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)
National Institute on Alcoholism and Alcohol Abuse (NIAAA) (http://www.niaaa.nih.gov)
Title: Complementary and Alternative Medicine for Substance and Alcohol Related Disorders (R03)
Announcement Type
This is a
reissue of PA-05-097 which was previously released April 26, 2005.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response
to this 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 should be started at least 4 weeks in advance of the planned submission. See Section IV.
Program Announcement (PA) Number: PA-06-424
Catalog of Federal Domestic Assistance Number(s)
93.279, 93.273
Key Dates
Release/Posted
Date: May 19, 2006
Opening Date: May 19, 2006 (earliest date an application may be submitted to Grants.gov).
Letters of Intent
Receipt Date(s): Not applicable.
NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission Date(s): Standard
receipt dates apply. Please see: http://grants1.nih.gov/grants/funding/submissionschedule.htm for
details.
AIDS
Application Receipt Date(s): Standard AIDS application receipt dates apply. Please
see: http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for
details.
Peer Review Date(s): Standard review dates apply.
Please see:http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details.
Council Review Date(s): Standard Council review
dates apply. Please see: http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details.
Earliest Anticipated
Start Date(s): Standard dates apply. Please see: http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
details.
Additional Information
To Be Available Date (Url Activation Date):
Expiration
Date:May 2, 2008 (now May 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
Clinical studies are needed to critically
evaluate the therapeutic effects of different CAM therapies in treating various
aspects of SUD and AUD, alone or in combination with conventional treatments.
In cases where issues of safety arise, the clinical study protocol may be
accompanied by an adjunct preclinical study protocol examining safety of the
proposed therapy in an animal model. Studies involving subjects from various
ethnic populations, ages, and genders are encouraged, although not necessarily
in a single study, depending upon the research questions. Identification,
evaluation and development of safe and effective CAM therapies for the
treatment of children, adolescents and pregnant women with SUD and AUD are
especially encouraged. For these vulnerable populations safety is a major
concern, hence the treatments proposed should have proven safety for developing
organisms.
Purpose
The National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) are seeking high quality clinical research grant applications focusing on the identification, evaluation and development of safe and effective Complementary and Alternative Medical (CAM) therapies for the treatment of substance use disorder (SUD) and alcohol use disorder (AUD), as defined by DSM-IV, including abuse or dependence on all licit (alcohol and tobacco) and illicit drugs/medications. Studies may also focus on treatments of neurological, psychiatric or medical consequences of drug abuse, e.g., acute and chronic drug and alcohol toxicities, psychoses, mood disorders, neurological and cognitive impairments, and brain atrophy.
There is a growing popularity in the United States of CAM for the treatment of various disorders and diseases. The recent report prepared by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) National Center for Health Statistics (NCHS), based on data from 2002 National Health Interview Survey (NHIS) obtained from interviews of 31,044 adult U.S. residents, shows that 62% of them used some kind of CAM during the past 12 months, while 75% have ever used CAM, (http://www.cdc.gov/nchs/data/ad/ad343.pdf). CAM interventions appear also popular among drug addicts. A recently published survey of 548 persons with a history of intravenous drug use recruited from a methadone maintenance clinic revealed that 45% of them reported use of at least one type of CAM therapy, usually supplemental to conventional treatments, (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12765213&dopt=Abstract). However, the effects of many CAM therapies in treating SUD and AUD have not been systematically examined, and the effectiveness of most CAM treatments in aiding recovery from drug and alcohol addictions is unknown. Such therapies need to be studied. For the purpose of this PA, CAM therapies are defined as those therapies that are outside of the realm of conventional medicine and consist of a broad spectrum of therapeutic modalities (their classification and examples are given further in the text). According to the National Center for Complementary and Alternative Medicine (NCCAM) of NIH, conventional medicine is medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses. Other terms for conventional medicine include allopathy, Western, mainstream, orthodox, and regular medicine, and biomedicine. Other terms for CAM include but are not limited to: unconventional, non-conventional, folkloric, nutritional, herbal, naturopathic, homeopathic, and non-Western medicine or health care. Some conventional medical practitioners are also practitioners of CAM.
