Opportunity Information: Apply for RFA RM 12 014

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Utility of Extracellular RNA for Therapy Development (UH2/UH3)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310 Trans NIH Research Support.
  • This funding opportunity was created on Aug 3, 2012 and posted on Aug 3, 2012.
  • Applicants must submit their applications by Nov 13, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Small businesses County governments Private institutions of higher education City or township governments For profit organizations other than small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized).
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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) 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 NIH funding opportunity titled "Clinical Utility of Extracellular RNA for Therapy Development (UH2/UH3)" (Funding Opportunity Number RFA-RM-12-014) supported research aimed at turning the emerging biology of extracellular RNA (exRNA) into practical therapeutic strategies. exRNA refers to RNA molecules found outside cells in many human body fluids, including blood, saliva, urine, breast milk, amniotic fluid, cerebrospinal fluid, ascites, and pleural effusions. The scientific premise behind the announcement is that secreted RNA can function as a signaling entity between cells, influencing the behavior and phenotype of recipient target cells. NIH framed this as an emerging and potentially universal paradigm of intercellular communication, and the program was designed to move beyond basic observations into therapy-oriented development work.

The core goal of the initiative was to develop and demonstrate the potential clinical utility of exRNAs as therapeutic agents, while also advancing the enabling technologies needed to deliver RNA extracellularly in a controlled and effective way. Projects were expected to pursue novel therapies that leverage exRNA signaling, either by using naturally occurring exRNA mechanisms or by engineering RNAs intended to act in target tissues once delivered. A major emphasis was placed on creating practical extracellular delivery vehicles, especially approaches that package engineered RNAs into extracellular vesicles or associate them with RNA-binding proteins so they can travel through extracellular space and reach specific target cells.

Applicants were expected to include concrete methods and workflows that address the key translational hurdles for exRNA-based therapeutics. This included methods for producing specific RNAs, purifying them at a quality and scale appropriate for downstream use, and packaging or complexing them into extracellular carriers (such as vesicles or RNA-binding protein complexes). In addition, proposals needed strategies for delivery to target cells through extracellular space, which implies attention to targeting, uptake, stability, biodistribution, and the ability of the delivered RNA to produce a measurable biological effect in recipient cells. Overall, the opportunity was geared toward therapy development rather than purely descriptive biology, with a focus on tools, technologies, and proof-of-potential demonstrations that could support eventual clinical translation.

Mechanistically and administratively, the award used a cooperative agreement mechanism and a phased UH2/UH3 structure, reflecting an expectation of milestone-driven progress under NIH involvement typical of cooperative agreements. The activity category was Health, and the program fell under CFDA 93.310 (Trans-NIH Research Support). There was no cost sharing or matching requirement listed.

Eligibility was broad and included many common applicant types in NIH programs: nonprofit organizations (including 501(c)(3) and non-501(c)(3) nonprofits), public and private institutions of higher education, small businesses, and for-profit entities other than small businesses, as well as a wide range of government applicants (city/township, county, state, special district governments, independent school districts, public housing authorities, and tribal governments/organizations). The announcement also explicitly included a variety of institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, and U.S. territories or possessions. Foreign institutions were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components were allowed as defined under NIH policy, signaling that NIH was open to international participation where appropriate.

Key dates in the posted source information indicate the opportunity was posted and created on August 3, 2012, with an original and current closing date of November 13, 2012, and an archive date of December 14, 2012. The sponsoring agency was the National Institutes of Health, and the full announcement was hosted on the NIH Grants Guide website. For access or technical issues, the listing provided NIH Office of Extramural Research (OER) webmaster contact information.

FAQs: Clinical Utility of Extracellular RNA for Therapy Development (UH2/UH3) - RFA-RM-12-014

What is the name of this NIH funding opportunity?

The funding opportunity is titled "Clinical Utility of Extracellular RNA for Therapy Development (UH2/UH3)."

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is RFA-RM-12-014.

What is the main purpose of this program?

The program supported research to turn the emerging biology of extracellular RNA (exRNA) into practical, therapy-oriented strategies. The emphasis was on developing and demonstrating clinical utility of exRNAs as therapeutic agents and advancing technologies that enable controlled extracellular delivery.

