Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

NIGMS Centers for HIV/AIDS-Related Structural Biology (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of RFA-GM-07-001

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-GM-12-003

Companion FOA

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

93.859

FOA Purpose

The National Institute of General Medical Sciences invites applications for Centers that will support structure determination and dynamic characterization of macromolecular complexes among and between components of the human immunodeficiency virus (HIV) and the components of host cells.

Key Dates
Posted Date

September 9, 2011

Letter of Intent Due Date

December 7, 2011

Application Due Date(s)

January 6, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March, 2012

Advisory Council Review

May, 2012

Earliest Start Date(s)

July 1, 2012

Expiration Date

January 7, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

The National Institute of General Medical Sciences invites applications for Centers that will support the determination of the structures of macromolecular complexes among and between components of the human immunodeficiency virus (HIV) and the components of host cells.

As for any virus, the life-cycle of HIV is comprised of a progression of assembly and disassembly of multiple macromolecular complexes among components of both the virus and the host cell.  From the interplay of viral proteins among themselves and with the cellular machinery, to the activity of viral enzymes and the usurpation of host factors to achieve infection, such complexes are the fundamental effectors of viral reproduction and proliferation.  These complexes range from binary protein-protein and protein-nucleic acid complexes to much larger multicomponent complexes.  A number of these interactions are documented in the HIV-1, Human Protein Interaction Database.  These complexes offer the potential to provide intervention strategies for the treatment and prevention of AIDS. Although the first step towards the exploitation of these targets, the determination of their high resolution structures, has been accomplished in several cases, much more remains to be done, including the identification and characterization of additional host factors.  Thus the goal of this Funding Opportunity Announcement (FOA) is the continuation and/or creation of Centers dedicated to the determination of the high-resolution structures of these complexes.  In order to succeed, these Centers must collaborate among themselves and must reach out to the biological community doing research aimed at identifying and validating the presence of these complexes, including sharing of data by timely submission of structural information to appropriate databases.

Centers are additionally encouraged to move the knowledge envelope beyond the determination of static structures and into an understanding of the dynamics of complexes with an eye toward informing “mechanism-based drug design.”  While the purpose of this FOA is not to directly fund specific drug development, the establishment of new technologies/methodologies to advance drug design is desirable.  Methods and studies that could elucidate the structural basis for anti-viral resistance are also desirable.

Protein/protein complexes, both among the viral proteins, as in the structures of the virion, and between viral and host proteins, have been the focus of most prior efforts.  This should continue, although an added emphasis should be placed upon those known components of the virus and/or host for which a sufficiently complete structure has yet to be determined, e.g. full-length Gag.  Restriction factor targets are also of particular interest, as well as newly recognized factors that contribute to the establishment or maintenance of viral latency.  Structures related to the mechanisms of therapeutic side effects are also of interest.  With this re-issued FOA we would also place additional emphasis on current poorly characterized categories of complexes that are critical to the virus life cycle, including RNA, RNA/protein, and protein/membrane interactions.  For all the above molecules and complexes integration of structure with validation strategies, including computational, biochemical, and systems biology/interactome analyses, is essential to understanding their biological functions.

The goal of this announcement is to attract the best scientists in relevant fields to attack the problem of characterizing HIV-related macromolecular complexes.  Hence the application should focus on

The research being proposed is expected to push the boundaries of what is feasible. As such, it is recognized that aspects of the plan necessarily will be of high risk.

Characteristics of the Centers

Each Center must have demonstrated capabilities for the determination of high-resolution structures of macromolecular complexes.

Each Center must have a focus of investigation within the broader biology of HIV replication and host cell interactions. This focus will help to guide selection of structure determination targets.

Each Center must actively collaborate with the biological community.  To foster these collaborations each Center will include a Collaborative Development Program, in which program development funds will be awarded and administered by the Center.  Although these awards are to be open to any interested collaborating investigator, special consideration should be given toward the recruitment and training of either early stage investigators or established investigators new to the HIV field.  Centers will also establish outreach and data sharing/dissemination mechanism(s) for the biological and collaborative community to have timely access to all data generated in the Center.

Each Center is strongly encouraged to have a technology component designed to push the state-of-the-art in the structure determination and dynamic characterization of HIV and/or host complexes.

