Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)

Title: The Genes, Environment, and Development Initiative (U01)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

• October 5, 2007 - See Notice (NOT-DA-08-003) NIDA will not be reissuing this FOA as NOT-DA-07-023 states.

Request For Applications (RFA) Number: RFA-DA-07-012

Catalog of Federal Domestic Assistance Number(s)
93.279, 93.399

Key Dates
Release Date: December 4, 2006
Letters of Intent Receipt Date(s): February 15, 2007
Application Receipt Date(s): March 15, 2007
Peer Review Date(s): June-July 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date(s): September 15, 2007
Additional Information To Be Available Date (Activation Date): N/A
Expiration Date: March 16, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• This Funding Opportunity Announcement (FOA) from the National Institute on Drug Abuse (NIDA) and the National Cancer Institute (NCI) launches the Genes, Environment, and Development Initiative (GEDI). This initiative will support research that investigates interplay among genetic, environmental, and developmental factors in the etiology of substance abuse and related phenotypes in humans.
• Applications qualifying for submission under this FOA must rely exclusively on existing studies/samples; new data collection is permitted only for the purpose of obtaining DNA from subjects from those established samples. Existing studies eligible for analyses within GEDI applications will be longitudinal in design, have collected data during at least two developmental periods, have assessed subjects in or through the period of risk for substance abuse and related phenotypes, have collected rich environmental data relevant to substance abuse and related phenotypes, have included DSMIIIR or DSMIV diagnoses as well as other categorical and/or quantitative measures of substance abuse and related phenotypes with demonstrated heritability, will have the ability to collect and share DNA, and contribute genetic, environmental, and developmental data to the NIDA Repository
• The total amount of funding to be committed to this program is $33.75 million (total costs) over 5 years. Each year $6.75 million will be awarded.
• Anticipated number of awards: 3-5
• Type of mechanism: Cooperative Agreement Project Grant (U01) Mechanism
• Budget and Project Period: Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. The total amount awarded and the number of awards will depend upon the focus, quality, and costs of the applications received. The total project period for an application submitted in response to this funding opportunity may not exceed five years. Awards issued under this FOA are contingent upon the availability of funds.
• Eligible Organizations include for-profit organizations; non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations; faith-based or community-based organizations.
• Eligible Principal Investigators include any individual with the skills, knowledge, experience, and resources necessary to carry out the proposed research. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Applicants may submit more than one application, provided each application is scientifically distinct.
• Telecommunication for the hearing impaired is available at: TTY 301-451-5936.

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

Nature of the Research Opportunity

This Request for Applications (RFA) from the National Institute on Drug Abuse (NIDA) and the National Cancer Institute (NCI) launches the Genes, Environment, and Development Initiative (GEDI). The GEDI will support research using existing research samples to investigate main effects, correlations, and interactions among genetic, environmental, and developmental factors in the etiology of substance abuse and related phenotypes in humans. The term "substance abuse" as used in this RFA refers broadly to several different but related concepts including substance use (quantity, frequency, patterns, trajectories) and substance abuse and dependence as defined by diagnostic criteria. While it is recognized that these concepts may not be interchangeable, the term substance abuse is used for the purposes of fluency. The term substance refers primarily to nicotine, alcohol, cannabis, cocaine, stimulants, and opiates, but also includes the entire range of licit and illicit substances of potential addiction. The term related phenotypes refers to constructs that have been shown empirically to convey risk for substance abuse, such as behavioral disinhibition. Developmental research refers to the study of progressive change that occurs as humans move through the lifecourse.

The National Institute on Mental Health (NIMH) has an interest in applications where the research contributes to knowledge about the interplay of genetic, environmental, and developmental factors in the etiology of adverse outcomes; however, no funds will be committed at this time.

