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EXPIRED

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: Developmental/Exploratory Alcohol Research Centers (P20)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-AA-07-001

Catalog of Federal Domestic Assistance Number(s)
93.891

Key Dates
Release Date: June 1, 2006
Letters of Intent Receipt Date(s): November 17, 2006
Application Receipt Date(s): December 20, 2006
Peer Review Date(s): March-May 2007
Council Review Date(s): October 2007
Earliest Anticipated Start Date(s): December 1, 2007
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: December 21, 2006

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Telecommunications for the hearing impaired is available at: TTY 301-451-5936

This funding opportunity will utilize the P20 mechanism, and is announced in parallel with alternative funding opportunities for Specialized Alcohol Research Centers (P50) (RFA-AA-07-002), and Comprehensive Alcohol Research Centers (P60) (RFA-AA-07-003).

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. 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
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

The Alcohol Research Center program of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides leadership in conducting and fostering interdisciplinary research on a wide variety of topics including, but not limited to, the nature, causes, consequences, diagnosis, treatment, and prevention of alcohol use disorders.

With this RFA the NIAAA invites applications for Developmental/Exploratory Alcohol Research Centers using the NIH planning grant (P20) mechanism. The purpose of Developmental/Exploratory Centers is to permit groups of researchers to initiate and develop a cohesive, interdisciplinary team focused on a significant alcohol research theme and to assist them in establishing the necessary collaborations, facilities and research capability to justify an application for new Specialized (P50) or Comprehensive (P60) Alcohol Research Center in the future. Grants awarded under this RFA will provide financial support for activities of various kinds including the general development of infrastructure and capacity and exploratory research projects such as pilot or feasibility studies.

Recent progress across a wide variety of disciplines has markedly advanced our understanding of factors that impact the development of alcohol use disorders and determine vulnerability to alcohol’s effects. Cross disciplinary approaches and translational research are facilitating the integration of basic and clinical research, and improving strategies for prevention and treatment. Alcohol research has progressed to the point that the most pressing issues are inherently complex and cross multiple disciplines. Hence a need for Developmental/Exploratory Centers with the explicit goal of building infrastructures capable of supporting interdisciplinary teams focused on a central theme and a series of interrelated questions.

The goal of the Developmental/Exploratory Center program is to build an infrastructure for new Alcohol Research Centers capable of using innovative multidisciplinary approaches to address high priority topics in alcohol research. While the award is limited to one five-year period, the intention is for successful Developmental/Exploratory Centers to apply for Specialized (P50) or Comprehensive (P60) Centers in the future and thereby maintain the sustained thematic approach required to make major contributions to the most important and complex issues in alcohol research.

Thus planning grant applications are expected to identify a relevant and important issue or problem, propose how innovative new research will address the related questions, provide a rationale for the proposed interdisciplinary approach, identify a planning strategy, and propose an appropriate timeline. Planning activities could include, but are not limited to, organizing and conducting workshops and symposia, developing mentoring opportunities for junior investigators, and conducting exploratory or feasibility studies.

The central theme of the proposed Developmental/Exploratory Center should reflect the expertise of the participating investigators, should take advantage of the institution’s strengths and/or unique facilities including, such as access to relevant clinical populations, and should be directed toward a high priority topic of significant importance.

Special Requirements

The NIAAA Developmental/Exploratory Alcohol Research Center grant provides a mechanism for: 1) planning and fostering interdisciplinary cooperation among established investigators conducting high quality alcohol research, 2) supporting investigators engaged in research that has potential for enhancing new discoveries relevant to alcohol and 3) promoting the inclusion of junior investigators likely to bring new ideas and expertise to the field.

All activities will be under the general direction and supervision of the Principal Investigator, who will function as Director of the Developmental/Exploratory Center. The Principal Investigator should be an established, independent scientist in the field of alcohol research and in the chosen scientific theme of the proposed Center. Existence of strong research capability together with viable research potential among faculty and students is fundamental to the establishment of collaborative research that involves participants in coordinated efforts beyond and across departmental structures of an institution. A Center should be an identifiable organizational unit within an institutional structure such as a university, medical center or a consortium of affiliated cooperating institutions. Collaborations that take advantage of unique scientific opportunities and availability of shared resources from other centers and/or investigators in other institutions are encouraged.

