and Human Services (HHS)
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Department of Health and Human
Services
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National
Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
Title: B Cell Immunology for Protective HIV-1 Vaccines (R21)
Announcement Type
New
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Request For Applications (RFA) Number: RFA-AI-07-015
Catalog of Federal Domestic Assistance Number(s)
93.855,
93.856
Key Dates
Release/Posted Date: March
13, 2007
Opening Date: May 23, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of
Intent Receipt Date(s): May 29, 2007
NOTE: On time submission requires that applications be
successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt
Date(s): June 29, 2007
Peer Review
Date(s): October 2007
Council Review
Date(s): January 2008
Earliest
Anticipated Start Date(s): February
2008
Additional Information To Be Available Date (Activation Date): Not
Applicable
Expiration Date: June 30, 2007
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research
Objectives
Section
II. Award Information
1. Mechanism of
Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A.
Eligible Institutions
B.
Eligible Individuals
2. Cost Sharing or
Matching
3. Other - Special
Eligibility Criteria
Section
IV. Application and Submission Information
1. Request
Application Information
2. Content and Form
of Application Submission
3. Submission Dates
and Times
A. Submission, Review, and Anticipated Start Dates
1.
Letter of Intent
B.
Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental
Review
5. Funding
Restrictions
6. Other Submission
Requirements
Section
V. Application Review Information
1. Criteria
2. Review and
Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated
Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative
and National Policy Requirements
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 goal of this funding opportunity is to support high impact basic immunology studies and innovative methods that may lead to induction of broadly reactive, neutralizing antibodies that can prevent infection by a wide spectrum of clinically relevant HIV-1 virus strains. The program will create new research enterprises focused on a key parameter for HIV-1 vaccine development: defining the basic immune mechanisms by which an effective and robust neutralizing antibody response can be elicited in uninfected individuals to protect against a broad range of HIV-1 strains. Broadly neutralizing antibodies are defined for the purpose of this funding opportunity as those with the ability to block multiple, diverse primary isolates of HIV-1 from infecting cells, such that the antibodies prevent or substantially limit infection in vitro or in vivo.
This R21 exploratory/development grant program will support basic immunology research on B cell and antibody regulation as a foundation for the future development of novel HIV-1 vaccine candidates. Preliminary data are not required, but expertise in basic immunology and the HIV-1 virus on the research team should be evident. In parallel with this announcement, the NIAID is also soliciting U01 single project cooperative agreement grant applications to support mature and well developed research projects focused on the same high impact scientific area (see RFA-AI-07-014).
Background
Identifying approaches that induce effective and broadly neutralizing antibodies is a priority of the Global HIV/AIDS Vaccine Enterprise (http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020025). Despite a large international investment of research funds, expertise, and innovative thinking over the past two decades, the prospects for an effective HIV-1 vaccine in the near future remain uncertain. The immune correlates of protection against HIV-1 are still unknown, in part because protective immunity has not been observed after natural infection. The immune responses known to be induced by infection are not able to sufficiently contain viral replication, and the virus has proved to be extraordinarily adept at mutating to escape responding immune cells and mediators. Extensive variability in pathogenic HIV-1 viruses dictates the need for a vaccine that can protect against most if not all of the circulating strains. Certain vaccine formulations were found to activate CD8 and CD4 T cell responses in nonhuman primates, but vaccines based primarily on T cell activation have not prevented infection in those models. On the other hand, the passive administration of defined neutralizing antibodies was found to block infection in nonhuman primates when virus was given either by mucosal or intravenous challenge. These results provide a strong impetus to refocus efforts on the antibody response, which, together with a strong T cell response, may be needed for a successful vaccine.
Clearly, the requirements for a protective antibody response are unusually difficult to fulfill in the case of the HIV-1 virus, which has extensive genetic variability and is constantly evolving with passage through human populations. A successful vaccine may need to generate systemic and mucosal antibodies and memory B cells reactive with conserved regions of the virus. Furthermore, given evidence that a single free gp120 trimer on a virion is sufficient to bind to and mediate entry into a CD4+CCR5+ cell, vaccine-generated antibodies should have high affinity for the envelope protein as well as broad cross-reactivity within and across HIV-1 clades.
