and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
National
Institutes of Health (NIH) (http://www.nih.gov)
Components of
Participating Organizations
National
Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
Title: Interdisciplinary
Research on Oral Manifestations of HIV/AIDS in Vulnerable Populations (P01)
Announcement Type
New
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For general information on this transition, please see the electronic submission website at http://era.nih.gov/ElectronicReceipt/ and the transition timeline at http://era.nih.gov/ElectronicReceipt/files/Electronic_Receipt_Timeline_Ext.pdf. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).
Program Announcement (PA) Number: PAR-08-117
Catalog of Federal Domestic Assistance Number(s)
93.121
Key Dates
Release Date: March 20, 2008
Letters of Intent Receipt Date(s): July 13, 2008; July 13, 2009; July 13, 2010
Application Receipt Date (s): August 13, 2008; August 13,
2009; August 13, 2010
Peer Review Date(s): October-November 2008; October-November 2009;
October-November 2010
Council Review Date(s): January 2009; January 2010; January 2011
Earliest Anticipated Start Date(s): February 15, 2009; February 15, 2010; February 15, 2011
Additional Information To Be
Available Date (Url Activation Date): N/A
Expiration Date: August 14, 2010
Due Dates for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1.
Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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
Purpose
The primary goal of this FOA is to drive interdisciplinary research to study the oral manifestations and complications associated with HIV/AIDS-related immunosuppression in vulnerable populations, including children and adolescents. The applicants are expected to develop highly integrated projects that comprehensively address the existing gaps in knowledge of the epidemiology, prevention and pathogenesis of the oral complications of HIV disease and that promote interventions that could reduce the burden of disease among disproportionately affected racial and ethnic minority communities. Regardless of the theme, projects in each multidisciplinary program are expected to be synergistic and to utilize cutting-edge approaches such as genomics, proteomics, molecular imaging and other emerging technologies to achieve their goals. Applicants are encouraged to include pediatric/adolescent populations in their research. In addition, it is expected that these projects will provide interdisciplinary career development opportunities for investigators new to the field of oral AIDS.
Background
In the past two decades significant progress has been achieved in HIV/AIDS research that has led to better treatments, longer life spans and better quality of life. The pattern of HIV/AIDS has now evolved to become a chronic infectious disease. With the increase in the life expectancy of patients with HIV/AIDS, attention to patient, family and provider awareness of the oral manifestations of HIV/AIDS and the complications that may be associated with the chronic infection and /or treatment is warranted particularly among children and adolescents. Vulnerable populations at risk of acquiring the disease include intravenous drug abusers, and racial and ethnic minorities. While African Americans make up approximately 13% of the population in the US, they account for approximately half of the HIV/AIDS new diagnoses. Other vulnerable populations that merit attention are children and adolescents. Half of the new HIV infections in the US annually are among young people 13 to 24 years of age. Oral manifestations of HIV infection occur in 30 to 80 percent of the affected patient population. Children and adolescents of ethnic minorities continue to bear a disproportionate burden of the epidemic.
Oral lesions are among the early signs of HIV infection and can predict the progression to AIDS. Oral lesions commonly associated with HIV infection include oral candidiasis, herpes simplex infection, oral kaposis sarcoma (KS), parotid enlargement, periodontal and gingival diseases and recurrent mucosal ulceration among others. Children share similar oral manifestations to adults but with a lower frequency of oral KS and more parotid enlargement. In addition HIV infected children develop dental caries at a higher rate than the general population, and exhibit delayed dental eruption and retention of primary teeth. HIV salivary gland disease (SGD) is also frequently observed in children; it is characterized by enlargement of the major salivary glands and xerostomia in the absence of xerogenic medications/agents. The decreased salivary flow associated with SGD predisposes these patients to rampant dental caries.
Adolescent populations are one of the more challenging age groups to study and treat due to their particular vulnerability to HIV infection and sexually transmitted diseases. The management of this age group requires an understanding of the behavioral and psychological issues pertaining to their development. The majority of HIV seropositive adolescents acquire their infection during the adolescent period. However with the improvement in antiretroviral therapy strategies a growing number of perinatally infected youth are now living to see the teenage and adult years. The fact that adolescents and children are living longer necessitates special considerations to their quality of life to ensure healthy dentition, adequate nutrition and fulfillment of the psychosocial aspects of their development. All of this can impact the outcome of the disease and adherence to therapy.
Our understanding of the pathogenesis of HIV infection and subsequent associated oral complications is incomplete. This area of research support includes oral disorders caused by pathogens such as EBV, HPV, CMV, HHV-8, HSV and candida. The relative ability of the oral cavity to resist HIV infection and replication while providing a safe haven for other pathogens provides a unique opportunity to dissect the differential patterns of host defenses. This can shed light on the mechanisms utilized by oral pathogens to evade the immune response and the mechanisms involved in reactivation of latent oral viral pathogens to cause disease. This knowledge has the potential for development of novel more effective strategies for prevention and treatment of such complications.