Background

Prior lines of research have established that genetic, environmental, and developmental factors all contribute to vulnerability to substance abuse and related phenotypes. Both animal and human studies have demonstrated genetic influences on substance abuse, with heritability estimates ranging from 40-60%, and promising candidate loci and genes for substance abuse have been identified. Genetic influences have also been shown for many related phenotypes, and some (e.g., externalizing disorders) share genetic factors with substance abuse. Like other complex disorders, it is likely that multiple genes of small effects contribute to vulnerability to substance abuse and related phenotypes, and that environmental conditions moderate genetic influence. A wide variety of environmental variables have been correlated with substance abuse and related phenotypes, including in utero exposures, parenting, trauma and stress, peer influences and/or neighborhood and societal factors. Many of these correlations have been very strong and frequently replicated, forming the basis for numerous preventive intervention studies with youth at high-risk due to individual and familial factors in combination with the social context over the course of development. The role of developmental factors is highlighted not only by the fact that the human brain is an organ that continues to develop until the mid-twenties, but also by the changes in substance abuse patterns associated with significant developmental shifts, including childhood transitions, pubertal transitions (often coinciding with substance use initiation), transitions to greater independence after high school (associated with increased substance use and shifts from use to dependence) and adult role transitions such as marriage, parenting and full time employment (associated with decreased substance abuse). Although less well-understood, developmental timing of substance abuse has been assumed to be important as well, with different outcomes (e.g., addiction) expected depending on when certain events (e.g., onset of substance use) occur over the lifecourse. Expression patterns of genes associated with substance abuse change over the course of development, either through epigenetic modifications that are developmental and tissue specific, or through genetic variation that may impact gene expression during certain stages of neurodevelopment. For instance, animal studies have shown that exposure to nicotine during adolescence, compared to adulthood, predicts greater drug-seeking behavior and neurological change in critical areas of the brain. Similarly, human research has shown that prenatal exposure to nicotine increases the risk of nicotine dependence during adulthood.

While these lines of research have made important contributions to our understanding of substance abuse, they each have limitations in delineating the etiology of substance abuse and related phenotypes, and they can benefit from integration and interaction with the others. The inferential power of environmental and developmental studies can be significantly enhanced by the inclusion of analyses of gene-environment correlations, that is, genetic influences on environmental exposures. For example, by accounting for family history or genetic susceptibility to substance abuse, studies of prenatal-exposure effects on later behavior can better determine the role of passive gene-environment correlation, which in turn can help distinguish between exposure effects and family history as the source of behavioral outcomes. Similarly, studies of peer influences or parenting behaviors in adolescence will be strengthened by taking into account passive, active and evocative gene-environment correlations, which can help to clarify the role of the adolescent’s choices and behaviors in eliciting these environmental factors. In addition, molecular genetics studies seeking to identify specific susceptibility genes can be greatly enhanced in their power and accuracy by attending to interactions with environmental and developmental factors which may affect the expression of these genes.

Over many years, NIDA, other NIH Institutes, and other organizations have funded numerous high-quality longitudinal and developmental studies that contain a wealth of data from individuals who are at risk for, or are in the course of development, progression, and desistance of, substance abuse and related phenotypes. A valuable variety of variables associated with these outcomes has been measured on diverse samples across multiple domains and time points, characterizing psychopathology, temperament, familial relations and practices, peer relations and characteristics, school factors and broader environmental influences, as well as biological variables including in utero and toxic exposures, endophenotypes, and neurocognitive structure and function. In addition, the many randomized intervention trials that have been conducted over the years provide opportunities for strong inferences about the role of social environment in causality by focusing on presumed etiologic social factors and examining covariance of the social environment and adjustment over time. The GEDI seeks to build on this substantial public investment by soliciting applications that integrate environmental and developmental variables with genotypic information in order to permit comprehensive model-building and hypothesis testing for determining genetic, environmental, and developmental contributions to substance abuse and related phenotypes.

