Opportunity Information: Apply for RFA AI 14 008
Apply for RFA AI 14 008
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Sustained Release for Antiretroviral Treatment or Prevention (SRATP) of HIV Infection (UM1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on May 14, 2014 and posted on May 14, 2014.
- Applicants must submit their applications by Nov 18, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Native American tribal governments (Federally recognized) Small businesses Public housing authorities/Indian housing authorities County governments Public and State controlled institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession 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.
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Opportunity Summary:
The Sustained Release for Antiretroviral Treatment or Prevention (SRATP) of HIV Infection (UM1) opportunity (Funding Opportunity Number RFA-AI-14-008) is a National Institutes of Health (NIH) cooperative agreement designed to push forward practical, longer-acting antiretroviral (ARV) products for either HIV treatment or HIV prevention. The main idea is to support teams that can take promising sustained-release drug delivery concepts and drive them far enough down the development path that a Phase 1 clinical test can begin before the award period ends. In other words, this is not just early discovery science; it is structured to move candidate products toward real-world clinical evaluation on an accelerated timeline.
A central feature of the program is its focus on sustained-release delivery platforms that could reduce dosing frequency and improve adherence, which is a major challenge in both HIV therapy and prevention. Applications can target a wide range of delivery approaches as long as they are designed for extended drug release, including oral sustained-release systems, long-acting injections, implants, transdermal systems (such as patches), or direct delivery approaches aimed at HIV target mucosa. The FOA is flexible about whether the end product is meant for treatment (supporting viral suppression in people living with HIV) or prevention (such as pre-exposure prophylaxis-type approaches), but it is firm about the expectation that development activities should be organized around reaching Phase 1 readiness.
Applicants are allowed to propose up to three separate Sustained Release Strategies (SRSs) within a single application. Each SRS must represent a distinct product development effort, meaning the strategies cannot be minor variations of the same concept; each one should stand on its own as an independent candidate with its own development plan, technical rationale, and pathway toward clinical testing. This structure is meant to let strong programs advance multiple shots on goal while still being accountable for progress on each discrete product.
The application is also required to include several core operational components, reflecting the fact that NIH is funding an integrated development program rather than isolated projects. Specifically, every application must include: (1) a Program Operation Section (POS) to describe how the overall effort will be managed and executed; (2) a Clinical Trial Section (CTS) to lay out the plan and capacity to conduct the Phase 1 clinical work; (3) an IND Enabling Section (IND ES) covering the studies and documentation needed to support an Investigational New Drug (IND) application and meet regulatory expectations; and (4) an Administrative Coordination Section to handle coordination, communication, and program administration across participating groups. Beyond these required sections, applicants may also include additional scientific projects and scientific support sections if they are genuinely helpful for achieving the sustained-release product development goals (for example, specialized analytics, formulation support, device engineering, pharmacokinetics, biocompatibility work, manufacturing scale-up planning, or other translational capabilities).
Another important requirement is meaningful private-sector participation. At least one of the required sections must include a for-profit or not-for-profit company partner, and that company is expected to contribute in a positive and significant way to the overall SRATP scientific agenda. This detail signals that NIH wants applicants to bring in partners with real product development experience, manufacturing and quality systems knowledge, regulatory familiarity, and/or platform technologies that can accelerate translation. It also reflects the practical reality that sustained-release drug-device or formulation products often require capabilities that are more common in industry settings, such as design controls, scalable manufacturing approaches, and robust quality assurance processes.
Because the funding mechanism is a cooperative agreement (UM1), the relationship between awardees and NIH is typically more collaborative and hands-on than with a standard research project grant. Cooperative agreements generally imply substantial NIH programmatic involvement, which often means closer coordination on milestones, development decisions, and the overall strategy needed to reach Phase 1 testing on time. The FOA sits within NIH program areas tied to infectious diseases and related biomedical research, as reflected by the CFDA listings (including allergy and infectious diseases research and microbiology and infectious diseases research, among others).
Eligibility for this opportunity is broad and includes single institutions as well as consortia. Eligible applicants span many organization types: public and private institutions of higher education, nonprofits (including 501(c)(3) organizations and certain nonprofits without 501(c)(3) status), for-profit organizations (including small businesses), state, local, county, city, township, and special district governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, and independent school districts. The FOA also allows non-U.S. entities (foreign organizations and foreign institutions) to apply, allows non-U.S. components of U.S. organizations, and permits foreign components as defined in the NIH Grants Policy Statement. It also explicitly includes a range of mission-focused institutions such as HBCUs, Hispanic-serving institutions, Tribal Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI organizations, along with faith-based and community-based organizations where appropriate.
In terms of timing and administrative details, the announcement was posted on May 14, 2014, with an original and current closing date of November 18, 2014, and it was archived on December 19, 2014. The FOA does not require cost sharing or matching. The full announcement was made available through the NIH grants site, and NIH provided contact pathways through the NIH Office of Extramural Research (OER) web support for access or linking issues.
Taken together, SRATP (UM1) is best understood as a translational, milestone-driven NIH program aimed at delivering tangible sustained-release ARV candidates into first-in-human testing. It encourages integrated teams that can combine formulation or device innovation with the regulatory, preclinical, manufacturing, and clinical infrastructure needed to move from concept to Phase 1 within the award period, while also ensuring that industry-relevant expertise is embedded in the program through required private-sector participation.
