Extramural Policy and Review Activities

Receipt, Referral, and Review

NIDA received 1485 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 1226 applications.

OEA arranged and managed 26 grant review meetings in which 706 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 14 contract proposal reviews and 2 concept reviews and 144 applications to the Loan Repayment Program.

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 22 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
Mechanism For Time-Sensitive Research Opportunities
Behavioral Science Track Award for Rapid Transition (B/START)
Cutting Edge Basic Research Awards (CEBRA)
Imaging Science Track Awards for Research Transition (I/START)
Conference Grants (R13)
Loan Repayment Programs
NIH Pathway To Independence (PI) Awards (K99/R00)
8 Special Emphasis Panels that reviewed RFA submissions

OEA managed the following RFA reviews:

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

• DA06-002: Pilot Clinical Trials Of Pharmacotherapies For Substance Related Disorders
• DA06-004: Social Neuroscience
• DA06-005: Prescription Opioid Use And Abuse In The Treatment Of Pain
• DA06-006: Developmental Centers For Translational Research On The Clinical Neurobiology Of Drug Addiction (P20)
• DA06-007: Epigenetics Of Neurobiology And Addiction
• DA06-008: Training In Translational Research In Neurobiology Of Disease (T32)
• DA06-010: Training In Computational Neuroscience: From Biology To Model And Back Again (T90)
• DA06-011: Training In Neuroimaging: Integrating First Principles And Applications (T90)

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

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

• N01DA-6-1129: NIDA's Science Meetings Logistical Support
• N01DA-6-8866: Development and Manufacture of Pharmaceutical Products
• N01DA-6-8867: Pharmacokinetic and Pharmacodynamic Studies for Medication Development

Phase I SBIR Reviews

• N43DA-7-7757 (Topic 083): Establishment of High Quality C57BL/6 ES Cell Lines

Phase II SBIR Reviews

• N44DA-6-5530 (Topic 073): Online Buprenorphine Practice Manager for Physicians

R&D Concept Reviews

• N01DA-7-8870: Pharmacokinetic Analysis Resource Center
• N43DA-7-4408: Develop a Real-time fMRI Feedback System that Allows Drug Abusers to Control Cravings and Urges and/or Increase their Self-Control of their Drug Taking
• N43DA-7-2209: Automation of the Development of Electronic Data Capture (EDC) System for Clinical Trials Data Collection and Management
• N43DA-7-5536: Development of State-of-the-Art Mechanisms for Epidemiological Research
• N43DA-7-2210: Development of Practical Training Materials for Evidence-Based Treatment
• N43DA-7-8868: Design and Synthesis of Treatment Agents for Drug Abuse
• N43DA-7-7760: Metabolomics in Drug Abuse Research
• N43DA-7-1131: Mechanisms and Methods to Maximize Data Utilization
• N43DA-7-5535: Marketing Evidence-Based Prevention Interventions for Substance Abuse and Related HIV Prevention

CTN-Related Review Activities

The Data and Safety Monitoring Board (DSMB) conducted a review on May 26, 2006 via Web conference. The board discussed the Final Study Reports of three studies: CTN 0009 Smoking Cessation Treatment with Transdermal Nicotine Replacement Therapy in Substance Abuse Rehabilitation Programs, CTN 0011 A Feasibility Study of a Telephone Enhancement Procedure (TELE) to Improve Participation in Continuing Care Activities, and CTN 0003 Bup/Nx: Comparison of Two Taper Schedules.

The DSMB met on July 27, 2006 in Bethesda, MD to review and discuss the study protocol: CTN 0014 Brief Strategic Family Therapy for Adolescent Drug Abusers (BSFT); and to discuss the Final Study Reports of studies CTN 0004 MET (Motivational Enhancement Treatment) To Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse and CTN 0021 (Motivational Enhancement Treatment to Improve Treatment Engagement and Outcome for Spanish-Speaking Individuals Seeking Treatment for Substance Abuse).

Certificates of Confidentiality

Between April 28, 2006 and August 14, 2006, OEA prepared 83 new Certificates, 37 Certificate extensions, and 4 Certificate amendments.

