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: Limited Competition: Collaborative Study on the Genetics of Alcoholism (COGA) (U10)
Announcement Type
This is a modified reissue of a previous Letter
of Intent (LOI, AA-98-004)
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-AA-09-005
Catalog of Federal Domestic Assistance Number(s)
93.273
Key Dates
Release Date: December 18, 2008
Letters of Intent Receipt Date: January 23, 2009
Application Receipt Date:
February 23, 2009
Peer Review Date(s): April-May
2009
Council Review Date: August 2009
Earliest
Anticipated Start Date: September
1, 2009
Expiration Date: February 24,
2009
Additional Overview Content
Executive Summary
Purpose. This
Funding Opportunity Announcement (FOA) issued by the National Institute
on Alcoholism and Alcohol Abuse (NIAAA), National Institutes of Health,
is a limited competition FOA soliciting a cooperative agreement (U10) application
from investigators currently supported under an existing study, entitled
Collaborative Study of the Genetics of Alcoholism (COGA) to
(i) identify genetic variants that affect the susceptibility to develop
alcohol dependence in adult and adolescent populations, (ii) determine molecular
and functional mechanisms of these variants, (iii) identify and characterize
gene x gene and gene x environment interactions leading to alcoholism, (iv)
develop and refine phenotypes that will facilitate genetic analysis. (v)
perform prospective studies of COGA probands.
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, Review and Anticipated
Start Dates
1.
Letter of Intent
B. Sending an Application
to the NIH
C. Application Processing
D. Application
Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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
1.
Principal Investigator Rights and Responsibilities
2.
NIH Responsibilities
3.
Collaborative Responsibilities
4.
Arbitration Process
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
Background
The Collaborative Study of the Genetics of Alcoholism (COGA) is a joint multi-disciplinary project that has been supported by the National Institute of Alcohol Abuse and Alcoholism (NIAAA) since 1989 and more recently also by the National Institute on Drug Abuse (NIDA). It seeks to identify the role of genes in susceptibility to (or protection from) developing alcohol dependence and related phenotypes. The ultimate goal is to understand the functional effects of variation at genes identified in these studies, including effects on expression, at the molecular and cellular level. Investigators with complementary expertise in molecular and cellular biology, neurophysiology, and psychiatry have collaborated over the years to identify genes in which nucleotide sequence variation affects the risk for alcoholism and related disorders. This approach was built on linkage and association studies in severely affected individuals within families. COGA collected data from more than 300 extended families consisting of more than 3,000 individuals. This dataset is a rich resource for alcohol researchers and for investigators interested in determining the genetic basis of other complex disorders that frequently influence the development of alcoholism, such as anxiety and major depression. The COGA dataset has also served the larger research community as a resource for examining functionally-based endophenotypes and in testing new analytical approaches.
COGA has identified a number of candidate genes associated with increased risk of alcoholism. One of the strongest findings of association was with GABRA2, which encodes one of the receptor subunits for the inhibitory neurotransmitter, GAGA. This association was replicated in many independent cohorts. More recently, COGA identified a novel candidate gene for risk of developing alcohol dependence, namely Nuclear Factor (NF) ?B, specifically the NF-?B1 gene. NF-?B is known to regulate many genes in the human brain. Family-based association studies indicated an association between alcohol dependence and SNP markers across the NF-?B1 gene, which encodes the p105 precursor protein of the p50 subunit of NF-?B.
Individual SNP genotyping across entire chromosomes, denser genotyping across exonic and intergenic regions, and the use of linkage disequilibrium (LD) mapping have been useful in identifying genes associated with alcohol dependence or related endopheonotypes. Candidate gene approaches are useful, but limited by the current level of knowledge in neurobiology and other functional aspects, such as the environment. However, in recent years, the development of economical dense SNP array-based technologies has led COGA to begin Genome-wide Association Studies (GWAS) to identify novel genes in their sample using a case-control approach to complement their family-based studies. Within the case sample were individuals from highly affected families used in previous family-based studies. Like the individuals in the case group, the control group members are unrelated to each other. Replication studies are needed to follow-up positive findings from GWAS.
In addition to genetic effects, COGA has also initiated studies examining in a high risk cohort of adolescents and young adults to identify environmental influences such as parental alcoholism, parental monitoring, and peer relations on binge drinking and the development of alcohol dependence. To complement these studies, COGA has participated in obtaining longitudinally-derived blood samples for establishing lymphoblastoid cell lines (in collaboration with Rutgers Cell Repository) for examining molecular indicators of effects of alcohol in individuals.
