Opportunity Information: Apply for RFA DA 09 022

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Biosignatures of Chronic Drug Exposure (R21)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279 Drug Abuse and Addiction Research Programs.
  • This funding opportunity was created on Oct 1, 2008 and posted on Oct 1, 2008.
  • Applicants must submit their applications by Jan 27, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $200,000.00 in funding.
  • Eligible applicants include: Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Special district governments County governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses State governments Private institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments).
  • 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
Apply for RFA DA 09 022

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Opportunity Summary:

The Biosignatures of Chronic Drug Exposure (R21) funding opportunity (RFA-DA-09-022) is a National Institutes of Health program run through the National Institute on Drug Abuse (NIDA) that aims to spark early-stage, higher-risk research to find measurable biological clues of a persons prior drug exposure. In this announcement, a "biosignature" means one or more biological indicators that can be measured through an assay and used to infer facts about past exposure to drugs of abuse. Rather than focusing on detecting the drug itself or its metabolites, the program is specifically looking for indirect, non-drug signals in the body that reflect longer-term biological changes associated with drug use, withdrawal, or relapse.

A core theme of the FOA is the search for peripheral biosignatures, meaning indicators found outside the central nervous system. The idea is to identify signals in easily obtainable clinical materials that could serve as practical surrogates for brain-related changes caused by chronic exposure to illicit or licit drugs. Examples of the kinds of clinically accessible biomaterials the FOA highlights include blood, lymphocytes, bladder epithelial cells, and stem cells. On the molecular side, applicants are encouraged to explore different classes of candidate biomarkers that could realistically be turned into assays, such as proteins, peptides, RNA species, microRNAs, and related measurable molecules.

These projects are framed as feasibility studies rather than full validation efforts. NIDA is emphasizing discovery and early proof-of-concept work using animal models only, with the goal of identifying (1) which peripheral tissues or sample types are most promising and (2) which molecular readouts provide the best signal for assay development. The FOA also makes clear that a biosignature can involve more than one biomarker, but the overall number of biomarkers needs to stay reasonably limited so that any eventual screening test remains developable and practical. In other words, the program is not encouraging massive, unwieldy panels if they cannot realistically translate into a workable assay.

In addition to identifying candidate biosignatures, the FOA explicitly calls out technical hurdles that these R21 feasibility projects should address. That includes assessing assay sensitivity, managing signal-to-noise challenges, and generating evidence for predictive validity, meaning the extent to which the peripheral biosignature can reliably indicate relevant drug exposure states (such as chronic exposure patterns, withdrawal, or relapse-related biology) as reflected by underlying brain changes. The emphasis on predictive validity signals that NIDA is not only looking for biological differences, but for markers that could plausibly function as indicators with interpretive value in a real screening or monitoring context.

The mechanism of support is the NIH R21 exploratory/developmental grant, chosen because NIDA considers this line of work high risk. The award information in the source data lists an award ceiling of $200,000. NIDA anticipated a total of about $2,000,000 in funding through this announcement, supporting approximately 5 to 7 awards, reflecting a relatively small, targeted portfolio of exploratory projects.

Eligibility is broad and spans many organization types, including public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and multiple levels of government entities (state, county, city/township, special districts), as well as tribal governments and tribal organizations. The FOA also notes additional eligible applicants such as historically underserved or mission-specific institutions (for example, HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions), faith-based or community-based organizations, federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). No cost sharing or matching is required.

Key dates in the posting indicate the opportunity was posted October 1, 2008, with an original and current closing date of January 27, 2009, and an archive date of February 27, 2009. The CFDA listing provided is 93.279 (Drug Abuse and Addiction Research Programs). The funding announcement is associated with NIH, with the NIDA program focus, and the full FOA was made available through the NIH grants guide. Contact notes in the source data point applicants to the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues.

Frequently Asked Questions (FAQs)

What is the "Biosignatures of Chronic Drug Exposure (R21)" funding opportunity?

It is an NIH funding opportunity (RFA-DA-09-022) run through the National Institute on Drug Abuse (NIDA) to support exploratory, early-stage research aimed at identifying measurable biological indicators (biosignatures) of a person's prior drug exposure.

What is the main goal of this FOA?

The goal is to spark higher-risk, early proof-of-concept studies that discover indirect biological signals associated with chronic drug exposure, withdrawal, or relapse-related biology, rather than detecting the drug itself or its metabolites.

