Department of
Health and Human Services
Participating Organizations
National Institutes of Health (NIH), http://www.nih.gov
Components of Participating Organizations
National Institute of
Allergy and Infectious Diseases (NIAID), http://www.niaid.nih.gov
Title: Development of Novel Interventions and Tools for the
Control of Malaria, Neglected Tropical Diseases and their Vectors (R01)
Announcement Type
New
Request for Applications (RFA) Number: RFA-AI-08-005
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:
93.856
Key Dates
Release/Posted Date: March
7, 2008
Opening Date: June 10, 2008 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): June
10, 2008
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 10, 2008
Peer Review
Date(s): November, 2008
Council Review Date(s): January 2009
Earliest Anticipated Start Date(s): May 2009
Additional
Information To Be Available Date (Activation Date): Not
Applicable
Expiration
Date: July
11, 2008
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. Receipt, 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 purpose of this Funding Opportunity Announcement (FOA) is to support and stimulate translational research leading to the development of novel and more effective interventions and research tools (e.g., genetic and computational tools) that will facilitate and promote the discovery and development of novel therapeutics, vaccines, diagnostics and vector management strategies, thereby reducing or eliminating morbidity and mortality from malaria and Neglected Tropical Diseases (NTDs), (see list of NTDs below). Projects that propose to develop molecular tools and biomarkers to support the development of novel and more effective interventions are also included in this initiative.
Background:
Malaria and NTDs occur in many of the poorest countries of the world, and often have a significant geographic overlap. Malaria and NTDs are caused by a wide range of organisms (protozoa, bacteria and helminths) and can be transmitted by a variety of vectors (mosquitoes, sandflies, black flies, tsetse flies, triatomine bugs and snails). Increasing evidence points to malaria and NTDs as contributors to poverty in these countries. Therefore interventions targeting malaria and NTDs could have a significant impact not only on the disease burden, but on the overall economic capacity of the countries where these diseases predominate.
For malaria and some NTDs there are effective interventions and control programs already in place (examples include The President’s Malaria Initiative, World Health Organization: Global Malaria Programme, Lymphatic Filariasis Elimination Program, the International Trachoma Initiative, WHO Alliance for the Global Elimination of Blinding Trachoma, Global Partnership to Eliminate River Blindness, the Carter Center Schistosomiasis Control Program, and the Southern Cone Initiative Against Chagas Disease). However, for other NTDs effective interventions are lacking or therapeutics have severe secondary effects; there is also concern that drugs that are currently effective in control programs may induce resistance. In addition, control strategies targeting the vectors have, in some cases, not been successful in decreasing morbidity and mortality from these diseases. In other cases, resistance to current vector control strategies is predicted to arise in the near future. There is, therefore, an urgent need to support research leading to the development of novel and more effective interventions as well as diagnostics.
Recently, private foundations and Public-Private Partnerships (PPPs) have been playing an increasing role not only in the deployment of interventions for malaria and NTDs, but also providing a route for the development of novel interventions. For a variety of reasons, however, market forces have been inadequate to support development or deployment of interventions for these diseases. There is, therefore, an ongoing need to support translational research to initiate the development of novel and improved interventions and research tools that can subsequently be further developed by PPPs and others.
DISEASES COVERED BY THIS FOA
Malaria is caused by infection with a parasite of the Plasmodium species, and is usually transmitted by the bite of an infected mosquito of the genus Anopheles. Each year malaria accounts for 300-500 million cases of clinical disease, and at least 1 million people die of malaria annually. There is also an estimated reduction of approximately 1.3% in annual economic growth rate of affected countries through malaria.
Neglected Tropical Diseases: For the purposes of this FOA, the diseases considered to be Neglected Tropical Diseases are limited to the following infectious agents and the corresponding vectors responsible for their transmission (where relevant; estimates for incidence are from references indicated):
African trypanosomiasis (sleeping sickness) is caused by protozoa of the genus Trypanosoma (Trypanosoma brucei gambiense and Trypanosoma brucei rhodesiense) and is transmitted by the tsetse fly (Glossina Genus). An estimated 60 million people are at risk in 36 countries mostly in sub-Saharan Africa with an estimated 300,000-500,000 people infected. Sleeping sickness is invariably fatal if untreated and currently available treatments produce severe side effects in some patients. Major epidemics are a constant threat to the economic development of Central and East Africa (http://www.cdc.gov/ncidod/eid/vol4no3/gubler.htm).
