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 Institutes on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute on Alcoholism and Alcohol Abuse (NIAAA) (http://www.niaaa.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov)
Title: Behavioral & Integrative Treatment Development Program(R01)
Announcement Type
This is a
reissue of PA-03-126 which was previously released May 19, 2003, and is now divided into separate
FOAs for the R01, R21 and R03 funding mechanisms.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PA-06-486
Catalog of Federal Domestic Assistance Number(s)
93.279, 93.272, 93.213
Key Dates
Release Date: July 14,
2006
Letters of Intent
Receipt Date(s): A
letter of intent is not required.
Application Submission Date(s): Standard
receipt dates apply. Please see: http://grants1.nih.gov/grants/funding/submissionschedule.htm for
details.
AIDS
Application Receipt Dates(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: 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): Not applicable.
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
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(s) 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. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and 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
The National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Center for Complementary and Alternative Medicine (NCCAM) are seeking research grant applications on the development and testing of behavioral and integrative treatments for drug and alcohol abuse and dependence. This program announcement (PA) reaffirms NIDA's, NIAAA's, and NCCAM’s continued and ongoing commitment to major programs of research on behavioral and integrative treatments. The term "behavioral treatments" is used here in a broad sense and includes various forms of psychotherapy, behavior therapy, cognitive therapy, family therapy, couples and marital therapy, group therapy, skills training, meditation, yoga, tai chi (taiji), guided imagery, counseling, and rehabilitative therapies. The term, Integrative treatments refers to treatments that combine behavioral interventions with other treatments, including other behavioral therapies, medications, and/or complementary/alternative therapies. Behavioral and integrative treatment research has been conceptualized, for the purpose of this initiative, to consist of three stages. Stage I, or early treatment development, involves research on the development, refinement, and pilot testing of behavioral and integrative interventions. Stage I may include translational research that incorporates concepts, methods or findings from other disciplines (e.g., neuroscience, cognitive science, etc.) into the development of behavioral and integrative treatments. Stage I may also include research to develop or adapt treatments to become more community-friendly. Stage II includes testing treatments that show promise and testing the dose-response of treatments. Stage III is research aimed at determining if and how efficacious behavioral treatments may be transported to community settings. Stage III may include studies that test treatments in community settings, with community therapists. Stage III may also include studies that develop or test methods of training treatment providers to administer treatments. Determination of mechanism of action of treatment is relevant to all three stages. This funding opportunity announcement (FOA) replaces in its entirety PA-03-126, published in the NIH Guide, May 19, 2003 at http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html.
Applicants interested in the organization, management, and economics of drug abuse treatment services, and the effects of these factors on the quality, cost, access to, effectiveness, and outcomes of care for drug abuse and addictive disorders are referred to the FOA "Drug Abuse Health Services Research" http://grants.nih.gov/grants/guide/pa-files/PA-05-139.html.
NIMH also encourages research examining innovative approaches to behavioral and integrative treatment aimed at combining and sequencing Mental Health treatment (to individualize and optimize care). NIMH supports pilot interventions research via the R34 mechanism (http://grants2.nih.gov/grants/guide/pa-files/PAR-06-248.html). This NIMH announcement encourages research in what is described in this announcement as Stage Ia and Ib (but uses different designations of these Stages).
RESEARCH OBJECTIVES
Background and Rationale
Behavioral treatments play a critical role in most evidence-based drug abuse treatments, and often constitute the entire treatment. This FOA is intended to promote all of the necessary stages of behavioral and integrative treatment research so that better treatments are developed as advancements in science are made, and so that evidence-based treatments may be readily transported to the community. Over the past two decades, numerous evidence-based behavioral and integrative treatments for drug abuse and addiction have been created. With recent advances in science, particularly in neuroscience, it is evident that more can be done to incorporate new scientific discoveries into behavioral treatment development, in order to improve treatment effects. In addition, as more is known about mechanism of action of treatment, and as new technologies are developed, it is clear that more can be done to make treatments more easily transportable to community settings. To achieve these goals, NIDA, in partnership with NIAAA and NCCAM, is continuing the Behavioral Therapies Development Program with the release of this announcement, renamed the Behavioral and Integrative Treatment Development Program.