Applications qualifying for submission under this FOA must rely exclusively on existing studies of human subjects; new data collection is permitted only for the purpose of obtaining blood from subjects so that DNA and cryopreserved lymphocytes can be generated as a renewable resource and stored. Studies with DNA already collected are required to demonstrate that their DNA is a publicly available sharable resource, with a clear process for access to the samples by other qualified investigators. If the DNA samples are stored at a site other than the NIDA repository, plans for electronically depositing clinical data, phenotypic data, and genetic data into the NIDA Repository for access and sharing need to be provided. If the collection of new data is required to evaluate the disorder (e.g., for studies where individuals are just entering the period of risk for substance abuse), plans for collecting these data through another funding mechanism should be included. Datasets drawn from studies that involve an intervention trial are appropriate for this RFA; these proposals should address the approach to handling intervention effects when exploring etiologic questions. If intervention datasets are proposed for use to infer causal influence (i.e., to explore whether intervening on mediating variables changed outcomes in expected ways, thus demonstrating the strength of the mediator in causing the outcome of interest), then investigators must demonstrate successful randomization procedures and sufficient power to detect and explicate observed short- and long-term environmental intervention effects in the sample. Proposals requesting support to collect new data other than DNA under this RFA research mechanism or to conduct research using animal models will be considered non-responsive and returned to the applicant.

Eligibility Requirements of Existing Studies/Samples

Established studies/samples eligible for analyses within GEDI applications must include the following characteristics:

• Subjects who are in or through the period of risk for substance abuse and related phenotypes
• Subjects who have provided the appropriate consent for or can be re-contacted for additional consent for GEDI research (e.g., to permit data sharing, blood collection, genetic analyses, etc.)
• DSMIIIR or DSMIV diagnoses as well as other categorical and/or quantitative measures of substance abuse and related phenotypes with demonstrated heritability
• Environmental data relevant to substance abuse and related phenotypes
• Data waves spanning at least two developmental periods, such as in utero, infancy, early childhood, late childhood, early adolescence, late adolescence, emerging adulthood, and/or adulthood

Requirements of Proposals

• Applications should present a rationale that carefully balances important substantive, methodological, and budgetary issues. In particular, applications should fully address each of the following points, where applicable:
• Sample selection (e.g., particularly informative sub-samples and subgroups, understudied valuable populations)
• Research design (e.g., genetically-informative, birth cohort, multi-generational, selection by prenatal exposure, randomized intervention)
• Statistical power to detect the proposed main effects, correlations, and interactions. In cases where individual datasets lack sufficient power to address study aims, data from multiple sites may be pooled
• Where pooling is planned, the application must include procedures for combining data. In all cases where multiple datasets are used, pilot data must be provided within the application to demonstrate reasonable compatibility of data across studies and evidence of feasibility of multi-sample analyses
• In cases where multiple datasets are used, evidence of collaboration among sites must be shown
• Generalizability of results (i.e., population(s) to which findings can be applied)
• Phenotype(s) selection (e.g., specific heritable phenotypes, related phenotypes, endophenotypes)
• Number and timing of assessments (e.g., multiple waves ranging from pre- to post-substance exposure, from substance use initiation to disorder onset, or from disorder onset to remission)
• Selection and quality of assessments (e.g., diagnostic and/or symptom-based scales, measurement of salient individual and environmental factors)
• Comorbidity (e.g., psychiatric, polysubstance, physical illness)
• Timeline to collect and submit clean data (i.e., genetic, environmental, developmental data) to the NIDA Repository
• Consent by subjects to allow qualified investigators to use and analyze data and DNA
• In view of the technical complexity of the science called for in this announcement, the GEDI requires transdisciplinary alliances among researchers with appropriate breadth and depth of expertise. Applications should have a substantial commitment of personnel for statistical genetics and bioinformatics, with detailed plans for data collection, storage, communication, integration, analyses, and dissemination.
• Proposals are required to include detailed plans and timelines for replicating initial GEDI findings within the five-year award period. Plan(s) for replicating should be fully explained and justified given that there are many approaches for duplicating research findings (e.g., reproducing results between randomly selected subsamples from a single dataset, replicating findings across multiple datasets with comparable measures, pooling data from multiple datasets and replicating findings from randomly selected subsamples).
• Genotyping and analytic methodologies: Applicants should note that the genotyping platform ultimately chosen will be dependent upon an agreement within the GEDI Steering Committee (described in Section 6.2.A.3) to ensure consistent and standard genotypes and allele names. Although the genotyping approaches (candidate genes or whole genome scans, for example) outlined for each funded grant may differ, the GEDI Steering Committee will be expected to provide input on this effort among the cooperative agreements so that a consensus strategy is achieved. Nevertheless, a description and rationale of the platform(s) proposed for genotyping should be included. Applications should address the following:
  
