Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Medication Initiative for Tobacco Dependence (MITD): A New Product Development Partnership (PDP)(UH2/UH3)

Activity Code

UH2/UH3 Phased Innovation Awards Cooperative Agreement

Announcement Type

New

Related Notices

  • March 25, 2011 - See Notice NOT-DA-11-013 This Notice issued by the National Institute on Drug Abuse provides clarification.

Funding Opportunity Announcement (FOA) Number

RFA-DA-11-015

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal DomesticAssistance (CFDA) Number(s)

93.279

FOA Purpose

The National Institute on Drug Abuse (NIDA) invites cooperative agreement applications from qualified non-profit, private and academic researchers/organizations to participate in the planning and execution of a new public-private partnership (PPP). 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). The mission of the PDP is to develop safe and effective medications for the treatment of tobacco dependence, including aids for smoking cessation. Phase two (UH3) funding will be utilized to support the implementation and execution phase of the PDP, with one selected cooperative agreement recipient assuming the role of the PDP’s Managing Partner. In this subsequent phase, the PDP will conduct a wide array of research and development (R&D) projects aimed at the fulfillment of regulatory requirements for approval for marketing in the US.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

March 26, 2011

Letter of Intent Due Date

March 26, 2011

Application Due Date(s)

April 26, 2011 by 5:00 PM local time of applicant organization

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2011

Advisory Council Review

August 2011

Earliest Start Date(s)

September 2011

Expiration Date

April 27, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

Cigarette smoking is the leading cause of preventable disease and untimely death in the United States. On average, 435,000 people in the United States die prematurely from smoking-related illnesses each year. Smoking causes 1 in 5 overall deaths, and more deaths are caused each year by tobacco use than by all deaths from human immunodeficiency virus (HIV), illegal drug use, alcohol use, motor vehicle injuries, suicides, and murders combined. The chance for a current lifelong smoker to die prematurely from a complication of smoking is 1 in 2. One smoker dies of a tobacco-related illness every 6 seconds. Because there is a lag of several years between when people start using tobacco and when their health suffers, the epidemic of disease and death has just begun.

Each year, tens of millions of American smokers attempt to quit, but fewer than 3% remain abstinent for more than 6 months. Several quit attempts (4 to 11) are generally undertaken before becoming permanently tobacco-free.  80% who attempt to quit on their own relapse within the first month, and, annually, only 2.5% of current smokers permanently stop smoking.

Despite extensive preventative and policy efforts, smoking prevalence among adults has remained unchanged since 2004, and lingers at about 20%. Among 43.4 million of US adult smokers, 44.2% (53.1% among ages 18–24 years) tried to quit during the preceding 12 months. Many will relapse and will try quitting again and again. Even greater number of smokers would try to quit smoking should effective and inexpensive treatments become available. The World Health Organization (WHO), which recognizes tobacco dependence as a disorder/disease, emphasizes that the more comprehensive the package of measures used against tobacco, the greater the impact will be. Treatment of the addicted tobacco smokers is one of the measures needed. The evidence is strong and consistent that pharmaceutical treatments significantly improve the likelihood of stopping, with success rates two to three times higher than those when no pharmaceutical treatments are used. As such, in 2004, WHO named medications for tobacco dependence Priority Medicines for Europe and the world. 

At the same time, many, including WHO, point out that very limited public funds are invested in tobacco dependence R&D activities, and suggest that encouraging the development of more effective pharmaceutical products to aid smoking cessation would be an effective use of public funds.

Public Private Partnerships (PPPs) are multidisciplinary partnerships between public (government agencies and institutes), non-profit organizations (i.e. academic institutions, non-governmental organizations and charitable organizations) and private sector entities.  PPPs represent a means to accomplish NIH’s mission to improve public health through biomedical research in a faster, more economical, and more effective way by leveraging its resources. PPPs benefit academia by increasing access to industrial drug development expertise and resources. PPPs benefit the pharmaceutical industry by enhancing their basic scientific knowledge base and facilitating access to novel targets, new platform technologies, new chemistries, disease expertise, and biomarker development.  Most critically, PPPs benefit the public by bringing together expertise from diverse areas to facilitate/accelerate the development of more efficacious and accessible medications.  One of the PPP types, Product Development Partnerships (PDP), is utilized to develop medicines. For example, PDPs are credited with having rapidly established a new R&D landscape for neglected tropical diseases (NTD). PDPs are generally initiated by the public sector.

