Opportunity Information: Apply for PAR 13 295
Apply for PAR 13 295
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Biomarkers Bridging Pediatric and Adult Therapeutics (R21)" 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 Aug 1, 2013 and posted on Aug 1, 2013.
- Applicants must submit their applications by Sep 7, 2016. (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 $200,000.00 in funding.
- Eligible applicants include: Native American tribal governments (Federally recognized) For profit organizations other than small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) State governments County governments Special district governments Independent school districts City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses.
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH grant opportunity "Biomarkers Bridging Pediatric and Adult Therapeutics (R21)" (Funding Opportunity Number PAR 13-295) supports early-stage, exploratory research focused on translating biomarkers that are already well established in adults into meaningful use in pediatric settings. The central goal is not to discover brand-new biomarkers, but to adapt, apply, and validate adult-derived biomarkers for children in ways that improve pediatric diagnosis, prognosis, and the ability to estimate disease progression, treatment response, and toxicity. In practical terms, the FOA is aimed at reducing the gap between adult and pediatric therapeutics by leveraging what is already known and heavily studied in adults, then generating the evidence needed to justify and guide pediatric use.
Projects are expected to stay tightly within a specific scope: the biomarkers must correlate with a clinical observation, must have been extensively studied in adult populations, and must have solid supporting evidence suggesting they could be relevant in pediatrics. The emphasis is on validation and appropriate adaptation, which may include determining whether the biomarker performs similarly in children, establishing pediatric reference ranges or age-related norms, assessing sensitivity and specificity in pediatric cohorts, understanding developmental or physiological factors that affect biomarker levels, and evaluating how well the biomarker tracks clinically relevant outcomes such as disease severity, progression, toxicity risk, or therapeutic response in children.
Several areas are explicitly excluded. The FOA does not support discovery of new biomarkers intended for new drug development pipelines or preclinical-only studies; it is not a basic discovery mechanism for identifying novel markers from scratch. It also excludes biomarkers for diseases that are unique to childhood and have no adult correlates, since the concept of this program is specifically to bridge adult evidence to pediatric applications rather than to build pediatric-only biomarker paradigms.
This is an R21 mechanism, meaning it is designed for exploratory and developmental research rather than large, confirmatory clinical trials, and it carries an award ceiling of $200,000 (as listed in the opportunity data). No cost sharing or matching is required. The opportunity was posted on August 1, 2013, with a closing date of September 7, 2016, and it was archived on October 8, 2016, indicating it is no longer open for new applications under that specific announcement, though similar NIH opportunities may exist under newer FOAs.
Eligibility is broad and includes many organization types across the public, private, nonprofit, academic, and governmental spectrum. Eligible applicants include public and private institutions of higher education; nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) nonprofits); small businesses and for-profit organizations (other than small businesses are also listed as eligible); and multiple levels of government such as state, county, city/township, special district governments, and eligible federal agencies. The FOA also recognizes a wide range of mission-driven and capacity-building institution types, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs), along with faith-based and community-based organizations. Importantly, non-U.S. entities are eligible as well, including foreign organizations and foreign institutions, non-domestic components of U.S. organizations, and foreign components as defined by NIH policy, which signals NIH openness to international expertise or pediatric cohorts where appropriate.
The sponsoring agency is the National Institutes of Health, and the activity category is listed under Health, Income Security, and Social Services, with CFDA number 93.865 (Child Health and Human Development Extramural Research). The full announcement was hosted on the NIH grants site (link provided in the source), and NIH Office of Extramural Research contact support was available via the NIH OER Webmaster for access or technical linking issues.
Frequently Asked Questions (FAQs)
What is the NIH "Biomarkers Bridging Pediatric and Adult Therapeutics (R21)" funding opportunity?
It is an NIH grant opportunity (Funding Opportunity Number PAR 13-295) that supports early-stage, exploratory research aimed at translating biomarkers that are already well established in adults into meaningful use in pediatric settings.
What is the central goal of PAR 13-295?
The central goal is to reduce the gap between adult and pediatric therapeutics by leveraging biomarkers that are heavily studied in adults and generating the evidence needed to justify and guide their use in children.
Is this opportunity meant to discover brand-new biomarkers?
No. The program is not focused on discovering new biomarkers from scratch. It is focused on adapting, applying, and validating adult-derived biomarkers for pediatric use.
What kinds of biomarkers are in scope for this FOA?
Biomarkers that (1) correlate with a clinical observation, (2) have been extensively studied in adult populations, and (3) have solid supporting evidence suggesting they could be relevant in pediatrics.
What types of pediatric biomarker work does the FOA emphasize?
The emphasis is on validation and appropriate adaptation for children. Examples mentioned include determining whether the biomarker performs similarly in children, establishing pediatric reference ranges or age-related norms, assessing sensitivity and specificity in pediatric cohorts, understanding developmental or physiological factors that affect biomarker levels, and evaluating how well the biomarker tracks clinically relevant outcomes in children.
What clinical uses in pediatrics is the FOA trying to improve?
The FOA targets improvements in pediatric diagnosis and prognosis, as well as better estimation of disease progression, treatment response, and toxicity.
