Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIEHS WTP Ebola Biosafety Training and Infectious Disease Response Initiative developed in partnership with CDC, DHHS, ASPR, OSHA, and NIOSH invites applications for cooperative agreements to support the development and implementation of occupational safety and health and infection control training programs for workers who may be at risk during infectious disease outbreaks. The awarded programs (awardees) will focus on dissemination of environmental infection control and hazard recognition training within a broad-set of occupational and community settings, including healthcare and non-healthcare job sectors. Awardees will identify target worker populations, environments or tasks that increase exposure to high risk pathogens (described within the CDC and NIAID Category A Priority Pathogens/Agents athttp://www.bt.cdc.gov/bioterrorism/overview.asp, and http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx. These are pathogens, such as Ebola Virus, that can be easily transmitted person-to-person and result in high mortality rates. In addition, awardees will provide training for workers on risk reduction and infection prevention for other infectious diseases that have the potential to result in high-to-moderate morbidity and mortality rates (described within the CDC and NIAID Category B and C Priority Pathogens/Agents at http://www.bt.cdc.gov/bioterrorism/overview.asp, and http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx), through work duties and occupational settings.

The major objective of this funding opportunity is to assist in the training and education of workers within the US in understanding how infectious diseases with varying transmissibility, incubation periods and clinical outcome are spread in an occupational environment and what measures can be taken to shield workers from potential exposure. Safety and health training will provide workers with the skills and knowledge to protect themselves and their communities from potential exposure to contaminated material (biological, chemical or radiological) or infected individuals who may be encountered.

A major goal of this program is to promote and establish national, regional or multi-state geographical partnerships that can provide training or training support in occupational settings that carry the potential for increased exposure to contaminated materials or infected individuals. Establishment of such partnerships will assist in hazard planning, mitigation, response and recovery activities while enhancing biosafety and infection control within a broad array of occupational settings.

The NIEHS WTP has identified a need for national coordination to promote occupational biosafety outside of the laboratory setting. Under the cooperative agreements, the NIEHS WTP encourages increased cooperation and collaborations, partnerships, affiliate engagement to build training coalitions and relationships with referral and treatment centers (such as ASPR and CDC frontline healthcare facilities, Ebola assessment hospitals, Ebola treatment and coordination centers) for a sustained infectious disease biosafety response.

Acknowledging this as a new initiative in worker safety and training, continuing improvements during the post-award-period will assist in planning and conduct of training programs to ensure they are closely aligned with NIEHS WTP mission priorities and administered efficiently.

The Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 126(g), authorizes an assistance program for training and education of workers engaged in activities related to hazardous waste generation, removal, containment or emergency response and hazardous materials transportation and emergency response. The Congress assigned responsibility for administering this program to NIEHS, an Institute of the NIH of the DHHS.

Working through cooperative agreement grants with 20 non-profit consortia representing over 100 training organizations including unions, universities, and community colleges, the NIEHS WTP focuses on workers who deal with hazardous materials, including biohazards, and emergency response. This includes healthcare and hospital workers at all levels, emergency responders, hazardous material truck drivers and transportation workers, hazardous and solid waste disposal workers, heavy equipment operators, and site decontamination workers.

In February 2007, NIEHS WTP updated its strategic plan to be consistent with the NIEHS vision, which includes identification and prevention of hazardous exposures, including those with infectious capacity. The NIEHS WTP uses environmental sciences to reduce risk and protect worker and public health through training. The strategic plan outlines the directions that the program seeks to take during the next 5 years. It includes information on the development of the plan, partnerships, roles of advanced training technologies, and the central role of 29 CFR 1910.120 in environmental response and cleanup whether at traditional superfund sites, uncontrolled hazardous waste sites, or sites emanating from a natural disaster or an act of terrorism. The NIEHS WTP Strategic Plan can be found at https://tools.niehs.nih.gov/wetp/public/hasl_get_blob.cfm?id=6430.

The NIEHS WTP is well-suited to address preparedness and response efforts supported by the Ebola Biosafety and Infectious Disease Response Training Initiative. The NIEHS WTP program has over 25 years of experience providing worker health and safety training related to potential exposures to biological hazards and safety as they perform their job duties. Many of the training courses provided by NIEHS WTP awardees are based off of OSHA’s standards that commonly apply to emergency response and recovery workers, and include Bloodborne Pathogens standard (29 CFR 1910.1030), OSHA s Respiratory Protection standard (29 CFR 1910.134), OSHA’s PPE standard (29 CFR 1910.132) and Section 5(a)(1) of the Occupational Safety and Health (OSH) Act of 1970, often referred to as the General Duty Clause, and OSHA Best Practices for Hospital-Based First Receivers of Victims From Mass Casualty Incidents Involving the Release of Hazardous Substances.

The NIEHS WTP awardees have been involved in providing occupational biological safety training to workers during the H5N1 outbreak, the 2001 Anthrax attacks, the H1N1 Avian Influenza 2009, mold remediation from Hurricanes Katrina and Sandy, and Ebola preparedness since late 2013. Its audiences have spanned the worker population spectrum from healthcare workers to community volunteers. Acknowledging the importance of networks and partnerships, private, federal, state and local, NIEHS WTP is committed to building capacity for networks and those workers who, with proper safety and health training and equipment, will continue to be the frontline of defense in controlling infectious disease outbreaks.

While the OSHA Hazardous Waste Operations and Emergency Response (HAZWOPER) standard, 29 CFR 1910.120 (59 FR 43268, August 22, 1994), only applies to occupational exposure to Ebola virus and other emerging infectious diseases during releases of such agents into the environment and certain other situations, its training, PPE, and other provisions may serve as a useful framework for a comprehensive worker protection program during other types of tasks (including those involved in Ebola and other emerging infectious disease preparedness and response work). In particular, non-mandatory Appendix E describes much of the NIEHS Minimum Criteria Worker Health and Safety Training for Hazardous Waste Operations and Emergency Response. This OSHA guidance is available at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9770.

At the request of ASPR, NIH, CDC, and the Institute of Medicine (IOM), in collaboration with the National Research Council (NRC), an Ebola response workshop with key stakeholders and experts convened on November 3, 2014, to discuss the research priorities that could guide medical and public health practice. Discussions included the degree of transmission and bio-persistence of the Ebola virus under a range of conditions and on a variety of materials, as well as issues of handling potentially infectious materials, decontamination, donning and doffing training for PPE usage with traditional and nontraditional workers involved in the full spectrum of this response.

