Opportunity Information: Apply for PAR 12 097
Apply for PAR 12 097
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Ancillary Studies in PREDICT HD (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Jul 25, 2013 and posted on Feb 6, 2012.
- Applicants must submit their applications by Aug 14, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: City or township governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses State governments For profit organizations other than small businesses Special district governments Public and State controlled 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 Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Public housing authorities/Indian housing authorities County governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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 not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Ancillary Studies in PREDICT HD (U01) opportunity (Funding Opportunity Number PAR-12-097) is a National Institutes of Health program led by the National Institute of Neurological Disorders and Stroke (NINDS) that supports add-on, or "ancillary," research projects that leverage the existing PREDICT HD study. The central goal is to deepen understanding of the earliest phases of Huntington's disease, specifically the premanifest or prodromal stages, by identifying and characterizing clinical features and biomarker patterns that appear before clear diagnosis. Rather than funding a brand-new cohort, the announcement is designed to help investigators make high-impact use of an unusually rich, well-characterized longitudinal dataset and associated biospecimen resources that have already been assembled through PREDICT HD.
PREDICT HD itself is described as a large international observational study conducted across 32 sites, focused on people who are at risk for Huntington's disease. The cohort includes approximately 800 premanifest HD participants and 200 healthy controls, making it one of the more substantial resources for studying early disease trajectories. Over about a ten-year span, the parent study collected extensive clinical and research measurements, including the Unified Huntington's Disease Rating Scale (UHDRS) motor examinations, cognitive assessments, neuropsychiatric evaluations, and structural MRI data. Importantly, the announcement highlights both the breadth of these longitudinal measures and the availability of at least a subset of the data through NIH's dbGaP repository (with a link provided in the notice), signaling that applicants are expected to build projects that coordinate with, and appropriately use, established data-sharing and governance mechanisms.
The funding mechanism is a U01 cooperative agreement, which typically means the project will involve substantial scientific or programmatic involvement from NIH staff compared with a standard research grant. In practical terms, applicants proposing ancillary studies should expect closer coordination with the NIH and with the PREDICT HD infrastructure than they would under an investigator-initiated R01. The focus is on studies that can plug into the existing PREDICT HD framework, whether by adding new analyses to existing data, incorporating additional measurements, or using available biospecimens, all while aligning with the overarching objective of clarifying early clinical and biomarker signatures of Huntington's disease.
From an administrative standpoint, this is a discretionary grant opportunity in the health research area, listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). There is no cost-sharing or matching requirement. Key dates in the listing include an original posted date of February 6, 2012; an original closing date of April 11, 2014; and a later current closing date shown as August 14, 2013, with an archive date of September 14, 2013, reflecting that this particular announcement is now historical rather than open for new submissions.
Eligibility is broad across many U.S.-based organization types, spanning state, county, city, township, and special district governments; federally recognized and other tribal governments and tribal organizations; public and private institutions of higher education; nonprofits with and without 501(c)(3) status (with certain distinctions for higher-education institutions); and for-profit entities including small businesses and other for-profits. The notice also explicitly includes various mission-driven institutional categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities (TCCUs), and faith-based or community-based organizations, among others. Non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible, although foreign components as defined under NIH policy are allowed, which typically means a U.S. applicant can include certain justified international elements consistent with NIH rules.
The main practical takeaway is that NINDS was seeking tightly integrated projects that extend the value of PREDICT HD by using its established participants, longitudinal clinical characterizations, imaging, and biospecimen resources to answer new questions about the earliest detectable changes in Huntington's disease. Applicants would be expected to coordinate with the parent study and relevant data-access systems (including dbGaP where applicable), and to design ancillary work that complements rather than duplicates what PREDICT HD already did, with the larger aim of improving early detection, staging, and understanding of disease progression before manifest diagnosis. For full details, the listing points to the NIH Guide announcement page (PAR-12-097) and provides NIH Office of Extramural Research webmaster contacts for access or linking issues.
Frequently Asked Questions (FAQs): Ancillary Studies in PREDICT HD (U01) - PAR-12-097
What is the Ancillary Studies in PREDICT HD (U01) funding opportunity?
It is a National Institutes of Health (NIH) grant opportunity (Funding Opportunity Number PAR-12-097) led by the National Institute of Neurological Disorders and Stroke (NINDS). It supports add-on, or "ancillary," research projects that leverage the existing PREDICT HD study resources rather than creating a brand-new cohort.
What is the primary scientific goal of this opportunity?
