Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
  

Components of Participating Organizations

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

DNA Repository for the NIAAA National Epidemiologic Survey on Alcohol and Related Conditions–III (NESARC–III) (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements 

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AA-12-001

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.273 

FOA Purpose

The purpose of this initiative is to support the infrastructure needed to ensure the receipt, DNA extraction and quality control, genotyping ancestry informative markers, storage, and distribution to a sequencing laboratory of high-quality DNA collected in the NIAAA National Epidemiologic Survey on Alcohol and Related Conditions–III (NESARC–III).  NIAAA seeks Research Resource Center applications (U24) under this Funding Opportunity Announcement (FOA).  The long-term goal of repository activities included under this FOA is to provide a foundation for future data sharing of phenotypic and genetic data from the NIAAA NESARC–III and the development of cyberinfrastructure that will integrate genetic and genomic resources to provide a usable and enabling framework for human genetic research and gene discovery in alcohol use disorders and their associated disabilities.

Key Dates
Posted Date

March 22, 2011

Letter of Intent Due Date

April 24, 2011

Application Due Date(s)

May 24, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July-August 2011

Advisory Council Review

October 2011

Earliest Start Date(s)

December 1, 2011

Expiration Date

May 25, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The National Epidemiologic Survey on Alcohol and Related Conditions–III (NESARC–III) is a nationally representative survey of the United States funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).  The NESARC-III will collect detailed information on alcohol use and disorders and related physical and mental disabilities in addition to DNA to be obtained through saliva samples.  The planned sample size is 46,500.  The target population of the NESARC-III is the civilian noninstitutionalized population, 18 years and older, residing in the contiguous United States (U.S.) and Alaska and Hawaii.  The sample will include persons living in households and selected noninstitutionalized group quarters.  The NESARC-III will be fielded in February, 2012, with a one-year data collection period.  A major objective of the NESARC–III is to quantify the magnitude of the problem of harmful alcohol use, alcohol use disorders, and their associated mental and physical disabilities in the general U.S. population.   Understanding the distribution of these conditions across important subgroups of the population, especially those defined by age, sex, and race-ethnicity, can also be invaluable in developing rational and scientifically based intervention and prevention programs.  Additional objectives include assessment of treatment utilization patterns and unmet treatment need for these conditions in order to understand the burden on treatment delivery systems and the number and characteristics of individuals in need of treatment for purposes of planning and redirecting treatment and services to those most in need of them.  Data on treatment utilization will also be used to examine barriers to treatment for alcohol use disorders and their associated disabilities, particularly among low-income groups, women, young adults, and race-ethnic minorities.  NESARC–III data on disparities in the prevalence of harmful alcohol use and alcohol use disorders, coupled with information on treatment disparities, will achieve the objective of reducing or eliminating health disparities by identifying environmental risk factors that give rise to those disparities.

At the heart of the NESARC-III is the objective of identifying environmental and genetic risk factors, and their interactions, that are associated with harmful alcohol use patterns, alcohol use disorders, and their associated disabilities.  The sample size of the NESARC–III defines it as the largest study ever conducted to examine environmental and genetic contributions related to alcohol use disorders and their associated disabilities that are often comorbid.  Neither genes nor environment alone can explain why any particular individual develops harmful drinking practices or alcohol use disorders and their associated, often comorbid, disabilities.  Rather, risk of these conditions is a complex interplay of multiple genes, multiple environmental factors, and their interactions.

To date, genome-wide association studies (GWAS) have examined about 3 million points of common variation in the human genome.  GWAS used genotyping to measure hundreds of thousands of these single base differences such as single nucleotide polymorphisms (SNPs), many of which have been shown to be associated with risks of alcohol use disorders and their associated physical and mental disabilities.  However, these genomic variants discovered to date can only explain less than 5.0 percent of the genetic risk.  Only recently has it become clear that, in addition to common variations in sequence(s), e.g., SNPs, individuals also have rare variations in genomic segments.  Generally, these variants are known as copy number variations (CNVs), which are variations within the genome that result from deletions or duplications of genomic segments.  These can be quite large, involving millions of bases of DNA.  Many scientists believe that CNVs, unlike single base changes studied in GWAS that have very modest effects on risk, may be more penetrant, that is, have larger effects and be more likely to cause alcohol use disorders and their associated disabilities.

Several recent advances in the genetic sciences have made it possible to move beyond the GWAS paradigm that described the DNA bases present at specific locations of the DNA sequence to DNA sequencing that allows determination of almost the complete DNA sequence of the human genome (three billion base pairs’ worth).  DNA sequencing information, in turn, facilitates the examination of a wider array of genetic variations that may relate to harmful alcohol use, alcohol use disorders, and their associated disabilities, including CNVs, substitutions, insertions, inversions,  and deletions of base letters, in addition to SNPs.  A further advantage of analyzing the entire genome is that unlike its predecessor, genotyping, it allows reanalysis of sequencing data in the future for further interpretation as new discoveries are made.  Accordingly, a major objective of the NESARC–III is to sequence the entire genome for the purpose of identifying the genetic and environmental contributions to harmful alcohol use, alcohol use disorders, and their associated disabilities.

