Department of Health and Human Services
National Institute for Occupational Safety and Health (NIOSH, http://www.cdc.gov/niosh)
Components of Participating Organizations
National Institute for Occupational Safety and Health (NIOSH, http://www.cdc.gov/niosh)
Title: Occupational Safety and Health Education and Research Centers (T42)
The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may differ from those used by other HHS agencies. Written guidance on completing an application is provided in this announcement and at various websites referenced herein.
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 Parts 52 and 86 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.
This Funding Opportunity Announcement (FOA) is a reissue of PAR-06-485.
Update: The following update relating to this announcement has been issued:
Announcement (PA) Number: PAR-10-217
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted in paper format. Application materials may be obtained from http://grants.nih.gov/grants/funding/phs398/phs398.html.
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
for E.O. 12372
Additional Overview Content
Table of Contents
I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Program Objectives
Section II. Award Information
1. Mechanism(s) 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. Sending an Application
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
A. Appendix Materials
B. Data Tables
V. Application Review Information
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
D. Selection Process
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," 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 2020" at www.healthypeople.gov.
1. Program Objectives
The purpose of this program is to continue existing, and/or establish new Education and Research Centers (ERC) that are focused on occupational safety and health training and research training. NIOSH is mandated to provide an adequate supply of qualified personnel to carry out the purposes of the Occupational Safety and Health Act, and the ERCs are one of the principal means for meeting this mandate. ERCs are academic institutions that provide interdisciplinary graduate training and continuing education in the core disciplines of Industrial Hygiene (IH), Occupational Health Nursing (OHN), Occupational Medicine Residency (OMR), Occupational Safety (OS), and other fields closely related to occupational safety and health (OSH). Research and research training are integral components of the ERC concept. Thus, ERC scientists should conduct peer reviewed, investigator-initiated research on issues related to the mission of NIOSH. The NIOSH homepage provides a full description of occupational safety and health program areas, http://www.cdc.gov/niosh/homepage.html.
The ERCs are multidisciplinary/interdisciplinary awards that address OSH training and research training in a cross cutting and integrated manner, and should result in cross-fertilization among the various disciplines and impact safety and health practice and research. The ERCs are the major part of a network of training grants that help ensure there is an adequate supply of qualified professional occupational safety and health practitioners and researchers. These training programs are intended to provide multi-level practitioner and research training.
The ERCs have a significant role in the research to practice (r2p) initiative of NIOSH. Thus, ERCs are expected to undertake projects that have a focus on the translation of occupational safety and health research products into the practitioner environment. Through their continuing education, outreach, training and research training activities, ERCs are expected to significantly impact the practitioner environment in a measurable way. The ERCs also serve as regional and national resource centers on OSH issues for industry, labor, government, and the public.
In reviewing ERC applications, and in order to encourage new applications, consideration will be given to the training program requirements specified below, as well as the developing nature of proposed programs and the applicants stated ability to produce program graduates who will meet documented occupational safety and health workforce needs. Proposed new ERCs may request up to three years of support under this announcement.
This program may support Masters, Doctoral and Post-Doctoral (OMR only) training. This program will not support academic certificate programs. Grantees are expected to track all program graduates, including placement and progress in their careers.
Certain training areas are considered “core disciplines”. The core disciplines are: OMR, OHN, IH, and OS. In addition to these core disciplines, in order to take full advantage of the unique strengths and capabilities of institutions, consideration will be given to the development of new and innovative academic component programs in allied disciplines that are relevant to the occupational safety and health field, e.g., ergonomics, industrial toxicology, occupational injury prevention, occupational epidemiology, occupational health psychology, health services research, and agricultural safety and health. Innovative technological approaches to training and education are encouraged. In addition, an ERC may offer Hazardous Substance Academic Training (HSAT) as a concentration within core IH academic programs. The HSAT program supports trainees at the Masters level only. Specific HSAT curricula course requirements vary and innovation is encouraged. The general model for HSAT Programs has been to add at least two new or existing hazardous substances core courses to the existing IH core program, and to require that all HSAT trainees take the Hazwoper 40-hour course.
Accreditation by the Accreditation Council for Graduate Medical Education (ACGME), http://www.acgme.org , is required for OMR programs. In addition, an ERC is encouraged to have accreditation of Masters level training programs by applicable recognized accrediting organizations, including ABET, http://www.abet.org.
ERCs must document that the proposed core or allied disciplines will fill a gap in the selected occupational safety and health disciplines and state how the selected disciplines meet a specific documented regional workforce need. Evidence of meeting such needs includes documented placement of graduates in responsible occupational safety and health practitioner and/or research positions in the private and/or public sectors.
Students and faculty in the core discipline programs and component programs in allied disciplines are expected to be fully engaged in the interdisciplinary activities of the ERC.
Each core area program curriculum should include courses that fully prepare trainees to move into and/or advance in the OSH work community. Appropriate clinical rotations and field experiences with occupational safety and health agencies or other appropriate groups and with labor-management health and safety groups are encouraged.