In accordance with the NIGMS mission to promote the training of the next generation of scientists, each Center will provide training activities for students, postdoctoral fellows, and early stage investigators.  Such activities may include a seminar program, a journal club, and/or short course that covers the areas of focus for the Center and HIV structural biology in general.  Also in accordance with the NIGMS mission to include underrepresented populations in science training, each Center will endeavor to maintain an open and inclusive environment for these activities.

Details on the above characteristics are given below:

Structure determination:  X-ray crystallography is generally the method of choice for determining the structures of macromolecular complexes.  However, it often may be useful to employ other methods either alone or in conjunction with x-ray crystallography.  For example, nuclear magnetic resonance may be the method of choice for structure determination in certain instances or may be used to determine interfaces between subunits whose individual structures have been determined by x-ray crystallography.  Likewise, electron microscopy may be used to determine moderate resolution structures of complexes or may be used to provide envelopes into which higher resolution models of subunits can be docked.  Small angle x-ray scattering and other methods also may play important roles.  Given the scope of the research to be undertaken, each Center must have available a range of structure determination methods, from routine to more advanced.  It is expected that methods unique to a Center will be made available to the other Center(s) on a collaborative basis.

Biological focus:  The proposed research should aspire to achieve a comprehensive structural analysis of a particular aspect in the biology of HIV-host cell interactions, for example, "uncoating" or "assembly."  This may be a continuation of the previous focus of a Center or a new focus for new or renewal applications.  A change in focus for a previously funded Center must be sufficiently justified.  A judiciously selected set of structures will provide a sufficiently extensive and detailed framework for interpreting, integrating, and guiding functional research related to that aspect of HIV biology.  Through such a focused approach, a deep and definitive understanding of that aspect of HIV biology should emerge that then may be capitalized effectively for therapeutic strategies.  Since in certain cases related systems, such as other lentiviruses, may be more tractable for structure determination, work on such is acceptable.  In these cases, the work must contribute demonstrably to our understanding of HIV biology and provide lessons that can be applied to the development of anti-HIV therapeutics.

Collaboration: The set of possible targets for structure determination is very large. Thus, it is unreasonable to expect the Centers, even when considered together, to possess the biological expertise to explore and develop all such targets.  It, therefore, is essential that each Center have a mechanism and infrastructure for establishing and maintaining collaborations with outside scientists studying HIV/host interactions.  These collaborators should be able to enter the structure determination “pipeline” at several points, from the provision of clones to actual purified complexes.  The collaborators’ expertise in the biological aspects may also be important as the Centers attempt to bring the particular biological system under the control needed for structure determination.  The goal is to mesh structural and functional studies of HIV – host interactions such that they inform and build on each other in pursuit of effective anti-HIV therapeutics.  Thus, it is expected that potential competitors will collaborate to the benefit of the project as a whole.

The Centers will also establish a collaborative development program, the purpose of which is to attract talented investigators into HIV structure-related research.  This development program will draw upon a fund, representing approximately 10% of the direct costs of the award, to be included in the budget.  The Center will establish, as a part of its management program, a mechanism for the solicitation and award of development grants.  A minimum of 3 projects are to be awarded at a time, subject to approval by the NIGMS program official.   To encourage recipients’ transition to independent funding, these awards should be of limited duration. Development grants may NOT be awarded to foreign components.

Collaborations and formal interactions are also highly encouraged between Centers and NIAID-funded Centers for AIDS Research (CFAR), the NIAID-funded Center for HIV/AIDS Vaccine Immunology (CHAVI), the NIH Roadmap Molecular Libraries Screening Centers Network (MLSCN) and NIGMS Centers in Chemical Methodologies and Library Development (CMLD) to both link Center efforts to HIV biology and to facilitate activities toward translational research and drug target validation.  Centers may also collaborate with government researchers and Centers, e.g. the NCI HIV Drug Resistance Program, NIAID Vaccine Research Center, US Military HIV Research Program, or any other investigator with the skills and interest to contribute in a substantial fashion to the goals of the Center.

Centers are also expected to establish mechanisms for outreach to the broader HIV community through data sharing and dissemination.  The form(s) of this outreach are to be detailed in the application and may, for example, include web-accessible and searchable databases.

