and Human Services (HHS)
EXPIRED
Participating Organization(s) |
Centers for Disease Control and Prevention (CDC) The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this funding opportunity announcement (FOA) might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information. |
National Institute for Occupational Safety and Health (NIOSH) |
|
Funding Opportunity Title |
Mentored Research Scientist Development Award (K01) |
Activity Code |
K01 Research Scientist Development Award - Research & Training |
Announcement Type |
Reissue of PAR-10-132 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-13-245 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.262 |
Funding Opportunity Purpose |
The purpose of the K01 is to provide support and 75% protected time for an intensive, supervised (mentored) career development experience in occupational health and safety research leading to research independence. The goal of the NIOSH Mentored Research Scientist Development Award (K01) is to help ensure the availability of an adequate numbers of highly trained scientists and educators to address occupational safety and health critical issues. |
Posted Date |
July 3, 2013 |
Open Date (Earliest Submission Date) |
July 3, 2013 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date |
Standard dates apply |
Expiration Date |
New Date May 18, 2018 per issuance of NOT-OH-17-008. (Original Expiration Date: March 14, 2017)
New Date March 16, 2016 per issuance of NOT-OH-16-005. (Original Expiration Date: November 16, 2015) New Date November 16, 2015 per issuance of NOT-OH-15-006. (Original Expiration Date: September 2, 2015) |
Due Dates for E.O. 12372 |
Not Applicable |
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Telecommunications for the Hearing Impaired: TTY 1-888-232-6348.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding
Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The objective of the NIOSH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of protected time (3-5 years) for intensive research career development under the guidance of an experienced mentor, or sponsor, in the biomedical, behavioral or clinical sciences that leads to research independence. The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.
Statutory Authority
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 the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 951(a); Section 301 of the Public Health Service Act as amended (42 USC 241) 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 HHS Grants Policy Statement.
Background
Every day, millions of U.S. workers go to work expecting to return home healthy and safe. The workplace environment, however, can have a significant impact on a worker’s physical and psychological health. Depending on the job, a worker may be at risk for many different kinds of injuries and illnesses. Illness statistics are significantly underestimated due to the difficulty of recognizing or associating illness or disease with past occupational exposures; however, approximately 49,000 deaths per year are attributed to work-related illness. For 2011, Bureau of Labor Statistics (BLS) reported a preliminary count of 4,609 fatal occupational injuries in the United States, almost 13 per day. In addition, 3 million U.S. workers sustained either a nonfatal occupational injury or illness. Work-related injuries, illnesses, and deaths are very costly to American society. In 2010, employers spent nearly $57.5 billion on workers' compensation (http://www.nasi.org/sites/default/files/research/NASI_Workers_Comp_2010.pdf).
Research and intervention activities are needed to reduce the tremendous burden and cost associated with occupational injuries and illnesses occurring in the American workplace.
Purpose
The purpose of the NIOSH Mentored Research Scientist Development Award (K01) is to provide "protected time" for junior research scientists to facilitate their transition from the mentored to the independent stages of their careers in occupational health and safety research. The NIOSH invites K01 applications from advanced postdoctoral and/or newly independent research scientists (usually with a Ph.D. or M.D. degree) in biomedical or behavioral sciences who are pursuing careers in research areas supported by the NIOSH. By providing support for the critical transition period between postdoctoral training and independent R01 funding for non-clinical investigators, the NIOSH hopes to foster the careers of these investigators who are vital for the future excellence of the NIOSH research endeavor. Applicants must justify the need for a period of mentored research experience and provide a convincing case that the proposed period of support will substantially enhance their careers as independent investigators.
The Research (R01) grant is an award made to support a distinct, specific, defined project to be performed by the named investigator(s) in an area representing the investigator's specific interest and competencies, based on the mission of the NIOSH.
Healthy People 2020 and other National strategic priorities
NIOSH is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020" http://www.healthypeople.gov/2020/default.aspx. Healthy People 2020 objectives related to occupational safety and health (OSH) are primarily addressed through NORA http://www.cdc.gov/niosh/nora/about.html. This program, established by NIOSH and its partners to stimulate innovative research and improve workplace practices, provides a framework to guide OSH research. The goal of the NIOSH research program is to support research that is relevant, of high quality, and that demonstrates impact in reducing occupational disease and injury. Emphasis is placed on research projects that address needs outlined in NORA. NIOSH has created a Program Portfolio to broadly guide activities by categorizing programs into ten (10) major NORA Sector Programs that represent groups of industrial sectors, and twenty-four (24) cross-sector programs organized around adverse health outcomes, statutory programs and global efforts. Detailed information about the Program Portfolio can be found at http://www.cdc.gov/niosh/programs/.
