What is a cooperative agreement – do I need an NIH scientific collaborator?
No. The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH. For more information, refer to Section VI. - Award Administration Information of the FOA.
What is milestone-driven research?
Milestones toward therapeutic intervention are not a description of specific aims and experiments, but rather are discreet goals that create go/no-go decision points in a progressive translational study plan that include quantitative success criteria. See examples of acceptable milestones.
Does the program support research on my threat agent?
Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare nerve agents such as sarin and VX, and toxic industrial chemicals and pesticides such as cyanide, chlorine, parathion, and sodium fluoroacetate. The only way of knowing for sure if the chemical threat you want to work with is one that NIH will support is to contact the NINDS Program Officer listed on the Funding Opportunity Announcement.
Does the program support research on pre-treatments?
The main focus of the CounterACT program is on post-exposure treatments. Drugs that are only effective if given prior to chemical insult (pre-treatment), or those that must be given within a very short period (1-15 minutes) after the insult may be supported, but will be of lower priority. If you want to propose a pre-treatment indication, it should be a minor part of a larger project on the post-treatment approach.
Do I need to partner with a lab that uses restricted agents in order to be competitive?
Not necessarily, many chemical threats are not restricted use agents. However, some agents like Chemical Warfare Agents, require special facilities when used in research. Applicants are strongly encouraged to contact the NINDS program official listed in the FOA for further information on working with restricted chemical agents.
Is my model appropriate, e.g. Drosophila?
This depends on the investigators’ ability to provide adequate scientific justification for the model for its intended use. For example, initial target identification and screening may not require vertebrate animal models, whereas more advanced natural history, efficacy and safety studies may require large animal models where lethality and serious morbidity can be extrapolated to human exposures and effects.
Should I apply for a CounterACT U54 Research Center of Excellence?
Only if three to five inter-related research and development projects can be brought together to utilize common resources provided under the Center. There must be a unifying well-defined goal or problem area of research to which each project relates and contributes, thereby producing a synergistic research environment that allows each research effort to share the resources and creative strengths of the others. There is the expectation that support of inter-related projects and collaborating investigators would yield results beyond those achievable if each project were pursued separately without formal interaction among the participating investigators. All investigators must contribute to, and share in, the responsibilities of fulfilling the Center objectives.
Can a foreign institution apply?
Foreign institutions are not eligible to apply but may be members of consortia headed by U.S. institutions. All requests for international collaborations will be managed on a case by case basis. Principal investigators who are interested in forming international collaborations should be informed to proceed with their applications. However, agency approval may not be confirmed prior to their submission.
Publications – will we be allowed to publish?
Yes, all NIH supported researchers are encouraged to publish their work.
Can we include an NIH Intramural Investigator in our grant application?
Maybe, we will need to review this on a case by case basis. Please contact the NINDS Program Officer listed on the Funding Opportunity Announcement.
Can I resubmit my previous application (resubmission application)?
Depends on whether your previous application was in response to the current Funding Opportunity Announcement (FOA). If the FOA for your previous application is expired and no longer active, you must submit a new application in response to the current active FOA.
Can government laboratories apply?
Yes academic, commercial, and government laboratories can apply. See eligibility section in each Funding Opportunity Announcement (FOA). For government laboratories, some restrictions regarding allowable budget requests may apply so you should contact the NINDS Program Officer listed on the FOA.
Do I have to submit the structure/sequence for my therapeutic agent in my application?
Yes, you should. If a potential therapeutic hit(s)/lead(s) was pre-identified, your application should contain a detailed description of the compound(s) to include chemical structure information. The lack of structural information for the potential therapeutic hit(s)/lead(s) may adversely affect assessment of scientific merit. NIH has multiple safeguards to protect the integrity of and to maintain confidentiality in peer review.
For PAR-19-039, it lists "Basic mechanistic research...", Development and utilization of animal models...", and other topics as part of the scientific scope. Does this mean, for example, I can propose to do an animal model development study only?
You can propose to do basic research, animal model development, or other research as long as by the end of the three year period you will reach the goal of lead identification, as outlined in the PAR-19-039. This may be difficult if you are developing an animal model from scratch.