Technological Component:  The determination of the structure of macromolecular complexes pushes the current state of the art, both in terms of the technology needed for structure determination and the biology needed to produce sufficient material for analysis.  Hence each Center is encouraged strongly to have a component devoted to advancing the state of the art of the determination and characterization of structures of macromolecular complexes.  While well-behaved, non-HIV related macromolecular complexes may be appropriate to develop and validate new methods, the methods developed must be clearly applicable to the determination of the structures of HIV/host complexes.

Centers are additionally encouraged to move the knowledge envelope beyond the determination of static structures and into an understanding of the dynamics of complexes with an eye toward informing “mechanism-based drug design.”  Methods that characterize the dynamics of structures and their complexes may provide a more realistic picture of biological function than static structures and potentially more relevant information for development of therapeutics targeted to those functions. Efforts to characterize the dynamics of virus or virus/host complexes may, for example, include modern “single-particle” and correlative microscopy methods, which are being used increasingly to examine biological processes in vivo.  Collaboration with scientists with demonstrated expertise in these methods is recommended strongly.

Management and Oversight

Because of the complex nature of these Centers, the single Principal Investigator must devote at least 25% of his/her effort to the project.  It is also essential that significant effort be exhibited by other key personnel.  The support of a Center coordinator, who will attend to the day-to-day operation of the Center, is strongly encouraged.  Since Collaboration Development Funds will be a component of an award, an explanation of the process by which fund use will be decided must be provided.

Overall success of this program depends critically on the success of each Center, the accomplishments of collaborating investigators and on the ability of the entire program to work in concert.  Therefore, each Center will appoint an advisory committee in consultation with and subject to the approval of the NIGMS Program Official.  This advisory committee will meet at least once a year and give advice directly to the Center.  The NIGMS Program Official will attend each meeting of the advisory committee as an observer.  Candidates for the advisory board should not be named in the application or solicited prior to award.  In addition, NIGMS will appoint an advisory committee to oversee the operation of the entire network.  That committee will function as a subcommittee of the National Advisory General Medical Sciences Council.  Members of this committee will be appointed directly by the Program Officials of NIGMS and will give advice directly to NIGMS.  The committee will meet at least annually.  Representatives from each Center are required to attend.

To ensure coordination and cooperation among the funded Centers and the other members of the scientific research community working in areas germane to the mission of the Centers, an annual scientific meeting will be held.  Attendance of the principal investigator and key participants from each Center is required.  Attendance of key collaborating investigators is highly encouraged.  Sufficient funds should be included in the budget for travel to these meetings.

The collaborative aspects of the overall program are essential for its success.  Given the dynamic nature of collaborations, this aspect is expected to change from year to year.  Therefore, each Center must update its plans for collaboration each year.  These updated plans for collaborations will be reviewed by the Advisory Committee and approved by the NIGMS Program Official.  This approval will be a condition of the award.  In the event additional funds become available, support could be provided for innovative approaches that are conceived after the onset of the Center grant.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

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

Funds Available and Anticipated Number of Awards

NIGMS intends to fund an estimate of 3 to 5 awards, corresponding to a total of $20,000,000 for fiscal year 2012   Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited for direct costs including equipment and Collaborative Development Program costs up to 3.2 million dollars per year, and for total costs including facilities and administrative costs (F&A)/indirect costs up to 4.7 million dollars per year.

Award Project Period

The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed as participating projects or cores of the Center, but NOT as recipients of collaborative development program awards.

Required Registrations

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

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

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

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Multiple Principal Investigators (mPI) are not permitted.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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


The letter of intent should be sent to:

Michael Sakalian, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 2As. 19E
Bethesda, MD 20892-6200
Telephone: 301-594-0828
Email: sakalianm@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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)

Page Limitations

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

Detailed Budget for Initial Budget Period

Follow the instructions in the PHS398 Application Guide, with the following additional instructions:

Annual Meeting: Applications should include travel funds for the appropriate personnel to attend an annual meeting at the NIH and the separate annual individual Center advisors' meeting.

Collaboration Development Fund:  Applicants must request part of their budget, equivalent to approximately 10% of direct costs, be allocated to a Collaboration Development Fund.  The Fund will be used for program development awards to be administered by the Center.  These awards will take the form of subcontracts administered through the Center.  Place the budget for the Collaboration Development Fund in the Other Expenses section of the budget.  Although the selection and administration of these awards will be performed by the Center, all such awards must be approved by NIH staff.

