Opportunity Information: Apply for PAR 12 036

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigations on Primary Immunodeficiency Diseases (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
  • This funding opportunity was created on Mar 4, 2015 and posted on Nov 28, 2011.
  • Applicants must submit their applications by Mar 4, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Special district governments Private institutions of higher education Native American tribal governments (Federally recognized) 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 Public housing authorities/Indian housing authorities State governments County governments.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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 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 "Investigations on Primary Immunodeficiency Diseases (R01)" (Funding Opportunity Number PAR-12-036) supports investigator-initiated research aimed at advancing the understanding and treatment of primary immunodeficiency diseases (PIDs). It is set up as an R01 discretionary grant mechanism under NIH health-related research programs and is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The main focus is on innovative, hypothesis-driven studies that can move the field forward by improving how these disorders are recognized, explaining what causes them at a molecular and genetic level, and laying the groundwork for new therapeutic approaches.

A central priority of the announcement is earlier and better detection of PIDs, including research that improves diagnostic strategies, screening approaches, biomarker development, and methods that help distinguish among different immunodeficiency syndromes. The FOA also emphasizes uncovering the molecular basis of disease, which can include identifying disease-causing genes or variants, defining disrupted immune pathways, clarifying mechanisms of immune dysfunction, and mapping genotype-phenotype relationships. Alongside discovery and mechanism work, the opportunity encourages projects that design and carry out preclinical development of innovative therapies, such as proof-of-concept approaches in relevant models, optimization and characterization of candidate interventions, and other preclinical studies that strengthen the rationale for future clinical translation.

The scope is intentionally broad in terms of research approach, and both human-sample-based studies and animal model studies are explicitly encouraged. This includes research using specimens obtained from human participants (for example, patient-derived cells, blood, tissue samples, or biobanked material) as well as studies leveraging animal models to test mechanisms or evaluate therapeutic concepts in vivo. At the same time, the FOA draws a firm boundary around clinical testing: clinical trials are not supported under this announcement, so proposed work should remain in the discovery, mechanistic, and preclinical phases rather than interventional clinical trial execution.

The eligibility pool is wide and includes many types of domestic and international institutions. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), small businesses and other for-profit organizations (with small businesses explicitly listed), and multiple levels of government entities (city/township, county, state, special district, and certain housing authorities). The announcement also highlights eligibility for organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, tribally affiliated organizations, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Non-U.S. entities (foreign institutions) may apply, foreign components as defined by NIH policy are allowed, and non-domestic components of U.S. organizations are eligible, signaling that international collaboration and globally situated research activities can fit within the program when well-justified.

From a workforce-development perspective, the FOA specifically encourages applications from investigators who have not previously received independent NIH funding in the PID field. While it is not limited to new investigators, this language indicates an interest in bringing new independent teams and ideas into the primary immunodeficiency research community, especially projects that introduce fresh methods, technologies, or conceptual frameworks.

Administratively, the opportunity does not require cost sharing or matching. The posting date listed is November 28, 2011, with later administrative dates indicating the lifecycle of the announcement, including an archive date of June 6, 2015. The full announcement and official requirements were hosted through the NIH grants guide page referenced in the additional information link. For access or technical issues, the contact listed is the NIH Office of Extramural Research (OER) webmaster.

Frequently Asked Questions (FAQs): NIH PAR-12-036 - Investigations on Primary Immunodeficiency Diseases (R01)

What is this funding opportunity?

This is an NIH Funding Opportunity Announcement (FOA) titled "Investigations on Primary Immunodeficiency Diseases (R01)" with Funding Opportunity Number PAR-12-036. It supports investigator-initiated research focused on advancing the understanding and treatment of primary immunodeficiency diseases (PIDs) using the NIH R01 grant mechanism.

What is the overall purpose of PAR-12-036?

The purpose is to support innovative, hypothesis-driven studies that move the primary immunodeficiency field forward by improving recognition of these disorders, explaining their molecular and genetic causes, and laying groundwork for new therapeutic approaches through discovery, mechanistic research, and preclinical development.

What grant mechanism is used for this opportunity?

