NIDDK Central Repositories Non-renewable Sample Access (X01 Clinical Trial Not Allowed) | PAR 19 319

Frequently Asked Questions (FAQs)

What is the NIDDK Central Repositories Non-renewable Sample Access opportunity (PAR 19-319)?

This is a discretionary NIH grant mechanism that supports investigator requests for access to limited, irreplaceable biological specimens and related data stored in the NIDDK Central Repositories. The goal is to enable new, high-value analyses using existing curated specimens and datasets rather than collecting new samples.

What is the main purpose of this program?

The core purpose is to encourage secondary scientific research by making existing NIDDK-funded (or NIDDK-supported) clinical study specimens and associated data available to qualified researchers. Because the materials are described as non-renewable, the program places strong emphasis on responsible, well-justified use of finite samples that cannot be replaced once distributed and used.

What does "non-renewable" mean in this context?

"Non-renewable" means the biospecimens are limited and cannot be replenished. Once a specimen aliquot or unit is distributed and consumed for research, it is gone. Applications are therefore expected to justify why the requested samples are essential, how many units are needed, and why the expected scientific value warrants using those finite materials.

What kinds of research projects are supported?

Projects are focused on secondary research that can be conducted using archived biospecimens and the accompanying study datasets. Examples mentioned in the opportunity description include laboratory, translational, and epidemiologic analyses, as well as other analyses feasible with repository-held samples and data.

Are clinical trials allowed under this opportunity?

No. The announcement explicitly indicates that clinical trials are not allowed. The supported work is intended to use existing specimens and linked data rather than initiate new clinical trial activity.

Where do the samples and data come from?

The NIDDK Central Repositories contain specimens collected through many large, well-known clinical studies that were funded or supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). These materials are carefully curated and stored for research access.

How do applicants find out what studies, specimen types, and data elements are available?

Applicants are directed to review the public catalog on the NIDDK repository website: https://repository.niddk.nih.gov. This site serves as the access point for understanding which studies are represented in the repository and what specimen types and data elements may be requested.

What is a key feasibility requirement for the application?

Applicants must include documentation of feasibility: specifically, a report from the NIDDK Central Repositories confirming sample availability for the specific materials being requested. This confirms that the proposed research matches what the repository can provide.

Why is a repository report confirming sample availability required?

Because the specimens are scarce and non-renewable, NIH requires confirmation that the requested materials exist and are available. This helps align the proposed aims with real inventory and supports fair management of limited samples across the research community.

What should a strong application emphasize given the limited nature of the samples?

Based on the description provided, strong applications typically show (1) a clear scientific rationale for why the particular non-renewable samples are essential, (2) a well-justified request for how many aliquots or units are needed, and (3) a compelling case that the analyses are high-value and worth the use of finite materials.

Who is eligible to apply?

Eligibility is broad and includes many organization types. Examples listed include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; and federally recognized Native American tribal governments. Additional eligible entities include public housing authorities/Indian housing authorities; tribal organizations that are not federally recognized governments; nonprofit organizations (including 501(c)(3) and nonprofits without 501(c)(3) status, other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entity types typically recognized by NIH.

Are smaller or community-based organizations included in eligibility?

Yes. The opportunity explicitly highlights faith-based or community-based organizations and regional organizations among the additional eligible applicant categories, signaling an intent to encourage broad participation across institution types and geographies.

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

Yes. The eligibility list explicitly includes non-domestic (non-U.S.) entities (foreign organizations).

Are applicants in U.S. territories or possessions eligible?

Yes. The opportunity explicitly includes applicants located in a U.S. territory or possession.

Are minority-serving institutions explicitly encouraged or included?

Yes. The notice highlights additional eligible categories that include Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and other institution types, indicating openness to a diverse range of applicants.

Which federal agency sponsors this opportunity?

The sponsoring agency is the National Institutes of Health (NIH), with NIDDK as the institute associated with the central repositories described in the opportunity.

What is the funding instrument type?

The funding instrument type is listed as a grant.

What is the CFDA number associated with this opportunity?

The activity is listed under CFDA number 93.847.

How is the activity category described?

The activity category is labeled under food and nutrition and health, consistent with NIDDK mission areas that span diabetes, endocrinology, metabolism, digestive diseases, and kidney and urologic conditions.

What are the dates mentioned for this announcement?

The source information lists a creation date of July 29, 2019, and an original closing date shown as June 28, 2022.

What should applicants do about the listed closing date if they are considering applying now?

The description notes that prospective applicants typically need to verify current status, active dates, and any reissued versions of the opportunity on NIH posting systems, because older announcements may be superseded or closed.

What is the practical first step for an applicant?

A central practical takeaway is to begin by identifying relevant studies, specimens, and data elements in the NIDDK repository catalog (https://repository.niddk.nih.gov), then obtain the required documentation from the NIDDK Central Repositories confirming that the specific non-renewable samples needed for the proposed analyses are available.

Does this opportunity fund new sample collection?

The stated purpose emphasizes using existing curated specimens and linked datasets rather than requiring new sample collection. Supported projects are described as secondary research using repository materials.

What makes this opportunity different from typical research funding that generates new data?

This opportunity is centered on unlocking additional scientific value from existing NIDDK-funded clinical study collections. It supports carefully designed analyses that rely on rare, limited biospecimens and accompanying data already stored in the NIDDK Central Repositories.