Background and Rationale
Substance abuse continues to be a grave threat to public health in the United States. According to the National Survey on Drug Use and Health (NSDUH) conducted by SAMHSA, based on interviews of approximately 67,500 persons, in 2002 an estimated 19.5 million Americans, or 8.3% of the population age 12 and older were current users of illicit drugs. Among 12- to 17-year-olds, current use of illicit drugs was 11.6%, and among pregnant women it was 3.3%. In addition, 6.2 million persons, or 2.6% of the population aged 12 or older, were current users of psychotropic medications taken nonmedically. http://www.drugabusestatistics.samhsa.gov/nhsda/2k2nsduh/Overview/2k2Overview.htm#highlights. A publication of the Executive Office of the President, Office of National Drug Control Policy (2001), reports that in 1998 the estimated total cost to the society due to illicit drug use was $143.4 billion. This cost has been increasing 5.9% annually between 1992 and 1998, giving an extrapolated value for 2004 (if similar trends continues) about $200 billion. (http://www.whitehousedrugpolicy.gov/publications/pdf/economic_costs98.pdf)
These numbers stress the urgency and importance of identifying, evaluating and developing effective therapies for treating substance dependence and abuse.
Acute or chronic abuse of drugs and alcohol can cause serious health and social problems. It may lead to life threatening health consequences, various neuropathologies, psychiatric disorders and addictions or dependencies that might require immediate medical interventions, specialized treatments employing pharmacotherapies, behavioral therapies, or combinations thereof. Clinical and preclinical research has documented drug-and alcohol-induced alterations of brain chemistry and function in chronic drug and alcohol abusers, which are believed to contribute to persistent drug and alcohol dependencies. Drug and alcohol abuse by children and adolescents may lead to serious developmental consequences and is associated with various medical problems, poor school performance and antisocial behaviors. Acute and chronic use of inhalants and stimulants seems to have particularly devastating effects on the brain. Substance and alcohol abuse or dependence is often comorbid with other psychiatric disorders, which may precede drug and alcohol abuse or follow as a consequence of it, and may contribute to poor treatment outcomes. Whereas many SUD and AUD can be effectively treated with pharmacotherapies, behavioral treatments, or combinations thereof, there is an ongoing need for treatments with long-term efficacy in maintaining abstinence and preventing relapse to drug and alcohol abuse.
The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health, classifies CAM therapies into 5 major categories: 1) Alternative Medical Systems e.g. homeopathic and naturopathic medicine, non-western medicine systems such as Ayurveda or traditional Chinese medicine (acupuncture, acupressure); 2) Mind-Body interventions such as meditation, yoga, spiritual and mental healing, art, music, dance therapy; 3) Biologically Based Therapies such as use of herbs, special macronutrient diets, megadoses of vitamins, minerals and other dietary supplements; 4) Manipulative and Body-Based Therapies such as chiropractic or osteopathic manipulations, therapeutic massage, balneotherapy, hyperbaric pressure therapy; and 5) Energy Therapies which utilize energy fields including unconventional use of electromagnetic fields, e.g. pulsed electromagnetic fields, alternating current or direct current fields [transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS)], or use biofield manipulations, such as qi gong, Reiki, and therapeutic touch, (http://www.nccam.nih.gov/health/whatiscam/). Research in all 5 NCAAM categories of therapies is encouraged, as it relates to the potential treatment of SUD and AUD.
Some CAM therapies have been evaluated in clinical studies for their potential in the treatment of SUD and AUD. Regarding alternative medical systems, acupuncture has received the greatest empirical attention as a potential treatment for substance and alcohol abuse and dependence, yielding equivocal results. In several clinical trials, acupuncture has been found to produce better cocaine abstinence rates (Avants et al, 2000), to reduce craving for cocaine (Avants et al, 1995), to improve mood, sleep, and appetite among substance abusers (Gurevich et al, 1996). However, other clinical trials have found no significant differences between active acupuncture conditions and comparison conditions in reducing cocaine use (Margolin et al, 2002), reducing use of or craving for crack-cocaine (Lipton et al, 1994), or reducing drug use in a prison population (Berman et al, 2004) and a population with chronic arrest histories (Russell et al, 2000). Studies that help to refine the treatment approach (e.g., duration and frequency of needle insertion, type of needle insertion, evaluation of different systems of acupuncture, etc.), the comparison condition (e.g., invasive versus non-invasive, more tightly-controlled delivery and assessment of concurrently offered psychotherapy, etc.) may help to clarify these mixed results. Applications seeking to develop, adapt, or test acupuncture or other non-biologically-based therapies for SUD or AUD based on alternative medical systems, please refer to the Behavioral Therapies Development Program Announcement (PA-03-126) for a detailed description of NIDA's conceptualization of therapy development research.
