Opportunity Information: Apply for PA 12 012

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "HIV Incidence Assays with Improved Specificity (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 Jul 10, 2012 and posted on Nov 10, 2011.
  • Applicants must submit their applications by Jan 7, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses State governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments City or township governments Public and State controlled institutions of higher education.
  • 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 HIV Incidence Assays with Improved Specificity (R01) funding opportunity (PA 12-012) is a discretionary NIH research grant issued by the National Institute of Allergy and Infectious Diseases (NIAID). Its main purpose is to support projects that create or substantially improve laboratory assays used to estimate HIV incidence by accurately distinguishing recent (incident) infections from long-standing (chronic) infections. In practical terms, NIAID is looking for assay approaches that reduce misclassification and improve confidence in incidence estimates, since current tools can label some chronic infections as recent, which can distort surveillance data and the evaluation of prevention programs.

This opportunity uses the NIH R01 mechanism, meaning it is intended for hypothesis-driven or technology development research that is mature enough for a full research project rather than early exploratory work. The scientific emphasis is on increasing assay specificity and reliability, so proposals would typically be expected to address the technical reasons existing incidence assays fail (for example, variability in immune response across individuals, effects of antiretroviral therapy, viral suppression, HIV subtype differences, and other biological or clinical factors that can confuse recency markers). Competitive applications would usually articulate a clear plan for assay design, optimization, validation, and performance characterization, including how the proposed method will be benchmarked against well-defined specimen sets or reference standards and how it will perform across relevant populations and epidemiologic settings.

The announcement is tied to NIH health research activity categories under CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). There is no cost sharing or matching requirement, which is typical for NIH research project grants and means applicants are not required to contribute non-federal funds to be eligible.

Eligibility is broad and includes many types of U.S. domestic organizations and governments as well as non-U.S. entities. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit organizations (including small businesses and other for-profits), independent school districts, public housing authorities/Indian housing authorities, and a wide range of governmental entities (city/township, county, state, special district). The FOA also explicitly includes a range of mission- or community-focused institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, tribal governments and tribal organizations, regional organizations, and faith-based or community-based organizations. Importantly, foreign institutions are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined by NIH policy, which signals that NIAID expects and supports international collaboration and validation work in diverse global epidemic settings.

Key dates in the public listing show the opportunity was posted on November 10, 2011, created July 10, 2012, had an original closing date of September 7, 2014, and a final listed closing date of January 7, 2015, with archiving on February 7, 2015. That timeline indicates the program was open for submissions over multiple cycles before being archived, consistent with NIH program announcements that run for a defined period.

For applicants or organizations trying to locate the full requirements, application instructions, and detailed scientific scope, the official announcement was published through the NIH Grants Guide as PA 12-012, with an associated link to the FOA page. The contact information provided in the listing is primarily technical support through the NIH Office of Extramural Research (OER) webmaster for access or linking problems, which suggests that scientific and grants management contacts would be found in the full FOA text itself.

Overall, the opportunity is best understood as NIH support for developing next-generation HIV incidence assay methods that can be trusted for public health surveillance and research, with an emphasis on boosting specificity (fewer false-recent results) and improving reliability across real-world conditions, populations, and HIV diversity.

Frequently Asked Questions (FAQs)

What is the name of this funding opportunity?

The opportunity is titled HIV Incidence Assays with Improved Specificity (R01) and is identified as PA 12-012.

Which agency and institute are offering this grant?

This is an NIH discretionary research grant issued by the National Institute of Allergy and Infectious Diseases (NIAID).

What is the main purpose of PA 12-012?

The main purpose is to support projects that create or substantially improve laboratory assays used to estimate HIV incidence by accurately distinguishing recent (incident) infections from long-standing (chronic) infections.

Why is NIAID emphasizing improved specificity for HIV incidence assays?

NIAID is looking for assay approaches that reduce misclassification, especially cases where current tools incorrectly label some chronic infections as recent. Those false-recent results can distort surveillance data and the evaluation of HIV prevention programs.

What grant mechanism does this opportunity use?

This opportunity uses the NIH R01 mechanism, which is generally intended for research projects that are mature enough for a full, hypothesis-driven or technology development study rather than early exploratory work.

What type of research is this opportunity intended to support?

It is intended to support hypothesis-driven and/or technology development research focused on improving HIV incidence assay performance, with a strong emphasis on specificity and reliability.

What scientific issues should applications typically address to be responsive?

Applications would typically be expected to address technical reasons existing incidence assays can fail, such as variability in immune response across individuals, effects of antiretroviral therapy, viral suppression, HIV subtype differences, and other biological or clinical factors that can confuse recency markers.

What kinds of performance improvements is NIAID looking for?

The stated emphasis is on increasing assay specificity (fewer false-recent classifications) and improving overall reliability so that incidence estimates are more trustworthy across real-world conditions.

Does the opportunity describe expectations for assay development and evaluation?

Yes. Competitive applications would usually articulate a clear plan for assay design, optimization, validation, and performance characterization, including how the method will be benchmarked against well-defined specimen sets or reference standards and how it will perform across relevant populations and epidemiologic settings.

Is this opportunity tied to any CFDA numbers?

Yes. The announcement is tied to NIH health research activity categories under CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement stated for this opportunity.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S. domestic organizations and governments as well as non-U.S. entities. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), independent school districts, public housing authorities/Indian housing authorities, and a wide range of governmental entities (city/township, county, state, special district).

Are minority-serving institutions and community-based organizations included in the eligible applicant types?

Yes. The listing explicitly includes institution and organization types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, tribal governments and tribal organizations, regional organizations, and faith-based or community-based organizations.

Are foreign institutions eligible to apply?

Yes. The information provided states that foreign institutions are eligible, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined by NIH policy.

Does the opportunity support international collaboration?

It signals support for international collaboration by explicitly allowing foreign institutions and foreign components, which aligns with the need to validate assays across diverse global epidemic settings and populations.

When was this opportunity posted and when did it close?

The public listing shows it was posted on November 10, 2011, created on July 10, 2012, had an original closing date of September 7, 2014, and a final listed closing date of January 7, 2015. It was archived on February 7, 2015.

Is this funding opportunity still open for submissions?

Based on the dates provided, it reached a final closing date of January 7, 2015 and was archived on February 7, 2015, indicating it is no longer active under that listing.

Where can applicants find the official announcement and full requirements?

The official announcement was published through the NIH Grants Guide as PA 12-012, with an associated FOA page link referenced in the listing. The full FOA text is where detailed requirements and instructions would be found.

What contact information is provided in the listing?

The contact information provided is primarily for technical support through the NIH Office of Extramural Research (OER) webmaster for access or linking problems. The listing suggests that scientific and grants management contacts would be located in the full FOA text.

In plain terms, what kind of outcome is this program trying to achieve?

It is aimed at developing next-generation HIV incidence assay methods that can be trusted for public health surveillance and research, with fewer false-recent results and more reliable performance across different populations, clinical contexts, and HIV diversity.

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