For alcohol abuse and dependence, most of the treatments available in the U.S. also have been behavioral in nature. A large number of clinical trials conducted over the past 15 years have demonstrated effectiveness for several types of behavioral therapies, including cognitive behavioral therapy, motivational enhancement therapy, marital family therapy, brief interventions, and the community reinforcement approach. Although progress has been made in a broad range of behavioral interventions to treat alcohol abuse and dependence, many alcoholics do not respond adequately to currently available behavioral therapies. For alcohol abuse and dependence, this FOA supports research to develop new innovative behavioral therapies or modify existing treatments to improve their effectiveness and devise ways to improve the engagement, retention, adherence, and outcome of alcoholism treatment across various populations of alcohol dependent and abuse subjects.
Behavioral and integrative treatment research has been conceptualized within a Stage Model having three stages.
Stage I. Stage I, early treatment development, is viewed as an iterative process involving: (1) identifying promising basic or clinical concepts, methods or findings relevant to treatment; (2) generating and formulating new behavioral and integrative treatments or modifying existing treatments; (3) operationally defining and standardizing principles and techniques of the treatments; and (4) pilot testing and, if necessary, refining the treatments. Stage I also involves testing the theory upon which a treatment is based to understand the mechanisms and principles of behavior change.
Although one goal of a Stage I project is to proceed to Stage II, another goal is to obtain scientific knowledge of behavioral processes that lead to behavior change. Early Stage I, or "Stage Ia" can be viewed as the most exploratory part of the treatment development process, in which theories of behavior change are tested, and the critical therapy development groundwork is laid. Late Stage I or "Stage Ib," although still exploratory, can be viewed as the phase of Stage I in which theory-relevant data continues to be obtained, and the treatment undergoes pilot testing (type of methodology is not mandated) to determine whether or not a Stage II (or Stage III) study is warranted.
When evidence-based treatments need to be adapted to be delivered by community treatment providers, that adaptation is considered to be early treatment development, a Stage I activity. Such Stage I research may be conducted with research therapists or community treatment providers. If Stage I research is conducted in this way, there may be immediate progression to Stage III.
Research on the development or modification, and pilot-testing of training procedures for treatment providers is considered a Stage I activity. After pilot testing, research on the full-scale testing of these procedures is considered to be a Stage III activity.
Stage II. Stage II research consists of testing of promising treatments. Stage II does not specify a particular research design. Testing treatments may refer to randomized clinical trials, but also may refer to other methodologies (e.g., single-case designs, A-B-A designs, etc.). Stage II studies may include examinations of the components of treatments, dose-response, and individual differences in treatment response. Stage II provides unique opportunities to further test the principles and mechanisms underlying behavioral change associated with treatment.
Proceeding to Stage II presumes that promising pilot data exist. If evidence of promise does not exist, or such evidence is not strong enough to warrant progression to Stage II, applicants are encouraged to reconsider a Stage II submission.
If results are robust, Stage II studies may progress to Stage III. However, information obtained from Stage II studies may also be used to inform future Stage I studies. For example, if it is shown that a treatment works for some people, but not for others, a Stage II study may lay the groundwork for a Stage I proposal aimed at developing a treatment (or modifying the treatment) so that it works on the patients who were unresponsive to the initial treatment.
Stage III. The ultimate goal of treatment development is to produce treatments that work, and continue to work when used in the community. Stage III research is aimed at obtaining knowledge and methods to ensure that an evidence-based treatment will retain its potency when delivered by community treatment providers. One question relevant to Stage III research is, Does this treatment work when administered by community treatment providers? Another question relevant to Stage III research is, How can this treatment be made to work when administered by community treatment providers? Stage III research does not require a particular research methodology, and may involve randomized clinical trials (of evidence-based treatments or of clinical training procedures), or a variety of other methodologies. Examination of the mechanism of action of treatments and/or training procedures is considered to be an integral part of Stage III.
Research on the development or modification of a treatment for use in a community setting is considered to be Stage I research, as is research on the development or modification of a training procedure for treatment providers.
As is the case for Stage II, information obtained from Stage III studies may also be used to inform future Stage I studies. For example, if it is shown in Stage III that a treatment works for some people, but not for others, a Stage III study may lay the groundwork for a Stage I proposal aimed at developing a treatment (or modifying the treatment) so that it works on the patients who were unresponsive to the initial treatment.
It is NIDA's, NIAAA's, and NCCAM’s objective to ensure sufficient emphasis and support for all stages of behavioral and integrative treatment research, so that scientific knowledge can readily be incorporated into newer and better behavioral and CAM interventions and treatments, and so that treatments can be effectively transported from research to the community. This PA is intended to promote this objective by encouraging research grant applications in any one of the three Stages of behavioral or integrative treatment research.