The central goal is to deepen understanding of the earliest phases of Huntington's disease, especially the premanifest or prodromal stages, by identifying and characterizing clinical features and biomarker patterns that appear before clear diagnosis.
What does "ancillary study" mean in this context?
An ancillary study is an add-on project designed to "plug into" the existing PREDICT HD framework. This can include new analyses of existing data, adding additional measurements, or using available biospecimens, while aligning with the parent study's objectives and infrastructure.
What is PREDICT HD?
PREDICT HD is described as a large international observational study conducted across 32 sites focused on people who are at risk for Huntington's disease. It provides a rich, well-characterized longitudinal dataset and associated biospecimen resources assembled over about a ten-year period.
Who is included in the PREDICT HD cohort?
The cohort includes approximately 800 premanifest Huntington's disease participants and about 200 healthy controls.
What kinds of data and measures were collected in PREDICT HD?
The parent study collected extensive longitudinal clinical and research measurements, including Unified Huntington's Disease Rating Scale (UHDRS) motor examinations, cognitive assessments, neuropsychiatric evaluations, and structural MRI data.
Why does this opportunity focus on using an existing cohort instead of enrolling a new one?
The announcement is designed to help investigators make high-impact use of an unusually rich, well-characterized longitudinal dataset and biospecimen resources that are already assembled through PREDICT HD, rather than funding creation of a new cohort from scratch.
Is any PREDICT HD data available through NIH data repositories?
Yes. The opportunity highlights that at least a subset of PREDICT HD data is available through NIH's dbGaP repository (a link is provided in the notice), and applicants are expected to coordinate with established data-sharing and governance mechanisms where applicable.
What is the funding mechanism for this program?
The mechanism is a U01 cooperative agreement.
What does a U01 cooperative agreement imply for how the project will be run?
A U01 cooperative agreement typically involves substantial scientific or programmatic involvement from NIH staff compared with a standard research grant. Applicants should expect closer coordination with NIH and with the PREDICT HD infrastructure than under an investigator-initiated R01.
What kinds of projects fit this opportunity?
Projects are expected to be tightly integrated with PREDICT HD and extend its value. Examples described in the opportunity include new analyses of existing longitudinal data, incorporating additional measurements into the existing framework, or using available biospecimens, all aimed at clarifying early clinical and biomarker signatures of Huntington's disease.
What types of outcomes or insights is the program trying to enable?
The program aims to improve early detection, staging, and understanding of disease progression before manifest diagnosis by identifying early clinical features and biomarker patterns in the premanifest/prodromal period.
Does this grant require coordinating with the parent PREDICT HD study?
Yes. The opportunity emphasizes that applicants would be expected to coordinate with the parent study and relevant data-access systems (including dbGaP where applicable), and to design ancillary work that complements rather than duplicates what PREDICT HD already did.
What is the CFDA number and program area for this opportunity?
It is listed under CFDA 93.853, Extramural Research Programs in the Neurosciences and Neurological Disorders, in the health research area.
Is cost-sharing or matching required?
No. The listing states there is no cost-sharing or matching requirement.
Is this funding opportunity currently open for applications?
No. The listing indicates this announcement is historical rather than open for new submissions. It includes an archive date of September 14, 2013, and shows dates including an original posted date (February 6, 2012), an original closing date (April 11, 2014), and a later "current closing date" shown as August 14, 2013, consistent with an archived opportunity.
Who is eligible to apply?
Eligibility is broad across many U.S.-based organization types, including various levels of government (state, county, city, township, and special district), federally recognized and other tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (with and without 501(c)(3) status, with distinctions for higher-education institutions), and for-profit entities including small businesses and other for-profits.
Are mission-driven institutions and community-based organizations included in eligibility?
Yes. The notice explicitly includes categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities (TCCUs), and faith-based or community-based organizations, among others.
Are foreign (non-U.S.) institutions eligible to apply?
No. Non-U.S. entities (foreign institutions) are not eligible to apply.
Can a U.S. organization include non-U.S. components in its application?
Non-U.S. components of U.S. organizations are not eligible. However, the notice states that foreign components (as defined under NIH policy) are allowed, meaning a U.S. applicant may include certain justified international elements consistent with NIH rules.
Where can applicants find the full official announcement details?
The listing points to the NIH Guide announcement page for PAR-12-097 for full details.
Who is listed as a contact for access or linking issues related to the announcement?
The listing provides NIH Office of Extramural Research webmaster contacts for access or linking issues.
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