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
Fogarty
International Center (FIC) (http://www.fic.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) ( http://nccam.nih.gov)
National Institute on Aging (NIA) ( http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism
(NIAAA) ( http://www.niaaa.nih.gov)
National Institute of Biomedical Imaging and
Bioengineering (NIBIB) ( http://www.nibib.nih.gov)
National Institute on Deafness and Other
Communication Disorders (NIDCD) ( http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial
Research (NIDCR) ( http://www.nidcr.nih.gov)
National Institute on Drug Abuse (NIDA) ( http://www.nida.nih.gov)
National Institute of Environmental Health Sciences
(NIEHS) ( http://www.niehs.nih.gov)
National Institute of Neurological Disorders and
Stroke (NINDS) ( http://www.ninds.nih.gov)
Title: International
Research Collaboration Basic Biomedical (FIRCA-BB) (R03)
Announcement Type
This
is a reissue of PAR-06-436, which was
released on May 31, 2006.
Update: The following update relating to this announcement has been issued:
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.
Program Announcement (PA) Number: PAR-07-335
Catalog of Federal
Domestic Assistance Number(s)
93.989,
93.213, 93.867, 93.866, 93.273, 93.286, 93.173, 93.279, 93.113, 93.114, 93.115,
93.853
Key Dates - New Dates
Opening Date: April 28, 2008 (Earliest date an application may be submitted to Grants.gov)
Application Submission/Receipt Date: May 28, 2008
Peer Review Date: November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 1, 2009
Expiration Date: May 29, 2008
Key Dates - Old Dates
Release/Posted Date: March 23, 2007
Opening Date: April 21, 2007 (Earliest
date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not applicable
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): May 21, 2007; September
21, 2007; and January 22, 2008
AIDS Application Submission/Receipt Date(s): Not applicable.
Peer Review Date(s): June/July for January
submission/receipt date; October/November for May submission/receipt date; and
February/March for September submission/receipt date
Council Review
Date(s): October of corresponding year for January submission/receipt date;
January of following year for May submission/receipt date; and May of following
year for September submission/receipt date
Earliest
Anticipated Start Date(s): December 1 for September council; April 1 for
January council; and July 1 for May council
Additional Information To Be Available Date (Activation
Date): Not Applicable
Expiration Date: January 23, 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. 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
A. Cooperative Agreement Terms and Conditions of Award
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II
- Full Text of Announcement
1.
Research Objectives
An
important role of the FIC is to foster discovery and reduce global health
disparities through the support of international research cooperation
across the continuum of basic, clinical and applied biomedical, social and
behavioral health sciences. This Funding
Opportunity Announcement (FOA) contributes to the FIC mission, and the
broad NIH initiative to reduce health disparities among nations, by
strengthening research infrastructure in developing countries,
particularly those with the least economic
resources.
Interests of Participating Institutes and Centers (ICs)
Applicants can obtain information and research interests for each of the sponsoring ICs listed on the first page of this announcement at their websites, or by contacting the IC program contact listed in Section VII, Agency Contacts. Some of the participating ICs have provided additional statements of interest:
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 Small Research Grant (R03)
award mechanism. The applicant will be solely responsible for planning,
directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. Applicants must submit detailed (non-modular) budgets.
Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments ) of a previously reviewed R03 grant application may be submitted. See NOT-OD-05-046 (April 29, 2005).
However, the Foreign Collaborator on an awarded Type 1 FIRCA may submit a new (Type 1) FIRCA application as the PI, directly from his/her home institution (the original foreign site), to follow up on the research in the initial three-year FIRCA period. The original U.S. PI must be included as Co-Investigator unless a change is approved by the FIRCA Program Officer.
For specific information about the R03 programs, see http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
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 participating organization(s), the Fogarty
International Center (FIC), the National Center for Complementary and
Alternative Medicine (NCCAM), the National Institute
on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA),
the National Institute on Biomedical Imaging and Bioengineering (NIBIB), the
National Institute on Deafness and other Communication Disorders (NIDCD), the
National Institute of Dental and Craniofacial
Research (NIDCR), the National Institute on Drug Abuse (NIDA), the National
Institute of Environmental Health Sciences (NIEHS), and the National Institute
of Neurological Disorders and Stroke (NINDS), intend to commit approximately $750,000 in FY 2008 and FY 2009 to fund 30 to 40 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.
Facilities
and Administrative (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
The Foreign Collaborator/Foreign PI must be at an institution in a developing country defined by the World Bank, according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income (see: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS).