As a result of the priorities laid out in the workshop and in consultation with CDC, DHHS, ASPR, OSHA, and NIOSH, the NIEHS WTP has broadly consulted public and private sector worker representatives, thought leaders and stakeholders to discuss best practices, needs, and gaps related to worker training for Ebola and other biological or infectious hazards, to elucidate training priorities for this comprehensive funding opportunity announcement.

Ebola Virus Disease (EVD), identified as a CDC Category A Priority Pathogen, is a severe, systemic illness that may initially present with fever, headache, myalgia (muscle aches), fatigue, nausea, vomiting and diarrhea and may lead to significant volume depletion. Late stage illness may involve progressive hypotension (low blood pressure), impaired immune system, shock, multi-organ failure, hemorrhage (bleeding), and is often fatal. Transmission of disease has been identified as mainly person-to-person; however other potential routes are under investigation. The likelihood of infection depends, in part, upon the type of body fluid to which an individual is exposed and the amount of active virus it contains. Supportive treatment is the current therapy and encompasses a multi-disciplinary approach.

The record scale and geographic extent of the 2014-2015 EVD outbreak in West Africa generated an extraordinary international response, resulting in a dynamic effort to contain the epidemic and deliver infection control and biological safety preparedness training. Several strategies are being employed to prevent the spread of Ebola virus, including, infection control and prevention precautions, environmental exposure control protections, monitoring and travel restrictions, and a host of public health response strategies.

Healthcare personnel are instructed to follow current bloodborne pathogen standards, and infection control and prevention recommendations from CDC and other guidance agencies. While these guidelines provide a review of the measures needed to manage individuals with suspected or confirmed infection in healthcare settings, they do not effectively cover a comprehensive range of occupational settings that may expose a worker to potential risks through work related responsibilities, tasks or scenarios.

This epidemic has revealed a need for training models to increase hazard recognition skill sets that promote the concurrent use and application of several infection control, standard precautions, industrial and universal practices to mitigate and remediate risk; comply with protective recommendations and standards; and develop site-specific protocols for targeted populations at risk for exposure to potentially contaminated materials or infected individuals.

For purposes of this FOA, hazard recognition is defined as the skilled ability to identify that a task or situation at hand carries potential for harm (physical or mental), associated with a condition or activity. Risk perception and assessment are the culmination of several factors following hazard recognition and transform skilled ability to estimate risk and benefits associated with the task or scenario, capability, and complacency. It is essential to cultivate the ability to stratify risk, critically judge potential impact of outcome, understand exposure control, communicate risk and impart confidence in selection of PPE, as appropriate, to prevent injury, disease and high risk behaviors.

The NIEHS WTP and its federal partners have identified the need for increased levels of such awareness- and operations-level hazard recognition and risk assessment training in the context of emerging infectious diseases. While a single guidance or standard may not be sufficient training, a combination of several applicable safety practices for frontline personnel, in addition to those workers who may be in potential exposure areas, may serve as a tool to harmonize and establish innovative biosafety and infection control practices for various targeted job sectors and occupational settings.

As part of a national coordinated effort to prevent, control and respond to potential occupational exposure to organisms causing infectious diseases, including Ebola, the NIEHS WTP defines biosafety or biological safety as practices, procedures and equipment needed to ensure adequate safety conditions in all facilities that are involved with collection or handling of potentially infectious microorganisms, contaminated materials and other biological hazards. These include, but are not limited to, health care settings, clinical, diagnostic, biological and teaching laboratories that handle clinical or animal tissue samples and a broad-range of non-healthcare facilities and occupational settings with the potential for transmission of diseases. It involves training as the practical application of precautionary principles and guidance that protect humans and the environment from exposure to infectious pathogens and materials and how to prioritize hazard recognition, mitigation, response, and recovery activities. Such training broadens the scope of practice and allows for implementation of a baseline system that encompasses an all-hazards approach to estimating risk of infectious disease and health hazard exposures, managing workplace controls, and promotes cross-cutting and coordinated strategies for occupational health and safety. Biosafety training may educate workers on epidemiologic and scientific principles to the reduction or prevention of infections (infection control), containment principles (isolation and biocontainment), techniques that use finite resources to identify and implement exposure controls (control banding) and standardized practices and approaches to infection control (universal or standard safety precautions including hand hygiene, cough etiquette), PPE including appropriate respiratory equipment and site-specific health hazard evaluation.

Since September 2014, NIEHS WTP has leveraged current awardees, through re-programming of existing extramural funds, to provide domestic Ebola preparedness training to more than 7,000 workers in 18 states. Supplemental funding was awarded in May 2015 with the purpose of broadening their existing training programs. Inclusion of hazard recognition, mitigation and prevention of potential EVD exposures was the focus of these supplemental awards through train-the-trainer, awareness- and operations-level instruction and promoted enhanced safety of healthcare and non-healthcare workers, and continues to contribute to ongoing NIEHS WTP Ebola biosafety response training efforts.

The NIEHS WTP and federal partners recognize infectious diseases and pathogens pose a unique hazard in the occupational setting through exposure of potentially contaminated materials or infected individuals due to various means for disease transmission. Earlier this year, DHHS embarked upon a multi-faceted program to enhance the nation’s preparedness for and response to infectious disease outbreaks. NIEHS has received $10 million funding to develop biosafety training for US based workers from a variety of disciplines and professions that may involve worker exposure to infectious diseases, including Ebola; and WTP, within NIEHS, has been charged to lead efforts to implement this program.

Endorsing an all-hazards approach within the whole-of-community, the scope of training should augment biosafety knowledge, build educational capacity for biosafety training and impart skill sets related to occupational risk assessment, and hazards, as it pertains to infection and environmental control. It is encouraged to incorporate suggested standards and guidance documents from NIEHS federal partners, as applicable for the target populations or training curricula, to substantiate development of evidence-based curricula. The NIEHS WTP Ebola Biosafety and Infectious Disease Response Training initiative suggests a mix of health and safety training levels. This includes awareness and operations level training either directly with specific organizations and agencies or through Train-the-Trainer methods as required.

Awareness-level training is intended to promote workers' understanding and knowledge of relevant potential exposures, precautions, safety standards and guidance. Examples may include, but are not limited to, increasing awareness of potential infectious disease exposure to workers who do not anticipate to have direct contact with suspected contaminated material or infected individuals or; increasing awareness of critical skills and resources for the use of universal safety precautions, which refers to the practice of wearing nonporous protective clothing and or equipment and standard precautions, which refers to a set of infection control practices used to prevent transmission of disease that can be acquired by contact with blood, body fluids, non-intact skin and mucous membranes, and provide awareness material to enhance current practices (such as hand hygiene, personal protective equipment, sharps injury prevention, cleaning and disinfection, respiratory hygiene and protection and waste disposal safety practices and so forth).

