Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Remote Monitoring System for Detecting Cocaine Ingestion/Intoxication (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-DA-12-007
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
FOA Purpose	This Funding Opportunity Announcement (FOA) requests applications for funding to develop and validate a reliable remote real-time cocaine monitoring system for use by clinical trials researchers testing cocaine dependence treatments. Applications proposing validation of the monitoring system that do not include validation of the monitoring system in cocaine dependent subjects will not be considered responsive to this FOA. Systems will leverage developments in behavioral and/or biometric sensing, mobile and wireless technology (e.g., mHealth) and real time data analysis to detect cocaine use in vivo. Completed systems will include hardware, software, storage and analysis solutions to provide for secure encrypted storage on devices, secure encrypted transmission to a database, and secure researcher interfaces from which data may be aggregated to plot and display data demonstrating clinically meaningful changes in cocaine consumption patterns by individual participants. The system will include safeguards to ensure the behavioral and/or biological data gathered was sampled from the actual participant enrolled by including reliable identity verification measures and protection against tampering and hacking. It will also include timestamp information to ensure data sampled was sampled at the times and for the durations specified by researchers. All hardware and software will be developed to ensure the system meets accepted standards for selectivity and specificity to identify cocaine. All hardware, software and databases will undergo sufficiently rigorous testing to be consistent with FDA medical device and software validation guidelines and the entire system will be Health Insurance Privacy and Portability Act (HIPPA) compliant. The purpose of this FOA is to notify qualified investigators of funding for research activities on the development and validation of a cocaine monitoring system which will provide for detection and measurement of cocaine ingestion in cocaine dependent people participating in clinical treatment trials. Ultimately the system may be used to monitor participants in clinical treatment or possibly judicial monitoring.

Posted Date	May 23, 2011
Open Date (Earliest Submission Date)	July 18, 2011
Letter of Intent Due Date	July 18, 2011
Application Due Date(s)	August 18, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not applicable
Scientific Merit Review	October/November 2011
Advisory Council Review	January 2012
Earliest Start Date(s)	April 2012
Expiration Date	August 19, 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.

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

Background: Currently, research on illicit drug use relies on data from either biological specimen testing or participant reported data collected via interviews or surveys. These approaches are useful, but have shortcomings. Saliva testing methods are subject to dilution. Blood testing is physically invasive, may be uncomfortable, and requires safety precautions for handling and storage. Urine testing requires special facilities for collection, is subject to faking if not observed and observed testing may be embarrassing to patients. Self-report measures are subjective, can be subject to the vagaries of memory which can be impaired by drug use and because of stigma and legal concerns drug users may not always tell the truth about use. Because most existing testing methods are not continuous, current assessment methods fail to capture fine grain changes in drug taking and amounts. Thus it is impossible to reliably discern drug use patterns over time, which may reflect positive effects of treatments.

Technologies now exist that allow monitoring of a variety of biological and behavioral variables using remote sensing, wireless data transfer, real time analysis and machine learning algorithms that utilize Dynamic Bayesian Networks (DBNs) to discover patterns predicting health risk behavior. Wearable wireless monitoring systems, which can test and transmit data in one minute intervals, are currently marketed for the detection of both alcohol use and glucose. NIDA funded investigators are developing mHealth systems using accelerometers and peripheral psychophysiological sensing devices which may be integrated with smart phone applications to providing wireless assessment and data transfer to treat drug abuse and model precipitants of relapse such as stress and craving. Development of similar technologies for measurement of cocaine use, in combination with DBNs, validated in cocaine dependent individuals will facilitate clinical trials treatment research by providing the capability to demonstrate efficacy in a fine grain fashion. NIDA’s primary interest is in the development and validation of a remote measurement system as a research tool for cocaine dependence treatment studies. However, such systems may have a variety of uses in the assessment, diagnosis, monitoring and treatment of cocaine dependent populations.

Cocaine use is associated with a number of well documented acute physiological reactions and behavioral phenomena which in theory may be used in aggregate to detect clinically meaningful changes in use patterns. In doses up to 100 milligrams, physical signs of cocaine ingestion include increased alertness, motor hyperactivity, increased heart rate, blood pressure and body temperature, pupil dilation, bronchodilation, and shifts in blood flow from internal organs to the muscles. Cocaine’s behavioral effects include talkativeness, increased locomotion; decreased appetite and need for sleep and may include stereotyped behaviors such as punding (complex prolonged, purposeless activities which in men often involves fidgeting with electronic gadgets and in women self-grooming and purse searching) and other repetitive reward seeking behavior as well as perseverative responding to reward. High doses of cocaine produce more intense effects than lower doses which may also induce tics and movement disorders including an acute chorea known as crack dancing . In mouse models, stereotypy has been shown to relate in a dose dependent manner to stereotyped behaviors linked to cocaine’s inhibition of the dopamine transporter.

Euphoria from cocaine may be intensified by the presence of other drugs. Thus measurable behavior such as rapid chain smoking of nicotine frequently occurs with cocaine use. As chain smoking contains its own unique topography, in theory, this type of behavioral marker may also be measured and included in establishing a behavioral measurement system.