Applicants must provide a statement about which industry sector(s) and which cross-sectors are being addressed and a rationale for how the proposal will contribute to the specified priority area (this information must be placed in the Project Description/Abstract).
R2P
In addition to NORA, NIOSH has initiated a Research to Practice (r2P) initiative to reduce or eliminate occupational illness and injury by increasing the transfer and translation of knowledge, interventions, and technologies into highly effective prevention practices and products into the workplace. R2p is an interactive process in which the occupational safety and health community including researchers, communicators, decision-makers, and employer/employee groups work collaboratively to
Additional information about r2p can be found at: http://www.cdc.gov/niosh/r2p.
NORA Sectors and Cross-Sectors
Applicants must provide a statement about which industry sector(s) and which cross-sector(s) are http://www.cdc.gov/niosh/programs/ being addressed and a rationale for how the proposal will contribute to the specified priority area (this information must be placed in the Project Description/Abstract).
Outputs and Outcomes
Governmental agencies/organizations have been faced with increasing demand to measure the effectiveness of their funded research in improving public health. Effectiveness can be measured by the products (outputs) of research activities and subsequent outcomes, i.e., benefits or changes at an individual or population level. Outputs are the immediate products or direct result of research activities. Examples include publications, reports, conference proceedings, presentations/posters, investigator career development, databases, tools, methods, guidelines, recommendations, education and training materials.
The causes of work-related injuries and illnesses are complex, and determining the effect that specific research activities have on them can take years. Thus, outcomes can be measured over time as either intermediate or end. Intermediate outcomes are specific changes that occur as a result of research activities. Examples of intermediate outcomes include public or private policy changes, conduct of training or workshops based on project outputs, citations in the literature, inventions and patents, and adoption of technologies or methods developed by the researcher. End outcomes are the ultimate goal of the research and the result of what individuals or institutions do with the knowledge or products generated by the research. Examples of end outcomes include reduction in workplace illnesses, injuries, fatalities, and/or hazardous exposures. Applicants must provide a brief statement about expected outputs and outcomes of their proposed research in the Description (Abstract) and in the Research Strategy (Significance) Sections.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
|
Funds Available and Anticipated Number of Awards |
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. Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications. |
Award Budget |
An applicant may request a budget for direct costs of up to $100,000 per year. Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. If an applicant submits a budget amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not be reviewed. HHS/CDC will notify the applicant that the application did not meet the submission requirements. |
Award Project Period |
The K01 program must be tailored to meet the individual needs of the candidate. Candidates may request 1 to 3 years of support. The actual duration of the award will depend upon the number of years of prior research experience, the demonstrated need for additional mentored experience to achieve research independence, and the policy of the awarding Institute or Center (IC). Awards are not renewable and are not transferable from one PD/PI to another. Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government. |
Salary |
The salary must be consistent with the established salary structure at the institution.
|
Other Program-Related Expenses |
NIH will contribute $ per year toward the research
development costs of the award recipient, which must be justified and
consistent with the stage of development of the candidate and the proportion
of time to be spent in research or career development activities. |
Indirect Costs |
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. |
HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Foreign components, as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf),
must follow policies and procedures for foreign organizations described
throughout the SF424 (R&R) Application Guide. International registrants
can confirm DUNS by sending an e-mail to [email protected] , including
Company Name, D-U-N-S Number, and Physical Address, and Country. Special
Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf.
For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (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. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.Citizenship and Residency: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.
Degree and Research: Candidates for this award must have a research or health-professional doctoral or medical degree. HHS/NIOSH uses this support mechanism to support career development experiences that lead to research independence. See Other-Special Eligibility below.
Level of Effort: Candidates must be able to commit a minimum of 9 person-months (75% of full-time professional effort) conducting research career development activities associated with this award. The remaining 3 months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K01 award, i.e., the candidate’s development into an independent investigator. NIOSH will apply the NIH policy for determining full-time professional effort for career awards, see NOT-OD-04-056.