Another category of NCCAM's complementary and alternative approaches is mind-body interventions, that is those interventions designed to enhance the mind's capacity to affect bodily function and symptoms (NCCAM website). Most often, the mind-body interventions are used to complement other treatments for substance abuse, rather than to serve as an alternative to treatment. While meditation, relaxation, and mindfulness-based approaches are included in NCCAM's framework as mind-body approaches, these approaches have been well integrated into current behavioral treatment research for substance abuse. Applicants wishing to develop, adapt, or test behavioral treatments emphasizing meditation or mindfulness are encouraged to respond to the Behavioral Therapies Development Program Announcement (PA-03-126).
Other types of behavioral therapies, while not typically integrated into current behavioral treatment research, are utilized fairly widely in community settings. These include faith-based interventions such as prison ministries and community outreach, exercise therapies, and therapies incorporating dance, art, and music. Research activities in which existing interventions are described in reproducible manuals, and these manualized interventions are pilot-tested for efficacy, (i.e., reverse-engineering ) may be most appropriate for these approaches. Studies testing these therapies, and other types of therapies which could be viewed as mind-body interventions, are also encouraged under PA-03-126.
Studies proposing to develop, adapt, or test mind-body interventions for SUD and AUD populations are encouraged to follow a three-stage model of therapy development. In Stage I therapy development research, activities include creating a well-specified treatment manual, designing psychometrically-sound measures of treatment fidelity and competence, and conducting a small pilot test of the treatment. In Stage 2 research, activities include larger-scale tests of the treatment through randomized designs, or other scientifically-appropriate research designs. In Stage 3 research, activities include preparing the treatment for dissemination to community settings, including developing and testing methods of training therapists and approaches to clinical supervision in the treatment. At all stages of therapy research, activities related to clarifying the mechanisms of action (i.e., how and why a therapy works) are relevant, and research is especially encouraged that clarifies the treatment of special populations such as racial and ethnic minorities, the elderly, pregnant women, adolescents, drug-abusers with co-morbid psychiatric conditions, etc. (For a more detailed description of a guiding framework to approaching behavioral therapy research, please refer to the Behavioral Therapies Development Program Announcement, PA-03-126.
Regarding biologically based therapies: a preliminary small placebo-controlled trial demonstrated that supplemental magnesium may reduce illicit opiate use in methadone-maintained cocaine abusing patients and decrease cocaine craving (Margolin et al., J. Addict. Dis. 22:49-61, 2003). Because magnesium ion is an endogenous blocker of the NMDA receptor complex, which is implicated in stimulant and opiate dependence, further testing of this supplement is needed in controlled studies for treating opiate and stimulant dependence. In small controlled clinical studies melatonin was shown to attenuate symptoms of nicotine and benzodiazepine withdrawal, and animal studies suggest that it reverses opiate tolerance. Controlled studies evaluating effectiveness of melatonin in the treatment of nicotine, opiate and sedative dependence are needed. Preclinical studies also suggest that melatonin and L-carnitine may be protective against methamphetamine-induced neuronal toxicities. Clinical studies, using psychological and brain imaging evaluation are needed to confirm, or not, such effects in methamphetamine addicts. Some clinical studies documented that extracts of Valeriana have anxiolytic and sedative effects with fewer motor-impairing effects than benzodiazepines. Studies are needed to evaluate Valeriana's utility in the treatment of benzodiazepine/sedative abuse/dependence. Because extracts of Valeriana have GABA-ergic properties and medications from this class have shown efficacy in the treatment of cocaine dependence, it is possible that Valeriana might be effective as well. Likewise, a GABA-ergic aminoacid, taurine, might be effective in the treatment of benzodiazepine and stimulant dependence. Clinical and preclinical studies suggest that fat-enriched diets may reverse hepatotoxic and neurotoxic effects of inhalant solvents. Such diets or specific fatty supplements (e.g. fatty acids, phoshatidylcholine) may have utility in reversing toxic effects of solvents and in the treatment of solvent addicted children and adolescents.
