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 Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov )

Title: Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD)(U01 and U24)

Announcement Type
This is a reissue of RFA-AA-03-002 which was previously released October 31, 2002. 

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

Request For Applications (RFA) Number: RFA-AA-07-004

Catalog of Federal Domestic Assistance Number(s)
93.273

Key Dates
Release Date:  November 28, 2006
Letters of Intent Receipt Date(s): December 22, 2006
Application Receipt Date(s): January 22 2007
Peer Review Date(s): March 2007
Council Review Date(s): May 2007  
Earliest Anticipated Start Date(s): September 1, 2007
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: January 23, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to continue support of the previously funded “Collaborative Initiative on Fetal Alcohol Spectrum Disorders” (CIFASD), a multidisciplinary consortium of domestic and international projects that was established to address the in utero prevention of fetal alcohol spectrum disorders (FASD); the diagnosis of the full range of birth defects associated with prenatal alcohol exposure; and ameliorative interventions for affected individuals.  The initiative aims to accelerate the translation of key research findings by fostering collaboration and coordinating clinical, basic, and translational research.  Through this RFA, applications are sought that will continue and expand ongoing research efforts of the CIFASD consortium, taking advantage of the infrastructure that was established and where feasible, the prenatal alcohol-exposed cohorts that were identified in the previous funding period.   In addition, new applications from investigators not currently part of the consortium may be submitted as long as documentation is provided to establish pre-existing contact and cooperation with the CIFASD infrastructure prior to the time of submission. The new projects should add substantially to the direction and goals of the CIFASD and enhance the progress of future investigation. 

BACKGROUND

FASD is the collective term for the broad array of documented adverse effects resulting from in utero alcohol exposure.  The most serious of these is fetal alcohol syndrome (FAS), a devastating developmental disorder characterized by craniofacial abnormalities, growth retardation, and nervous system impairments that may include mental retardation.  Other diagnostic categories include partial FAS, alcohol-related neurodevelopmental disorder (ARND), and alcohol-related birth defects (ARBD)(Stratton et al., Fetal Alcohol Syndrome, Diagnosis, Epidemiology, Prevention and Treatment, National Academy Press, 1996).  Children with FASD may exhibit multiple cognitive, behavioral, and emotional deficits that impair daily functioning in many domains.

Despite major progress in characterizing the adverse effects of prenatal alcohol exposure and understanding the multiple mechanisms of ethanol teratogenicity in animal models, translational research leading to quantification of alcohol exposure, improved diagnosis of FASD, and appropriate treatments or interventions for affected individuals has not advanced sufficiently to improve clinical management of FASD.  Similarly, pharmacological or nutritional in utero interventions have only been minimally investigated.  To address these needs, the CIFASD consortium was established in 2003 in response to RFA AA-03-002 (http://grants.nih.gov/grants/guide/rfa-files/RFA-AA-03-002.html).  The consortium is led by a Consortium Coordinator and consists of core facilities (U24’s) and individual research projects (U01’s) that encompass epidemiology, clinical laboratory research, and non-human basic neuroscience research.

RESEARCH OBJECTIVES

The goals of this RFA are to develop definitive diagnoses of FASD at different stages of the lifespan based on biological, physical, neurological, or behavioral assessment, or a combination thereof; to develop and test effective interventions or therapies to improve functioning of individuals with FASD; and to develop potential maternal in utero therapeutics that may prevent or mitigate FASD outcomes.  The research projects should focus on one or more of the themes common to the overarching goals of the consortium, while making use of core resources established by the consortium during the initial funding period.  The composition of research projects and resource cores under the CIFASD consortium should reflect the progress made during the initial funding period, as well as new opportunities identified by the consortium. 

Research themes include the study of the FASD brain through imaging (functional and anatomical); the study of FASD craniofacial morphology using state-of-the-art morphometric technologies; further delineation of the FASD behavioral phenotype through the development of new or utilization of existing standardized neuropsychological tests with diverse populations of individuals with FASD and control populations that include individuals with other developmental disabilities as well as non-impaired individuals; exploration of potential screening or diagnostic modalities such as biomarkers of fetal or in utero alcohol exposure; development and testing of nutritional and/or age-appropriate behavioral, cognitive, or educational therapies for affected individuals; and structural chemical studies directed toward the development of new pharmacologic agents that may prevent or mitigate alcohol teratogenic injury.