What does "biosignature" mean in this announcement?

In this FOA, a biosignature is one or more biological indicators that can be measured through an assay and used to infer facts about past exposure to drugs of abuse.

Is the FOA focused on detecting drugs or drug metabolites?

No. The FOA specifically emphasizes indirect, non-drug signals in the body that reflect longer-term biological changes linked to drug use, withdrawal, or relapse.

What kinds of biosignatures are especially encouraged?

The FOA highlights peripheral biosignatures, meaning indicators found outside the central nervous system, with the intent of finding practical surrogate signals for brain-related changes caused by chronic drug exposure.

What does "peripheral biosignature" mean here?

It refers to a measurable indicator found in tissues or materials outside the brain and spinal cord, ideally in clinically accessible samples that could be obtained more easily than central nervous system tissue.

What sample types or biomaterials are mentioned as examples?

The FOA provides examples of clinically accessible biomaterials including blood, lymphocytes, bladder epithelial cells, and stem cells.

What types of molecular readouts or biomarker classes are suggested?

Applicants are encouraged to consider biomarker classes that could realistically be turned into assays, including proteins, peptides, RNA species, microRNAs, and related measurable molecules.

Are projects expected to be discovery/feasibility studies or full validation studies?

They are framed as feasibility and early proof-of-concept discovery studies, not full validation efforts.

Are human subjects allowed or required?

The FOA emphasizes early proof-of-concept work using animal models only.

What are the specific discovery targets NIDA wants these projects to identify?

The FOA describes a goal of identifying (1) which peripheral tissues or sample types are most promising and (2) which molecular readouts provide the best signal for assay development.

Can a biosignature include multiple biomarkers?

Yes. The FOA states that a biosignature can involve more than one biomarker.

Is there any guidance on how many biomarkers a biosignature should include?

Yes. The FOA indicates the overall number of biomarkers should remain reasonably limited so that any eventual screening test stays developable and practical, and it discourages massive panels that are unlikely to translate into a workable assay.

What technical hurdles are these R21 projects expected to address?

The FOA explicitly calls out issues such as assessing assay sensitivity, managing signal-to-noise challenges, and generating evidence related to predictive validity.

What does "predictive validity" mean in the context of this FOA?

It refers to the extent to which a peripheral biosignature can reliably indicate relevant drug exposure states (for example, chronic exposure patterns, withdrawal, or relapse-related biology) as reflected by underlying brain changes.

What NIH grant mechanism is being used for this opportunity?

This opportunity uses the NIH R21 exploratory/developmental grant mechanism, selected because NIDA considers this research area high risk.

What is the award ceiling listed for this opportunity?

The source information lists an award ceiling of $200,000.

How much total funding did NIDA anticipate for this announcement?

NIDA anticipated approximately $2,000,000 in total funding under this announcement.

About how many awards were expected?

The announcement anticipated supporting approximately 5 to 7 awards.

Who is eligible to apply?

Eligibility is broad and includes public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and government entities at multiple levels.

Are tribal entities eligible?

Yes. The FOA includes tribal governments and tribal organizations among eligible applicants.

Are mission-specific or historically underserved institutions included as eligible applicants?

Yes. The FOA notes additional eligible applicants such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and similar organizations.

Are faith-based or community-based organizations eligible?

Yes. The FOA explicitly includes faith-based and community-based organizations among eligible applicants.

Can federal agencies apply?

Yes. Federal agencies are listed among the eligible applicant types in the provided information.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The FOA information notes that non-U.S. entities (foreign organizations) are eligible.

Is cost sharing or matching required?

No. The provided information states that no cost sharing or matching is required.

When was this opportunity posted?

The opportunity was posted on October 1, 2008.

What was the closing date for applications?

The original and current closing date listed is January 27, 2009.

When was the opportunity archived?

The archive date listed is February 27, 2009.

What CFDA number is associated with this opportunity?

The CFDA listing provided is 93.279, titled Drug Abuse and Addiction Research Programs.

Which NIH institute is associated with this program?

The program focus is through the National Institute on Drug Abuse (NIDA), within the National Institutes of Health (NIH).

Where was the full FOA made available?

The information indicates the full FOA was made available through the NIH grants guide.

Who should be contacted for technical access or linking issues?

The contact notes point applicants to the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues.

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