The integral part of PDP success is the dedication and core capabilities of a Managing Partner (MP), the business entity that provides organizational leadership to the entire PDP enterprise (or to the majority of its core activities). Analysis of current practices of existing Product Development Partnerships indicate that MPs provide a wealth of pharmaceutical project management and drug discovery expertise to the partnership. The Managing Partner may or may not have in-house (internal) R&D capabilities. Preferably, the MP functions as a virtual pharma entity, as the majority of the currently practicing PDPs work with minimal infrastructure, low overhead, and strategic outsourcing. The partnering entity/ies within the partnerships are also expected to raise funds in support of PDP’s mission, to contribute/administer financing for research projects carried out by the PDP and to manage various functions of the PDP such as subcontracting and outsourcing. Furthermore, the MP(s) are 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.  Sometimes, PDPs obtain the full-range of needed expertise by engaging more than a single managing partner.

The National Institute on Drug Abuse (NIDA) invites cooperative agreement applications to facilitate the initiation of a new public-private partnership to develop new, safe and effective medications for the treatment of tobacco dependence, including aids for smoking cessation. Nicotine dependence is the most common form of chemical dependence in the United States. A  Centers for Disease Control  and Prevention (CDC) morbidity and mortality report, released in September 2010, indicates that previous declines in smoking prevalence in the United States have stalled during the past 5 years. Considering the widespread occurrence of tobacco smoking, and the devastating consequences of tobacco addiction, NIDA is committed to the goal of enhancing the translation of basic science   discoveries into new, more efficacious treatments for tobacco dependence. Toward this, NIDA aims to facilitate the initiation of a public-private partnership, specifically, a Product Development Partnership (PDP). The mission of this PDP, Medication Initiative for Tobacco Dependence (MITD PDP) is to develop new, safe and effective medications for the treatment of tobacco dependence, including aids for smoking cessation. The NIDA is assisting the formation of this MITD PDP by soliciting UH2/UH3 Phased cooperative agreement applications from qualified (based on eligibility criteria) and interested non-profit, private and academic researchers/organizations. 

NIDA plans to foster the creation of the MITD PDP through a Phased Innovation (Cooperative Agreement) mechanism (UH2/UH3), to support a feasibility/planning phase (UH2) and an expanded PDP execution phase (UH3). The present FOA is issued with the hope that UH2 planning activity would lead to a UH3 initiative. Up to five UH2 and, subsequently, one UH3 cooperative agreements are anticipated from this solicitation. The successful UH3 awardee will assume to role of a Managing Partner of the PDP. NIDA expects that UH3 awardee will develop a sound strategy to bring together the basic research skills inherent in the academic institutions, the scientific expertise of industry, the interests of anti-tobacco- and anti-smoking-oriented non-government organizations and non-profit groups, and the administrative support, resources, and knowledge of nicotine and tobacco research residing at NIDA and other NIH’s Institutes.  The impetus behind this new NIDA program is to promote public-private partnerships that will advance our basic knowledge in areas of tobacco dependence and nicotine addiction, and to apply that knowledge to the development of novel smoking cessation interventions. Transition from UH2 to UH3 is contingent upon successful completion of the UH2 milestones and administrative review to ensure the UH3 fulfills NIDA needs. The transition from the UH2 feasibility phase and eligibility for award of the UH3 phase will be determined by NIH program staff. UH2 support is restricted in level of support and in time, and UH2 awards should not continue to be supported beyond one year of funding. Although only UH2 awardees are generally eligible to apply for UH3 support, due to unique requirements of MITD program, NIDA reserves the right to establish eligibility criteria under which applications could be accepted from applicants demonstrating progress equivalent to that expected under UH2. Prospective UH3 only applicants may monitor the NIH Guide for Grants and Contracts regarding a Notice for the MITD expansion phase (http://grants.nih.gov/grants/guide/index.html).

The UH2 phase will be utilized to:  1) systematically study and assess the scientific opportunities in area of anti-smoking drug discovery and development ; 2) study, by the systematic gathering, editing, recording, computing, and analyzing of data, the feasibility of founding the partnership to develop new, safe and effective medications for the treatment of tobacco dependence, including aids for smoking cessation, outlining the pharmaceutical/non-profit/academic interactions necessary for its establishment and support; and 3) present a fully developed scientific understanding of the opportunities for PDP in a form of a justifiable strategic business plan, including comprehensive R&D strategies and approaches.