Specific research areas include the following: 

Diagnosis of FASD

Diagnosis of FAS and ARND is difficult due to the lack of a definitive biological marker, nonspecific and often subtle symptomatology, differences in the severity and timing of the insult, individual differences in response and resiliency, and the overall complexity and plasticity of brain development.  Diagnosis in neonates and infants is further complicated because neurodevelopmental deficits important to case identification may not be discernable in infancy, and facial features may not be prominent in the neonate.  A clear diagnosis of FAS or ARND at any age greatly facilitates the management and treatment of neurobehavioral deficits and associated secondary disabilities.  Because the physical signs of FAS moderate with age, and behavioral manifestations of FASD change according to developmental stage, diagnosis during later childhood (puberty and beyond) is even more difficult than at younger ages.  Standardized diagnostic criteria and methods of assessing them are needed for all age groups from infants to adults. 

Enhanced understanding of the neurobehavioral phenotype of FAS and ARND

A comprehensive neurobehavioral database derived from data collected across multiple clinical sites is sought.  This database will enhance our ability to define diagnostic criteria that distinguish FAS, partial FAS, and ARND in children in different age groups and of different ethnic origins.   Investigations may seek to distinguish deficits that represent developmental delay from those that are the result of permanent structural or functional defects, as well as identify deficits that are shared with other neurodevelopmental disorders (e.g., attention deficit hyperactivity disorder, Williams syndrome, autism) and those that are unique to prenatal alcohol injury.  Knowledge gained from the database will also inform intervention studies targeted to the deficits characteristic of FASD.

Enhanced understanding of FASD dysmorphology through 2-D and 3-D image analyses

During the previous funding period a substantial database of facial and other structural features obtained by analysis of 2-D and 3-D camera images of individuals with prenatal alcohol exposure was established.  Data collection should be expanded to include images of exposed and unexposed children in different age groups and from different ethnic groups.  In prospective studies, collection of serial images of the same individuals over time is encouraged.   With a sufficiently large database, it may be possible to develop computer-based case recognition based upon machine learning for facial recognition coupled with neurobehavioral and other relevant data measurement (i.e., growth parameters, ethnicity, age).

Characterization of structural and functional neurobehavioral deficits

Non-invasive imaging techniques such as MRI, functional MRI, diffusion tensor imaging, and magnetoencephalography (MEG) applied to assess children with various degrees of prenatal alcohol exposure can enhance our understanding of the brain structural underpinnings responsible for the deficits in many cognitive and behavioral domains.  With detailed data on prenatal alcohol exposure (obtained either prospectively or retrospectively) correlations of structural and functional deficits with quantity and frequency of alcohol exposure, gestational period of exposure, dysmorphic features, and various co-factors may be achieved.  Such correlations may help to define the relationship between specific outcomes or severity of alcohol effects and patterns and/or gestational timing of exposure.

Early Case Identification

Neurobehavioral intervention research has shown that initiation of interventions at very early ages enhances performance outcomes.  However, this requires early case identification, which for FAS and ARND has been hampered by the difficulty of making diagnoses in neonates and infants.  To increase the potential for early case recognition, studies are needed to identify biological markers of prenatal alcohol exposure or alcohol-induced fetal injury utilizing clinical samples obtained from subjects identified prospectively or from animal models of prenatal alcohol exposure.  Genomic, proteomic, and metabolomic approaches may be appropriate. The utility of prenatal or neonatal ultrasound as a screening or diagnostic modality may also be explored.

Interventions to Reverse or Ameliorate Neurobiological Deficits

Brain damage resulting from ethanol teratogenesis leads to a broad array of neurobiological deficits that affect daily functioning in many domains.  Therapies of all types are needed at different developmental stages from infant to adult, and in different settings, in order to enable individuals affected by prenatal alcohol to reach their full potential.  Knowledge of the neurobehavioral characteristics of children with FAS and ARND will enhance development or application of targeted interventions.  A coordinated strategy combining a variety of therapeutic approaches, including medications, nutritional supplements, behavioral or cognitive therapy, and family therapy, may be needed to maximize the effectiveness of interventions.  It will be important to establish standardized protocols for testing potential therapies, which may include informative non-invasive functional imaging. 

