexpected outcomes, such as delays in the finalization of inter-institutional agreements, delays in initiating Go/No-Go animal and/or clinical studies, and changes in leadership of the IPCP-MBP award, projects and/or cores. A contingency plan should be in place to replace the application’s PD/PI, if required.

Applicants are encouraged to identify an administrative program manager for routine daily management and communication of the Administrative Core with the IPCP-MBP program and its investigators.

Scientific Advisory Panel: Describe the Scientific Advisory Panel (SAP) and how the IPCP-MBP team will implement it and accomplish the following tasks. Each IPCP-MBP awardee is required to establish a SAP no later than 6 months after award, consisting of 3 or more qualified individuals not affiliated with any of the institutions comprising the IPCP-MBP, but who may be collaborators with IPCP-MBP investigators with relevant expertise. Membership will be determined in consultation with the NIAID Project Scientist and applicants should only describe the expertise categories to be represented on the SAP, and how the SAP will be utilized to guide the IPCP-MBP program. The SAP will attend the IPCP-MBP annual meetings to review program activities and evaluate progress, adherence to timelines, and the continued relevance of each project to the overall goals. The SAP will recommend new directions as appropriate and will provide upon request of the PD/PI and NIH Project Scientist a comprehensive written evaluation of the group’s activities and the Panel s recommendations following the annual meeting. A discussion of the role of the SAP and the integration of its proposed expertise into the operations of the IPCP-MBP should be provided. Applicants should describe procedures and approaches for obtaining SAP input via teleconferences, ad hoc and annual meetings, review of written materials/data, etc. If clinical research or a clinical trial is proposed in the application the SAP should include relevant clinical trial experience.

NOTE: Applicants MUST NOT name proposed SAP members in their applications or contact potential SAP members prior to application submission and completion of peer review

Steering Committee: A Steering Committee will be established and chaired by the PD/PI. The Steering Committee will consist of the designated leaders for each Project and Core, the NIH Project Scientist, other NIH scientists as identified by the PD(s)/PI(s) and/or Steering Committee, and any other key personnel identified by the PD(s)/PI(s). The day to day management of the IPCP-MBP award will be overseen by a Steering Committee. Describe how the overall PD/PI of the IPCP-MBP application will lead the Steering Committee. Describe the management and frequency of Steering Committee teleconferences and how decisions made by the Steering Committee will be communicated to the rest of the IPCP-MBP program. Describe how the Steering Committee will be used to oversee progress of the IPCP-MBP award and create, monitor and administer the policies and procedures created by the Administrative Core.

Milestones: Administrative Core specific milestones and timelines are required and must fall within the page limits. Describe how milestones will be used by the IPCP-MBP team, Steering Committee, and SAP to track successes and failures of the program. Plans to address the failure to achieve milestones and Go/ No-Go criteria and meet application timelines should be discussed. Applicants should describe plans for periodically revisiting and revising milestones and timelines, if needed, to assure that the Administrative Core services remain relevant to the projects and cores they are serving. Describe how futility will be identified and addressed in the cases where milestone and Go decisions cannot be achieved and the process in collaboration with assigned NIAID personnel for modifying unachievable milestones and Go criteria. Milestones should not be a restatement of application Administrative Core specific aims. The best constructed milestones will be a concise summary/outline of the quantitative specifications for successful Administrative Core management of the IPCP-MBP program.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Scientific Core(s))

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scientific Core(s))

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific Core(s))

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Facilities & Other Resources: Provide information on resources available for the Core. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances. Include a description of how the scientific environment in which the core service or resource will be conducted contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport).

Equipment: Provide information on equipment available for the Core.

Project /Performance Site Location(s) (Scientific Core(s))

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Scientific Core(s))

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Scientific Core(s))

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Each individual Core Component should have a separate budget that details the costs required to support that Core.

Describe the apportionment of dollars or percentage of dollars within the Scientific Core that will be required to support each component research project.

Requests for additional travel to visit subcontractor or consortium sites for discussion and planning involved in supplying specific assays or services, such as GLP/GMP services in support of an IND-enabling critical path project, animal testing or clinical trial support must be specifically justified. In the case of travel for facility audits and oversight of GLP and GMP activities not in the IND-enabling Project, applicants should provide not only justification for the travel, but also assurances that the personnel traveling are qualified to conduct the audit and provide oversight.

Applicants proposing Pre-phase I clinical trials where travel is required to coordinate activities among clinical sites, may request additional travel funds for clinical trial site oversight within a regulatory core. If a regulatory core is requested then this funding should reside in this core.

No additional travel funds may be requested for attendance of scientific meetings.

Scientific Core Leaders are requested to commit substantial time and effort to ensure success of the complex IPCP-MBP program. It is recommended that these individuals devote a minimum of 2.4 person months per year effort to the Program. This level of commitment can be all in one project/core or a total effort across several projects/cores within a single application. If leadership effort is devoted to multiple cores and/or individual research projects, the level of overall effort is expected to be commensurate with the direct involvement necessary to ensure adequate oversight of the proposed scientific core.

Budgets to support non-clinical research in Scientific Cores at foreign sites (non-U.S.) should not be requested for creation of new infrastructure (remodeling, etc.) or purchase of more than $30,000 in equipment or computers, and no more than 15% of a requested foreign site budget should be allotted for personnel training.