Operations-level training is intended to promote workers' understanding and demonstrate the capacity for effectively executing standards of proficiency, by practice, for applicable activities related to potential occupational exposure to Ebola or other emerging infectious diseases and hazardous scenarios. Examples may include, but are not limited to, demonstrated ability to recognize and mitigate hazards in scenarios where direct contact with suspected contaminated material or infected individuals is anticipated and emphasize hierarchy of controls, appropriate interaction with direct or close contacts with potentially contaminated material or infected individuals, chemicals, donning and doffing of PPE, demonstrated use of appropriate respiratory protection, decontamination and waste management protocols, hazard and risk communication and reporting, post-exposure protocols, and site specific operational training.

The developed awareness and operations training program will need to incorporate an evaluation process that will include, at a minimum, a pre- and post-training assessment. In addition, follow-up evaluation may be performed to measure training benefit and information retention in an effort to improve training and presentation methodologies.

The NIEHS WTP awardees may help develop a TTT program targeted to various healthcare and non-healthcare job sector representatives, with the objectives of providing prospective instructors with knowledge, skills and tools needed to return to their respective organizations and provide awareness or operations level training to their worker members.

The TTT model will provide instructors with critical training skills to identify and determine the need for training, identify training objectives, design participant-oriented learning materials and exercises, apply learning concepts, develop supportive climates conducive to learning, apply training activities, strategize for different learning needs, encouraging learners to utilize available and applicable resources, assist learners in evaluating their own learning, understand factors related to educational motivation, passion, conditioning and facilitate a training program with stimulating exercise activities as applicable to biosafety training and infection control in the occupational setting for targeted populations. Awareness-level TTT may focus on increasing skills and knowledge in various occupational settings, whereas operations-level TTT may focus on specific exercises, drills, coaching of specific skills, demonstration and practice of PPE dress outs, reflective supervision and so forth.

To enable standardized curricula for awareness and operations level training, a set of performance topics and objectives have been suggested by NIEHS WTP as the minimum level of preparation for incorporation within developing programs. These performance objectives can be found on the NIEHS WTP Ebola website: http://tools.niehs.nih.gov/wetp/index.cfm?id=2542.

The developed TTT program will need to incorporate an evaluation process that will include, at a minimum, a pre- and post-training assessment. In addition, follow-up evaluation may be performed to measure instruction benefit, incorporation of appropriate worker-levels needs and instructor proficiency in an effort to improve training and presentation methodologies.

The NIEHS WTP awardee instructors will provide training to designated healthcare and non-healthcare audiences utilizing site specific information with regards to protocols, supplies, and job tasks. This may be conducted at the sponsoring institution's location with smaller groups where awareness or operations-level training is desired with hands on activity and may include technical drills such as donning and doffing of PPE.

The process to conduct such training would include, but not be limited to, the following elements:

• Outreach to stakeholder organizations in each of the target sites for site-specific and facility-specific issues affecting Ebola response workers with the formation of local advisory groups.
• Development of curriculum and materials in collaboration with CDC, NIOSH, OSHA and DHHS, ASPR subject matter experts (SME s).
• Creation of course modules and learning activities for a 2-8 hour awareness-level training course
• Creation of course modules and learning activities for a 24-40 hour operations-level training course that will include technical exercises and drills, such as PPE dress-out appropriate for workers reasonably anticipated exposures.
• Facilitator and participants handbook.
• Train-the-trainer curriculum and handbook.
• Evaluation of training effectiveness and quality.

The NIEHS WTP has developed a series of PowerPoint slides for awareness- operations-level training that could serve as a starting point for developing customized trainings that meet the needs of various worker groups. These Ebola Awareness and Operations Level training slides can be found on the NIEHS WTP Ebola site: http://tools.niehs.nih.gov/wetp/index.cfm?id=2542.

The developed direct training program will need to incorporate an evaluation process that will include, at a minimum, a pre- and post-training assessment. In addition, follow-up evaluation may be performed to measure training benefit and information retention in an effort to improve training and presentation methodologies.

The NIEHS WTP will work collaboratively with awardees to develop and target safety and health training for workers in various occupational settings and help establish basic risk assessment skill sets needed to handle other emerging infectious disease outbreaks. Integrating our HAZMAT trainers understanding of worker safety and health protection, the NIEHS WTP will coordinate with the CDC, DHHS, ASPR, OSHA, and NIOSH to provide guidance materials, as developed or suggested under the cooperative agreements by federal partners, such as targeted fact sheets, videos, podcasts and so forth, and assist awardees to develop an evidence-based curricula that address understanding:

(1) The science of Ebola (such as clinical manifestations, transmission of disease, persistence in the environment, and current protection and prevention measures);

(2) Appropriate application of controls and worker protection protocols as suggested by federal partners and other guidance agencies, when handling potentially contaminated materials or potentially infected individuals. These include, as appropriate, an understanding engineering controls, administrative and work practices, selection and use of a PPE, including training on donning and doffing of PPE, isolation and containment protocols, disinfection and disposal protocols;

(3) The protection needed when working in potentially contaminated environments (such as a clinical or research laboratories and non-clinical facilities);

(4) Appropriate waste management and decontamination protocols, shipping and transport of infectious materials, and safer mortuary practices;

(5) Occupational health medical surveillance protocols (such as incident exposure reporting, medical surveillance of potentially exposed individuals, reporting of health status changes and post-exposure protocols);

(6) Behavioral health resiliency (such as coping techniques for work related stress, protection from mental or physical exhaustion, promote psychosocial health and minimization of fear) and;

(7) The need for and the objectives of training evaluation.

A standard process is required by all applicants in collaboration with NIEHS WTP to ensure that the quality and content of information are consistent and take into consideration the organization s engineering, administrative, work practice, and PPE policies, procedures, and supplies (see NIEHS WTP Minimum Performance Objectives document). The safety of workers must be foremost in the infection control and preparedness instruction activities. The skills of the instructor to assess the audience s job duties, literacy level, cultural or language needs are critical to conveying information that is relevant for the worker.