Can projects focus on how biomarkers track outcomes like disease severity or toxicity risk in children?
Yes. The FOA explicitly highlights evaluating whether the biomarker tracks clinically relevant outcomes such as disease severity, progression, toxicity risk, or therapeutic response in pediatric populations.
Are preclinical-only biomarker studies allowed under this FOA?
No. The FOA excludes preclinical-only studies and is not intended as a basic discovery mechanism.
Does the FOA support biomarker discovery for new drug development pipelines?
No. It does not support discovery of new biomarkers intended for new drug development pipelines.
Are biomarkers for diseases unique to childhood eligible?
No. Biomarkers for diseases that are unique to childhood and have no adult correlates are excluded, because the program is specifically designed to bridge adult evidence to pediatric applications.
What grant mechanism is used for this opportunity?
This FOA uses the NIH R21 mechanism, which is designed for exploratory and developmental research rather than large, confirmatory clinical trials.
What is the award ceiling for this R21 opportunity?
The opportunity lists an award ceiling of $200,000.
Is cost sharing or matching required?
No. The FOA states that no cost sharing or matching is required.
Is this funding opportunity still open?
No. It was archived on October 8, 2016, indicating it is no longer open for new applications under that specific announcement.
What were the key dates for PAR 13-295?
The opportunity was posted on August 1, 2013. The closing date listed is September 7, 2016. It was archived on October 8, 2016.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include public and private institutions of higher education; nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) nonprofits); small businesses; for-profit organizations (including those other than small businesses); and government entities such as state, county, city/township, and special district governments, as well as eligible federal agencies.
Are mission-driven or capacity-building institutions included in the eligibility described?
Yes. The FOA recognizes a wide range of institution types, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs). It also mentions faith-based and community-based organizations.
Are non-U.S. or foreign organizations eligible to apply?
Yes. Non-U.S. entities are eligible, including foreign organizations and foreign institutions, non-domestic components of U.S. organizations, and foreign components as defined by NIH policy.
Which agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What CFDA number is associated with this FOA?
The CFDA number listed is 93.865 (Child Health and Human Development Extramural Research).
What is the listed activity category for this opportunity?
The activity category is listed under Health, Income Security, and Social Services.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants site (link referenced in the source information).
Who was listed for contact support for access or technical linking issues?
NIH Office of Extramural Research contact support was available via the NIH OER Webmaster for access or technical linking issues.
Browse more opportunities from the same category: Health Income Security and Social Services
Next opportunity: Biomarkers Bridging Pediatric and Adult Therapeutics (R01)
Previous opportunity: Biomarkers Bridging Pediatric and Adult Therapeutics (R03)
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Applicants who have applied for this opportunity (PAR 13 295) also looked into and applied for these:
| Funding Opportunity |
|---|
| Biomarkers Bridging Pediatric and Adult Therapeutics (R01) Apply for PAR 13 296 Funding Number: PAR 13 296 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R01) Apply for PAR 13 309 Funding Number: PAR 13 309 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R03) Apply for PAR 13 310 Funding Number: PAR 13 310 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R21) Apply for PAR 13 311 Funding Number: PAR 13 311 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01) Apply for PAR 13 325 Funding Number: PAR 13 325 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21) Apply for PAR 13 326 Funding Number: PAR 13 326 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R03) Apply for PAR 13 344 Funding Number: PAR 13 344 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R43) Apply for PAR 13 345 Funding Number: PAR 13 345 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems STTR (R41) Apply for PAR 13 346 Funding Number: PAR 13 346 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Sustained Release of Antivirals for Treatment and Prevention of HIV (SRATP) (R01) Apply for PAR 13 349 Funding Number: PAR 13 349 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Enhancing the Capacity for Biomedical Research on Tuberculosis for HIV infected Mothers and Children in India (R01) Apply for RFA HD 14 025 Funding Number: RFA HD 14 025 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $350,000 |
| Developmental Origins of Health and Disease (DOHaD) Epigenetic Modification in Gametogenesis and Transgenerational Inheritance (R01) Apply for PAR 13 385 Funding Number: PAR 13 385 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
| Female Contraceptive Development Program (U01) Apply for RFA HD 14 024 Funding Number: RFA HD 14 024 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (SBIR) (R43/R44) Apply for RFA HD 14 031 Funding Number: RFA HD 14 031 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01) Apply for PAR 13 389 Funding Number: PAR 13 389 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (STTR) (R41/R42) Apply for RFA HD 14 032 Funding Number: RFA HD 14 032 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Centers for Collaborative Research in Fragile X (U54) Apply for RFA HD 14 033 Funding Number: RFA HD 14 033 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $1,300,000 |
| Juvenile Protective Factors and Their Effects on Aging (R03) Apply for PAR 14 022 Funding Number: PAR 14 022 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| U.S South Africa Program for Collaborative Biomedical Research (U01) Apply for RFA AI 14 018 Funding Number: RFA AI 14 018 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $225,000 |
| Data Sharing for Demographic Research Infrastructure Program (U24) Apply for RFA HD 14 015 Funding Number: RFA HD 14 015 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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