Notice Number: NOT-HL-13-196

Key Dates
Release Date: September 13, 2013

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to clarify the requirements regarding the use or collection of new data or specimens from human subjects in CADET-funded research in RFA-HL-14-001 "Centers for Advanced Diagnostics and Experimental Therapeutics in Lung Diseases Stage II (UH2/UH3)."

Additionally, this is to inform prospective applicants that NHLBI has posted a recorded presentation and Frequently Asked Questions (FAQs) regarding applications for this FOA. The recorded presentation and FAQs are available on the NHLBI website at the following link: http://www.nhlbi.nih.gov/funding/inits/faq-hl-14-001.html. Although not a prerequisite to applying, all applicants are encouraged to review the presentation and FAQs prior to submitting their application.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

CADET Requirements

Current language:
Applications will be considered non-responsive to this FOA if any of the following are included in the application:
1. Studies of combination products that include only elements of previously approved products (e.g., combining an approved drug with a device to deliver it as an aerosol).
2. Studies for changing the indication (disease) for an approved product without a novel approach to management (e.g., using a drug approved for use in COPD patients in patients with asthma).
3. Using an existing product in a sub-population of patients that is identified by an existing test (e.g., using Vitamin D in subjects who are Vitamin D deficient).
4. Clinical trials.

Revised language:
Applications will be considered non-responsive to this FOA if any of the following are included in the application:
1. Studies of combination products that include only elements of previously approved products (e.g., combining an approved drug with a device to deliver it as an aerosol).
2. Studies for changing the indication (disease) for an approved product without a novel approach to management (e.g., using a drug approved for use in COPD patients in patients with asthma).
3. Using an existing product in a sub-population of patients that is identified by an existing test (e.g., using Vitamin D in subjects who are Vitamin D deficient).
4. Clinical trials. CADET will not support the collection of new specimens or data from human subjects. However, such specimens and data may be used if collected with a funding source other than CADET.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Michelle Freemer, M.D.
National Heart, Lung, and Blood Institute
Telephone: 301-435-0202
Email: michelle.freemer@nih.gov