PHS 398 Research Plan (Scientific Core(s))

Specific Aims: List in priority order the broad, long-range objectives and goals of the proposed core. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the core’s relationship to the goals of the overall application and how it relates to the individual research projects or other cores in the application.

Research Strategy: Applicants can propose a Scientific Core to act as a resource for the IPCP-MBP Program. The Scientific Core must provide services or activities that support at least 2 research projects and the cores must be scientifically justified. Use this section to describe how the proposed Core activities will contribute to meeting the Program’s goals and objectives and explain the rationale for selecting the general methods and approaches proposed to accomplish the Specific Aims. In addition, this section should indicate the relevance of the Scientific Core to the primary theme of the application. If an activity is being performed in multiple projects applicants may want to consider moving the activity from a project and creating a core or making the project a core. Describe how the Scientific Core does not overlap with the activities within the other proposed IPCP research projects and how core resources will be allocated to the projects, and the process for prioritizing the resources and services to be provided.

Previously published experimental details should be cited using the Bibliography and References Cited attachment and need not be detailed in the Research Strategy.

Applicants must provide Scientific Core specific, well-described, quantifiable, and scientifically justified milestones and Go/ No-Go criteria that are not simply a restatement of Specific Aims for the overall application. All proposed Scientific Core milestones should be integrated with the overall goals of the proposed IPCP-MBP Program and the Research projects they serve. Applicants should describe plans for periodically revisiting and revising milestones and timelines, if needed, to assure that their services remain relevant to the projects they are serving. Describe how futility will be identified and addressed in the cases where milestone and Go decisions cannot be achieved and the process in collaboration with assigned NIAID personnel for modifying unachievable milestones and Go criteria. Milestones and timelines should be placed at the end of the Research Strategy section and fall within the page limits.

A Scientific Core can propose to conduct activities typically associated with the IND-enabling process, i.e. manufacturing, performance of GLP and GMP activities. However, these cores are not eligible for the IND-enabling critical path project funds. Scientific Cores devoted solely to coordinating contractual activities to support preclinical development of an nBP, such as those associated with fee-for-service support, i.e. GLP toxicology, GMP manufacturing, etc., are strongly discouraged. These activities in the absence of a Regulatory Core are best coordinated within individual research project(s) requiring these services and/or the Administrative Core.

If a Scientific Core is created to support regulatory activities (Regulatory Core) in the IPCP-MBP, applicants should describe its role in meeting the NIAID/DAIDS administrative and FDA requirements for conducting clinical trials. Describe how Regulatory Core guidance will be performed, communicated and implemented by the IPCP-MBP team, as well as its processes for developing guidance.

A Scientific Core which includes or is derived solely from an Industry partner should address the expertise that the industrial partner brings to the IPCP-MBP. Descriptions should include how the partners expertise will be integrated into and what value it will bring to the overall objectives and operations of other projects and cores in the IPCP-MBP, and the IPCP-MBP as a whole.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Facilities & Other Resources: Provide information on resources available for the project. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances. If analysis of clinical research obtained secretions, blood and/ or tissues is to be conducted outside the Continental U.S. the applicant should provide evidence of adequate research infrastructure and training to conduct the proposed studies. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport) for Early Stage Investigators; describe institutional investment in the success of the investigator.

Equipment: Provide information on equipment available for the project.

Project/Performance Site Location(s) (Research Project)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Each individual Research Project component should have a separate budget that details the costs required to support that Research Project.

Applicants may request a total direct base cost limit per year of $0.6 million (range $0.5 to $0.6 million), and may add additional elements to proposed projects or create a project from the areas listed below. The total request must not exceed $2.6 million in direct costs per year:

• Up to $0.2 million (range $0.1 to $0.2 million) per year may be requested for applications using non-human primates and/or humanized mouse models for assessment of in vivo safety and/or efficacy of an nBP product or strategy.
• Up to $0.6 million (range $0.2 to $0.6 million) per year may be requested for applications incorporating an exploratory Pre-phase I clinical trial(s).
• Up to $0.2 million (range $0.1 to $0.2 million) per year may be requested for applications incorporating behavioral studies of nBP acceptability and/or adherence, as either a standalone project or to incorporate these studies into a proposed Pre-phase I clinical trial(s).
• Up to $0.2 million (range $0.1 to $0.2 million) per year for development and pilot clinical testing of quantitative biomedical methods to measure product adherence.
• Support for no more than three (3) years in either a four (4) year preclinical or a five (5) year clinical IPCP-MBP for a single IND-enabling critical path project per application with a maximum direct cost per year of $0.8 million (range $0.4 to $0.8 million). The monies identified for support of this activity should not be used for these types of activities when they are incorporated into another project or core.

Projects containing Pre-phase I clinical trials can request budgets as early as year one (1) of the award to support protocol development and meeting DAIDS clinical trial requirements and regulatory requirements.

The $0.8 million (range $0.4 to $0.8 million) requested for support of IND-enabling critical path activities should only be used within this project. The specific IND-enabling funds [$0.8 million (range $0.4 to $0.8 million)] may not be used to support IND-enabling activities when incorporated in any other project or core within the IPCP-MBP.

Budgets to support non-clinical research at foreign sites (non-U.S.) should not be requested for creation of new infrastructure (remodeling, etc.) or purchase of more than $30,000 in equipment or computers, and no more than 15% of a requested foreign site budget should be allotted for personnel training.