Animal models of FASD are an important avenue for identifying potential interventions.  For example, dietary supplementation of the neurotransmitter precursor choline had beneficial effects on learning and memory performance in rats exposed to prenatal alcohol.  In another study, enhanced synaptic plasticity in the cerebellum of FASD rats was correlated with improved performance on a motor task after intensive training.   Pre-clinical evaluation of new combinations of behavioral and pharmacological therapies targeted to specific deficits would be appropriate.  Innovative exploratory research, such as repair and regeneration approaches, is also encouraged.

In Utero Therapeutics to Prevent FASD

In previous animal research using rodents, nutritional fortifications or pharmacologic agents administered during pregnancy have shown some potential as preventive therapeutics.  For example, neurotransmitters, antioxidants, trophic factors, and specific neuroprotective peptides have been shown to exert significant protection from prenatal alcohol injury.  Promising agents may warrant further investigation as to mechanism or efficacy and safety in additional models.  Where the identified therapy is a nutritional supplement (e.g., vitamins), limited trials in humans may be proposed.

ORGANIZATION OF THE CIFASD CONSORTIUM

An Administrative Coordinating Core is to be submitted by the designated Consortium Coordinator.   The administrative coordinating core will continue to provide oversight, coordination, and direction to the consortium.  It will coordinate use of core resources among the research projects, facilitate communications among the PIs, and facilitate data collection.  It will be responsible for managing the Scientific Advisory Panel and the Data and Safety Monitoring Board and oversee the activities of the clinical and basic research Steering Committees.  The administrative coordinating core may include an exploratory R21-like high-risk and high-return component.  The anticipated number of projects to be supported each year must be stated, and the process for selection and management of these types of projects must be described.  A brief description (no more than five pages) of the projects to be supported initially should include the rationale, objectives, approach, investigators, and importance to the consortium.

The Informatics Core will continue to collaborate with all projects and cores within the consortium and provide support and guidance to the research project components with respect to data collection, data entry, and statistical analyses.  Improvements or refinements of the current database operations may be proposed. 

Clinical Research Component:  Clinical projects should include cohorts of subjects at multiple sites, where appropriate and feasible, to increase the probability that results can be generalized to diverse FASD populations in terms of age, ethnicity, level of alcohol exposure, and postnatal environment.  Not all cohorts identified in the initial funding period will be suitable for all projects; every effort should be made to include existing cohorts from either the CIFASD or other prenatal alcohol exposure projects.  New cohorts may be proposed, provided their use will enhance the research goals of the consortium and feasibility can be demonstrated.

Basic Research Component:  Basic science projects must be clearly translational in nature and complement the clinical research projects.  Clinical biological samples should be used whenever it is feasible.  However, hypothesis-driven animal or in vitro studies that could not be conducted using clinical samples or human subjects may be proposed, provided the potential application to humans is clearly described. 

It is possible that the structure and function of some of the existing resource cores may be modified to increase efficiency and facilitate the consortium goals.  This process may include conversion of a core to an individual research project (U01), elimination of some cores that have outlived their utility, distribution of core objectives to multiple sites in order to take advantage of different expertise, or restructuring existing cores to enhance services and resources.  Any changes to the current resource core structure must be addressed and justified in the Administrative Coordinating Core application and the appropriate applications where they reside.  

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 NIH U01 and U24 cooperative agreement award mechanisms.

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 and U24 are cooperative agreement award mechanisms. 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". Plans to continue the CIFASD consortium beyond the current funding opportunity are indefinite.

2. Funds Available

The participating IC NIAAA intends to commit a total of $4 million dollars in FY 2007 to fund the continuation of the CIFASD consortium consisting of 8-10 new and/or competing continuation cooperative agreement awards in response to this RFA .  The CIFASD consortium has two components.  The set-aside for the clinical research component will be $3 million, and the set-aside for the basic research component will be $1 million.  The anticipated award date is September 1, 2007.  An applicant may request a project period of up to five years.  The average total cost of the cooperative agreement awards was $247,000 in FY 2003.   

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:

Foreign institutions may participate as applicants or subcontractors if they have unique patient or laboratory resources, unusual scientific merit, or documented evidence of prior successful collaborative arrangements. Several special provisions apply to applications submitted by foreign organizations.  These are detailed in Section IV.2.     
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. Applicants who are not currently PIs in the CIFASD consortium must provide evidence in the application of a collaborative relationship with the consortium.   

