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 Alcohol Abuse and Alcoholism (NIAAA),
(http://www.niaaa.nih.gov)
Title: Impact
of Adolescent Drinking on the Developing Brain (R21)
Announcement Type
New
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Request For Applications (RFA) Number: RFA-AA-07-006
Catalog of Federal
Domestic Assistance Number(s)
93.273
Key Dates
Release/Posted Date: December 29, 2006
Opening Date: January 5, 2007
(Earliest date an application may be submitted to Grants.gov
Letters of Intent Receipt Date(s): February 28, 2007
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/Receipt
Date(s): March 28, 2007
AIDS Application Submission/Receipt Date(s): Not Applicable
Peer Review Date(s): June/July 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date(s): September 2007
Additional Information:
To Be Available Date (Activation Date): Not Applicable
Expiration Date: March
29, 2007
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
As part of a two-phase Funding Opportunity Announcement (FOA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to further our understanding of the effects of child and adolescent alcohol use on the developing human brain. We now know that the brain continues to develop into a person’s twenties with dramatic changes in structure and function coincident with a period of life during which most youth initiate and escalate their consumption of alcohol. This FOA calls for applications to propose and test the feasibility of research study designs addressing the following fundamental questions about the impact of child and adolescent alcohol consumption on the developing brain: (1) what are the effects (both long and shorter-term) of alcohol exposure on the developing brain; (2) what is the effect of timing, dose and duration of alcohol exposure on brain development; and (3) to what extent do these effects resolve or persist.
This is a two phase FOA. Phase I which is addressed in this FOA is the study design and feasibility testing phase. Phase II will be the subject of a future FOA for conducting the full-fledged study. Phase I seeks applications to propose the optimal research design to address the stated critical questions as well as testing the feasibility of the proposed design in order to improve it in preparation for the Phase II application. Addressing the key questions about alcohol’s effects on the developing brain is a challenging problem that will require creative designs and innovative solutions.
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. Submitting an Application
Electronically 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
A. Cooperative Agreement Terms and Conditions of Award
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
As part of a two-phase FOA , the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to further our understanding of the effects of child and adolescent alcohol use on the developing human brain. We now know that the brain continues to develop into a person s twenties with dramatic changes in structure and function coincident with a period of life during which most youth initiate and escalate their consumption of alcohol. This FOA calls for applications to propose and test the feasibility of research study designs addressing the following fundamental questions about the impact of child and adolescent alcohol consumption on the developing brain: (1) what are the effects (both long and shorter-term) of alcohol exposure on the developing brain; (2) what is the effect of timing, dose and duration of alcohol exposure on brain development; and (3) to what extent do these effects resolve or persist.
This is a two phase FOA. Phase I which is addressed in this FOA is the study design and feasibility testing phase. Phase II will be the subject of a future FOA for conducting the full-fledged study. Phase I seeks applications to propose the optimal research design to address the stated critical questions as well as testing the feasibility of the proposed design in order to improve it in preparation for the Phase II application. Addressing the key questions about alcohol’s effects on the developing brain is a challenging problem that will require creative designs and innovative solutions.
BACKGROUND
Introduction
The second decade of life which encompasses adolescence is increasingly recognized as a time of rapid neuromaturation involving many key brain regions involved in self-regulation, emotionality, and a broad range of higher-level cognitive functions. Human post-mortem data, animal studies and neuroimaging all suggest that the dramatic changes in behavior and cognition that occur during this period are paralleled by equally dramatic changes in brain anatomy and physiology. The basic process of overproduction followed by selective/competitive elimination that shapes the developing nervous system in utero seems to continue to refine the central nervous system throughout adolescent development as prepubertal peaks in the number of synapses, glucose utilization, and neurotransmitter receptors are reduced during the teenage years. At the neural level, changes in brain structure and function become readily apparent in early adolescence, particularly robust alterations in secondary and tertiary expanses of the cerebral cortex. Following a period of overproduction of synapses, there is a gradual decrease in gray matter volume, which presumably arises from a series of developmental processes such as reductions in synaptic connections among neurons, known as dendritic pruning. Thus, plasticity of the brain continues during adolescence through the processes of overproduction and elimination of synapses, progressive myelination, neurotransmitter system development, and changes in the rate of brain electrical and metabolic activity (Giedd et al., 1999; Spear, 2000) resulting in increasingly more efficient neural communication. Ultimately, remodeling of the adolescent brain leads to the attainment of adult cognition, decision-making, emotional regulation, and social behavior.