Whether reliable and valid remote measurement of cocaine use via assessment of physiological and behavioral signs is possible is an empirical question. Tolerance, sensitization, and specificity and sensitivity of measures all must be considered in the development of any measurement system for cocaine use.

Tolerance to some of the effects of cocaine develops over repeated administrations such that an individual needs to use more of the drug to experience the same subjective effects. Because of tolerance, the same user taking the same quantity of cocaine via the same mode of administration at two different time points, will likely show a diminished response to the second administration. Any measurement system will need to control for the effects of tolerance on variables measured.

Sensitization involves a progressive increase in locomotor activity which can develop over successive administrations and which can persist for months following cessation of use. Any measurement system will need to control for the effects of sensitization if measures selected are affected by it.

Development of a cocaine measurement system is also complicated by the fact that many of the effects of cocaine are similar to those of other stimulants and also to regular daily human activity. For example bruxism (teeth grinding) is displayed by both amphetamine and cocaine users but it may also be experienced by people with dental problems. Fear, sexual behavior, and physical exercise all may produce an adrenaline surge that acutely elevates physiological responses. Reliability testing is needed to establish a system that can successfully isolate the effects of cocaine from the effects of other conditions and daily activities. Any measurement system must be able to detect cocaine and cocaine related signals, and not yield false positives in the face of other drug use or typical human activity.

In rare cases proximity to other users may cause false positive readings in some sensors. Measurement systems should include methods to parse these occurrences as well as accidental contact with similar substances (smoke, perfume, hairspray) from deliberate use. In alcohol bracelet detection systems this is accomplished by very frequent sampling which can be used to differentiate accidental contact from sustained ingestion.

Arguably, any cocaine use at all is clinically relevant. However, for dependent patients undergoing treatment, slips, lapses, and relapses are a routine part of the recovery process. A system is needed which can detect all episodes of use and durations of actual use and provide clinically meaningful data regarding whether a person is entering remission or failing to respond to treatment.

Systems that include continuous measurement of cocaine or its metabolites in body fluid such as the interstitial fluid, saliva, or nasal mucosa are acceptable under this FOA. Systems for continuous measurement of a variety of behavioral and/or physiological variables that combined reliably identify use episodes and their duration over time may also be considered under this FOA.

Ideally final systems will be minimally invasive with respect to participant privacy and pose minimal burden on patients in terms of comfort and daily maintenance. Patients can be expected to charge power supplies at home and/or reapply wearable sensor components daily if needed but a system requiring minimal patient involvement is most desirable. Additionally, a major objective of the research program is the production of a system that can be worn for several weeks at a time to detect the intermittent nature of cocaine use which is often marked by periods of binges and abstinence. To be most useful the system should also be suitable for ambulatory use for a week or longer between clinic visits.

Because cocaine users clinical needs often conflict with their desire to continue using, tamperproof systems with identity verification and timestamps for data collection must be a part of all systems. Ideally identify verification will be scalable (e.g., applying computerized image verification rather than verification of video by a remote staff person). Methods for identity verification may include the use of radio frequency identification tags on bracelets participants can t remove which can only transmit when triggered by a sensor within arm’s reach of the patient.

Because equipment may have street value and be subject to loss or sale by participants, budgets may include costs for patient incentives for research participation and safe return of equipment.

Research Scope: Research activities will depend upon the current stage of research development for current selected system components. Initial activities may involve ascertaining the reliability of measures for cocaine detection when cocaine is administered in lab settings to cocaine dependent non-treatment seekers. However, in order to be responsive, later activities must build on this work to validate the system in cocaine dependent patients in treatment in comparison with urine testing results. Because the nature of these applications is developmental, pilot data are not required. However, applicants are welcome to submit pilot data where they are available and as they apply to the stage of research being proposed.

Activities supported by this opportunity will include the development of a reliable and valid measurement system for remote continuous real time measurement of cocaine in ambulatory cocaine dependent patients. As such activities can include but are not limited to:

• Testing biosensors, psychophysiological sensors and/or behavioral sensors individually and in combination to identify a practical, reliable and valid set of variables and sensors for the detection of cocaine use and quantification of the frequency and duration of its use in human cocaine users in lab settings
• Software development for data collection, transfer and storage
• Hardware development for data collection, transfer, and storage
• Hardware and software validation per FDA guidelines for sale of medical devices in medical diagnosis and treatment
• Feasibility studies to ensure the entire system including its sensors, patient interfaces, integration devices, and data transmission can be used by patients in treatment and end users (researchers)
• Validation studies of the final system in actual in-treatment cocaine dependent people for up to one month at a time to ensure that the system can detect use episodes as corroborated by thrice weekly patient urine testing with minimal research visits for trouble shooting
• Development of patient and researcher training and support resources to facilitate system use outside the clinic and outside of normal business hours

Systems may include any behavioral, biological, or psychophysiological measurement devices or combination of devices. Examples of testable technologies include but are not limited to:

• wearable interstitial fluid tests,
• remote breath metabolite detection,
• heart rate, skin conductance body temperature and other telemetry,
• cell phone video recording and computerized analysis of movements and/or facial expression,
• voice sample analysis by computer,
• accelerometer assessment measures of positions and postures,
• interactive behavioral testing such as reaction time tests

Remote measurement is the main priority of this FOA. As such measures may come from wearable or portable sensors (e.g., devices on a mobile phone) or via an interface accessed remotely by a user (e.g., automated interactive voice response phone system or a tablet or a website accessible over a browser). Ideally final systems will pose minimal burden to participants.