AREAS OF INTEREST
This announcement solicits research targeting Stage I, II, and III behavioral and integrative treatment of any drug- or alcohol-abusing population, including but are not limited to women, minorities, families, couples, specific cultural groups, adolescents, the elderly, and persons with disabilities, such as the deaf. This includes research targeting the behavioral and integrative treatment of any drug of abuse, including marijuana, methamphetamine, MDMA and other club drugs, prescription drugs, inhalants, sedative-hypnotics, hallucinogens, appetite suppressants and other supplements, heroin, cocaine, nicotine, and alcohol.
It should be noted that if a subject is identified as being at risk for HIV acquisition and/or transmission, HIV testing and counseling should be offered to the subject in accordance with current guidelines. Wherever possible and appropriate, investigators are encouraged to collect data on the effect of treatment on AIDS risk behaviors, including data on the route of drug administration and sexual behaviors that may place individuals at risk for HIV transmission. Also, as appropriate, investigators should offer risk-reduction counseling and collect data on the effect of treatment on the acquisition/transmission of HIV/AIDS and other infectious diseases, such as Hepatitis C, associated with drug use.
Applicants are encouraged to include, and if necessary develop, measures of mediators of behavior change and mechanism of action of behavioral and integrative treatment in all three Stages. This may include research on the neurobiological, behavioral, cognitive, social, affective, etc. mechanism of action, and may involve any number of methodologies. If focus on mechanisms of action is not appropriate for a particular application, applicants are encouraged to address and justify why this will not be done.
Specific areas of interest include, but are not limited to:
Translational Research:
Major advances have been made in understanding how drugs of abuse alter various brain processes and systems, both structurally and functionally. Further advances in understanding the neurobiology of drug abuse, neurobiological and genetic predictors of response to behavioral treatment, and the neurobiology of the effects of behavioral treatment are imminent. Translational research linking neuroscience and/or genetics to behavioral treatment development is encouraged. Examples include, but are not limited to:
o Stage I studies developing or improving behavioral treatments and/or HIV risk reduction interventions by incorporating findings, methods, or principles from basic, clinical, cognitive, affective or social neuroscience (e.g., exercises to improve brain function).
o Stage I, II, or III translational research to develop and test components to boost treatment effects (e.g., sleep hygiene modules).
o Stage I, II, or III research linking behavioral constructs (e.g., affect regulation, attention, learning, memory, self-monitoring, craving, delay discounting, impulsivity, etc.) associated with drug abuse with their neurobiological underpinnings and behavioral treatment development.
o Stage I, II, or III research identifying neurobiological or genetic predictors of behavioral treatment response and/or developing methods for assessing these predictors.
Community-friendly treatment: For treatments to be used in community settings, they must not only work, but also must be workable in those settings. For instance, one setting may necessitate group treatment (e.g., community mental health settings with limited resources), but another setting may call for an individual-based, brief screening and treatment (e.g., in a primary care or dental office). The complexity and/or intensity of the treatment, training or additional staff requirements, fit with existing treatment programs, and of course cost can all be factors determining whether a treatment is community friendly.
Where appropriate and potentially feasible, Stage I research is needed to modify evidence-based treatments into community-friendly formats (e.g., individual to group, briefer formats, computer-assisted delivery, etc.), and to test these community-friendly treatments to determine if potency is diminished, retained, or improved. In addition, promising existing treatments, already being utilized in the community, may be the basis for a Stage I proposal, and such treatments may be operationally defined, modified, pilot tested (in Stage I), and ultimately tested in Stage III (possibly but not necessarily by-passing Stage II).
Understanding how and why a treatment works and for whom a treatment works may be critical to paring it down to its most essential elements, ultimately making it not only more streamlined and less costly, but also easier to administer and more principle-driven. Therefore, most community-friendly behavioral treatment research is inextricably linked to understanding mechanism of action. Behavioral and integrative treatment research, particularly in Stage I and Stage III, is encouraged that is aimed at determining mechanism of action while developing or adapting treatments to be community-friendly, including, but not limited to, the following:
o Group therapy Evidence-based individual treatments sometimes cannot be readily incorporated into community treatment programs. Where appropriate and potentially feasible, research is needed to modify evidence-based individual treatments into group formats, and to test these group treatments to determine if potency is diminished, retained, or improved. In addition, promising existing community-based group treatments may form the basis for a Stage I proposal, and such treatments may be operationally defined, modified, pilot tested, and ultimately tested. Research aimed at understanding the mechanism(s) of action of group treatment, e.g., research that links group treatment development to social neuroscience, basic social science, clinical science, etc., is particularly encouraged.