2. Cost Sharing or Matching

Cost sharing is not required.

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

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.  Investigators who are currently a member of the CIFASD consortium may submit a competing continuation and/or a new application. 

Applicants not previously funded under the CIFASD consortium must have established a collaborative relationship with the CIFASD consortium before the application is submitted.  A letter of collaboration from the Consortium Coordinator in the application is required as evidence of this eligibility criterion.

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) 435-0714, Email: GrantsInfo@nih.gov.

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.

Each application submitted as part of the CIFASD consortium must clearly indicate whether it is to be considered a U01 research project or a U24 resource core.  Research applications should add “(U01)” after the project title on the face page of the PHS 398.  Resource core applications should add “(U24)” after the title on the face page of the PHS 398.

Each application must have a cover letter that lists all of the applications that are being submitted in response to the RFA.  The list must include the following information for each application:  PI name, project title, applicant institution, and whether the application is to be considered part of the clinical research component or the basic research component.  The administrative coordinating core application from the Consortium Coordinator should identified as the lead application.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

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

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: December 22, 2006
Application Receipt Date(s): January 22, 2007
Peer Review Date(s): March 2007
Council Review Date(s): May  2007
Earliest Anticipated Start Date(s): September 1, 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Abraham P. Bautista, Ph.D.
Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3039, MSC 9304  
Bethesda, MD 20892-9304
Telephone: (301) 443-9737
FAX:  301-443-6077
Email:  bautista@mail.nih.gov  

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:

Abraham P. Bautista, Ph.D.
Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3039, MSC 9304 
Bethesda, MD 20892-9304
Telephone: (301) 443-9737
FAX:  301-443-6077
Email: bautista@mail.nih.gov

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 the NIAAA. Incomplete and non-responsive applications will not be reviewed. If the application is not responsive to the RFA, 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 or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Since the CIFASD consortium is a collaboration among the various projects, the applications will include both common text and unique text as follows.  Each application should have a clearly expressed intent to participate in a cooperative manner with all of the investigators in the consortium and with the NIH in all aspects of collaborative research as outlined in this FOA.  All awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in subsection 2.A of Section VI “Award Administration Information.” 

Research Plan

Items A-D of the Research Plan should not exceed 30 pages in each application. 

A. Specific Aims should include a common section that describes the consortium’s goals and objectives followed by the specific hypotheses and/or aims of the individual research project or resource core.

B. Background and Significance should include a common section that describes the rationale for the consortium, its organization and purpose, the unique aspects of the consortium, the nature of the collaborations, and the overall significance of the consortium.  This will be followed by background and significance specific to the aims of the individual research project or resource core.  This latter part will include a description of the continued/planned collaboration with the CIFASD and the significance of the project to the consortium.

C. Progress/Preliminary Data:  If the application is from a current member of the consortium, this section should include a common section that describes the general progress of the consortium as a whole to include major accomplishments, any changes in the goals and objectives of the CIFASD, new research opportunities identified, a description of problems encountered and how they were resolved.  This will be followed by a description of the progress related to the specific aims of the previously funded individual project (if the application is a competing continuation), a description of specific collaborations that were established during the previous funding period, and any additional new preliminary data.

D. Research Design and Methods.  This section is to be prepared in accordance with the PHS 398 instructions.  In addition, it should include a detailed description of how the project will integrate with other projects of the consortium, plans for utilization of specific resource cores and/or human subject cohorts established by the CIFASD if applicable, and plans for communication with other CIFASD investigators who will be collaborators on the project.

Budget Preparation

All applicants will use 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.

Requested budgets must include funds for travel by the Principal Investigator and selected key personnel to two meetings annually either at the NIAAA in Rockville, Maryland, at a relevant scientific meeting, or at one of the awardee institutions.  The Consortium Coordinator should request funds for conference calls for the entire consortium and for four Steering Committee meetings annually. 

Budgets for future years will include an annual increment for recurring costs, such as base salary and travel costs, of no more than three percent.

Appendix Materials

The appendix materials should include consent forms, manuals of operation, data forms, or standardized protocols specific to the individual research projects or resource cores.  Any materials that were developed in the initial funding period by a resource core that has been subsumed within another project should be included in that project’s application.