Core programs can offer masters and doctoral degrees. Pre-doctoral training must lead to the Masters degree and/or the Ph.D. degree or a comparable research doctoral degree. Pre-doctoral research training should emphasize fundamental training in areas of occupational safety and health sciences. Undergraduate degrees and training are not authorized under this program. If an HSAT program is proposed, the HSAT program must ensure the successful completion by trainees of a 40-hour Hazardous Waste Operations training course to meet the requirements of 29CFR1910.120 either during or prior to enrollment.
Training Program Guidelines
An ERC is encouraged to provide Masters, Doctoral and Postdoctoral (OMR only) trainees instruction in the following areas:
1. Responsible conduct of research (required for Masters [research], Doctoral, and Postdoctoral trainees)
2. How to write research grant proposals (optional)
3. How to manage research laboratories (optional)
An ERC may provide training in as many core or allied program OSH areas as resources allow; however, it must be demonstrated that students will be exposed to the principles and issues of all four core disciplines. The ERC application must have the components that are marked below as required. If one of the required components is not proposed, the application will be considered non-responsive and it will be returned to the applicant without a review:
There must be a minimum of five (5) full time trainees in each program, with the exception of OMR, where there must be at least four (4) full time trainees. For new applications, consideration will be given to the developing nature of academic programs and the ability to meet these requirements.
There must be an additional program in the core disciplines of OHN, IH, OMR, OS or other allied OSH discipline (for example Occupational Epidemiology, Ergonomics, Occupational Injury Prevention, Occupational Health Services, Occupational Health Psychology).
There must be at least three (3) full time trainees in any additional allied OSH or HSAT programs. HSAT programs do not qualify as one of the three required programs for an ERC.
An ERC must include a continuing education
program for OSH that provides training courses for occupational physicians, occupational
health nurses, industrial hygienists, safety professionals and other
occupational safety and health professionals, paraprofessionals and
technicians, including personnel from labor-management health and safety
committees, in the DHHS region in which the ERC is located. The ERC continuing
education course offerings should be based on the regional and national needs
and the applicant should provide a rationale for the courses that are offered. Continuing
Education (CE) programs are strongly encouraged to provide CE courses at
reduced cost to ERC academic trainees.
As a goal, an ERC is expected to provide continuing education training to a minimum of 600 trainees per year representing the above categories of personnel. ERCs must describe plans to target occupational safety and health training to occupational physicians, industrial hygienists, occupational health nurses, and safety professionals. All ERC academic programs are expected to actively participate and contribute to the ERC continuing education program.
A priority for this program is to establish/continue new and innovative training technologies, including distance learning programs and short-term programs designed to prepare a cadre of skilled practitioners in occupational safety and health.
Where appropriate, Continuing Education Units (as approved providers) should be awarded. Also, the courses should be structured so that higher educational institutions, public health and safety agencies, professional societies or other appropriate agencies can utilize them to provide training at a local level to occupational health and safety personnel in the workplace.
NIOSH recognizes the significant development time and costs for establishing continuing education programs. Thus, consideration will be given to new applicants for their potential to develop and deliver continuing education courses.
This program must be structured the same as the OSH continuing education program. The program must include public sector student participation.
This is an allied occupational safety and health academic program that is a new area of interest to NIOSH. Occupational health physicists establish radiation protection measures and radiation exposure characteristics for individual and classes of workers in various occupational environments where radioactive materials are used. Occupational Health Physics academic and research training programs are needed that provide masters and doctoral level training in health physics, radiation protection measures, exposure pathway analysis, and radiation dose estimation and reconstruction. These are critical areas of instruction and essential components of occupational health radiation protection programs.
This aspect of an ERC is comprised of multiple program activities. The list below notes whether the activities are required or optional:
The ERC will have an administrative structure and management plan that supports the operation of the ERC. The Administrative Core will provide a supportive structure to ensure accomplishment of: 1) coordination and integration of Center components and activities; 2) assessment of productivity, effectiveness, and appropriateness of Center activities; 3) coordinate the evaluation plan for all ERC training programs; 4) organization of Center activities, such as retreats, invitation of consultants, meetings, and focus groups; 5) organization of the Internal and External Advisory Committees; 6) record keeping of meeting minutes and measures of success, including training outcomes for the various academic and CE Programs, including the Pilot Project Research Training Program, and Outreach activities; and 7) Interactions with other ERCs, the NIOSH, and other appropriate individuals, groups, or organizations.
A strategic plan, including Center goals, should be developed and described in the application. The Center Director must provide a written strategy for how the Center will implement this plan and which future directions will likely be followed during the project period. The plan should describe how the Center will enhance ongoing programs, assist in the introduction of new programs, respond to future challenges and opportunities, promote collaborations, and achieve progress in occupational safety and health training. An organizational chart should be included to illustrate the structure, interactions, and leaders of the Center.
The Center Director must attend an annual Center Director’s meeting that will rotate between ERC sites. For planning purposes, the applicant should budget for the meeting to be held in Washington, DC.