Targeting the conserved regions of the HIV-1 envelope for antibody responses has proven to be extremely difficult, as a number of mechanisms combine to make these regions either non-immunogenic or poorly accessible to antibodies. For example, approximately 50% of the gp120 mass consists of carbohydrate groups that are synthesized by host cell enzymes and therefore resemble host glycoproteins to which the individual is immunologically tolerant. This glycan shield is surprisingly flexible in that many mutants with altered glycosylation sites resulting from antibody-mediated viral selection still retain significant pathogenicity. The five variable loops on the surface of gp120 can be highly immunogenic but they generally induce only strain specific and not broadly neutralizing antibodies.
Importantly, key conserved regions required for viral entry into cells are effectively masked by gp120 conformation to prevent antibody binding. The gp120 site that engages the CD4 cellular receptor to initiate cell binding is relatively conserved, but is recessed on the protein and is hidden on the gp120 trimer such that most antibodies are unable to bind. After engaging CD4, the gp120 trimer undergoes a major conformational change that exposes the binding site for the coreceptor (CCR5 or CXCR4) and also exposes the fusion domain of gp41. Thus, these conserved envelope domains crucial for cell binding and entry are only transiently available for antibody blockade. Although antibodies reactive with the coreceptor binding site have been observed in HIV-1-infected individuals, they are non-neutralizing in vitro, although Fab or single chain Fv fragments of the same antibodies can have neutralizing activity.
Finally, there is evidence that some of the conserved regions of HIV-1 may mimic epitopes on human antigens and therefore would not elicit effective antibody responses due to B cell tolerance to self antigens. Helper T cell tolerance to autoantigens might also prevent robust antibody responses to these epitopes.
Despite the many mechanisms by which HIV-1 can preclude or evade antibody responses to conserved domains, and despite its extraordinary capacity to generate mutant variants that retain pathogenicity, there is still optimism for an antibody-inducing vaccine strategy, based on the description of a small group of monoclonal antibodies that do have broadly neutralizing activity. These antibodies were isolated from human sources and shown to neutralize diverse primary isolates of HIV-1 in vitro. Several were also shown to protect against virus challenge in nonhuman primate model systems when administered singly or in combination. Examples of such antibodies include 2G12, which binds oligomannose chains on the gp120 trimer; IgG1b12, which binds to the CD4 contact site; 47e and 412d, which react with the coreceptor binding site of gp120 that is exposed only after CD4 binding; and 2F5 and 4E10, that bind membrane proximal gp41 epitopes. IgG1b12, 2F5, and 4E10 were recently shown to crossreact with certain human autoantigens, and structural features of 2F5 and 4E10 suggest the possibility that they might derive from polyreactive B cells of the B-1 or marginal zone subsets. Furthermore, some sera from HIV-1 infected persons are broadly neutralizing. Thus, although broadly neutralizing antibodies have not been found in most infected individuals, the existence of these monoclonal antibodies and antisera demonstrates that broadly neutralizing antibodies can be produced in humans and provides important clues about structures useful for broadly neutralizing activity. Recent advances in defining HIV-1 envelope protein structures either alone or complexed with such antibodies provide important information that may lead to new methods of inducing broadly neutralizing antibody responses by vaccination.
In addition, advances in understanding the basic immunology of B cell regulation, as well as helper T cells, dendritic cells, and innate immune mechanisms important for initiating and defining antibody responses, provide a strong foundation for renewed efforts to define the immunological requirements to develop a successful HIV-1 vaccine. In particular, the more sophisticated understanding of B cell biology that has evolved over the past several years supports the hope that innovative immunological approaches will result in successful HIV-1 vaccine development. Recent advances include a better understanding of the molecular mechanisms responsible for B cell tolerance; the checkpoints in B cell differentiation at which tolerance may be broken or imposed; improved methods for B cell antigen receptor repertoire analysis; the differential activation requirements of B cell subsets; definition of the surface receptors and intracellular signaling pathways that promote or inhibit B cell proliferation, survival, somatic mutation, and antibody production; the immunoregulation of plasma cells; and the mechanisms by which robust B cell memory is induced and maintained.