American trypanosomiasis (Chagas disease) is caused by Trypanosoma cruzi and is transmitted by insects of the subfamily Triatominae (Family Reduviidae). An estimated 100 million people are at risk in 21 countries in Central and South America with 16-18 million people infected. There are one million new cases of chronic disease and more than 45,000 deaths annually. Transfusion-acquired infection is common and recent cases of disease after organ transplantation in the United States have led to considerations of screening the U.S. blood supply for American trypanosomiasis (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5110a3.htm).
Buruli ulcer is caused by infection with Mycobacterium ulcerans and can result in extensive skin ulcerations, which are typically found on a patient’s arms or legs. If not treated early, the ulcerations can cause extensive skin damage that restricts joint movement and in time may result in limb amputation. M. ulcerans is an environmental pathogen in tropical regions. Humans appear to have increased risk of infection in areas with stagnant or slow moving water, but the mode of transmission is still under investigation. The disease has been reported in 30 countries, according to the WHO, but the extent of the disease is not known (http://www.who.int/mediacentre/factsheets/fs199/en/index.html).
Intestinal helminth (roundworm) infections are among the most common human infections, especially in tropical and sub-tropical countries, and the leading cause of disease burden in children aged 5 to 14 years (World Bank World Development Report, 1993) (World Development Report 1993: Investing in Health), While moderate infections are associated with poor physical and mental development, more intense infections can result in severe anemia (hookworms), intestinal obstruction (ascariasis) and chronic colitis (trichuriasis). Estimates of clinical disease are: 12-59 million with Ascaris, 7-26 million with Trichuris, and 35-148 million with hookworm (Bundy et al., Health Priorities and Burden of Disease, Harvard University Press, 1997).
Leishmaniasis is caused by protozoa of the genus Leishmania (20 species are pathogenic for humans) and is transmitted by the phlebotomine sandfly. An estimated 350 million people are at risk in 88 countries with 12 million people infected. There are up to 1.5 million cases per year of cutaneous disease and 500,000 cases and more than 50,000 deaths per year from visceral disease. More than 90 percent of the world's cases of visceral leishmaniasis are in India, Bangladesh, Nepal, Sudan, and Brazil. In addition, the incidence of HIV/Leishmania co-infections is increasing, especially in Southern Europe (http://www.cdc.gov/Ncidod/dpd/parasites/leishmania/factsht_leishmania.htm).
Leprosy is a chronic disease that affects skin and nerve tissue and is caused by infection with Mycobacterium leprae. While treatment is available in early stages of the disease, there is no treatment once nerves are damaged. In recent years, despite public health efforts, incidence of the disease globally has remained constant in a number of tropical countries, while prevalence due to treatment is dropping; (http://www.who.int/mediacentre/factsheets/fs101/en/).
Lymphatic/Bancroftian filariasis (elephantiasis) is caused by the parasitic filarial worms Wuchereria bancrofti and Brugia malayi. An estimated 905 million people are at risk in 73 countries throughout the tropics and sub-tropics of Asia, Africa, the Western Pacific, and parts of the Caribbean and South America. An estimated 120 million people are infected world wide with 1 million people severely disabled. In addition, the prevalence of this disease is increasing in many countries due to urbanization.
Onchocerciasis (river blindness) is caused by the filarial worm Onchocerca volvulus and is transmitted through the bites of infected blackflies of the Simulium species. An estimated 90 million people are at risk in 34 countries mainly in Africa with additional foci in Latin America and the Middle East. There are 18 million people infected with more than 300,000 blinded, reducing life expectancy by 65 percent (Final Report on the Conference on the Eradicability of Onchocerciasis; http://www.cartercenter.org/documents/1047.pdf).
Schistosomiasis is caused by trematode flatworms of the genus Schistosoma. An estimated 600 million people are at risk in 74 countries with 200 million infected. While mortality remains relatively low, tens of millions have debilitating chronic morbidity. Significant pathological changes can affect multiple organ systems, including the kidneys and urinary tract, the liver and spleen, the gastrointestinal tract, and the uterus, especially in individuals with longstanding or heavy infections.
