Opportunity Information: Apply for RFA MH 10 040
Apply for RFA MH 10 040
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Biosignature Discovery for Personalized Treatment in Depression (U01)" 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.
- This funding opportunity was created on Sep 16, 2009 and posted on Sep 16, 2009.
- Applicants must submit their applications by Jan 13, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $6,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education State governments For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education 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 Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The funding opportunity "Biosignature Discovery for Personalized Treatment in Depression (U01)" (Funding Opportunity Number RFA-MH-10-040) is a National Institutes of Health initiative led through the National Institute of Mental Health (NIMH) focused on improving how major depressive disorder (MDD) is treated. The central goal is to support exploratory research aimed at discovering panels of biomarkers, described in the announcement as "biosignatures," that can predict how an individual patient will respond to treatment. In practical terms, the opportunity is about moving beyond trial-and-error prescribing by identifying measurable biological patterns that help clinicians anticipate which treatment is most likely to work for which patient, thereby supporting more personalized care in depression.
This announcement uses the NIH Cooperative Agreement mechanism (U01), which signals a more collaborative relationship between the awardee and NIH compared with a traditional research grant. Under a U01, NIH program staff typically have substantial scientific or programmatic involvement during the project, which can include coordination, shared expectations around milestones, and active engagement to help guide the research toward the initiative's goals. The emphasis on a cooperative mechanism fits the nature of biosignature discovery, where harmonized methods, carefully defined outcomes, and coordinated data practices often matter for producing findings that are robust enough to inform future clinical development.
For funding, NIMH anticipated committing approximately $6,000,000 in total costs in Fiscal Year 2010 to support one or more U01 awards under this initiative. The language "one or more" indicates that the final number of awards would depend on the quality, scope, and budget of the applications received, rather than being a fixed number. The opportunity was posted on September 16, 2009, with an original and final application closing date of January 13, 2010, and an archive date of February 13, 2010, meaning it is no longer open but remains available for reference.
The opportunity falls under the discretionary category and the health funding activity area, with CFDA number 93.242 (Mental Health Research Grants). There is no cost sharing or matching requirement, so applicants were not expected to provide non-federal matching funds as a condition of award. The sponsoring agency is the National Institutes of Health, and the full announcement was provided through the NIH grants guide at: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-10-040.html.
Eligibility was broad and included many types of organizations that could plausibly contribute to biomarker and clinical outcome research in depression. Eligible applicants included public and state-controlled institutions of higher education, private institutions of higher education, state governments, U.S. territories or possessions, and Native American tribal governments (federally recognized). Nonprofit organizations were eligible both with and without 501(c)(3) IRS status (in categories other than institutions of higher education), and for-profit organizations other than small businesses were also listed as eligible. The eligibility section additionally highlighted specific institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and regional organizations, as well as eligible agencies of the federal government. Taken together, this signals an intent to encourage participation from a wide range of research environments, including minority-serving and tribally controlled institutions, and to support diverse institutional partnerships that might be needed to assemble clinical cohorts, collect biological measures, and analyze complex data.
The scientific focus is specifically on identifying biosignatures that are "predictive of treatment outcomes" in major depressive disorder. By emphasizing panels of biomarkers rather than single markers, the FOA reflects a realistic view of depression as biologically and clinically heterogeneous, where combinations of measures (for example, multi-analyte blood-based measures, neurophysiological signals, imaging-derived features, genetics, or other biological readouts) may collectively provide better prediction of response, remission, side effects, or relapse than any one marker alone. The deliverable implied by the announcement is not simply descriptive biology, but actionable predictive biosignatures that could eventually be tested and validated for guiding treatment decisions.
For administrative and technical support, the notice included contact guidance for applicants who had trouble accessing the announcement or linking to it, directing them to the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Biosignature Discovery for Personalized Treatment in Depression (U01)." The Funding Opportunity Number is RFA-MH-10-040.
Which federal agency and NIH institute sponsor this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), and the initiative is led through the National Institute of Mental Health (NIMH).
What is the main purpose of this funding opportunity?