Research Objectives and Scope
This program will focus on B cell immunology and the basic mechanisms by which a broadly protective anti-HIV-1 antibody response may be induced and maintained. Examples of several specific areas of interest are described below. These and other research areas may be addressed in response to this FOA to define new antibody-focused immunological approaches relevant to the development of a successful HIV-1 vaccine.
Targets of broadly neutralizing antibodies. Epitopes for many of the known broadly neutralizing antibodies have been described, and it is not clear why HIV-1 vaccine candidates have been unsuccessful in inducing these types of antibodies. It would be useful to identify and characterize additional broadly neutralizing antibodies to provide a more comprehensive picture of the epitope and antibody structures involved. The potential HIV-1 specificities of the human pre- and post-selection B cell antigen receptor repertoires can be defined using current immunological methods, and examples of such antibodies can be tested for broadly neutralizing activity. The possibility that most of the conserved epitopes of the HIV-1 envelope may mimic human autoantigens should be further explored to determine whether immune self tolerance limits the repertoires of B or helper T cell specificities available to combat HIV-1. Should this be the case, studies to define neutralization antibody induction that bypass tolerance without generating serious autoimmune reactions may be undertaken. For conserved epitopes that are not crossreactive with human antigens but are hidden from antibodies by gp120 structural features, strategies are needed that activate and expand B cells producing antibodies with properties that enable access to the site.
Relevant B cell subsets. Characteristic features of some of the known broadly neutralizing monoclonal antibodies suggest that they might derive from B-1 or marginal zone B cells, which often express polyreactive immunoglobulins. Studies in this area might provide insight on the specific B cell types that are the most promising targets for vaccine development. A related area is the study of the most appropriate isotypes of antibodies to target for protective responses.
Other immune cell types. The activation and expansion of helper T cells and inhibitory regulatory T cells are important parameters to study in the generation of an effective antibody response. The efficiency of uptake, processing, and presentation of HIV-1 immunogens by antigen-presenting cells will help dictate the magnitude and quality of the antibody response, and there may be value in specifically targeting antigens to particular dendritic cell subsets or to different antigen-presenting cell types. Study of the roles of HIV-1 specific B cells as antigen-presenting cells may also provide important information for vaccine design.
Innate immune responses and adjuvants. The stimulation of innate immune responses in the presence of appropriate antigens might allow activation of relevant B cells as well as generate a quantitatively greater response. The detection of functional Toll-like receptors on B cells suggests that there may be direct effects of innate immune stimulators on antigen responsive B cells as well as indirect effects resulting from dendritic cell maturation and cytokine secretion. Studies in this area could provide important new information to support adjuvant development for broadly neutralizing antibody responses.
Immune memory. Clearly, an HIV-1 vaccine will be most useful if the protection induced by priming can be maintained by a limited number of boosting immunizations. Immune memory must be maintained in both the CD4 helper T cell and B cell compartments, and creative research is needed in this area to define the requirements for the maintenance of immune memory for a broadly neutralizing antibody response.
Mucosal immunity. Most new HIV-1 infections occur via mucosal routes, and vaccine elicited antibody responses should block infection at mucosal surfaces as well as through systemic immunity. Little is known about the requirements for induction of broadly neutralizing antibodies that can function effectively at mucosal surfaces, and the activation and regulation of secretory IgA and IgG isotypes will be fruitful areas for further study. In addition, work is needed on adjuvants that target appropriate mucosal innate responses to foster productive B cell responses; approaches that bypass immune tolerance mechanisms unique to mucosal compartments; and methods to promote robust and long lasting mucosal B cell memory.
Clinical Studies. Clinical trials will not be supported by this FOA; applications that include clinical trials are non-responsive and will not be accepted. However, studies on human tissues may be included if they do not involve a clinical intervention and/or are performed with samples obtained from ongoing clinical trials supported outside of this FOA. Applicants should describe how such studies will help to identify and characterize the underlying immune mechanisms and contribute to the goals outlined in this solicitation. Methods to address all regulatory requirements and the protection of human subjects must be described in the application.