Biographical Sketch

All instructions in the PHS398 Application Guide must be followed, with the following additional instruction:

Collaborator biosketches must be provided as appropriate

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Section 1 - Center in its entirety using the following subsections:

Specific Aims:

In one page, the specific aims should be presented for the Center as a whole.  Describe the biological theme of the Center and include what you wish to accomplish over the term of the grant

Significance:

In up to three pages, place the proposed studies in the context of the field and the Center, and present the biological and technological problems that need to be solved to push the field forward.

Innovation:

In up to three pages, describe how the Center will move the field forward and how the relevant expertise of the group will contribute, including the rationale for each investigator. 

Approach:

In up to ten pages, outline the approach to be taken to further knowledge on the biological theme.  Include milestones and a discussion of the likely major bottlenecks to be encountered.  Alternative approaches should be described in sufficient detail to give reasonable confidence that bottlenecks can be overcome.  Include also a brief description of preliminary results and, if applicable, the progress since the last competative award.  Describe how these results have advanced the field.  Cite relevant publications.  For renewals, provide a Progress Report Publication List in the References Secton.

Section 2 - Technology Development

Specific Aims:

Use one page.  For a technological component, outline the technological barriers to be overcome.  Outline the biological goals for the new technology that might not otherwise be achieved, achieved as well, or achieved as easily.

Significance:

In up to two pages describe the problem or barrier the technological advances will solve or overcome and the advantage the technological advances will have over existing technology.  Place the proposed studies in the context of the field and the Center.

Innovation:

In up to two pages describe the technological novelty of the advancement.  Is this a completely new technology, the evolution of an existing technology, or the new application of an existing technology to a biological problem?  Outline how the experience of the group will contribute to this innovation.

Approach:

In up to four pages outline the approach to be taken.  Included should be milestones, a description of the bottlenecks to be encountered, the kinds of expertise required and the steps taken to acquire that expertise, either by direct participation or collaboration.  Possible approaches to circumvent bottlenecks should be described.  Include also any unpublished preliminary results and/or cite relavant key publications.

Section 3 - Collaborative Development Program

In up to three pages describe the scientific goals of the Development Program.  What will be the size, scope, and selection criteria for development awards?  What expertise will be solicited to perform the selection?  Describe also the mechanisms and infrastructure that will be used to establish and maintain collaborations with the scientific community that is engaged in the identification, validation and study of HIV/host complexes.  This section should document existing collaborations.  Letters of collaboration should be included in the Letters of Support and must document the extent of the collaboration.  It is essential that sufficient travel funds be allocated in the budget for the collaborations envisaged.

Section 4 - Management Plan

In up to three pages detail the management plan for the entire Center, its Development Program, and its collaborations with other Centers and the community at large.  Describe the roles of the Principal Investigator, the Project/Core Managers, Collaborators, and Administrative Assistant.  Describe also the intended composition and activities for the Center Scientific Advisory Committee.  Do not name or solicit advisory board candidates prior to award.

Resource Sharing Plan

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

Appendix

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Developmental Program funds will be restricted for that purpose and may not be used or rebudgeted without NIH approval.l

6. Other Submission Requirements and Information

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

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Innovation

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

Approach

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

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

Are the Center and its management plan, including the Development Program, well organized?  Will this organization achieve the Center's goals?  Have the criteria for selection of Development Awards been carefully considered?  Are the plans for coordination and collaboration between the projects adequate?  Do these plans for coordination and collaboration include the development projects?

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned to NIGMS andwill compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in theNIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

Michael Sakalian, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 2As.19E
Bethesda, MD 20892-6200
Telephone: 301-594-0828
Email: sakalianm@mail.nih.gov

Peer Review Contact(s)

Robert Freund, Ph.D.
Chief, AIDS and AIDS Related Research (AARR) Integrated Review Group
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: 301-435-1050
Email: freundr@mail.nih.gov

Financial/Grants Management Contact(s)

E.C. Melvin
National Institute of General Medical Sciences
45 Center Drive
Building 45, Room 2An.32E
Bethesda, MD 20892-6200
Telephone: 301-594-3912
Email: olascoag@nigms.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.