  
  • An explicit rationale for the genotyping approach chosen (candidate gene, linkage analysis, whole genome association)
  • A plan to implement the genotyping and milestones for achieving the genotyping in the time frame of the funded period. This proposal should thoroughly discuss and justify the plans for genotyping, assessing genotype quality, and depositing the genotypes into the NIDA Repository.
  • All costs for genotyping, taking into account delivery of the DNA, genotyping SNPs, repeating failed samples, assessing genotype quality, deposition of the data, costs of the genotyping facility preferred. Depending on the GEDI Steering Committee recommendations, the genotyping facility may not be the one initially proposed. Budgets for future years may be contingent on the genotyping strategy chosen. Applicants should be aware that future years of allocation of funds for this component may be changed to reflect the scientific approach chosen and the funds needed.
  • A detailed analytic plan addressing issues related to the large amount of GEDI data to be generated, such as multiple-testing issues, assessing correlations and complex interactions (gene x environment, gene x development, environment x development, gene x environment x development), impact of population ancestry (stratification), false positives, etc.
  • A rationale for single SNP, multiple SNP (e.g., from multiple pathways) and/or haplotype-based analyses
    
    
• All phenotypic, environmental, developmental, and genotypic data analyzed through GEDI will be made available in de-identified form to the scientific community through the NIDA Repository. All investigators, whether or not they join the NGC, will be required to provide a timeline for submitting cleaned data to the NIDA Repository, and to participate in the NGC bi-annual meetings in Rockville, MD; travel and accommodations should be included in the budget.
• All applicants are encouraged to join the NIDA Genetics Consortium (NGC) and to submit blood samples as well as the required genetic, environmental, and developmental data to the NIDA Repository. Funds for up to 15,000 total samples (or 3,000-5,000 per award) for blood processing, DNA extraction, storage, and distribution will be provided for all awards joining the NGC. A budget needs to be presented if more than 5,000 samples will be collected. Additionally, a fee structure for distribution of DNA from the NIDA Repository can be found at: http://www.nida.nih.gov/about/organization/Genetics/FAQ_NCGS.html and applicants should determine if additional budgetary allocations are needed for DNA requests exceeding the NIDA Repository allowances. Studies funded under this FOA will not require NIDA Access Committee review.
• In cases where NGC membership is prohibited (e.g., by laws governing foreign-derived samples) or not chosen, applicants must (a) demonstrate that genetic, environmental, and developmental data can be submitted to the NIDA repository; (b) demonstrate that DNA samples have been or will be submitted to a publicly available repository that permits data sharing to qualified researchers; (c) present the repository’s quality control procedures for processing DNA, cryopreserving or immortalizing blood, and archiving DNA samples; and (d) describe the repository’s track record of providing data access by qualified investigators.

Close interaction among GEDI Investigators will be required to develop appropriate strategies and tools to design and conduct GEDI research. The awardees will convene as a GEDI Steering Committee, which will include representatives from each of the awards and the NIH, will meet twice a year and participate on monthly conference calls to share information on data resources, methodologies, analytical tools, as well as data and preliminary results. Subcommittees and working groups may be established, such as a genotyping or analysis group. A 4-5 member GEDI Advisory Board will also be created by the GEDI Steering Committee. Costs associated with attending meetings and monthly conference calls should be included in the proposed research budget. An additional budgetary item should include costs to support two of the GEDI Advisory Board members who will convene annually.

Scientific Knowledge to be Achieved

The GEDI has the primary goal of elucidating the contribution of genetic, environmental and developmental factors to the etiology of substance abuse and related phenotypes. Funded research under the GEDI is expected to lead to improved and tailored preventive and treatment interventions for these common and costly outcomes.

Examples of GEDI Research Topics

GEDI applications must address the interplay of genetic, environmental, and developmental factors related to substance abuse and related phenotypes. While individual components (e.g. genetic, environmental or developmental or their combination) may be examined within the application, the ultimate goal of the study must integrate these components.