A Developmental/Exploratory Center may be organized in a variety of ways and may include one or more institutions. There is no single model and the structure will depend upon research questions and approaches used to study them. However, a conceptual and theoretical rationale for the organizational structure should be discussed in the application. A center should have a focus or theme which serves as the framework for the proposed cores and research components.

Information regarding the existing NIAAA centers programs is available at: http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/ResCtrs1198.htm

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Developmental/Exploratory Alcohol Research Center (P20) award mechanism.

The applicant is solely responsible for planning, directing, and executing the proposed project. A grant supporting an Alcohol Research Center is not transferable to another institution.

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 (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" for the entire Center and for each project and core must be provided in the application.

2. Funds Available

The NIAAA intends to commit approximately 12 million dollars in FY2008 to fund 7-9 new and/or competing continuation Center grants in response to this and the two related RFAs which together employ three different mechanisms (P20, P50 and P60). An applicant may request a project period of up to five (5) years and a budget for total costs up to $500,000 per year under the P20 mechanism. 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 may also vary.

Developmental/Exploratory Centers funded under this RFA are not renewable. However, current awardees of Alcohol Research Centers utilizing the P20 mechanism may apply in response to this RFA. Awardees of Developmental/Exploratory Centers supported through this RFA are encouraged to direct their future activities toward applying for a Specialized (P50) or Comprehensive (P60) Alcohol Research Center. Future applications for a Specialized or Comprehensive Center may be submitted by the Principal Investigator and Applicant Organization of the Developmental/Exploratory Center (P20) in response to any future NIAAA Alcohol Research Center funding opportunity and need not wait to coincide with the completion of the five year project period for the Developmental/Exploratory Center. However, applicants may not hold concurrent Center awards.

Although the financial plans of the NIAAA 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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

In addition, the institution must have the resources to sustain a long-term, coordinated research program and be able to attract qualified scientists from the appropriate disciplines who are willing to make such a commitment to the proposed research. The institution must also assure the availability of research-training opportunities. Foreign institutions are not eligible to apply.

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. The individual named as Principal Investigator for the Center grant will serve as Center Director. This individual must demonstrate the ability to organize, administer, and direct the Center, and have sufficient authority to allocate space, personnel, and other resources essential to the Center.

2. Cost Sharing or Matching

Cost sharing is not required under this program. 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

Applicants may submit a response to only one of the three Alcohol Research Center RFAs released together: RFA-AA-07-001 (for P20), RFA-AA-07-002 (for P50) and RFA-AA-07-003 (for P60). An applicant may hold only one Alcohol Research Center Grant award at any given time.

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.

The following paragraphs describe the Special Requirements for an Exploratory/Developmental Center application.

Only applications that focus on alcohol related research will be considered responsive to this RFA.

A Developmental/Exploratory Alcohol Research Center must have a clearly articulated Administrative Core that should serve to integrate the scientific and infrastructure aims. This core should specify the administrative and organizational structures that will be used to support the proposed research and research development activities. It should describe a structure that maximizes efficiency through program planning and monitoring, an infrastructure development and maintenance plan, opportunities for investigators to do integrative work, and plans for accountability. Administrative functions should include: management of fiscal resources; establishment of mechanisms for regular meetings of participating investigators; communication, data management and security operations; and allocation of space, equipment and resources. The Administrative Core should serve as the central operations hub to foster an environment conducive to research excellence, support innovation and creativity, facilitate collaborations, coordinate efforts, and monitor progress of a comprehensive plan.

