Notice of Increased Budget Limits and NINDS Participation in PAS-19-317 "Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)"

Notice Number: NOT-NS-20-001

Key Dates
Release Date: August 19, 2019

Related Announcements
PAS-19-317

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)

Purpose

This Notice informs potential applicants of new budget limits for PAS-19-317 "Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional)". In addition, the National Institute of Neurological Disorders and Stroke (NINDS) will participate in this funding opportunity announcement. This notice will be effective for the January 5, 2020 receipt date and subsequent due dates.

The following sections of PAS-19-317 have been updated (shown in bold italics) to reflect these changes.

Currently Reads:

Part 1. Overview Information

Components of Participating Organizations

National Institute on Aging (NIA)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866

Section II. Award Information

Funds Available and Anticipated Number of Awards

NIA intends to fund an estimate of 10 awards, corresponding to a total of $4 million for fiscal year 2020. Future year amounts will depend on annual appropriations.

Award Budget

According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $252,131 for Phase I awards and $1,680,179 for Phase II awards (with appropriate justification from the applicant). However, NIH has received a waiver from SBA, as authorized by statute, to exceed $252,131 for Phase I or $1,680,179 for Phase II for specific topics. The current list of approved topics can be found at https://sbir.nih.gov/funding#omni-sbir. Applications that address the approved waiver topics may request total cost budgets up to $300,000 for Phase I and $2,000,000 for Phase II. Applicants are strongly encouraged to contact NIH program officials prior to submitting any application in excess of the guidelines early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.

Phase IIB budgets must be submitted in accordance with participating IC-specific budget limitations described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC and FDA.

Section VII. Agency Contacts

Scientific/Research Contact(s):

Zane Martin, Ph.D.
National Institute on Aging (NIA)
Division of Neuroscience (DN)
Telephone: 301-827-7130
Email: zane.martni@nih.gov

Michael-David ARR Kerns, M.M., M.S., Ph.D.
National Institute on Aging (NIA)
NIA SBIR-STTR Program Coordinator
Telephone: 301-402-7713
Email: kernsmd@mail.nih.gov

Financial/Granst Management Contact(s):

Jessica Perez
National Institute on Aging (NIA)
Telephone: 301-403-7739
Email: jessi.perez@nih.gov

Modified to Read:

Part 1. Overview Information

Components of Participating Organizations

National Institute on Aging (NIA)

National Institute of Neurological Disorders and Stroke (NINDS)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866, 93.853

Section II. Award Information

Funds Available and Anticipated Number of Awards

NIH intends to fund an estimate of 11 awards, corresponding to a total of $4.4 million for fiscal year 2020. Future year amounts will depend on annual appropriations.

Award Budget

According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $252,131 for Phase I awards and $1,680,179 for Phase II awards (with appropriate justification from the applicant). However, NIH has received a waiver from SBA, as authorized by statute, to exceed $252,131 for Phase I or $1,680,179 for Phase II for specific topics. The current list of approved topics can be found at http://sbir.nih.gov/funding#omni-sbir. Applications that address the approved waiver topics may request total cost budgets up to $500,000 for Phase I and $2,500,000 for Phase II. Applicants are strongly encouraged to contact NIH program officials prior to submitting any application in excess of the guidelines early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.

Phase IIB budgets must be submitted in accordance with participating IC-specific budget limitations described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC and FDA.

Section VII. Agency Contacts

Scientific/Research Contact(s):

Zane Martin, Ph.D.
National Institute on Aging (NIA)
Division of Neuroscience (DN)
Telephone: 301-827-7130
Email: zane.martni@nih.gov

Michael-David ARR Kerns, M.M., M.S., Ph.D.
National Institute on Aging (NIA)
NIA SBIR-STTR Program Coordinator
Telephone: 301-402-7713
Email: kernsmd@mail.nih.gov

Stephanie Fertig, M.B.A.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
Email: fertigs@ninds.nih.gov

Financial/Granst Management Contact(s):

Jessica Perez
National Institute on Aging (NIA)
Telephone: 301-403-7739
Email: jessi.perez@nih.gov

Tijuanna DeCoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@mail.nih.gov

In addition to the changes outlined above, NINDS is adding the following text to Section I. Funding Opportunity Description:

National Institute for Neurological Disorders and Stroke (NINDS)

The National Institute for Neurological Disorders and Stroke (NINDS) is interested in applications within the NINDS mission. The small business program at NINDS is used to achieve the mission of the Institute by supporting innovative ideas at different stages of development, including applied bench research, translational research, and early stage clinical trials. NIA and NINDS have shared interest in all areas of AD/ADRD, with NINDS as the lead for vascular contributions to cognitive impairment and dementia (VCID), lewy body dementia (LBD), and frontotemporal lobar degeneration (FTLD); and NIA as the lead for applications focused on Alzheimer’s Disease.

For those applications that propose a clinical trial and use an FDA-regulated intervention, NINDS will give priority to those applications with (a) A protocol submitted under an open IND and the IND is not under full or partial hold. (b) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has fully approved the IDE or IDE supplement. (c) A protocol submitted under an IND and is on full or partial hold. (d) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has conditionally approved the IDE or IDE supplement. (e) A protocol is exempt from an IND. (f) A protocol is either exempt from the IDE regulations or does not require IDE approval because it is determined to be nonsignificant risk.

NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. STTR applicants considering projects involving human subjects research are strongly encouraged to contact program staff early in the process of preparing a submission.

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Stephanie Fertig, M.B.A.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1447
E-mail: fertigs@ninds.nih.gov