Requests for additional travel to visit subcontractor or consortium sites for discussion and planning involved in supplying specific assays or services, such as GLP/GMP services in support of an IND-enabling critical path project or animal testing must be specifically justified. In the case of travel for facility audits and oversight of GLP and GMP activities, applicants should provide not only justification for the travel, but also assurances that the personnel traveling are qualified to conduct the audit and provide oversight.

If clinical trial(s) are proposed the applicants must budget support for the creation of a clinical trial report that meets regulatory authority requirements as specified by the International Conference on Harmonization (ICH) E3 reporting requirements at the conclusion of each proposed clinical trial.

No travel funds may be requested for attendance of scientific meetings.

Project Leaders are requested to commit substantial time and effort to ensure success of the complex IPCP-MBP program. It is recommended that these individuals devote a minimum of 2.4 person months per year to the Program. This level of commitment can be all in one project/core or a total effort across several projects/cores within a single application. If leadership effort is devoted to multiple cores and/or individual research projects, the level of overall effort is expected to be commensurate with the direct involvement necessary to ensure adequate oversight of the Administrative Core and participation in any additional project(s) or core (s).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Research Project)

Specific Aims: List, in priority order, the Specific Aims of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual Research Project s relationship to the Program goals and how they relate to other Research Projects or Cores in the application.

Research Strategy: Use this section to describe how the proposed research and project will contribute to meeting the IPCP-MBPs goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the scientific significance of the research, indicate the project's relevance to the primary theme of the application. Previously published experimental details should be cited using the Bibliography and References Cited attachment and need not be detailed in the Research Strategy. Describe the research design, conceptual procedures, and analyses to be used to accomplish the Specific Aims of the project. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss associations with the other projects and cores in the IPCP-MBP application, highlighting interactions that are essential to application success or unique to this application. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.

Describe how the proposed research will be carried out in the context of an identifiable anti-HIV product(s) or strategy(s) with the outcome of the research project activities directly supporting the advancement of the product or strategy forming the thematic basis of the application.

If needed to establish the product as a IPCP-MBP candidate, describe how the product under development meets the FOAs definition of a specific anti-HIV agent by describing its mechanism of action, lack of harm to beneficial Lactobacilli sp., and/or its lack of effect on the viability of vaginal or rectal epithelia primary or cell lines.

If the applicant is supporting potential safety of the proposed nBP product or strategy by using inferential safety data from mucosal tissues other than the female or male reproductive and GI tract or inferring safety of excipients and/or formulary components based on vaginal and/or rectal use for other indications, e.g. anti-bacterial, yeast medicines, or health purposes or inclusion on the FDA’s Generally Regarded As Safe (GRAS) list, describe how genital and/or GI tract product and /or DDS safety will be established within the IPCP-MBP award.

If clinical research is proposed for conduct at a foreign/ Non-U.S. site, describe the qualifications and experience of the site. If the samples proposed for clinical research will be exported to other countries and agreements for export of samples have to be established, describe the process for negotiation, anticipated pitfalls and potential alternatives, and the effect that delays in the negotiations will have on research progress.

Milestones, Go/No-Go decisions, Gantt Charts and Timelines: Milestones, Go/ No-Go decision, Gantt charts and timelines are required and are to be placed at the end of the Research Strategy section and fall within the page limits. Research project milestones should be described and should identify research outcomes by providing quantifiable measures of success within a specific time interval. The milestones should be integrated into the Gantt charts and selection algorithms with specific Go/ No-Go criteria for use in identifying superiority of products and to guide decisions for implementation of specific development steps. Individual Research Project Milestones, Go/ No-Go decision, Gantt charts and timelines should be integrated into the proposed IPCP-MBP program and support the Overarching Milestones, Go/ No-Go decision, Gantt charts and timelines of the application (Overview section). Go/ No-Go decisions and milestones should also be used to identify futility for research efforts, and to adjust or modify the development process as needed. Applicants should describe plans for periodically revisiting and revising milestones and timelines, if needed, to assure that the proposed Research Projects continue to support the objectives of the overall IPCP-MBP Program. Milestones that are a restatement of application and/or project specific aims do not meet the definition of milestones used here. The best constructed milestones should be a concise summary/outline of the quantitative specifications for identification of a successful research and/or developmental effort. Describe how futility will be identified and addressed in the cases where milestone and Go decisions cannot be achieved and the process in collaboration with assigned NIAID personnel for modifying unachievable milestones and Go criteria. Funding beyond the first year may be negotiated downward depending on the progress in meeting milestones and Go/No-Go decision points negotiated with NIAID after award.

Targeted Product Profile (TPP) (Optional): If the application includes a TPP (optional) to be used to support the development and validation of candidates this may be placed as a table in the Research Strategy section of the appropriate project. Applicants are encouraged to present the TPP in a table format, which lists the product attributes and the optimal and minimally acceptable properties of the product or DDS for each identified physical or chemical attribute to be assessed. Applicants should describe how the proposed TPP integrates with the application, the project's specific aims, milestones and Go/ No-Go decision criterion. Examples of potential product attributes that can be captured are: product release profile of the DDS, delivery/injection/implant volume, PK maximums and minimums, PD targets, stability and storage requirements, desirable physical attributes, acceptability, cold chain requirements and feasibility of GMP production. Applicants are advised that the proposed TPP should be used as a tool for identifying the optimal product/DDS proposed in the application, and therefore will be less complicated and comprehensive than the FDA required TPP used to map and guide regulatory responses for the complete product development pathway from nonclinical studies to licensure. If appropriate, applicants can describe any cost of goods (COG) or GMP manufacturing issues that will impact development of the product or strategy.