At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the NIOSH Scientific/Research Contact listed in this FOA prior to preparing an application to discuss their eligibility.
Special Eligibility Requirements
Number of Applications: Applicants may only have one individual Career Development Award application pending peer review at any time.
A candidate for a NIOSH K01 Award may not simultaneously submit or have an application pending for any other PHS career award (e.g., K07, K08, K22, K23) or any PHS or award that duplicates any of the provisions of the K01 award. Current principal investigators on NIOSH or NIH career awards are not eligible.
Resubmissions: Applicants may submit one resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). NIOSH no longer accepts A2 applications.
Renewals: Awards are not renewable and are not transferable from one PD/PI to another.
Candidates: Candidates for the K01, under some circumstances, may have been principal investigators on CDC/NIOSH or NIH research or career development awards, provided the research experience proposed in the K01 application is in a fundamentally new field of study. Candidates are therefore strongly encouraged to contact the NIOSH Scientific/Research Contact listed in Section VII prior to preparing an application to discuss issues of eligibility, program relevance, and review the specific provisions of this award.
Mentor(s): The candidate must name a primary sponsor/mentor, who together with the candidate is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
Institutional Environment: The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to serve as mentors. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the candidate. The candidate, mentor, and institution must describe a research career development program that will maximize the use of this environment, including available facilities and resources.
Responsiveness: Applicants must provide a statement about which NORA sector(s) and cross-sector(s) are being addressed and a rationale for how the proposed research will contribute to the specified priority area. They also must provide an explanation of how the proposed research will contribute to the NIOSH Research to Practice (r2p) initiative and a statement about their expected Outcomes and Outputs (see Purpose). This information must be placed in both the Description/Abstract and in the Research Strategy (Significance) sections of the application. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement .
Institutions can support more than one K01 student but the applications must be scientifically distinct.
NIOSH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Resubmission applications may be submitted, according to the Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. Such applications must include an "Introduction" addressing the previous peer review critique (Summary Statement).
K01 award recipients are encouraged to obtain funding from CDC (including NIOSH), NIH, or other Federal sources either as a named PD/PI on a competing research grant award or cooperative agreement or as sub-project director on a competing multi-project award (see NOT-OD-08-065). At the time the research grant is awarded the effort required on the K01 award may be reduced to no less than 6 person-months (50% full-time professional effort) at the grantee organization and replaced by effort from the research award so that the total level of research commitment remains at 9 person-months (75% full-time professional effort) or more for the duration of the K01 award. To be eligible for salary support from peer-reviewed research awards from any Federal agency:
The K01 award recipient must be the PD/PI (or one of the
named PD/PIs, if following the multiple-PD/PI model) on a competing NIOSH or
NIH research grant application (R01, R03, R15, R21, R34, or
equivalent application from another Federal agency) or a sub-project
director on a competing multi-component research or center grant or cooperative
agreement application (P01, P50, U01, U50, U60 etc. or an equivalent
application from another Federal agency).
The K01 award must be active when the competing research grant application is submitted.
The K01 award must be in its final two years before the reduction in effort to 6 person-months (50% full-time professional effort) is permitted.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or [email protected] for further instructions. Hours: Monday - Friday, 7am 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
A letter of intent is not required for this funding opportunity.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
PHS 398 Research Plan Component
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (https://grants.nih.gov/grants/guide/url_redirect.htm?id=12000) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description). Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:
1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.
2. Specific Aims state the problem the proposed research addresses and how it 2. Specific Aims state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.
3. Research Strategy the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.
4. Targeted/Planned Enrollment Table (for New Application ONLY)
5. Inclusion Enrollment Report (Renewal and Revision applications)
6. Progress Report Publication List (for Continuation ONLY)
Human Subjects Section
7. Protection of Human Subjects
8. Inclusion of Women and Minorities
9. Inclusion of Children
Other Research Plan Sections
10. Vertebrate Animals
11. Select Agent Research
12. Multiple PD/PI Leadership Plan.
13. Consortium/Contractual Arrangements
14. Letters of Support
15. Resource Sharing Plan(s)
16. Appendix
Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.