Where possible, investigators are encouraged to explore how relationships differ by sex/gender and race/ethnic group.

Examples of appropriate research topics include, but are not limited to, the following:

• Studies of the role of gene-environment-development interactions in the initiation of drug use and progression to addiction, including but not restricted to studies of the impact of environmental factors in individuals with known genotypes for particular alleles
• Studies of the role of gene-environment correlation that clarify how individuals select and influence their environments over developmental stages, and to help identify true gene-environment-development interactions
• Studies employing refined and systematic environmental and developmental measures that identify salient factors (e.g., trauma, peers, siblings) associated with risk for substance abuse, stratified by genotypes associated with substance abuse or related disorders
• Studies to address the salience of initial drug exposure (e.g., developmental timing, type, amount, context, subjective and objective responses) for subsequent substance abuse risk and course, incorporating the role of genetic risk (genotype; gene-environment correlations and interactions)
• Studies that explore the heterogeneity of genetic, environmental and developmental contributions to substance abuse for different subgroups, including race/ethnic groups, sex/gender groups, cultural groups, etc.
• Identification of biomarkers, endophenotypes, and sub-clinical phenotypes that vary or change over development as a function of environmental and genetic risk
• Studies distinguishing the genetic, environmental, and developmental factors and their interactions in the vulnerability to substance abuse on specific drugs vs. factors contributing to general liability
• Studies that examine the differential effects of salient developmental (e.g., pubertal timing) and environmental (e.g., stress, peer influences) events interacting with other variables that confer or protect from vulnerability to substance abuse and related phenotypes
• Studies that explicate the mechanisms by which genes, environment, and development confer risk for substance abuse and related phenotypes (e.g. delinquency, gambling, HIV-risk behaviors)
• Studies of the interplay of genetic, environmental and developmental factors on differential patterns of risk associated with comorbid psychiatric disorders, including psychotic and internalizing disorders
• Studies of the interplay of genetic, environmental and developmental factors on differential patterns of risk associated with the timing and dosages of prescribed medications, including but not limited to psychostimulants
• Studies of underlying vulnerability factors and endophenotypes that may mediate genetic risk for substance abuse and related phenotypes, including studies of temperament and neurophysiology
• Studies that explore the impact of population differences in allele frequencies on gene x environment x development interactions for substance abuse and related phenotypes
• Research using molecular approaches to study the impact of cumulative, acute, and/or chronic environmental exposures or psychosocial stressors in specific developmental periods
• Research evaluating environment and development data that include the analysis of combined effects of gene variants from a gene family or cellular pathways involved in addiction
• Studies of in utero drug exposure that identify genetic and environmental factors that discriminate individuals who do and do not develop substance abuse and related phenotypes
• Studies that explore whether effective interventions focusing on social or other environmental elements work by altering gene expression, or whether genetic variability accounts for why interventions work for some participants and not for others
  
• Studies that address the interplay of genetic, environmental, and developmental factors within intervention outcome datasets, taking advantage of the unique opportunity within intervention research to infer causal influence by demonstrating changes in mediators that are related to outcomes of interest
• Studies of the interplay of genetic, environmental, and developmental factors associated with increased risk for behavioral disorders in offspring exposed to smoking in utero
  
• Studies of the interplay of genetic, environmental, and developmental factors conferring resilience in individuals at high risk for substance abuse and related outcomes
• Evaluation of functional polymorphisms that are moderated by environmental and developmental factors
• Studies analyzing the genetic mechanisms by which environmental factors such as therapeutic compounds, stress, alcohol, and drugs alter the expression of genes, e.g. through changing methylation status
• Approaches that specifically model combinations of:
  
  
  • Single SNPs, multiple SNPs, and/or haplotypes and environmental exposures,
  • Single SNPs, multiple SNPs,and/or haplotypes and developmental trajectories,
  • Single SNPs, multiple SNPs,and/or haplotypes and environment and development variables

Application Information Teleconference

NIDA staff will conduct an Application Information Teleconference at a date and time to be determined. This meeting will allow potential applicants to discuss and clarify any issues related to this FOA with NIDA staff. Detailed information about the meeting will be updated and available on the NIDA website (http://www.nida.nih.gov/about/organization/Genetics/index.html), and a set of frequently asked questions and staff responses will be posted. Please submit your questions via email to Dr. Weinberg ([email protected]) at least one day in advance of the teleconference.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U01 Research Project Cooperative Agreement award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator 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".

