NOT-OD-16-075: Notice of Correction of Application Open Date in PAR-16-094 "Improvement of Animal Models for Stem Cell-Based Regenerative Medicine (R21)"

Notice of Correction of Application Open Date in PAR-16-094 "Improvement of Animal Models for Stem Cell-Based Regenerative Medicine (R21)"

Notice Number: NOT-OD-16-075

Key Dates
Release Date: March 3, 2016

Related Announcements
PAR-16-094

Issued by
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute of Environmental Health Sciences (NIEHS)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

The purpose of this Notice is to add an earlier application due date and the corresponding Key Dates to PAR-16-094 "Improvement of Animal Models for Stem Cell-Based Regenerative Medicine (R21)". The added due date applies to all application types (New, Resubmission and AIDS). For the added submission date, all Institutes/Centers/Offices listed above will participate, but the National Heart, Lung, and Blood Institute (NHLBI) and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) will only participate for this one date.

Topics for applications that will be considered by ORIP, NIAID, and NIDCR are listed in PAR-16-094. Topics for applications that will be considered by the National Heart, Lung, and Blood Institute (NHLBI) and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) for the additional application due date are as follows:

The National Heart, Lung, and Blood Institute (NHLBI) is interested in the following research topics as applied to the mission areas of the Institute: i) stem cell engineering and regeneration of complex heart, vascular, lung, and blood systems; ii) stem cell correction of either congenital or acquired heart, lung and blood defects, iii) stem cell regeneration/reconstruction of heart, lung, and blood tissue; and iv) optimization of the host’s microenvironment to improve the survival and function of transplanted human heart, vascular, lung, and blood tissues, including but not limited to, in vivo models that aim to overcome immunological/ex vivo manipulation/tumorigenic safety concerns associated with FDA regulatory requirements. Preference will be given to in vivo models developed using NHLBI resources (e.g., Production Assistance for Cellular Therapies (PACT), Science Moving towards Research Translation and Therapy (SMARTT), and the Gene Therapy Resource Program (GTRP). NHLBI has interest in the development of new in vivo models for health and disease, particularly large animal models such as sheep, pig, dog and non-human primates, to overcome the unique dynamics of heart, lung, and blood systems, which can be scientifically justified. New models should include in their research plan validation studies for the purpose of preclinical experiments that may lead to an Investigational New Drug (IND), Investigational Device Exemption (IDE) or similar regulatory approval. NHLBI does not have interest in applications proposing mechanistic studies on mouse models.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in applications conducting basic and translational research to facilitate the use of stem cell-based therapies for both rare and common diseases/conditions in the NIAMS mission (arthritis, musculoskeletal and skin diseases). Some diseases/conditions that would be of interest include, but are not restricted to, acute injury and chronic degenerative diseases and conditions affecting the musculoskeletal system and skin, as well as monogenic diseases affecting these systems, such as epidermolysis bullosa, some ichthyoses, Duchenne muscular dystrophy, osteogenesis imperfecta, osteopetrosis, and chondrodysplasias. Proposed projects can include the improvement of animal disease models for testing stem cell-based therapeutics for these diseases/conditions. Other research areas covered by this FOA may be of interest to NIAMS, provided that the research focuses on musculoskeletal and skin tissues and diseases within the NIAMS mission.

Part 1. Key Dates

Currently reads:

Posted Date	February 9, 2016
Open Date (Earliest Submission Date)	May 16, 2016
Application Due Date(s)	Standard dates apply by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	New Date per issuance of NOT-OD-16-070: Standard AIDS dates apply by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	May 8, 2019
Due Dates for E.O. 12372	Not Applicable

Updated Key Dates

Updated Key Dates

Posted Date	February 9, 2016
Open Date (Earliest Submission Date)	March 8, 2016
Application Due Date(s)	April 4, 2016, then Standard dates apply. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	April 4 2016, then Standard AIDS dates apply by 5:00 PM local time of applicant organization (per issuance of NOT-OD-16-070). All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	June 2016 then Standard dates apply
Advisory Council Review	October 2016 then Standard dates apply
Earliest Start Date	December 2016 then Standard dates apply
Expiration Date	May 8, 2019
Due Dates for E.O. 12372	Not Applicable

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Oleg Mirochnitchenko, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0749
Email: oleg.mirochnitchenko@nih.gov

Martha S. Lundberg, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0513
Email: lundberm@nhlbi.nih.gov

Carl Baker, M.D., Ph.D.
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5017
Email: bakerc@mail.nih.gov

Fei Wang, Ph.D.
Division of Musculoskeletal Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5055
Email: wangf@mail.nih.gov

Nadya Lumelsky, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-7703
Email: nadyal@nidcr.nih.gov

Les Reinlib, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4998
Email: reinlib@niehs.nih.gov

Brigitte Sanders, DVM, PhD, RAC
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3209
Email: Brigitte.Sanders@nih.gov

Alison Deckhut Augustine, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3475
Email: augustine@niaid.nih.gov