The ERC should also establish a Board of Advisors that represents the users and affected populations and should include representatives of labor, industry, government agencies, academic institutions and professional associations. It is expected that this advisory board would meet annually and provide critical advice to the ERC Director. The ERC should also have an executive committee that assists the ERC Director in the management of the program. It is recommended that this committee be composed of the ERC Director, Deputy Director, Academic Program Directors, Continuing Education Program Director, and others whom the ERC Director may determine are needed for the management of the ERC.
An essential component of an ERC is the outreach and research to practice activities with other institutions, businesses, community groups or agencies located within the region. Programs should address serving area needs and implement innovative strategies for meeting those needs with a focus on impacting the practitioner environment. Partnerships and collaborative relationships are encouraged between ERCs and NIOSH-funded Training Project Grantees. Examples of outreach activities might include: interaction with other universities or other educational institutions in the ERC region to integrate occupational safety and health principles and concepts within existing curricula (e.g., Colleges of Business Administration, Engineering, Architecture, Law, and Arts and Sciences); providing curriculum materials and consultation for curriculum/course development in other institutions; use of a visiting faculty program to involve labor and management leaders; cooperative and collaborative arrangements with professional societies and scientific associations; and presentation of awareness seminars to undergraduate and secondary educational institutions (e.g., high school science fairs and career days) as well as to labor, management and community associations. A priority for outreach is for activities that will have a measurable impact on the practitioner environment. Thus, outreach activities that facilitate the translation of research and training products into the practitioner environment are the highest priority.
ERCs are encouraged to recruit and train racial and ethnic minority and disabled students to help address the under-representation among the occupational safety and health professional workforce. A detailed plan to address the under-representation of racial and ethnic minority and disabled occupational safety and health professionals and for the recruitment and retention of underrepresented trainees to the core programs must be a part of the application. The initial review group will review this plan as part of the overall rating of the application. Specific efforts to conduct outreach activities to develop collaborative training programs with academic institutions serving underrepresented populations, such as Tribal Colleges and Universities, Historically Black Colleges and Universities, and Hispanic-Serving Institutions are encouraged.
The applicant should describe a plan for ensuring the interdisciplinary coordination and interaction of the trainees in all academic training programs. For each core program (OMR, IH, OHN, OS), the applicant may request up to 5% effort for the program director for interdisciplinary coordination/integration of the ERC training programs. This plan should include a listing of specific courses and other activities that comprise the trainee interdisciplinary program.
Support for projects relevant to the National Occupational Research Agenda (NORA) of NIOSH is considered fundamental to sustaining the quality, breadth, and dynamics of the ERC program. These projects are intended for the exploration and development of new and creative exploratory, prevention/intervention and translation projects, and are considered an important and integral part of the support provided to the ERC. Any projects that would be conducted beyond the U.S. and Territories must be submitted to the NIOSH Program Official for prior approval. The request for approval must include documentation of IRB approval both from the grantee institution as well as from the appropriate IRB within the host country. These pilot/small projects should provide support for new, short-term projects and applicants for such projects must be limited to junior faculty, new faculty investigators, or research trainees. Funded projects are not eligible for renewal.
This program will enable investigators to collect sufficient data to pursue subsequent support through other funding mechanisms. Examples of pilot/small projects may include, but are not limited to:
1. Provide initial support to develop innovative approaches/lines of investigation in the program areas.
2. Allow exploration of possible innovative new directions in OSH sciences.
3. Stimulate investigators from other fields to apply their expertise to OSH issues.
4. Develop new external or multi-ERC partnerships to address emerging safety and health concerns.
5. Provide initial support for a translational/research to practice project.
6. Support for trainee capstone projects.
While the administrative framework for management of the ERCs Pilot/Small Project Research Training Program is left to the Center Director's discretion, certain minimal requirements must be met. Management of the program must include mechanisms to ensure:
1. Appropriate announcement of the availability of pilot/small project funding.
2. Merit review of pilot/small project proposals and documentation that projects address a NORA topic. Copies of all proposals, with documentation of their reviews, relative ranking, and final action must be retained by the Center. These records must be available to reviewers in the event of a site visit. These records should include a categorization of the projects funded by NORA area.
3. Complete and accurate records of subsequent results of each pilot/small project (abstract, RO1/R21 submission/award, dissertation, etc.) recipient. This record must be available to reviewers in the event of a site visit for competing renewals. Input by both the Internal Executive Committee and the External Advisory Committee into the management of the Pilot/Small Projects Research Training Program is strongly recommended.
4. Appropriate IRB review and approval for all pilot/small projects involving human subjects to ensure protection of the rights and welfare of human subjects (see 45 Code of Federal Regulations 46). This must be obtained prior to project funding and applies to projects conducted by other institutions. The IRB must be registered with the DHHS Office of Human Research Protections and must have a current Federalwide Assurance Number. Documentation of IRB approval of protocols, and copies of currently approved consent forms, must be maintained in the ERC administrative files. Documentation of IRB approvals for pilot/small projects must be submitted as a component of ERC annual progress reports. "IRB Approval" means full, final IRB approval. In addition, all ERC project protocols must comply with all applicable Federal and State regulations.
