Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

Centers for Disease Control and Prevention (CDC)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this funding opportunity announcement (FOA) might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.

Components of Participating Organizations

National Institute for Occupational Safety and Health (NIOSH)

Funding Opportunity Title

State Occupational Health and Safety Surveillance Program (U60)

Activity Code

U60 Cooperative Agreement

Announcement Type

Reissue of PAR-09-184

Related Notices
  • September 25, 2020 - This PA has been reissued as PAR-20-312.
  • August 19, 2016 - Additional Factor for Consideration in Making Funding Decisions for PAR-15-303. See Notice NOT-OH-16-023.
  • August 15, 2016 - Closing PAR-14-275. See Notice NOT-OH-16-021.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
  • July 9, 2015 - Clarifications and Updates for PAR-14-275. See Notice NOT-OH-15-007.
  • April 3, 2015 - Notice of Clarification and Update for PAR-14-275. See Notice NOT-OH-15-004.
  • July 30, 2014 - Notice of Clarification for Expanded Program Proposal Budget and Number of Sub Projects Allowed. See Notice NOT-OH-14-011.
Funding Opportunity Announcement (FOA) Number

PAR-14-275

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.262

Funding Opportunity Purpose

Occupational health and safety (OH) surveillance is the ascertainment and tracking of work-related injuries, illnesses, hazards, or exposures. OH surveillance includes population/group- and case-based approaches and activities. Occupational surveillance data are used to identify state priorities and guide efforts to improve and protect worker safety and health; monitor statistical and other trends and progress over time; and to develop prevention intervention recommendations.

Key Dates
Posted Date

July 3, 2014

Letter of Intent Due Date(s)

August 15, 2014, August 15, 2015, August 15, 2016 by 5:00 PM U.S. Eastern Time.

Application Due Date(s)

September 15, 2014, September 15, 2015, and September 15, 2016.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November-December 2014; November-December 2015; and November-December 2016

Advisory Council Review

January-February 2015, January-February 2016, and January-February 2017

Earliest Start Date

July 1, 2015

Expiration Date

New Date August 15, 2016 per issuance of NOT-OH-16-021. (Original Expiration Date: September 16, 2016)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Note: For this PAPER APPLICATION, the Research Strategy component of the Research Plan for a Fundamental and Fundamental-Plus Program Application as well as for each project (i.e., OHI or Indictors; priority focus area or PFA) of an Expanded Program Application is limited to 12 pages. A separate page for Aims for each subproject is acceptable. Applications that do not comply with these instructions may be delayed or not accepted for review.

CDC NIOSH has designated applications for this FOA as public health research (CDC Policy: CDC-SA-2010-02, July 29, 2010). See Section IV., number 11. Therefore, compliance with human subjects research protections under 45 CFR Part 46 will apply.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and NIH’s Applying Electronically website for more information.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background

Every year, millions of the 135 million workers in the U.S. are injured on the job or become ill as a result of exposure to health hazards at work. In 2010, more than 4,500 U.S. workers died from occupational injuries. Although difficult to enumerate, annually about 49,000 deaths are attributed to work-related illnesses (NIOSH, 2013). Work-related injuries and illnesses result in substantial human and economic costs for workers and employers and for society at large; it has been estimated that the direct and indirect costs of work-related injuries and illnesses exceed $170 billion annually (CSTE, 2013). In 2009, employers spent $74 billion on workers' compensation insurance (NIOSH, 2013).

Work-related injuries and illnesses can be prevented, and successful approaches to making workplaces safer and healthier begin with having the data necessary to understand the problem. As part of its mission to prevent injuries, illness, and caused by hazards in the workplace, the NIOSH has established surveillance programs intended to assess the extent and severity of workplace injury and illness, to identify workers and occupations at greatest risk, to develop research and prevention priorities, and to measure the effectiveness of prevention activities. States have a central role in public health surveillance because they are uniquely positioned to utilize state-specific data sources and/or agreements for occupational health (OH) surveillance, and integrate surveillance with intervention and prevention activities as well as program evaluation.

Occupational safety and health surveillance presents numerous methodological and program-development challenges especially at the state level. Research is needed to evaluate existing surveillance systems and approaches. New approaches to capture the experience of special populations and/or factors (e.g., economic, legal) of workers who participate in nontraditional work arrangements is of interest. The use of nontraditional data sources and data linkages may be helpful for these surveillance efforts, but not fully understood and characterized.

The NIOSH surveillance research program acknowledges and values that states have a vital role to play in the surveillance of occupational injuries, illnesses, and hazards. In 2010, the Institute increased funding to support 23 state OH surveillance programs 2010-2015. The research portfolio consists of 14 Fundamental Programs and 9 Expanded Programs including 9 states receiving a new award. The portfolio includes 49 projects addressing work related morbidity and mortality, exposure reduction, or special population of interest topics. State OH surveillance systems and activities provide a vital foundation for several federal surveillance systems and augment other federal surveillance systems. A long-range NIOSH vision of a comprehensive surveillance research program would include all 50 States with core capacity or infrastructure to conduct surveillance of occupational injuries, diseases, and hazards that will contribute to State and local prevention efforts, as well as to national data concerning magnitude, trend, and distribution for OH morbidity and mortality.

