Participating Organization(s)	U.S. Food and Drug Administration (FDA) The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult Part 2 Sections IV.2 and V.2 respectively for additional information regarding page limits and FDA's Objective Review Process.
Components of Participating Organizations	Center for Drug Evaluation and Research [CDER] Office of the Center Director, Safe Use Initiative
Funding Opportunity Title	Misuse and Abuse of DEA Schedule II-V Opioid Analgesic Drugs: Researching Strategies to Ensure Safe Use and Reduce Preventable Harm (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-FD-12-005
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
Funding Opportunity Purpose	As part of the FDA's Safe Use Initiative's mission to seek solutions to reduce preventable harm from suboptimal use (e.g., misuse and abuse) of medications, CDER is seeking to support a limited number of research projects aimed at examining interventions and strategies that can be used by prescribers to increase the safe use and reduce misuse and abuse of opioid analgesic drugs. This funding opportunity announcement (FOA), issued by the FDA, will provide resources for research to further define the knowledge, attitudes, and behaviors that lead to inappropriate use and abuse of opioid analgesics; to research and implement strategies impacting inappropriate use and abuse of these drugs; and subsequently reduce the preventable harm, morbidity and mortality caused by Schedule II-V prescription opioid analgesic drugs. Inappropriate use and abuse can include but is not limited to prescriber misprescribing or over-prescribing and patient or citizen use of a drug in a manner that is not its intended use (e.g., non-medical use), dose or schedule, or inappropriate or inadvertent mixing of multiple drugs that interact. The goal of this FOA is to increase the body of knowledge around effective strategies that can reduce misuse and abuse of prescription opioid analgesic drugs, and are applicable in a variety of settings and can be easily sustained by the people who will implement and use the strategies.

Posted Date	March 9, 2012
Open Date (Earliest Submission Date)	March 9, 2012
Letter of Intent Due Date	April 9, 2012
Application Due Date(s)	May 9, 2012 by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July, 2012
Advisory Council Review	September, 2012
Earliest Start Date(s)	September, 2012
Expiration Date	May 10, 2012
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.

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

Needs Assessment:

The National Center on Addiction and Substance Abuse at Columbia University reported that from 1993 - 2007 college students had increased their misuse of scheduled prescription drugs such as Percocet, Vicodin and Oxycontin (343%), Adderall and Ritalin (93%), Xanax and Valium (450%), and Nembutol and Seconal (225%). In 2009, Centers for Disease Control and Prevention (CDC) reported that that misuse and abuse of prescription drugs overtook abuse of illegal or illicit drugs as the reason for an emergency department visit. A retrospective study of hospitalizations for poisoning from prescription opioids, sedatives and tranquilizers demonstrated an increase of 65% in the number of hospitalizations from 1999 to 2006. In at least 16 states prescription drugs have overtaken automobiles as the number one cause of accidental injury and death. Nationwide CDC reported mortality data from all drug overdoses has steadily increased from 1999 to 2009; while those deaths from automobile accidents have remained relatively static. All of these reports point to a growing public health problem of preventable harm from prescription opioid analgesic drug use, misuse and abuse.

Program Background:

The Safe Use Initiative is part of the FDA’s Center for Drug Evaluation and Research (CDER) larger Drug Safety Plan to enhance the protection and promotion of the public's health. The actions of the Safe Use Initiative are non-regulatory. The Safe Use Initiative’s charge is to engage healthcare stakeholders in researching and developing implementable, measurable, and sustainable strategies and interventions to reduce preventable harm from FDA regulated drugs. As part of that charge, FDA’s Safe Use Initiative is announcing this FOA to further define the information gaps, attitudes, and behaviors that lead to inappropriate use and abuse of opioid analgesics; to research and implement strategies impacting inappropriate use and abuse of these drugs; and subsequently reduce the preventable harm, morbidity and mortality caused by Schedule II-V prescription opioid analgesic drugs. Inappropriate use and abuse can include but is not limited to prescriber misprescribing or over-prescribing and patient or citizen use of a drug in a manner that is not its intended use (e.g., non-medical use), dose or schedule, or inappropriate or inadvertent mixing of multiple drugs that interact. The goal of this FOA is to increase the body of knowledge around effective strategies that can reduce misuse and abuse of prescription opioid analgesic drugs, and are applicable in a variety of settings and can be easily sustained by the people who will implement and use the strategies.

