National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Funding Opportunity Title
Grand Opportunity in Medications Development for Substance-Related Disorders (U01)
U01 Research Project – Cooperative Agreements
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestic Assistance (CFDA) Number(s)
The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the development of medication for the treatment of Substance-Related Disorders (SRDs) by soliciting research applications to support a diverse array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and quickly yield the necessary results to advance medications closer to FDA approval. It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) cooperative agreements with close monitoring and significant scientific involvement of NIDA staff. This funding mechanism will enable critical medications development studies that would not be feasible using the traditional R01 mechanism.
February 9, 2011
Open Date (Earliest Submission Date)
April 26, 2011
Letter of Intent Due Date
April 26, 2011, July 26, 2011, February 27, 2012, June 27, 2012, February 27, 2013, June 26, 2013
Application Due Date(s)
May 26, 2011, August 26, 2011, March 27, 2012, July 27, 2012, March 27, 2013, July 26, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
August 14, 2011, November 8, 2011, March 27, 2012, August 14, 2012, March 27, 2013, August 14, 2013, by 5:00 PM local time of the applicant organization.
Scientific Merit Review
June-July 2011, October-November 2011, June-July 2012, October-November 2012, June-July 2013, October-November 2013
Advisory Council Review
January 2012, May 2012, October 2012, January 2013, October 2013, January 2014
Earliest Start Date(s)
December 2011, April 2012, December 2012, April 2013, December 2013, April 2014
August 15, 2013
Due Dates for E.O. 12372
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
The purpose of this FOA is to accelerate the development of medications for the treatment of Substance-Related Disorders (SRDs) by soliciting research applications to support a diverse array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and yield the necessary results to advance medications closer to FDA approval. It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) grants, with close monitoring and significant scientific involvement of NIDA staff. These U01s will enable studies that would not be feasible using the traditional R01 mechanism.
The development of safe and effective medications for the treatment of Substance-Related Disorders (SRDs) including substance use (i.e., abuse and dependence) and induced disorders (e.g., intoxication, delirium, psychotic disorder, and anxiety disorder) is a public health priority. According to the National Survey of Drug Use and Health (NSDUH) of 2009, an estimated 22.5 million Americans aged 12 or older met DSM-IV criteria for substance dependence or abuse (i.e., marijuana, cocaine, heroin, hallucinogens, inhalants and the nonmedical use of prescription-type pain relievers, tranquilizers, stimulants, and sedatives). Furthermore, an estimated 70 million Americans aged 12 or older were current users of tobacco products.
Although most individuals with SRDs do not seek treatment, there is a number that seek and receive treatment. According to the 2009 NSDUH, approximately 4.3 million people aged 12 or older received treatment for a problem related to the use of alcohol or illicit drugs. Of these, 1.6 million received treatment for the use of alcohol and illicit drugs, 0.8 million received treatment for the use of illicit drugs but not alcohol. Results from the same study revealed that, 1.2 million persons reported receiving treatment for marijuana use, 787,000 persons for cocaine, 739,000 for pain relievers, 517,000 for stimulants, 507,000 for heroin, 443,000 for hallucinogens, and 421,000 for tranquilizers. Moreover, according to the CDC, approximately 40% of current smokers make a quit attempt. Therefore, there is a potential to improve the lives of a large number of individuals by enhancing the armamentarium of efficacious pharmacotherapies for SRDs.
Currently, there are medications approved by the Food and Drug Administration for the treatment of nicotine and opiate dependence. However, none of these medications provide the optimal therapy. Moreover, there are no FDA approved medications for cocaine, methamphetamine, or cannabis use disorders. Thus, the development of safe and effective medications to treat these disorders is an urgent public health need. Improving the outcome of treatments for SRDs with medications can have vast public health implications. It has been suggested that, for example, smoking cessation programs yield more immediate reductions in the rates of tobacco addiction. In addition, tobacco use cessation offers many important health benefits, including a reduction in premature mortality due to cardiovascular events to near nonsmoker levels within two years or less of smoking cessation. Similarly, it is likely that effective pharmacotherapies for illicit drug use will produce more not only immediate reductions in the rates of drug use as well as on its immediate medical and psychosocial consequences.
Scientific advances are offering extraordinary opportunities for the development of medications to treat SRDs. These include the discovery of genes and proteins, receptors, neurotransmitters, neuromodulators, and brain circuits associated with drug abuse, as well as risk and protective factors for the onset and progression of these disorders, and the development of new small and large molecules such as vaccines. Multiple therapeutic approaches, ranging from small molecules to biologics (e.g., vaccines) are ready for the next step in the FDA approval process, and concerted efforts are needed to advance these potential pharmacotherapies to approval.
Applications submitted in response to this FOAmay focus on studying 1) new chemical entities (NCEs), 2) already-marketed pharmacotherapies, 3) biologics (immunotherapies such as vaccines and antibodies, enzymes, gene therapies, etc.), 4) combinations of medications, and/or 5) new delivery devices/technologies.
The medications investigated for SRDs may target one or more of the neuropathological mechanisms, the various clinical stages, and/or the medical/psychiatric complications of one or multiple SRDs.
This FOA encourages, but is not limited to, studies of medications for SRDs in the following areas:
Chemistry and Pharmaceutics: lead compound optimization, creation/expansion of small molecular libraries, high-throughput screening, medicinal chemistry, formulation or drug-delivery technology, prodrug, proteinaceous (e.g., vaccines and antibodies), and/or bioassay development of potential medications for SRDs.
