Opportunity Information: Apply for RFA HD 22 018
The grant opportunity "Biomarker Research to Support Fertility Regulation Development by Small Business (R43 Clinical Trial Optional)" (Funding Opportunity Number RFA-HD-22-018) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding announcement designed to push forward the development of practical biomarker tools that can speed up and strengthen the clinical development of non-hormonal contraceptives for both men and women. In plain terms, NIH is looking for small businesses to create new or better ways to measure biological signals (biomarkers) tied to fertility and contraceptive effects, and to turn those biomarkers into usable diagnostic tests that can support contraceptive product development in real-world clinical settings.
A central focus of the announcement is on clinical biomarkers and companion biomarker diagnostics. That includes technologies such as point-of-care tests that can be used quickly in clinics and potentially direct-to-consumer (DTC) tests that can be used outside traditional medical environments. The emphasis on "companion" diagnostics signals that NIH is interested in tools that can be paired with contraceptive candidates in development, helping developers determine whether a product is working as intended, how strongly it is working, how quickly it starts or stops working, or which users are most likely to respond. The overall aim is to make non-hormonal contraception development more efficient and evidence-based by providing reliable biological readouts that can support clinical decision-making, trial design, and product evaluation.
This is a discretionary grant using the SBIR R43 mechanism, which typically corresponds to a Phase I small business award intended to establish feasibility and early proof of concept. The notice specifies "Clinical Trial Optional," meaning applicants may propose projects that include a clinical trial if it is appropriate for the biomarker work, but they are not required to do so. The funding activity category is listed under Health, Income Security and Social Services, and the CFDA (now often referred to as Assistance Listing) number provided is 93.865, aligning it with NIH activity in this broader program area.
Eligibility is limited to small businesses, consistent with SBIR rules. The announcement also makes clear boundaries around foreign involvement: non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, it notes that "foreign components," as defined by the NIH Grants Policy Statement, may be allowed, which generally means certain elements of work may be performed outside the U.S. if they meet NIH policy requirements and are well-justified, even though the applicant organization itself must be an eligible U.S. small business.
Key administrative details in the source information include an original closing date of 2021-07-29 and a creation date of 2021-04-15. The award ceiling is listed as 259,613 (typically interpreted as the maximum amount for an award under this opportunity, subject to NIH SBIR budget rules and any specifics in the FOA). The opportunity is issued by the National Institutes of Health. Overall, the program is structured to encourage small companies to translate biomarker science into deployable diagnostic products that can directly support the clinical pipeline for next-generation, non-hormonal fertility regulation methods.Apply for RFA HD 22 018
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Biomarker Research to Support Fertility Regulation Development by Small Business (R43 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
- This funding opportunity was created on 2021-04-15.
- Applicants must submit their applications by 2021-07-29. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $259,613.00 in funding.
- Eligible applicants include: Small businesses.
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| Funding Opportunity |
|---|
| NICHD Small Research Grant Program (R03 Clinical Trial Required) Apply for PA 21 221 Funding Number: PA 21 221 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| NICHD Small Research Grant Program (R03 Basic Experimental Studies with Humans Required) Apply for PA 21 231 Funding Number: PA 21 231 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Human Milk as a Biological System (R01 Clinical Trial Optional) Apply for RFA HD 22 020 Funding Number: RFA HD 22 020 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $499,999 |
| Screening and Functional Validation of Human Birth Defects Genomic Variants (R01 Clinical Trial Not Allowed) Apply for PAR 21 229 Funding Number: PAR 21 229 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $499,999 |
| HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed) Apply for RFA NS 21 029 Funding Number: RFA NS 21 029 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Pediatric Immune System Ontogeny and Development (INTEND) (R01 Clinical Trial Not Allowed) Apply for PAR 21 248 Funding Number: PAR 21 248 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Impact of Technology and Digital Media (TDM) Exposure/Usage on Child and Adolescent Development (P01 Clinical Trial Optional) Apply for RFA HD 22 009 Funding Number: RFA HD 22 009 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Learning Disabilities Innovation Hubs (P20 Clinical Trial Optional) Apply for RFA HD 22 005 Funding Number: RFA HD 22 005 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $390,000 |
| Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R41/R42 Clinical Trial Not Allowed) Apply for PAR 21 298 Funding Number: PAR 21 298 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R43/R44 Clinical Trial Not Allowed) Apply for PAR 21 297 Funding Number: PAR 21 297 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Pelvic Floor Disorders Network (U24 Clinical Trial Required) Apply for RFA HD 22 022 Funding Number: RFA HD 22 022 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $1,500,000 |
| Pelvic Floor Disorders Network (UG1 Clinical Trial Required) Apply for RFA HD 22 021 Funding Number: RFA HD 22 021 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $170,000 |
| Promoting Reproductive Health for Adolescents and Adults with Disabilities (R01 Clinical Trial Optional) Apply for RFA HD 23 005 Funding Number: RFA HD 23 005 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Elucidating the Role of Nutrition in Care and Development of Preterm Infants (R01 Clinical Trial Optional) Apply for RFA HD 22 023 Funding Number: RFA HD 22 023 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $499,999 |
| Home and Community-Based Physical Activity Interventions to Improve the Health of Wheelchair Users (R01 Clinical Trial Required) Apply for RFA HD 22 017 Funding Number: RFA HD 22 017 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional) Apply for PAR 21 355 Funding Number: PAR 21 355 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $275,000 |
| Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R03 - Clinical Trial Optional) Apply for PAR 21 354 Funding Number: PAR 21 354 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R01 - Clinical Trial Optional) Apply for PAR 21 353 Funding Number: PAR 21 353 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management (R61/R33, Clinical Trial Required) Apply for RFA AT 22 003 Funding Number: RFA AT 22 003 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Child Health Research Career Development Award (CHRCDA) Program (K12 Clinical Trial Not Allowed) Apply for RFA HD 23 010 Funding Number: RFA HD 23 010 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
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