Opportunity Information: Apply for RFA FD 16 008
Apply for RFA FD 16 008
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Apr 01, 2016 and posted on Apr 01, 2016.
- Applicants must submit their applications by Jun 03, 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 $250,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses.
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Opportunity Summary:
The grant opportunity titled "Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01)" is a U.S. Food and Drug Administration (FDA) funding announcement focused on improving how critical animal study data are structured and submitted electronically when products are developed under the FDA's Animal Rule. The Animal Rule is the regulatory pathway used when human efficacy trials are not ethical or feasible, and it relies heavily on well-designed animal efficacy studies and supporting natural history studies. Because these submissions can involve complex, high-stakes datasets, the FDA is emphasizing the need for clear, standardized electronic formats so data can be interpreted consistently, compared across studies, and reviewed efficiently.
At the center of the project is the development of voluntary consensus data standards specifically tailored to animal efficacy and natural history studies used in Animal Rule applications. FDA's Center for Drug Evaluation and Research (CDER) indicates it has already done preliminary work in this area and is looking for an organization (or organizations) to refine and complete that work. The goal is not to start from scratch, but to build on existing frameworks and produce a complete, publishable set of standards that the broader community can use. The standards are intended to be "voluntary consensus" standards, meaning they should be developed in a way that supports broad adoption across stakeholders, rather than being proprietary or limited to a single sponsor or platform.
A major requirement is that the resulting standards incorporate relevant elements from two widely used clinical and nonclinical data standardization efforts: SEND (Standard for Exchange of Nonclinical Data) and SDTM (Study Data Tabulation Model). SEND is commonly used for organizing nonclinical study data in a structured way, while SDTM is central to standardizing clinical trial submission datasets. CDER is explicitly asking applicants to leverage what already exists in SEND and SDTM wherever it fits, and then create new standards only where gaps remain. In practice, that means mapping Animal Rule animal efficacy and natural history concepts to established domains and variables when possible, then defining additional domains, variables, controlled terminology, and implementation guidance to capture features unique to these studies. The emphasis on "characterizing data" suggests the scope includes not only data tables but also the metadata, controlled vocabulary, and rules needed to represent study design, endpoints, observations, and interpretation-ready structures in a consistent way.
The scientific and regulatory context is tied directly to the Animal Rule regulations for drugs and biologics. The opportunity cites 21 CFR 314.600-650 for drugs and 21 CFR 601.90-95 for biological products, reinforcing that these standards are meant to support submissions where animal data replace traditional human efficacy evidence. Natural history studies, which describe how a condition progresses in the relevant animal model without intervention (or under defined conditions), are particularly important for interpreting whether an observed treatment effect is meaningful. By standardizing both efficacy and natural history datasets, the FDA is aiming to reduce ambiguity and improve comparability across studies, models, and sponsors, ultimately strengthening review quality and speed when decisions depend heavily on animal evidence.
Administratively, this is a discretionary funding opportunity from HHS-FDA using a cooperative agreement mechanism (U01). A cooperative agreement typically implies substantial involvement from the funding agency, so the awardee would likely work closely with CDER staff as the standards are refined, validated, and prepared for publication. The opportunity is listed under CFDA number 93.103 and categorized under consumer protection, food and nutrition, and health, reflecting the FDA public health mission and the regulatory significance of standardized submissions.
The grant anticipated a single award (ExpectedAwards: 1) with an award ceiling of $250,000. The announcement was created and posted on April 1, 2016, with an original and current closing date of June 3, 2016. Eligibility is broad and includes many types of organizations that could credibly lead a standards development effort: state and local governments, federally recognized tribal governments and certain tribal organizations, public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions where specified), public housing authorities/Indian housing authorities, and for-profit organizations (including small businesses and other for-profit entities). This wide eligibility suggests FDA was prioritizing technical capability and stakeholder coordination experience over institutional type, consistent with a project that blends data science, regulatory knowledge, and consensus-building.
In practical terms, the expected end product is a publishable, complete set of electronic data standards that can be used for Animal Rule-related animal efficacy and natural history studies, aligned with SEND and SDTM where possible and extended where necessary. That implies deliverables such as standardized dataset structures, variable definitions, controlled terminology, guidance on how to represent common study designs and endpoints, and documentation sufficient for consistent implementation by sponsors and review by regulators. The intended impact is clearer submissions, more efficient regulatory review, and a shared data language for a niche but critical class of studies where human efficacy trials cannot be done.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01)."
Which federal agency is offering this grant?
This funding announcement is offered by the U.S. Food and Drug Administration (FDA), within the U.S. Department of Health and Human Services (HHS). The effort is tied to FDA's Center for Drug Evaluation and Research (CDER).