Extramural Outreach

Dr. Rita Liu, OEA, participated in a NIH Grantsmanship Workshop On July 12, 2006 for the 2006 International Narcotics Research Conference (INRC) in St. Paul, MN. This Workshop was co-sponsored by the University of Minnesota Postdoc Association. Other participants from NIH were Dr. Christine Colvis of the Division of Basic Neuroscience and Behavioral Research, NIDA, and Dr. Sayed Hussain of the Center for Scientific Review, NIH.

Dr. Rita Liu co-chaired a NIH Grants Writing Workshop on July 19, 2006, at the 11th SCBA (Society for Chinese Bioscientists in America) International Symposium in San Francisco, covering the topic of Peer Review aspects of the grant application process. Other participants from NIH were Dr. Yen Li of NIAID and Dr. Roy Wu of NCI.

Dr. Teresa Levitin, Director, OEA, gave a presentation in San Francisco on electronic grant submission of applications in July 2006 at the 11th International Symposium of the Society of Chinese Bioscientists in America.

Dr. Levitin served as faculty for a workshop in May 2006 on grant writing for graduate students and new faculty at the 18th Annual Convention of the Association for Psychological Science in New York.

Dr. Eliane Lazar-Wesley, OEA, gave a presentation entitled "Training and Career Opportunities at NIDA" at the INRC meeting in Minneapolis in July 2006.

Dr. Gerald McLaughlin, OEA, is the NIDA Liaison to the NIH-wide committee dealing with all aspects of the transition to electronic grant submission. He presented a 90-minute educational talk on this topic to the 2006 HMO Research Network Conference, and has provided brochures and other presentation materials to NIDA staff to disseminate at additional professional meetings including the 2006 American Society of Addiction Medicine, the Prevention Sciences meeting, and others.

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.

Dr. Gerald McLaughlin is a member of the trans-NIH workgroup that addresses issues related to public or community members in peer review meetings, and attended a COPR meeting in which related issues were discussed with the NIH OD. He is also updating NIDA guidelines for public and community reviewers.

Dr. Gerald McLaughlin is a member of the trans-NIH workgroup tasked with implementing the electronic transition of the R01 and U01 grant mechanisms.

Dr. Gerald McLaughlin is a member of the trans-NIH workgroup to improve technologies and SOP's associated with contract-provided reviewer lodging and review meeting room arrangements. He is also the NIDA representative to this group's parent trans-NIH PSA Review User Group transition team. He is also preparing related NIDA OEA's guidelines.

Dr. Mark Green, OEA, 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.

Dr. Mark Green ran a mock review at the June 2006 NIDA International Forum to introduce international researchers to the peer review process.

Dr. Mark Green made a presentation "Update on Electronic Grant Submission and Process for Foreign Investigators" at the June 2006 NIDA International Forum.

Dr. Teri Levitin co-chaired with Dr. Mark Green a workshop at the June 2006 CPDD meeting entitled "Job Interviews: Tips, Tricks, and Traps". The panelists were Dr. Linda Cottler, Dr. Barry Hoffer, Dr. Mary Jeanne Kreek, and Dr. James Smith.

Dr. Mark Green co-chaired with Dr. Teri Levitin a workshop at the June 2006 CPDD meeting entitled "What's New at NIDA and NIH: Electronic Submission of Applications and More."

Dr. Mark Green presented a talk about the NIH peer review process as part of the workshop on Grant Writing at the June meeting of CPDD.

Staff Training and Development

The OEA Symposium Series, a forum for staff training and sharing of ideas and information, continued through the spring and summer. Topics included a number of policy updates including changes to the PHS 398, SF424 and PHS 2590 instructions; required disclaimer/acknowledgement of NIH support on R13/U13 mechanisms; pilot study to shorten the review cycle for new investigator R01s; publication by OER of the new NIH Extramural NEXUS bimonthly update for grantees and applicants; Katrina supplements/extensions; DEAS re-engineering; changes to summary statement format; initiatives to examine the need for appendix materials and the possibility of shortening the length of the research plan in grant applications; K99/R00 review update.