2. Funds Available

The total amount of funding committed to this program is $33.75 million (total costs) over a 5-year period. NIDA and NCI intend to commit approximately $6.75 million in FY2007 to fund 3-5 new grants in response to this FOA. An applicant may request a project period of up to 5 years and a budget for direct costs up to $2,000,000 dollars per year.

The anticipated start date is September 2007 and the program period will be from September 1, 2007 to August 31, 2012.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Foreign Institutions
• Domestic Institutions
• Faith-based or community-based organizations

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Milestones

All applications must include a specific section labeled Milestones for each year. Milestones should be listed for each year of the study, well-described, quantitative, and scientifically justified and not simply a restatement of the specific aims. Rather, the milestones should offer a timeline and a pathway for the development of the proposed research. For funded studies, these milestones will be used to judge the success of the research on an individual-project basis. It is expected that the milestones will be adjusted annually at the award anniversary dates to incorporate the group's scientific accomplishments and progress and to reflect any recommendations of the Steering and Advisory Committees.

Meetings

The GEDI investigators will be expected to attend Steering Committee meetings two times per year and participate in monthly conference calls to discuss their research progress. Funds to support travel of the key investigators to attend these meetings should be included in the application budget.

Multiple Applications

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

• Charge back of customs and import fees is not allowed.
• Format: every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8.5" x 11."
• Funds for up to 8% administrative costs (excluding equipment) can now be requested (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html)
• Organizations must comply with federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with federal/NIH biosafety and biosecurity regulations. See Section VI. 2. Administrative and National Policy Requirements .
• Applications from foreign (non-U.S.) institutions submitted using the PHS 398: Follow the NON-MODULAR FORMAT instructions and submit Form Page 4 and Form Page 5. Do not complete or submit the Modular Budget Format Page.

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): February 15, 2007
Application Receipt Date(s): March 15, 2007
Peer Review Date(s): June-July 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date(s): September 15, 2007

3.A.1. Letter of Intent

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 Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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:

DA-07-012
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications 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 additional copies of the application and all copies of the appendix material must be sent to:

Teri Levitin, Ph.D.
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by NIH. Incomplete and non-responsive applications will not be reviewed. If the application is not responsive to the FOA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

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 http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new 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 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

Plan for Sharing Research Data

Applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

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 (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Applicants are expected to include a plan addressing how they will exercise their intellectual property rights, while making such research resources available within and across the GEDI programs, and to the broader scientific community for research purposes consistent with the goals of the GEDI. A reasonable time frame for release of materials should be specified in the data sharing plan and will be considered by program staff. Furthermore, transfers of research resources must be made consistent with the NIH Research Tools Policy (http://www.ott.nih.gov/policy/rt_guide_final.html) and other NIH sharing policies. In the development of any sharing and intellectual property plans, applicants should confer with their own institution's office(s) responsible for handling technology transfer related matters and/or their sponsored research office. If applicants or their representatives require additional guidance in preparing these plans, they are encouraged to make further inquiries to the appropriate contacts listed below for such matters.

Program staff, in determining whether the application shall be awarded, will consider the adequacy of the proposed plans. The plans as approved after negotiation with the applicant when necessary will be part of the terms and conditions of the award. Evaluation of progress reports (PHS 2590) will include assessment of the awardee's adherence to the proposed plans, and will be a criterion for continued funding of the award.

Applicants also are reminded that the grantee institution is required to disclose each subject invention within 2 months after the inventor discloses it in writing to grantee institutional personnel responsible for patent matters. The lead institute reserves the right to monitor awardee activity in this area to ascertain if patents or patent applications are adversely affecting the goals of this FOA.