For over 30 years, NIOSH has provided financial and technical assistance to state health and labor agencies to develop or expand OH surveillance program capacity and technical infrastructure. Examples include new data collection approaches, training and continuing education, acquisition of computers and software, informatics or methods improvements, contracting for specialized statistical expertise, and program webpage and resources. With recent years funding, the breadth and depth of 23 state OH surveillance program accomplishments and major outputs are evident in the Annual Report. In recent years, NIOSH and states have increasingly collaborated in joint publications, presentations and workshops, webinars, and for data quality check for OH Indicators (i.e., measures of work related health, diseases, injury or factors associated with health) before publication. The Indicators are intended to be used in conjunction with other guidelines for state OH surveillance of occupational injuries and illnesses (NIOSH 1995, CSTE 2013) and to be used as a complement to overall state and national goals to improve the health of the population (DHHS 2000). In addition, NIOSH works with other CDC programs to incorporate occupational information into CDC surveillance activities e.g., Health People 2020, NCIPC injury surveillance.

Purpose

The primary purpose of the PAR is to provide financial and technical support to states for the development or expansion of an occupational safety and health (OSH) surveillance program including data acquisition-analysis-dissemination of findings (up to 20 consensus Indicators); outreach and partnership development; prevention intervention recommendation; and state-proposed surveillance priority research projects. OH surveillance is the ascertainment and tracking of occupational injuries, illnesses, deaths, hazards, or exposures to support and enhance prevention of these outcomes and conditions. OH surveillance includes worker population/group- and case-based approaches and activities. Occupational surveillance data are used to identify state priorities and guide efforts to improve and protect worker safety and health; monitor statistical and other trends and progress over time; and develop prevention intervention strategies and recommendations. Partnerships are integral to the NIOSH OH Surveillance Program. Partners add expertise or specialized experience to the research team and have access to select data sources which benefits the collection, analysis, interpretation, and communication of results.

Healthy People 2020 and other National strategic priorities: Occupational safety and health related Healthy People 2020 objectives are primarily addressed through the National Occupational Research Agenda (NORA). NORA was established by the Centers for Disease Control and Prevention (CDC) NIOSH and its partners to stimulate research and improve workplace practices. Now in its second decade (2006 2016), NORA focuses on occupational safety and health in 10 sectors available at www.healthypeople.gov. Ten occupational health and safety goals have been identified for prioritizing and guiding research and public health practice. In addition, NIOSH is interested in monitoring changes in the workforce, workplace, work organization factors, and emerging issues in OSH. For example, in recent years states have served in meaningful investigational, educational and/or outreach roles for work-related non communicable disease clusters or events.

Public Health Impact: NIOSH expects this FOA to have meaningful impact on: 1) OH surveillance and epidemiology and public health research, 2) dissemination and use of findings for the incidence and/or prevalence of occupational injuries, illnesses, deaths, and exposures; 3) identification of surveillance trends, emerging issues, high-risk occupations, industries, and worker populations; 4) audience-specific educational materials, outreach and other resources for optimizing their uptake or adoption or adaptation for protecting workers; and 5) development and dissemination of public health recommendations for workplace interventions. These goals foster the integration of occupational public health into broader public health goals and objectives.

Relevant work: NIOSH is an active partner in OH surveillance and epidemiology in terms of developing consensus goals , programs and scientific coordination, sharing OSH data and research statistics, and for communicating national and regional major accomplishments and impact. NIOSH has also co published surveillance and epidemiology articles for OH exposures and illnesses in cooperation with state programs. NIOSH collaborates and coordinates with the CSTE for occupational public health including strategic, scientific, technical and programmatic components. More recently, NIOSH established a virtual workers compensation data program/office to explore opportunities for use of this type of data to improve worker protection.

Approach

Research Objectives and Priorities:

The goal of the program will be to 1) collect and analyze data, 2) identify work related disease, injury and exposure trends, 3) set program priorities, and 4) develop prevention and outreach throughout the state. In addition, supported programs are expected to be resourceful and proactive in assessment, policy/rule/standard development, and strategic and organizational activities to foster and ensure a competent OSH program. To learn more, interested persons are encouraged to review the 2008 CSTE publication Guidelines for Minimum and Comprehensive State-Based Public Health Activities in Occupational Safety and Health at http://www.cste.org/?OHPublications.