Other Submission Requirements for Administrative Coordinating Core

The responsibilities and activities of the Administrative Coordinating Core were outlined in Section I.1 “Research Objectives” under Organization of the CIFASD Consortium.  The application for this core must be submitted by the Consortium Coordinator. The Progress Report in the application will report on the overall success of the consortium and the specific activities of the consortium, including those of the Steering Committee and Advisory Panel.  Any changes in objectives or scope of the consortium that occurred during the previous funding period and the reasons should be described.  The Progress Report will also include a brief summary of the most significant findings from the pilot projects and list any publications arising from them.  Materials developed by any resource cores that have been eliminated should be in the appendix.  The Research Plan will include an administrative management plan for the consortium that describes how the various responsibilities of the Administrative Coordinating Core will be accomplished.  The plan will also detail the number, location, expertise, and services of the sites comprising the resource core facilities.  The rationale for any changes in the number and/or structure of existing resource cores should be described.

Exploratory project component:  If an exploratory project component is planned, a separate section for this component, not to exceed 25 pages, should be included in the application.  The component should describe all of the exploratory projects initially proposed for the consortium.  It is recognized that additional new projects may be proposed in later years of the renewal period.  The plan for selecting new projects and administering the projects, including the process for terminating projects should it become necessary, should be described fully, though succinctly.  The total number and anticipated scientific directions of the exploratory projects for the entire renewal period should be provided.  A full description of each study proposed for the first two years, not to exceed five pages each, will include its rationale, objectives, approach, investigators, and significance for the consortium.

Plan for Sharing Research Data

Because the investigators responding to this RFA will be part of the CIFASD consortium, all applications must contain a common data sharing plan.  The precise content of the data-sharing plan will depend on the data that are being collected and how the consortium is planning to share the data, both among the consortium investigators themselves and with the rest of the research community.  Both aspects of data sharing must be addressed in the plan.  The plan may include a schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices, or through a data archive).

All 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 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.  

NIAAA Program staff will also consider the adequacy of the plan and may negotiate modifications of the plan before an award is made.  The final approved version of the data sharing plan will be part of the terms and conditions of the award. The NIAAA 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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAAA in accordance with the review criteria stated below.

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project contribute to the overall goals and objectives of the consortium? Does the consortium address a complex biological problem that would be difficult to address by separate grants? 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  Is the proposal well integrated with other projects of the consortium?  Are the resources and subject cohorts utilized appropriately and effectively? 

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Is there evidence of effective collaboration with other investigators in the consortium? Does the expertise of the investigators strengthen the consortium as a whole?   

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

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

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: 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. All applications responding to this funding opportunity will contain a common data sharing plan.  The plan will include a description of how data will be shared among the consortium investigators and when and how data will be made available to the larger scientific community. 

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/archive/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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (NIH U 01 and U24), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for defining the research objectives, approaches and details of the project within the guidelines of the RFA and for performing the scientific activity.  Specifically, awardees have primary responsibility as described below.

The Principal Investigator retains primary responsibility for the performance of the scientific activity, and agrees to abide by the policies and rules set up by the CIFASD consortium.  This includes accepting the actions and recommendations approved by the Steering Committee.  In addition, each Principal Investigator agrees to accept close assistance in coordination, cooperation and participation of NIAAA staff in scientific and technical management of the project in accordance with the terms formally and mutually agreed upon prior to award.  The responsibility for the planning, direction, and execution of the proposed research project or resource core will be solely that of the Principal Investigator.  Each U01 and U24 project will receive a separate award, and the Principal Investigator will have control over the project’s operating budget.

Awardees will be required to attend monthly conference calls and two Steering Committee meetings annually.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIH Project Scientist will be an extramural staff person from the NIAAA, who is a partner within the consortium representing the NIH’s interest in the substantive work of the consortium.  The primary role of the Project Scientist is to facilitate the coordination necessary to accomplish the goals of the CIFASD consortium.  The Project Scientist will 1) assist in all functions of the two Steering Committees as described in section 2.A.3 below; 2) provide advice and technical assistance; 3) recommend consultants for appointment to the Steering Committees as needed; 4) participate in monitoring progress of ongoing research; 5) assist in the analysis, interpretation, and reporting of findings in the scientific literature and to the community at large and the public policy community within the Federal government through various media.  The NIAAA Project Scientist is subject to the same publication/authorship policies governing all participants in the consortium, as well as to the official NIH publication policy governing extramural employees.