Frequently Asked Questions (FAQs)
What is the SRATP (UM1) funding opportunity?
The Sustained Release for Antiretroviral Treatment or Prevention (SRATP) of HIV Infection (UM1) is a National Institutes of Health (NIH) cooperative agreement intended to advance practical, longer-acting antiretroviral (ARV) products for HIV treatment or HIV prevention. It is tied to Funding Opportunity Number (FON) RFA-AI-14-008.
What is the main goal of this program?
The program is designed to support integrated teams that can take sustained-release drug delivery concepts and move them far enough along the development pathway that a Phase 1 clinical test can begin before the award period ends. It is structured around readiness for real-world clinical evaluation rather than early discovery work alone.
Is this opportunity focused on HIV treatment, HIV prevention, or both?
Both are allowed. Applications may propose sustained-release ARV products intended for HIV treatment (supporting viral suppression in people living with HIV) or HIV prevention (for example, pre-exposure prophylaxis-type approaches). Regardless of the use case, the expectation is that development activities are organized around reaching Phase 1 readiness.
What types of sustained-release delivery approaches are eligible?
A wide range of sustained-release delivery platforms may be proposed as long as they are designed for extended drug release. Examples listed include oral sustained-release systems, long-acting injections, implants, transdermal systems (such as patches), and direct delivery approaches aimed at HIV target mucosa.
How many sustained-release product concepts can be included in one application?
An application may propose up to three separate Sustained Release Strategies (SRSs) within a single submission.
What qualifies as a distinct Sustained Release Strategy (SRS)?
Each SRS must represent a distinct product development effort. The strategies should not be minor variations of the same concept; each must stand on its own with an independent candidate, its own development plan, technical rationale, and pathway toward clinical testing.
What required sections must be included in the application?
Every application is required to include the following core operational components:
- Program Operation Section (POS) describing how the overall effort will be managed and executed
- Clinical Trial Section (CTS) describing the plan and capacity to conduct the Phase 1 clinical work
- IND Enabling Section (IND ES) addressing the studies and documentation needed to support an Investigational New Drug (IND) application and meet regulatory expectations
- Administrative Coordination Section covering coordination, communication, and program administration across participating groups
Can applicants include additional projects or cores beyond the required sections?
Yes. Applicants may include additional scientific projects and scientific support sections if they meaningfully support the sustained-release product development goals. Examples mentioned include specialized analytics, formulation support, device engineering, pharmacokinetics, biocompatibility work, manufacturing scale-up planning, and other translational capabilities.
Is private-sector participation required?
Yes. At least one of the required sections must include a for-profit or not-for-profit company partner, and that partner is expected to contribute in a positive and significant way to the overall SRATP scientific agenda.
What kind of contribution is the company partner expected to provide?
The announcement emphasizes that NIH wants industry-relevant expertise embedded in the program. Company participation is intended to bring product development experience, manufacturing and quality systems knowledge, regulatory familiarity, and/or platform technologies that can accelerate translation, recognizing that sustained-release drug-device or formulation products often require capabilities common in industry settings.
What does it mean that this is a cooperative agreement (UM1)?
A UM1 cooperative agreement typically involves a more collaborative, hands-on relationship between NIH and awardees than a standard research project grant. The description indicates substantial NIH programmatic involvement, which often includes closer coordination on milestones, development decisions, and overall strategy to reach Phase 1 testing on time.
Is this opportunity intended for early discovery research?
No. The program is described as translational and milestone-driven, focused on pushing candidate sustained-release ARV products toward first-in-human (Phase 1) testing within the award period rather than supporting only early-stage discovery science.
Who is eligible to apply?
Eligibility is broad and includes single institutions and consortia. Eligible applicants include public and private institutions of higher education; nonprofits (including 501(c)(3) organizations and certain nonprofits without 501(c)(3) status); for-profit organizations (including small businesses); state, local, county, city, township, and special district governments; tribal governments and tribal organizations; public housing authorities/Indian housing authorities; and independent school districts.
Are non-U.S. (foreign) organizations eligible?
Yes. The opportunity allows non-U.S. entities (foreign organizations and foreign institutions) to apply. It also allows non-U.S. components of U.S. organizations and permits foreign components as defined in the NIH Grants Policy Statement.
Are specific institution types explicitly included as eligible?
Yes. The announcement explicitly includes mission-focused institutions such as HBCUs, Hispanic-serving institutions, Tribal Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI organizations. It also notes faith-based and community-based organizations where appropriate.
Is cost sharing or matching required?
No. The FOA states that cost sharing or matching is not required.
When was the opportunity posted and when did it close?
The announcement was posted on May 14, 2014. The original and current closing date listed is November 18, 2014. The FOA was archived on December 19, 2014.
Where was the full announcement made available?
The full announcement was made available through the NIH grants site.
Who should be contacted for technical issues accessing or linking to the announcement?
NIH provided contact pathways through the NIH Office of Extramural Research (OER) web support for access or linking issues.
What NIH program areas does this opportunity relate to?
The FOA sits within NIH program areas tied to infectious diseases and related biomedical research, as reflected by CFDA listings that include allergy and infectious diseases research and microbiology and infectious diseases research, among others.
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