COGA is also focused on developing and refining phenotypes and endophenotypes (i.e. neurophysiological phenotypes) and applying these measures to adolescents and young adults in the COGA sample, and in performing genetic analyses on measures as predictors of risk to develop alcoholism and related disorders.
In total, the COGA project will likely add to its accomplishments enhancing our understanding of the genetic and biological basis of alcoholism. The information afforded will suggest better treatments and help identify subsets of individuals who respond better to treatment, making a significant step toward attaining the goal of personalized medicine.
Objectives
The goal of this limited competition is to identify and characterize gene variants that confer risk for, or protection from, the development of alcohol dependence and to understand molecular mechanisms that are impacted by these variants. The following scientific areas are of interest to NIAAA in the continuation period. However, NIAAA recognizes that not all of these studies may be possible due to budget limitations and leaves the justification of the studies selected for this continuation period to principal investigators. Thus, areas of research areas appropriate to this announcement include, but are not limited to:
The Role of NIAAA
The NIAAA staff role in these cooperative agreements will extend the level normally required for stewardships of a grant because of the need for coordination across sites. An NIAAA Program Official will be convened to effect management decisions required during the course of the project. As the genetic analysis and functional studies are planned, NIAAA will oversee the collection of certain common data elements to be collected across all sites, and provide technical assistance and support as needed to further access genetic variations within COGA samples. In addition, an NIAAA Staff Collaborator(s) will have substantial scientific input, in collaboration with award recipients, in both the planning and conduct of the study. The primary purpose of participation by the Staff Collaborator(s) is to facilitate the coordination necessary to perform this complex collaborative project. The NIAAA Staff Collaborator(s) will participate in monitoring the progress of the ongoing study, perform quality control, data analysis, and interpretation, and possibly assist in the preparation of publications. To assist in fostering the collaborative nature of this project and to monitor its progress, NIAAA will sponsor an annual meeting at which each site will present the major findings of its activities and plan collaborative efforts to analyze, interpret and disseminate findings based on the common items included across sites. Applicants should include cost for this meeting in their budgets.
1. Mechanism of Support
This funding opportunity will use the U10 award
mechanism.
The Project Director/Principal Investigator (PD/PI)
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award.
This FOA uses Just-in-Time information. It also uses non-modular budget formats. U.S. Applicants requesting more than $250,000 in annual direct costs must submit budget requests using the budget component. Applicants see http://grants.nih.gov/grants/funding/modular/modular.html.
2. Funds Available
Because of the nature and scope
of the proposed research, it is anticipated that the size and duration
of the award may 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.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
The following organizations/institutions are eligible
to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
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
Number of Applications. This is a limited competition. Only one application
will be considered.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are permitted in response to this FOA.
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 in item (box) 2 only of the face page of the application form
and the YES box must be checked.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed 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 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, and should include 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.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
Applications must be received on or before the receipt
date described below (Section IV.3.A). Submission
times N/A.
3.A.Receipt,
Review and Anticipated Start Dates
Letters of Intent Receipt Date:
January 23, 2009
Application Receipt Date: February 23, 2009
Peer Review Date(s): April-May 2009
Council Review Date: August 2009
Earliest
Anticipated Start Date: September
1, 2009
3.A.1. Letter of Intent
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
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2085
Bethesda, MD 20892-9304
Telephone: 301-443-9737
FAX: 301-443-6077
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the 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 three 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).
At the time of submission, two (2) additional copies
of the application and all copies of the appendix material must be sent
to:
Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2085
Bethesda, MD 20892-9304
Telephone: 301-443-9737
FAX: 301-443-6077
Email: [email protected]
3.C. Application Processing
Applications must be received on or before the application receipt date) described
above (Section IV.3.A.). If an application is
received after that date, the application may be delayed in the review process
or not reviewed. Upon receipt, applications will be evaluated for
completeness by the CSR and for responsiveness by the reviewing Institute
Incomplete and/or non-responsive 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 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.
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 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 an award if such costs: 1) are necessary to conduct the project,
and 2) 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 limited competition
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 and Information
The awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A Award Administration Information.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/ for recent modifications.
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 that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAAA and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer 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 meritorious 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?
For applications designating multiple PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance, and organizational
structure, consistent with and justified by the aims of the project and
the expertise of each of the PDs/PIs?
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 PD/PI(s) and other key personnel 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 PD/PI(s)
and investigative team bring complementary and integrated expertise to the
project (if applicable
Environment: Do(es) the scientific environment(s) 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 rating:
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 on Human Subjects in the PHS 398
instructions).