Adolescence is also the period of life during which most youth initiate and escalate alcohol use. In fact, alcohol is the most commonly abused substance among adolescents, and its use by adolescents in the US and in other countries around the world is a normative, not an exceptional, behavior. According to the 2005 Monitoring the Future Study of US adolescents, 41.0 percent of 8th graders, 63.2 percent of 10th graders, and 75.1 percent of 12th graders have used alcohol in their lifetime. Of even greater concern is the widespread occurrence of binge or heavy episodic drinking. Data from the 2005 Monitoring the Future Study, show that the prevalence of this behavior (defined in this survey as drinking five drinks or more in a row) among high school seniors was 28.1 percent during the two weeks asked about in the survey.
Given the early onset of drinking and its frequency, studies are urgently needed to identify and characterize the impact of alcohol exposure (particularly heavy episodic or binge drinking) on the maturation of the brain and on associated neurocognitive and behavioral processes. With brain development proceeding at the same time as rapid escalation in alcohol use, it is critical to consider potential effects of alcohol on brain functioning during and after adolescence. Recent reviews of research on the neurocognitive effects of alcohol on adolescents and college students as well as animal models of adolescence (Brown & Tapert, 2004; Spear & Varlinskaya, 2005; Zeigler et al., 2005) indicate that adolescent alcohol use can be associated with alterations in the brain and neurocognitive deficits, with implications for learning and other cognitive abilities that may continue to affect the individual into adulthood.
Alcohol Effects on the Developing Brain - Findings from Animal Studies
Animal studies have suggested that adolescence is a period of heightened vulnerability to the deleterious effect of alcohol on the brain, particularly the hippocampus, a key region for encoding new information. Other studies in animals have addressed the question of whether chronic alcohol exposure during adolescence results in behavioral changes in adulthood. In one study, rats were exposed to chronic, intermittent alcohol exposure either during adolescence or early adulthood. After a 20-day recovery period, there were no differences in spatial learning. However, when the animals were challenged with a low dose of alcohol, learning was significantly more impaired in the animals exposed to alcohol in adolescence than in those exposed as adults. In a study using a high-dose, four-day binge alcohol exposure paradigm applied to adolescent or adult rats, some brain damage was found in both age groups, but only the animals that had been exposed to alcohol during adolescence manifested damage in the frontal cortical olfactory regions and the anterior portions of the piriform and perirhinal cortices. This finding indicates that, at least with an extreme, binge-type alcohol exposure, certain brain regions are more susceptible to alcohol-induced damage during adolescence.
Taken together, these animal studies suggest that the adolescent brain is more susceptible to overt damage by alcohol when the exposure is sustained and very high, while long-term changes in behavioral alcohol sensitivity, possibly reflecting more subtle changes occur with lower doses in adolescent than in adult animals. Assuming that the latter behavioral findings are the result of alcohol-induced central nervous system changes, it is not clear whether such changes are the result of overt neurotoxicity or an alteration in the normal developmental trajectory of neural circuit development in adolescence.
Alcohol Effects on the Developing Brain - Findings from Studies of Human Adolescents
Morphometric studies of humans suggest that some neural alterations may predispose to risk for alcohol use whereas others may be the result of it. For example, the right amygdala has been found to be smaller in youths with a family history of alcohol dependence even prior to the onset of problem drinking, whereas hippocampal volumes may only be reduced after a history of alcohol use. In human adolescents with alcohol abuse or dependence, hippocampal volume has been found to be smaller than in age-matched non-drinkers. In other studies, neuropsychological and functional magnetic resonance imaging (fMRI) have shown that heavy alcohol use during adolescence is associated with poorer scores on tests of information retrieval, attention, visuospatial functioning, and abnormal brain response during spatial working memory. In addition, drinking which results in hangover or withdrawal symptoms is associated with decreases in performance over time. However, only longitudinal studies can determine whether,and to what extent, alcohol exposure during adolescence interferes with the normal trajectory of brain and behavioral development, and whether changes are permanent or reversible. Likewise longitudinal work will be important in establishing whether, and to what extent, the differences seen in the brains of drinking adolescents predate or result from their alcohol consumption.