Training evaluation objectives will focus on development of standardized metrics to measure immediate learning, satisfaction, and use of newly learned material, safety culture and safety climate that facilitates or impedes retention and long-term implementation of material, and overall impact of training to protect workers from potential exposure to EVD and other infectious pathogens

In addition, it is strongly encouraged to embrace a whole community approach, which promotes improved communications and integration of activities with local response organizations, both inside and outside of hospitals and health care facilities.

For purposes of this FOA the following approaches are considered responsive:

• Specifically, applicants, independently or as part of partnered relationships, should develop safety and health training curriculum for workers who are at high risk of coming in contact with persons potentially infected with Ebola virus and other emerging infectious diseases, through potentially contaminated materials (biological, chemical or radiological) or infected individuals. High risk workers may include: air transport (such as cabin crew, airline crew, border protection officers, transportation security screeners, and other air transport workers), medical treatment (such as physicians, allied health care professionals, nurses, midwives, emergency medical technicians, paramedics, humanitarian aid workers, emergency medical service workers, healthcare attendants, clinical and research laboratory workers, other allied health care professionals, morticians, coroners, medical examiners, and forensic scientists), environmental services in hospital and non-hospital settings (such as janitors, housekeepers, sanitizing personnel, maintenance workers, dietary aide workers), waste handling (such as solid and household waste handlers, Department of Transportation (DOT) permitted waste disposal and collection workers) and cleanup (decontamination and disinfection workers). Through the DHHS ASPR-led interagency working group, a matrix of potentially exposed populations for Ebola response training and protection has been constructed. The link to the Ebola PPE matrix is: https://www.osha.gov/Publications/OSHA3761.pdf. This would involve identified target populations that have been stratified according to occupational exposure in both health care and non-health care scenarios. The NIEHS Ebola Biosafety and Infectious Disease Response Training Initiative is focused on reaching at-risk populations which may or may not have been identified by the interagency working group and PPE matrix. Applicants are highly encouraged to integrate collaborators from infectious disease, occupational medicine, industrial hygiene and other worker safety fields who have experience in developing the respective integrated training. This person(s) can be an occupational medicine physician or other (Medical Doctor, Nurse Practitioner or Physician's Assistant, Certified Industrial Hygienist) and their role and qualifications in this area must be described within this response.
• Applicants, independently or as part of partnered relationships, must have demonstrated ability to directly access target worker populations in addition to having demonstrated experience with implementing and operating worker health and safety training and education programs. Applicants must integrate an all-hazards and whole community training approach to worker safety and health protection, including teaching: risk assessment and management; hazard recognition and communication; appropriate PPE selection and usage and; demonstrate experience in training targeted worker populations, as a necessitated means to enhance worker empowerment and use of best practices. The NIEHS WTP potential awardees will work collaboratively to develop and target safety and health training for workers in various occupational settings and help establish basic risk assessment skill sets needed to handle other emerging infectious disease outbreaks. The NIEHS WTP will coordinate with the CDC, DHHS, ASPR, OSHA, and NIOSH to provide guidance materials, as developed or suggested under the cooperative agreements by federal partners, such as targeted fact sheets, videos, podcasts and so forth, and assist awardees to develop an evidence-based curricula that addresses understanding: (1) the science of Ebola (such as clinical manifestations, transmission of disease, persistence in the environment, and current protection and prevention measures); (2) appropriate application of controls and worker protection protocols as suggested by federal partners and other guidance agencies, when handling potentially contaminated materials or potentially infected individuals. These include, as appropriate, an understanding engineering controls, administrative and work practices, selection and use of a PPE, including training on donning and doffing of PPE, isolation and containment protocols, disinfection and disposal protocols; (3) the protection needed when working in potentially contaminated environments (such as a clinical or research laboratories and non-clinical facilities); (4) appropriate waste management and decontamination protocols, shipping and transport of infectious materials, and safer mortuary practices; (5) occupational health medical surveillance protocols (such as incident exposure reporting, medical surveillance of potentially exposed individuals, reporting of health status changes and post-exposure protocols); (6) behavioral health resiliency (such as coping techniques for work related stress, protection from mental or physical exhaustion, promote psychosocial health and minimization of fear) and; (7) the need for and the objectives of training evaluation.
• Curricula must integrate the NIEHS WTP foundational performance topics into the overall training framework addressing risk-stratified awareness- and operations-level knowledge, skills and or exercises for all workers including, but not limited to: potentially infectious material; chemicals; safety risk management; exposure risk management; modes of disease transmission; engineering controls; administrative controls and safe work practices; PPE, including respiratory protection; decontamination and waste management; hazard and risk communication; compliance with guidelines, standards and regulations; occupational health-medical surveillance and post-exposure protocols; and emergency and incident response. Instruction should additionally include a train the trainer component that would permit the creation of a large cadre of trainers who will provide local/regional training to impacted populations. The NIEHS WTP strongly encourages developed curricula to include training and exercise drills to demonstrate ongoing technical proficiency and safety capacity. Locations for some exercises and drills in biosafety training will be targeted in consultation with DHHS, CDC and other state and local biosafety response organizations. The proposed training program will build substantial capacity for epidemic and pandemic preparedness and response for a broad spectrum of infectious disease conditions. The performance based objectives can be found on the NIEHS website: http://tools.niehs.nih.gov/wetp/index.cfm?id=2542
• Curricula must have outcomes that: (a) demonstrate increased training capacity to provide biosafety training that addresses worker safety and health protection concerns surrounding Ebola virus and other emerging infectious diseases and (b) demonstrate improved knowledge and skill for workers with potential exposure to contaminated materials or infected individuals.
• Curricula must integrate appropriate infection control and occupational worker safety recommendations from CDC, DHHS, ASPR, OSHA, and NIOSH into training materials based on the needs of the target population being trained. Recommended resources from federal partners can be found at t http://www.cdc.gov/vhf/Ebola/ , http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/current-treatment-centers.html, https://www.osha.gov/SLTC/ebola/index.html , http://www.cdc.gov/niosh/topics/Ebola/ , and http://www.hhs.gov/news/press/2015pres/07/20150701a.html.
  • Applicants from the state of California must integrate the Cal/OSHA Aerosol Transmissible Disease (ATD) standard as per Title 8 CCR; Section 5199 occupational standard guidelines to prevent worker illness from infectious diseases that can be transmitted by inhaling air that contains viruses, bacteria or other disease organisms. The Cal/OSHA ATD standard resource can be found on the California Department of Public Health website: http://www.cdph.ca.gov/programs/ohb/Pages/atdstd.aspex
  • Applicants outside of California may wish to integrate provisions of the Cal/OSHA ATD standard into their proposed training programs. The ATD standard may provide useful guidance for protecting workers who may be exposed to airborne pathogens; and integration of its safety provisions into a proposed program may be applicable whether delivered in California or elsewhere.
• Applicants must incorporate evaluation and performance measurement plans in an effort to continuously improve the safety training provided. The NIEHS WTP will work with applicants over the initial post-award period to develop or expand the evaluation and performance measurement strategy. In order to create uniformity between performance measurements, potential measures for the project period may include, but are not limited to, (i) immediate learning (pre-and-post) design used to evaluate what is learned immediately after training, compared to baseline knowledge prior to the training; (ii) measures of trainee satisfaction to evaluate relevance of training content, and if training topics were covered in an applicable and effective manner; (iii) use of newly learned material to determine if the training is transferred to a behavior (e.g., three to six months post-training), and, if so, measures to determine how much of the training content is being used to estimate ideal time gap between refresher courses; (iv) safety culture and safety climate measures to determine if issues within the work environment are impeding an individual’s transfer of learning to behavior or slowing a worker’s ability to complete a task on the job; (v) evaluation tools to measure what changes, quantitative or qualitative, occurred at a work site as a result of training and; (vi) methodologies to obtain practical site-specific feedback from end-user level workers.
• Applicants must demonstrate new or existing national, regional or multi-state geographical partnerships that can provide the essential training, tools and infrastructure needed to strengthen risk assessment and prevention mechanisms for enhanced biosafety in various occupational settings for workers at risk for increased exposure to infectious individuals or contaminated material. The NIEHS WTP encourages increased cooperation and collaborations, partnerships, affiliate engagement to build training coalitions and relationships with referral and treatment centers. These centers include ASPR and CDC frontline healthcare facilities, Ebola assessment hospitals, and Ebola treatment and coordination centers to collectively facilitate a sustained infectious disease biosafety response and avoid duplication of efforts or overlap in program development and delivery.