In the UH3 stage of award, the successful project will apply the proposed credible developmental research plan, scientific approaches and evaluation tools from the planning phase to a large PDP execution phase. The issuing of a successful UH3 award is dependent upon negotiations and final approval by NIDA. Progress, scientific merit and research alignment with NIDA goals will be administratively reviewed prior to issuance of the second phase (UH3) of the award. The NIH funding institute reserves the right to terminate or curtail any individual award, including the UH3 phase of this award. The UH2/UH3 mechanism has been used successfully in both the roadmap Human Microbiome Demonstration Projects (RFA-RM-08-012) and the Biomedical Research on the International Space Station program (PAR-09-120).

Each UH2/UH3 application should address  two key  aspects : the demonstration of understanding the public-private partnership/product development partnership concepts and its potential to develop new, safe and effective medications for the treatment of tobacco dependence; and the applicant’s ability (based on track record) to participate in and, preferably, manage a large scale, collaborative, drug discovery and development effort.  Both are considered critical for the projects to be funded under this FOA and applicants should carefully address both as indicatedin this FOA.  Cross-disciplinary collaborations are encouraged to ensure development of a high quality plan that addresses both of these elements. 

The recipient of a planning phase (UH2) award will be responsible for systematic gathering, editing, recording, computing, and analyzing of scientific data with the goal of outlining an implementation plan(s) which would make the public-private partnership concept a reality. Up to five UH2 and, subsequently, one UH3cooperative agreements are anticipated from this solicitation.

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.  UH2 data will inform the tobacco research communities of 1) existing scientific opportunities in areas of anti-smoking drug discovery and development, and 2) the feasibility of founding the public-private partnership to develop new, safe and effective medications for the treatment of tobacco dependence, including aids for smoking cessation. Specifically, the data will serve to:

In the UH3 stage of the award, the successful project will apply the proposed credible developmental research plan, scientific approaches and evaluation tools from the planning phase to a large PDP execution phase.

The criteria that will be used to determine which of the UH2 projects will make the transition to the UH3 phase will include:

It is expected that the results and accomplishments of the activities that NIH (NIDA) funds should be made available to the public. PD/PIs and grantee organizations are expected to make the results and accomplishments of their activities, including the papers and documents produced in UH2 phase, available to the research community and to the public at large. In accordance with NIH data-sharing policy, NIDA expects that the respondents to this FOA will comply with the timely release and sharing of final research data and documents from these NIH-supported planning activities for use by other researchers and the general public (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).  Applicants should detail their outreach plans to disseminate knowledge to the biomedical research community and collect feedback from that community on the proposed approaches and R&D ranking tool(s).  It is expected that results of the outreach and feedback will be included in the UH2 annual progress reports. MITD PDP UH2 tool(s) and documents will be useful to biomedical researchers. NIDA plans to post the documents produced in the UH2 phase on the NIDA website.

Program Governance: A Steering Committee will serve as the main governing board of the MITD project.  The Steering Committee membership will include NIDA Project Scientists and the PI of each awarded cooperative agreement. External Scientific Consultants (ESC) will be selected by NIDA and will provide recommendations on the progress of the members of MITD toward meeting their individual and collective goals. The ESC will be composed of four to six senior scientists with relevant expertise who are not Principal Investigators of a cooperative agreement involved in MITD. The membership of the External Scientific Consultants may be enlarged permanently, or on an ad hoc basis, as needed.

The External Scientific Consultants will meet once a year. During part of this meeting, there will be a joint meeting with the Steering Committee to allow the External Scientific Consultants members to interact directly with the awardees. Annually, the External Scientific Consultants will make recommendations regarding progress of MITD and present advice about changes, if any, which may be necessary to the Director of NIDA.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement. 

To ensure all information provided by NIDA is available to all prospective investigators, queries to NIDA must be submitted in writing through emails and will become part of the publicly distributed question and answer matrix. A matrix of all queries from prospective investigators and responses from NIDA staff will be maintained at the MITD page on the NIDA website.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDA intends to commit an estimated total of $500,000 in total costs in FY 2011 to fund up to five awards for the pilot phase (UH2). For the subsequent UH3 phase, the total amount of funds available is approximately $10 million in total costs per year for 5 years.  

Award Budget

For the UH2 phase, budgets up to $125,000 (direct costs) per year and time periods up to one year may be requested. For the UH3 phase, applications may propose budgets up to $10,000,000 direct costs per year and time periods up to five years.