The NIAAA Project Scientist will have full voting membership (one vote) on each Steering Committee and will attend all meetings of the Steering Committees.  The Project Scientist will provide liaison between the CIFASD consortium, the Steering Committees, and the NIAAA.   

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program official will attend the Steering Committee meetings as a non-voting member.

2.A.3. Collaborative Responsibilities

Scientific Advisory Panel

The CIFASD consortium will include an external scientific advisory panel whose purpose is to assess progress and provide feedback to the clinical and basic research Steering Committees on the proposed goals of the consortium each year.  The panel will also advise the Steering Committees on research design issues and data quality and analysis.  The external advisors will be appointed by the Consortium Coordinator in consultation with NIAAA program staff.  They will be research scientists not involved in the consortium.

Consortium Coordinator’s Rights and Responsibilities

The Consortium Coordinator coordinates the scientific and administrative activities of the CIFASD consortium and is responsible for the overall operation of the consortium, including the scientific and technical direction of the research projects.  The Consortium Coordinator also administers the selection and award of exploratory projects in consultation with the Steering Committees and reports on their progress.  The Consortium Coordinator ensures that all projects within the consortium are fully integrated within the scientific scope and mission of the consortium, including full access to all core resource facilities.  In addition, the Consortium Coordinator chairs the clinical and basic research Steering Committees (see below) and like all other participating investigators, must abide by the operating rules and guidelines developed by the Steering Committee.  The Consortium Coordinator agrees to accept participation of NIAAA staff in those aspects of management of the project described under “NIH Responsibilities.”  Finally, the Consortium Coordinator ensures the timely dissemination of information generated by the individual consortium projects to both the consortium investigators and the scientific public.

Steering Committees

The CIFASD consortium will have two Steering Committees, one for the clinical research component and one for the basic research component.  These committees are the main governing board for their respective components. Each committee develops collaborative protocols, sets research priorities, defines parameters for study, identifies technological impediments to success and strategies to overcome them, and decides when data and resources generated by the respective consortium component should be made available to the scientific community.  In addition, each Steering Committee will review the policies and procedures for oversight of the consortium currently in place and amend them as necessary.  The committees will also be responsible for monitoring compliance with those policies and procedures.

Each Steering Committee is composed of the Consortium Coordinator or his/her designate, who serves as the chairperson, the Principal Investigators of the relevant research project components and the core resource facilities, and the NIAAA Project Scientist.  Each Steering Committee may, when deemed necessary, invite additional, non-voting scientific advisors to the meetings at which research priorities and opportunities are discussed.  The NIAAA also reserves the right to augment the expertise of the Steering Committees when necessary, and to appoint additional NIAAA staff as non-voting members of the Steering Committees and any subcommittees.  Each Steering Committee may establish subcommittees to facilitate the planning and operation of the respective consortium components.

Each Steering Committee will conduct monthly telephone conferences and will meet two times each year to review progress and to set research priorities, modify goals or scientific directions of its respective research component, integrate relevant new information, and discuss any proposed modifications to the scientific approaches of individual projects.    In addition, proposed new exploratory projects that are relevant to the particular research component will be discussed and voted upon annually.  The two Steering Committees may meet jointly if the Consortium Coordinator deems that such a meeting is needed.  

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


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:

Laurie Foudin, Ph.D.
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2027, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-0912
FAX: 301-594-0673
Email: lfoudin@mail.nih.gov

or

Susan Maier, Ph.D.
Office of the Director
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2017, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 451-7583
FAX:  (301) 443-7043
Email: maiers@mail.nih.gov

2. Peer Review Contacts:

Abraham P. Bautista, Ph.D.
Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3039, MSC 9304 
Bethesda, MD 20892-9304
Telephone: (301) 443-9737
FAX:  301-443-6077
Email:  bautista@mail.nih.gov

3. Financial or Grants Management Contacts:

Judy Fox
Chief, Grant Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
FAX:  (301) 443-3891
Email: jfox@mail.nih.gov  

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

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

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/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.

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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