Foreign institutions may only apply if they meet the eligibility requirements for foreign collaborating institutions listed above and the PI and Collaborating Investigators meet the criteria listed below in Section 1.B., Eligible Individuals.
Occasionally, scientific opportunities may arise that warrant a formal collaborative effort between the PI and individuals from more than one country. Such applications may be considered only after consultation with and pre-approval by the FIC Program Officer.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI), and who meets the other eligibility requirements below, 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.
The scientist who applies as PI must either be (1) an NIH-funded Investigator or (2) have previously been the Foreign Collaborator on an awarded FIRCA.
The Foreign Collaborator/Foreign PI on a FIRCA must be employed at a developing country institution that meets the eligibility requirements described in Section 1.A., Eligible Institutions.
Applicants
may already be FIRCA grantees on another FIRCA at the time of the application.
However, only one FIRCA application may be submitted by the same PI, or involve
the same Foreign Collaborator as Co-Investigator, per review cycle. No Foreign Collaborator/Foreign PI may be involved in more than
one competing new FIRCA award per fiscal year or be involved in more than two
awarded FIRCAs active at any one time.
FIRCAs
require a team science approach. 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
Eligible
Parent Grants
The following NIH research project grants that will be active and funded at the start of the proposed FIRCA budget period are eligible as parent grants:
Among the mechanisms not generally accepted as parent grants are: training grants and research contracts, and Small Business Innovation Research (R43/R44) and Small Business Technology Transfer (R41/R42) Awards.
The parent grant may have been awarded by any NIH Institute or Center (IC), regardless of whether the IC is listed as a participating component in this FOA. For the initial FIRCA application, it must have a minimum of 12 months of funding, which may include a no-cost extension, remaining at the time of the FIRCA application deadline, to be eligible as the parent grant. For the follow-up application from the Foreign Collaborator as PI, the former PI Collaborator’s parent grant must simply be active, in a no-cost extension and/or submitted for renewal on the FIRCA receipt date.
The initial FIRCA research proposal, submitted by the NIH-funded Investigator, may be an extension or a new direction of the parent grant. However, the proposed research must not overlap with research already supported by the parent grant or by other sources. If the proposal is for work that is not an obvious extension of the parent grant, the research must be clearly within the expertise and field of interest of both Co-Investigators, as indicated by the general area of science in the parent grant and other research support and published work. Such research should ideally make use of the comparative strengths and expertise of both Co-Investigators.
Special consideration may be given to proposed research which addresses significant global health problems, particularly those of high relevance to the foreign country or region, and to research that makes use of unique of special resources, circumstances, or environment of the foreign site.
Foreign Collaborators on previously funded FIRCA grants
which have ended, or will end at least six months before the new FIRCA application deadline, must apply for a FIRCA as PI with
their original FIRCA collaborator as Co-Investigator, if they wish to continue
the collaboration under the FIRCA program. Current grantees and collaborators
may want to consider whether their collaboration has
developed to the point where they can submit a Research Project (R01) grant
application (direct foreign grant or domestic grant with a foreign component).
Section
IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI(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 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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
This NIH R03 uses ONLY the detailed Research & Related Budget. (Do NOT use the PHS398 Modular Budget.)
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:
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.
Supplementary Instructions
In the SF424 RESEARCH & RELATED section:
Checklist
Facilities and Administrative (F & A) Costs: F & A costs must be calculated on the basis of the off-site rate, if one has been approved, for U.S. sponsoring institutions.
For applications from foreign institutions and applications that have foreign consortium agreements, F & A costs of up to eight percent of total direct costs (less equipment) may be requested by the foreign institutions. See NOT-OD-01-028, March 29, 2001.
3.
Submission Dates and Times
See Section
IV.3.A for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: April 21, 2007 (Earliest
date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not applicable
Application
Submission/Receipt Date(s): May 21, 2007; September 21, 2007;
January 22 2008.
Peer Review Date(s): June/July for January submission/receipt date;
October/November for May submission/receipt date; February/March for September
submission/receipt date.
Council Review
Date(s): October of corresponding year for January
submission/receipt dates; January of following year
for May submission/receipt dates; May of following year for September
submission/receipt dates.
Earliest
Anticipated Start Date(s): December 1 for January
submission/receipt dates; April 1 for May submission receipt dates; July 1 for September submission/receipt dates.
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the Fogarty International Center (FIC) Referral Office by email ([email protected]) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
3.C.
Application Processing
Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov no
later than 5:00 p.m. local time (of the
applicant institution/organization) on the
application 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, all errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will
be evaluated for completeness by the Center for Scientific Review, NIH.
Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
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.