Preclinical Development: drug interaction studies between medications and drugs of abuse and evaluation of safety and/or efficacy in established animal models, as well as pharmacokinetic and pharmacodynamic studies of potential pharmacotherapies for SRDs.
Clinical Development: Phase I - Evaluation of the pharmacokinetics, safety, tolerability, dose-ranging, and/or initial efficacy in human subjects. Phase II - Proof-of-concept, pilot studies, safety and efficacy testing in a larger sample of human subjects. Phase III - Safety and efficacy of medications tested in a large sample of patients.
It is expected that all applications involving individuals seeking treatment will provide a behavioral therapy component. However, the scope of this FOA does not include the evaluation of the safety and/or efficacy of psychosocial interventions.
Awardees of this FOA are expected to collaborate with other awardees, pharmaceutical companies, and NIH project officers. Awardees are also expected to make their individual datasets and aggregated datasets available for data sharing to other investigators when appropriate.
NIDA Program Officials will be substantially involved in the scientific direction of the grant in a partnership role. The NIDA Program Scientists will collaborate on developing common measures, procedures and data management protocols, monitor study progress, insure disclosure of conflicts of interest and adherence to NIDA and NIH policies, and participate in data analysis and manuscript preparation as appropriate.
For studies involving NIH defined clinical trials, the Data and Safety Monitoring Board (DSMB) of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA) of NIDA will monitor and oversee the quality of the study data and the safety of study participants in all of the studies supported by this initiative. The DSMB will report to the Director of the NIDA DPMCDA. The DSMB will review the protocols, monitor and review recruitment, adverse events, data quality, outcome data, and overall awardee performance. The DSMB will be responsible for reviewing interim and final data, and recommend whether the study should be continued, modified, or terminated. Applications involving one or more clinical trials must state that the clinical trial(s) will be monitored by the DSMB of the NIDA DPMCDA. All clinical trial applications must include methods to evaluate subjects' compliance with the study medications.
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
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
NIH intends to fund an estimate of range awards, corresponding to a total of $15,000,000, for fiscal year 2012. Future year amounts will depend on annual appropriations.
The direct costs of an application cannot exceed $5 million per year.
Award Project Period
The maximum period is 3 years.
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.
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
Foreign (non-U.S.) components of U.S. Organizations are 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
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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.
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.
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
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 - Grand Opportunity PAR
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)
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.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed..
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, with the following modifications:
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 (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.
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 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.
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.
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, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115,
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.
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.
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?
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?
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?
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
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?
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.
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.
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal applications are not allowed.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s)convened by NIDA , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. 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:
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.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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.
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), ad 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 authority and
responsibility of awardees to define objectives and approaches, and to plan,
conduct, analyze, and publish results, interpretations, and conclusions of
their studies. Awardees should be advised that they will retain custody of and
primary rights to their data developed under the award, subject to current
Government policies regarding rights of access consistent with current DHHS,
PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NIH Project Scientist (NPS) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards and will be named in the award notice. The responsibilities of the NPS include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants. The NPS will participate in the definition of objectives and approaches, and in planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their studies. However, the dominant role and prime responsibility for the activity reside with the awardee(s) for the project as a whole, but not necessarily for each task.
Additionally, an agency program official (PO) program will be responsible for the programmatic stewardship of the award and will be named in the award notice. The Government, via the PO, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. The NIDA PO may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards.
Areas of Joint Responsibility include:
The PI(s) and the NPS will work collaboratively in evaluating the most appropriate research methods, data quality control strategies, medical safety monitoring, protocol design and implementation, data analysis and interpretation and publication and dissemination of study results.
During performance of the award, the NPS, with assistance from other scientific program staff who are designated based on the research topic and their relevant expertise, may provide appropriate assistance, advice, and guidance. The role of the NIH Project Scientist will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus between the Principal Investigator and the NIH Project Scientist, and that NIDA staff will be given the opportunity to offer input into this process. The NIH Project Scientist will facilitate liaison activity for partnerships, and provide assistance with access to NIDA-supported resources and services.
The release of each annual funding increment by NIDA will be based on the NIDA PO review of progress towards achieving the previously agreed upon research goals, interim objectives and milestones. NIDA reserves the right to terminate or curtail a study (or any individual award) in the event of inadequate progress, poor quality, or other major breach of the approved project.
The specific timelines, interim objectives and funding levels agreed to by the awardee and the NIDA shall be included in the terms and conditions of award. Given the nature of product development, it is recognized that timelines and interim objectives may require revision and renegotiation during the course of the project period. The Principal Investigator and NIDA PO must agree to all such revisions.
For clinical trials, a detailed data and safety monitoring plan (DSMP) must be approved by the PO before recruitment of subjects can start. Any change or modification of the DSMP must be approved by the PO before it takes effect. A DSMB convened by NIDA will monitor the medical safety of participants and the quality of the data on a regular basis, as stipulated in the DSMP.
In order to advance the development of lead compounds, it is expected that awardees will collaborate or cooperate with other NIDA -funded projects and/or U.S. government agencies, for example, CDC, FDA, and/or USDA, and/or industry.
The PI(s) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement. Manuscripts shall be submitted to the NIDA PO within two weeks of acceptance for publication. Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of NIDA support. Timely publication of major findings is encouraged.
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 academic members who are not involved in the study will be convened. 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 NIH 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 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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Potential applicants are strongly encouraged to contact NIDA staff to discuss the research strategy before submitting an application.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
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)
Ivan D. Montoya, M.D., M.P.H.
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse (NIDA)
Mark Swieter, Ph.D.
Chief, Extramural Activities Branch
National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
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.
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.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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