The central goal is to support exploratory research to discover panels of biomarkers (called "biosignatures" in the announcement) that can predict how an individual patient with major depressive disorder (MDD) will respond to treatment. The intent is to improve depression care by moving beyond trial-and-error prescribing toward more personalized treatment selection.
What does the FOA mean by "biosignatures"?
In this announcement, biosignatures refer to panels (combinations) of biomarkers intended to predict treatment outcomes in MDD. The emphasis is on predictive, actionable biological patterns rather than a single biomarker or purely descriptive findings.
What kinds of outcomes are the biosignatures expected to predict?
The FOA frames biosignatures as "predictive of treatment outcomes" in MDD. Examples of outcomes referenced in the description include response, remission, side effects, or relapse, with the overarching focus on predicting how a patient will do with treatment.
Is this opportunity focused on major depressive disorder (MDD) specifically?
Yes. The scientific focus described is on major depressive disorder and predicting treatment outcomes for individuals with MDD.
What grant mechanism is being used?
This opportunity uses the NIH Cooperative Agreement mechanism (U01).
What does a U01 cooperative agreement imply for applicants and awardees?
A U01 indicates a more collaborative relationship with NIH than a traditional research grant. NIH program staff typically have substantial scientific or programmatic involvement during the project, which may include coordination, shared expectations around milestones, and active engagement to help guide the research toward the initiative's goals.
Why does the FOA use a cooperative agreement mechanism for this topic?
The description notes that biosignature discovery often benefits from harmonized methods, carefully defined outcomes, and coordinated data practices so results are robust enough to inform future clinical development. The cooperative agreement structure aligns with those needs.
How much funding did NIMH anticipate committing to this initiative?
NIMH anticipated committing approximately $6,000,000 in total costs in Fiscal Year 2010 to support one or more U01 awards under this initiative.
How many awards were expected to be made?
The FOA states "one or more" awards. The final number of awards would depend on the quality, scope, and budgets of the applications received rather than being a fixed number.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement, meaning applicants were not expected to provide non-federal matching funds as a condition of award.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.242 (Mental Health Research Grants).
What category and funding activity area does this opportunity fall under?
The opportunity is listed under the discretionary category and the health funding activity area.
When was the opportunity posted, and what were the application dates?
The opportunity was posted on September 16, 2009. The original and final application closing date was January 13, 2010.
Is this funding opportunity still open?
No. The FOA has an archive date of February 13, 2010, and is no longer open, though it remains available for reference.
Where can the full announcement be found?
The full announcement was provided through the NIH grants guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-10-040.html.
What types of organizations were eligible to apply?
Eligibility was broad and included public and state-controlled institutions of higher education, private institutions of higher education, state governments, U.S. territories or possessions, and Native American tribal governments (federally recognized). It also included nonprofit organizations (with and without 501(c)(3) IRS status, in categories other than institutions of higher education) and for-profit organizations other than small businesses. Eligible agencies of the federal government were also included.
Were minority-serving and tribally controlled institutions included in the eligibility list?
Yes. The eligibility section specifically highlighted institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and regional organizations.
Does the broad eligibility suggest anything about the intended applicant community?
Based on the eligibility list and highlighted institution types, the FOA signals an intent to encourage participation from a wide range of research environments, including minority-serving and tribally controlled institutions, and to support diverse institutional partnerships that could help assemble clinical cohorts, collect biological measures, and analyze complex data.
Is the FOA focused on single biomarkers or panels of biomarkers?
The emphasis is on panels of biomarkers (biosignatures) rather than single markers, reflecting the view that depression is biologically and clinically heterogeneous and that combinations of measures may better predict outcomes.
What kinds of biomarker measures are contemplated in the description?
The description gives examples of potential components of biosignatures, including multi-analyte blood-based measures, neurophysiological signals, imaging-derived features, genetics, or other biological readouts, used in combination to predict outcomes.
What is the practical clinical motivation behind this research?
The opportunity is motivated by the goal of helping clinicians anticipate which treatment is most likely to work for a specific patient, supporting more personalized care rather than relying on trial-and-error prescribing.
Who should be contacted for technical issues accessing the announcement?
For trouble accessing the announcement or linking to it, the notice directs applicants to the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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