Industry Partner(s): At least one component of the IPCP-MBP application (Research Project or Scientific Core) is required to be from and have participation of a private sector for-profit or not-for-profit company. The private sector component must play a significant and active role in the proposed IPCP product development plans. The role of the private sector partner, including what resources they provide to the IPCP-MBP program must be described. The expertise, activities, other resources and processes that would not otherwise be available to the investigators should be described.

For the purposes of this FOA, industry is broadly defined as for-profit or not-for-profit pharmaceutical, biotechnology, bioengineering, or chemical companies that are large or small, domestic or foreign in origin. This broad definition is used in recognition of the lack of substantial involvement of for-profit industry in nBP development, and the limited number of groups meeting the above definition within the nBP field.

Industrial partners may fulfill several roles in the applications such as PD(s)/PI(s) (note this includes PD(s)/PI(s) designation on a multi PD(s)/PI(s) application), Project and/or Core Leader, or act as key personnel with commensurate time commitments to a Project and/or Core.

For IPCP-MBP applications where the application is derived solely from industry, describe the advantages that sole industry sponsorship brings to the proposed IPCP-MBP application. Although industry applicants are not required to involve collaborators from academic and/or non-profit research organizations, they are encouraged to include members of these organizations when appropriate to the scope and focus of the application.

The requirement for a private sector partner is NOT met by incorporation of Contract Research Organizations (CROs) into IPCP-MBP applications solely for the purpose of providing fee-for-service resources. CROs proposed to fill this role must have demonstrable scientific input, contribution and involvement in the IPCP-MBP strategic planning and development process to be a private sector partner.

Quality Use of Animal Models: Applicants may include animal model research such as humanized mice and/or nonhuman primates (NHP) for safety and/or efficacy determinations of the nBP strategies or candidates. The use of the models should be described and justified based on the following guidance. For the purposes of this FOA, animal studies are divided into two categories. The first category includes studies that address the basic and developmental science issues of virus transmission within the context of the nBP product or strategy. Examples are assessments of environmental and physiological factors resulting from nBP exposure that might alter susceptibility, acquisition and dissemination of virus at the mucosal tissues. These may include sexual trauma, age, hormonal and immune status. For the first category, describe the proposed animal studies and how they will support the advancement of the proposed nBP product or strategy by answering broader developmental questions for the nBP prevention field. The second category is the use of animal models for screening/testing candidates to support their plausibility as clinical candidates.

Applications proposing animal model research to establish clinical plausibility should address and describe how their proposed studies meet the following points:

• Represents a superiority assessment of the drug product(s) with appropriate positive control and placebo arms.
• Inclusion of sufficient numbers of animals to allow for either hypothesis generating or hypothesis-driven assessment of a specific endpoint. Applicants are cautioned that underpowered studies can reduce reviewer enthusiasm for the application.
• Uses formulated products, characterized for API stability and release. Use of unformulated products and vehicle admixtures without establishing some level of drug stability and release are strongly discouraged.
• Incorporates, where appropriate, secondary endpoints to support the proposed plausibility of the nBP candidate, using pharmacokinetic (PK), pharmacodynamic (PD) and safety measurements (colposcopy, histology, vaginal pH, microbiome analysis and/or the immune response, etc.).
• Discuss how the proposed animal efficacy studies meet the requirements for conduct of high quality animal studies when being used as a screening tool or gateway to justify clinical testing.

Project Type Specific Instructions: As identified in Section I, IPCP-MBP projects can be of 4 general types: nBP field enhancement, preclinical development, IND-enabling critical path project and Pre-phase I clinical trials. Each of these Research Project types has specific themes and roles in the development of an nBP product. Inclusion of these specific types or themed Research Projects is at the discretion of the applicant.

nBP field enhancement:

• Describe the impact of the nBP field enhancement project in the context of both the advancement of the thematic IPCP nBP product and potential impact on nBP product development and the prevention field in general.
• Describe the general knowledge obtained and how it will be of use to the nBP prevention field in developing the current and, if applicable, future nBP products and DDS.
• Applicants should describe the hypothesis-driven research proposed for this type of project, including the appropriate Go/ No-Go decision criteria and milestones to relate the relevancy of the expected outcomes to the proposed nBP product development pathway outlined in other Research Projects. Applicants are discouraged from conducting broad surveys of potential biomarkers, microbiome and/or gene/protein expression which are not directly informative on the development of the IPCP-MBP thematic nBP product and/or DDS.

