Opportunity Information: Apply for PAR 13 073

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Clinical Study Planning Grant Program (R34)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.867 Vision Research.
  • This funding opportunity was created on Jan 4, 2013 and posted on Jan 4, 2013.
  • Applicants must submit their applications by Jan 7, 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 $150,000.00 in funding.
  • Eligible applicants include: State governments Special district governments Private institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Independent school districts Public and State controlled institutions of higher education City or township governments County governments Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments).
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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) Non domestic (non U.S.) Entities (Foreign Organizations) 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 NEI Clinical Study Planning Grant Program (R34), Funding Opportunity Number PAR-13-073, is a discretionary NIH grant from the National Eye Institute focused on helping investigators plan large-scale clinical vision research before they submit a full application for a major clinical study. It targets the common problem that well-designed randomized clinical trials and epidemiologic studies require extensive up-front documentation and operational detail at the time of application, including the scientific rationale, study design, analytic plan, protocols, staffing and governance structures, facilities, and multi-site collaborative arrangements. NEI emphasizes that the best way to present this level of operational readiness is through a thoroughly developed Manual of Procedures (MOP), but recognizes that producing a high-quality MOP is expensive and time-consuming. This R34 is therefore meant to pay for the key planning work that makes a later, larger clinical study application credible, complete, and feasible.

In practical terms, the grant supports activities that refine and finalize the study protocol and study procedures and produce a detailed MOP. Applicants can use the award to build out the operational playbook for the future study, spelling out how the study will actually run day to day, how data will be collected and managed, how outcomes will be measured, how quality control will be handled, how recruitment and retention will work, and how participating sites and collaborators will coordinate. The announcement also allows funding for preliminary or pilot-type planning studies when they directly inform feasibility, such as testing and improving study procedures, confirming the practicality of measurements, or gathering information that documents recruitment potential. The scope explicitly applies to both epidemiologic studies and clinical trials in vision research, meaning it can be used for planning observational population-based work as well as interventional randomized designs, as long as the purpose is to strengthen the protocol and operational plan for a future large-scale effort.

Key administrative details include an award ceiling of $150,000 and no cost-sharing or matching requirement. The program is categorized under Health, tied to CFDA number 93.867 (Vision Research). The opportunity was posted and created on January 4, 2013, with an original and final closing date of January 7, 2016, and it was archived on February 7, 2016. Even though it is archived (meaning it is no longer open under these dates), the summary describes the intent and structure of this particular NEI planning mechanism as it existed for that funding cycle.

Eligibility is broad and includes many organization types that commonly apply for NIH funding. Eligible applicants listed include state and local governments (including counties, cities/townships, special district governments, and independent school districts), public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), small businesses and other for-profit organizations (other than small businesses are also included), public housing authorities/Indian housing authorities, and federally recognized tribal governments as well as other tribal organizations. The eligibility section also highlights additional categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, Asian American and Native American Pacific Islander serving institutions, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Foreign participation is allowed: non-U.S. entities (foreign organizations and foreign institutions) may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are permitted as defined in the NIH Grants Policy Statement.

For more detail, the announcement points to the NIH Grants Guide posting (http://grants.nih.gov/grants/guide/pa-files/PAR-13-073.html). Technical access or linking issues are directed to the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.

Frequently Asked Questions (FAQs): NEI Clinical Study Planning Grant Program (R34) - PAR-13-073

What is the NEI Clinical Study Planning Grant Program (R34) under PAR-13-073?

It is a discretionary NIH grant opportunity from the National Eye Institute (NEI) designed to support the planning work needed before submitting a full application for a large-scale clinical vision research study. The goal is to help investigators build the detailed scientific and operational foundation required for a credible future application for a major clinical trial or epidemiologic study.

What problem is this R34 planning grant meant to solve?

NEI notes that well-designed randomized clinical trials and epidemiologic studies require extensive up-front documentation and operational detail at the time of application, including the scientific rationale, study design, analytic plan, protocols, staffing and governance structures, facilities, and multi-site collaborative arrangements. This R34 is meant to fund the work required to develop that level of readiness.

What is the main deliverable NEI emphasizes for this planning grant?

NEI emphasizes that the best way to present operational readiness is through a thoroughly developed Manual of Procedures (MOP). A key purpose of the R34 is to support the time and expense needed to produce a high-quality MOP.

What is a Manual of Procedures (MOP) in the context of this opportunity?

Based on the description, the MOP is the detailed operational playbook for how the future study will run. It documents day-to-day procedures and operational detail such as data collection and management, outcome measurement, quality control, recruitment and retention processes, and coordination across participating sites and collaborators.

What activities can the R34 funds support?

The grant supports activities that refine and finalize the study protocol and study procedures and produce a detailed MOP. It can also support preliminary or pilot-type planning studies when they directly inform feasibility, such as testing and improving study procedures, confirming the practicality of measurements, or gathering information that documents recruitment potential.

Does this funding support clinical trials, epidemiologic studies, or both?

Both. The scope explicitly applies to epidemiologic studies and clinical trials in vision research. It can be used to plan observational population-based work or interventional randomized designs, as long as the purpose is to strengthen the protocol and operational plan for a future large-scale effort.

Is this grant intended to fund the full clinical study?

No. It is intended to pay for key planning work that makes a later, larger clinical study application credible, complete, and feasible, rather than funding the full conduct of a major clinical study.

What kinds of operational details are expected to be planned under this R34?

The opportunity highlights the need for extensive operational detail, including the scientific rationale, study design, analytic plan, protocols, staffing and governance structures, facilities, and multi-site collaborative arrangements. It also specifically mentions planning for how the study will run day to day, how data will be collected and managed, how outcomes will be measured, how quality control will be handled, how recruitment and retention will work, and how sites and collaborators will coordinate.

What is the award ceiling for PAR-13-073?

The award ceiling is $150,000.

Is cost-sharing or matching required?

No. The opportunity states there is no cost-sharing or matching requirement.

What is the CFDA number and program area associated with this opportunity?

The opportunity is categorized under Health and is tied to CFDA number 93.867 (Vision Research).

When was this opportunity posted, and what were the closing dates?

It was posted and created on January 4, 2013. The original and final closing date listed is January 7, 2016.

Is PAR-13-073 currently open for applications?

No. The listing indicates it was archived on February 7, 2016, and the final closing date was January 7, 2016. The summary describes the intent and structure of the mechanism as it existed for that funding cycle.

Who is eligible to apply?

Eligibility is broad and includes many organization types that commonly apply for NIH funding. The listed eligible applicants include state and local governments (including counties, cities/townships, special district governments, and independent school districts), public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), small businesses, other for-profit organizations (including those other than small businesses), public housing authorities/Indian housing authorities, federally recognized tribal governments, and other tribal organizations.

Are specific institution types and community-based organizations included in eligibility?

Yes. The eligibility section highlights additional categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, Asian American and Native American Pacific Islander serving institutions, faith-based and community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies.

Is foreign participation allowed?

Yes. Non-U.S. entities (foreign organizations and foreign institutions) may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are permitted as defined in the NIH Grants Policy Statement.

Where can applicants find the official NIH Grants Guide announcement for PAR-13-073?

The announcement points to the NIH Grants Guide posting at http://grants.nih.gov/grants/guide/pa-files/PAR-13-073.html.

Who should be contacted for technical access or linking issues related to the announcement?

Technical access or linking issues are directed to the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.

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