Update: The following update relating to this announcement has been issued:

• April 3, 2008 - This PA has been reissued as (PA-08-129).
• September 18, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and should be started at least four weeks in advance of the planned submission. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release/Posted Date: April 10, 2006
Opening Date: May 2, 2006 (Earliest date an application may be submitted to Grants.gov)
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of applicant institution/organization).
Letters of Intent Receipt Date(s): Not Applicable
Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Receipt Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (Activation Date): Not applicable.
Expiration Date: January 3, 2008 (now January 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• The purpose of this Funding Opportunity Announcement (FOA) from the National Institute on Drug Abuse is to encourage research aimed at reducing prescription drug abuse while supporting appropriate medical use of therapeutic agents with abuse liability. A range of research is needed to combat prescription drug abuse--from specifying the extent and nature of the problem (including health and social consequences) and identifying their determinants, to discovering effective clinical practices that identify those at risk and designing and disseminating prevention and treatment interventions.
• The R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.
• The R03 is intended to support small research projects that can be carried out in a short period of time with limited resources.
• The total amount to be awarded depends on the scientific merit of applications and the funds available in NIDA's general funding pool.
• This funding opportunity utilizes the R03 mechanism, but will run in parallel with a program announcement of identical scientific scope (PA-04-110) that will utilize the traditional research project grant (R01) and the exploratory/developmental grant (R21) mechanism (PA-06-339).
• Eligible organizations: For-profit organizations; non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State government; units of local government; eligible institutions of the Federal government; domestic institutions; foreign institutions; faith-based or community-based organizations; units of State Tribal government; and units of Local Tribal government.
• Eligible Project Director/Principal Investigators (PD/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution 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.
• Applicants may submit more than one application, provided each application is scientifically distinct.
• See Section IV.1 for application materials. The application instructions for this FOA are located at the following links:
• http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc (MS Word)
• http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf (PDF)
• For general information on SF424 (R&R) Application and Electronic Submission, see the following Web sites:
• SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
• General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
  

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

This FOA supersedes PA 01-048, Prescription Drug Abuse issued on February 12, 2001. In revising and reissuing this FOA, NIDA continues to encourage research aimed at reducing prescription drug abuse while supporting appropriate medical use of therapeutic agents with abuse liability. To promote the Nation’s health, research is needed to understand the factors contributing to prescription drug abuse, to characterize the adverse medical and social consequences associated with this abuse, and to develop effective prevention and service delivery approaches and behavioral and pharmacological treatments. Applications to address this issue are encouraged across a broad range of experimental approaches including basic, clinical, and epidemiological studies. This FOA uses the small grant (R03) mechanism, which is designed to provide limited funding for a short period of time. Examples of the types of projects supported with the R03 include the following: pilot or feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology

Background

Prescription drug abuse is a major public health concern. The 2002 National Survey on Drug Use and Health (formerly known as the National Household Survey on Drug Abuse) reports that 6.2 million Americans age 12 and older are current users of prescription drugs for nonmedical purposes. An estimated 4.4 million used pain relievers, 1.8 million used tranquilizers, 1.2 million used stimulants, and 0.4 million used sedatives. Lifetime nonmedical pain reliever prevalence among youths aged 12 to 17 increased from 2001 (9.6%) to 2002 (11.2%), continuing an increasing trend from 1989 (1.2%). Among young adults aged 18 to 25, the rate increased from 19.4% in 2001 to 22.1% in 2002. The young adult rate had been 6.8% in 1992. Lifetime nonmedical use of stimulants increased steadily from 1990 to 2002 for youths aged 12 to 17 (0.7 to 4.3%). For young adults aged 18 to 25, rates declined from 1981 to 1994 (from 10.9 to 5.9%), then increased to 10.8% in 2002. Rates increased between 2001 and 2002 for both youths (3.8 to 4.3%) and young adults (10.2 to 10.8%).

The number of new initiates to nonmedical pain reliever use increased from 628,000 in 1990 to 2.7 million in 2000. About half (52%) of the new users in 2001 were females. In 2001, the number was 2.4 million, not significantly different from 2000. First use of stimulants increased during the 1990s from 270,000 in 1991 to 983,000 in 2000 and 808,000 in 2001. Initiation of tranquilizer use increased steadily during the 1990s, from 373,000 initiates in 1990 to 1.3 million in 2000 and 1.1 million in 2001. The number of sedative initiates has remained below 300,000 per year since 1981.