Trachoma is an infection of the eye caused by the bacterium Chlamydia trachomatis and is the leading cause of preventable blindness in the world. Trachoma presents as a chronic follicular conjunctivitis that can cause scarring of the conjuntiva and cornea, leading to blindness. Chronic, repeat infections occur most often in children less than 10 years of age. Approximately 11 million cases of infection and 8 million cases of blindness occur annually worldwide. Trachoma is endemic in the poorest regions of Africa, Asia and the Middle East, and in some parts of South America and Australia
Applications that do not have a focus on these diseases and/or the corresponding vectors will be considered non-responsive to this FOA as determined by the NIAID program staff and will not be reviewed. Applications that do not have a focus on translational research will be considered non-responsive to this FOA as determined by the NIAID program staff and will not be reviewed. Applications focused on genital infection by C. trachomatis or that utilize genital models of C. trachomatis infection will also be considered non-responsive to this FOA and will not be reviewed.
Research Objectives:
The objective of this FOA is to stimulate translational research leading to the development of novel interventions and tools to contribute to the control of malaria and NTDs.
For diseases covered by this FOA, translational research is defined as the stage of research at which a potential target, molecule, metabolic pathway, gene product, etc. is ready for validation and/or proof of concept as a prospective tool/intervention for diagnosis, prevention or treatment of these diseases. Examples of the types of research on pathogens causing malaria and NTDs that could be supported under this program include, but are not limited to, the following:
For vectors, translational research is defined as the stage of research at which a potential target, molecule, metabolic pathway, gene product, etc. is ready for validation and/or proof of concept as a prospective tool/intervention for vector management. Examples include, but are not limited to, the following:
While strategies for clinical development, which may be part of an investigator’s overall product development plan, may be included in the application to provide supporting information and context, this FOA will NOT support clinical trials or field trials. Applications requesting support for clinical or field trials will not be reviewed. Field assessments of interventions not involving human subjects are permitted under this FOA, and utilization of human cell lines and human derived samples to support preclinical development complying with regulatory requirements is encouraged.
Applications must include a description of the timelines for the objectives of the proposed research, and milestones to be achieved during the course of the project. (See Section IV.6, Other Submission Requirements - Milestones and Timelines.)
See Section VIII, Other Information - Required Federal
Citations, for
policies related to this announcement.
Section
II. Award Information
1. Mechanism
of Support
This FOA will use the NIH Research Project Grant (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 approximately $4 million
dollars (total costs) in fiscal year 2009 to fund 4-6
applications.
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
Applicants are not permitted to submit
a resubmission application in response to this FOA.
Renewal applications are not permitted in response to this FOA. In addition, applications for supplementation of existing projects are NOT eligible; only applications proposing new projects will be considered responsive to this FOA.
Applicants may submit more than one application, provided each application is scientifically distinct. For example:
Applications not considered scientifically distinct as determined by the NIAID program staff will not be reviewed.
Applications that do not have a focus on the diseases and/or the corresponding vectors indicated in Section I.1. will be considered non-responsive to this FOA as determined by the NIAID program staff and will not be reviewed.
Applications that do not have a focus on translational research as defined in Section I.1 will be considered non-responsive to this FOA as determined by the NIAID program staff and will not be reviewed.
Applications focused on genital infection by C. trachomatis or that utilize genital models of C. trachomatis infection will be considered non-responsive to this FOA and will not be reviewed.
This FOA will NOT support clinical trials or field trials. Applications requesting support for clinical or field trials will be considered non-responsive to this FOA and will not be reviewed.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) SBIR/STTR 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 SBC 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 PDs/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: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. 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 10, 2008 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt Date: June
10, 2008
Application Due Date: July 10, 2008
Peer Review
Date: November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: May 2009
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
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 435-8537
Fax: (301) 480-2310
Email: ESchroder@niaid.nih.gov
3.B. Submitting an Application Electronically to the
NIH
To submit an
application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m.
local time (of the applicant
institution/organization) on the application due date(s).