Multidisciplinary studies with a common theme, addressing the epidemiology, prevention and pathogenesis of the oral manifestations associated with AIDS, are crucial for increasing our understanding of these disorders. The information gained can provide the basis for the development of novel preventive, diagnostic and therapeutic strategies for HIV-related oral disorders and reduce the burden of disease in vulnerable populations.
Scope
The aim of this FOA is to encourage the submission of interdisciplinary research proposals with three or four highly integrated projects and any necessary cores that will comprehensively address the existing gaps in our knowledge of the epidemiology, prevention and pathogenesis of the oral complications of HIV infection. Integrating expertise from diverse scientific fields such as virology, immunology, pathology, epidemiology, behavioral sciences, molecular biology, bioimaging, nanotechnology, systems biology, mathematical modeling and bioinformatics will facilitate the performance of cutting edge studies to advance the field.
Examples of research that are responsive to this initiative include but are not limited to:
Each program project is expected to provide an outstanding environment for training of graduate students, postdoctoral fellows and other health professionals. This initiative is not designed to support clinical trials. However, the use of clinical samples from patients is allowable and encouraged.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1.
Mechanism of Support
This funding opportunity announcement will use the Program Project (P01) award
mechanism. Program Project grants support broadly based, multi-disciplinary
research programs that have a well-defined, central research focus or
objective. An important feature is that the interrelationships of the
individual scientifically meritorious projects will result in a greater
contribution to the overall program goals than if each project were pursued
individually. The program project grant consists of three or four interrelated
individual research projects that contribute to the program objective. This
type of award also can provide support for certain common resources (cores).
Such resources should be utilized by two or preferably more projects within the
program project. The total project period may not exceed five years. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
2. Funds Available
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.
Facilities
and Administrative (F&A) costs requested by
consortium participants are not included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your
institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost
Sharing or Matching
This program does not require cost sharing as
defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants may submit a resubmission application; however
such application must include an Introduction addressing the issues raised in
the previous peer review critiques (Summary Statement).
Renewal applications will be permitted under this FOA.
Applicants may submit more than one application, provided that each application is scientifically distinct.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398
application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms.
Applications must have a D&B Data Universal Numbering
System (DUNS) number as the universal identifier when applying for Federal
grants or cooperative agreements. The D&B number can be obtained by calling
(866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The
title and number of this funding opportunity must be typed on line 2 of the
face page of the application form and the YES box must be checked.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new
section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, titled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is
planned, the distribution of resources to specific components of the project
or the individual PDs/PIs should be delineated in the Leadership Plan. In the
event of an award, the requested allocations may be reflected in a footnote
on the Notice of Award.
Additional information is
available in the PHS 398 grant
application instructions
3.
Submission Dates and Times
Applications must be received on or before the receipt
date described below (Section IV.3.A).
3.A.
Submission, Review, and Anticipated Start Dates
Letters of Intent
Receipt Date(s): July 13, 2008;
July 13, 2009; July 13, 2010
Application Receipt Date(s): August 13, 2008; August 13,
2009; August 13, 2010
Peer Review Date(s): October-November 2008; October-November 2009;
October-November 2010
Council Review Date(s): January 2009; January 2010; January 2011
Earliest Anticipated Start Date(s): February 15 2009; February 15, 2010; February 15,
2011
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is
not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Boulevard, Room 662
Bethesda, MD 20892-6402
(United States Postal Service (USPS) Express or Regular mail)
Or
Bethesda, MD 20817 (Express/Courier Non-USPS Service
Telephone: (301) 594-5006
Fax: (301) 480-8303
Email: Lynn.King@nih.gov
3.B.
Submitting an Application to the NIH
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit the original
and three identical, legible, single-sided photocopies of each
application, including the checklist. The original must be signed by an authorized organizational
official.
Send the application to the following address, making sure to use the correct ZIP code:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
(United States Postal Service (USPS) Express or Regular mail)
or
Bethesda, MD 20817 (Express/Courier Non-USPS Service)
C.O.D. applications will not be accepted.
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 materials must be sent to:
Lynn Mertens
King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Boulevard, Room 662
Bethesda, MD 20892-4878(U.S. Postal Service Express or Regular mail)
Or
Bethesda, MD 20817 (Express/Courier Non-USPS Service)
Telephone: (301) 594-5006
Fax: (301) 480-8303
Email: Lynn.King@nih.gov
3.C.
Application Processing
Applications
must be received on or before the application receipt dates 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 CSR and for responsiveness by the
reviewing Institute. Incomplete and/or 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 merit review unless the
applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. This does not
preclude the submission of a substantial revision of an application already
reviewed, but such application must include an Introduction addressing the
previous critique.
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 and Information
The applicants should include an Overview of the synergistic interactions that
will be achieved through the establishment of multi-disciplinary teams, the
utilization of novel approaches and the integration of the various projects.