It is expected that Center participants will have ongoing active research activities at their institution. The application should explain how alcohol research can be expanded and enhanced by the support requested under this RFA. Particular emphasis should be given to how a Center would facilitate interdisciplinary collaboration that is not otherwise occurring, or is occurring only to a limited extent. The application should describe how the Center will expand and enhance research training and mentoring opportunities for junior investigators and encourage established investigators to focus their efforts on alcohol research. The direct support of training efforts (e.g., stipends), however, must be sought through other mechanisms such as NIH training and career development grants.

A Developmental/Exploratory Center may propose specific research projects which are relevant to the scientific focus and theme the applicant has chosen. If developmental research projects are included they must be described in the application with sufficient detail to allow appropriate peer-review of their scientific merit and methodological soundness. Due to the purpose of this RFA and its funding limitations, such projects are not expected to be major research proposals for testing experimental hypotheses in a rigorous, definitive manner. Rather these projects are more comparable to feasibility or pilot studies to provide preliminary data to be useful in guiding design of future, more definitive investigations. Developmental projects are similar to those typically supported through mechanisms such as small grants. The focus of pilot-type projects should be relevant to the principal research theme that the applicant has chosen for the application.

While the management and direction of the pilot projects is left to the discretion of the Center, the application must provide a description of the process to be followed in the solicitation and selection of new projects and/or replacing projects proposed in the application during the award period. All proposed pilot projects need not be ongoing at any one time but may be phased in at different time points during the life of the center grant.

Applications for NIAAA Developmental/Exploratory Alcohol Research Centers are to use the standard format of PHS Form 398 with the exception of page limits. The Administrative Core and the discussion of the Center as a whole will be limited to 25 pages. Other components such as resource cores, each exploratory project, and the pilot projects as a group are limited to 15 pages each. In addition to the overall Center budget, each component requires a separate detailed budget.

The application must also present a detailed plan or timeline for the duration of the proposed Center program.

Other Requirements:

Facilities and Environment

Applicants must demonstrate the availability of adequate facilities (e.g., laboratory, clinical, and or other facilities) needed to carry out the objectives of the proposed developmental Center program. Although not required, it is desirable for all Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Reference facilities affording access to relevant scientific literature must be readily available. It is expected that such reference facilities will be primary repository for additional reference materials that may be obtained through Center funding. Relevant support services, including adequate data processing facilities, must also be readily accessible within the Center or through the Institution. Assurances of such support must be included within the proposal.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): November 17, 2006
Application Receipt Date(s): December 20, 2006
Peer Review Date(s): March-May 2007
Council Review Date(s): October 2007
Earliest Anticipated Start Date(s): December 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 NIAAA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed above.

The letter of intent should be sent to:

Ernestine Vanderveen, Ph.D.
Acting Chief, Extramural Project Review Branch
Director, Office of Extramural Activities
ATTN: RFA AA-07-001
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
[For express mail use: Rockville, MD 20852-1705]
Telephone: 301-443-2531
FAX: 301-443-6077
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

ATTN: RFA AA-07-001
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:

Ernestine Vanderveen, Ph.D.
Acting Chief, Extramural Project Review Branch
Director, Office of Extramural Activities
ATTN: RFA AA-07-001
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304
[For express mail use: Rockville, MD 20852-1705]
Telephone: 301-443-2531
FAX: 301-443-6077
Email: [email protected]

Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, the applicant will be notified and the application will not be reviewed.

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.

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected 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 by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

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.

Sharing Research Resources

NIH policy requires that grant awardee 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.

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 NIAAA in accordance with the stated review criteria.

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 will be discussed and assigned a priority score. All applications will receive a written critique.

Applications recommended by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific merit of the application as determined by peer review, as well as such considerations as program balance, relevance to the mission and goals of NIAAA, research program priorities, continuity of support, and availability of funds. Awards will be made for up to 5-year project periods with separate fiscal awards made annually.

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.

The general review criteria for the Developmental/Exploratory Alcohol Research Center application are:

Significance: Does the proposed Center address an important problem in alcohol research? 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? What is the long-term potential for the proposed Center to make a unique contribution to the field of alcohol research? What is the potential for the proposed Developmental/Exploratory Center to lead to a successful application for a Specialized or Comprehensive Alcohol Research Center?