What is the main purpose of the grant?
The purpose is to refine, complete, and publish voluntary consensus electronic data standards for animal efficacy studies and natural history studies used in FDA Animal Rule applications, so submissions can be structured, interpreted, compared, and reviewed more consistently and efficiently.
What is the FDA Animal Rule in the context of this opportunity?
The Animal Rule is a regulatory pathway used when human efficacy trials are not ethical or feasible. Under this pathway, FDA relies heavily on well-designed animal efficacy studies (and supporting natural history studies) to evaluate product efficacy.
Which types of studies are specifically targeted by the data standards to be developed?
The standards are specifically intended for (1) animal efficacy studies and (2) natural history studies that support Animal Rule applications.
Why is FDA emphasizing standardized electronic data formats for these studies?
Animal Rule submissions can involve complex, high-stakes datasets. Standardized electronic formats help reduce ambiguity, support consistent interpretation, enable comparison across studies, and improve the efficiency and quality of FDA review.
Is FDA asking applicants to create data standards from scratch?
No. CDER indicates preliminary work already exists and the awardee is expected to refine and complete that work. The intent is to build on existing frameworks and produce a complete, publishable set of standards rather than starting from zero.
What does "voluntary consensus data standards" mean here?
It means the standards should be developed in a way that supports broad adoption across stakeholders, rather than being proprietary or limited to a single sponsor, organization, or platform.
Which existing data standards must be incorporated into the final output?
The resulting standards must incorporate relevant elements from SEND (Standard for Exchange of Nonclinical Data) and SDTM (Study Data Tabulation Model) wherever they fit.
How are SEND and SDTM expected to be used in this project?
Applicants are expected to leverage SEND and SDTM where applicable by mapping Animal Rule animal efficacy and natural history concepts to established domains and variables when possible, and creating new standards only to address remaining gaps.
What kinds of new standard components might be created if SEND and SDTM do not cover certain needs?
Where gaps exist, the work may include defining additional domains, variables, controlled terminology, and implementation guidance to capture features unique to Animal Rule animal efficacy and natural history studies.
What does the scope imply by emphasizing "characterizing data"?
The emphasis suggests the scope extends beyond simple data tables to include the metadata, controlled vocabulary, and rules needed to represent study design, endpoints, observations, and interpretation-ready structures consistently.
Why are natural history studies important for Animal Rule applications?
Natural history studies describe how a condition progresses in the relevant animal model without intervention (or under defined conditions). This context helps interpret whether an observed treatment effect in an efficacy study is meaningful.
Which regulations are referenced as the scientific and regulatory context for the standards?
The opportunity cites Animal Rule regulations for drugs under 21 CFR 314.600-650 and for biological products under 21 CFR 601.90-95.
What funding mechanism is used for this opportunity?
The mechanism is a cooperative agreement (U01), which typically implies substantial involvement from the funding agency during the project.
What does the cooperative agreement (U01) structure imply about FDA involvement?
It implies the awardee would likely work closely with CDER staff as the standards are refined, validated, and prepared for publication.
How many awards are anticipated?
The opportunity anticipated a single award (ExpectedAwards: 1).
What is the maximum funding amount available?
The award ceiling is $250,000.
When was the announcement posted and what was the closing date?
The announcement was created and posted on April 1, 2016. The original and current closing date listed is June 3, 2016.
What is the CFDA number for this opportunity?
The opportunity is listed under CFDA number 93.103.
How is the opportunity categorized?
It is categorized under consumer protection, food and nutrition, and health, aligning with FDA's public health mission and the regulatory importance of standardized submissions.
Who is eligible to apply based on the information provided?
Eligibility is broad and includes state and local governments, federally recognized tribal governments and certain tribal organizations, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status, with the noted exception language regarding higher education institutions where specified), public housing authorities/Indian housing authorities, and for-profit organizations (including small businesses and other for-profit entities).
Does the eligibility description suggest FDA is limiting applicants to a specific sector?
No. The wide eligibility suggests FDA is prioritizing technical capability and stakeholder coordination experience over institutional type, consistent with a standards development effort requiring data expertise, regulatory knowledge, and consensus-building.
What are the expected deliverables or end products?
The expected end product is a publishable, complete set of electronic data standards for Animal Rule-related animal efficacy and natural history studies. The description implies deliverables such as standardized dataset structures, variable definitions, controlled terminology, implementation guidance, and documentation sufficient to support consistent implementation by sponsors and review by regulators.
What is the intended impact of publishing these standards?
The intended impact is clearer electronic submissions, reduced ambiguity, better comparability across studies and models, and more efficient regulatory review in cases where decisions rely heavily on animal evidence because human efficacy trials cannot be conducted.
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