The ERCs represent a variety of strengths and approaches that are required in order to promote high quality research in occupational safety and health, and are a major vehicle for the development of future leaders in occupational safety and health research. They are structured to foster development of interdisciplinary research skills that are needed to effectively address the National Occupational Research Agenda (NORA) priority areas and are a critical link to practicing occupational safety and health professionals and others to translate research findings into interventions that prevent illness and injury in the workplace. These programs are also intended to provide practical training opportunities and thus must include trainee(s) participation in the projects.
Examples of relevant programs that would be responsive include:
1. Research Training and Research to Practice.
a. Collaborative Research Training Programs. These are programs that train occupational safety and health professionals from other disciplines but who enroll in appropriate OSH courses and participate in ERC interdisciplinary activities. Pilot Programs to attract MS/PhD or doctoral students from closely related occupational safety and health disciplines and conduct NORA-related dissertation research may be supported. For some closely related occupational safety and health disciplines it may be too costly to establish independent research training programs and collaborative arrangements with other training programs may be a more cost effective approach. The pilot effort for this announcement is intended to encourage ERC applicants, where appropriate, to partner with such existing research training programs. Support may include NORA-related dissertation research, occupational safety and health coursework, and stipend and other support for trainees enrolled in the program. Applications should include sample curricula that demonstrate how supported students will obtain an understanding of the technical, professional, regulatory, and interdisciplinary components of occupational safety and health as it relates to their discipline. Proposed programs should be developed similar to the NIH Institutional NRSA T32 program. Supported trainees are expected to fully participate in the ERC interdisciplinary interaction program.
b. Research to Practice (R2P) Programs. R2P is an underlying principle for NIOSH research programs and are an integral component of the NIOSH research philosophy. Projects that advance research findings into the workplace may be supported. Translational, intervention, and dissemination projects that focus on the delivery of NORA-related research findings to partners who can effect change and prevent worker illness and injury are strongly encouraged. Such projects must include evaluation plans that will enable the assessment of their impact on worker illness and injury. Mechanisms that may be utilized include outreach, continuing education, and visiting scholars programs.
c. Interdisciplinary Research Training Programs. Programs to provide interdisciplinary predoctoral research training in NORA-related projects may be supported. The research training must emphasize specialized skills to assist in addressing NORA priorities in occupational safety and health. Supported trainees must be enrolled in approved ERC academic core or allied training programs.
See Section VIII, Other
Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This funding opportunity announcement will use the NIOSH T42 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
Competing supplement grant applications from current T42 grantees are also permitted. Applicants should follow the PHS 398 application instructions for competing supplement applications. (See http://grants.nih.gov/grants/funding/phs398/phs398.html). Separate competing supplement grant applications should be submitted for each new or amended Training Program.
This funding opportunity uses the just-in-time information
concepts (see PHS 398 Application
Guide). It also uses the non-modular budget format described in the PHS 398
application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget
Period" and the "Entire Proposed Period of Support" is to be
submitted with the application.
This program is an ongoing program. The announcement is open for applications for up to five years, and NIOSH intends to re-announce the program upon expiration of this announcement. An Applicant may request a project period of up to five years. Proposed new ERCs may request up to three years of support under this announcement.
2. Funds Available
The total amount of funds available to be awarded under this program is about $20 million dollars per year. This includes all new competing applications, competing renewal applications, and noncompeting continuation awards. The number of ERC awards is expected to be between 12 and 20 depending on the quality of the applications and funds available. New and competing renewal ERC awards may vary from one to ten each year, and will depend on the number of awards that have ended. The anticipated start date for these awards is July 1 of the year following application submission. The maximum performance period that may be requested by a new applicant is three years. The maximum performance period that may be requested by a competing renewal applicant is five years.
Applicants may request awards up to $1,800,000 per year in total costs.
the nature and scope of the proposed training program will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of NIOSH provide
support for this program, awards pursuant to this funding opportunity are
contingent upon the availability of funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation; NIOSH will follow NIH policy on this item: see NOT-OD-05-004.
HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
The following organizations/institutions are eligible to apply:
NOTE: Foreign institutions are not eligible to apply
1.B. Eligible Individuals in Organizations/Institutions
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed training program as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current HHS Grants Policy Statement.
3. Other-Special Eligibility Criteria
Post-doctoral trainees (OM residents only) must meet the NIH guidelines for support under the National Research Service Award (T32) program. See the following web site for further information on the NIH guidelines: http://grants.nih.gov/grants/guide/pa-files/PA-10-036.html.
Trainee Citizenship: The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Noncitizen nationals are people, who, although not citizens of the United States, owe permanent allegiance to the United States. They generally are people born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals who have been lawfully admitted for permanent residence must have a currently valid Permanent Resident Card (USCIS Form I-551) or other legal verification of such status. For example, if an individual has the proper validation on his/her passport, a notarized photocopy of the passport could suffice. Because there is a 6-month limitation on this validation, it is the grantee’s responsibility to ensure that the individual renews the I-551 prior to each 6-month expiration date.
A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving Kirschstein-NRSA support. Individuals on temporary or student visas are not eligible for Kirschstein-NRSA support.