Preclinical Development:

• Describe how the proposed research will be carried out in the context of an identifiable nBP product, DDS and/or strategy (ies).
• Describe how the Preclinical Development project Specific Aims, Objectives, Go/No-Go decision criteria and milestones supports the proposed prevention delivery route and indication for use as a microbicide, topical or systemic PrEP or as an MPT. If applicable, describe the role of the TPP in this process.
• Describe the scientific rationale for the order and types of preclinical studies to be performed. Justify the impact of each of these studies on the overall IPCP-MBP plan for product advancement.
• If the project is focused on development of nBP delivery systems, describe their potential to enable use of the candidate and proposed DDS in the male and/or female genital and/or GI tracts to prevent HIV transmission/ acquisition.
• Describe how the preclinical development project addresses the FDA guidance for preclinical virology and Microbicides and how the results of the project can support a preclinical virology section for a proposed IND.
• Describe the proposed nBP product mechanism of action and how it is compatible with the concept of preventing HIV transmission/acquisition.
• If the project is proposing selection of the best candidate or combination of candidates for advancement describe the down-selection process to the best candidate. Describe the Go/ No-Go criteria milestones and timelines to be used to identify the best candidate (s) and/or DDS for further development If a TPP was proposed, describe how this process is designed to identify the optimal candidate/product for further development in the IPCP-MBP program.
• If the candidate has the potential to be identified as a nonspecific inhibitor, describe the criteria being used to justify the inhibitor as specific and responsive to the FOA.

IND-enabling critical path project:

Only one IND-Enabling Critical Path Project may be proposed per application. The IND-enabling Critical Path Project can last for no more than 3 years and must be a single stand-alone project in the IPCP-MBP application. Applicants are cautioned that IND-enabling critical path projects may not be used for production of clinical trial supplies (API or drug product) or to support Phase II or III clinical trial-enabling studies. Achievement of milestones and Go decisions will be used by Program staff to measure this project’s success. Funding beyond the first year may be negotiated downward depending on the progress in meeting milestones and Go/No-Go decision points negotiated with NIAID after award. Describe how within the above criterion the Pre-IND-enabling critical path project will:

• Be implemented as a standalone project and how its goals can be accomplished in the allotted time. Describe how the 3 year IND-enabling critical path project will support the performance of the nonclinical studies required to either file an IND or meet the regulatory requirements to initiate clinical testing.
• Incorporate the expertise to conduct and oversee the GLP and GMP compliant activities required to file an Investigational New Drug (IND), Investigational Device Evaluation (IDE) and/or New Device Exception (NDE) application.
• Be conducted in compliance with applicable International Conference on Harmonization (ICH), United States Pharmacopeia (USP), GLP and GMP guidance’s and regulations.
• The IND-enabling critical path project can be started at any time during the award period of the IPCP-MBP. Describe how the IND-enabling critical part project will support the objectives of the proposed IPCP-MBP product and/or DDS development program. Describe how the timing and proposed activities of the IND-enabling critical path project will either result in an IND at the end of a 4 year preclinical IPCP-MBP or support clinical trial(s) proposed in a 5 year IPCP-MBP award.
• Milestones, Go/ No-Go decisions and Gantt charts must be incorporated, within page limits and used to track the progress of the proposed IND-enabling critical path studies.
• If contract research organizations (CRO) are identified for performance of the IND-enabling critical path studies, describe plans for vendor selection and the quality management and oversight of the studies. It is expected that CRO chosen to perform the studies will have experience in conducting the required studies and the IND-enabling critical path project investigators will have experience in managing of CRO activities. Oversight of the CRO activities may take the form of quality audits and on-sight observations of animal handling, dosing and necropsy.

Pre-phase I Exploratory Clinical Trial: While Pre-phase I clinical trials conducted within the continental United States (U.S.) are responsive, Pre-phase I clinical trials proposed to be conducted at non-U.S. sites will not be supported under this FOA. This FOA will not support any clinical trials (Phase I, II or III) that do not meet the definition of a Pre-phase I clinical trial (above). Applicants are encouraged to seek other sources of support for Phase I, II, or III trials and the production of drug substance and products used to enable them. Pre-phase I projects may be proposed to start, i.e. initiate enrollment, as early as year 1, but no later than the end of year 4 of the clinical 5 year award period. The IPCP-MBP awardee can establish collaborations with NIAID DAIDS networks to facilitate proposed IPCP-MBP clinical activities. Applicants should:

• Describe the rationale for the proposed Pre-phase I clinical study(s) and how the clinical trial supports the scientific rationale and advancement of the nBP product or strategy.
• Describe the design of the Pre-phase I clinical trial and how it meets the FOA requirements, including the appropriateness of the primary, secondary and exploratory endpoints of the clinical trial, and how they will provide insight into the product and/or delivery system safety, efficacy, and acceptability.
• If the Pre-phase I clinical trial is designed to test technological innovations to measure nBP activity/efficacy, safety, acceptability and/or adherence using new/novel /unique assays and analysis, describe these activities and what they contribute to the development of the nBP product, DDS and/or the prevention field in general.
• If the proposed Pre-phase I clinical trial will use a product and/or procedures that have been identified as having potential safety issues or its use in an animal study or clinical trial has been associated with harm, justify the use of the product as a control or comparator in the proposed trial and describe how potential harm and risk will be managed and communicated to research subjects.
• Clinical trial network resources must not be used to expand the scope to a Phase I trial and the proposed clinical trial cannot exceed the limitations identified above for risk and size. If collaborations are proposed with NIAID DAIDS-supported clinical trial networks, describe how these collaborations will be conducted and the advantages brought to the IPCP-MBP by the collaboration. Describe how the IPCP-MBP applicant will assume primary responsibility for the planning and conduct of the proposed trial(s).
• If appropriate, describe how the Pre-phase I trial will be designed as a test bed for new nBP hypotheses and analysis technologies.
• Describe the human subject risk, how it will be minimized and the appropriate safety controls to manage research risk for subjects.
• In the case of sustained release strategy testing, time of exposure and risk will need to be balanced to maintain an overall low-risk for subjects. Appropriate safety controls should be described, such as limiting initial exposure before repeated or prolonged exposures are tested.
• For behavioral and/or user perception studies, describe how this work relates to the program as a whole and how this research will inform on the product design and/or DDS delivery strategy.
• Upon completion of the clinical trial, an International Conference on Harmonization (ICH) E3 report must be submitted by the IPCP-MBP team. Describe the resources required to submit a clinical trial report that meets the International Conference on Harmonization (ICH) E3 reporting requirements to the appropriate sponsors, regulatory agency(s) and the NIAID Program Officer at the conclusion of the Pre-phase I clinical trial.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Research Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Research Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) 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 applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 before the due date 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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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 System for Award Management (SAM). 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 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 of the application, but will not give a separate score for each.

