# Presentation: 071068

## Centers for Medical Countermeasures against Radiation (CMCR)

**Centers for Medical Countermeasures against Radiation (CMCR)**

***Helen Quill, PhD***
***Chief, Basic Immunology Branch***
***Division of Allergy, Immunology & Transplantation***
***National Institute of Allergy and Infectious Disease, NIH***

## CMCRPrimary Goal

- 	Develop new medical products to
- protect against,
- mitigate the effects of, and/or
- treat the short- and long-term consequences of
- radiation exposure due to terrorist attack.

## CMCRObjective

- 	Establish a goal-oriented network of Centers to support
- basic research,
- translational/regulatory studies, and/or
- product development, and
- education,
- to develop medical countermeasures against radiation.

## CMCRAwards

-  **$5M annual total (direct + indirect) costs max [incorrect in RFA]**
-  Smaller budgets welcomed; be realistic
-  5 year max award
-  5 – 8 CMCR awards possible
-  Awards based on scientific merit and programmatic needs

## CMCRAreas of Research/Development

- Medical products for post-exposure treatment
- Medical products for pre-exposure protection
- Biodosimetry methods
- Immune protection/restoration
- Mechanisms of injury and repair
- Low dose exposure/long term effects
- New assays/animal models
- GLP capacity for product evaluation

## CMCRApplication Components

- Multiproject application _must_ include:
- Overview
- Center Management and Operations
- Administrative Core
- Research/Development Projects (3 minimum)
- Pilot Research Projects Core
- Scientific Core(s)
- Training & Education Program Core

## CMCRApplication Components

- _Overview_ (20 pages max total):
- Center Management and Operations
- Administrative Core
- Organizational structure
- Participant roles
- Research theme/strategic plan
- Action plan
- Annual milestones of progress
- Product development plan
- Data sharing plan
- Statement of institutional commitment
- Any Alteration & Renovation request

## CMCRApplication Components

- _Research/Development Projects_ (3 minimum)
- Each project research plan = 25 pages max each
- Hypothesis-generating projects
- Hypothesis-driven projects
- Basic, translational, applied research
- Animal model/assay development
- Regulatory studies for FDA approvals
- Preclinical and/or Phase I clinical trials
- Preliminary data
- Goal-oriented projects

## CMCRApplication Components

- _Scientific Core(s)_
- Each Core research plan = 10 pages max each
- Currently available resource
- Possible repository
- Each Core used by at least 2 Research/Development Projects of proposed Center
- Centralized research service facility proposed for Center network

## CMCRApplication Components

- _Pilot Research Project Core_
- Research plan = 10 pages max
- Pilot research, new technologies, collaborations
- Within or outside of Center
- Plan for selection, evaluation, etc.
- Managed by Administrative Core
- $500K max/yr total direct costs/Center
- $100K, 2 yr max support per individual pilot project
****DO **_**NOT**_** INCLUDE DESCRIPTIONS OF PROJECTS****

## CMCRApplication Components

- Training and Education Program Core
- Research plan = 10 pages max
- Laboratory training
- Principles of radiobiology etc.
- Seminar series, symposia
- Within or outside Center
- Managed by Administrative Core
**NO FORMAL COURSES or DEGREE PROGRAMS**

## CMCROther Requirements

- PI must commit 10% effort for Administrative Core
- PI also manages the Pilot Research Project Program & the Training and Education Program Core
- Each applicant may submit only one application as a PI

## CMCROther Requirements

- PI must participate in regular local meetings of his/her CMCR and attend annual meetings of the CMCR network
- PI must participate as voting member of the CMCR Steering Committee
- The CMCR Steering Committee will:
- Promote synergistic interactions
- Evaluate plans for project changes within the CMCR network
- Evaluate Training & Education Programs within the CMCR network
- Develop policies for data sharing/publication of collaborative results

## CMCRFunding Mechanism

- U19 Cooperative Agreement Grant
- Terms and Conditions of Award
- Substantial NIH programmatic involvement with the awardees in a partnership role – beyond normal grant stewardship role
- Dominant role and prime responsibility resides with awardees

## CMCR ApplicationThings to do

-  Follow all instructions; read entire RFA
-  Follow instructions for application preparation
-  Do not omit any component of the application (or it may be returned as unresponsive)
- Remain within the page limits
- Submit on time
- Receipt date (Feb 22) means it must be _at_ NIH (CSR _and _NCI review office) _on or before that date_
-  Pay attention to the review criteria in the RFA
- Highlight synergistic interactions

## CMCR ApplicationDATES

-   Letter of intent: Jan 24, 2005
-  Application receipt: Feb 22, 2005
-  Peer Review: June 2005
-  Award: Sept 2005
**NOTE: No additional materials/data will be accepted after Feb 22, 2005**