Opportunity Information: Apply for PAR 12 053
Apply for PAR 12 053
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Advanced Neural Prosthetics Research and Development (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Dec 8, 2011 and posted on Dec 8, 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.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- Eligible applicants include: Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses State governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts Small businesses Special district governments County governments Public housing authorities/Indian housing authorities City or township 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 Advanced Neural Prosthetics Research and Development (U01) opportunity (Funding Opportunity Number PAR-12-053) is a National Institutes of Health (NIH) cooperative agreement designed to push neural prosthetics closer to real-world clinical use. The central goal is to support translational work and early-stage human testing, specifically proof-of-concept and pilot clinical studies, rather than basic discovery research alone. The program is structured around milestone-driven development, meaning applicants are expected to propose clear, measurable technical and clinical milestones that demonstrate steady progress toward a device that could realistically benefit patients.
This FOA focuses on the development and demonstration of clinically useful neural prosthetic devices, and it supports the key steps that typically stand between a promising lab concept and first-in-human evaluation. Supported activities include building and implementing clinical prototype devices, conducting preclinical safety and efficacy testing, and performing design verification and validation work that is often required to show a device is manufactured and performs consistently. It also explicitly supports efforts to move through the regulatory pathway needed to begin clinical studies, including preparation for regulatory submissions and other work aimed at obtaining approval to initiate human research. In practical terms, the scope covers the late preclinical and early clinical phases where engineering, safety, usability, reliability, and regulatory readiness become just as important as scientific novelty.
Because the mechanism is a U01 cooperative agreement, the government anticipates substantial NIH involvement during the project. Compared with a standard grant, this type of award generally implies a more collaborative relationship where NIH program staff may help guide progress, monitor milestone completion, and coordinate aspects of project oversight to keep the work aligned with the translational aims of the program. The emphasis on milestone-driven planning signals that competitive applications should lay out a disciplined development plan, including risk management and go/no-go decision points tied to performance, safety, and clinical feasibility.
The opportunity falls under the discretionary category and is associated with multiple CFDA program areas: 93.286 (technological innovations to improve human health), 93.853 (neurosciences and neurological disorders), and 93.865 (child health and human development extramural research). The posted and creation date were December 8, 2011, with an original and current closing date of January 7, 2015, and an archive date of February 7, 2015. The listed award ceiling is $1,000,000, indicating the maximum award amount expected under the announcement.
Eligibility is broad and includes many types of domestic U.S. organizations such as public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses), small businesses, independent school districts, and multiple levels of government (state, county, city/township, special district governments, and public housing authorities). It also includes Native American tribal governments (federally recognized) and other tribal organizations. The announcement further clarifies that additional eligible applicants include Alaska Native and Native Hawaiian Serving Institutions, Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Notably, non-U.S. entities (foreign institutions) are eligible to apply, and foreign components of U.S. organizations are allowed as defined under NIH policy. The FOA specifies that there is no cost-sharing or matching requirement.
For applicants seeking more information, the full announcement was hosted on the NIH grants site at http://grants.nih.gov/grants/guide/pa-files/PAR-12-053.html. For access or technical issues related to the posting, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is PAR-12-053 (Advanced Neural Prosthetics Research and Development, U01)?
PAR-12-053 is a National Institutes of Health (NIH) funding opportunity for the Advanced Neural Prosthetics Research and Development program using the U01 cooperative agreement mechanism. It is intended to move neural prosthetics closer to real-world clinical use by supporting translational research and development activities, including early-stage human testing.
What is the main goal of this funding opportunity?
The central goal is to support translational work and early-stage human testing, specifically proof-of-concept and pilot clinical studies. The focus is on advancing clinically useful neural prosthetic devices toward patient benefit rather than supporting basic discovery research alone.
What kinds of studies does the FOA emphasize?
The FOA emphasizes translational development and early clinical evaluation, including proof-of-concept and pilot clinical studies. It targets the late preclinical and early clinical phases where safety, usability, reliability, and regulatory readiness are essential.
Is basic discovery research the primary focus?
No. The program is designed to push promising concepts toward clinical use, with emphasis on translational development and early-stage human testing rather than basic discovery research alone.
What types of activities are supported under this FOA?
Supported activities include building and implementing clinical prototype devices, conducting preclinical safety and efficacy testing, and performing design verification and validation work to demonstrate consistent manufacturing and performance. The FOA also supports work needed to move through the regulatory pathway to initiate human studies.
Does the program support prototype development for clinical use?
Yes. The FOA explicitly supports building and implementing clinical prototype neural prosthetic devices as part of the steps leading to early-stage human evaluation.
Does the FOA support preclinical safety and efficacy testing?
Yes. The scope includes preclinical safety and efficacy testing that typically stands between a lab concept and first-in-human evaluation.
What is meant by design verification and validation in this FOA?
Design verification and validation refers to development work often required to show that a device is manufactured consistently and performs consistently. The FOA identifies this as a supported activity as applicants prepare devices for clinical study readiness.
Does the FOA support regulatory preparation for human studies?
Yes. The FOA supports efforts to move through the regulatory pathway needed to begin clinical studies, including preparation for regulatory submissions and other work aimed at obtaining approval to initiate human research.
What does “milestone-driven development” mean for applicants?
Applicants are expected to propose clear, measurable technical and clinical milestones that demonstrate steady progress toward a device that could realistically benefit patients. The FOA places strong emphasis on disciplined planning, including risk management and go/no-go decision points tied to performance, safety, and clinical feasibility.
What are “go/no-go” decision points in the context of this program?
They are decision points tied to milestone achievement and project risk management, where continued progression is based on meeting defined performance, safety, and clinical feasibility targets described in the application.
