and Human Services (HHS)
EXPIRED
Department of
Health and Human Services
Issuing Organization
National
Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
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: Partnerships for Development of Therapeutics and
Diagnostics for Drug-Resistant Bacteria and Eukaryotic Parasites (R01)
Announcement Type
New
Request for Applications (RFA) Number: RFA AI-09-026
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 (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.856
Key Dates
Release/Posted Date: July 31, 2009
Opening Date: October 9, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 9, 2009
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 Due Date(s): November 9, 2009
Peer Review Date(s): March, 2010
Council Review Date(s): May, 2010
Earliest Anticipated Start Date(s): June, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable.
Expiration Date:November 10, 2009
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. 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 Contacts
1. Scientific/Research Contact(s)
2. Peer Review
Contact(s)
3. Financial/Grants
Management Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by infectious agents. In response to potential threats presented by bioterrorism and emerging infectious diseases, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established research programs to facilitate development of countermeasures for select pathogens and toxins.
Through this FOA, the NIAID invites translational research applications for projects that will lead to development of newer therapeutics or medical diagnostics for drug-resistant NIAID Category A, B or C bacteria and eukaryotic parasites. Additionally, applications are invited for development of diagnostics or broad-spectrum therapeutics against non-listed bacteria and eukaryotic parasites for which naturally-occurring drug resistance is a significant and/or rapidly growing clinical problem. Research may include, but is not limited to: discovery and early development of new or improved antimicrobial agents, including small molecule inhibitors, antibodies, and peptides; discovery and early development of new or improved therapeutics; target identification and/or validation; development of broad-spectrum drugs and/or drugs targeting novel mechanisms; development of broad spectrum platforms and/or production technologies; optimization of products; process development; preclinical evaluation; scale-up; and production of quantities sufficient for preclinical regulatory requirements. Applications that include collaborations between researchers from different disciplines and/or with industry are strongly encouraged.
The NIAID recognizes that the inherent nature and demands of the product development process may require complex grants with interdependent specific aims. Furthermore, some aspects of the product development process (e.g., Good Laboratory Practice [GLP] or current Good Manufacturing Practice [cGMP] production) are inherently not innovative. Recognizing that product development is often an iterative and sequential process, and that steps early in the process may not be successful and may need to be modified or reworked, NIAID staff will be actively involved in evaluating the milestones of awardees and determining whether continued investment in the development is warranted.
NOTE: While clinical development strategies may be included within an overall product development plan, this FOA will NOT support clinical trials; applications requesting support for clinical trials will be deemed unresponsive to this FOA and will not be reviewed. Utilization of human derived material in pre-clinical studies in support of compliance with regulatory requirements is permitted.
NOTE: This FOA will NOT support research on environmental or workplace detection technologies or targets. Diagnostics applications must focus on detection and identification of NIAID Category A, B or C priority pathogens or toxins in human clinical samples.
Partnerships
A key component of this initiative is the formation of collaborative partnerships between academic researchers from different disciplines or with industry. For the purpose of this FOA, "industry" is defined as large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies. Since academic organizations are often the source of new candidate products, this FOA will also support a partnership between industry and collaborator(s) as necessary from academic (or non-profit) research organizations. For this FOA, partnerships are strongly encouraged, but not required. The Principal Investigator of the project may be affiliated with industry, an academic organization or non-profit research organization.
Applications submitted to this FOA will include a Product Development Plan (PDP) to assist reviewers and program staff in project evaluation. The PDP will define the general goals of the project, intended use/indication of the proposed therapeutic or diagnostic, and biodefense/public health gap the product is intended to fill. Additionally, the PDP will detail the stage-specific product development activities that will be performed during the project period and outline plans for further development after completion of the project.
Background
The NIH and other agencies in the Department of Health and Human Services (DHHS) support development of countermeasures to protect the public from bioterrorist threats and emerging infectious diseases. The biological agents deemed to pose the greatest threat are prioritized in the NIAID Category A, B and C priority pathogens and toxins list (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm). The initial NIAID Strategic Plan for Biodefense Research (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/strategic_plan.htm) was published in 2002 and followed by research agendas for Category A agents (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biotresearchagenda.htm) and Category B and C agents (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/categorybandc.htm). In 2007, the DHHS Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) published an Implementation Plan (http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html), outlining strategies for identifying medical countermeasure requirements and establishing priorities for their research, development and acquisition.