Purpose/Research Objectives:

The causes of preventable drug harm are most likely multifactorial. For prescription opioid analgesic drugs, causes of preventable harm might include but are not limited to mis- or inappropriate prescribing or over prescribing, lack of awareness or understanding and misperceptions on the part of health care providers, healthcare givers or caretakers as well as patients, family and friends regarding the risks and benefits, and the safe and appropriate use of Schedule II-V opioid analgesic drugs. The development of interventions and strategies to reduce preventable harm should focus on professional groups who are prescribing the drugs and vulnerable populations such as school age children, college students, or those on treatment for long term pain and mental health, as all of these different populations have demonstrated vulnerability to preventable harm from scheduled prescription opioid analgesic drugs. The strategies to reduce preventable harm might be variable depending on the professionals and populations affected by the strategy or intervention and the barriers and challenges to safe use that they face. We recognize that under treatment can also be a form of preventable harm, but it will not be addressed in this FOA.

As there are many facets to defining preventable harm and the populations most vulnerable to harm, there will be many strategies to address areas and populations affected by preventable harm from

Schedule II-V drugs. The experience and expertise of stakeholders who would be involved in the process of implementing or utilizing a specific strategy or intervention should be sought out to ensure that any strategy is feasible (e.g., resource availability and process flow), sustainable (e.g., resource availability and time), evaluable (e.g., efficacy as well as ease of use) and scalable. In addition as part of the implementation science process, the strategy should be able to be evaluated and, as necessary, revised to improve and streamline it.

FDA recognizes that some strategies to reduce misuse and abuse of prescription opioid analgesic drugs are being used (e.g. patient prescriber agreements, opioid treatment agreements or treatment contracts), but are not well characterized as to their efficacy in preventing harm or have been characterized in controlled environments. Research studies on tools or strategies to reduce misuse and abuse are appropriate for this FOA. Research of these tools and or strategies can examine their utility in defined patient populations, settings, healthcare provider specialty groups. The strategies to be studied might already be in use or promoted, but might not be characterized as to their impact and effectiveness.

Research proposals must:

• Define the issue
• Define the opioid analgesic(s) involved
• Contain a needs assessment: background research, information and data on preventable medication harm area of interest
• Define professional and patient population(s) involved
• Contain a proposed intervention or strategy to reduce preventable harm
• Define similar strategies (if any) that have been used to reduce preventable harm
• Describe how key stakeholders in the research will be identified and engaged
• Define metrics or measures to determine the effects of the implemented strategy
• Contain an evaluation plan to ensure re-evaluation and refinement of the strategy

Specific Areas of Research Interest

Research topic examples might include but are not limited to:

• Researching how professional healthcare provider awareness and utilization of prescription drug monitoring programs change prescribing of scheduled drugs and if that reduces preventable harm.
• Defining which healthcare professionals are using patient provider treatment agreements and the conditions of use.
• Researching how patients perceive patient provider treatment agreements and determining if, how and in what ways the agreements change patient perceptions around their use of scheduled drugs.
• Researching methods to provide best practice information on prescription opioid analgesic drugs to the front line healthcare provider.
• Defining how patients best understand and retain important information regarding their treatment with and use of opioid analgesic drugs.
• Researching methods to reach out to, collect information and counsel populations at risk for preventable harm from scheduled drugs including drug-drug interactions, prescriptions for multiple drugs with similar mode of action, misuse and abuse.

The intent of this FOA is to increase the knowledge and understanding of methods that are implementable, adaptable, and sustainable throughout healthcare (providers and patients) and can be demonstrated through defined metrics to improve patient safety through reducing preventable harm from scheduled drugs.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA 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	The FDA intends to invest up to $300,000 contingent upon the availability of funds and the number of meritorious applications received.
Award Budget	Application budgets may not exceed $75,000 total costs per budget period and must reflect actual project needs as outlined in the budget narrative.
Award Project Period	The scope of the proposed project should determine the requested length of support. The maximum project period is 3 years. Applicants requesting multiple years of support must indicate this in the application and provide a budget for each period of support requested.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 FDA support.

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

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

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

FDA 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. FDA will not accept any application that is essentially the same as one already reviewed.

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.

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Stephanie D. Bogan
Division of Acquisition Support and Grants
Office of Acquisitions & Grants Services
Food and Drug Administration
FHSL Rm 1095, HFA-500
5630 Fishers Lane
Rockville, MD 20857
Email: stephanie.bogan@fda.hhs.gov

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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide must be followed, with the following exceptions or additional requirement:

• For this specific FOA, the Research Strategy section is limited to 30 pages.

All instructions in the SF424 (R&R) Application Guide must be followed.

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 with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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.

This initiative is not subject to intergovernmental review.