Number of Applications. An applicant institution may only submit one comprehensive center grant application under this announcement. However, current T42 grantees can submit one or multiple competing supplement grant applications according to the PHS 398 Instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). Separate competing supplement grant applications should be submitted for each new or amended Training Program.
Resubmissions. Applicants may submit one resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Applicants submitted as of January 25, 2010 are permitted one amendment. Renewal applications submitted prior to January 25, 2010 are permitted two amendments (A1 and A2) until January 25, 2011. As of January 25, 2011, NIOSH will only accept one amendment.
Renewals. Applicants may submit a renewal application.
1. Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 770-488-2783.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.
The application for this program uses both the detailed budget page (form page 4) and the substitute form page 4 (“NRSA Substitute Detailed Budget for Initial Budget Period Direct Costs”) of the 398 application. Applicants that do not submit the budget in the required format will have their applications returned as non-responsive. Limits on funding levels for each component are listed below in section IV.6, “Other Submission Requirements.”
All training activities should be consistent with the goals of the ERC program and should be based on well documented occupational safety and health needs. In order to assist applicants in the preparation of an application that can be reviewed, a number of supplemental instructions are provided. The applicant should follow the special instructions for institutional training grants contained within the PHS 398 and the supplemental instructions for preparing an ERC application, http://www.cdc.gov/niosh/oep/funding.html#train . The applicant should follow the page limits specified in the outline below, and ensure that each activity is clearly described and identified. The application should be organized as indicated below:
TABLE OF CONTENTS FOR AN EDUCATION AND RESEARCH CENTER APPLICATION
In order to facilitate the preparation and review of the ERC application, the following Table of Contents should be used. It is a minor modification of the PHS 398 Table of Contents.
Suggested tables for an ERC application are listed in the supplemental instructions at: http://www.cdc.gov/niosh/oep/funding.html#train.
Note: In the top left margin of the detailed
and summary budget pages, the Center Director should identify the project
title. For example, Academic Training Program: Industrial Hygiene. Type density
and size throughout the entire application must conform to format
specifications provided in the PHS 398 instructions.
The format and content of competing supplement grant applications should conform to the PHS 398 Instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). Separate competing supplement grant applications should be submitted for each new or amended Academic Training Component or Targeted Research Training Program.
Appendices are needed but should include only those materials appropriate for the proposed ERC components. Appendices should include course descriptions, sample curricula and schedule, and course brochures. Syllabi for academic disciplinary areas and publications and manuscripts that are related to research projects may also be included. Appendix materials should be supplied in the form of a PDF file contained on a CD ROM disk. The appendices should be bookmarked and the CD memory size should not exceed 25 MB. Please follow the guidelines for creating PDF files provided by the eRA Commons (see http://era.nih.gov/ElectronicReceipt/pdf_guidelines.htm). Paper copies of appendix materials will not be accepted. Otherwise, the preparation of appendices should conform to the guidelines described by the PHS 398 Instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in this FOA.
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 PHS 398 budget forms. All other institutions should have their individual PHS 398 budget forms attached to the prime institution budget pages.
3. Submission Dates
Applications must be received on or before the due dates specified in Section IV.3.A.
Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): Not applicable
Application Due Date(s): September 10, 2010; August 15, 2011; August 14, 2012; August 14, 2013; August 14, 2014
Peer Review Date(s): February/March, 2011; February/March, 2012; February/March 2013; February/March, 2012; February/March 2013
Council Review Date(s): May, 2011; May, 2012; May, 2013; May, 2014; May, 2015
Earliest Anticipated Start Date: July 1, 2011; July 1, 2012; July 1, 2013; July 1, 2014; July 1, 2015
Expiration Date: August 14, 2014
3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity.
3.B. Submitting an Application to NIOSH
Applications to this FOA must be prepared using PHS 398 grant application forms and related instructions. Policy guidelines for the NIH Ruth L. Kirschstein National Research Service Awards also provide a useful reference: (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600187).
Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Concurrently, submit two photocopies of the application and five CD ROM disks containing appendix materials to:
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) 498-2543
FAX: (404) 498-2571
Overnight Mail Address:
Century Parkway NE (4th Floor)
Atlanta GA 30345-3114
3.C. Application Processing
Applications must be received on or before the application receipt/submission dates listed in Section IV.3.A. Upon receipt, NIOSH will evaluate applications for completeness and responsiveness to this FOA. Applications which are either incomplete or nonresponsive will not be reviewed.
NIOSH will not accept any application that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIOSH will not accept any application that is essentially the same as one previously reviewed. For those applications which are accepted, reviewed, but not funded, NIOSH will accept one amended application (resubmission). All amended applications must include an Introduction addressing the critique from the previous review.
Information on the status of an application should be checked by the Program Director in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
The ERC Center funding mechanism should not be used as a substitute for individual research grant support. It is expected that research investigators participating in the ERC Centers will have a history of independent project support in addition to the special support available to ERC members.
Generally, funds for renovation of existing facilities or to purchase substantial amounts of equipment will not be allowed. If such requests are made, they must be justified in terms of the critical nature of the equipment/renovations for the success of the overall objectives of the ERC award.
Indirect costs are limited to 8% of total direct costs exclusive of tuition and fees, and equipment.