NIAID recently published an updated Strategic Plan for Biodefense Research (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biosp2007.pdf) that is consistent with the DHHS PHEMCE Implementation Plan and related components of the national biodefense strategy. The updated plan continues to focus on translation of basic research to product development, but with an emphasis shift from the current one bug-one drug approach towards a more flexible, broad spectrum approach. This approach is centered on development of countermeasures that are effective against multiple pathogens or toxins, development of technologies that can be widely applied to improve classes of products, and developing platforms that can reduce the time and cost of creating new products. The broad spectrum approach recognizes the expanding range of biological threats and the limited resources available to address each individual threat.
Research Goals and Objectives
Development of therapeutics and diagnostics for drug-resistant bacteria and eukaryotic parasites is a high priority. Current antimicrobial drugs remain constrained to a limited number of mechanistic classes, and rapid diagnostics, capable of quickly identifying both the infectious agent and its drug susceptibilities, are lacking. This initiative will support collaborative, multidisciplinary projects that seek to develop new therapeutics and/or diagnostics for select drug-resistant pathogens. Projects that characterize novel therapeutic or diagnostic targets are encouraged provided they focus on product discovery and include downstream product development steps. Research on broad-spectrum therapeutics, truly novel drug classes, or platformed diagnostics is particularly encouraged.
Therapeutic and/or diagnostic projects may focus on one or more drug-resistant NIAID Category A, B or C bacteria or eukaryotic parasite. Additionally, diagnostic and/or broad-spectrum therapeutic projects may focus on one or more non-listed bacterial pathogen or eukaryotic parasite for which naturally-occurring drug-resistance is a significant and/or rapidly growing clinical problem, particularly if limited therapeutic options are available. Examples of such non-listed pathogens include Clostridium difficile, Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumanii, Pseudomonas aeruginosa, Enterobacter spp., Neisseria gonorrhea, Plasmodium falciparum, Trypanosoma cruzi, and Giardia lamblia.
The research should be original, innovative, and based on scientifically sound concepts and technologies. Multidisciplinary team efforts are responsive. Research utilizing state-of-the-art metabolomic technologies, including genomics, proteomics and bioinformatics, is encouraged. The research is not required to result in a final product but must advance toward a defined therapeutic or diagnostic for use in patient care or a tertiary care hospital clinical laboratory, respectively.
Therapeutics for Drug-Resistant Bacteria and Parasites
This initiative will support discovery and/or development of new or improved antimicrobial agents, including small molecule inhibitors, therapeutic antibodies, and peptides. Projects focused on development of broad-spectrum drugs and/or drugs targeting novel mechanisms are encouraged. Projects can also focus on the development of secondary treatments used together with primary treatments for the primary purpose of assisting and enhancing the process, also called adjunctive therapeutics. Such approaches need not be geared to a specific pathogen, but rather should directly target known mechanisms of resistance in order to extend the clinical utility of existing antimicrobials. Projects may include, but are not limited to, one or more of the following areas:
Diagnostics for Drug-Resistant Bacteria and Parasites:
This initiative will support development of rapid point-of-care diagnostics to quickly identify pathogens and their resistance profiles. Eligible pathogens are described above. Diagnostics are needed to identify infectious agents or toxins in clinical samples (swabs, sputum, blood, serum, cerebrospinal fluid, urine, stool, etc.) from individuals at multiple stages of infection. Multiplexed diagnostics, as well as those able to provide diagnostic information on potential early, non specific symptoms are particularly encouraged. Medical diagnostics that use platforms to simultaneously detect multiple pathogens and their drug sensitivities in clinical specimens and to rapidly distinguish whether an individual is infected by a biological threat agent or a common infection with similar, generalized symptoms are of high priority. It is anticipated that the medical diagnostics developed through this initiative will aid healthcare providers in diagnosing individuals exposed to and/or infected with aforesaid pathogens and will be developed with the eventual and ultimate goal of obtaining FDA-clearance. However this need not be the final result of the proposed research project period.
Medical diagnostics will ideally be:
Applications for applied research for medical diagnostics including both technology and development of tests to detect the aforesaid pathogens are invited. Projects may include, but are not limited to, one or more of the following areas:
NOTE: This program will NOT support research on the development of environmental detection devices or their deployment. As such, applications for the development of environmental detection devices and/or their deployment will be deemed unresponsive and will not be reviewed.
See Section VIII, Other Information - Required Federal
Citations, for
policies related to this announcement.
Section
II. Award Information
This FOA will use the R01 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2. Funds Available
The estimated amount of funds available for support of 5-10 projects awarded as a result of this announcement is $7.3M for fiscal year 2010. Future year amounts will depend on annual appropriations. An applicant may request a project period of up to 5 years.