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 on Human Subjects in the PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five
points described in the Vertebrate Animals section of the Research Plan
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. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and
Award Dates
Not applicable.
Section VI. Award Administration
Information
1. Award Notices
After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
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).
The following Terms and Conditions will be incorporated
into the award statement and will be provided to the Principal Investigator
as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of
Award
The following special terms of award are in addition
to, and not in lieu of, otherwise applicable OMB administrative guidelines,
HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92
is applicable when State and local Governments are eligible to apply), and
other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients' activities
by involvement in and otherwise working jointly with the award recipients
in a partnership role; it is not to assume direction, prime responsibility,
or a dominant role in the activities. Consistent with this concept, the
dominant role and prime responsibility resides with the awardees for the
project as a whole, although specific tasks and activities may be shared
among the awardees and the NIH as defined below.
2. A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for:
Awardees will retain custody
of and have primary rights to the data and software developed under these
awards, subject to Government rights of access consistent with current
HHS, PHS, and NIH policies.
2.
A.2. NIH Responsibilities
A NIAAA Program Director, acting as the Staff Collaborator, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.
The NIAAA Staff Collaborator will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, this individual will seek NIAAA waiver.
Additionally, an NIAAA Program Director, acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice.
2. A.3. Collaborative Responsibilities
The PIs and the NIAAA Staff Collaborator will participate in regularly scheduled monthly Steering Committee meetings to coordinate implementation and evaluation of the ongoing projects. The Steering Committee will consist of a minimum of one member from each participating site and the NIAAA Staff Collbarator. Every participating site and the NIAAA Staff Collaborator will each have a single vote on the Steering Committee. All Steering Committee decisions and recommendations that require voting, will be based on a majority vote.
Additionally, the PIs and the NIAAA Staff Collaborator will participate in a yearly meeting to present major findings, to plan collaborative efforts, to assist in analysis, interpretation, and dissemination of scientific findings.
2.A.4. Arbitration Process
Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to arbitration. An Arbitration Panel composed
of three members will be convened. It will have three members: a designee
of the Steering Committee chosen without NIH staff voting, one NIH designee,
and a third designee with expertise in the relevant area who is chosen by
the other two; in the case of individual disagreement, the first member
may be chosen by the individual awardee. This special arbitration procedure
in no way affects the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Antonio Noronha, Ph.D.
Director, Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2016, MSC 9304
Bethesda, MD 20892-9304
Telephone: 301-443-7722
FAX: 301-443-1650
Email: [email protected]
2. Peer Review Contacts:
Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2085
Bethesda, MD 20892-9304
Telephone: 301-443-9737
FAX: 301-443-6077
Email: [email protected]
3. Financial or Grants Management Contacts:
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane MSC 9304 Room 3023
Bethesda, MD 20892-9304
[For express mail use: Rockville, MD 20852-1705]
Telephone: 301-443-4704
FAX: 301-443-3891
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and
Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference
to the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risks to the
participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants
and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions,
on issues related to institutional policies and local IRB rules, as well
as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor
the plan into the determination of the scientific merit or the priority
score.
Policy for Genome-Wide Association Studies
(GWAS):
NIH is interested in advancing
genome-wide association studies (GWAS) to identify common genetic factors
that influence health and disease through a centralized GWAS data repository.
For the purposes of this policy, a genome-wide association study is defined
as any study of genetic variation across the entire human genome that
is designed to identify genetic associations with observable traits (such
as blood pressure or weight), or the presence or absence of a disease
or condition. All applications, regardless of the amount requested, proposing
a genome-wide association study are expected to provide a plan for submission
of GWAS data to the NIH-designated GWAS data repository, or provide an
appropriate explanation why submission to the repository is not possible.
Data repository management (submission and access) is governed by the
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies, NIH Guide
NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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 Requirement:
In accordance with the NIH Public Access Policy
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their
final, peer-reviewed manuscripts that arise from NIH funds and are accepted
for publication as of April 7, 2008 to PubMed
Central (http://www.pubmedcentral.nih.gov/),
to be made publicly available no later than 12 months after publication.
As of May 27, 2008, investigators must include the PubMed Central reference
number when citing an article in NIH applications, proposals, and progress
reports that fall under the policy, and was authored or co-authored by the
investigator or arose from the investigator’s NIH award. For
more information, see the Public Access webpage at http://publicaccess.nih.gov/.
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.
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. 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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