What is extracellular RNA (exRNA) in the context of this announcement?

exRNA refers to RNA molecules found outside of cells in many human body fluids, including blood, saliva, urine, breast milk, amniotic fluid, cerebrospinal fluid, ascites, and pleural effusions.

Why was exRNA considered important or promising for therapy development?

The scientific premise described secreted RNA as a signaling entity between cells that can influence the behavior and phenotype of recipient target cells. NIH framed this as an emerging and potentially universal paradigm of intercellular communication and designed the program to move beyond basic observations into therapy development work.

Was this opportunity focused on basic research or therapy development?

It was geared toward therapy development rather than purely descriptive biology, with a focus on tools, technologies, and proof-of-potential demonstrations that could support eventual clinical translation.

What types of therapeutic approaches were expected under this opportunity?

Projects were expected to pursue novel therapies that leverage exRNA signaling, either by using naturally occurring exRNA mechanisms or by engineering RNAs intended to act in target tissues once delivered.

What enabling technologies were emphasized?

A major emphasis was placed on practical extracellular delivery vehicles, especially approaches that package engineered RNAs into extracellular vesicles or associate them with RNA-binding proteins to support travel through extracellular space and delivery to specific target cells.

What kinds of delivery carriers were specifically mentioned?

The opportunity highlighted extracellular carriers such as extracellular vesicles and RNA-binding protein complexes (i.e., engineered RNAs packaged into vesicles or complexed/associated with RNA-binding proteins).

What translational hurdles were applicants expected to address?

Applicants were expected to include concrete methods and workflows addressing key hurdles for exRNA-based therapeutics, including producing specific RNAs, purifying them at appropriate quality and scale, packaging or complexing them into extracellular carriers, and delivering them through extracellular space to target cells.

What production and purification expectations were described?

Proposals were expected to include methods for producing specific RNAs and purifying them at a quality and scale appropriate for downstream use (in the context of therapy development workflows).

What delivery considerations were implied for proposed projects?

Proposals needed strategies for delivery to target cells through extracellular space, implying attention to targeting, uptake, stability, biodistribution, and the ability of delivered RNA to produce a measurable biological effect in recipient cells.

What kind of outcomes or demonstrations did NIH want to see?

The program sought proof-of-potential demonstrations showing that exRNAs could have clinical utility as therapeutic agents, alongside development of practical tools and technologies supporting eventual translation.

What award mechanism was used?

This opportunity used a cooperative agreement mechanism.

What does the UH2/UH3 structure indicate for this program?

The phased UH2/UH3 structure reflected an expectation of milestone-driven progress, with NIH involvement typical of cooperative agreements.

What was the activity category for this opportunity?

The activity category was Health.

What CFDA program was this opportunity associated with?

The opportunity fell under CFDA 93.310 (Trans-NIH Research Support).

Was cost sharing or matching required?

No cost sharing or matching requirement was listed.

Who was eligible to apply?

Eligibility was broad and included nonprofit organizations (including 501(c)(3) and non-501(c)(3) nonprofits), public and private institutions of higher education, small businesses, for-profit entities other than small businesses, and many government applicant types (including city/township, county, state, special district governments, independent school districts, public housing authorities, and tribal governments/organizations).

Were minority-serving and other institution types explicitly included?

Yes. The announcement explicitly included institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, and U.S. territories or possessions.

Were foreign institutions allowed to apply?

Yes. Foreign institutions were eligible to apply.

Were non-U.S. components of U.S. organizations eligible?

Yes. Non-U.S. components of U.S. organizations were eligible.

Were foreign components permitted under NIH policy?

Yes. Foreign components were allowed as defined under NIH policy, indicating NIH openness to international participation where appropriate.

Which agency sponsored this funding opportunity?

The sponsoring agency was the National Institutes of Health (NIH).

Where was the full announcement hosted?

The full announcement was hosted on the NIH Grants Guide website.

When was the opportunity posted?

The posted and created date was August 3, 2012.

What was the closing date?

The original and current closing date was November 13, 2012.

When was the opportunity archived?

The archive date was December 14, 2012.

Who was listed for access or technical issues related to the posting?

For access or technical issues, the listing provided contact information for the NIH Office of Extramural Research (OER) webmaster.

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