What is a U01 cooperative agreement, and how is it different from a standard grant?
A U01 is a cooperative agreement mechanism where the government anticipates substantial NIH involvement during the project. Compared with a standard grant, this typically implies a more collaborative relationship in which NIH program staff may help guide progress, monitor milestone completion, and coordinate aspects of project oversight to keep the work aligned with translational program aims.
How involved will NIH be during the project?
Because this is a U01 cooperative agreement, substantial NIH involvement is anticipated. NIH staff may help guide progress, monitor milestones, and coordinate oversight to maintain alignment with translational goals.
What is the award ceiling for this opportunity?
The listed award ceiling is $1,000,000, which indicates the maximum award amount expected under the announcement.
Is cost-sharing or matching required?
No. The FOA specifies that there is no cost-sharing or matching requirement.
What CFDA program areas are associated with this opportunity?
This opportunity is associated with multiple CFDA program areas: 93.286 (technological innovations to improve human health), 93.853 (neurosciences and neurological disorders), and 93.865 (child health and human development extramural research).
What is the Funding Opportunity Number?
The Funding Opportunity Number is PAR-12-053.
When was this funding opportunity posted?
The posted and creation date listed for the opportunity is December 8, 2011.
What were the closing and archive dates?
The original and current closing date listed is January 7, 2015. The archive date listed is February 7, 2015.
What is the category of this funding opportunity?
The opportunity is listed under the discretionary category.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic U.S. organizations such as public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses), small businesses, independent school districts, and multiple levels of government (state, county, city/township, special district governments, and public housing authorities). It also includes Native American tribal governments (federally recognized) and other tribal organizations.
Are specific institution types (such as HBCUs, HSIs, or TCCUs) eligible?
Yes. The announcement specifies additional eligible applicants including Alaska Native and Native Hawaiian Serving Institutions, Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. The FOA states that faith-based or community-based organizations are among the additional eligible applicants.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are included among the additional eligible applicants.
Are eligible federal agencies allowed to apply?
Yes. The FOA includes eligible federal agencies among the additional eligible applicants.
Can non-U.S. (foreign) institutions apply?
Yes. The announcement states that non-U.S. entities (foreign institutions) are eligible to apply.
Are foreign components of U.S. organizations allowed?
Yes. Foreign components of U.S. organizations are allowed as defined under NIH policy.
Where can applicants find the full FOA text?
The full announcement was hosted on the NIH grants site at: http://grants.nih.gov/grants/guide/pa-files/PAR-12-053.html
Who should be contacted for access or technical issues with the posting?
For access or technical issues related to the posting, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 12 053) also looked into and applied for these:
| Funding Opportunity |
|---|
| Enhancing Developmental Biology Research at Undergraduate Institutions Academic Research Enhancement Award (R15) Apply for PAR 12 057 Funding Number: PAR 12 057 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $300,000 |
| Specialized Cooperative Centers Program in Reproduction and Infertility Research (U54) Apply for RFA HD 13 005 Funding Number: RFA HD 13 005 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Learning Disabilities Innovation Hubs (R24) Apply for RFA HD 12 203 Funding Number: RFA HD 12 203 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $450,000 |
| Leadership Group for a Clinical Research Network on HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations (UM1) Apply for RFA AI 12 001 Funding Number: RFA AI 12 001 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV associated Infections in Adults (UM1) Apply for RFA AI 12 004 Funding Number: RFA AI 12 004 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Leadership Group for a Clinical Research Network on Microbicides to Prevent HIV Infection (UM1) Apply for RFA AI 12 008 Funding Number: RFA AI 12 008 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Biomedical and Behavioral Research Innovations to Ensure Equity (BRITE) in Maternal and Child Health (R15) Apply for PAR 12 093 Funding Number: PAR 12 093 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Academic Community Partnership Conference Series (R13) Apply for PAR 12 102 Funding Number: PAR 12 102 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $30,000 |
| Child Health Research Career Development Award (CHRCDA) Program K12 Apply for RFA HD 13 011 Funding Number: RFA HD 13 011 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $400,000 |
| Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U24) Apply for PAS 12 165 Funding Number: PAS 12 165 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Limited Competition Revision Applications to Advance Evidence Based Research Related to Protections for Human Subjects (U10) Apply for PAS 12 168 Funding Number: PAS 12 168 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Advanced Tools and Technologies for Cerebrospinal Fluid Shunts SBIR (R43/R44) Apply for PA 12 189 Funding Number: PA 12 189 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Advanced Tools and Technologies for Cerebrospinal Fluid Shunts STTR (R41/R42) Apply for PA 12 190 Funding Number: PA 12 190 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Global Network for Womens and Childrens Health Research (U10) Apply for RFA HD 13 006 Funding Number: RFA HD 13 006 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Data Coordinating Center for the NICHD Cooperative Multicenter Maternal Fetal Medicine Units Research Network (U10) Apply for RFA HD 13 013 Funding Number: RFA HD 13 013 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Data Coordinating Center for the NICHD Cooperative Multicenter Neonatal Research Network (U10) Apply for RFA HD 13 014 Funding Number: RFA HD 13 014 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| NICHD Research Short Courses (R25) Apply for PA 12 207 Funding Number: PA 12 207 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $125,000 |
| Juvenile Protective Factors and Their Effects on Aging (R01) Apply for PAR 12 218 Funding Number: PAR 12 218 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Reproductive Scientist Development Program (RSDP) K12 Apply for RFA HD 13 015 Funding Number: RFA HD 13 015 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Genetic and Genomic Analysis of Xenopus (R21) Apply for PAR 12 249 Funding Number: PAR 12 249 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
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