Extramural Policy and Review Activities

Receipt, Referral, and Review

NIDA received 1219 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 763 applications.

OEA arranged and managed 18 grant review meetings in which 300 applications were evaluated. OEA's reviews included applications in chartered, standing review committees and Special Emphasis Panels (SEPs). In addition, OEA's Contracts Review Branch (CRB) arranged and managed 13 contract proposal reviews.

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 14 Special Emphasis Panels for a variety of reasons:

Conflicts with the chartered committees
Center Grant Applications
Program Project Grant applications
Behavioral Science Track Award for Rapid Transition (B/START)
Imaging Science Track Awards for Research Transition (I/START)
Cutting-Edge Basic Research Awards (CEBRA) (R21)
Conference Grants (R13)
NIH Pathway To Independence (PI) Awards (K99/R00)
Requests for Applications (RFA)

OEA managed the following RFA reviews:

• DA07-001: Announcement of A Limited Competition of The National Drug Abuse Treatment Clinical Trials Network (U10)
• DA07-005: Field-Deployable Tools for Quantifying Exposures to Psychosocial Stress and to Addictive Substances for Studies of Health and Disease (U01)

Completed Contract Reviews from the Contracts Review Branch since the last Council are as follows:

Contract Reviews (R&D and non-R&D)

• N01DA-7-1132: Technical Support for Constituency Outreach and Research Dissemination
• N01DA-7-2211: Administrative and Meeting support for the Clinical Trials Network
• N01DA-7-8872: Rodent Drug Discrimination
• N01DA-7-9911: Research Support and Animal Care Services

Phase I SBIR Contract Reviews

• N43DA-7-1131 (Topic 092): Mechanisms and Methods to Maximize Data Utilization
• N43DA-7-1133 (Topic 076): Development of Science Literacy Materials or Programs
• N43DA-7-2210 (Topic 089): Development of Practical Training Materials for Evidence-Based Treatment
• N43DA-7-7760 (Topic 085): Metabolomics in Drug Abuse Research
• N43DA-7-8869 (Topic 082): Development of Novel Drug Delivery Systems for Treatment Medications

Phase II SBIR Contract Reviews

• N44DA-7-1128 (Topic 084): International Virtual Collaboration (First of 2 planned Awards)
• N44DA-7-5534 (Topic 080): Training and Infrastructure Development
• N44DA-7-7756 (Topic 064): Molecular Profiling of Tissues (First of 2 Planned Awards)
• N44DA-7-7759 (Topic 064): General Analytical Techniques (Second of 2 Planned Awards)

Certificates of Confidentiality

Between December 8, 2006 and April 5, 2007, OEA processed 83 Certificate applications, including 19 for extension of expiration dates and 6 for amended protocols.

Extramural Outreach

Dr. Gerald McLaughlin, OEA, is the NIDA Liaison to the NIH-wide committee dealing with all aspects of the NIH transition to electronic grant submission and also serves on the trans-NIH workgroups tasked with implementing the electronic transition of the R01, U01 grant mechanisms, and appendix guidelines, and serves as a NIDA resource for related issues.

Dr. Gerald McLaughlin is a member of the NIH Review Users Group and an associated workgroup to improve J2EE Peer Review functionalities and assure related training, as well as another associated workgroup dealing with subproject capabilities.

Dr. Gerald McLaughlin is a member of a trans-NIH Human Subjects committee that is developing a revised and updated Human Subjects reference manual. He is also updating NIDA guidelines for public and community reviewers, and summarizing a Cultural and Ethical Issues in Review workgroup for NIDA OEA.

Dr. Teresa Levitin, Director, OEA, continues to serve on the NIH Director's Pioneer Award implementation committee.

Dr. Mark Swieter, OEA, continues to serve as NIDA's representative on the NIH Review Policy Committee and was recently selected to be a member of the RPC Steering Committee.

The OEA Symposium Series, a forum for staff training and sharing of ideas and information, continued through the spring. Activities included open forums for discussions about electronic submission of R01 applications, proposed plans for shortening research plans in R01 applications, and new rules for appendix materials. There were presentations about Certificate of Confidentiality procedures by Dr. Mark Green and about the NIDA AIDS Program by Dr. Jacques Normand.

The CTN Data and Safety Monitoring Board(s) met: January 11, 2007 to discuss a safety update of study protocol CTN 0029, A Pilot Study of Osmotic-Release Methylphenidate (OROS MPH) in Initiating and Maintaining Abstinence in Smokers with Attention Deficit Hyperactivity Disorder (ADHD).

January 29, 2007 to review and discuss study protocol CTN 0031 Stimulant Abuser Groups to Engage in 12-Step (STAGE-12): Evaluation of a Combined Individual-Group Intervention to Reduce Stimulant and Other Drug Use by Increasing 12-Step Involvement.

March 22, 2007 to review and discuss the progress of study protocol CTN 0029, A Pilot Study of Osmotic-Release Methylphenidate (OROS MPH) in Initiating and Maintaining Abstinence in Smokers with Attention Deficit Hyperactivity Disorder (ADHD).

April 5, 2007 to review and discuss the progress of study protocol CTN 0027 Starting Treatment with Agonist Replacement Therapies (START) study implementation. The board discussed the Final Study Reports of four studies:

• CTN 0010: Bup/NX for Adolescents/Young Adults
• CTN 0013: MET for Pregnant Drug Users
• CTN 0017: HIV Intervention
• CTN 0020: Job Seekers

April 6, 2007 to review and discuss the progress of study protocol CTN 0030 Prescription Opioid Addiction Treatment Study (POATS).