Awards are made to the PI’s institution to support a collaborative research project that will be carried out mainly at
the Foreign Collaborator s/Foreign PI s developing country research site. The major portion of
the funds and items purchased with these funds must be used at the foreign site
to support this research.
Pre-award costs are allowable. A grantee
may, at its own risk and without NIH prior approval, incur obligations and
expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new award if such costs: are necessary to conduct
the project, and would be allowable under the grant, if awarded, without NIH
prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH
Grants Policy Statement.
Budget:
o Consultant fees for the developing country Foreign Collaborator/Foreign PI and staff must not exceed a total of $5,000 annually.
o Salary for a U.S.-based Principal Investigator, or any other staff at the non-developing country site, is not allowed.
o Travel funds for the Principal Investigator, Collaborator, or colleagues to visit the U.S or foreign research sites must not exceed $7,000 annually.
o Additional travel funds for the Foreign Collaborator/Foreign PI to
attend scientific conferences must not exceed $2,000 annually. Also refer to http://www.fic.nih.gov/funding/grants_info/costs.htm.
6. Other Submission
Requirements
PD/PI
Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
PHS398 Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, with the following requirements for FIRCA R03 applications:Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
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)
Indicate how the proposed project will enhance the ability of the Foreign Collaborator/Foreign PI and developing country site to conduct research of particular relevance to global health or health concerns of the country or region.
Plan for Sharing Research Data
Not
applicable.
Sharing Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant Progress
Report (PHS 2590). See Section
VI.3., Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be
considered in the review process.
2. Review and
Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established Public Health Service (PHS) referral
guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/)
will evaluate applications for scientific and technical merit.
Applications that are complete and responsive to the
FOA will be evaluated for scientific and technical merit by an appropriate peer
review group convened by the Center for Scientific Review (CSR) in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The FIC is interested in all eligible applications and will fund or co-fund each FIRCA award. Special consideration will be given to proposed research that addresses significant global health problems, particularly those of high relevance to the foreign country or region. Special consideration may also be given to research that makes use of unique or special resources, circumstances, or environment of the foreign site.
The various ICs each support FIRCA research in their respective areas of interest. Applicants can obtain further information for each of the sponsoring ICs at the Internet addresses listed on the first page of this announcement or by contacting the respective program contact listed herein.
The NIH R03 FIRCA Small Grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in three years and that require limited levels of funding. Because the research plan is restricted to 11 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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 research on an important topic in a developing country with
underdeveloped research infrastructure but with unique resources, environment,
or knowledge not readily available in the U.S. or other developed nations. Such projects may be slower
to achieve their scientific goals, but may receive
special consideration for their potential to build research capacity along with
scientific impact in the long-term.
Significance: Does this study address an
important problem relevant to global health issues? 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?
How is this research relevant to
the foreign country involved?
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?
In conducting an evaluation of the scientific assessment of
Approach criteria, scientific review groups will also evaluate the
involvement of human/animal subjects, and the proposed plans for inclusion of minorities and members of both sexes/genders. The
evaluation will be factored into the overall score of scientific and technical
merit of the application. For applications
designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and
communication among the PDs/PIs? Are the administrative plans for the
management of the research project appropriate, including plans for resolving
conflicts?
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 project make use of unique or special expertise,
resources, circumstances, or environment at the foreign site to frame or
address the research question? Does the project propose innovative or special
ways to incorporate capacity building or training
into the research program at the foreign site?
Investigators: Are the investigators appropriately trained
and well suited to carry out this work? Is the work proposed appropriate to the
experience level of the Principal Investigator and the Co-Investigator? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
The collaborators may each be at various stages in their
respective careers and may or may not have prior collaborations. If the Foreign Collaborator is submitting as the PI, is she/he
able to undertake and direct the continuation of the research efforts
independently but still with some level of collaboration with the original (or
pre-approved new) FIRCA Co-Investigator? How will
this award continue to enhance the Foreign PI’s research and career development
and help her/him towards achieving a position of scientific leadership in
her/his home country and field?
Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional support? Has the Foreign Collaborator’s (or Foreign PI s) home
institution made a convincing commitment (e.g., provided a research/academic
appointment and salary support)? Are the resources necessary to perform the
research available or obtainable?
Research Capacity Building: Does the collaboration have the potential to enhance the research capability of the Foreign Collaborator/Foreign PI and the foreign site? Does the research constitute a substantial scientific endeavor of the Foreign Collaborator/Foreign PI, including creative and scientific input to the research proposal? The foreign site and investigator should not be used merely to gather biological samples (clinical, plants, etc.) or behavioral data (interviews, surveys, etc.). In all cases, the Foreign Collaborator/Foreign PI should be actively involved in analyzing and interpreting the data. If the research is not on a biomedical problem of particular relevance for the foreign country involved, how will the award contribute to building needed biomedical research capacity/capability at the foreign site? If the PI is from the foreign site, how will the award contribute to advancing his/her research and career, research at the PI’s institution and the field of research in the PI’s country?