Renewal Application and Progress Reports
The Inclusion Enrollment Report (https://grants.nih.gov/grants/funding/424/SF424R-R_ enrollmentreport.doc) must be used for reporting accrual data to NIOSH. For Revision applications, any proposed additions to the Targeted/Planned Enrollment Tables should be provided, in addition to the Inclusion Enrollment Report. In annual progress reports, investigators conducting clinical research are required to provide the cumulative total enrollment of subjects to-date, showing the distribution by ethnic/racial categories and sex/gender on the Inclusion Enrollment Report, and must update the Targeted/Planned Enrollment Table as needed.
All instructions in the SF424 (R&R) Application Guide (https://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf)
must be followed along with any additional instructions provided in the FOA.
Special Instructions
All applications should address one of the NIOSH Program Priority areas NIOSH Program Portfolio.
Applicants should state which industry sectors and cross-sectors are being addressed and a rationale for how the proposal will contribute to the specified priority area. This information should be placed in the "Background and Significance" section of the "Research Plan" of the application.
Detailed information about the NIOSH Program Portfolio can be found at http://www.cdc.gov/niosh/programs/.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All application instructions outlined in the SF424 (R&R) Application Guide (See Supplementary Instructions for Research Career Awards, Part I.7.5) are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Introduction (required for a resubmission or revision application) is limited to 1 page.
Specific Aims is limited to 1 page. Items 2-5 (Candidate's Background, Career Goals and Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research) and Item 11 (Research Strategy) are limited to a combined total of 12 pages, including tables, graphs, figures, diagrams, and charts.
While each section of the Candidate Information and Research Strategy components needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Candidate Information component and the Research Strategy 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.
Candidate Information
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate s Background
Career Goals and Objectives:
Career Development/Training Activities:
Training in the Responsible Conduct of Research:
Applications must include a plan to obtain instruction in the responsible conduct of research. This section should document prior instruction in responsible conduct of research during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research. Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained in NOT-OD-10-019. The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research. The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.
Statements of Support
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Statements by Mentor, Co-mentor(s), Consultants, Contributors
(All statements/letters should be appended to each other and uploaded as a single pdf document):
The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the program. The candidate may also nominate co-mentors as appropriate to the goals of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models. The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to the independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and progression towards independence. Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any of the co-mentors are not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings. Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator. The mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report, PHS 2590 (see Section VI.3. Reporting).
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Description of Institutional Environment
Institutional Commitment to the Candidate’s Research Career Development
Research Plan
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Research Strategy
Appendix
Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available.
Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
[January 20, 2011 - Please see NOT-OD-11-036 informing applicants that the Letters of Reference are due by the application receipt deadline date.]
Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov. Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R Application Guide for Research Career Awards (Instructions, Part 7.3) (see https://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf).
Letters of reference are an important component of the application for the mentored career award. Candidates for this career award must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the NIH eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new. The letters should be from well-established scientists (referees) addressing the qualities of the candidate as well as their potential for becoming an independent investigator. These letters should be from individuals not directly involved in the application, but who are familiar with the candidate s qualifications, training, and interests, including advisory committee members (if applicable).
The mentor/co-mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. Resubmission applications must include new letters of reference.
Applications that are missing the required letters of reference may be delayed in the review process or not accepted.
Budget for the Entire Proposed Period of Support
Budget Component (Section 4.7): Use the SF424 (R&R) Detailed Budget component and review the instructions found in Part I.4.7(R&R Budget Component) of the Application Guide. However for K applications only limited budget information is required; therefore, candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7. In budget section A (Senior/Key Persons) include base salary, person months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on NIOSH policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this 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.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
Applicants are
responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are
provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.
For more information on expanded authority and pre-award costs, go to http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf.
Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the
application due date. Section III. Eligibility
Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying
Electronically.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the CDC mission (http://www.cdc.gov/about/organization/mission.htm), all applications submitted to the CDC/NIOSH in support of occupational health and safety research are evaluated for scientific and technical merit through the CDC/NIOSH peer review system.
Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact score.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Candidate
Does the candidate have the potential to develop as an
independent and productive researcher? Is the candidate’s academic, clinical
(if relevant), and research record of high quality? Is there evidence of the
candidate’s commitment to meeting the program objectives to become an
independent investigator in research? Do the letters of reference from at least
three well-established scientists address the above review criteria, and do
they demonstrate evidence that the candidate has a high potential for becoming
an independent investigator?