The opportunity uses the NIH R01 mechanism and is described as an R01 discretionary grant mechanism under NIH health-related research programs.

Which CFDA numbers are associated with this FOA?

This FOA is associated with CFDA 93.855 (Allergy and Infectious Diseases Research) and CFDA 93.856 (Microbiology and Infectious Diseases Research).

What research topics are emphasized?

The FOA emphasizes three broad areas: (1) earlier and better detection of PIDs, (2) uncovering the molecular basis of disease, and (3) preclinical development of innovative therapies that can support future clinical translation.

What kinds of projects fit under the "earlier and better detection" priority?

Projects that improve how PIDs are detected and distinguished are a central priority, including research on diagnostic strategies, screening approaches, biomarker development, and methods that help differentiate among immunodeficiency syndromes.

What does the FOA mean by uncovering the molecular basis of primary immunodeficiency diseases?

This includes work such as identifying disease-causing genes or variants, defining disrupted immune pathways, clarifying mechanisms of immune dysfunction, and mapping genotype-phenotype relationships.

Are therapeutic-development projects allowed?

Yes. The FOA encourages preclinical development of innovative therapies, including proof-of-concept approaches in relevant models, optimization and characterization of candidate interventions, and other preclinical studies that strengthen the rationale for later clinical translation.

Does this FOA support clinical trials?

No. Clinical trials are not supported under this announcement. Proposed research should remain in the discovery, mechanistic, and preclinical phases rather than interventional clinical trial execution.

Can studies use human participant specimens?

Yes. The FOA explicitly encourages human-sample-based studies, including research using specimens obtained from human participants such as patient-derived cells, blood, tissue samples, or biobanked material.

Are animal model studies allowed?

Yes. Animal model studies are explicitly encouraged, including studies designed to test mechanisms or evaluate therapeutic concepts in vivo.

How broad is the scope in terms of research approach?

The scope is intentionally broad. The FOA supports a range of approaches as long as the work is innovative, hypothesis-driven, and aligned with improving recognition, understanding molecular/genetic causes, and/or advancing preclinical therapeutic development for PIDs.

Who is eligible to apply?

Eligibility is broad and includes many domestic and international institutions, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3)), small businesses, other for-profit organizations, and multiple levels of government entities.

Are small businesses and for-profit organizations eligible?

Yes. Small businesses are explicitly listed as eligible, and other for-profit organizations are also included in the eligibility pool.

Are nonprofit organizations eligible?

Yes. Both 501(c)(3) and non-501(c)(3) nonprofit organizations are listed as eligible applicants.

Are government entities eligible?

Yes. Eligible applicants include city/township governments, county governments, state governments, special district governments, and certain housing authorities, as well as eligible federal agencies.

Are minority-serving institutions and tribally affiliated organizations eligible?

Yes. The FOA highlights eligibility for organizations 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 tribally affiliated organizations.

Are faith-based or community-based organizations eligible?

Yes. Faith-based and community-based organizations are explicitly listed among eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among the eligible applicant types mentioned.

Can foreign (non-U.S.) institutions apply?

Yes. Non-U.S. entities (foreign institutions) may apply under this FOA.

Are foreign components allowed on an application?

Yes. Foreign components (as defined by NIH policy) are allowed, and non-domestic components of U.S. organizations are also eligible. This indicates international collaboration and globally situated research activities may fit when well-justified.

Does the FOA encourage applications from investigators new to the PID field?

Yes. The FOA specifically encourages applications from investigators who have not previously received independent NIH funding in the PID field, signaling interest in new independent teams and ideas. It is not limited only to new investigators.

Is cost sharing or matching required?

No. The opportunity does not require cost sharing or matching.

When was this FOA posted, and is it still active?

The posting date listed is November 28, 2011. Administrative lifecycle information includes an archive date of June 6, 2015.

Where were the official requirements and full announcement hosted?

The full announcement and official requirements were hosted through the NIH grants guide page referenced in the additional information link for the FOA.

Who is listed as the contact for access or technical issues?

For access or technical issues, the contact listed is the NIH Office of Extramural Research (OER) webmaster.

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