The following page limitations will apply:
Overall Research Strategy describing the Program Project synergy - 12 pages
Cores - six pages for any individual core.
Individual projects 12 pages. Do not exceed 12 pages for Item 3 of the Research Plan of the PHS 398 form. All tables, graphs, figures, diagrams, and charts must be included within the 12-page limit. Be succinct and remember that there is no requirement to use all 12-pages allotted to Item 3.
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.
Special Requirements
Grantees will meet annually at or near NIH, Bethesda, MD, to share results, to ensure that the NIDCR has a coherent view of the advances in the field, and to have an opportunity for collective problem solving among investigators. Applicants should budget for travel in their requested budget for the principal investigator and Project leaders to attend the annual meeting.
Contact the NIDCR program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Resource Sharing Plan(s)
NIH considers the
sharing of unique research resources developed through NIH-sponsored research
an important means to enhance the value and further the advancement of the
research. When resources have been developed with NIH funds and the associated
research findings published or provided to NIH, it is important that they be
made readily available for research purposes to qualified individuals within
the scientific community. If the final data/resources
are not amenable to sharing, this must be explained in the Resource Sharing
section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only
the review criteria described below will be considered in the review process.
2. Review and
Selection Process
Applications that are
complete will be evaluated for scientific and technical merit by an appropriate
peer review group convened by NIDCR and in accordance with NIH review procedure (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
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 impact/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.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) Protections for Human Subjects, 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? For applications designating multiple PDs/PIs, does the
Leadership Plan ensure that there will be sufficient
coordination and communication among the PDs/PIs? Are the administrative
plans for the management of the research project appropriate, including plans
for resolving conflicts?
Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Administration: Are, for example, equipment calibration and maintenance, personnel oversight, internal communication, and synergistic interactions between investigators adequately addressed? Will there be an external review committee?
Multidisciplinary Research: Is the Program composed of collaborative efforts between individuals from different scientific disciplines?
Integration of Projects: Are the proposed projects and cores well integrated?
Utilization of Contemporary Technologies: Are state of the art technologies applied to the exploration of the selected topic?
Training Environment: Does the Program provide an environment conducive to the training of graduate students, postdoctoral fellows and other health professionals?
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.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
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.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents 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).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
2.C.
Resource Sharing Plan(s)
When relevant, reviewers will be
instructed to comment on the reasonableness of the following Resource Sharing
Plans, or the rationale for not sharing the following types of resources.
However, reviewers will not factor the proposed resource sharing plan(s) into
the determination of scientific merit or impact/priority score, unless noted otherwise
in the FOA. Program staff within the IC will be responsible for monitoring the
resource sharing.
3.
Anticipated Announcement and Award Dates
Not applicable.
Section
VI. Award Administration Information
1.
Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his/her Summary Statement (written critique) via the NIH 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.
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.
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 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 Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Isaac R. Rodriguez-Chavez, Ph.D., M.S., M.H.S.
Director, AIDS and Immunosuppression Program
Division of Extramural Research, Integrative Biology and Infectious Diseases
Branch,
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd., Rm. 614
Bethesda, MD 20892-4878
Telephone: (301) 594-7985
Fax: (301) 480-8319
Email: isaac@nidcr.nih.gov
2.
Peer Review Contacts:
Lynn
Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Boulevard, Room 662
Bethesda, MD 20892-4878
Telephone: (301) 594-5006
Fax: (301) 480-8303
Email: Lynn.King@nih.gov
3. Financial or Grants
Management Contacts:
Mary Daley
Grants Management Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Boulevard, Room 658
Bethesda, MD 20892-4878
Telephone: (301) 594-4808
Fax: (301) 480-3562
Email: md74u@nih.gov
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
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 (45 CFR 46) 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 impact/priority score.
Policy for Genome-Wide Association Studies (GWAS):
NIH is
interested in advancing genome-wide association studies (GWAS) to identify
common genetic factors that influence health and disease through a centralized GWAS
data repository. For the purposes of this policy, a genome-wide association
study is defined as any study of genetic variation across the entire human
genome that is designed to identify genetic associations with observable traits
(such as blood pressure or weight), or the presence or absence of a disease or
condition. All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for submission of
GWAS data to the NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. Data repository
management (submission and access) is governed by the Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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.
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.
Inclusion of Women, Minorities, and Children:
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 SF424 (R&R) application; 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-09-116.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.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance
for publication, to be made publicly available no later than 12 months after
the official date of publication. The NIH Public Access Policy is
available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For
more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
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 HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must
be self-contained within specified page limitations. For publications listed in
the appendix and/or Progress report, Internet addresses (URLs) or PubMed
Central (PMC) submission identification numbers must be used for publicly
accessible on-line journal articles. Publicly accessible on-line journal
articles or PMC articles/manuscripts accepted for publication that are directly
relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
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 FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 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 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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