Key Dates

Related Announcements

PAR-18-950 - Pre-application: Opportunities for Collaborative Research at the NIH Clinical Center (X02 Clinical Trial Optional)

PAR-18-951 - Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)

Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to clarify the language in Funding Opportunity Announcements (FOAs) PAR-18-951 and PAR-18-950 regarding the length of the Award Project Period.

Background:

Potential applicants are reminded about the following language in PAR-18-951, Section IV.2. Application and Submission Information -- Content and Form of Application Submission

“Planning Activities: For projects where additional time may be needed for planning prior to starting the trial, it would be allowable to submit a 5-year Research Plan where the first year of the project focuses on planning activities, and a commensurately smaller budget for that year, with the actual trial commencing in years 2-5 of the project period. Such planning activities could include development of a Manual of Procedures, creation of a Data Safety and Monitoring Board charter, development of data handling and statistical analysis plans, establishment of recruitment sites, preparation of preliminary submissions for regulatory approvals, development of training materials, credentialing at the NIH Clinical Center, and other tasks essential to a clinical trial.For applications taking that approach, these activities should also be included in the study timeline and milestones. If a planning year is proposed as part of the Research Plan, it is expected that any planning activities will be completed and planning milestones accomplished prior to commencing the trial in years 2-5.”

Therefore, while it is still expected that the research portion of the study plan will not exceed 4 years, the FOA allows the ability to request a 5^th year, where the first year is focused on planning activities and regulatory approvals with a commensurately smaller budget.

To clarify this intent, the following language is changed:

PAR-18-951

Specific language regarding the U01 application in PAR-18-951, Part I. Award Project Period, is hereby changed as follows:

From:

“The scope of the proposed project should determine the project period. The maximum project period is 5 years.”

To:

“The scope of the proposed project should determine the project period. The maximum project period is 5 years for projects that include a planning year as part of the research plan. For projects that do not need a planning year, the maximum project period is 4 years.”

PAR-18-950

Since the X02 pre-application FOA (PAR-18-950) does not require a budget and does not result in an award, the FOA indicates the Award Project Period as “not applicable” for the pre-application. Therefore, no changes are being made to the language in this FOA, but potential applicants are reminded to consider the project period limitation for the U01 application (PAR-18-951) when developing their research plans for the X02 pre-application.

All other aspects of these FOAs remain unchanged.

Inquiries

Please direct all inquiries to:

Eugene G. Hayunga, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6856
Email:ehayunga@mail.nih.gov