and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH) ( http://www.nih.gov)
Components of Participating
Organizations
National
Institute of Child Health and Human Development (NICHD)(http://www.nichd.nih.gov )
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
Title: Diagnostic and Pharmacokinetic Research in Pediatric HIV/TB and Effects of Co-infection on the Central Nervous System (R01)
Announcement Type
New
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply)..
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Request for Applications (RFA) Number: RFA-HD-07-006
Catalog of Federal
Domestic Assistance Number(s)
93.865, 93.242
Key Dates
Release/Posted
Date: July 23, 2007
Opening Date: September 23, 2007 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): September 23, 2007
NOTE:
On time submission requires that applications be successfully submitted to
Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt Date(s): October 23,
2007
Peer Review Date(s): March 2008
Council Review Date(s): May 2008
Earliest Anticipated Start
Date(s): July 2008
Additional Information to Be
Available Date (Activation Date): Not Applicable
Expiration
Date: October 24, 2007
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency 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
Background
Mycobacterium tuberculosis (MTB) is a significant global health challenge. MTB is estimated to infect 30 percent of the world s population, with 95 percent of tuberculosis (TB) cases and 98 percent of TB deaths occurring in developing countries. While data on global prevalence of TB in children are sparse, the 2005 World Health Organization Global Report estimated that approximately one million cases of tuberculosis occur yearly in children < 15 years old, of whom 100,000 die each year. Children with TB reflect ongoing transmission in a community, and are also at greatest risk of activation of TB infection and development of disseminated disease.
Superimposed on this burden of TB is human immunodeficiency virus (HIV) infection, which has reached pandemic proportions in areas of the world in which TB is endemic. UNAIDS statistics for 2005 indicate that 2.3 million children are living with HIV/AIDS, the majority in sub-Saharan Africa. Globally, both TB and HIV are leading causes of morbidity and mortality in children, as in adults.
TB and HIV are inextricably linked. TB hastens the progression of HIV disease by increasing viral replication and further reducing CD4 counts, and the immune deficiency induced by HIV fuels TB resurgence and drives TB incidence and mortality in high prevalence areas. TB is the most common opportunistic infection in HIV-infected people. It is estimated that 50-80 percent of TB patients in sub-Saharan Africa are co-infected with HIV. In 2004, at least 50 percent of children aged 0 9 years who developed TB were also HIV-infected. Risk of progression from TB infection to TB disease is greatest in the very young and in those infected with HIV. Even in the absence of HIV co-infection, the risk of TB disease after infection is 40 percent in children under 1 year of age, and 23 percent in those aged 1 to 4 years. TB is a major cause of death among HIV-infected children over 1 year of age, accounting for 20-32 percent of deaths among HIV-infected children over age 1 year in Zambia, Cote d Ivoire, and South Africa.
In high burden communities, 20 percent or more of the TB caseload may comprise children. Childhood TB incidence rates in excess of 100-200/100,000 have been reported; however, early and accurate diagnosis of TB using currently available technology is particularly difficult in young children, and this difficulty is exacerbated by HIV co-infection. The true burden of TB among children is therefore difficult to assess, as up to 95 percent of children aged less than 12 years are sputum smear-negative and are rarely culture positive. New sensitive diagnostic modalities to rapidly identify TB in children are necessary due to rapid progression of TB disease in children and because latent infection and disease in children are sentinel events for recent MTB transmission.
Most young children present with non-cavitating pulmonary TB and are unable to expectorate sputum for microscopy. In addition, most published figures of the burden of childhood tuberculosis do not reflect the occurrence of extra-pulmonary tuberculosis (20-30 percent of the caseload in some settings) which occurs much more commonly in young children than in adults with tuberculosis. Thus, true incidence of TB disease in children is significantly underestimated. The central nervous system (CNS) is a major site of extra-pulmonary disease in children. Autopsy studies in adults with TB, particularly in low-income countries have shown a high prevalence of CNS abnormalities. Data regarding the incidence and prevalence of CNS TB in co-infected children are sparse. The clinical consequences of CNS TB on the developing brain in children with HIV have also not yet been reported.
