and Human Services (HHS)
EXPIRED
Department of
Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National Institute on Allergy and
Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
Title: Partnerships for Development of Vaccines for
Selected Pathogens (R01)
Announcement Type
New
Request for Applications (RFA) Number: RFA-AI-09-016
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: April 3, 2009
Opening Date: June 27, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): June 26, 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): July 27, 2009
Peer
Review Date(s): November 2009
Council
Review Date(s): January 2010
Earliest Anticipated Start
Date(s): April 2010
Additional Information
To Be Available Date (Activation Date): Not Applicable
Expiration Date: July
28, 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 and Information
Section V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3.
Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2.
Administrative and National Policy Requirements
3.
Reporting
Section VII. Agency 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), solicits research applications for projects that will advance development of vaccines against five pathogens that have a significant impact on public health: cytomegalovirus, respiratory syncytial virus, Staphylococcus aureus, Pseudomonas aeruginosa and Clostridium difficile. All of these pathogens have been the subject of vigorous vaccine development efforts that to date have not resulted in a successful candidate moving to licensure. Applications that include collaborations between researchers from different disciplines and/or with industry are strongly encouraged, but not required.
The NIAID recognizes that the inherent nature and demands of the product development process may require funding 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 not innovative by nature. Recognizing that product development is often an iterative and sequential process and steps early in the process may not be successful and may need to be modified or reworked, progress made toward the successful completion of milestones and targeted objectives will be a significant factor in evaluating progress of awardees.
The NIAID also encourages applicants to incorporate the use of contract pre-clinical services offered by the NIAID as a means of augmenting the resources provided under this FOA. See http://www3.niaid.nih.gov/research/resources/dmid/ for more information.
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 viewed as unresponsive to this FOA and will not be reviewed. Utilization of human derived material in pre-clinical studies in support of complying with regulatory requirements is considered responsive.
Partnerships
A key component of this FOA is the formation of collaborative partnerships, which may be between academic researchers from different disciplines or between academic and industry researchers. 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 support partnerships between industry and collaborator(s) from academic (or non-profit) research organizations. For this FOA, partnerships are strongly encouraged, but not required.
Applications submitted in response 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.
The Principal Investigator of the project may be affiliated with industry, an academic organization or non-profit research organization.
Background
Vaccines are a critical component of a public health strategy aimed at reducing the burden of infectious diseases. For some infections, vaccination is a long-established and demonstrably successful prevention strategy. Other diseases have yielded more recently to vaccine development efforts. In the last twenty-five years, vaccines have been licensed for hepatitis A and B viruses, varicella-zoster virus, Haemophilus influenzae type b, and Bordetella pertussis. There also remain several infectious diseases for which vaccines are both needed and for which there is robust basic research activity aimed at developing vaccine candidates, yet no candidate has advanced in its development to where licensure is imminent. This FOA targets five such agents that are responsible for significant morbidity and mortally in the U.S., incurring major health care costs. Despite their longstanding public health and economic impacts, treatment options for these infections are very limited or non-existent, and no licensed vaccines are available.
Two viruses cytomegalovirus (CMV) and respiratory syncytial virus (RSV) are causes of significant morbidity and mortality in infants and children. The need for vaccines against these viruses was highlighted in a 2000 report from the Institute of Medicine (IOM), Vaccines for the 21st Century: A Tool for Decision Making, which assessed the feasibility of development for 26 candidate vaccines directed against conditions of domestic importance, which potentially could be developed within two decades. CMV was designated as one of seven most favorable; RSV was one of nine vaccine targets designated more favorable.
Intrauterine infection with CMV leads to congenital deafness and mental retardation in up to 10,000 children annually in the U.S. Treatment with antivirals can slow progression of hearing loss, but not reverse it. Several approaches to CMV vaccines have emerged, some of which have advanced to early clinical evaluation, including using: glycoprotein subunits, viral vectors (poxvirus and alphavirus vectors), DNA, disabled and other non-replicating mutants, and peptides. Encouraging results were reported recently showing that a subunit vaccine has at least 50% efficacy in preventing primary infection in seronegative post-partum women. Further development requirements include the evaluation of modified and alternative approaches with the potential for higher efficacy, and an assessment of efficacy against congenital infection and disease.
