Expanding the Target Landscape by Drugging the Undruggable (R21 Clinical Trial Not Allowed)

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for exploratory and early-stage projects that focus on undruggable target classes within intractable human disease. Applicants will identify a human disease relevant undruggable target class and develop a method or agent that is selective for one or more targets within that target class. This NOFO is intended to jumpstart research that demonstrates innovative strategies to modulate targets that cannot be addressed by established therapeutic types, furthering the development of methods and/or agents selective for undruggable target classes.

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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

The primary criteria for evaluating grant applications include assessment of: (1) the scientific merit, significance and overall impact of the proposed study and its objectives; (2) the competency of the proposed investigator(s) to successfully pursue the project; (3) the innovation and novelty of the concepts, approaches, or methodologies; (4) the technical adequacy of the experimental design and approach; (5) the adequacy of the available proposed facilities and resources; (6) the necessity of the budget components requested in relation to the proposed project; and (7) the relevance and importance to the posted institute program objectives. Also evaluated, where applicable, but not scored are: (1) protections for human subjects; (2) inclusion of women, minorities, and children; (3) vertebrate animal welfare; and (4) adequate protection of research personnel and/or the environment, biosafety, biocontainment and the security of select agents; (5) resource sharing plans; (6) authentication of key biological and/or chemical resources, (7) budget and period of support. In addition, the following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: the potential of the proposed research for commercial application. Phase II grant applications will reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit...

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.

The following consideration will be used in determining projects to be funded: (1) Technical merit of the proposed project as determined by peer review; (2) Availability of funds; and (3) Relevance to program priorities.

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives and (7) the availability of funds.

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the...

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.

The major elements in evaluating proposals include assessments of the significance of the proposed research; approach; innovation; investigators; and environment. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget...

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Fiscal Year2025: The following is a tiny sample of fiscal year 2025 NICHD funded grants within the discretionary award class type. 1) Understanding the role of early life social determinants and sex-specific pubertal pathways in the development of adolescent chronic pain. 2) Improving In Vitro Fertilization Success through Multiplexed Optical Metabolic Imaging. 3) Genetic Studies of Large Palindromes. 4) A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery. The following is a tiny sample of fiscal year 2025 NICHD funded grants within the cooperative agreement award class type. 1) Study of Treatment and Reproductive outcomes. 2) Pediatric HIV/AIDS Cohort Study (PHACS): Research on Immune Aging, Sexual and Reproductive Health, and Perinatal Acquisition: Elucidating Relationships in HIV (RISE). 3) Pelvic Floor Disorders Network Data Coordinating Center. 4) NICHD Maternal-Fetal Medicine Units (MFMU) Network: Data Coordinating Center.Fiscal Year2026: The following is a tiny sample of fiscal year 2026 NICHD funded grants within the discretionary award class type. 1) Placental Proteins and Prematurity. 2) In...

The following consideration will be used in determining projects to be funded: (1) Technical merit of the proposed project; (2) Availability of funds; and (3) Relevance to program priorities.

This program has no statutory formula. Matching requirements are not applicable to this assistance listing. MOE requirements are not applicable to this assistance listing.

Not Applicable.