Drug Abuse Warning Network (DAWN) data show that rates per 100,000 of emergency room mentions of narcotic analgesics/combinations (category consists of drugs containing narcotic analgesics alone as well as narcotics in combination with other drugs) have increased 138.7% from 1995 to 2002 and 18.5% from 2001 to 2002. In 2002, the Monitoring the Future study added new questions on the nonmedical use of Vicodin and OxyContin. In both 2002 and 2003, past year use of Vicodin (hydrocodone) and OxyContin (oxycodone hydrochloride) by 12th graders has been about 4% while past year use of Vicodin has been about 10%, raising serious concern about prescription opioid abuse among youth.

In addition, concerns have been raised about increasing substance abuse among older adults (age 60 and older) and the potential impact of the aging of the baby boom generation on the need for substance abuse treatment (Gfroerer et al., Drug Alcohol Depend. 69, 127-135, 2003). Alcohol and prescription drug misuse may affect as many as 17% of older adults [Substance Abuse Among Older Adults, SAMHSA/CSAT Treatment Improvement Protocol (TIP) Series 26]. Yet, proper treatment of many medical conditions requires the use of medications that can be misused, abused, and/or lead to dependency.

Applications are sought to define the extent of the problem of prescription drug abuse, to characterize this problem in terms of class of drug abused, etiology of abuse, and populations most affected (including racial/ethnic minority and gender analyses). Studies are needed on all classes of prescription drugs with abuse liability, including analgesics, stimulants, sedative/hypnotics, anxiolytics, and muscle building/performance enhancing drugs such as anabolic steroids. Researchers are encouraged to study the relationship between the prescription medication, the indication for which the medication was prescribed (e.g., pain, sleep disorder, anxiety disorder, obesity), and the environmental and individual factors contributing to abuse.

Studies are also needed on the factors leading to diversion of prescription drugs into channels of illicit drug distribution and on measures to lessen this diversion, such as science-based education of health professionals. The recent proliferation of internet sites offering controlled substances for sale without a prescription (Forman, JAMA, 290, 889, 2003) requires further investigation. Research is needed to describe the populations most at risk for abuse of particular classes of drugs (including demographic factors and reasons for use), the social norms and social contexts associated with use, the source(s) of these drugs, and the consequences of drug use (e.g., adverse health outcomes such as drug overdose and drug interactions and behavioral and social consequences such as cognitive impairment, absenteeism, and accidents). To reduce prescription drug abuse, research is needed on prevention approaches, service delivery, and behavioral and pharmaco- therapies targeted to particular populations (e.g., the elderly, women, adolescents, health professionals, and those with comorbid substance abuse and mental health disorders and/or medical disorders).

Clinical studies are needed that take into account the patient’s age, gender, race/ethnicity, medical and psychiatric diagnoses, and current symptomatology and past and present treatments, as well as the clinical appropriateness or inappropriateness of prescribing practices. Clinical neurobiological investigations using a variety of brain imaging methods also can allow for a better understanding of how these prescription drugs affect brain processes and systems over the life span. Studies are also necessary to determine how attitudes, knowledge, and patterns of prescribing vary across categories of patients and health care providers and how these contribute to inappropriate prescribing practices and disparities in health care. For example, pharmacies may not stock opioid pain medications in racial and ethnic minority communities or low-income communities, and there may be disparities in physicians prescribing practices to minority and low socioeconomic status (SES) patients. Conversely, women are much more likely than men to be prescribed abusable prescription drugs, and prescription drug misuse/abuse among older women is a serious problem that has received little attention and often goes unrecognized by health professionals (CASA Report, June 1998).

In general, prescription drug abuse in older adults begins with misuse due to inappropriate prescribing or lack of patient compliance with medication regimens. Continued misuse may progress to abuse and dependence. Older adults may be more vulnerable to prescription drug abuse because of age-related physiological changes that may influence the metabolism and response to prescription drugs, greater likelihood of having undiagnosed psychiatric and medical comorbidities, and difficulties in compliance with complex multiple drug regimens that may increase the likelihood of drug interactions. For example, benzodiazepines are frequently prescribed to older adults, but age-related changes in drug metabolism, interactions with other prescription and over-the-counter medications, and use of alcohol may lead to increased use/misuse/abuse and adverse consequences such as impaired functional capacity and cognition.