• Do the Program Director(s)/Principal Investigator(s) have the leadership and scientific ability to develop and oversee an integrated and focused research program?
  
  
• Will the Program Director(s)/Principal Investigator(s) devote adequate time and effort to the program?
  
  
• Has innovation been established in the context of the global need for an nBP to prevent HIV acquisition/transmission?
  
  
• Is the innovation of the IPCP-MBP Program realized through iterative development and advancement of the nBP product or strategy, where the value added to the field is achieved through the interactions of the individual projects and cores?
  
  
• Does the integration of the overall program establish an iterative approach to the developmental problem(s) of creating an nBP candidate or strategy?
  
  
• Are the multi-disciplinary scope of the program and the coordination and interrelationships for all individual research projects and Scientific Core(s) focused and synergized on the common theme?
  
  
• Is the private sector component well integrated and positioned to contribute significantly to the proposed IPCP-MBP Program?
  
  
• Do the proposed milestones, Go/ No-Go criteria timelines and Gantt charts, support the overall goals and objectives of the proposed IPCP-MBP program? If the applicant chooses to develop a TPP does it also support the overall goals and objectives of the proposed IPCP-MBP program?

Reviewers will provide an overall impact 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? What is the potential biomedical significance of the proposed project and will it advance the nBP field by providing new technologies, single or combination nBP products or strategies? For applications proposing Pre-phase I clinical trial projects, have the applicants provided sufficient information to describe the proposed trial and demonstrate that it has the potential to advance the field of nBP?

Investigator(s)

Are the Project Leaders, 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-lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the time commitments of the Project Leaders appropriate?

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?

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Is the Pre-phase I clinical trial(s) appropriately designed to control subject risk, and if iterative Pre-phase I clinical trials are proposed, how do the outcomes relate to the objectives of the project, and to the overall program? Are there a sound scientific rationale and basis for the nBP candidate and/or strategy, and does the strength of the existing data support product feasibility, safety and potential efficacy? Is there a sound scientific rationale and basis for the development of any proposed new nBP-associated technology or model? Is the proposed project appropriate for the stage of development of the product nBP?

If there is an IND-enabling clinical path project, is it adequately described and does it incorporate appropriate oversight of GMP and GLP activities? Are the proposed outcomes of the IND-enabling clinical path project adequately justified and timed in terms of the information it may supply to other projects and cores?

Does the proposed private sector (industry) involvement provide access to expertise, activities, other resources and processes that would not otherwise be available to the investigators?

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?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core 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 core proposed).

Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of scientific merit and provide an overall impact score for each Core, but will not give separate scores for these items.

Administrative Core

Is the administrative and organizational structure appropriate to facilitate attainment of the objective(s) of the proposed IPCP-MBP? Are the experience, level of commitment, and established competence in organizing multi-project and cores demonstrated, and availability of the Administrative Core Leader and administrative staff adequate to manage the IPCP-MBP program? Are the operational activities of the Administrative Core appropriately justified as supporting the research projects and cores? Are the plans for coordination, problem identification and resolution, and the organizational structure proposed appropriate and adequate to the attainment of the objective(s) of the proposed program? Does the management plan provide for ongoing formal and informal communications within the IPCP-MBP? Has an administrative structure been proposed that allows for decisions to be made in the absence of the IPCP-MBP Program leader or to replace him/her if the need arises? Are the proposed plans to manage subcontracts and fee-for-service activities adequate to assess the quality/appropriateness of the facilities, methods and other resources to be used?

Scientific Cores

Is provision of resources and core services for the individual Research Projects critical and justified? Is the relationship of a Scientific Core to the central focus of the overall program strong? Is the quality of the relevant facilities or services provided and criteria for prioritization and usage appropriate? Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate? Are the core facilities appropriate and adequate to support at least two of the individual research projects? Is the relationship of each core to the central focus of the overall IPCP-MBP established and well justified? Are the criteria for prioritization and usage of core facilities or services (including procedures, techniques, and quality control) appropriate?