6. Other Submission Requirements and
To help assure the stability of the Center, the Center Director, Deputy Director, and Program Directors must be full-time faculty and administrative staff.
Applications for this announcement will use the budget form page 4 and 5 and NRSA substitute form page 4 and 5 to display the budgets. The facilities and administrative costs for this program are limited to 8% of the total direct costs, exclusive of tuition and fees, and equipment. The NIOSH web site provides an example of tables for this program. The web address is http://www.cdc.gov/niosh/oep/funding.html#train .
Individuals may receive up to five years of support at the predoctoral level and three years of support at the postdoctoral level (OM Residents only). Any exception to the maximum period of support requires a waiver from NIOSH based on review of justification form the individual and d the institution. Stipends are not allowed for part-time trainees.
Funding may be requested up to the levels described below. Unless an applicant receives written permission from the NIOSH program director named below, any requests for funding above these levels will cause the application to be determined non-responsive, and the application will not be reviewed. No new ERC Supplemental Program awards will be made in Fiscal Year 2011.
Stipends are provided as a subsistence allowance to help trainees defray living expenses during the training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends may be paid to eligible trainees. Stipend budgets must be based on the levels established for the current fiscal year of the grant. For appointments of less than a full year, the stipend will be prorated using a monthly or daily basis. The monthly stipend amount is calculated by dividing the current annual stipend by 12. The daily stipend is calculated by dividing the current annual stipend by 365.
Tuition and Fees
The institution may request tuition and fees (including appropriate health insurance) only to the extent that the same resident or nonresident tuition and fees are charged to regular non-Federally supported students. Tuition at the postdoctoral level is limited to that required for specified courses.
Other Trainee Costs
Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's training, is an allowable trainee expense.
Additional support for travel to a training experience away from the institution may be permitted. Training experiences away from the parent institution must be justified considering the type of opportunities for training available, the manner in which these opportunities differ from and compliment those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and goals.
This type of training requires prior approval from NIOSH. Letters requesting such training may be submitted to NIOSH at any time during the award period. For OMR training, applicant may request funds for other necessary costs required for the residency training such as malpractice insurance, hospital parking and other required expenses for all residents at the institution.
Trainee Related Expenses (cannot exceed 40% of total budget for all academic programs)
Funds may be requested to defray the cost of other training related expenses such as staff salaries, consultant costs, equipment, supplies, and travel expense for the training faculty. Because there are core costs that are fixed, the following scale should be used to determine the training related expenses:
1. Core academic programs (IH/OS/OHN). $12,000 per full time trainee supported by the ERC award for the first five (5) trainees; $3,000 per each additional full time/full time equivalent trainee supported by the ERC award.
2. Allied OSH and HSAT programs. $12,000 per full time trainee supported by the ERC award for the first three (3) trainees; $3,000 per each additional full time/full time equivalent trainee supported by the ERC award.
3. Core academic OMR program. $20,000 per full time trainee supported by the award for the first four (4) trainees; $5,000 per each additional full time/full time equivalent trainee supported by the ERC award.
Training related expenses cannot exceed 40% of the total program budget for all academic programs. Academic training programs use both budget page 4 and substitute form page 4. On substitute form page 4 in the training related expense section, the name of the students and academic status (full time (f/t), half time (1/2), one third time (1/3) are listed. Because many programs provide support for trainees from other sources, it is appropriate to list all trainees in the program. Students that are to be supported should be identified. If needed, use a continuation page to list the names of the trainees. For programs that have vacant positions that will be filled during the year, enter TBN for each position requested.
Administrative Core Funds (up to $250,000/year in direct costs)
The administrative core will support the management, academic and research development, and other center activities not supported by other categories. Up to one half of a full-time equivalent effort between the center director and deputy director may be requested. Up to 100% of a full-time equivalent for administrative support for the Center may be requested. Funds may also be requested to support the external advisory committee. These funds should be requested on a budget form page 4 labeled administrative core. Up to $250,000 per year in direct costs may be requested.
Center Director’s Fund (up to $50,000 per year in direct costs)
An applicant may request up to $50,000 per year in direct costs for a Center Director’s fund as part of the administrative core budget. These funds are intended to provide ERC Directors discretionary funds to meet unplanned expenses and take advantage of unexpected opportunities. A portion of these funds (10%) may be used for travel to the Center Director’s meeting and other necessary travel for the Center personnel. Although specific uses of these funds may vary each year, the applicant should provide a best estimate description of how these funds would be used.
Continuing Education for OSH (REQUIRED)
Up to $100,000 per year in direct costs may be requested.
Continuing Education for Hazardous Substance Training (OPTIONAL)
Up to $75,000 per year in direct costs may be requested. This budget must include a minimum of $10,000 for public sector student participation assistance.
Outreach to Occupational Community/ Research to Practice (REQUIRED)
Up to $35,000 in direct costs may be requested per year. A detailed budget for this activity is required; in the budget justification, the Center Director should describe the use of these funds.
