and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH),
(http://www.nih.gov)
Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
Title: Prescription Drug
Abuse (R21)
Announcement Type
This is a modification of PA-04-110
which was previously released on June 16, 2004, and now is divided into separate
FOAs for R21 and R03 grant mechanisms.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
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 applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number:
PA-06-339
Catalog of Federal Domestic Assistance Number(s)
93.279
Key Dates
Release 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
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 (R21) mechanism, which is intended to encourage new exploratory and developmental research projects. Studies using the R21 mechanism should break new ground or extend previous discoveries toward new directions or applications.
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
o 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.
o 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.
o 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.
o 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.
o 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.
o Studies to evaluate whether noncompliance with prescription drug dosing increases the likelihood of transition from misuse to abuse, possibly by inducing sensitization.
o 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.
o 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).
o 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.
o 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.
o 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.
o 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.
o 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
o Employ basic studies using animal models to probe the effects of prescription drugs on neurobiological, neurochemical, and neurobehavioral processes.
o Study possible associations between physical dependence, produced by either medical or nonmedical prescription drug use, and the development of addiction.
o 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).
o 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.
o 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.
o 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.
o 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?
o 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.
o Cross-sensitization and relapse. In animal models determine if exposure to prescription drugs can precipitate relapse or lead to cross-sensitization to other drugs.
o 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.
o 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.
o 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?
o 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
o 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.
o Studies to develop and evaluate treatment approaches that maintain abstinence from prescription drug abuse and prevent relapse.
o Studies of brief behavioral treatment interventions for prescription drug misuse and abuse in primary care settings.
o Studies to develop and test age-appropriate, gender-sensitive, and culturally-relevant treatment approaches for prescription drug abusing individuals.
o Studies to adapt existing treatments for other drugs of abuse, or for other conditions, for use with individuals who abuse prescription drugs.
o 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.
o 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.
o 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.
o 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.
o 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.
o 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.
o Research on effective detoxification strategies for various classes of prescribed drugs with abuse liability.
o Pharmacotherapy studies to evaluate the use of medications for new indications in the treatment of prescription drug abuse (e.g., buprenorphine for oxycodone abuse).
o 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.
o 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.
o 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.
o 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.
o 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.
o 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.
1. Mechanism of Support
This FOA will use the National Institutes of Health (NIH) the NIH Exploratory/Developmental
Research Grant (R21) award mechanism. The applicant will be solely responsible
for planning, directing, and executing the proposed project.
Applicants are advised to contact NIDA program staff listed under INQUIRIES for additional information. Awards under the R21 mechanism are limited to 2 years. Modular budgeting procedures apply for grants up to $250,000; see http://grants1.nih.gov/grants/funding/modular/modular.htm for further information about modular budgets.
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. 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).
Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
2. Funds Available
Because the nature and scope of the proposed research will vary from application
to application, it is anticipated that the size and duration of each award
will also vary. Although the financial plans of the IC(s) provide support
for this program, awards pursuant to this funding opportunity are contingent
upon the availability of funds and the receipt of a sufficient number of meritorious
applications.
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 2-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 2-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 costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-04-040.
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:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources
necessary to carry out the proposed research is 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.
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
Not Applicable.
Section IV. Application and Submission
Information
Registration and Instructions for Submission via Grants.gov
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:
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
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 organization/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 instructions for this FOA through the Grants.gov Apply http://www.grants.gov/Apply Web site.
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
Research & Related Subaward Budget Attachment(s)
Form
Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 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:
Proposed research should provide
a unique research opportunity not available in the U.S.
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)
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.
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 AOR/SO have
two business days to view the application image.
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 (CSR), 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 are to be followed, with the following requirements for R21 applications:
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 (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.
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). 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:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place 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, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
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.
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 PD/PI 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 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), See Section VI.3.,
Reporting.
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 NIH 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.
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 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:
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). 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
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