Kudzu ( Pueraria lobata) is a medicinal plant used in traditional Chinese medicine to treat alcoholism. Kudzu extracts have been shown to decrease alcohol intake in several animal models (Keung and Vallee, Proc Natl Acad Sci 90:1008-10012, 1993; Overstreet et al., Alcohol Clin Exp Res 20:221-227, 996). Several active components of kudzu, including puerarin, daidzin and daidzein, have also reduced drinking in animals. Silymarin, the active constituent of Milk Thistle, is an herbal remedy that has shown efficacy in treating alcoholic liver disease (Saller, Drugs 61:2035-2063, 2001). This Program Announcement invites studies of these and other biologically-based therapies for their potential use in treating AUD.
Regarding energy therapies: a small double-blind crossover trial showed that high frequency repeated TMS of left dorsolateral prefrontal cortex significantly reduced cigarette smoking (Eichhammer et al., J. Clin Psychiatry, 64:8, 2003). TMS is a non-invasive neurotechnique, which offers a unique tool to selectively and regionally alter brain cortical activity. It has been reported to reduce symptoms of depression, post traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), epilepsy, migraine, Parkinson's disease, hallucination in schizophrenic patients, and to alter cognition. Repetitive TMS may alleviate drug craving by transient deactivation of certain brain regions or may stimulate hypoactive brain regions in addicts, thus promoting better control of drug-use compulsions and other behaviors. It may improve mood and enhance cognition, thus facilitating abstinence from drugs of abuse and increasing effectiveness of cognitive therapies. Preclinical studies showed that TMS induced neuronal sprouting and produced lasting plastic changes in the brain, which may aid recovery from drug dependence by promoting neuroregenerative processes and by restoring brain homeostasis. Studies are needed to evaluate effects of TMS on different psychological, physiological, neurobiological and behavioral aspects of drug abuse.
Another neurotechnique that may be utilized to bidirectionally, regionally change brain activity is TDCS, which involves transcranial application of a weak current. It has been used in neurology and psychiatry to control pain and seizures, and to alter perception or cognition. Like TMS, it may have utility in the treatment of drug use disorders by reducing drug craving, improving cognitive therapy and promoting brain plasticity, necessary for restoration of CNS homeostasis in recovering drug addicts.
Also unilateral visual field stimulation using goggles that allow vision only through one eye was shown to alter mood and anxiety in psychiatric patients, which suggests its potential utility in treating drug abuse/dependence. Kundalini yoga is another technique, which allows for lateral hemispheric control of brain activity through one nostral breathing. Applicants interested in manipulative and body-based therapies, energy therapies, and the development of treatments based upon neuroscience are also referred to PA-03-126.
The therapeutic effects of many other CAM therapies in the treatment of SUD have not been scientifically examined. Such research is needed and timely in view of the apparent popularity of CAM therapies among some drug abusing populations.