Award Project Period

For the UH2 phase, time periods up to one year may be requested. For the UH3 phase, time periods up to five years may be requested.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are allowed

 Additional Eligibility Considerations

A Request for Information (RFI) was released in January, 2010, in order to assess outside interest in a PDP/collaborative drug discovery and development endeavor and to assess if any organizations exist that could function in a managing partner capacity (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-10-006.html). Based on responses to RFI, NIDA established the criteria for possible PDP Managing Partner (PDP MP). Those criteria are presented below and provide sufficient information to allow prospective applicants to assess their capabilities and to determine whether to apply:

1.    Evidence of expertise in pharmaceutical portfolio and project management, as well as due diligence.

2.    Evidence of solid experience in research and development for central nervous system (CNS) diseases, with expertise in nicotine/tobacco research being highly desirable

3.    Evidence of ability to develop new partnerships among, or build on existing relationships with, academia, pharmaceutical and biotechnology companies, nonprofit organizations, and/or government agencies

4.    Evidence of ability to assemble scientific advisory or key opinion leaders (KOL) committees consisting of external experts from both academia and the private sector

5.    Evidence of ability to solicit and evaluate projects for subcontracting or grant awards

6.    Evidence of experience in Request for Proposal (RFP) writing and proposal evaluation

7.    Evidence of ability to solicit project proposals  through different solicitation means such as open calls, open source announcements, and open innovation (global web-based) solicitation tools and mechanisms

8.    Evidence of ability to establish a subcontracting network of public and private organizations and CROs based on cost, efficiency, and site competencies and expertise

9.    Evidence of ability to efficiently coordinate, integrate and advance the development process across subcontractors

10.  Evidence of capacity to provide close monitoring and support to multiple R&D projects, as projects are steered through research and development stages, preferably utilizing modern IT to operate virtually

11.   Evidence of ability to provide scientific input and suggestions for alternatives to lagging projects/contracts and, when needed, quickly terminate those that are underperforming

12.  Evidence of expertise in managing intellectual property issues

13.  Evidence of ability to obtain financial support from biotechnology, pharmaceutical, academic, nonprofit, and non-NIH government partners

14.  Evidence of ability to develop a formal structure, policies and memoranda of understanding for all PDP partners, and include these in a PDP membership agreement.

Only those university, non-profit or private (such as pharmaceutical consultant firms) institutions that can provide evidence to satisfy the majority of aforementioned eligibility criteria, or all of them, are expected to apply for this award.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov 

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Director - DA-11-015
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550
Rockville, MD  20852 (for express/courier service)

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R Application Guide).

Regardless of the amount of direct costs requested, it is expected that all data resulting from these cooperative agreements will be made available to the public. PD/PIs will be expected to include a brief 1-paragraph description of how research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with NIDA program staff. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html for additional information.)

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.  

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIDA. Applications that are incomplete  and/or nonresponsive will not be reviewed.

SF424 (R&R) COVER COMPONENT: Complete as appropriate

SF424 (R&R) PROJECT/PERFORMANCE SITE LOCATIONS COMPONENT:  Complete as appropriate

SF424 (R&R) OTHER PROJECT INFORMATION COMPONENT:

Item Number 7. Project Summary/Abstract:  Attach abstract (not to exceed one page) describing the goals of the project. The Project Summary must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives for UH2 and UH3 phases.

Item Number 10.  Facilities & Other Resources: Upload a statement (4 pages length suggested) of the facilities to be used for the conduct of the research. A brief description of the capabilities of the institution, including faculty and infrastructure, and the commitment of the institution to the proposed PDP (address Additional Eligibility Considerations, Section III, criteria 3 through 13). Describe institutional investment in the success of the proposed PDP. If there are multiple performance sites, describe the resources available at each site.

Item Number 11.  Equipment:  Upload a statement if needed (1 page length suggested). List major items of equipment already available for this project and, if appropriate identify location and pertinent capabilities.

SF424 (R&R) SENIOR/KEY PERSON PROFILE (Expanded) COMPONENT:

Profile – PD/PI – Attach Biographical Sketch:  Complete items only for Project Director/Principal Investigator(s). Do not submit profiles for other senior/key personnel.  Attach PD/PI’s biographical sketch, two pages maximum, describing  the scientific and managerial experience of the Principal Investigator (PI), specifically addressing  Additional Eligibility Considerations, Section III, criteria 1 and 2.

Profile – PD/PI – Attach Current and Pending Support:  Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project.

Profile – Senior Key Person 1:  Complete as appropriate

PHS 398 RESEARCH PLAN COMPONENT:

Research Plan Attachments

UPLOAD DOCUMENTS TO THE FOLLOWING FIELDS ONLY:

Specific Aims: State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. Specific Aims should be limited to 1 page.