EXCLUDED from this RFA are applications that include research in the following areas; such applications will not be accepted for review:
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
1. Mechanism of Support
This
FOA will use the NIH Exploratory/Developmental Research Grant (R21) award
mechanism. As an applicant, you will be solely responsible for planning,
directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it
is anticipated that the size and duration of each award will also vary.
Although the financial plans of the Institutes and Centers (ICs) provide
support for this program, awards pursuant to this funding opportunity are
contingent upon the availability of funds and the submission of a sufficient
number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project. Direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.
NIAID intends to commit approximately $1.5 million in FY2008 to fund 6-8 new applications in response to this FOA.
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.
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.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 and 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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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 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 more than one application, provided each application is
scientifically distinct.
Because the R21 grant mechanism is limited to a 2 year period, applicants proposing clinical studies must:
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants must
download the SF424 (R&R) application forms and SF424 (R&R) Application
Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the "Attachment"
files may be useable for more than one FOA.
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
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424
(R&R) (Cover component)
Research &
Related Project/Performance Site Locations
Research &
Related Other Project Information
Research &
Related Senior/Key Person
PHS398
Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as
appropriate (See Section IV.6., Special
Instructions, regarding appropriate required budget component.)
Research & Related Budget
(required for foreign applications)
Optional
Components:
PHS398 Cover Letter
File
Research &
Related Subaward Budget Attachment(s) Form
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies
concerning grants to foreign (non-U.S.) organizations can be found in the NIH
Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
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, entitled Multiple PD/PI Leadership Plan (Section 14 of the Research Plan Component in the SF424 (R&R)), 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.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are note required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission
Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: May 23, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of
Intent Receipt Date(s): May 29, 2007
NOTE: On time submission requires that applications be
successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): June 29, 2007
Peer Review
Date(s): October 2007
Council Review
Date(s): January 2008
Earliest
Anticipated Start Date(s): February
2008
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:
Priti Mehrotra, Ph.D.
Division of
Extramural Activities
National Institute of
Allergy and Infectious Diseases
Room
Number 3138, MSC 7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for
express/courier service; non-USPS service)
Telephone: (301) 435-9369
FAX: (301) 402-2638
Email: pmehrotra@niaid.nih.gov
3.B. Submitting an Application Electronically to the
NIH
To submit an
application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application
submission/receipt date(s). (See Section IV.3.A. for
all dates.) If
an application is not submitted by the receipt date(s) and time, the
application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Incomplete applications
will not be reviewed.
There will be an acknowledgement of receipt of applications from
Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the
Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
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.
Pre-award costs are allowable. A grantee may, at its own risk and
without NIH prior approval, incur obligations and expenditures to cover costs
up to 90 days before the beginning date of the initial budget period of a new
award if such costs: are necessary to conduct the project, and would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new award.
The
incurrence of pre-award costs in anticipation of a competing 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 the NIH Grants
Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Appendix Materials
IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html .
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Clinical Studies
Because the R21 grant mechanism is limited to a 2 year period, applicants proposing clinical studies must:
Include the plan that explains how IRB approval will be obtained (if applicable) and the plan for subject accrual as an attachment to the Research and Related Other Project Information form of the SF 424 application package.
Plan for Sharing Research DataThe precise content of the
data-sharing plan will vary, depending on the data being collected and how the
investigator is planning to share the data. Applicants who are planning to
share data may wish to describe briefly the expected schedule for data sharing,
the format of the final dataset, the documentation to be provided, whether or
not any analytic tools also will be provided, whether or not a data-sharing
agreement will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data arcHIV-1e or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
All applicants must include a plan for sharing research data in their
application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH policy expects that grant
recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
Program staff of the funding organization when making recommendations about
funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be
considered in the review process.
2. Review and Selection Process
Applications
that are complete and responsive to the FOA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by NIAID in
accordance with 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 priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this study address
an important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field? Does this study
address an important aspect of how to induce broadly reactive anti-HIV-1
neutralizing antibody? If the Aims of the application
are achieved, how will scientific knowledge or community/clinical practice be
advanced?
