Opportunity Information: Apply for RFA HD 14 032
Apply for RFA HD 14 032
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (STTR) (R41/R42)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Nov 7, 2013 and posted on Nov 7, 2013.
- Applicants must submit their applications by Feb 27, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $500,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) 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, may be allowed.
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Opportunity Summary:
The funding opportunity titled "Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (STTR) (R41/R42)" (Funding Opportunity Number RFA-HD-14-032) was issued by the National Institutes of Health (NIH), under the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) program area reflected by the CFDA listing 93.865 (Child Health and Human Development Extramural Research). It is a discretionary grant program in the Health category and uses the Small Business Technology Transfer (STTR) mechanism, specifically the phased R41/R42 structure. In practical terms, this means the announcement is designed for small businesses that want to move a scientific concept from early feasibility work into more advanced development, while formally partnering with a nonprofit research institution (a standard STTR feature).
The core purpose of the FOA is to stimulate projects that do two closely linked things: first, identify and validate molecular targets that drive pregnancy-associated or pregnancy-induced disorders; and second, use those targets as the foundation for developing therapeutic candidates intended to prevent or treat these conditions in pregnant individuals. The emphasis is not just on basic discovery for its own sake, but on discovery that clearly enables translation into drug or biologic development. A repeated theme in the description is safety and effectiveness in pregnancy, reflecting a long-standing gap in therapeutics where many medications are either inadequately studied during pregnancy or carry risks that make clinicians hesitant to use them. The FOA is therefore aimed at encouraging new treatment approaches that are specifically suited to pregnancy, rather than simply adapting drugs developed for non-pregnant populations.
Because it is an STTR R41/R42 opportunity, applicants are expected to propose a staged development plan. Phase I (R41) generally aligns with establishing feasibility, generating key proof-of-concept data, and demonstrating that the proposed target and therapeutic approach are credible and technically achievable. Phase II (R42) typically supports expansion and advancement of the work toward a development-ready product, such as optimization, additional preclinical testing, prototype refinement, or other steps that position the candidate for later-stage investment and regulatory planning. While the announcement text provided here does not spell out specific technical milestones, the structure of the mechanism implies that NIH is looking for a coherent path from molecular target identification through therapeutic development activities that could realistically yield a medication candidate appropriate for pregnancy-related use.
Eligibility is limited to small businesses, consistent with the STTR program. Non-U.S. (foreign) organizations are not eligible to apply as the applicant organization, and non-U.S. components of U.S. organizations are also not eligible. However, the FOA notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed, which typically means certain parts of the work can be conducted abroad if well-justified and compliant with NIH policy, even though the applicant itself must be a qualifying U.S. small business. The announcement also states there is no cost sharing or matching requirement, lowering the financial barrier for small businesses pursuing early-stage translational work.
From an administrative standpoint, the opportunity was posted on November 7, 2013, with an original and current closing date of February 27, 2014, and an archive date of March 30, 2014. The estimated total funding amount listed is $500,000, which signals a relatively targeted program budget and reinforces the expectation that proposed projects are focused, milestone-driven, and geared toward early translational traction rather than large-scale clinical trials. Applicants were directed to the full FOA on the NIH Grants Guide website, and support contacts were provided through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.
Overall, this FOA is best understood as a targeted NIH/NICHD effort to push pregnancy-therapeutics innovation forward by funding small business led, academia-partnered translational projects that (1) pinpoint actionable molecular mechanisms behind pregnancy-related disorders and (2) convert those mechanisms into concrete therapeutic development programs with an emphasis on safer and more effective medication options for use during pregnancy.
Frequently Asked Questions (FAQs)
What is the official title of this funding opportunity?
The opportunity is titled "Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (STTR) (R41/R42)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-HD-14-032.
Which federal agency is offering this grant?
This funding opportunity is issued by the National Institutes of Health (NIH).
Which NIH institute is associated with this FOA?
The FOA is associated with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
What CFDA program listing is associated with this opportunity?
The CFDA listing is 93.865, described as Child Health and Human Development Extramural Research.