Designing the Study to Address the Key Questions
Proposed designs should:
This may require a multi-site approach and innovative sampling strategies. Applicants may want to collaborate across sites to get the most appropriate sample. If so they will need to show evidence of collaboration and address any problems that a multi-site design might introduce.
Testing the Feasibility of the Design
Once the study has been designed, its feasibility should be evaluated. The feasibility portion of the application should be designed to improve the original study design through careful and selective piloting, and feasibility testing. The goal is to fine-tune the study in preparation for a Phase II application to conduct the full-fledged study.
Testing the feasibility of the design does not necessarily mean conducting a small scale version of the study. For example, the full fledged study may involve subjects all recruited at the same age, while testing the feasibility of the total design over a two year period may require recruiting subjects of different ages. Feasibility testing could also involve accessing existing cohorts to address certain design issues. Furthermore, some aspects of the study will require more extensive and/or intensive feasibility testing than others. For example, more may be known about the feasibility of certain aspects of the proposed overall design than others; more piloting and feasibility testing of the latter than the former will be needed. The feasibility phase should also demonstrate, in so far as possible, recruitment and retention of an appropriate sample.
Conclusion
This is part I of a two phase FOA. Ultimately the research feasibility studies in response to this Phase I FOA will lead to full-fledged Phase II studies to:
Assess the effects of alcohol exposure on brain, cognitive, and emotional/regulatory behavioral development during the pre-adolescent and adolescent periods.
Understand the short and long-term developmental sequelae of alcohol’s effects on the developing brain
Understand how other key aspects of development/maturation factor into alcohol’s effects on the developing brain;
Assess recovery of neural and behavioral function to better delineate alcohol’s short and long term effects on the developing brain and to determine if the plasticity characteristic of the adolescent brain makes it more or less vulnerable than the adult brain to alcohol's acute and chronic effects.
References
Brown SA, & Tapert,’s F (2004). Health consequences of adolescent alcohol use. In National Research Council and Institute of Medicine, Reducing underage drinking: A collective responsibility, background papers. [CD-ROM]. Committee on Developing a Strategy to Reduce and Prevent Underage Drinking, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press.
Giedd JN, Blumenthal J, Jeffries NO, Castellanos FX, Liu H, Zijdenbos A, Paus T, Evans AC, Rapoport JL. (1999). Brain development during childhood and adolescence: a longitudinal MRI study. Nat Neurosci, 2:861-863.
Spear LP. (2000). The adolescent brain and age-related behavioral manifestations. Neurosci Biobehav Rev, 24:417-463.
Spear LP, Varlinskaya, E. I. (2005). Adolescence alcohol sensitivity, tolerance, and intake. In M. Galanter (Ed.), Recent developments in alcoholism, Volume 17: Alcohol problems in adolescents and young adults, (pp. 143-159). New York: Kluwer Academic / Plenum Publishers.
Zeigler DW, Wang CC, Yoast RA, Dickinson BD, McCaffree MA, Robinowitz CB, Sterling ML. (2005). The neurocognitive effects of alcohol on adolescents and college students. Preventive Medicine, 40:23-32
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)
will use the NIH
Exploratory/Developmental Research Grant Award (R21) award mechanism. The
applicant will be solely responsible
for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete a detailed budget.
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
The R21 is not renewable.
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 Institutes and
Centers (ICs) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the submission of
a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, direct costs for applications submitted in response to this funding opportunity are limited to $350,000 per year.
The participating organization National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to commit approximately $2 million dollars in FY2007 to fund 3-5 applications.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
You may submit an application(s) if your institution/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 as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
2.
Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants may submit more than
one application, provided each application is scientifically distinct.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
one FOA.
For further assistance, contact GrantsInfo: Telephone
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.