2.3 Research Strategy: Upload 12-page Essay here.  See detailed instructions for Essay below.

1) Literature Review . Complete a 3-page review researching the following points:

2) UH3 Developmental Research and Business Plan (4 pages). Propose a research-based plan to fill and manage the development pipeline using a Public Private Partnership/ Product Development Partnership model that would result in two new medications for tobacco dependence.  This plan would include the following:

3)    Examples of simulated R&D projects (3 pages). A one to two page summary for each of at least three simulated initial projects involving drug discovery and development for smoking cessation, addressing how the projects would impact the PDP pipeline, and how the areas of research are appropriate to the institutional environment . Provided examples should illustrate both pharmaceutical program management rigor and valid scientific rationale.

4) Feedback and Outreach (1 page). Applicants should detail their outreach plans to disseminate knowledge to the biomedical research community and collect feedback from that community on the proposed approaches and R&D ranking tool(s).  At the end of UH2, letters from at least three potential PDP members from biotech, pharmaceutical, academic, non-profit organization, or non-NIH government agencies evaluating the proposed research agenda of the PDP model which was explored by the applicant must be presented. Those letters should indicate that the proposed research agenda of the applicant’s PDP model is concordant with the organization (biotech, pharmaceutical, academic, non-profit organization, advocacy, or non-NIH government agency), and that the organization would or would not consider joining if the PDP were formed. 

5) Milestones. The Research Strategy must have a section (1 page) labeled "Milestones" which must include:

Quantitative milestones for six months and 1 year of the pilot/planning phase must be provided.

Expanded execution phase (UH3):    Applicants should describe how the expanded development phase will build on the knowledge and data generated in the pilot/planning phase.  Clear milestones must be set for each year, although the applicant will have an opportunity to revise them as the work progresses.  

2.6 Protection of Human Subjects: If research involving human subjects is mentioned in theResearch Strategy, upload the Human Subjects Plan using Part II, Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan.

2.7  Inclusion of Women and Minorities:  Upload, as appropriate.

2.8 Targeted/Planned Enrollment Table:  Upload, as necessary.

2.9 Inclusion of Children:  Upload, as necessary.

2.10 Vertebrate Animals:  If research involving vertebrate animals is mentioned in the Research Strategy, you must address the five points discussed in the Application Guide, Section 5.5.10 Vertebrate Animals.

2.11 Select Agent Research:  Upload the requested information, if applicable.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   Is there an evidence of the adequacy of PI and institutional/organizational staff's day-to-day oversight, coordination, and commitment to logistical support of drug discovery and development pipeline, as needed to make the PDP successful? Is there an evidence of the appropriateness of PI's academic preparation and professional experience to contribute effectively to pertinent aspects of this planning project?    Are drug development expertise and expertise in Portfolio and Project Management sufficiently demonstrated? Recognizing that the NIDA does not explicitly require the applicant to have an expertise in nicotine research area, is the experience with R&D sufficient to support and inform a drug development effort in smoking cessation area specifically? Is there access to a subcontracting network (of public and private organizations and CROs) and an evidence of ability to efficiently coordinate, integrate and advance the development process across subcontractors? Is there a capacity to provide monitoring and support as projects are steered through research and development stages? Is there a competence to establish a subcontracting network based on cost, efficiency, and site competencies and expertise?  Is there access to clinical expertise necessary to define the goals of a drug development effort in the target disorder? 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  With regard to the three sample initial projects involving drug discovery and development for smoking cessation , are there novel ones among examples of proposed drug targets, representing ongoing drug development programs in industry and academia?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 
With regard to the three sample initial projects involving drug discovery and development for smoking cessation, is the target project at an appropriate stage of translational readiness for a drug development effort? Is there a compelling biological rationale for the role of the proposed drug target in the tobacco dependence/smoking cessation? Has the target been properly and appropriately validated, at least at a pre-clinical stage? Is there clinical feasibility for testing a compound that would emerge from the proposed effort? Is the biological testing strategy maximally efficient and feasible for a five- or ten-year development program? Is the proposed primary screening assay suitable for a rapidly iterative medicinal chemistry program?  Is there a sufficient clarity of the process used to identify the opportunity for potential partnerships development? What is the potential of the proposed projects/programs to generate adequate interest from potential partners to become sustainable and competitive for future financial and in-kind support? What are the promise and potential of the proposed PDP implementation strategy to be the basis for the PDP execution phase?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   Is there evidence of the organizational ability to disseminate information through professional and less formal mechanisms? Is there an evidence of the ability to attract and assemble the groups of key opinion leaders (KOL) consisting of external experts from both academia and the private sector? Is there an evidence of established collaborations between PI and external scientists from research intensive institutions? Is there an evidence of institutional commitment to R&D in anti-smoking pharmacotherapy area?  Is there an evidence of institutional commitment to ensuring the success of the PDP by providing additional resources and other contributions?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

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. 