The annual direct costs that can be requested may not exceed $750,000. Requested budgets must be justified by the proposed research and will be evaluated by the review panel and program staff. NIAID recognizes that some developmental projects with advanced components (GMP production, pre-clinical evaluation in non-human primates, etc.) may require annual direct costs exceeding $750,000. For such projects, applicants may seek prior approval by program staff to request annual direct costs greater than $750,000. NOTE: Applications with unapproved direct costs greater than $750,000 in any year will be deemed non-responsive and will not be reviewed.
Applicants may request up to a total of $300,000 in first-year costs for major equipment to ensure that research aims can be met and biohazards can be contained. Prior approval from program staff, listed below under Section VII. Agency Contact(s) must be obtained for requests for equipment that exceed this amount. Unapproved equipment requests that exceed $300,000 will not be considered for funding.
Because the nature and scope of the proposed research will
vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the
IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The
following organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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 (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do 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 electronic Research Administration (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 grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, 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 PDs/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
Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
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, use the Apply for Grant Electronically button in this FOA or 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 NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
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(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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 the 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: [email protected].
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. Some fields within the SF424 (R&R) application components, 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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.)
Optional Components:
PHS398 Cover Letter
File
Research &
Related Subaward Budget Attachment(s) Form
Foreign Organizations (Non-domestic [non-U.S.] Entities)
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 (U.S.) 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 plan approach for the proposed 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, and should include 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 (NoA).
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 not 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: October, 9, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 9, 2009
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 Due Date(s): November 9, 2009
Peer Review Date(s): March, 2010
Council Review Date(s): May, 2010
Earliest Anticipated Start Date(s): June, 2010
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:
Dr. Lynn Rust
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3120, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Telephone: (301) 402-3938
Fax: (301) 480-2408
Email: [email protected]
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/applicants/apply_for_grants.jsp 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 due date(s).
(See Section IV.3.A. for all dates.) If an application is not submitted
by the due 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 weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
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. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons
acknowledgments. 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 FOA 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.
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 or renewal award if such costs: 1) are necessary to conduct the
project, and 2) 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 renewal
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.
6. Other Submission
Requirements
RESEARCH PLAN
1. Research Focus
Applicants are encouraged to read the updated NIAID Strategic Plan for Biodefense Research (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biosp2007.pdf) before preparing an application. This program supports development of new and promising products for biodefense. Each application must propose a research and development project whose goal is to develop and/or advance a therapeutic or diagnostic focused on a drug-resistant NIAID Category A, B or C bacterium or eukaryotic parasite, and/or a non-listed bacterium or eukaryotic parasite where drug resistance is a significant and/or rapidly growing clinical problem. It is not necessary to propose to complete the product development process up to the point of readiness for clinical trials within the time frame of this project. Applications that would significantly advance a specific product toward clinical or field usefulness are responsive.
NOTE: Applications proposing translational antimicrobial research and development of a therapeutic against a non-listed drug-resistant bacterium or eukaryotic parasite must focus on development of a broad-spectrum therapeutic. For these projects, applicants must clearly describe the broad-spectrum capability of the proposed therapeutic technology.
NOTE: All applications for research projects focused on diagnostics should include in the Research Plan:
2. Mandatory Meetings
One mandatory progress review meeting will be held annually at the NIAID, or at a site designated by the NIAID Program Official, during which the Principal Investigator and appropriate Key Personnel will present project accomplishments. Requested budgets must include funds for travel by the Principal Investigator and key personnel to an annual meeting in Bethesda, Maryland (USA), or to a relevant scientific meeting, as determined by NIAID Program staff. The NIAID Program Official and External Advisors (when applicable) will be present. A critical determinant of success will be the degree of communication between the Principal Investigator, Project Leaders and other significantly involved parties. Therefore, in addition to the one meeting listed above, additional meetings, which may be necessary for coordination of project activities, may be scheduled if justified. Regular telephone and written communication with the NIAID Program Official is considered to be very important and is strongly encouraged.
3. Major Equipment
Applicants may request up to a total of $300,000 for major equipment to ensure that research aims can be met and biohazards can be contained. Funds for equipment must be included in the first year requested budget with justification. Prior approval from program staff, listed below in Section VII. Agency Contact(s), must be obtained for requests for equipment that exceed this amount. Unapproved equipment requests that exceed $300,000 will not be considered for funding.
4. Good Laboratory and Good Manufacturing Practices
When appropriate, applicants must document in the Research Plan compliance with guidelines that govern GLP, as defined by 21 CRF (58), and cGMP, as defined by 21 CRF (211), manufacturing and/or IND/IDE enabling studies that will be performed under the project award as they would be applicable to eventual product licensure in the U.S.