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 Frequently Asked Questions Application Guide, 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 (required for foreign
applications.)
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional
Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants
to foreign (non-U.S.) organizations can be found in the NIH Grants Policy
Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
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.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: January 5, 2007 (Earliest
date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): February 28, 2007
Application Submission/Receipt Date(s): March
28, 2007
Peer
Review Date(s): June/July 2007
Council
Review Date(s): August 2007
Earliest
Anticipated Start Date(s): September 2007
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Abraham
Bautista, Ph.D.
Chief,
Extramural Project Review Branch, Office of
Extramural Activities
National
Institute on Alcohol Abuse and Alcoholism
Room 3039
5635 Fishers Lane
Bethesda, MD 20892-9304
Telephone:
(301) 443-9737
Fax: (301)
443-6077
Email:
[email protected]
3.B.
Submitting an Application Electronically 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.
In order to expedite the review, applicants are requested to notify the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Referral Office by email ([email protected]) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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, and for responsiveness
by the NIAAA.. Incomplete or non-responsive 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.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5.
Funding Restrictions
All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable. A grantee may, at
its own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.
6. Other Submission
Requirements
PD/PI
Credential (e.g., Agency Login)
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 Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
Organizational DUNS
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component 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.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:
Appendix Materials
The following materials may be included in the Appendix:
Foreign Applications (Non-domestic (non-U.S.) Entity)
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the administrative
review of each Non-Competing
Grant Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be
considered in the review process.
2. Review and
Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established Public Health Service
(PHS) referral guidelines.
Appropriate scientific
review groups convened in accordance with the standard NIH peer review
procedures (http://cms.csr.nih.gov/ResourcesforApplicants/)
will evaluate applications for scientific and technical merit. This language is
usually used when CSR is conducting the review, for this announcement the NIAAA
will be conducting the review. KFS 12/13/06.
Applications that are
complete and responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the National Institute on Alcohol Abuse and Alcoholism
(NIAAA) in accordance with the
review criteria stated below.
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 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?
Other Review Criteria
Is the application responsive to the FOA?
Is the proposed design appropriate for answering the key questions?
Will the study accrue a sample appropriate for addressing the key questions?
Are the proposed measures appropriate for addressing the key questions?
Have the high risk aspects of the study design been adequately identified, and appropriate feasibility testing to address them proposed?
How well is the proposed technology integrated into the theoretical perspective?
Is the proposed Phase I study designed to yield maximum input for preparation of a Phase II application?
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).
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.
Applications from Foreign Organizations: Whether the project presents 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 will be assessed.
2.C.
Sharing Research Data
Not Applicable.
2.D.
Sharing Research Resources
NIH policy expects
that grant recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources
sharing plan and any related data sharing plans will be considered by Program
staff of the funding organization when making recommendations about funding
applications. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
3.
Anticipated Announcement and Award Dates
Not applicable.
Section
VI. Award Administration Information
1.
Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his/her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under
consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the grants
management officer is the authorizing document. Once all administrative and
programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., Funding Restrictions.
2.
Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of
award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
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:
Vivian
Faden, Ph.D.
Division of
Epidemiology and Prevention Research
National
Institute on Alcohol Abuse and Alcoholism/NIH/DHHS
5635 Fishers Lane
Room 2087
Bethesda, MD 20892
Telephone:
(301) 594-6232
FAX:
301-443-8614
Email:
[email protected]
2. Peer Review Contacts:
Abraham
Bautista, Ph.D.
Chief,
Extramural Project Review Branch, Office of Extramural Activities
National
Institute on Alcohol Abuse and Alcoholism
Room 3039
5635 Fishers Lane
Bethesda, MD 20892-9304
Telephone:
(301) 443-9737
Fax: (301)
443-6077
Email: [email protected]
3. Financial or Grants
Management Contacts:
Judy
Fox, Chief
Grants
Management Branch|
National
Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Room 3023
Bethesda, MD 20892-9304
Telephone:
(301) 443-4704
Fax: (301)
443-3891
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal regulations (45 CFR 46) 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.
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) application; 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.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
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 HHS 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.
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 FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations: This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 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 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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