o Setting-specific treatment: Research is sought for behavioral and integrative treatments for use in medical and dental settings, mental health settings, the criminal and juvenile justice systems, the welfare system, workplace settings, school settings, faith-based settings, etc.
o Technology-assisted treatment and training: Research is sought at all three Stages on treatments, treatment add-ons or components, and therapist training modules, administered or assisted by technological devices and software applications such as computers, virtual reality software, the Internet, expert systems models, telephone, pagers, or hand-held computers.
o More brief, less complex, and/or less intensive treatment. Research that attempts to gain and use knowledge about how and why a treatment exerts its effects, to make that treatment briefer, less complex and/or less intensive while retaining its effectiveness-is encouraged.
o Extended behavioral and integrative treatment. It is understood that drug addiction is a chronic, relapsing disorder, and that treatment and continuing care may be required over an extended period of time. Research is needed to determine when continued treatment is necessary, how to administer extended behavioral and integrative treatments in the most community-friendly ways.
o Therapist training research. Research on how to best train treatment providers to administer specific interventions is sought.
Combined behavioral and medication treatment research: Stage I - III studies are solicited in areas such as:
o Behavioral treatment to complement and/or potentiate the effects of medications. Therapies to be utilized in conjunction with medications, to optimize the efficacy of drug/alcohol addiction treatment.
o Behavioral treatment integrated with medications for drug abusers with comorbid disorders.
o Optimal combinations and sequencing of behavioral and pharmacological treatments.
o Adherence to drug and alcohol abuse treatment medications.
Adherence to HIV and other infectious disease treatment: Stage I, II, and III studies on adherence to treatment regimens for drug abusers with infectious disease, such as HIV, Hepatitis C, etc. are needed. This includes research on drug abusers with comorbid psychiatric disorders.
HIV prevention in drug abuse treatment: Many types of drug abuse are associated with increased HIV risk. Although drug abuse treatment in and of itself may reduce HIV risk, behavioral interventions to specifically reduce HIV risk may decrease risk further. Examples of research are supported under this FOA include, but are not limited to:
o Stage I projects to develop and pilot test HIV risk reduction modules to be used in conjunction with evidence-based behavioral and integrative treatments, and Stage II or Stage III projects on these modules.
o Research aimed at decreasing sexual risk behavior in drug abuse treatment populations.
o Research aimed at decreasing HIV risk behavior in HIV+ drug abuse treatment populations.
Behavioral and brain development: As the brain develops, different treatment approaches may be necessary. Understanding the developing brain and the mechanism of action of behavioral treatments in the developing brain is critical to producing the best treatment. Behavioral and integrative treatment research is needed in, but are not limited to the following areas:
o Stage I projects linking brain development to behavioral and integrative treatment research
o Stage I research linking adolescent social behavior, family process, social neuroscience, and behavioral treatment approaches
o Stage II and III projects testing the efficacy/effectiveness of promising treatments for adolescents alone or in combination with pharmacotherapies.
Comorbidity: Substance abusers often have psychiatric and medical problems. These problems may be related to the onset and/or maintenance of drug abuse, and may affect treatment. In addition, the neurobiology of comorbid disorders may be related to the neurobiology of the addictive disorder, and may help inform treatment development. Examples of Stage I, II and III comorbidity-related behavioral and integrative research areas included in this PA are:
o Borderline personality disorder, suicide, affect regulation, neurobiology, and treatment mechanisms.
o Anxiety disorders, distress tolerance, and mechanisms of treatment.
o Translational research linking behavioral and integrative treatment development to serious mental illness, drug abuse, family and group dynamics (e.g., expressed emotion) and neurobiology.
o Obesity (or other eating disorders) and behavioral treatment development and mechanisms.
o Behavioral and integrative treatment of substance abusing patients with HIV/AIDS, hepatitis, or other infectious diseases.
Therapies to manage precipitants of relapse: Relapse to drinking or drug use is common after treatment. Patients have identified multiple precipitants of relapse including negative affect, stress, insomnia, anger, depression, anxiety, and social and environmental cues associated with prior drinking or substance use experiences. Behavioral and integrative treatments to enable patients to manage these precipitants without resorting to drinking or drug use are needed. Research on the long term maintenance of behavior change is encouraged.