The immediate goal of this worker health and safety training initiative is educational in nature, designed to provide workers with relevant information on potential infectious disease exposures or outbreaks, such as EVD. It will integrate applicable infection control, safety and protection measures, build problem-solving skills, and kindle the confidence needed to use available resources and recommendations as tools. Partnerships or coalitions with a group of healthcare organizations, training facilities, public safety and public health partners that can join forces to enhance biosafety training are encouraged to facilitate sharing of resources, innovations and best practices. These acute goals carry the potential to empower communities and occupational settings with more knowledge, tools and resilience.

Long-term goals of the biosafety and infectious disease response model training programs should be to establish basic approaches to infection prevention and enhanced control practices, with an underpinning risk-management framework, that can be applied to a wide range of occupational settings and emerging infectious outbreaks. It should assure that workers become and remain active participants in determining and improving the health and safety conditions under which they work and that avenues are established for collaborative employer-employee relationships in creating safe workplaces. Worker safety and health training is action-oriented, and result-centered with goals and training objectives that focus on outcomes. Workers come to training with a great volume of experience, and are, in many ways, the richest resources of a training class. Appropriate methods for adult education should be used for learning, retention, and emphasize peer-sharing activities, such as problem-solving and simulation exercises, to tap the experience of the learner. After training, workers should be able to bring what they have learned in the classroom back to their jobs.

The NIEHS WTP has learned that successful examples of training partnerships involve the creation of clear mechanisms for assuring input and collaboration by labor, management, local government officials and other stakeholders, as well as a vision for integrating biosafety training into other workplace programs and initiatives.

It is clear that the context, engagement, technical approaches to safety and practice of health training in the infection control and biosafety capacity are undergoing a rapid transition. This is a pivotal period in which to explore windows of opportunity for change within infection control, biosafety, and biohazard training efforts for emerging infectious threats.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Janice B. Allen, PhD
Scientific Review Officer
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233; Mail drop K3-03
Telephone: 919-541-7556
Fax: 301-480-3705
Email: allen9@niehs.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 30 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Other Attachments: The application should include the following attachments:

Organizational Structure: Applicants should include a diagram of the organizational structure and describe the interaction and inclusion of subject matter and training experts. This diagram should demonstrate how the interactions between potential training partners and coalitions will achieve the goals of the curriculum as applicable to the target population. The diagram should be uploaded as a pdf file titled "Ebola Biosafety Training Organizational Structure".

Curricula Outlines: Describe in outline form the applicable standards, curricula components, modules, learning objectives and performance measures. The outline for each curriculum must not exceed two pages in length and should be included here only. Do not include copies of the actual curricula. The diagram should be uploaded as a pdf file titled "Curricula Outlines".

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. Allowable indirect costs for this program are limited to 8% of a modified indirect cost base which excludes amounts over the first $25,000 for each consortia agreement, equipment costs, and tuition and related trainee fees.

All instructions in the SF424 (R&R) Application Guide must be followed. Allowable indirect costs for this program are limited to 8% of a modified indirect cost base which excludes amounts over the first $25,000 for each consortia agreement, equipment costs, and tuition and related trainee fees.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: State the objectives and specific aims for worker health and biosafety training. Describe the proposed target populations for training including: size, types of work, and geographic locations. Project the number of workers anticipated to be trained.

Research Strategy: State the broad, long-term objectives and concisely and realistically describe what the proposed training is intended to accomplish. This section should include the following: Background and Significance; Administration, Staff, and Advisory Board; Target Populations; and Training Plan.

a. Background and Significance.

Briefly sketch the relevant background and the need for the proposed health and safety training. Give the rationale for the proposed training program. Applicants must strongly document the organization's past success in performance and effectiveness in planning, implementing, and operating worker health and safety training programs and employing adult education techniques. Give a summary of worker health and safety activities for the last five years for the major participating organizations in the proposed program. Emphasis should be placed on worker health and safety training and education experience including information on the workers trained and their jobs, type of worker health and safety training given, number of workers trained, training duration, outreach activities, and new advances in training. Applicants must state how their proposed training clearly addresses the important problem or a critical barrier to progress in training workers in this field.

b. Administration, Staff, and Advisory Board.

Describe the administrative structure of the proposed program, including interaction with partnered associations, and the distribution of responsibilities within it, including the means by which the PD/PI will obtain continuing advice with respect to the operation of the program.

Describe the extent to which participating faculty members have collaborated in the past. For individuals who are not Senior/Key Personnel, list technical support staff members and identify their roles in the program. Minimum position qualifications and position descriptions must be provided for proposed staff not yet hired. Be sure to include relevant publications and scholarly articles pertaining to public health, safety, and training.