Yet, older Americans, their families, and their health care and service providers are frequently uninformed about the potential problems with psychoactive prescription drugs and, therefore, do not recognize these problems when they occur. The aging of the baby boom cohort may enhance the occurrence of substance abuse, including prescription drug abuse among older Americans because of this cohort’s prior use and abuse of psychoactive compounds. There is a need for research to develop screening, assessment, and diagnostic instruments (especially for use by health professionals in primary care settings) and prevention and treatment approaches targeted to prescription drug misuse and abuse in older adults.

The increased use of prescription drugs among high school and college age youth is also of great concern. In the 2003 Monitoring the Future study, among twelfth graders, annual prevalence of Vicodin use was second only to marijuana use. Young people frequently mix prescription drugs with other drugs of abuse, such as marijuana and alcohol, putting them at risk for drug interactions and overdose. Prescription of methylphenidate and other stimulants to treat attention-deficit hyperactivity disorder (ADHD) has increased in recent years. A new, stand-alone question on nonmedical Ritalin (methylphenidate) use was added to the Monitoring the Future survey in 2001, (Secondary School Students, 2002). Using this new question, annual prevalence rates among twelfth graders was 4.0%; about half (1.9%) reported using only once or twice in the past year, but 0.9% reported using 10 or more times during the year. Studies are needed on the extent of misuse and abuse of prescribed stimulant medications and on the extent to which youth share prescribed stimulants with their peers. There is also a need for developmentally appropriate therapies that can engage and retain adolescents in treatment for prescription drug abuse.

In addition, doctors, nurses, dentists, pharmacists, veterinarians, and other health professionals are at risk because of their ready access to prescription drugs with abuse liability. Research is needed to identify the components of effective prevention and treatment approaches targeted toward health professionals. Furthermore, while some health professionals may contribute to the misuse and abuse of prescription drugs because of inappropriate prescribing behaviors, others may provide inadequate pharmacotherapy for pain and other conditions because of fear that their patients will become addicted or that they will incur regulatory scrutiny. There is a need to develop and evaluate innovative science based education approaches for health professionals. Best practices and training protocols for health care workers require research not only on approaches, but also on methods to transfer science into the field.

Program Description

A range of research is needed to combat prescription drug abuse--from specifying the extent and nature of the problem (including health, behavioral, and social consequences) to developing, evaluating, and disseminating effective prevention and treatment approaches. Research is needed to identify addiction risk factors, including those associated with the chronic therapeutic use of analgesics, stimulants, and sedative-hypnotics for psychiatric and other medical illnesses. Improved means of screening, assessing, and diagnosing those at high risk of abusing or becoming addicted to prescribed psychoactive medications are needed. Research is needed to examine the interaction of patient behavior, social and physical environment, and medical and drug abuse treatment practice to improve prescribing, screening, referral, and treatment processes in the health care system. Treatment studies are needed to develop and evaluate behavioral therapies and combined behavioral and pharmaco-therapies for prescription drug abuse, with particular attention to populations at highest risk (adolescents, women, patients with comorbid psychiatric and/or physical illness, the elderly, and those with a history of polydrug abuse). Basic preclinical and clinical research is needed to understand the neurobiological, behavioral, pharmacological, and genetic basis of prescription drug abuse. Research is needed to identify interactions between abused prescription drugs and other abused drugs and alcohol. Across levels of analysis and research domains, there is also an interest in stimulating development and integration of technologies (for example, from genetic, imaging, proteomic, metabolomic information and approaches) to observe and understand the etiology and biological and behavioral mechanisms associated with prescription drug abuse.

Areas of research interest include, but are not limited to, the following:

Epidemiology and Prevention Research

• Studies, by class of drug, on the nature and magnitude of prescription drug diversion from both licit and illicit sources. Research to identify sources of illicit prescription drugs in different population subgroups. Studies of the demographics of populations abusing each class of prescription drugs, including regional variations and rural-urban gradients. Studies should consider the methodological aspects of measuring prescription drug abuse such as the nomenclature for prescription drugs used in various population groups and the accuracy of recall and reporting of medication names and dosing regimens.
• Research on the factors that influence temporal trends in abuse of prescription drugs such as changes in the health care system, prescriptive practices, and sources of prescription medications (local pharmacy, mail order, internet, other) and in the training of health care providers regarding prescribing medications with abuse liability.
• Studies on the role of the internet as both a source of prescription drugs and a source of information about these drugs. Studies on the role of the internet and direct-to-consumer advertising in shaping attitudes and in influencing beliefs about the risks associated with prescription drugs.
• Studies to identify patient populations who are under- or over-medicated or have difficulty obtaining adequate treatment with controlled substances. Studies on prescribing practices and attitudes of physicians (by specialty area, including primary care physicians) toward prescribing medications with abuse liability to different patient populations (such as children and adolescents, women, the elderly, racial/ethnic minorities, uninsured) and patients with current or past substance abuse problems.
• Studies to evaluate whether prolonged treatment with prescription psychoactive drugs for conditions such as ADD/ADHD, sleep disorders, pain, obesity, anxiety disorders, etc. contributes to drug abuse or relapse to drug abuse in vulnerable individuals.
• Studies to evaluate whether noncompliance with prescription drug dosing increases the likelihood of transition from misuse to abuse, possibly by inducing sensitization.
• Studies to determine how prescription drug misuse and abuse, particularly by pregnant women, children, and adolescents, might increase the risk of abuse/addiction of illicit drugs over the life span.
• Studies of the factors that predispose an individual to over-rely on and to misuse psychoactive prescription and over-the-counter drugs (e.g., health beliefs and practices, health promotion behaviors, reliance on media, family and cultural practices).
• Studies of the adverse behavioral and social consequences associated with prescription drug misuse, abuse, and dependence, such as impairment in school performance, driving, parenting, job performance, independent living for the elderly, etc.
• Studies to determine incidence and prevalence of medical and health consequences of prescription drug misuse and abuse. Of particular interest are studies in those with HIV/AIDS, hepatitis, and other infectious diseases that are prevalent in drug abusers.
• Studies to identify, design, and evaluate prevention interventions for those adolescents and college-age youth at increased risk for prescription drug misuse and abuse. Types of prescription misuse and abuse among youth include: 1) the mixing of prescription drugs with other drugs of abuse (e.g., marijuana, alcohol), which places them at risk for drug interactions and overdose; 2) misuse and abuse of prescribed stimulants and providing these drugs to their peers; 3) abuse of dextromethorphan (DXM), an over-the-counter drug, alone and in combination with other drugs of abuse; 4) use of stimulants on college campuses for appetite suppression, wakefulness, increased attention, and euphoria.
• Studies to design and evaluate prevention interventions for individuals who may be at increased risk for prescription misuse and abuse in the following populations: 1) individuals with illnesses, such as arthritis, back pain, insomnia, fatigue, obesity, anxiety, eating disorders, etc., who are prescribed abusable prescription drugs; 2) health care professionals; and 3) the elderly.
• Studies that theoretically and empirically explore the impact of existing evidence-based drug abuse prevention approaches, or variants of existing approaches, on prescription drug abuse patterns.

Basic Preclinical and Clinical Research

• Employ basic studies using animal models to probe the effects of prescription drugs on neurobiological, neurochemical, and neurobehavioral processes.
• Study possible associations between physical dependence, produced by either medical or nonmedical prescription drug use, and the development of addiction.
• Study the pharmacokinetics, pharmacodynamics, and pharmacogenetics of drug-drug interactions between abused prescription drugs and other illicit drugs, as well as between prescription drugs and dietary supplements and drugs for treatment of infections (e.g., antiretrovirals).
• Conduct pharmacogenetic studies examining the genetic variation in physiological homeostasis, neurocognitive processes, biological systems and/or metabolic effects of prescription drugs and vulnerability to addiction.
• Conduct studies to determine the health consequences of prescription drug abuse and their underlying pathophysiology in diverse populations, e.g., those with HIV/AIDS and other infectious diseases, adolescents, the elderly, women. Consequences may include developmental, psychiatric, metabolic (including nutritional), endocrine, pharmacokinetic/pharmacodynamic drug-drug interactions, or other physiological system effects caused by, or associated with the abuse of prescription drugs.
• Research is needed to determine the extent and mechanisms by which abused prescription drugs affect neurobiological mechanism and behavioral processes during development (including prenatal exposure), adolescence and adulthood, including older adulthood.
• Determine how prescription drug abuse has a differential effect on brain processes across adulthood, particularly in elderly populations. For example, what are the effects of prescription drugs on normal aging processes in the brain, and do they place individuals at increased risk (or earlier expression) of neurodegenerative diseases such as Parkinson’s disease, Alzheimer’s disease, and other neurocognitive disorders?
• Assess the risk of addiction to prescribed medications as a function of the medical condition for which the drug is prescribed. For example, is the risk of addiction to opioids lessened as a function of the degree of pain present? If so, the mechanism responsible for this variation needs to be examined.
• Cross-sensitization and relapse. In animal models determine if exposure to prescription drugs can precipitate relapse or lead to cross-sensitization to other drugs.
• Determine the mechanism responsible for feelings of well-being induced by certain steroids (e.g., prednisone). Is the euphoria sufficient to maintain drug-seeking? Do steroids stimulate relapse under, for example, conditions of psychomotor stimulant abstinence? Determine if steroids reduce the aversive effects of drug withdrawal.
• Assess whether prescription drugs affect the toxicity of other abused substances. For example, fluoxetine is used in the treatment of depression and obsessive-compulsive disorder (OCD), but it is being misused/abused in an attempt to protect from the neurotoxic action of methamphetamine, ecstasy, and other "club drugs." Studies are needed to determine the consequences of these drug combinations on neural mechanisms and behavioral.
• Study the acute and chronic interactions between prescription drugs and illicit substances at the behavioral and cognitive level of analysis. Most notably, what are reinforcing characteristics of drug combinations?
• Develop and apply interoperable and scalable analytic, modeling and other computation and information tools (such as those for dynamic semantic profiling, social and other network analysis, and data integration and management) to enable pattern recognition and analysis to facilitate understanding of emerging patterns of use, vulnerabilities, drug use and disease relationships, economic relationships, and other factors related to prescription drug abuse.