Pilot/Small Projects Research Training Program (OPTIONAL)
Up to $100,000 in direct costs may be requested per year. There is a maximum of $20,000 allowed per project. The Center Director is solely responsible for these funds. A detailed budget for this activity is required; in the budget justification, the center director should describe the use of these funds. These projects must be on a NORA topic and may not be renewed.
Interdisciplinary Coordination (REQUIRED)
For each core program (OMR, IH, OHN, OS), the applicant may request up to 5% effort for the academic program directors for interdisciplinary coordination/integration of the ERC academic training programs. A total of up to up to $30,000 per year in direct costs may be requested.
Diversity Recruitment Plan (REQUIRED)
Up to $5,000 in direct costs may be requested per year. Include in the overall budget page under “Other Expenses”, and label it Diversity. A detailed budget for this activity is not required, however in the budget justification; the center director should describe the use of these funds.
Targeted Research Training in Occupational Safety and Health (OPTIONAL)
Up to $300,000 per year for support may be requested for the Targeted Research Training Program. The Program must have a cover sheet, a PHS 398 Form page 2 description, a detailed and summary budget, and a program plan not to exceed 15 pages. The Program proposed must include a detailed budget and justification and the program plans should not exceed 15 pages. Projects that are solely for the support of trainees through collaborative partnerships should follow the guidance for training program budgets.
PD/PI Credential (e.g., Agency Login)
The HHS/CDC requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.
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.”
All application instructions outlined in the PHS398 Application Guide are to be followed, incorporating "Just-in-Time" information concepts.
6. A. Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. See Section IV.3.B. for details on submission of five identical CDs. The appendices should be bookmarked and the CD memory size should not exceed 25 MB. Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html. Do not use the Appendix to circumvent the page limitations of the Training Program Plan component. An application that does not observe the required page limitations may be delayed in the review process.
6.B. Data Tables
Applications must include data tables using the NIOSH Instructions and Sample Tables (the web address is http://www.cdc.gov/niosh/oep/funding.html#train). The information in the data tables will be used by reviewers and NIOSH staff during peer review and in reaching funding decisions.
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIOSH in accordance with HHS/NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. See http://enhancing-peer-review.nih.gov/ for additional information concerning the enhanced peer review process to be used for this announcement.
A site visit to the applicant institutions may be made (but such site visits are not assured) to evaluate the overall merit of the application. The site visit team includes members of the Special Emphasis Panel who have expertise in major academic training, continuing education, facilities, outreach, and other activities of the proposed Center, the NIOSH Scientific Review Officer, and the NIOSH Program Officer.
A site visit is not a prerequisite and is not assured for consideration of an application by NIOSH. Therefore, the application is considered a complete document for review purposes. Furthermore, the applicant should not use the site visit as an occasion for adding programs, projects, or personnel, for making major changes, or for delivering another exposition of the application. Rather, it should be used by the Center Director and associates to elaborate on the Center and it’s programs, cost effectiveness and quality control features of the programs, and on other Center activities for which funding is requested, as well as to answer reviewers' questions. The site visit team will not consider any area that is presented for evaluation at the site visit which has not been included in the application. Budgetary changes also will not be considered at the time of a site visit. The findings of the site visit team are reported and discussed by the members of the SEP, which makes the final peer review recommendations and assigns the priority score.
Initial Merit Review
As part of the initial merit review, all applications will:
NIOSH objectives include the support of education programs that train personnel to address occupational safety and health issues, and provide continuing education programs for personnel engaged in occupational safety and health work. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed training and research training will have a substantial impact on the pursuit of these objectives. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. ERC component programs will also be scored based on the specific program review criteria below.
REVIEW CRITERIA FOR OVERALL ERC IMPACT (INCLUSIVE OF ALL CENTER WIDE ACTIVITIES, ACADEMIC TRAINING PROGRAMS, CONTINUING EDUCATION PROGRAMS, AND TARGETED RESEARCH TRAINING PROGRAM)
REVIEW CRITERIA FOR CENTER WIDE ACTIVITIES
REVIEW CRITERIA FOR ACADEMIC TRAINING PROGRAMS
(Applies to Core, other allied OSH Academic Training Programs, and HSAT Programs)
REVIEW CRITERIA FOR TARGETED RESEARCH TRAINING PROGRAM
REVIEW CRITERIA FOR CONTINUING EDUCATION TRAINING PROGRAM
(Also applies to Hazardous Substance Continuing Education Program, if proposed)
2.A. Additional Review Criteria:
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the internet at the following address: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1.
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. Please see http://www.cdc.gov/OD/foia/policies/inclusio.htm for more information.
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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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 project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific training program presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
2.B. Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed training program.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Diversity Recruitment and Retention Plan
NIOSH remains committed to increasing the participation of individuals from underrepresented racial and ethnic groups as well as individuals with disabilities in occupational safety and health research and practice. All competing applications for institutional training grants must include a specific plan to recruit and retain underrepresented groups in the training program. In addition, all competing continuation applications must include a report on the recruitment and retention of underrepresented groups during the previous award period. If an application is received without a plan or without a report on the previous award period, the application will be considered incomplete and will be returned to the applicant without review.
Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide information on the racial/ethnic distribution of:
Students who applied for admission within the department(s) relative to the training grant,
Students who were offered admission to or a position within the department(s),
Students actually enrolled in the academic program relevant to the training grant,
Students who were appointed to the training grant.
For those trainees who were enrolled in the program whether the trainees finished their training.
The success of efforts to recruit and retain underrepresented trainees is a factor in the assessment of the quality of the trainee pool and thus will be included within the priority score. In addition, peer reviewers will separately evaluate the minority recruitment plan and report (for competing renewals) after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of underrepresented trainees and whether the experience in recruitment during the previous award period has been incorporated into the formulation of the plan for the next award period. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan or the record of underrepresented trainee recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within NIOSH, with guidance from the NIOSH Secondary Review Committee, will determine whether amended plans and reports submitted after the initial review are acceptable.
Training in the Responsible Conduct of
Every pre-doctoral and Masters (if research) trainee supported by an institutional training grant must receive instruction in the responsible conduct of research. (NIOSH follows the NIH policies for this requirement, see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html).
Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.
Although NIH and NIOSH do not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students appointed to the program.
Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided. Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and non-competing applications. The NIOSH encourages institutions to provide instruction in the responsible conduct of research to all graduate students, and research staff regardless of their source of support.
2.C. Resource Sharing Plan(s)
Plan for Sharing Research Data – Not applicable to Training Grants.
Sharing Research Resources - Not applicable to Training Grants.
2.D. Selection Process
NIOSH initial review group will assess the
applicant's plans on the basis of the appropriateness of topics, format, amount
and nature of faculty participation, and the frequency and duration of
instruction. The plan will be discussed after the overall determination of
merit, so that the review panel's evaluation of the plan will not be a factor
in the determination of the priority score. Plans will be judged as acceptable
or unacceptable. The acceptability of the plan will be described in an
administrative note on the summary statement. Regardless of the priority score,
applications with unacceptable plans will not be funded until the applicant
provides a revised, acceptable plan. NIOSH Staff will judge the acceptability
of the revised plan.
Following initial review, the NIOSH Secondary Review Committee will consider the assessment of the scientific and educational merit of the training grant application as well as the initial review group's comments on the recruitment of individuals from underrepresented groups and the plan for instruction in the responsible conduct of research.
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:
3. Anticipated Announcement and Award Dates
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding, HHS/CDC may request "just-in-time" information from the applicant. HHS grants policies as described in the http://grants.nih.gov/grants/forms.htm.
We encourage your inquiries concerning this
funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may fall into three areas: scientific/research
(program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
John Talty, MS, P.E.
Office of Extramural Programs
National Institute for Occupational Safety and Health
4676 Columbia Parkway, Mail stop C- 7
Cincinnati, OH 45226-1998
Telephone: (513) 533-8241
FAX: (513) 533-8564
2. Peer Review Contact(s):
Chris Langub, 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) 498-2543
FAX: (404) 498-2571
Overnight Mail Address:
Century Parkway NE (4th Floor)
Atlanta GA 30345-3114
3. Financial/Grants Management Contact(s):
Peter Grandillo, Jr.
Grants Management Branch, Procurement and Grants Office
Centers for Disease Control and Prevention
(Courier) 626 Cochrans Mill Road
(USPS) P.O. Box 18070 – MS P05
Pittsburgh, Pennsylvania 15236-0070
Telephone: (412) 386-6834
FAX: (412) 386-6429
General Questions Contact(s):
Technical Information Management Section
HHS/CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Federal regulations (45 CFR Part 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). Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Use of Animals in Research
Recipients of PHS support for activities involving live, vertebrate animals must comply with the 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. Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found at http://www.cdc.gov/od/pgo/funding/ARs.htm.
for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.
Inclusion of Persons Under the Age of 21 in
The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.
In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.
The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.
The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.
Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.
Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.
Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.
HIV Program Review Panel Requirements
Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.
To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.
If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.
Before funds are used to develop educational materials,
determine whether suitable materials already exist in the CDC National
Prevention Information Network (NPIN). The website can be found at; http://www.nchstp.cdc.gov/od/infocenter/npin.htm.
Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.
Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).
Smoke-Free Workplace Requirements
HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.Healthy People 2020
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2020," 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 2020" at www.healthypeople.gov.
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.
In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation
It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.
Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent HHS/CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.
Prohibition on Use of HHS/CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."
Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.
In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC’s Appropriations Act to mean that HHS/CDC’s funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.
Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.
Proof of Non-profit Status
Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.
Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.
Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:
The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).
Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.
Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations. All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS. If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance. A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above. A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities. For further guidance on the use of DHHS direct financial assistance, see Title 45, Code of Federal Regulations, Part 87, and Equal Treatment for Faith-Based Organizations, and visit the internet site: http://www.whitehouse.gov/government/fbci/
Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions. The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency. HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.
National Historic Preservation Act of 1966
(Public Law 89-665, 80 Stat. 915)
The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:
a. Section 106 of the National Historic Preservation Act (NHPA) states:
The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking, shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register. The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.
b. Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”
Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.
Conference Disclaimer and Use of Logos
Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:
“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”
Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer. It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.
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