Innovation: Does the center propose to develop novel concepts, approaches, measures or methods in alcohol research? Are the specific aims original and innovative? Do the aims represent the current state of science and do they form a convincing theoretical or conceptual model to achieve significant advancement? Does the center extend existing approaches or develop new methodologies or technologies that will significantly advance the field? Do the projects challenge existing paradigms or clinical practice; address innovative hypotheses or critical barriers to progress in the field?

Approach: Is there adequate rationale to support the use of a Center, as opposed to other mechanisms (e.g., individual R01 applications)? Does the conceptual and theoretical framework of the Center make optimal use of collaborations to promote a multidisciplinary approach consistent with the Center’s research theme? Specifically:

Innovation: Does the center propose to develop novel concepts, approaches, measures or methods in alcohol research? Are the specific aims original and innovative? Do the aims represent the current state of science and do they form a convincing theoretical or conceptual model to achieve significant advancement? Does the center extend existing approaches or develop new methodologies or technologies that will significantly advance the field? Do the projects challenge existing paradigms or clinical practice; address innovative hypotheses or critical barriers to progress in the field?

Investigators: Is the Center Director and other senior investigators at the forefront of their respective fields? Have the investigators planned to devote sufficient time to the center-related research, administrative, and mentoring activities? Do they have the experience and authority necessary to organize, administer and direct the center?

Environment: Does the scientific environment of the center contribute to the probability of success? Does the center draw on the strengths of the institution or take advantage of unique features of the scientific environment? Are convincing letters of support and collaboration included? Is there evidence of institutional support? Does the Center have appropriate access to required resources such as existing data sets or clinical populations?

Center as a whole: Does the application demonstrate an organizational structure, a unifying theme and the cohesiveness capable of creating a whole that is greater than the sum of its parts?

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

2.D. Sharing Research Resources

NIH policy requires that grant awardee 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.

The adequacy of the resources sharing plan will be considered by Program staff of the NIAAA 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

N/A

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).

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.

Centers will be required to submit detailed annual progress reports including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modifications in long-term research plans. Also required are reporting of inventions, reports of expenditures, final reports, and other reports in accordance with NIH policy.

In view of the special significance of this program, close coordination and communication between the NIAAA staff and staff of the Alcohol Research Centers is intended. The NIAAA program official will have responsibility for maintaining liaison with appropriate Center leadership, serving as resource consultant to the Center program, and keeping NIAAA staff informed on progress and accomplishments of the Centers. In addition, the program official with other NIAAA staff and consultants will, from time to time, make on-site visits for purposes of program coordination and exchange of information.

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:

Peter J. Delany, D.S.W.
Division of Treatment and Research Recovery
National Institute on Alcohol Abuse and Alcoholism/NIH
5635 Fishers Lane, Room 2039
Bethesda, MD 20892-9304
Telephone: 301-443-0788
FAX: 301-443-8774
Email: [email protected]

R. Thomas Gentry, Ph.D.
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2025
Bethesda, MD 20892-9304 [For express mail use: Rockville, MD 20852-1705]
Telephone: 301-443-6009
FAX: 301-594-0673
Email: [email protected]

Antonio Noronha, Ph.D.
Director, Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2061
Bethesda, MD 20892-9304 [For express mail use: Rockville, MD 20852-1705]
Telephone: 301-443-7722
FAX: 301-443-1650
Email: [email protected]

2. Peer Review Contacts:

Ernestine Vanderveen, Ph.D.
Acting Chief, Extramural Project Review Branch
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3039
Bethesda, MD 20892-9304 [For express mail use: Rockville, MD 20852-1705]
Telephone: 301-443-2531
FAX: 301-443-6077
Email: [email protected]

3. Financial or Grants Management Contacts:

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane MSC 9304 Room 3023
Bethesda, MD 20892-9304 [For express mail use: Rockville, MD 20852-1705]
Telephone: 301-443-4704
FAX: 301-443-3891
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

NIH Public Access Policy:
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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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, No.93.891 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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