Treatment engagement and retention: Stage I, II and III research is needed on behavioral interventions to enhance motivation, and to facilitate treatment engagement and retention, including outreach and engagement approaches in community and specialty clinic settings. For example, engagement and retention strategies may be informed by advances in neuroscience relating brain systems associated with trust, cooperation, empathy, and other social behaviors.
Complementary and alternative medicine treatment: To treat drug abuse, behavioral treatments are sometimes combined with complementary and alternative treatments. Research on complementary and alternative treatments is included under this program announcement, as sole treatments or as adjunctive strategies to enhance the therapeutic potency of existing drug and alcohol abuse treatments. For a detailed description of complementary and alternative treatments for alcohol and drug abuse, see Program Announcement: http://grants.nih.gov/grants/guide/pa-files/PA-05-097.html.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the National Institutes of Health (NIH) traditional research project (R01) grant award mechanism, but will be run in parallel with program announcements of identical scientific scope that will utilize the small grant (R03) or the exploratory/developmental (R21) grant mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This
funding opportunity 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: http://grants.nih.gov/grants/policy/policy.htm#gps).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less (excluding consortium F&A costs), use the Modular
Budget Component provided in the SF424 (R&R) Application Package and
Instructions Guide (See specifically the Modular Budget Component). Otherwise,
follow the instructions for non-modular research grant applications.
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.
Facilities and
administrative 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 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
There are no requirements
for cost sharing or matching by applicant institutions.
The most current Grants
Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
There is no limit to the number of applications an applicant may submit in response to this announcement, provided that each application is scientifically distinct.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. 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
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
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
Letter
of Intent Receipt Date: Not applicable
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
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
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
signed photocopies in one package to:
Center for Scientific
Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
Applications must be submitted on or before the application
receipt/submission dates described above (Section
IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt
applications will be evaluated for completeness by CSR. Incomplete applications
will not be reviewed.
The NIH will not accept
any application in response to this funding opportunity 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 a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous critique.
Information on the
status of an application should be checked by the Principal Investigator in the
eRA Commons at: https://commons.era.nih.gov/commons/.
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. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
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 continuation 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 continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific
Instructions for Modular Grant applications.
Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular budget
format. The modular budget format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must
use the currently approved version of the PHS 398. Additional information on
modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific
Instructions for Applications Requesting $500,000 (direct costs) or More per
Year.
Applicants requesting
$500,000 or more in direct costs for any year must carry out the following
steps:
1) Contact the IC
program staff at least 6 weeks before submitting the application, i.e., as you
are developing plans for the study;
2) Obtain agreement
from the IC staff that the IC will accept your application for consideration
for award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy
applies to all investigator-initiated new (type 1), competing continuation
(type 2), competing supplement, or any amended or revised version of these
grant application types. Additional information on this policy is available in
the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Plan for Sharing Research
Data
Applicants requesting
more than $500,000 in direct costs in any year of the proposed research must
include a plan for sharing research data in their application. The funding
organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that
grant awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section
VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
2. Review and Selection Process
Applications submitted
for this funding opportunity will be assigned to the ICs on the basis of
established PHS referral guidelines.
Appropriate scientific review groups convened in accordance
with the standard NIH peer review procedures(http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial
merit review, all applications will:
The following will be considered in making funding decisions:
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 principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the above
criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions 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: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
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/part_ii_5.htm#availofrr and http://ott.od.nih.gov/policy/rt_guide_final.html). 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.
3. Anticipated Announcement and Award Dates
N/A
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 (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the NoA
are at the recipient's risk. These costs may be reimbursed only to the extent
considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (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.
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:
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]
Robert B. Huebner, Ph.D.
Deputy Director
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, MSC 9304,
Room 2049
Bethesda, MD 20892-9304
Telephone: (301) 443-4344
Fax: (301) 443-8774
E-mail: [email protected]
Catherine M. Stoney, Ph.D.
Division of Extramural
Research and Training
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd.,
Suite 401
Bethesda, MD 20892
Telephone: (301) 402-1272
Fax: (301) 480-3621
E-mail: [email protected]
2. Peer Review Contacts:
N/A
3. Financial or Grants Management Contacts:
Edith Davis
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]
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
E-mail: [email protected]
Mr. George Tucker
Grants Management Branch
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594-9102
FAX: (301) 480-2419
E-mail: [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 the scientific merit or the priority score.
Access to Research
Data through the Freedom of Information Act:
The Office of Management
and Budget (OMB) Circular A-110 has been revised to provide access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with Federal funds and (2) cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; 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. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information
necessary for 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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