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

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(s)/PI(s) 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 FDA.

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 assigned Grants Management Specialist and responsiveness by a member of the Safe Use Initiative's staff. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

As required by HHS Grants Policy, all discretionary grant and cooperative agreement applications must undergo an independent, objective review to be considered for funding. Only the review criteria described below will be considered in the review process.

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).

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(s)/PI(s), 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?

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?

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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

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.

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

Not applicable.

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Group(s), in accordance with HHS Grants Policy, using the stated review criteria.

As part of the objective review process, all complete and responsive applications will be assessed and receive:

• A numerical score.
• A written critique.

Appeals of objective review will not be accepted for applications submitted in response to this FOA.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following objective review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by the objective review group.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the independent, objective review of the application is completed, the PD(s)/PI(s) will receive a copy of his/her Summary Statement. 

For more information regarding the disposition of applications, please reference the HHS Grants Policy Statement.

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

All FDA grant and cooperative agreement awards include the FDA Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement.

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 FDA 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 FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA 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 FDA as defined below.

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

• Day-to-day oversight of the scientific, technical, and programmatic aspects of the project.
  
  
• Ensuring the award is administered in compliance with applicable terms and conditions and ensuring their staff has sufficient clearance and/or background checks to work on the project.
  
  
• Working closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.
  
  
• Submitting interim progress reports, when requested, to the FDA Project Officer (PO), including summary data on progress to date.
  
  
• Preparing material for the two meetings involving participants from FDA, to occur in the Washington, D.C. metro area.
  
  
• Disseminating results, data and other products of the study, concordant with the study protocol and governance and the approved plan for making data and materials available to the scientific community and FDA.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

As part of a cooperative agreement applicants must be transparent in their activities and be willing to provide information and to discuss their protocols, data and findings with FDA on at least a quarterly basis. Each award will be assigned to an FDA Project Scientist (PS). The PS will have substantial programmatic involvement that is above and beyond the normal stewardship role of the assigned Project Officer (PO) as described below:

• PS will actively participate in the assessment of data to adequately characterize and quantify preventable harm.
• Review identified root causes of preventable harm.
• Identify and actively engage relevant healthcare stakeholders.
• Review strategies for harm reduction prior to implementation.
• Assess the impact and effectiveness of approved interventions.
• Work closely with PD/PI to develop and implement an appropriate rapid data release policy.

In addition to the involvement of the PS, each recipient will be assigned to an FDA Project Officer (PO) to monitor programmatic stewardship of the award.

Areas of Joint Responsibility include:

• None; all responsibilities are divided between awardees and FDA staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members; one FDA staff member one FDA 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.

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 HHS Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

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 HHS 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 HHS Grants Policy Statement for additional information on this reporting requirement.

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

Pre-Application Meeting

FDA/CDER/Safe Use Program Staff will host a pre-application meeting for prospective applicants on April 6, 2012 from 1:00 p.m. - 2:30 p.m. via webinar. Interested parties are invited to participate in this meeting to discuss the purpose of the Program, application requirements, selection criteria, application content, submission requirements, and reporting requirements. Interested parties may participate in this meeting either by conference call or via the World Wide Web.

Individuals interested in attending this meeting should register via electronic mail no later than March 30, 2012 with the following information: participant name, organization, and contact information with PRE-APPLICATION MEETING in the subject line to stephanie.bogan@fda.hhs.gov. There is no registration fee for participating in this meeting. For further information contact:

Stephanie D. Bogan
Division of Acquisition Support and Grants
Office of Acquisitions & Grants Service
Food and Drug Administration
FHSL Rm 1095, HFA-500
5630 Fishers Lane
Rockville, MD 20857
Email: stephanie.bogan@fda.hhs.gov

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 301-710-0267
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

Dale Slavin, PhD
Food and Drug Administration
Center for Drug Evaluation and Research
Safe Use Initiative
Telephone: 301-796-6000
Email: Dale.Slavin@FDA.hhs.gov

Stephanie D. Bogan
Division of Acquisition Support and Grants
Office of Acquisitions & Grants Service
Food and Drug Administration
FHSL Rm 1095, HFA-500
5630 Fishers Lane
Rockville, MD 20857
Email: stephanie.bogan@fda.hhs.gov

Stephanie D. Bogan
Division of Acquisition Support and Grants
Office of Acquisitions & Grants Service
Food and Drug Administration
FHSL Rm 1095, HFA-500
5630 Fishers Lane
Rockville, MD 20857
Email: stephanie.bogan@fda.hhs.gov

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 HHS Grants Policy Statement.

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.