The presence of TB disease is particularly difficult to recognize and diagnose in children and is further complicated by the fact that HIV and TB disease share many clinical and radiologic features. Current diagnostic tests for TB in this population are inadequate. Due to immune suppression, Tuberculin skin testing (TST) using the Mantoux method as a means of identifying TB infection is frequently negative in children with HIV infection. Little is known about the sensitivity of the TST at different levels of immunosuppression, particularly in children. Data are also limited on the sensitivity and specificity of whole blood interferon-gamma assays or enzyme-linked immunospot T-cell-based assays for detection of TB infection in children with HIV infection.
Further, for evaluation of suspected TB disease in low-income settings, many physicians must rely on acid-fast staining of unconcentrated sputum, evaluated by light microscopy only. The sensitivity of this method for detecting mycobacteria is limited. In the U.S. and Europe, patients suspected of having TB are first evaluated by carbolfuchsin and/or fluorescent acid-fast staining of concentrated expectorated sputum (i.e., the sputum is spun in a centrifuge at high speed to increase the number of organisms visible under the microscope) and subsequently examined under light and fluorescent microscopes for evidence of mycobacteria. Even with the use of concentrated sputum, microsopy is still a relatively insensitive test, requiring more than 10,000 organisms/ml in the sputum in order to be detected by this method.
For this reason, in the U.S. and Europe all specimens are also submitted for culture to determine if MTB is present. In the U.S., 40-42 percent of culture-proven cases of TB are AFB smear-negative using concentrated sputum; these figures are even higher for patients co-infected with HIV and TB. Conventional culture methods using Lowenstein-Jensen medium are very slow, requiring three to six weeks for the organism to grow. Culture methods that involve the use of liquid media are faster, but there is still an additional lag time of four to six weeks to obtain drug sensitivity testing after an organism is successfully isolated. These methods have long been considered unaffordable in most low-income countries. In addition, none of these methods are of particular value in diagnosing extra-pulmonary TB. Lastly, the recently developed microscopic-observation drug-susceptibility (MODS) assay, which microscopically detects TB growth in liquid broth in one week and is able to determine drug susceptibility rapidly, is promising, but has not been studied in children. The most vulnerable populations those with HIV and young children have a substantially increased risk of mortality when treatment is delayed due to the inability to make a timely diagnosis.
Treatment of TB/HIV co-infection is complex because of the possibility of cumulative toxicity from both antiretroviral agents and TB therapies, poor drug absorption, drug interactions, pill burden, and, in children, lack of appropriate drug formulations. Integration/collaboration of research on anti-TB drug pharmacokinetics and antiretroviral drug interactions in children is essential to determine appropriate management of therapy of TB and HIV in co-infected children. Rifampicin, an essential first-line antituberculosis drug and a backbone of anti-TB therapy, is a strong inducer of the cytochrome P-450 metabolic enzymes, which can profoundly affect levels of protease inhibitors and non-nucleoside reverse transcriptase inhibitors (NNRTI), the cornerstones of highly active antiretroviral therapy (HAART). There are some data in adults to suggest that this hepatic enzyme induction may be overcome by incremental increases in the doses of specific ARVs. However, little is known about these interactions in children or what specific ARV doses might result in maintaining efficacy without increasing toxicity. There are many potential drug interactions between anti-HIV and anti-TB drugs that can lead to low or excessive levels of the various drugs. Few TB drug pharmacokinetic or efficacy trials have been performed in children and, due to the difficulty of isolating an organism, verifiable microbiological endpoints are often unavailable to accurately measure treatment success. Doses for children are based on weight and extrapolated from studies in adults, yet pharmacokinetics in young children, are likely to be different than those of adults due to developmental differences in metabolism. There are some data that demonstrate that children receiving equivalent mg/kg body weight doses of antitubercular agents are exposed to considerably lower serum concentrations than adults. There is a paucity of pharmacokinetic data on existing TB drugs given to children with TB and HIV co-infection, who may be taking antiretroviral medications concurrently. As new classes of anti-tubercular medications become available, it is essential that safety, toxicity, and appropriate dosing information be available in children with TB and HIV co-infection. Additionally, it is important to evaluate the penetration of anti-TB drugs into the central nervous system in children.