(See Section IV.3.A. for all dates.) If an application is not submitted
by the due date(s) and time, the application may be delayed in the review
process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for completeness by the CSR 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 the 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 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 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).
6. Other Submission Requirements and Information
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Milestones and Timelines
Applications must include a specific section labeled Milestones and Timelines that details project performance and timeline objectives. Milestones should be well described, quantitative and scientifically justified. This section must include:
The Milestones and Timelines section is NOT included in the page limit for the Research Plan of the application. However, this section must NOT exceed five pages. The Milestones and Timelines must be included as an attachment to the Research & Related Other Project Information form under item 11 Other Attachments.
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(s) convened by the 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
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, and weighted 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 meritorious 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? Is the
proposed translational research likely to facilitate the
development and discovery of a vaccine, therapeutic, diagnostic or vector
control strategy (where relevant) for the specific disease? If the aims of the
application are achieved, are important novel and more effective interventions or control strategies for malaria and/or NTDs likely
to result?
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? Does the approach represent the
best use of current or emerging technologies and appropriate collaborations to
achieve the research objectives of advancing development
of novel interventions or control strategies for malaria and/or NTDs?
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? Does the proposed research leverage research opportunities that will accelerate the development of novel interventions or control strategies?
Investigators: Are the PD(s)/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? Do(es) the PD(s)/PI(s) and investigative
team bring complementary and integrated expertise to the project (if
applicable)? Is the proposed overall involvement of the PD(s)/PI(s) and
the research team appropriate to the scope, complexity, and timelines of the project?
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? Does
organizational experience of the applicant institution demonstrate that it is
actively engaged in research on malaria and/or NTDs? If relevant, does the prior experience and track record of the collaboration(s)
contribute to the research proposed on malaria and/or NTDs?
In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating.
Milestones and Timelines: Are the Milestones well-defined, appropriate, feasible, and indicative of future development of novel tools, interventions and/or control strategies? Are the Timelines well-justified and appropriate for the specific aims of the proposed research? If appropriate, are alternative strategies suggested to ensure completion of the Milestones?
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 rating:
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)
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and use
will be assessed. See the Other Research Plan Sections of the PHS398 Research
Plan component of the SF424 (R&R).
Biohazards/Select
Agents Research: 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. Resource Sharing Plan(s)When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Dates
Not
Applicable.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his 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
The specific timelines,
milestones and funding levels agreed by the awardee and the NIAID shall be
included in the terms and conditions of award. It is recognized that
milestones and timelines may require revision and renegotiation during the course of the project period. Release of each yearly funding
increment by NIAID will be based on a NIAID review of progress towards
achieving the previously agreed upon milestones.
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
All PDs/PIs are required to attend
an Annual Research Meeting, which may be held in conjunction with other
NIH-supported programs, and will be held within the Washington, D.C. metropolitan area. Such a meeting should include the
PDs/PIs and will be attended by the NIAID staff. The PDs/PIs
shall present: 1) an update on results for each scientific project; 2) a review
of the progress in achieving the proposed aims and milestones, any
modifications in the research, and a discussion of scientific, technical and
any other problems; and 3) future plans for achieving
the remaining aims and milestones, including identifying potential problems and
contingency plans.
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 Contacts:
Martin John Rogers, Ph.D.
Division of Microbiology and
Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5069, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 496-2544
Fax: (301) 402-0659
Email: mr92i@nih.gov
Adriana Costero, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5097, MSC-6603
6610 Rockledge Drive, Room 5097
Bethesda, MD 20892-6603
Telephone: (301) 496-2544
Fax: (301) 402-0659
Email: ac252a@nih.gov
2. Peer Review Contact:
Edward
W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room
3116, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 435-8537
Fax: (301) 480-2310
Email: ESchroder@niaid.nih.gov
3. Financial/Grants Management Contact:
Kimberly Chatman
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2241, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 402-6580
Fax: (301) 493-0597
Email: chatmank@niaid.nih.gov
Section VIII. Other Information
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. Applications that do not provide this
information will be returned without review.
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
or Health Systems Agency review. Awards are made under the authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and under Federal Regulations 42 CFR Part 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and advance
the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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