Given the high prevalence of psychiatric comorbidities such as depression, attention deficit hyperactivity disorder (ADHD), PTSD, OCD and conduct disorders with SUD and AUD, and the potential for common origins or pathways of SUD and AUD and these comorbidities, it seems reasonable to predict that CAM therapies intended for the treatment of psychiatric and neurological disorders might be beneficial in the treatment of SUD and AUD. In the case of biologically-based therapies, for example, several controlled studies showed that omega-3 fatty acids and Hypericum can be are beneficial in the treatment of depression; melatonin and Valerian for anxiety and insomnia; Ginkgo biloba, phosphatidylserine and L-carnitine for memory impairments; mega doses of vitamin E for slowing down the progression of Alzheimer's dementia. Mind-body therapies such as biofeedback or meditation are effective for treating anxiety and for stress management. Novel neurotechnologies such as TMS have shown beneficial effects in the treatment of depression, and a potential in the treatment of OCD, PTSD, epilepsy, Parkinson's disease, memory impairments, and hallucinations. Some of these disorders, such as depression, OCD, PTSD, cognitive deficits, are comorbid with drug dependence, hypodopaminergia is common for Parkinson's disease and stimulant dependence, and hallucinations are common for schizophrenia and for intoxications with certain drugs. By alleviating these neuropsychiatric disorders/symptoms, such neurotechnologies may also aid drug abuse therapies.
Research topics of interest include, but are not limited to:
Combinations of different CAM therapies with each other, or with conventional treatments for SUD and AUD that are expected to enhance their efficacy, may also be tested. Such combinations may target simultaneously several biological and clinical aspects of SUD and AUD. Because treatment of SUD and AUD usually requires a multidisciplinary approach, it is expected that proposals, which assess effects of biologically based CAM therapies will use - when appropriate - some behavioral intervention platform (i.e., psychotherapy).
Certain CAM therapies may require INDs and FDA approval. With biologicals and natural products quality certificates will be required. For information and guidance on NIH policy on the quality of natural products, please refer to NCCAM instructions. (http://nccam.nih.gov/research/policies/naturalproducts.htm) For guidance on designing clinical trials of NCCAM therapies determining dose ranges, please refer to the NCAM site. (http://nccam.nih.gov/research/policies/guideonct.htm)
For studies developing, adapting, reverse-engineering, and/or testing behavioral therapies and other non-biologically-based therapies for the treatment of SUD and AUD drawing from CAM therapies traditions such as mindfulness, meditation, martial arts, tai chi, yoga, dance and others, or using virtual reality as a way to help improve the efficacy of a therapy, applicants should refer to the Behavioral Therapies Development Program Announcement, which can be found at: http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html.
Because clinical and preclinical studies have documented that males and females respond differently to drugs of abuse, alcohol, and to various pharmacological and behavioral treatments, the investigators are encouraged to evaluate, if feasible, sex/gender differences in response to their selected CAM therapies.
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 called revisions or
amendments") of a previously reviewed small grant application may be
submitted as defined in NIH Policy. See NOT-OD-05-046,
which was published in the NIH Guide on April 29, 2005.
For specific
information about the R03 programs, see http://grants.nih.gov/grants/funding/r03.htm.
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 NIH Institutes and Centers (ICs) 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.
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.
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 his/her 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
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
Registration and Instructions for Submission via Grants.gov
To download an Application Package and 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:
Project Directors/Principal Investigators (PDs/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.
2) Organization/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 4 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, E-mail: [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
Research & Related Budget
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
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:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A.
Submission, Review and Anticipated Start Dates
Opening Date: May 19, 2006
Letter
of Intent Receipt Date: Not applicable
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
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.
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 or competing renewal 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 or competing renewal 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:
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 at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at 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 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:
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 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.
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 scientific health 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).
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 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 at 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: If applicable, 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 Notice of Grant Award (NoA). For these
terms of award, see 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)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
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:
For applications focusing on drug abuse and dependence research:
Melissa W. Racioppo, Ph.D.
Division of Treatment Research and Development
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., MSC 9551
Bethesda, Maryland 20892-9551
Telephone: 301-443-2261
Fax: 301-443-6814
E-mail: [email protected]
For applications focusing on alcohol abuse and dependence research:
Raye Litten, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS
Willco Building, Suite 505
6000 Executive Blvd., MSC-7003
Bethesda, MD 20892-7003
Telephone: 301-443-0636
Fax: 301-443-8774
Email: [email protected]
2. Peer Review Contacts:
Not applicable.
3. Financial or Grants Management Contacts:
For applications to NIDA:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: 301-443-6710
Fax: 301-594-6849
E-mail: [email protected]
For applications to NIAAA :
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
Telephone: 301-443-4704
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
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).
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 at 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.
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 PA 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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