Multiply Drug Resistant (MDR) tuberculosis is caused by a strain of MTB resistant to isoniazid and rifampin. Extensively drug resistant (XDR) TB has recently been identified in 10 percent of all isolates from reference laboratories in 49 countries, and in four percent of isolates in the U.S. XDR tuberculosis is currently defined as MDR with additional resistance to fluoroquinolones and at least one of the three second-line injectable drugs: capreomycin, kanamycin, and amikacin. The vast majority of those with XDR TB are co-infected with HIV. Mortality is extremely high and at least 17 countries have recently reported cases of XDR TB. The extent and amount of MDR and XDR TB in children are unknown. In adults much of XDR TB appears to represent primary resistance as most isolates were taken from subjects na ve to anti-TB agents. Inadequate TB drug regimens do, however, select for drug-resistant strains, which are then able to proliferate. Inappropriate dosing of anti-TB medications in children may contribute to the development of resistance. There are no data on the prevalence of either MDR or XDR TB in children because isolates are rarely cultured and susceptibility testing is seldom done.
Research Scope
This FOA is intended to stimulate and strengthen a multidisciplinary approach to a complex, under-researched area and to form a basis for future research and clinical care.
Specifically, the NICHD, with co-funding from the NIMH, invites new and experienced researchers and clinical investigators to submit research grant applications to further identify and optimize diagnostic modalities for TB infection and disease in HIV-infected children. We will support research to rapidly identify cases of MDR and XDR TB in children with co-infection. Additionally, studies to provide pharmacokinetic data and drug interaction studies of first- and second-line anti-TB therapies in HIV-infected children on various antiretroviral therapies are encouraged. Finally, NIMH is specifically interested in applications that address diagnosis- and treatment-related studies designed to evaluate the effects and interactions of HIV/TB co-infection in children on the central nervous system.
Examples of research projects that are responsive to this FOA include, but are not limited to, the following:
New sensitive diagnostic modalities to rapidly identify TB in children are necessary as latent infection and disease in children are sentinel events for recent M tuberculosis transmission. TB is the most common opportunistic infection in HIV-infected people and is a leading cause of morbidity and mortality in HIV/AIDS worldwide. TB accelerates HIV progression, while HIV fuels TB resurgence and drives TB incidence and mortality in high prevalence areas. Integration/collaboration of research of anti-TB drug pharmacokinetics and antiretroviral drug interactions in children is essential to determine appropriate management of therapy of TB and HIV in co-infected children.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This Funding Opportunity
Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism.
The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are a U.S. organization and are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
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 found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
2.
Funds Available
Because the nature and
scope of the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plans of the Institutes and Centers (ICs) provide support for
this program, awards pursuant to this funding opportunity are contingent upon
the availability of funds and the submission of a sufficient number of
meritorious applications.
The NICHD intends to commit $1.4 million and NIMH intends to commit $500,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2008 to support three to six meritorious applications.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
F&A costs
requested by consortium participants are not included in the direct cost
limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You may submit an
application(s) if your institution/organization has any of the following
characteristics:
1.B. Eligible Individuals
Any individual(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, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2.
Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants may submit more than one application, provided
each application is scientifically distinct.
Section IV. Application and Submission Information
To download a SF424
(R&R) Application Package and SF424 (R&R) Application Guide for
completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get 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/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download
the SF424 (R&R) application forms and 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. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application 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.)
Research & Related Budget (required for foreign
applications)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Foreign
Organizations (Non-domestic (non-U.S.) Entity)
NIH
policies concerning grants to foreign (non-U.S.) organizations can be found in
the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are 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: September 23,
2007 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 23, 2007
Application Submission/Receipt
Date(s): October 23, 2007
Peer Review Date(s): March 2008
Council Review
Date(s): May 2008
Earliest Anticipated
Start Date(s): July 2008
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:
Carol Worrell, M.D.