Approach: Are the conceptual or clinical framework, design, methods, and
analyses adequately developed, well integrated, well reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics? 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? Does the
application reflect clear integration of expertise in B cell immunology and HIV
such that advances in B cell immunology are applied
to the problem of HIV-1 vaccine design? Is the approach designed to overcome a
defined problem in eliciting broadly reactive anti-HIV-1 neutralizing antibody?
Innovation: Is the project original and innovative? For example: Does the project challenge existing
paradigms or clinical practice; address an innovative hypothesis or critical
barrier to progress in developing a preventive HIV-1 vaccine? Does the project
develop or employ novel concepts, approaches, methodologies, tools, or
technologies for this area?
Investigators: Are the
investigators appropriately trained and well suited to carry out this work? Is
the work proposed appropriate to the experience level of the principal
investigator and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)? Does the research team comprise and benefit from
generally recognized experts in B cell immunology and HIV who are considered to
be uniquely qualified to address the goals of this FOA?
Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support?
2.A.
Additional Review Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection of
Human Subjects from Research Risk: The involvement of human subjects and protections
from research risk relating to their participation in the proposed research
will be assessed. See item 6 of the Research Plan component of the SF424
(R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the
SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the five items described under item 11 of the
Research Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B.
Additional Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed. The priority score should not be affected by this evaluation.
Applications that Propose Clinical Studies: The adequacy of the plan to obtain IRB approval, if not available at the time of application submission, and adequacy of the patient accrual plan will be assessed. The priority score should not be affected by this evaluation.
2.C.
Sharing Research Data
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score. The presence of a data sharing plan will be part
of the terms and conditions of the award. The funding organization will be
responsible for monitoring the data sharing policy.
2.D. Sharing Research Resources
NIH policy expects that grant
recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will
be responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.
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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When
multiple years are involved, awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
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:
Helen Quill Ph.D.
Division of Allergy,
Immunology and Transplantation
National Institute of Allergy
and Infectious Diseases
6610
Rockledge Drive, Room 3013
Bethesda, MD 20892-6601
Telephone: (301) 496-7551
FAX: (301) 480-2381
Email: hquill@niaid.nih.gov
Anthony J. Conley, Ph.D.
Division of Acquired Immune Deficiency Syndrome
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive,
Room 4100
Bethesda, MD 20892-7626
Telephone: (301) 496-8197
Fax: (301) 402-3211
Email: conleyto@niaid.nih.gov
2. Peer Review Contacts:
Priti Mehrotra, Ph.D.
Division of
Extramural Activities
National Institute of
Allergy and Infectious Diseases
Room
Number 3138, MSC 7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for
express/courier service; non-USPS service)
Telephone: (301) 435-9369
FAX: (301) 402-2638
Email: pmehrotra@niaid.nih.gov
3. Financial or Grants Management Contacts:
Ms. Victoria Connors
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive, Room 2122
Bethesda, MD 20892-7614
Telephone: (301) 402-5065
Fax: (301) 493-0597
Email: vp14v@nih.gov
Section VIII. Other Information
Required Federal
Citations
Use of Animals in Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations
(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).
Sharing Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local IRB rules, as well as local, State and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
Access to Research Data through the Freedom of Information
Act:
The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public arcHIV-1e, 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 arcHIV-1ing plan in the study design and include information
about this in the budget justification section of the application. In addition,
applicants should think about how to structure informed consent statements and
other human subjects procedures given the potential for wider use of data
collected under this award.
Sharing of Model Organisms:
NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants
Policy Statement. 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.
Inclusion of Women And Minorities in Clinical Research:
It
is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the 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-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH
is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For
more information about the Policy or the submission process, please visit the
NIH Public Access Policy Web site at http://publicaccess.nih.gov/
and view the Policy or other Resources and Tools, including the Authors' Manual.
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) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy
People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This 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/ , in the following citations: 93.855, Immunology, Allergy,
and Transplantation Research and 93.856, Microbiology
and Infectious Diseases Research, 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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