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:
Resubmission Applications (formerly revised/amended
applications): Are the responses to comments from the previous
scientific review group adequate? Are the improvements in the resubmission
application appropriate?
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: 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.
2.C.
Sharing Research Data
Not
Applicable.
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.
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.
Program staff may negotiate modifications of the data and resource sharing plans with the applicant before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each Non-Competing
Grant Progress Report (PHS 2590), See Section
VI.3., Reporting.
Model Organism
Sharing Plan: Reviewers are
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis,
taking into consideration the organism, the timeline, the applicant's decision
to distribute the resource or deposit it in a repository, and other relevant
considerations
3.
Anticipated Announcement and Award Dates
Not
applicable.
Section
VI. Award Administration Information
1.
Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his/her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under
consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the extent
considered allowable pre-award costs. See Section
IV.5., Funding Restrictions.
2.
Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of
award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
In
the Performance Site block on the PHS2590, grantees must list the foreign site
at which the FIRCA work is being carried out and the
primary contact at the foreign site. Please include full contact information,
including telephone and fax numbers and email addresses for the NIH-funded
investigator and the Foreign PI/Foreign
Collaborator.
Section
VII. Agency Contacts
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues.
1. Scientific/Research
Contacts:
FIC/NIH:
Kathleen Michels, Ph.D.
FIRCA Program Officer
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 435-6031
Fax: (301) 402-0779
Email: [email protected]
NCCAM/NIH:
Craig Carlson, M.P.H.
International Health Program Specialist
Office of International Health Research
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 496-2583
Fax: (301) 480-3621
Email: [email protected]
NIA/NIH:
Dallas W. Anderson, Ph.D.
Program Director,
Population Studies
Dementias of Aging Branch
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 350, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
Fax: (301) 496-1494
Email: [email protected]
NIAAA/NIH:
Margaret M. Murray, M.S.W.
Office of the Director
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2013, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-2594
Fax: (301) 480-1726
Email: [email protected]
NIBIB/NIH:
John W. Haller, Ph.D.
Acting Division Director
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200, MSC 5469
Bethesda, MD 20892-5469
Telephone: (301) 451-4780
Fax: (301) 480-4973
Email: [email protected]
NIDCD/NIH:
Lana Shekim, Ph.D.
Director, Voice and Speech
Programs
Division of Scientific Programs
National Institute on Deafness and Other
Communication Disorders
6120 Executive Boulevard, EPS-400C, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
Fax: (301) 402-6251
Email: [email protected]
NIDCR/NIH:
Kevin Hardwick, D.D.S., M.P.H.
Extramural Training Officer
National Institute of Dental and Craniofacial
Research
45 Center Drive, Room 4AS-13
Bethesda, MD 20892
Telephone: (301) 594-2765
Fax: (301) 402-7033
Email: [email protected]
NIDA/NIH:
Steven Gust, Ph.D.
Director, International Program
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5-274, MSC 9581
Bethesda, MD 20892-9581
Telephone: (301) 443-6480
Fax: (301) 443-9127
Email: [email protected]
NIEHS/NIH:
David M. Balshaw, Ph.D.
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of
Environmental Health Sciences
P.O. Box 12233, EC-27
79 T. W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-2448
Fax: (919) 541-4937
Email: [email protected]
NINDS/NIH:
Yuan Liu, Ph.D.
Chief, Office of International Activities
National Institute of Neurological Disorders and
Stroke
Neuroscience Building, Room 2187
6001 Executive Boulevard, MSC 9523
Bethesda, MD 20892-9523
Telephone: (301) 496-0012
Fax: (301) 402-1501
Email: [email protected]
2. Peer Review Contacts:
Sherry
L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD 20892-7840
(For express/courier service use ZIP 20817)
Telephone: (301) 435-1021
Fax: (301) 480-3567
Email: [email protected]
3. Financial or Grants
Management Contacts:
FIC/NIH:
Randolph Williams
Grants Management
Specialist
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-5710
Fax: (301) 594-1211
Email: [email protected]
NIA/NIH:
Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: [email protected] (email
correspondence preferred)
NIAAA/NIH:
Ms. Judy fox
Chief Grants
Management Branch
National
Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane,
Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Fax: (301) 443-3891
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.
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% 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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