Pediatric, Adolescent
and Maternal AIDS Branch
National Institute of
Child Health and Human Development
6100 Executive
Boulevard, Room 4B09C, MSC 7510
Bethesda, MD
20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS
service)
Telephone: (301) 435-6842
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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NICHD. 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 receives the Grants.gov acknowledgments. The AOR 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 funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
renewal (formerly competing continuation ) award if such costs: are necessary
to conduct the project, and would be allowable under the grant, if awarded,
without NIH prior approval. If specific expenditures would otherwise require
prior approval, the grantee must obtain NIH approval before incurring the cost.
NIH prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or competing
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 the NIH Grants
Policy Statement.
Terms and Conditions for Clinical Trials
Special Terms and Conditions of Award specifying performance requirements in several specific areas, will be included in any awards intended to support
clinical trials:
(1) Protocols for clinical trials must adhere to International Conference on Harmonisation E6: Good Clinical Practices (GCP), Section 6, and must adequately address issues related to safety.
(2) Documentation of protocol approval by Institutional Review Board/Ethics Committee
(3) Adequate plans for Data and Safety Monitoring Board oversight
(4) Requirements for reporting to NICHD on safety issues, IRB actions, enrollment demographics, and addition of new study personnel
(5) Facilitating site visits by NICHD Program Officials.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/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
Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. 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:
Special Instructions for Modular Grant applications
R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.
Foreign organizations may not submit modular budgets. See NOT-OD-06-096.
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Scientific Productivity
Applicants must demonstrate a capacity to develop and implement studies focused on HIV and TB in children, and provide evidence of recent research productivity in one or more areas related to the scientific scope and objectives set forth in this FOA. Relevant research studies should be described and related publications listed.
U.S. and foreign applicants may apply separately. If a partnership between a U.S. PI/institution and a foreign investigator/institution is proposed, applicants must describe any relevant international collaborative research activity undertaken between a U.S. applicant PI/institution and a developing country partner institution. The U.S. PI should clearly document previous time spent, activities, and outcomes at the foreign site.
Organizational Capability
Applicants should describe their research organization and include plans, information, and documentation that indicate their institutional or organizational capability to manage funds and to accomplish the proposed research successfully. Details of special administrative strengths or experience should be described.
Applicants who propose clinical research projects should describe their organization’s participation in administrative aspects of clinical research [Institutional Review Boards (IRBs), advisory boards for clinical research, Federal Wide Assurance, clinical research committees, special consent procedures].
Site Expertise
The clinical research site(s) named in the application should be described, including site expertise and experience in pediatric HIV and TB clinical research. If more then one clinical site is proposed, then all proposed sites must meet basic requirements for the conduct of clinical research which include identified clinical investigators, necessary infrastructure for the research proposed such as personnel, clinical, laboratory and pharmacy facilities, and evidence of institutional support for the conduct of clinical research under U.S. regulations.
Sites conducting laboratory research should describe the roles, experience, and expertise of the laboratory staff in the development and execution of required laboratory work. Innovative approaches for identification and evaluation of new tests, reagents, and instruments for clinical studies, including collaborations with other laboratories and experts, should be addressed. Procedures for conducting and reporting laboratory studies in the areas necessary to the proposed research plan should be addressed, including: plans for laboratory administration; procedures for collection, testing, tracking, storage, and retrieval of laboratory specimens; quality assurance and quality control procedures; plans for data management; and, where applicable, plans for training clinical site personnel to perform specimen processing, shipping, and other protocol-specific specimen handling requirements.
Access to Appropriate Populations for Clinical Trials
Applicants must describe access to target populations of TB/HIV-infected children to participate in any proposed clinical trial. Investigators must be prepared to demonstrate the ability to recruit and enroll appropriate subjects.
Plan for Sharing Research Data
The precise content of the
data-sharing plan will vary, depending on the data being collected and how the
investigator is planning to share the data. Applicants who are planning to
share data may wish to describe briefly the expected schedule for data sharing,
the format of the final dataset, the documentation to be provided, whether or
not any analytic tools also will be provided, whether or not a data-sharing
agreement will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their institutional
or personal Web site, through a data archive or enclave). Investigators
choosing to share under their own auspices may wish to enter into a
data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
All applicants must include a plan for sharing research
data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2.
