Extramural Policy and Review Activities

Receipt, Referral, and Review

NIDA received 944 applications, including both primary and dual assignments, for which the Office of Extramural Affairs (OEA) managed the programmatic referral process during this Council cycle. Of these, NIDA received the primary assignment on 733 applications.

OEA arranged and managed 17 grant review meetings in which 182 applications were evaluated. OEA's reviews included applications in chartered, standing review committees and Special Emphasis Panels (SEPs). In addition, OEA's Contract Review Branch (CRB) arranged and managed 10 contract proposal review meetings.

NIDA's chartered committees consist of NIDA-E (Treatment Review Committee), NIDA-F (Health Services Review Committee), NIDA-L (Medications Development Committee), and NIDA-K (Training Committee). In addition to meetings of each of these committees, OEA staff held 13 Special Emphasis Panels to review grant applications for a variety of reasons:

Conflicts with the chartered committees
Program Project grant applications
Behavioral Science Track Award for Rapid Transition (B/START)
Imaging Science Track Award for Research Transition (I/START)
Cutting-Edge Basic Research Awards (CEBRA) (R21)
Conference Grants (R13)
Mechanism for Time-Sensitive Research Opportunities
Minority Institutions' Drug Abuse Research Development Program (MIDARP)
Requests for Applications (RFAs)

OEA managed the following RFA review:

• DA09-006: Criminal Justice Drug Abuse Treatment Studies 2 (CJ-DATS 2) (U01)

Completed contract-related review activity from the Contracts Review Branch since the last Council includes:

R&D and non-R&D Contract Reviews

• NO1DA-9-8882: Drug Testing for Clinical Trials
• NO1DA-9-8883: Non-Clinical ADME Studies

Phase II SBIR Contract Reviews

• N44DA-9-2213: Web Based training for Pain Management Providers

Phase I SBIR Contract Reviews

• N43DA-9-5543: Electronic Drug Abuse Treatment Referral Systems for Physicians
• N43DA-9-5544: Virtual Reality Simulations to Train Caregivers/Providers
• N43DA-9-8886: Design and Synthesis of Treatment Agents for Drug Abuse
• N43DA-9-8888: Web Based Cognitive/Neuropsychological Testing for Substance Abuse
• N43DA-9-8884: Development of Therapeutic Agents for Substance Use Disorders
• N43DA-9-8885: Pharmaceutical Approaches for Development of Pharmacotherapies for Drug Addiction
• N43DA-9-7768: Screening, Characterization and Validation Assays for Protein Capture Reagents

CTN Data and Safety Monitoring Board(s) Meetings

• September 12, 2008 for the final report on the CTN 0029 study "A Pilot Study of Osmotic-Release Methylphenidate (OROS MPH) in Initiating and Maintaining Abstinence in Smokers with Attention Deficit Hyperactivity Disorder (ADHD)."
• September 26, 2008 to review the rationale and design of the study CTN 0037: Exercise as a Treatment for Substance Use Disorders.
• October 24, 2008 to discuss the progress of study protocols CTN 0027: Starting Treatment with Agonist Replacement Therapies (START) and CTN 0031: Stimulant Abuser Groups to Engage in 12-Step (STAGE-12).

Certificates of Confidentiality

Between August 5 and December 4, 2008, OEA processed 109 Certificate applications, including 28 amendments for either extension of expiration date or protocol change.

Staff Training and Development

The OEA Symposium Series, a forum for staff training and sharing of ideas and information, continued through the summer. Activities included open forums for discussions and presentations that included NIH GWAS policies, Enhancing Peer Review Update, NIH staff training on handling financial COI, The Program Leadership Committee, the Program Module Users Group, Updates to the Program Module, and NIH/NSF collaborations.