RSV is the leading cause of lower respiratory tract illness in infants and children. In the U.S., roughly 70,000 to 120,000 infants are hospitalized annually with RSV related pneumonia or bronchiolitis. More importantly, RSV can re-infect individuals throughout their life. Although there is a definite need for a vaccine in infants and children (and elderly), there have been many challenges in the development of a vaccine. A primary reason is the immunopotentiation seen with previous inactivated RSV vaccine. In addition, effectiveness will be limited by an infant’s immature immune response and the presence of maternal antibodies. Further, an RSV vaccine needs to be effective against antigenically divergent groups A and B. Much progress has been made in the evaluation of vaccines for RSV and PIV3. Many RSV vaccines have been tested in clinical trials, including RSV subunit vaccines, live attenuated vaccines, and recombinant RSV vaccines. However, the vaccines tested to date have not been able to generate adequate neutralizing antibody titers.
Three bacterial pathogens Staphylococcus aureus, Pseudomonas aeruginosa and Clostridium difficile are among the most common causes of nosocomial infections and are particularly difficult to treat due to resistance against multiple antibiotics and persistence in the environment. Recent reports of community-acquired S. aureus and C. difficile cases have raised public awareness and concern. For these particular bacterial pathogens, a vaccine may be valuable either prophylactically or therapeutically in conjunction with other treatments.
S. aureus is one of the major causes of fatal nosocomial infection, and causes complications following surgery, wounds and various parenteral therapies. It is the leading cause of ward closure in hospitals. Strains resistant to multiple antibiotics (methicillin resistant S. aureus or MRSA) are becoming more common, and S. aureus is an increasingly important community-acquired infection. It is estimated that S. aureus annually accounts for 12 million outpatient visits and 292,000 hospitalizations (of which 126,000 are due to MRSA). Vaccine strategies being investigated include whole bacteria, purified antigens and purified toxoids. Several candidates have failed in Phase III clinical trials in the past decade.
P. aeruginosa is a gram-negative bacterium that causes serious nosocomial and community-acquired infections. It is of particular concern in wound healing, and can be a chronic problem in diabetic and cystic fibrosis patients, and is prominent in burn units. Annual mortality in the U.S. is estimated at 70,000- 150,000. Antibiotic therapy is useful, but incomplete treatment and resistant strains often result in severe chronic infections. Several vaccine candidates have been developed using a variety of strategies (attenuated strains; killed bacteria; antigens based on bacterial polysaccharides, outer membrane proteins, flagella, and pili), but none has been successful in moving to licensure.
C. difficile is a leading cause of hospital-acquired diarrheal disease. It is estimated that over 300,000 cases of C. difficile-associated diarrhea (CDAD) occur annually in the U.S. Depending on the strain, the annual mortality rate ranges from about 3-17%. The condition is difficult to treat as antibiotic options (vancomycin, metronidazole) are limited and the recurrence rate is high (10-40% of patients). In addition, community-acquired cases of CDAD are on the rise, even among healthy young people. Research in animal models show that antibodies against C. difficile toxins protect against disease and a toxin-based vaccine is in the early stages of development. Vaccines targeting other antigens may also be protective.
Research Goals and Objectives
To facilitate the development and testing of candidate vaccines, it is imperative that promising basic research findings/technologies be translated rapidly into new approaches and strategies for product development. The involvement of experts from diverse disciplines (e.g., biochemists, structural biologists, protein chemists, pharmacologists, immunologists, molecular biologists, engineers and clinicians) within academia and industry is needed to enable development of well-designed candidates for vaccines.
The objectives of this FOA are:
1. To support research that will advance the development and/or production of vaccines specific for the pathogens described above. Developmental research is not required to result in a "final" product but must advance the development of a candidate product; and
2. To stimulate scientifically sound, original, and innovative research requiring a comprehensive team and multidisciplinary effort that will facilitate advancement of a promising candidate product or platform technology through the product development pathway.
To most effectively achieve these objectives, applications must include in vivo efficacy data in at least one animal model with accompanying general safety and immunogenicity data. It is understood that the animal studies may involve a vaccine or endpoint that does not precisely replicate the planned human vaccine.
