Notice of Clarification to RFA-DA-11-015, Medication Initiative for Tobacco Dependence (MITD): A New Product Development Partnership (PDP)(UH2/UH3)


Notice Number:  NOT-DA-11-013

Key Dates

Release Date:  March 25, 2011

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

This Notice issued by the National Institute on Drug Abuse provides clarification to RFA-DA-11-015, Medication Initiative for Tobacco Dependence (MITD): A New Product Development Partnership (PDP)(UH2/UH3), published on February 22, 2011.   

Who is eligible to apply?

UH2/UH3 Phased cooperative agreement applications are encouraged from qualified (based on eligibility criteria) and interested non-profit, private and academic researchers/organizations.  Section III. Eligibility information, under Additional Eligibility Considerations, provides sufficient information to allow prospective applicants to assess their capabilities and to determine whether to apply, and lists 14 criteria. Statement addressing criteria 1 through 2 is uploaded as Profile – PD/PI – Biographical Sketch.  Statement addressing criteria 3 through 13 is uploaded as Item Number 10 of SF424 (R&R) OTHER PROJECT INFORMATION COMPONENT.  Complete details are provided in Section IV. Application and Submission Information; 6. Other Submission Requirements and Information.

How will the transition from UH2 to UH3 Phase be determined?

At the end of the first year of the UH2 awards, there will be an administrative review to determine which of the cooperative agreements will continue to the UH3 phase.  The administrative review will be conducted by the NIDA staff and NIDA Advisory Council, who will consider several factors, including both the progress made in UH2 and potential for achieving the goals of the program, i.e. to develop new, safe and effective medications for the treatment of tobacco dependence, including aids for smoking cessation, with the use of the tools and documents developed in UH2 phase. Specific selection criteria are described in Section V. Application Review Information, Additional Review Criteria. NIDA reserves the right to terminate or curtail any individual award, including the UH3 phase of this award. 

What is the award budget?

For the UH2 phase, budgets up to $125,000 (total costs) per year and time periods up to one year may be requested. NIDA intends to commit an estimated $500,000 (in total costs) in FY 2011 to fund up to five awards for the pilot phase (UH2).  For the UH3 phase, applications may propose budgets up to $10,000,000 (total costs) per year and time periods up to five years. A non-modular budget may be used for the UH2 phase. 

What are the Milestones?

A 1-page section labeled "Milestones” must be submitted as part of Research Strategy. Quantitative, well-defined, objective, scientific milestones for six months and 1 year of the pilot/planning UH2 phase must be provided. Applicants should also briefly describe clear milestones for each year of the expanded development UH3 phase, building up on the knowledge and data generated in the UH2 phase.  Applicants will have an opportunity to revise UH3 milestones as the work progresses. 

Must the partnership be formed (established) at the time of application?

No. The National Institute on Drug Abuse (NIDA) invites cooperative agreement applications to facilitate the initiation of this new public-private partnership to develop new, safe and effective medications for the treatment of tobacco dependence, including aids for smoking cessation. The purpose of a one-year planning phase (UH2) is to provide support for the systematic study directed toward fuller scientific understanding of the opportunities in the area of drug discovery and development for tobacco dependence, with the ultimate goal of establishing a PPP, specifically, a Product Development Partnership (PDP).  Eligible applicant must simply demonstrate the understanding of the public-private partnership/product development partnership concepts and its potential to develop new, safe and effective medications for the treatment of tobacco dependence in their UH2/UH3 application. Theoretical knowledge will be described in PHS 398 RESEARCH PLAN COMPONENT as part of Research Strategy Essay, UH3 Developmental Research and Business Plan.  Practical PDP-related knowledge could be described in SF424 (R&R) SENIOR/KEY PERSON PROFILE (Expanded) COMPONENT and SF424 (R&R) OTHER PROJECT INFORMATION COMPONENT. If feasibility of PDP is established, the successful UH3 awardee will assume to role of a Managing Partner of the PDP. MP is envisioned to function as a virtual pharma entity with minimal infrastructure, low overhead, and strategic outsourcing. Furthermore, the MP is expected to explore potential partnership opportunities to extend and enhance the work of the PDP, including collaborations with other organizations and/or groups that could advance the mission of the PDP.

All other aspects of the FOA remain the same.

Inquiries

Please send inquiries to:

Medications Initiative for Tobacco Dependence
TELEPHONE: 301-443-9800
EMAIL: NIDAMedTDWG@mail.nih.gov


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