As applicable for the Projects and Cores proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Milestones, Go/ No-Go criteria and Gantt Charts/Timelines

Given the critical nature of the milestones, Go/ No-Go criteria and Gantt charts/timelines to measure the success of the IPCP-MBP program and nBP development, are they appropriate, adequately described, feasible, quantifiable and achievable within the proposed time frame for the elements they support? Do the milestones incorporate Go/No-Go criteria appropriate for the described testing? Are the Milestones well-integrated into the Gantt charts/timelines provided and will achievement be measured using Go/ No-Go decision criteria? And if the applicant included a TPP for the nBP product and/or DDS, do the proposed milestones, Go/ No-Go criteria, Gantt charts/timelines support achieving desired product properties identified in the TPP? Is it clear how the IPCP-MBP Program Gantt charts/timelines and the scientific and operational objectives will evolve as milestones and Go/ No-Go criteria are achieved? Given the potential benefits of the proposed research, do the milestones, Go/ No-Go criteria and Gantt charts/timelines support the potential for the overall program to advance the proposed nBP strategy? Are the individual project(s), Scientific Cores(s) and Administrative Core milestones, Go/ No-Go criteria and Gantt charts/timelines appropriate for their proposed efforts, feasible within the proposed timeframes, and integrated with the overall milestones for the IPCP-MBP program?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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 application 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 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 National Institute of Allergy and Infectious Diseases in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group 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 score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines 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:

• 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.

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, SAM 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• The PD(s)/PI(s) retain primary responsibility for the performance of the scientific activity, and understands the role of the Program Officer in the Cooperative Agreement award mechanism as described below.
  
  
• The PD(s)/PI(s) will be solely responsible for:
  
  
• Planning, directing, and executing the proposed project,
• Organizing, attending and chairing the IPCP-MBP annual meeting and Steering committee activities,
• Integrating and implementing the recommendations of the SAP into the activities IPCP-MBP Program,
• Assuring compliance of the IPCP-MBP Program with all applicable Federal, State, and Local, regulations and with all applicable DHHS/NIH/NIAID/DAIDS policies for conduct of research and clinical trials.
  
  
• Annual IPCP-MBP Meetings:
  
  
• All awardees are required to host an annual meeting attended by Project Leaders, Scientific Core Leaders, SAP members, other key IPCP-MBP staff and NIAID staff. The PD(s)/PI(s) and other IPCP-MBP members shall present: (1) an update on the results achieved for each research project and Scientific Core, (2) a review of progress in achieving established milestones within the specified timelines, any modifications in milestones or timelines that are proposed or have been implemented and their rationale, (3) discussion of scientific, technical and other problems and obstacles encountered and the methods/approaches proposed or implemented to overcome and/or resolve obstacles and problems, and (4) future plans for achieving remaining milestones, addressing any identified or potential problems that may impede or slow progress, and proposed methods/approaches to dealing with such problems, including contingency plans for delays, acceleration of timelines, and/or recommended modifications to established milestones Go/ No-Go criteria and Gantt charts/timelines.
  
  
• IPCP-MBP Awards Involving Clinical Trials:
  
  
• Applicants are encouraged to familiarize themselves with Division of AIDS Clinical Research Policies, which specify requirements for conducting clinical research under Division of AIDS sponsorship, (http://www3.niaid.nih.gov/research/resources/DAIDSClinRsrch/). Protocols for clinical trials must be reviewed and approved by the Division of AIDS Prevention Sciences Review Committee (PSRC) prior to implementation. In addition, awardees engaged in the conduct of clinical trials will be required to adhere to the NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf).
• When Pre-phase I trials are a component of the research conducted, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. All clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for human subjects. The PD(s)/PI(s) is responsible for providing information to the IND holder for required FDA annual IND reports, http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html) guidance on clinical study content after the completion of the Pre-phase I trials for regulatory submission.
• The PD(s)/PI(s) is responsible for putting in place monitoring and overseeing any documents supporting the clinical trial, such as Clinical Trial Agreements (CTA), regulatory binders, case forms, etc.
• At the completion of the trial the PD(s)/PI (s) are responsible for writing and submitting to the proper authorities an ICH Compliant E3 clinical report.
  
  
• All activities involving animal research performed outside of the U.S. must, in addition to U.S. Federal Regulations, comply with the host country regulations and the International Guiding Principles for Biomedical Research Involving Animals.
• Intellectual Property:
  The PD(s)/PI(s) are responsible for properly working with their respective applicant institution(s) in addressing Intellectual Property, consistent with achieving the goals of this program. The successful development of high priority nBP products will require substantial investment and support by private sector industries, and may involve collaborations with other organizations such as academic and/or non-profit research institutions not directly involved in the IPCP-MBP. It is the intent of this initiative to encourage the formation of the appropriate public-private partnerships that are essential to meet urgent public health needs. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees shall understand and acknowledge the following:

• The PD(s)/PI(s) and the applicant institution are solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the applicant to perform the project.
• Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
• The applicant institution is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).
• PD(s)/PI(s) and the applicant institution(s) are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, reports to the NIAID, and other mechanisms.
  