Provide evidence of lines of responsibility and accountability and this evidence must be clearly delineated when two or more organizations are collaborating on an activity. Provide detailed plans for collaboration.

Describe the hazard communication protocols on how faculty or coalition members will notify the identified points of contact, other member facilities, local and state public health officials and community partners of any persons under investigation for Ebola or other infectious pathogens.

Describe the extent to which faculty or coalition members will participate in exercises (such as discussion tabletop, tracers) that detect gaps (such as planning, staffing) in the ability to provide adequate and effective training to target populations.

Evidence that the administrative/business official has experience or knowledge in the management of federal programs and will participate in program decisions should be contained in the application. Provide evidence of sufficient program staff with demonstrated training experience using appropriate adult education techniques to assure effective direct training, and quality assurance.

This must include:

• Describing the program's experience with adult education.
• For individuals who will not be Senior/Key Personnel, document the faculty members' relevant experience and training in appropriate adult education techniques in the area of worker health and safety, biosafety and infection control.
• Access to appropriate technical expertise including, but not limited to, infectious disease prevention, infection control, biosafety and hazmat training. It is intended that offsite instruction funded by the NIEHS assistance program will be supplemented with onsite training under the direct supervision of trained, experienced personnel at the time of initial job assignment. Provide details of an existing or convene a new external board of advisors that represents user populations, labor, industry, governmental agencies, academic institutions or professional associations with interest and expertise in worker health and safety training related to hazard recognition, risk management, infection control, hazard communication, occupational safety and biosafety practices.

Describe the role of the Advisory Board. Show plans for how they will be used to assure the quality of the training program including frequency of meetings and how they will advise the PD/PI. This should include a description of the expertise of the membership of the external board, detailed plans on when the board will meet, how the board will evaluate training activities, and what formal procedures the board will follow to provide advice to the PD/PI. The advice should include at a minimum incorporation of worker feedback mechanisms; review of course critiques and Board of Advisors evaluations and other appropriate evaluations and quality assurance procedures. New Advisory Board members should not be contacted before application or named in the application..

c. Target Population(s).

Describe methods and techniques to be used for identifying and accessing target specific worker population(s), whether organized or not, that may be potentially exposed to EVD or other infectious pathogens or biohazardous materials, to be trained. Describe the population(s) to be trained, including size of the target population(s), worker profiles, trades and job categories to be trained, potential occupational exposure scenarios, geographic locations of workers and the degree of health and safety training already received. Letters of support should demonstrate assurances of access to these populations for training and identify the target populations requiring training.

Describe the qualifications of prospective workers and the criteria and procedures by which workers will be selected. Describe outreach and recruitment plans. Describe the type and give the number of workers who have applied for worker health and safety training given by your organization over the last five years and the number of workers who have completed this training and the resulting benefit of the program to the workers and their employers.

Applications should include plans for reaching underserved and vulnerable workers in the proposed target populations especially those disadvantaged in education, language skills or limited in literacy or immunocompromised health (such as pregnant mothers).

d. Training Program.

Describe the proposed training program including the number of workers to be trained, type of training (such as awareness, operations, combination or TTT), durations of training and anticipated course content and training objectives. Document the program's achievement of the minimum criteria for worker health and safety training as related to biosafety and infectious disease response. Refer to Appendix E of 29 CFR 1910.120 (59 FR 43268, August 22, 1994), which references much of the NIEHS Minimum Criteria Worker Health and Safety Training for Hazardous Waste Operations and Emergency Response. This OSHA guidance is available at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9770.

Describe curricula to be used, distribution of course materials, and conduct of direct worker training.

Describe the extent of hands-on demonstration and instruction, which simulates hazard recognition, risk perception, infection control, standardized practices or techniques for infection prevention and biosafety training. Describe extent of participation in exercises (such as discussion, tabletop, drills) and describe frequency of such exercises. Describe the extent of just-in-time training, if applicable. Describe methods for employing adult education techniques and approaches for training and evaluating instructors. Advanced training technologies, such as e-learning, when used, should be part of a blended learning approach that combines these new technologies with hands-on, small group and other learning activities. Describe how both initial and appropriate refresher training will be covered. Describe if developed training curricula will be used or accessible on multiple platforms (tablet, computer, phone, and so forth). The plan must include involvement of appropriate health and safety disciplines. A responsive design should be used when applicable.

The plan must provide evidence of methods proposed for evaluating appropriateness, quality, impact and effectiveness of worker health and safety training. The plan must include information on the training of instructors, including worker trainers, and on-going trainer development and support activities. Indicate how the proposed worker health and safety training will be integrated with other specialized training already provided to the proposed target worker population. Specify and highlight the integration of new program initiatives as identified in the FOA with your proposed training plan.

Plans for reaching underserved and vulnerable worker populations especially those disadvantaged in education, culture, or language or limited in literacy and access to training or immunocompromised health (such as training for pregnant moms) should be included. Provide evidence of arrangements to assure the inclusion of institutions and organizations, which have historical involvement and expertise in responding to occupational health disparities. For example, does your plan include a community outreach and involvement component which can augment the delivery of high quality training in order to promote hazard reduction, infectious disease preparedness in the community, and community awareness of safety, infection control and exposure prevention?

Quality Control and Evaluation Plan: Describe how each worker s progress will be measured and how the worker’s performance will be monitored and evaluated. Describe methods and procedures for evaluating appropriateness, quality and effectiveness of worker health and safety training proposed. Evaluation protocols should quantitatively describe a process for assessing instructor effectiveness, trainee retention of knowledge and hands-on skills, and the positive impacts of training activities on work practices and overall worker protection from on-the-job hazards. Describe how your training and evaluation can be utilized to show reduced exposure or infection rates and communicate preparedness in the workplace setting. NIEHS WTP will work with applicants over the initial post-award period to develop the evaluation and performance measurement strategy. In order to create uniformity between performance measurements, potential measures for the project period may include, but are not limited to, (i) immediate learning (pre-and-post) design used to evaluate what is learned immediately prior to and after training; (ii) measures of satisfaction to evaluate relevance of training content, and if it was covered effectively; (iii) use of newly learned material to determine if the training is transferred to a behavior (e.g., three to six months post-training), if so, then measures to determine how much is being used to estimate time gap between refresher courses; (iv) safety culture and safety climate measures to ascertain issues within the work environment are not impeding an individual’s transfer of learning to behavior or slows worker s ability to complete a task on the job; (v) evaluation tools to measure what changes, quantitative or qualitative, occurred at a work site as a result of training and; (vi) methodologies to obtain practical site-specific feedback from end-user level workers.