NOTE: While clinical development strategies may be included within an overall product development plan, this FOA will NOT support Phase I, II, and III clinical trials or field trials. Applications requesting support for clinical trials will be viewed as unresponsive to this FOA and will not be reviewed. However, utilization of appropriate human cell lines and human derived material in pre-clinical studies in support of complying with regulatory requirements is considered responsive and is encouraged.
For all vaccine projects, approaches should consider the ultimate potential of candidate vaccines to induce safe and protective responses in a diverse population. Projects may include, but are not limited to, one or more of the following areas:
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) must 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 NIAID intends to commit $4.0 million in total costs in FY2010 to fund three to five applications in response to this FOA. An applicant may request a project period of up to five years and a budget for direct costs of no more than $500,000 in any single year.
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. 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 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: June 27, 2009 (Earliest
date an application
may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): June 26, 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): July 27, 2009
Peer
Review Date(s): November, 2009
Council
Review Date(s): January, 2010
Earliest Anticipated Start
Date(s): April, 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:
Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3116, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier service; non-USPS
service)
Phone: (301) 435-8537
Fax: (301) 480-2310
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.
In order to expedite the review, applicants are requested to notify the NIAID Referral Office by email to NIAID [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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 and responsiveness by the IC. Incomplete and non-responsive 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 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 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 and Information
Research Plan
1. Research Focus
Each application must propose a research and development project whose goal is to develop and/or advance a vaccine against cytomegalovirus, respiratory syncytial virus, Staphylococcus aureus, Pseudomonas aeruginosa or Clostridium difficile. Projects proposed in response to this FOA must provide in vivo efficacy data in at least one animal model with accompanying general safety and immunogenicity data. It is not necessary to complete the product development process up to the point of readiness for clinical trials within the project period. Applications that would significantly advance a specific product toward clinical usefulness are responsive.
2. Mandatory Meetings
An annual mandatory progress review meeting will be held in Bethesda, Maryland, during which the Principal Investigator and appropriate Key Personnel will present significant findings.
Requested budgets must also include funds for travel by the Principal Investigator and Key Personnel to the annual mandatory progress review meeting of all awardees in Bethesda, Maryland, or to a relevant scientific meeting. The NIAID Program Official will attend these meetings.
A critical determinant of success will be the degree of communication among the Principal Investigator, Project Leaders and other significantly involved parties. Therefore, in addition to the annual mandatory progress review 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. 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) (see: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58), and cGMP, as defined by 21 CRF (211) (see: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211), manufacturing and/or IND/IDE (Investigational New Drug/Investigational Device Exemption) 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
1. Milestones and Timeline
Applicants must provide detailed project performance and timeline objectives in a section entitled Milestones and Timeline. The Milestones and Timeline section may not exceed five pages and should follow the Research Plan of the application (these additional pages do not count towards the page limits for the Research Plan). The Milestone and Timeline section must be included as an attachment to the Research & Related Other Project Information form under item 11 Other Attachments. This section must include:
2. Product Development Plan
Applicants must include an add-on section entitled Product Development Plan in the application to assist reviewers and program staff in project evaluation. The Product Development Plan section may not exceed eight pages and should follow the Research Plan of the application (these additional pages do not count towards the page limits for 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 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 FOA, 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.
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.
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/.)
Foreign Applications (Non-Domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.
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 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 vaccine against one of the specific agents identified in this
FOA ? If the aims of the application are achieved, is
an effective vaccine likely to result? What will be the effect of these studies
on the concepts or methods that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? If regulatory resources are proposed, are the associated project leaders sufficiently capable of guiding cGMP manufacture and/or related processes?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) 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.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select 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
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. Christopher Beisel
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 1211, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 496-7453
Fax: (301) 480-1594
Email: [email protected]
2. Peer Review Contact(s):
Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3116, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier service; non-USPS
service)
Phone: (301) 435-8537
Fax: (301) 480-2310
Email: [email protected]
3. Financial/Grants Management Contact(s):
Kimberly Belk
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2251, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 451-7380
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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