What type of grant mechanism does this opportunity use?
This opportunity uses the Small Business Technology Transfer (STTR) mechanism with the phased R41/R42 structure.
What does the R41/R42 phased structure mean in practical terms?
The R41/R42 structure reflects staged development. Phase I (R41) generally focuses on feasibility and proof-of-concept, while Phase II (R42) typically supports expansion and advancement toward a development-ready product.
Who is this FOA intended to support?
It is designed for small businesses pursuing translational research and development while formally partnering with a nonprofit research institution, which is a standard feature of STTR.
What is the main purpose of the FOA?
The FOA aims to stimulate projects that (1) identify and validate molecular targets that drive pregnancy-associated or pregnancy-induced disorders, and (2) use those targets to develop therapeutic candidates intended to prevent or treat these conditions in pregnant individuals.
Is this opportunity focused on basic science, product development, or both?
Both are included, but the emphasis is on discovery that enables translation. The target identification and validation are expected to feed directly into therapeutic (drug or biologic) development activities.
What kinds of diseases or conditions are in scope?
The scope includes pregnancy-associated or pregnancy-induced disorders, with a focus on underlying molecular targets and therapeutic development intended for use in pregnant individuals.
What kinds of outputs is NIH likely looking for under this FOA?
Based on the stated purpose and the STTR phased structure, the FOA is oriented toward actionable molecular targets and therapeutic candidates, supported by feasibility/proof-of-concept work in Phase I and more advanced development steps in Phase II.
Does the FOA emphasize safety and effectiveness during pregnancy?
Yes. A central theme is developing therapeutics that are specifically suited to pregnancy, addressing the gap where many medications are inadequately studied during pregnancy or may carry risks that limit clinical use.
Is adapting drugs developed for non-pregnant populations the main goal?
No. The FOA emphasizes treatment approaches specifically suited to pregnancy rather than simply adapting drugs developed for non-pregnant populations.
What is generally expected in Phase I (R41)?
Phase I generally aligns with establishing feasibility, generating key proof-of-concept data, and showing that the proposed target and therapeutic approach are credible and technically achievable.
What is generally expected in Phase II (R42)?
Phase II typically supports advancing the work toward a development-ready product. Examples mentioned include optimization, additional preclinical testing, prototype refinement, or other steps that position the candidate for later-stage investment and regulatory planning.
Does the provided description list specific technical milestones?
No. The information provided does not spell out specific technical milestones, but the R41/R42 structure implies NIH expects a coherent, staged path from target discovery/validation into therapeutic development.
Who is eligible to apply as the applicant organization?
Eligibility is limited to small businesses, consistent with the STTR program.
Are foreign (non-U.S.) organizations eligible to apply?
No. Non-U.S. (foreign) organizations are not eligible to apply as the applicant organization.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible.
Are any foreign components allowed at all?
The FOA notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed. This typically means certain parts of the work can be conducted abroad if justified and compliant with NIH policy, even though the applicant must be a qualifying U.S. small business.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What is the estimated total funding amount for this program?
The estimated total funding amount listed is $500,000.
What does the $500,000 estimated total funding suggest about project scope?
It suggests a relatively targeted program budget and reinforces that proposed projects are expected to be focused and geared toward early translational traction rather than large-scale clinical trials.
When was this opportunity posted?
The opportunity was posted on November 7, 2013.
What was the closing (due) date?
The original and current closing date listed is February 27, 2014.
When was the opportunity archived?
The archive date is March 30, 2014.
Where were applicants directed to find the full FOA?
Applicants were directed to the full FOA on the NIH Grants Guide website.
Who was listed as a contact for access or linking issues?
Support contacts were provided through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.
How should this FOA be summarized in one sentence?
It is a targeted NIH/NICHD STTR R41/R42 opportunity for U.S. small businesses (partnering with a nonprofit research institution) to identify and validate molecular targets underlying pregnancy-related/induced diseases and translate them into therapeutic development programs aimed at safer, more effective treatments for use during pregnancy.
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Previous opportunity: Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01)
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