Review criteria for transition planning phase (UH2) to execution phase (UH3)

The criteria that will be used to determine which of the UH2 projects will make the transition to the UH3 phase will include:

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Drug Abuse.  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. 

The PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) will have the primary responsibility for all aspects of the research and coordination with MITD partners. These responsibilities include conducting the research, assuring quality and integrity of data, analyzing and interpreting data, preparing publications, and dissemination of research findings. The PD/PI will agree to accept close coordination, cooperation, and participation of NIH Program staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities." In addition, the PD(s)/PI(s) agree to:

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Scientific Program Staff from NIDA will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Award Notice. The assigned program staff may also serve as the NIDA Project Scientist. An NIDA Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NIDA Project Scientists will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination.  However, the role of NIDA Project Scientists will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be made by the PD/PI and NIDA Project Scientists will be given the opportunity to offer input to this process.

The NIDA Project Scientist(s) will have primary responsibility for:

The Project Scientists adhere to stringent NIH ethics rules and financial disclosure reporting to eliminate overt and perceived conflict of interest; Project Scientist are prohibited from observing scientific review of competing applications from an investigator with whom they have published in the last three years; recommendations from Project Scientist about budgetary requests (e.g., carryover, administrative supplements, no-cost extensions) are reviewed by other NIH program staff without any perceived conflict of interest and approved by their supervisors (e.g., Branch Chiefs, Division Director, and Institute Director); recommendations made by Project Scientist in annual progress reports are reviewed by grant management specialists; Project Scientists will not seek lead authorship on any publications and will obtain approval from their supervisors to participate in any writing group.

Progress will be administratively reviewed prior to issuance of the second phase (UH3) of the award. This review will be performed by NIDA staff with recommendations from the NIDA Advisory Council. If needed, recommendations from ESC could be solicited. The NIH funding institute reserves the right to terminate or curtail an individual award.

Areas of Joint Responsibility include:

A Steering Committee will serve as the main governing board of the MITD project.  The Steering Committee membership will include NIDA Project Scientists and the PI of each awarded cooperative agreement. Each PI will have one vote on the Steering Committee. The NIDA Project Scientists may vote. The Steering Committee Chair will not be an NIH staff member. Additional members may be added by action of the Steering Committee. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Consultation with NIH Program Staff: Due to the unique requirements of the program, prospective applicants should consult with NIH program staff as plans for applications are being developed. Pre-application consultation should be done with adequate lead time before the application receipt date in order for applicants to have sufficient time to consider advice from NIH program staff. This early contact will provide an opportunity to clarify the applicant's understanding of the MITD program goals and guidelines, including the scope of projects within the program and the requirement that project objectives be milestone-driven.   

To ensure all information provided by NIDA is available to all prospective investigators, queries to NIDA must be submitted in writing through emails and will become part of the publicly distributed question and answer matrix. A matrix of all queries from prospective investigators and responses from NIDA staff will be maintained at the MITD page on the NIDA website.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Elena Koustova, MBA, PhD
Division of Basic Neuroscience and Behavioral Research (DBNBR)
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd - Room 4292
Bethesda, MD 20892-9593
Tel: 301-496-8768
Fax: 301-402-0008
koustovae@nida.nih.gov

Kristopher Bough, PhD
Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA)
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd - Room 4153
Bethesda, MD 20892-9593
Tel: 301-443-9800
Fax: 301-443-9649
boughk@nida.nih.gov

Geetha Subramaniam, MD
Division of Clinical Neuroscience and Behavioral Research (DCNBR)
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd – Room 3129
Bethesda, MD 20892-9593
Tel: 301-435-0974
Fax: 301-443-6814
subramaniamga@nida.nih.gov

Udi Ghitza, PhD
Center for Clinical Trials Network (CCTN)
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd – Room 3151
Bethesda, MD 20892-9593
Tel: 301-443-9983
Fax: 301-443-2317
ghitzau@nida.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Pamela Fleming
Grants Management Branch/OM
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email:  pfleming@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information see  http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.


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