Notice of Change to Funds Available and Award Budget for PAR-15-187 "Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01)"

Notice Number: NOT-FD-15-007

Key Dates
Release Date:   June 9, 2015

Related Announcements
PAR-15-187

Issued by
U.S. Food and Drug Administration (FDA)

Purpose

The purpose of this Notice is to change the Funds Available and Award Budget for PAR-15-187.

Now Reads:

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications.  Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

FDA/CDER intends to fund up to $2,000,000, for Fiscal Year 2015 in support of this grant program. Future year amounts will be contingent on availability of Federal funds but it is estimated that FDA/CDER intends to commit up to the following amounts for Fiscal Years (FY) 2016-2019:

FY2016: $2,000,000

FY2017: $2,000,000

FY2018: $2,000,000

FY2019: $2,000,000

It is anticipated that up to two (2) awards will be made, not to exceed $1,000,000 in total costs (direct plus indirect), per award, per Fiscal Year.

Award Budget

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $1,000,000
YR 02: $1,000,000
YR 03: $1,000,000  

 

Should Read:

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications.  Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

FDA/CDER intends to fund up to $6,000,000, for Fiscal Year 2015 in support of this grant program. Future year amounts will be contingent on availability of Federal funds but it is estimated that FDA/CDER intends to commit up to the following amounts for Fiscal Years (FY) 2016-2019:

FY2016: $6,000,000

FY2017: $6,000,000

FY2018: $6,000,000

FY2019: $6,000,000

It is anticipated that up to two (2) awards will be made, not to exceed $3,000,000 in total costs (direct plus indirect), per award, per Fiscal Year.

Award Budget

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $3,000,000
YR 02: $1,000,000
YR 03: $1,000,000  

Inquiries

Please direct all inquiries to:

Lisa Ko
U.S. Food and Drug Administration (FDA)
Office of Acquisition and Grants Services
5630 Fishers Lane
Rockville, MD 20857
Telephone:  240-402-7592
Email:  Lisa.Ko@fda.hhs.gov