Review and Selection Process
Appropriate scientific
review groups convened in accordance with the standard NIH peer review
procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications
will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? For applications
designating multiple PDs/PIs, is the leadership approach, including the
designated roles and responsibilities, governance, and organizational
structure, consistent with and justified by the aims of the project and the
expertise of each of the PDs/PIs?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Do the investigators demonstrate the capacity to develop and implement studies focused on HIV and TB in children? Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Do they provide evidence of recent research productivity in one or more areas related to the scientific scope and objectives of the RFA? Is the necessary infrastructure to complete the proposed project available at the site?
Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Do the investigators provide evidence of adequate organizational capability and site expertise to carry out the proposed research? Do the investigators provide evidence of sufficient access to target populations of HIV/TB infected children to participate in any proposed clinical trial?
2.A. Additional Review Criteria
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See the Human Subjects Sections
of the PHS398 Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the Human Subjects Sections of the PHS398
Research Plan component of the SF424 (R&R)
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period
of Support: The reasonableness of the proposed budget and the appropriateness of the
requested period of support in relation to the proposed research may be
assessed by the reviewers. The priority score should not be affected by the
evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C.
Sharing Research Data
Data Sharing
Plan: The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score. The presence of a data sharing plan will be part
of the terms and conditions of the award. The funding organization will be
responsible for monitoring the data sharing policy.
2.D.
Sharing Research Resources
NIH policy
expects that grant recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff
will be responsible for the administrative review of the plan for sharing
research resources.
The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
Model Organism Sharing Plan: Reviewers are
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis,
taking into consideration the organism, the timeline, the applicant's decision
to distribute the resource or deposit it in a repository, and other relevant
considerations.
3.
Anticipated Announcement and Award Dates
Applicants
may learn of the outcome of the peer review of their grant applications on or
after July 15, 2008. The earliest award will be August 1, 2008.
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 Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Carol Worrell, M.D.
Pediatric, Adolescent and Maternal AIDS Branch
National Institute of
Child Health and Human Development
6100 Executive
Boulevard, Room 4B09C,
MSC 7510
Bethesda, MD
20892-7510
Telephone: (301)
435-6842
Email: [email protected]
Pim
Brouwers, Ph.D.
Associate
Director, Infant,
Child, & Adolescent Research Programs
Chief,
Primary Prevention Branch
Center for
Mental Health Research on AIDS
National
Institute of Mental Health
6001
Executive Boulevard, NSC Room 6216, MSC 9619
Rockville, MD 20892-9619
Telephone:
(301) 443-4526
Email: [email protected]
2. Peer Review Contact(s):
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room
5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS
service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]
3. Financial/Grants Management Contact(s):
Bryan S. Clark, MBA
Chief Grants Management Officer
National Institute of Child Health and Human Development
6100
Executive Boulevard, Room 8A01A
Rockville, MD 20852
Telephone: 301-435-6975
Fax: 301-402-0915
Rita V. Sisco
Supervisory
Grants Management Officer
National Institute of Mental Health
6001
Executive Boulevard, Room 6120,
MSC 9537
Bethesda, MD 20892-9537
Telephone:
(301) 443-2805
Fax:
(301) 443-6885
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 IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public 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.
Sharing of
Model Organisms:
NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of
Women And Minorities in Clinical Research:
It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH maintains
a policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required
Education on the Protection of Human Subject Participants:
NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human
Embryonic Stem Cells (hESC):
Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public
Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov/) at
PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting
that authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more
information about the Policy or the submission process, please visit the NIH
Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of
Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
Internet addresses (URLs) or PubMed Central (PMC) submission identification
numbers must be used for publicly accessible on-line journal
articles. Publicly accessible on-line journal articles or PMC
articles/manuscripts accepted for publication that are directly relevant to the
project may be included only as URLs or PMC submission identification
numbers accompanying the full reference in either the Bibliography &
References Cited section, the Progress Report Publication List section, or the
Biographical Sketch section of the NIH grant application. A URL or PMC
submission identification number citation may be repeated in each of these
sections as appropriate. There is no limit to the number of URLs or PMC
submission identification numbers that can be cited.
Healthy
People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review. Awards
are made under the authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH
Grants Policy Statement.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50 percent 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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