  
• Data: PD(s)/PI(s)’s institution will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
  
  
• Publications: The PD(s)/PI(s) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The PD(s)/PI(s) and Project Leaders are requested to submit manuscripts to the NIH Project Scientist after acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate Project Leaders and will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• During performance of the IPCP-MBP award, the NIH Project Scientist will provide appropriate assistance, advice, and guidance by: participating in scheduled meetings and teleconferences that may include, but are not limited to, Steering Committee meetings and teleconferences to discuss program coordination and/or progress; participating in annual meetings and SAP deliberations; participating in the design of the activities; facilitating collaboration with other NIAID-supported research resources; and advising in project management and technical performance. The role of the NIH Project Scientist will be to facilitate and not to direct the activities. It is anticipated that the NIH Project Scientist, and other NIAID staff identified by the PD(s)/PI(s), the Steering Committee and/or the NIH Project Scientist as having relevant expertise, may be given the opportunity to offer advisory input. The NIH Project Scientist will facilitate liaison activities for partnerships, and provide assistance with access to NIAID-supported resources and services.
  
  
• Other appropriate NIH program staff assistance will be coordinated by the NIH Project Scientist and may include Medical Officer(s), clinical operations and regulatory staff and other expertise as required. The NIH Project Scientist, with the support of appropriate staff and expertise, will provide coordination and assistance to the awardee to meet the Division of AIDS requirements for clinical protocol content, PSRC review and Pre-phase I clinical trial initiation and conduct. For awardees conducting Pre-phase I clinical trials, the NIAID reserves the right to terminate or curtail a clinical trial in the event of (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, (b) substantive changes in the consensus protocol to which the NIAID does not agree, (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) human subject ethical issues that may dictate a premature termination.
  
  
• The Government, via the NIH Project Scientist, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards.
  
  
• The assigned agency program official or IC program director may also serve as an NIH Project Scientist.
  
  
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Steering Committee
  
  
• Within two months of award, a Steering Committee will be established and chaired by the PD/PI. The Steering Committee will consist of the designated leaders for each Project and Core, the NIH Project Scientist, other NIH scientists as identified by the PD(s)/PI(s) and/or Steering Committee, and any other key personnel identified by the PD(s)/PI(s). The NIH Project Scientist will act in an advisory capacity and be a non-voting member of the Steering Committee. The Steering Committee may add additional members by majority vote.
• Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
  
  
• The Steering Committee will serve as the main governing board of the IPCP-MBP Program. The Steering Committee will:
• Assist the PD(s)/PI(s) in achieving the goals of the IPCP-MBP Program.
• Create subcommittees and request input from the SAP as needed.
• Evaluate progress of the IPCP-MBP and make recommendations for achieving Project, Core and IPCP-MBP milestones. This may include recommending alterations in the level of effort for specific Projects and/or Cores and/or modification of milestones.
• Be responsible for identifying policies and procedures to be implemented by the PD(s)/PI(s) to support IPCP-MBP operations and scientific progress, including development of guidelines for publication of the results of collaborative projects.
• Assist the PD(s)/PI(s), as required, in preparing formal reports summarizing IPCP-MBP activities and/or progress, such as the Annual Progress Report.
• Advise the NIH Project Scientist on scientific opportunities, emerging needs and impediments.
• Assist in protocol development for clinical studies and evaluate human subject's issues as needs arise.
• Ensure timely release of data to NIH-supported and/or public databases.
  
  
• The NIH Project Scientist will participate in the activities of the Steering Committee as required, providing verbal or written responses to the Steering Committee or its designated subcommittees upon request.
  
  
• Milestones and Timelines: The milestones and timelines proposed by the PD(s)/PI(s) shall be referenced in the terms and conditions of award. It is recognized that milestones and timelines may require revision and renegotiation during the project period. The PD(s)/PI(s) and NIAID must agree to all such revisions.

IPCP-MBP Scientific Advisory Panel (SAP):

• Each IPCP-MBP Program will establish an SAP of at least 3 investigators not affiliated with any of the institutions participating in the IPCP-MBP research program. SAP membership will be determined in consultation with the NIH Project Scientist. The SAP should be constituted no later than 6 months following award. The members of the SAP are expected to attend one or more of the IPCP-MBP annual meetings during the award period. The complete SAP membership is not required to attend all annual meetings, but at least 1 member of the SAP must attend each annual meeting. When a majority of the SAP is in attendance it will assist in review of the IPCP-MBP activities and evaluate progress toward achieving milestones, adherence to the original time frames, and the continued relevance of each project and Scientific Core to the overall goals of the research program. The Panel will recommend new directions as appropriate and will provide the PD(s)/PI(s) with a comprehensive written evaluation of the IPCP-MBP activities and recommendations after the annual meeting, as required by the NIAID Project Scientist. For awards involving a Pre-phase I clinical trial, the Panel may, at the discretion of NIAID, also be called upon to evaluate the feasibility of initiating a clinical study per the final goals and milestones. When a majority of the SAP is in attendance the SAP will provide the PD(s)/PI(s) and the NIH Project Scientist with a written evaluation of the SAP’s activities and recommendations after each meeting, if requested by either.
  
  
• Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

• Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) 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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Jim A. Turpin, Ph.D
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-2732
Email: jturpin@mail.nih.gov

Kristen A. Porter, Ph.D
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4783
Email: porterka@niaid.nih.gov

Cynthia Grossman, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-8962
Email: grossmanc@mail.nih.gov

Peter R. Jackson, Ph.D
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5049
Email: pjackson@niaid.nih.gov

Mollie Shea
National Institute of Allergy and Infectious Diseases (NIAID)
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Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.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.