Extramural Policy and Review Activities

Receipt, Referral, and Review

NIDA received 1052 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 841 applications.

OEA arranged and managed 17 grant review meetings in which 314 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 7 contract proposal reviews and 2 concept 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 13 Special Emphasis Panels for a variety of reasons:

Conflicts with the chartered committees
Center Grant Applications
The Minority Institutions' Drug Abuse Research Development Program (MIDARP)
Program Project Grant applications
Behavioral Science Track Award for Rapid Transition (B/START)
Imaging Science Track Awards for Research Transition (I/START)
Conference Grants (R13)
NIH Pathway To Independence (PI) Awards (K99/R00)

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

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

• N01DA-7-8859: Preclinical Medications Discovery and Abuse Liability Testing for NIDA
• N01DA-7-5537: State and Local Epidemiology Planning and Information Development
• N01DA-7-8873: Purity Specifications, Storage and Distribution for Medications Development
• N01DA-7-8870: Pharmacokinetic Analysis Resource Center

Phase I SBIR Reviews

• N43DA-7-5536 (Topic 087): Development of State-of-the-Art Mechanisms for Epidemiological Research
• N43DA-7-4408 (Topic 090): Develop a Real-Time fMRI Feedback System that Allows Drug Abusers to Control their Cravings and Urges and/or Increase their Self-Control of their Drug Taking
• N43DA-7-5535 (Topic 086): Marketing Evidence-Based Prevention Interventions for Substance Abuse and Related HIV Prevention

R&D Concept Reviews

• N01DA-7-8870: Pharmacokinetic Analysis Resource Center
• N01DA-7-8873: Purity Specifications, Storage and Distribution for Medications Development

CTN-Related Review Activities

The Data and Safety Monitoring Board (DSMB) met:

• September 19, 2006 to review and discuss 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).
• November 16, 2006 to review and discuss study protocols:
  
  • CTN 0027 Starting Treatment with Agonist Replacement Therapies (START); and
  • CTN 0031 (Twelve-Step Facilitation: Evaluation of an Intervention to Improve Substance Abuse Treatment Outcomes by Increasing 12-Step).
  The board discussed the Final Study Reports of two studies:
  
  • CTN 0018 (Reducing HIV/STD Risk Behaviors: A Research Study for Men in Drug Abuse Treatment); and
  • CTN 0019 (Reducing HIV/STD Risk Behaviors: A Research Study for Women in Drug Abuse Treatment).
• November 13, 2006 to review an update on protocol CTN 0028, Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents with Substance Use Disorders (SUD).
• October 23, 2006 to review an interim analysis of protocol CTN 0014, Brief Strategic Family Therapy for Adolescent Drug Abusers (BSFT).
• October 6, 2006 to review an update on protocol CTN 0030, Prescription Opioid Addiction Treatment Study (POATS).

Certificates of Confidentiality

Between August 15, 2006 and December 7, 2006, OEA processed 85 Certificate applications, including 18 for extension of expiration dates and 4 for amended protocols.

Extramural Outreach

Dr. Rita Liu, OEA, co-chaired with Drs. David Shurtleff, DBNBR, and Cathrine Sasek, OSPC, the 2006 NIDA Miniconvention: Frontiers of Addiction Research held as a satellite of the Society for Neuroscience annual meeting in Atlanta on October 13, 2006. The meeting drew 455 domestic and international attendees.

Dr. Rita Liu co-chaired with Drs. David Shurtleff and Cathrine Sasek, the program for the 2006 Society for Neuroscience Jacob P. Waletzky Memorial Award that was given to Dr. Yavin Shaham from the NIDA Intramural Research Program.

Drs. Mark Green and Rita Liu of OEA, along with Drs. Cathrine Sasek of OSPC and Diane Lawrence of DBNBR participated in the NIH Electronic Submission Outreach Workshops on October 14 to 17 at the 2006 Society for Neuroscience Annual Meeting, Atlanta, GA.

Dr. Levitin, Director, OEA, continues to serve on several NIH-wide committees, including the committee to evaluate the CSR pilot for new investigators to allow them to resubmit their applications earlier in the review cycle and the committee to evaluate the pilot multi-principal investigator initiative.

In January 2007, Dr. Levitin spoke at two separate conversation hours on social psychological research at NIDA and on the grant review and funding process at NIH at the annual meeting of the Society for Personality and Social Psychology.

Dr. Meena Hiremath attended the Addiction Health Services Research conference in Little Rock on October 22-25, 2006 and presented a talk entitled "Study Sections and Review" to junior investigators.

Dr. Eliane Lazar-Wesley, OEA, helped organize the Research Training Directors Meeting, held November 3rd, 2006 at the North Marriott Hotel in Bethesda and also gave a presentation at the meeting entitled: "T32 Training Programs: A New Framework".

Dr. Gerald McLaughlin, OEA, continues to serve as the NIDA Liaison to the NIH-wide committee dealing with all aspects of the transition to electronic grant submission, committees recommending guidelines for R01's, U01's and Appendixes, and the Review User's Group.

Dr. Gerald McLaughlin presented talks at several national and regional specialty NIDA meetings and provided guidelines and materials to NIDA staff to for other meetings including the 2006 Society for Neuroscience.

Dr. Gerald McLaughlin has co-arranged sessions for review staff of NINDS/NIMH/NIDA to learn inter-Institute operating and training procedures in these Institutes' review units, including the new J2EE Web Peer Review module.

Dr. Mark Swieter participated in NIDA's Research Training Directors' meeting held at the North Bethesda Marriott on November 3, 2006, serving as co-Chair with Dr. Cindy Miner of a Best Practices Forum on Components of Successful Program Evaluation and Tracking.

Dr. Mark Swieter 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.

OEA staff attending the Society for Neuroscience meeting in Atlanta, GA and working at the NIDA booth included Drs. Rita Liu and Mark Green.

Dr. Mark Green continues to participate on the NIH-wide Electronic Submission/424 Contingency Workgroup that deals with emerging issues related to the transition to electronic submission of grant applications.

Staff Training and Development

The OEA Symposium Series, a forum for staff training and sharing of ideas and information, continued through the fall. Topics included a presentations by Dr. Gerald McLaughlin of OEA on recent experiences with the review of the K99/R00 applications, by Tom Hilton of DESPR (who also serves as NIDA's representative on the Program Module Update Group) on the Program Module in IMPAC, by Pam Fleming, the Chief of the Grants Management Branch and by Carol Krause, the recently hired Chief of the Public Information and Liaison Branch.