Letters of Support: Letters of support should demonstrate collaborative commitment with partnerships and support for the biosafety training program. They should demonstrate assurances of access to proposed populations for training and identify the target populations requiring training.

Resource Sharing Plan: Not Applicable

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness, responsiveness and compliance with application instructions by the National Institute of Environmental Health Sciences. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

A briefing for interested applicants will be held at NIEHS in Research Triangle Park (RTP), NC on Friday September 18, 2015 from 1:00 3:00pm EST, Keystone Conference Room 1003-AB at 530 Davis Drive, Research Triangle Park, NC 27709. NIEHS Staff will explain the purpose of the Program, provide instructions about the application process and answer questions. A summary of responses from the briefing will be available upon request from NIEHS wetp@niehs.nih.gov and may be posted on an FAQ page at a later date. The briefing will be webcast live and a registration page will be available closer to the event. The webcast can be found at http://www.niehs.nih.gov/news/webcasts/index.cfm.

Visiting NIEHS and Directions: You must submit your contact information in advance to Mr. Clifton Baldwin at Baldwin@niehs.nih.gov or via phone (919) 541-0303 to RSVP for the informational meeting. All attendees must contact Mr. Baldwin by Tuesday September 15, 2015 to attend in person only.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Does the project address an important problem or a critical barrier to progress in training workers? If the aims of the training program are achieved, how will training be improved? How will successful completion of the aims change the concepts, methods, technologies, services associated with training that drive this field?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: Does the PD/PI strongly demonstrate the capacity for providing leadership and assuring productivity of appropriate worker health and safety training and education programs and for overall management of the training programs including quality assurance and program evaluation? Is there sufficient evidence of an applicant’s organizational structure or consortium, if applicable, that provides adequate knowledge and oversight of resources and administrative management of the program? Do the PD/PI and the proposed staff have the ability to implement and manage complex training programs? Does the proposed staff have the demonstrated training experience using appropriate adult education techniques to assure effective direct training, and quality assurance in the area of worker health and safety training?

Does the applicant or proposed training team demonstrate appropriate technical expertise as related to worker training for, but not limited to, understanding and providing instruction on established guidance’s related to pathogenicity, transmission routes for infectious pathogens; infection prevention concepts and industry best practices; identifying biosafety needs inside and outside of healthcare settings and; identifying hazard vulnerabilities as related to the proposed target populations occupational health and safety standards?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA: Is there evidence of inclusion of worker training initiatives and innovations?

Does the application demonstrate the ability to empower workers through awareness and operational or TTT training curriculum? Does the application demonstrate the ability for long-term sustainability of baseline risk assessment and infection control practices within the workplace setting? Does the application promote unique partnerships among existing or current associations as related to workplace health and safety and occupational infection control? Does the application promote unique awareness and or operational level training curriculum in a way that is stimulating? Does the application promote annual hands-on training drills and exercises to demonstrate ongoing technical proficiency and safety capacity? Does the application demonstrate all-hazards preparedness and whole community approaches to achieve enhanced biosafety practices? Does the application demonstrate a clear potential for return on investment (e.g., reduced exposure or infection rates) and communicate preparedness accomplishments to help ensure sustainability of the NIEHS WTP cooperative agreements?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Are the methods and techniques to be used for identifying, describing, and accessing target specific worker populations for worker health and safety training and anticipated impact of the proposed program adequate? Does the applicant provide detailed program plans for adapting existing curricula, training of instructors, distributing course materials, directing worker training, and conducting program evaluations? Are principles of adult education used, with combinations of classroom instruction and hands on demonstration and instruction appropriate to simulate worker site activities and conditions? Are there plans for independently continuing the program; for the generation of program income, if applicable; and for assuring the long-term viability of the program? Is the training plan adequate for reaching underserved worker populations especially those disadvantaged in education, culture, or language or limited in literacy and access to training? Has the organization or consortium demonstrated effectiveness in planning, implementing and operating appropriate worker health and safety training and education programs? Are they able to immediately initiate direct worker health and safety training, program evaluation, and related support activities?

Does the applicant describe partnerships or formal arrangements with local, multi-state geographical or national training partners, healthcare or public health coalitions to provide biosafety awareness, operational or TTT training? Does the applicant describe partnerships or formal arrangements for development and delivery of training with local responder groups at potentially impacted at-risk facilities and local, state and federal entities with infectious disease response capacity? Does the application describe aligned preparedness training capabilities with coordinated and integrated system planning? Does the application clearly delineate level of training, audience, delivery method, duration and evaluation measures to assess impact? Does the application justify inclusion or exclusion of target population for awareness and or operational level training?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA: Are the facilities and equipment appropriate to support the described worker health and safety training and education activities, including hands on instruction? Is there evidence that the operation of training facilities assures the protection of prospective trainees during program delivery? Are there appropriate policies and procedures for assuring fitness for training and medical clearance?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

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).

Not Applicable

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Environmental Health Sciences in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other DHHS, PHS, and NIH grant administration policies.

The funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• The PD/PI of each awardee has primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies and training activities. It is the responsibility of each awardee to develop the details of the training plan, which will be required to describe the technical approaches, target population access and recruitment, curricula modification, training methodology, and program evaluation procedures.
• NIEHS will promote national coordination among awardees by convening one program workshop each year and by conducting annual summary reviews of each awardee’s program evaluation for use in future training activities.
• NIEHS will promote the need to facilitate the ongoing exchange of relevant scientific and technical information between awardees and the Institute; to promote effective exchange of information, NIEHS will convene at least one topical technical workshop on an annual basis.
• NIEHS will promote mutual interest of awardees and the Institute in developing peer-reviewed, high quality model training programs for hazardous waste workers and emergency responders; the process for developing model programs will include development of consistent instructor and trainee evaluations, effective teaching techniques and pedagogical approaches, and a consensus between awardees and the Institute regarding adequate minimum criteria for effective worker training programs.
• Before use, awardees must submit draft copies of training manuals, instructor guides, course curricula and other materials developed for use in training activities supported by NIEHS to the NIEHS Program Coordinator to receive technical comments and suggestions regarding the adequacy, technical accuracy and suitability of materials to be used for worker safety and health training. Final copies of all materials developed with support from NIEHS will be transmitted in approved electronic format by the awardees to the National Clearinghouse for Worker Safety and Health Training for Hazardous Materials, Waste Operations and Emergency Response and made available to the general public, subject to any specific legal caveats on use or copyright protection.
• Each awardee is required to demonstrate an existing or convene a new Board of Advisors representing user populations, labor, industry, governmental agencies, academic institutions or professional associations with interest and expertise in worker health and safety training related to biosafety and infectious disease response. The Board of Advisors must meet annually to evaluate training activities and provide advice to the PD/PI.
• Each awardee is required to have one individual assigned the responsibility for information technology transfer and dissemination as the point of contact for the NIEHS Program Coordinator. This person would ensure the effective communication and transfer of important training and administrative information to NIEHS and other appropriate audiences, including trainee tracking activities, computation and submittal of training data, coordination of special meetings/conferences, submission of curricula, and other training activities conducted by the program.
• Each awardee will retain custody of and primary rights to the data and the curricula materials developed under these awards, subject to appropriate Government rights of access consistent with current DHHS and NIH policies. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The substantial programmatic involvement by NIEHS staff has been an important factor in the continuing success of the training program. A Project Coordinator designated by the Director, NIEHS for the Worker Training Program will provide substantial programmatic involvement and facilitate with administration and coordination of cooperative agreements under this program. NIEHS Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The role of the NIEHS Project Coordinator will be to facilitate, not to direct, the development of a high quality national worker training curriculum and resources. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, DHHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other DHHS, PHS, and NIH Grant Administration policy statements.

The NIEHS Project Coordinator will coordinate activities of mutual interest and benefit to awardees and the Institute. The primary objective of the Worker Training Program will be to stimulate collaborative work between NIEHS and the awardees in the creation of model worker safety and health training programs. Substantial programmatic involvement by the NIEHS Project Coordinator will assure that there is not duplication of efforts or overlap in worker safety and health training delivery and program development by the awardees.

• In order to provide consistent use and delivery of existing curricula for high- quality worker safety and health training, the NIEHS Project Coordinator will ensure that there will be close coordination among awardees, other state and federal governmental agencies, and other training providers. Such program coordination between NIEHS and the awardees will make maximum use of worker safety and health training materials and curricula that have already been developed, evaluated, and used. Training materials developed by the awardees will be submitted for review by the NIEHS Project Coordinator for consistency, appropriateness and technical accuracy before the initiation of worker safety and health training activities.
• The NIEHS Project Coordinator will convene a working meeting at least once annually to review progress, share information, and discuss technical issues and to coordinate training activities. Additional coordination meetings maybe held via teleconference or other communication venue to facilitate coordination and direction. NIEHS will extend invitations to subject matter and training experts from applicable scientific disciplines to discuss and elicit challenges, limitations, gaps, and best practices as related to biosafety training and infectious disease response.
• The NIEHS Project Coordinator will provide ongoing technical assistance to the awardees through arrangement of technical workshops related to the substantive technical issues that affect the program. Technical workshops will bring together program directors from each awardee with the relevant technical experts from a number of scientific fields involved in hazardous waste, occupational health, environmental health sciences, and adult education. Examination of training technologies and technical issues which are specific to the program will be developed and coordinated through technical workshops, which will be held at least once per fiscal year.
• To assure that training programs developed with assistance from NIEHS will comply with all applicable federal safety and health regulations, the NIEHS Project Coordinator will assist the awardees through continual involvement with other federal regulatory agencies. Operational monitoring by the NIEHS Project Coordinator will assist the awardees in complying with general federal statutory requirements regulating worker safety and health training activities.
• The NIEHS Project Coordinator will coordinate overall program evaluations to show the impact of the training on improving work practices, reducing work related injury, exposure and illness and to document the increased understanding of relevant biosafety health sciences by frontline workers in addition to those who may be potentially exposed to biohazardous or infectious material or pathogens. While each awardee must have its own evaluation program, the NIEHS Project Coordinator will work with applicants in the initial post-award period to develop the evaluation and performance measurement strategy and strive to assess the overall effectiveness of the training programs supported under the cooperative agreements in terms of the nation's needs and in relation to the target populations identified by Congress in SARA Section 126 and related statutes which are referenced above.
• NIEHS maintains a National Clearinghouse for Worker Safety and Health Training for Hazardous Materials, Waste Operations and Emergency Response to assist awardees by providing information and technical support services to the PD/PIs of NIEHS funded hazardous materials, waste operations, and emergency response worker training programs. The Clearinghouse will also function as a national resource for the dissemination to the general public of program related information and curricular materials that have been developed by the awardees.
• There is a need to have a timely and appropriate response to the new role of the NIEHS WTP and it awardees in the National Response Framework (NRF). The DHHS, which includes the NIH and the NIEHS, is a signatory to the NRF. The NIEHS WTP has been activated to develop health and safety training for Ebola. In the event of an Ebola virus or other infectious disease outbreak, NIEHS WTP may be activated to do other roles as assigned. Upon the activation of the NRF, NIEHS may be activated through the OSHA under the NRF's Worker Safety Health Annex to provide:
  • Training technical assistance such as instructional staff, curriculum development experts, subject-matter experts, and professional staff.
  • Safety training to worker target populations with respect to the nature and location of the incident and the particular hazards.
  • Assistance and support in the development and delivery of site-specific health and safety training through appropriately qualified WETP awardee instructional staff.
  • Assistance such as respirator fit-testing and distribution of personal protective equipment.
• Training materials for Infection Control and Biosafety are made available to the general public, subject to any specific legal caveats on use or copyright protection.
• An NIEHS Program Official will be responsible for normal program stewardship of the award.

Areas of Joint Responsibility include:

None. All of the responsibilities have been described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report using the RPPR are posted at http://grants.nih.gov/grants/policy/myf.htm.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Sharon D. Beard, MS
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1863
Email: beard1@niehs.nih.gov

Joseph T. Hughes, Jr., MPH
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0217
Email: hughes3@niehs.nih.gov

James Remington, RN
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0035
Email: remingtonj@niehs.nih.gov

Demia S. Wright, MPH
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-361-4638
Email: demia.wright@nih.gov

Janice B. Allen, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7556
Email: Allen9@niehs.nih.gov

Alfonso Latoni, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7571
Email: Latonia@niehs.nih.gov

Pamela B. Clark
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7629
Email: evans3@niehs.nih.gov

George Tucker, MBA, CGMS
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2749
Email: tuckerg@niehs.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 126(g) and the Consolidated and Further Continuing Appropriations Act 2015.