The Elm

The FDA Center for Drug Evaluation and Research (CDER) Office of Surveillance & Epidemiology (OSE) requests 1- to -2-page proposals (no specific format required) from CERSIs for a potential project related to the risk associated with adult use of stimulants.

This could include: Conducting studies of adults prescribed Rx stimulants for ADHD or other conditions to evaluate the associated risks of illicit stimulant use, substance use disorders (including, but not limited to stimulant use disorders), and stimulant-associated adverse outcomes (e.g., stimulant-involved emergency department encounters, long-term safety outcomes, self-reported adverse events). Consider analyses stratified by stimulant type (amphetamine vs methylphenidate), with population and non-stimulant ADHD control groups, as well as a contextual comparator group of individuals dispensed opioid analgesics. Both prospective and retrospective study designs are of interest. Feasibility assessment, causal models (e.g., DAGs), and instrument or algorithm validation studies may be necessary.  

OSE requests that the following information be included in the proposal:

1. Proposed PI/staff
2. Description of aims/objectives
3. Expected deliverables/outcomes for each aim
4. Estimated timeline and proposed dates for deliverables
5. Anticipated regulatory or public health impact
6. Budget by proposed aim. Indirect cost rate is 20%, and pre-proposal only needs to list total direct cost, total indirect cost, and total cost amounts by proposed aim.

Investigators should propose a budget that is sufficient to complete the proposed work within the ~$150,000 - $350,000 range. If a potential project is larger and would require more funding to complete adequately, breaking the project into phases and including funding per phase would be helpful.

OSE will review the proposals and determine whether to invite investigators to submit a full CERSI research proposal. Please direct any questions and submit proposals to Ellen Pinnow (Ellen.Pinnow@fda.hhs.gov), Jana McAninch (Jana.Mcaninch@fda.hhs.gov), Caroline Huang (caroline.huang@fda.hhs.gov)  and ORSI-CERSI-Team@fda.hhs.gov by Sept. 6, 2023