Program Objectives

The intent of this FOA is to seek applications for and support of one DNA Repository for the NIAAA National Epidemiologic Survey on Alcohol and Related Conditions–III (NESARC–III) to ensure the infrastructure necessary to receive, extract and conduct quality control procedures, genotype ancestry informative markers, store, and distribute high-quality DNA to a sequencing laboratory.  The Repository funded under this FOA will be directed by a Principal Investigator (PI), and will receive guidance from NIAAA program staff to assist with identification and implementation of appropriate strategies and procedures.

Research Topics

Specific functions and services to be performed by the DNA Repository for the National Institute on Alcohol Abuse and Alcoholism National Epidemiologic Survey on Alcohol and Related Conditions–III will include, but are not limited to:

Receipt of approximately 43,000 Oragene–500 DNA Tube Format saliva samples collected in respondents’ households by the NESARC–III interviewers.  All samples will be de-identified and barcoded with preset format (128C format with 14 digits).  Bulk shipments of samples will be sent to the Repository by Westat (NIAAA NESARC–III contractor) and will commence on or about February, 2012, and each month thereafter for 12 months.  The number of samples shipped each month to the Repository will be greater during the first 6-month data collection period (between 3,600 and 3,800 samples) than during the last 6-month data collection period (between 2,850 and 3,425 samples).  Any new barcodes applied by the Repository must retain links to the original barcodes.

Automated extraction of genomic DNA from each 4 ml saliva sample (2 ml of saliva, 2 ml of Oragene DNA preserving solution) using the most optimal platform in terms of integrity, quality, and quantity of the purified samples.

Good-quality DNA has an A260/280  ratio between 1.8 and 2.0.  In the event that a sample has a ratio of less than 1.6, methods should be used to clean impurities from that sample and increase the quality of the DNA (e.g., additional centrifugation of re-hydrated DNA samples, chloroform purification step).

Extensive DNA extraction quality control on each sample including determination of concentration and purity (e.g., gel electrophoretic analysis), detection of DNA contamination and genotyping of all DNA samples (96-SNP marker panel).  Samples failing to genotype will undergo additional purification and normalization. 

In rare instances, performance of whole genome amplification for samples containing very limited amounts of DNA.

If applicable, carrying out all pre-testing requirements for DNA supplied by the Repository to the sequencing facility (e.g., OD260/280  ratios, sample concentration standardization).

Aliquot in 96-well format for genotyping using a SNP panel not to exceed 200 ancestry-informative markers specified by NIAAA.

Storage of DNA samples in solely NIAAA-dedicated -80°C freezer(s).  Samples are to be stored in 2D barcoded  microvials in 96-well format in  barcoded racks.

Sample selection to allow for cherry picking of specific samples  across storage racks prior to distribution.

Distribution of DNA in 96-well format or other required format to sequencing facility specified by NIAAA.

Entry of sample identification and all quality control and related data into a laboratory information management system to track and monitor sample status and generate reports.  This information management system will receive saliva sample tracking, receipt ,shipment, and other  related data from Westat.

Assurance of security, privacy, and confidentiality of genetic data through all information infrastructure components.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities..

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAAA intends to fund one award, corresponding to a total cost of $3.0 M, for fiscal year 2012.

Award Budget

Ceiling level of funding for the program is $2.7 M total costs (including direct and indirect costs) per year.

Award Project Period

4 years

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
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are allowed.   

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.   

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity


The letter of intent should be sent to:

Abraham P. Bautista, PhD.
Director, Office of Extramural Activities, NIAAA
5635 Fishers Lane, Suite 2089
Rockville MD 20852
Telephone: 301-443-9737
Email: bautista@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Abraham P. Bautista, PhD.
Director, Office of Extramural Activities, NIAAA
5635 Fishers Lane, Suite 2089
Rockville MD 20852
Telephone: 301-443-9737
Email: bautista@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the PHS398 Application Guide..

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.     

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute on Alcohol Abuse and Alcoholism, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.     

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?        

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.   

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research..   

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIAAA , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the national Advisory Council on Alcohol Abuse and Alcoholism. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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.

The PD(s)/PI(s) will have the primary responsibility for:

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NIAAA Project Collaborator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIAAA Project Collaborator will not attend peer review meetings of renewal or supplemental applications related to the project (unless IC waiver is obtained) and may not be involved in the normal programmatic stewardship of the project.  If such participation is essential, this individual will seek NIAAA waiver. An NIAAA Program Official will handle the normal stewardship of the award, as described below.

NIAAA Staff Responsibilities:

The NIAAA Project Collaborator will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the NIAAA Program Official, and the NIAAA Project Collaborators.

The NIAAA Project Collaborators will coordinate and facilitate the DNA repository activities, and in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action.

The NIAAA Program Official will review the scientific progress of the U24, and review them for compliance with the operating policies, and may recommend withholding of support, suspension, or termination of an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee.

The NIAAA Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.   

Areas of Joint Responsibility include:

Dispute Resolution:

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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16..

3. Reporting

When multiple years are involved, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.      

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Bridget F. Grant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone 301-443-7370
Email: bgrant@mail.nih.gov

Peer Review Contact(s)

Ranga Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: srinivar@mail.nih.gov

Financial/Grants Management Contact(s)

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov  

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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