Treatment and Services Research

• Research on the development and testing of effective and comprehensive treatment approaches that may include behavioral, pharmacological, alternative or complementary therapies for individuals who abuse or become dependent on prescription analgesics, stimulants, anxiolytics, or sedative-hypnotics. Behavioral treatment and combined behavioral and pharmacological studies should be informed by the stage model of therapy development, described in detail in the Behavioral Therapies Development Program

Announcement (http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html). Treatment studies are encouraged to include tests of the mediators, moderators, key ingredients, and/or mechanisms of action at all stages of therapy development.

• Studies to develop and evaluate treatment approaches that maintain abstinence from prescription drug abuse and prevent relapse.
• Studies of brief behavioral treatment interventions for prescription drug misuse and abuse in primary care settings.
• Studies to develop and test age-appropriate, gender-sensitive, and culturally-relevant treatment approaches for prescription drug abusing individuals.
• Studies to adapt existing treatments for other drugs of abuse, or for other conditions, for use with individuals who abuse prescription drugs.
• Studies to develop and evaluate new and innovative therapies to treat prescription drug abuse that are based on promising findings from basic behavioral and cognitive research.
• Studies to develop and test, or to adapt, developmentally-appropriate behavioral treatments for adolescents who abuse prescription drugs, with particular attention to the types and patterns of drug use among adolescents and the challenges to engaging adolescents in treatment.
• Studies to develop and evaluate therapies for individuals who abuse prescription drugs and have comorbid mental disorders, such as depression, anxiety disorders, post-traumatic stress disorder, and eating disorders or comorbid physical disorders such as sickle cell anemia, HIV/AIDS, musculoskeletal disease, etc. associated with chronic pain.
• Studies which utilize e-health tools such as computers and portable digital and wireless devices to improve access to treatment for prescription drug abuse and/or augment provision of treatment by health care providers.
• Studies to develop and evaluate effective treatment approaches for the management of pain, anxiety, sleep disorders, obesity etc., in substance abusing patients and people with a history of substance abuse. Therapies are needed for patients who are self-medicating in an attempt to manage comorbid medical and/or psychiatric problems.
• Studies to develop and evaluate behavioral treatments to improve medication adherence and prevent misuse of prescribed medications among substance abusing patients with comorbid medical illnesses or mental disorders.
• Research on effective detoxification strategies for various classes of prescribed drugs with abuse liability.
• Pharmacotherapy studies to evaluate the use of medications for new indications in the treatment of prescription drug abuse (e.g., buprenorphine for oxycodone abuse).
• Studies to improve the screening, assessment, and recognition of prescription drug misuse, abuse, and dependence among patients being treated in health care settings for medical and/or psychiatric illnesses, especially those which are chronic in nature.
• Studies to improve the recognition and referral for intervention of employee prescription drug misuse and abuse in the workplace to ensure timely and appropriate referral for treatment. Research is needed on educational approaches to increase workforce awareness of prescription drug misuse and abuse.
• Studies to determine the factors that may affect access to treatment for prescription drug abuse and addiction, including treatment entry, readiness for treatment, retention in treatment, compliance with treatment, and treatment outcomes among prescription drug abusing women, adolescents, older adults, and racial/ethnic minorities.
• Studies to identify organizational characteristics (e.g., climate, culture, age, and size), financing, and managerial approaches to providing the most accessible and effective treatment for prescription drug abuse and addiction, including factors that enhance motivation to participate and remain in treatment, compliance with treatment, and relapse avoidance. Research to identify the value added by linkages to relevant treatment services such as psychiatric, wellness, and social services is also welcome.
• Research to develop and evaluate effective strategies/approaches for disseminating science-based information on the recognition, prevention, and treatment of prescription drug abuse to health professionals and community-based health care providers. Research to determine the most effective approaches for enhancing utilization of science-based information and whether these approaches actually change practice behaviors.
• Research to develop and evaluate innovative health professional prescription drug education programs using new technologies, e.g. palm pilot, interactive computer based programs, virtual reality, etc.