Career Development Plan/ Career Goals
& Objectives
What is the likelihood that the plan will contribute
substantially to the scientific development of the candidate leading to
scientific independence? Are the content, scope, phasing, and duration of the
career development plan appropriate when considered in the context of prior
training/research experience and the stated training and research objectives
for achieving research independence? Are there adequate plans for monitoring
and evaluating the candidate’s research and career development progress?
Research Plan
Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan?
Mentor(s), Consultant(s), Collaborator(s)
Are the mentor's research qualifications in the area of the proposed research appropriate? Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? Is there evidence of the mentor s, consultant s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support? Is active/pending support for the proposed research project appropriate and adequate? Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
Environment & Institutional Commitment to the Candidate
Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? Is the institutional commitment to the career development of the candidate appropriately strong? Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate, adequate and appropriate? Is the environment for scientific and professional development of the candidate of high quality? Is there assurance that the institution intends the candidate to be an integral part of its research program?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: (1) risk to
subjects, (2) adequacy of protection against risks, (3) potential benefits to
the subjects and others, (4) importance of the knowledge to be gained, and (5)
data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: (1) the justification for the exemption, (2) human
subjects involvement and characteristics, and (3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the application.
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
NORA Sectors and Cross-Sectors
Does the applicant provide a statement about which NORA sector(s) and cross-sector(s) are being addressed and a rationale for how the proposal will contribute to the specified priority area?
r2p
Does the applicant provide information about how their proposal addresses r2P?
Outcomes and Outputs
Does the applicant provide information about the expected outcomes and outputs and how this research will impact the field of occupational health and safety?
Training in the Responsible Conduct of Research
Applications must include a plan to obtain instruction in the responsible conduct of research.
This section should document prior instruction in responsible conduct of research during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research.
Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained in NOT-OD-10-019.
The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research.
The role of the sponsor/mentor in responsible conduct of research instruction must be described.
Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.
The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.
Select Agent Research
Not Applicable
Resource Sharing Plans
Program staff will be responsible for the administrative review of the plan for sharing research resources and data. The adequacy of the resources sharing plan 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 (HHS/PHS 2590; https://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an appropriate peer review group, in accordance with CDC/NIOSH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review all applications will receive a written critique. Only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
Applications will compete for available funds with all other recommended applications submitted in response to this FOA.
Following initial peer review, recommended applications will receive a second level of review for programmatic relevance. The following will be considered in making funding decisions:
Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
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 eRA Commons.
If the application is under consideration for funding, NIOSH
will request "just-in-time" information from the applicant as
described in the HHS Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. 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.
All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award (http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf).
Additional requirements are available at the following internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.
Federal Funding Accountability and Transparency Act of 2006: Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, www.USASpending.gov (http://www.usaspending.gov/). The web site includes information on each Federal financial assistance award and contract over $25,000, including such information as
1. The name of the entity receiving the award
2. The amount of the award
3. Information on the award including transaction type, funding agency, etc.
4. The location of the entity receiving the award
5. A unique identifier of the entity receiving the award; and
6. Names and compensation of highly-compensated officers (as applicable)
Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the Central Contractor Registry; and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.
For the full text of the requirements under the Federal Funding Accountability and Transparency Act of 2006, please review the following website: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590). (https://grants.nih.gov/grants/guide/url_redirect.htm?id=11160) annually and financial statements as required in the HHS Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required when for closeout an award is relinquished, as described in the HHS Grants Policy Statement.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-945-7573
TTY 301-451-5936
Email: [email protected]
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Steve Dearwent, Ph.D.
Scientific Program Official
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road N.E., Mailstop E74
Atlanta, GA 30333
Telephone: 404-498-6382
Fax: 404-498-2571
Email: [email protected]
Price Connor, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2511
FAX: (404) 498-2571
Email: [email protected]
Mary Pat Shanahan
OD, Environmental, Occupational Health, and Injury
Prevention Services Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: (412) 386-4453
FAX: (412) 386- 6429
Email: [email protected]
All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670); Federal Mine Safety and Health Act, Section 501(a), 30 USC 951(a); Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||