When fully developed, it is expected that researchers and possibly clinical providers and others with the need for monitoring services will access the system and its components as a research service with a fee per patient. Moreover it is expected that costs for prototypes may be reduced through improvements in technology over time. As such, estimated final system cost per patient will not be a primary consideration in review and questions of how systems will be paid for do not need to be addressed in the application. However applications should demonstrate that the team has the theoretical and engineering expertise to create and integrate the components requiring development and less complex systems are likely to be prioritized by reviewers because of the need for an easy to use, safe, secure system which can remain functional in settings where drug users live and work.

NIDA Program reserves the right to negotiate substitution of less expensive but similar methods to those proposed in the application in the event that such a substitution would not constitute a major change to the scope of the reviewed application or negatively affect a company’s IP interests.

It is strongly suggested that the proposed approach limit participant eligibility for outpatient studies to individuals diagnosed with cocaine dependence and that the application provide evidence of support for the ability to recruit and enroll sufficient participants meeting these criteria to meet the project’s aims. This system may be useful for detecting cocaine in a wide variety of settings and individuals. However, limiting eligibility to dependent patients will maximize the likelihood that there will be relapse episodes for the system to detect during validation. Additionally, it is strongly suggested that applications proposing inpatient cocaine administration detection studies show evidence of the ability to recruit and enroll sufficient cocaine dependent non-treatment seeking current cocaine users to validate the system in these users. Cocaine administration in other patients may expose them to the risk of developing dependence. In the event that the DSM V is released prior to award, NIDA Program will negotiate revised eligibility criteria if needed. Validation studies only proposing to use participants who are not cocaine dependent or proposing to use patient groups not comprised entirely of cocaine dependent patients are at risk of being deemed unresponsive.

Funding Instrument	Grant
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 $1,000,000 in FY 2012. Between 2-4 awards are anticipated.
Award Budget	Budgets of up to $300,000 per year in direct costs may be requested.
Award Project Period	The maximum project period is 2 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:

• 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 NIH 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 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 registrations.

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

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 Program 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.

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
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-12-007
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

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:

Letters of Support

Letters from clinic partners documenting availability of sufficient cocaine dependent participants and agreeing to participate in the proposed research.

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.,

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, with the following modifications:

• Special appendixes containing in lab validation protocols and the patient testing protocols are permitted. Reviewers are not required to view protocols but may chose to.
• If the application is from a business with the intent to market and commercialize products generated from this research, it needs to appropriately document (in the appendix) Intellectual Property (IP) ownership issues by providing, where necessary, IP agreements and partnership agreements.  

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.

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 the National Institute on Drug Abuse, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

If funds are sought for validating the system in outpatients, applications need to demonstrate that the investigators and clinic sites can recruit and quickly enroll sufficient cocaine dependent treatment seekers for feasibility testing and a validation study to validate the system for detecting use episodes in comparison with observed urine collection. For example, this should be demonstrated via letters of support from potential participating clinics documenting a sufficient pool of cocaine dependent patients, and inclusion of investigators and research staff who have experience recruiting samples of cocaine dependent patients for clinical trials or other clinical studies at these clinic sites as well as the inclusion of qualified staff to conduct diagnostic interviews to ensure participants meet enrollment criteria for cocaine dependence.

Applications need to contain a statement indicating intent to obtain a Federal Certificate of Confidentiality for each study involving enrollment of cocaine dependent people.

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.

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? If a lab reliability study is proposed, are the investigators qualified to safely and securely conduct and medically monitor an inpatient drug administration study in non-treatment seeking humans with cocaine dependence to evaluate the reliability and validity of the measurement system for detecting actual cocaine use (e.g., does the team include staff for medical monitoring, does a team member have experience with cocaine administration to humans, and does the setting allow for safe and secure cocaine administration)?

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? If validating the system in outpatients is proposed, does the application demonstrate that the investigators and clinic sites can recruit and quickly enroll sufficient cocaine dependent treatment seekers for feasibility testing and a validation study to validate the system for detecting use episodes in comparison with observed urine collection?

Is there evidence that sufficient patients meeting criteria for cocaine dependence can be recruited and enrolled for any measurement reliability and validity testing 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

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).

Projects will develop a unique research resource and so applications must include a preliminary plan for resource sharing. The plan may allow for sale of the final system for a reasonable fee. (Program staff will work with applicants selected for funding to develop a final completed plan.)

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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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:

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

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 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.

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

Not Applicable.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award as described 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.

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

Cecelia McNamara Spitznas, Ph.D.
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-0107
Email: spitznasc@mail.nih.gov

Mark Swieter, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1389
Email: mswieter@mail.nih.gov

Pam Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: pfleming@mail.nih.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 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

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