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

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) invites applications for small research projects that can be carried out in a short period of time with limited resources. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement). All applications submitted in response to this FOA must use the modular budget format. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).

Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed small grant application may be submitted as defined in NIH Policy. See NOT-OD-05-046 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-046.html

For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.

2. Funds Available

Although the financial plans of the ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.

F&A costs requested by consortium participants are not included in the direct cost limitation, See NOT-OD-05-004, November 2, 2004. The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

• For-profit organizations;
• Non-profit organizations;
• Public or private institutions, such as universities, colleges, hospitals, and laboratories;
• Units of State government;
• Units of local government;
• Eligible institutions of the Federal government;
• Domestic institutions;
• Foreign institutions;
• Faith-based or community-based organizations;
• Units of State Tribal government; and
• Units of Local Tribal government.

1.B. Eligible Individuals

Any individual 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.

2. Cost Sharing or Matching

Not applicable. This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/GetStarted) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

Project Directors/Principal Investigators (PD/PIs) should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organization/Institutional Registration in Grants.gov/Get Started

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
• Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organization/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
• eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
• The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Signing Official (SO) or their designee who is already registered in the Commons.
• Both the PD/PI and SO need separate accounts in the NIH eRA Commons since both are required to verify the application.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget

Optional Components:
PHS398 Cover Letter File
R&R Sub-award Budget Attachment Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:

• Charge back of customs and import fees is not allowed.
• Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF.
• Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements.

Proposed research should provide a unique research opportunity not available in the United States.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: May 2, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically.

PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

• If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
• If the two day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

Renewal (formerly competing continuation or Type 2 ) applications are not permitted.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:

• R03 applications will use the modular budget format and Just-in-Time concepts, with direct costs of up to two $25,000 modules, or $50,000 per year, may be requested for up to two years (i.e., a maximum of $100,000 over two years in four modules of $25,000 each).
• Items 2-5 of the PHS398 Research Plan component of the R03 application may not exceed 10 pages, including tables, graphs, figures, diagrams, and charts.
• "Introduction (required for a resubmission application) is limited to one page.
• Preliminary data are not required but may be included if available.
• R03 Appendix materials may include graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is contained within the 10-page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.
• Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique
• Receive a second level of review by an appropriate national advisory council or board.

The following will be considered in making funding decisions:

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written comments, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

• Significance
• Approach
• Innovation
• Investigator
• Environment
• Additional Review Criteria

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For the R03 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

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

3. Reporting

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

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

Participating ICs and their contacts are listed at http://grants.nih.gov/grants/funding/r03.htm.

1. Scientific/Research Contacts:

Richard A. Denisco M.D., M.P.H.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse, NIH. DHHS
6001 Executive Boulevard, Room 5193
Bethesda, Maryland 20892
Telephone: 301-594-4371
E-mail: [email protected]

Lisa Onken, Ph.D.
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., MSC 9551
Bethesda, Maryland 20892-9551
Telephone: 301-443-2235
Fax: 301-443-8694
E-mail: [email protected]

2. Peer Review Contacts:

Not applicable

3. Financial or Grants Management Contacts:

Gary Fleming, J.D.
Chief, Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R); and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. 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 Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
NIH... Turning Discovery Into Health®