Public Domain of Data

All awards made under this FOA are subject to the Final NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (http://www.ott.nih.gov/policy/rt_guide_final.html). This document also defines terms, parties, and responsibilities, prescribes the order of disposition of rights, prescribes a chronology of reporting requirements, and delineates the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, http://www.iedison.gov. It is expected that research resources generated through the award will be shared by awardees according to these guidelines. The plans for the development of resources for use by the biomedical community will have the appropriate timelines and milestones. Program staff will evaluate the compliance with the sharing plan and scientific progress in the non-competing progress report (Form 2590); such compliance will be a criterion for continued funding of the award.

All extramural scientists will meet two times a year in order to share information. Key co-investigators and pre- and post-doctoral trainees, in addition to the PIs are eligible to attend these meetings. The costs of attending these meetings should be included in the proposed research budget.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance to program priorities

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 NIDA in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the appropriate national advisory council or board.

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 aspect of the interplay among genetic, environmental, and developmental factors in the etiology of substance abuse and related phenotypes? If the aims of the application are achieved, how will scientific knowledge 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 framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the approach take into account the interplay among genetic, environmental, and developmental factors in the vulnerability to substance abuse and related phenotypes? What is the compatibility of datasets when pooling or multisite analyses are proposed? Is there sufficient statistical power for the proposed analyses? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the data sharing and consent forms appropriate for the proposed research? What is the feasibility of obtaining consent to recapture samples and obtain consent to draw bloods, when necessary? What is the reasonableness of the milestones, timelines, and goals in relation to the proposed research? Is there a reasonable likelihood that the proposed project will produce results by the end of the funding period?

Innovation: Is the project original and innovative? Does the project integrate genetic, environmental, and developmental factors in a new way? Does the project develop or employ novel hypotheses, approaches, or methodologies to forward understanding of the etiology of substance abuse and related phenotypes?

Investigator: 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 in genetics, environmental studies, development, and statistical genetics and methodology to the project? What is the likelihood that the interdisciplinary team will work together productively, across sites when necessary, to meet the aims of the study?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (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 U01 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 final group of Awardees (Principal Investigators) funded through RFA-DA-07-012 may include one or more Research Projects in their entirety as originally submitted and/or may include individual Research Project components chosen to add value to the overall effort. The Genes, Environment, and Development Initiative (GEDI) Investigators will be expected to work in collaboration with each other, the GEDI Steering Committee, and the NIH Project Scientist(s) to achieve the goals of the initiative.

• Determine experimental approaches, design protocols, set program and project milestones and conduct experiments;
• Participate in all group activities, including meeting of awardees;
• Serve as a voting member of the GEDI Steering Committee, which is the governing board for the GEDI program;
• Not disclose confidential information obtained from other members of the project;
• Adhere to NIH policies regarding intellectual property and other policies that might be established as part of this activity;
• Submit periodic progress reports in a standard form, as agreed upon by the GEDI Steering Committee;
• Attend Steering Committee meetings and accept and implement the common guidelines and procedures approved by the GEDI Steering Committee and NIH

The Principal Investigator will retain custody of, and have primary rights to information developed under the cooperative agreement, subject to Government rights of access consistent with the current HHS, PHS, and NIH policies. Publication and copyright agreements and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH Grants Policy Statement.

An NIH Project Scientist will be assigned to each of the awarded U01 projects. This staff member is a scientist from the staff of any of the participating NIH institutes who is selected because of relevant scientific content-area expertise and experience with regard to the scientific goals and objectives of a given U01 award. These staff members will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of the NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the GEDI Steering Committee and that NIH will be given the opportunity to offer input into this process. There will be no more than 4 NIH Project Scientists participating as members of the Steering Committee; however, there will be only one NIH vote, reached by consensus. The Project Scientists will have the following substantial involvement:

• Participate with other GEDI Steering Committee members in the group process of setting research priorities, establishing and monitoring program milestones, and determining unique opportunities to enhance research. The Project Scientists will assist and facilitate the group process, not direct it.
• Attend all GEDI Steering Committee meetings and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action. The Project Scientists should be informed of all major interactions of members of the GEDI Steering Committee.
• Report periodically on the progress of the U01 program to the NIDA and NCI Directors and Advisory Councils.
• Serve on subcommittees of the GEDI Steering Committee as appropriate.
• Assist awardees in the development, if needed, of policies for dealing with situations that require coordinated action.
• Provide advice in the management and technical performance of the investigation.
• Assist in promoting the availability of the resultant products of the program to the scientific community at large.
• Participate in data analysis, interpretations and, where warranted, co-authorship of the publication of results of research conducted in this program.