Applications for projects involving cGMP manufacture should ensure inclusion of appropriate personnel to provide regulatory guidance before, during and after manufacture.
ADDITIONAL SUBMISSION REQUIREMENTS (DO NOT COUNT TOWARDS PAGE LIMITS FOR RESEARCH PLAN)
1. Milestones and Timeline
Applicants are required to provide detailed project performance and timeline objectives in a section entitled Milestones and Timeline. This section must be no more than 5 pages and is not included in the 25-page limit of the Research Plan. The Milestones and Timeline must be included as an attachment to the Research & Related Other Project Information form under item 11 Other Attachments. The Milestones and Timeline section must include:
2. Product Development Plan
Applicants are required to include an add-on section entitled Product Development Plan in the application to assist reviewers and program staff in project evaluation. This section must be no more than 5 pages and is not included in the 25-page limit of the Research Plan. The Product Development Plan must be included as an attachment to the Research & Related Other Project Information form under item 11 Other Attachments. The Product Development Plan should follow the Milestones and Timeline and must include:
Additionally, the Product Development Plan must include descriptions pertaining to early-stage and/or mid-stage-specific product development activities, as applicable, detailed below. Applications for projects that span early-stage and mid-stage should include the relevant information requested for both activities.
Early-Stage Product Development Projects
For the purpose of this RFA, early-stage is defined as all activities leading to and including lead candidate identification (vaccines, therapeutics, or adjuvants) or identification of clinical diagnostic targets and development of assays to detect these targets or initial development of diagnostic platform technology (diagnostics).
Product Development Plans for early-stage projects should include:
Mid-Stage Product Development Projects
For the purpose of this FOA, mid-stage is defined as all activities beyond lead candidate identification (e.g. safety evaluation, stability testing, manufacturing, development, etc.), diagnostic assay development, or initial development of diagnostic platform technology.
Product Development Plans for mid-stage vaccine, therapeutic or adjuvant projects should summarize:
Product Development Plans for mid-stage diagnostics projects should summarize:
NOTE: Applications lacking a free-standing and detailed Product Development Plan will be deemed unresponsive and will not be reviewed.
3. Physical and/or Facility Security
Applicants must address issues related to physical or facility security and biocontainment and biosafety (http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm) pertinent to the specific pathogens of interest in an add-on section entitled Biosafety and Biocontainment . Guidelines for Institutional Biosafety Committees are available at: http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm. This section must be no more than 1 page and is not included in the 25-page limit of the Research Plan. The Biosafety and Biocontainment section must be included as an attachment to the Research & Related Other Project Information form under item 11 Other Attachments and should follow the Product Development Plan.
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) 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.
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.
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. 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.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Appendix Materials
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 comply with the required page limitations may be delayed in the review process.
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: Regardless of the amount requested, investigators 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 where 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 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
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 this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the 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? Is this project
likely to significantly advance the development of a therapeutic or diagnostic
against one or more of the specific biologic threat agents identified in this
initiative? If the aims of the application are
achieved, are important biomedical agents or products likely to result?
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? Do the regulatory personnel possess the appropriate expertise to guide cGMP manufacture and/or related processes (if applicable)?
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? Does the research proposed in each project leverage multi-disciplinary involvement to accelerate therapeutics, immunotherapeutics, and diagnostics product development, many aspects of which may not be inherently innovative? In addition, does the approach represent the best use of current or emerging technologies and appropriate collaborations to achieve the research objectives?
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) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are the proposed objectives/milestones appropriate and feasible? Is the proposed product development plan feasible and appropriate for future product development?
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.
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.
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/priority 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 Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
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.htm); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
3.
Anticipated Announcement and Award Dates
Not
Applicable.
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the 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
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Dr.
Suman Mukhopadhyay
Division
of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room
4226, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone:
(301) 451-3032
FAX:
(301) 402-2508
E-Mail: [email protected]
Dr. Michael Schaefer
Division
of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5003, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451-3758
FAX: (301) 480-1263
E-Mail: [email protected]
2. Peer Review Contact(s):
Dr.
Lynn Rust
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3120, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 402-3938
Fax: (301) 480-2408
Email: [email protected]
3. Financial/Grants Management Contact(s):
Cassandra Fields
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2245, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20817-7614
Telephone: (301) 594-6355
Fax: (301) 493-0597
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use
of Animals in Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human
Subjects Protection:
Federal regulations
(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 institutional review board (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.
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 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.
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
Medicine’s 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. 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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