Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease (U10)

Notice Number: NOT-HL-12-154

Key Dates
Release Date: September 18, 2012

Issued by
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

On August 10, 2012, the NHLBI and NICHD issued the Funding Opportunity Announcement (FOA) RFA HL-13-014 Limited Competition: Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease (U10).

The following three corrections to this FOA are being made:

Correction 1:

Section I. Funding Opportunity Description

Objectives and Scope

CURRENT LANGUAGE: "two years postpartum"

NEW LANGUAGE: "approximately two years postpartum"

Correction 2:

Section II. Award Information

CURRENT LANGUAGE:

Award Budget

Budget submissions should clearly delineate between the DCAC and each clinical research site for application purposes.

The DCAC may request up to $3.5 million in aggregate direct costs over the four-year duration. This includes centralized costs for specialized assessments (e.g., laboratory assays/reading center/equipment) anticipated to be approximately $2.6-2.8 million.

Clinical research sites should use the following metrics for Direct Costs commensurate with expected patient enrollment levels from the parent award. Clinical research sites with:
500 patients can request up to $240,000 Directs Costs for all years combined.
1200 patients can request up to $550,000 Direct Costs for all years combined.
1900 patients can request up to $830,000 Direct Costs for all years combined.

Direct cost limits exclude first-tier consortium/contractual facilities and administrative (F&A) costs when determining if an applicant is in compliance with the direct cost limitation. While consortium F&A costs may be requested and awarded, applicants should not consider these costs when determining if a budget exceeds the direct cost limits.


NEW LANGUAGE:

Award Budget

The aggregate total costs for the combined nine applications across four years may not exceed $11.26 million.

The DCAC budget should include centralized costs for specialized assessments (e.g., laboratory assays/biorepository/reading center/equipment) anticipated to be approximately $2.6-2.8 million in direct costs.


Correction 3:

Section IV. Application and Submission Information

2. Content and Form of Application Submission

CURRENT LANGUAGE:

Research Plan
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

  • All applications should have the same Specific Aims and Research Plan.

NEW LANGUAGE:

Research Plan
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

  • All applications should have the same Specific Aims and Research Strategy.
  • All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Megan Mitchell, MPH
Clinical Trials Specialist
Vascular Biology and Hypertension Branch
Division of Cardiovascular Sciences
National Heart, Lung and Blood Institute
6701 Rockledge Drive
Room 8113, MSC 7940
Bethesda, MD 20892
Tel: 301-594-4335
mailto:mitchellm3@mail.nih.gov