Additionally, a Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Grant Award. The Program Director will closely monitor progress of assigned grants and recommend the withholding or reduction of support from any project that fails to achieve its goals or comply with the Terms and Conditions of award. The Program Director will not serve as the Project Scientist.

The GEDI Steering Committee will serve as the governing board for the Cooperative Agreements made in response to RFA-DA 07-012. Membership will consist of the Principal Investigator of each U01 award and NIH Project Scientist(s). The chair of the Steering Committee will be selected by vote. Principal Investigators are eligible to become the chair of the Steering Committee. It is anticipated that there will be no more than 4 NIH Project Scientists on the Steering Committee. If more are assigned to the awards, then membership will be rotated. There will be only one NIH vote, reached by consensus.

GEDI PIs must indicate their intention to be responsive to recommendations provided by an independent GEDI Advisory Board (GAB). Members of the GAB will be nominated by the GEDI Steering Committee in collaboration with NIH and will be invited by NIH. A chairman will be chosen from among the 4-5 members, who will be accomplished senior scientists from academia and industry with backgrounds in epidemiology, genetics, bioinformatics, statistics, and/or psychology. The GAB will meet annually in conjunction with one of the semi-annual meetings of the GEDI Steering Committee to review interim progress of the GEDI program and provide an annual report and recommendations to NIH and to the GEDI Steering Committee. The GEDI Steering Committee will discuss implementation of recommendations, plan a strategy and timeline for making these changes in a timely fashion, and report back to the GAB.

The GEDI Steering Committee will meet face to face two times a year and monthly on conference calls. The roles and responsibilities of the Steering Committee include:

• Developing common scientific and administrative policies, guidelines, and procedures for the GEDI program.
• Nomination and selection of members of the GEDI Advisory Board.
• Defining and monitoring program milestones and setting annual goals for the overall program.
• Identifying unique opportunities and providing recommendations to the NIDA and NCI Directors when collaborations, expediting a timeline, or additional supplement support, would substantially accelerate products that are in the pipeline in the research laboratories.
• Setting procedures and guidelines for program operations such as publication of research findings, data sharing, or distribution of unique resources emanating from the projects.
• Creating subcommittees as needed that include other Project Scientists who are not members of the Steering Committee.

All phenotypic, environmental, developmental, and genotypic data analyzed through GEDI will be made available in de-identified form to the scientific community through the NIDA Repository. All investigators, whether or not they join the NIDA Genetics Consortium (NGC), will be required to provide a timeline for submitting cleaned data to the NIDA Repository, and to participate in the NGC bi-annual meetings in Rockville, MD.

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:

Naimah Weinberg, M.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5185
Bethesda, MD 20892-9589
Telephone: (301) 402-1908
Fax: (301) 443-2636
Email: [email protected]

Glen D. Morgan, Ph.D.
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., Room 4034
Bethesda, MD 20892-7337
Telephone: (301) 496-8585
Fax: (301) 496-86756
Email: [email protected]

2. Peer Review Contacts:

Teri Levitin, Ph.D.
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email: [email protected]

3. Financial or Grants Management Contacts:

Daisey Parker
Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: 301-443-6710
Fax: 301-594-6849
Email: [email protected]

Crystal Wolfrey
Chief, Cancer Control and Population Sciences Branch
Office of Grants Administration
National Cancer Institute
6120 Executive Blvd., Suite 243
Bethesda, MD 20892
FAX: 301-496-8601
Phone: 301-496-8634
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 in response to this FOA regardless of cost, are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: Researchers funded by NIH who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see http://www.lrp.nih.gov.

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NIH Funding Opportunities and Notices

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