For this PAR, three types of program applications, with increasing degree of program capability and sophistication and commensurate funding, will be acceptable. They are: 1) Fundamental Program, 2) Fundamental-Plus Program, and 3) Expanded Program. Conceptually, the Fundamental-Plus Program requires a moderate increase in programmatic and organizational capability and commitment for OSH surveillance compared to the Fundamental Program. Alternatively stated, the Fundamental-Plus Program is not a mid-point program between the Fundamental and Expanded Programs.

All three programs will compile, analyze, and interpret surveillance data for a minimum of 15 of the 20 occupational health indicators (OHIs) using existing data sources (http://www.cste.org). An applicant can only apply for one type of program below and must identify that program in the application. All three types of programs will calculate OHI/Indicator 13/Elevated Blood Lead Levels among Adults, as part of the minimum requirements. If applicants propose to conduct follow-back site investigations or intervention activities, they may receive additional funds based on quantitative criteria.

Regarding Indicator 13/Elevated Blood Lead Levels among Adults, in the application it should acknowledge the existence or non-existence of a state/tribe/territory law requiring reporting of elevated (adult) BLL to a public health department or equivalent, the reporting limit for BLL and whether the law requires statewide electronic data notification (e.g., public and private laboratory) or reporting to a public health department.

Type of Program

1. Fundamental Program

A Fundamental Program will include the activities, capabilities and function as follows:

  • Collect, analyze, interpret a minimum 15 of the 20 occupational health indicators.
  • Create partnerships with local and state public health agencies as well as other agencies to obtain input on the priority OSH concerns for their state and to disseminate surveillance information. Establish and maintain contacts with appropriate organizations, groups, and individuals who may provide or use surveillance data.
  • Establish and maintain an advisory committee, or other process (es) to obtain stakeholder input and to identify relevant state-specific issues and priorities for state surveillance.
  • Address the utility and limitations (e.g., lack of reliable denominators, incomplete data, and lack of uniformity or consistency) of existing databases for collecting and analyzing occupational illnesses and injuries.
  • Develop and/or explore use of new data sources, as appropriate.
  • Conduct follow-up prevention activities such as investigations, interventions or policy/rule changes for high priority issues in their state.
  • Consult, as needed, with NIOSH scientists for questions and problems that arise, e.g., data limitations, statistical questions and emerging issues.
  • Participate actively in NIOSH- and recipient-convened meetings and conference calls of with grantees to share experiences, lessons learned, and materials created, and learn about emerging issues or hazards.
  • Produce and disseminate, at a minimum annually, data on the magnitude of occupational injuries and illnesses identified from existing data sources. Surveillance reports should include the following whenever possible: trend, emerging issues, high-risk occupations, industries, worker populations, and Industry Sector information that can be used to inform priority setting for the state and support National Occupational Research Agenda (NORA) Sector Programs.
  • Prepare an Annual Report of major outputs and impact of their surveillance program appropriate for public release. This report is required in addition to the non-competing continuation application (PHS 2590).
  • Publish results/findings in reports, peer-reviewed journals, trade association journals and magazines, and NIOSH/CDC Alerts or MMWR or Workplace Solutions, and by posting them on websites, including the State-based Occupational Health Clearinghouse. The type of publication should be selected to achieve the best distribution to the targeted audience and the greatest impact.

NIOSH intends to conduct a request for state OHI/Indicators annually in order to perform basic quality checks, and then transmit these data to CSTE for publication on the CSTE website. States are fully responsible for Indicators accuracy, quality and completeness.

Instruction for Budgeting for ALL Types of Program: For applicants proposing adult lead poisoning outreach and intervention activities (as described in the Fundamental, Fundamental-Plus or OHI/Indicators area), for yearly budgeting consideration and using year 2011 BLL data, states with a case load of >1,000 cases of adult BLLs =10 g/dL should budget for an additional $20,000 total; states with a case load of between 300-1000 cases of adult BLLs =10 g/dL should budget for an additional $10,000 total; and states with a case load of fewer than 300 cases of adult BLLs =10 g/dL should budget for an additional $5,000 total. A case of an adult with a BLL =10 g/dL is a person, 16 years and older, reported in a given year. This case may have multiple blood lead laboratory reports, but is counted as one case in that given year.

2. Fundamental-Plus Program

Candidate institutions for this type of program application are the 14 NIOSH-funded Fundamental and perchance 9 Expanded Program recipients.

The intent of the Fundamental-Plus Program is to provide an applicant with demonstrated capacity in OH surveillance including the development of prevention recommendations the opportunity to transition or increase capacity beyond that of an Fundamental Program, in support of the Guidelines for minimum and comprehensive state-based public health activities in occupational safety and health http://www.cdc.gov/niosh/docs/2008-148. An applicant for the Fundamental-Plus Program would include a focused, data-driven in-depth investigation of a particular exposure or condition as well as intervention activities that have impact on significant occupational safety and health topics in the state.

A Fundamental-Plus Program will include the activities, capabilities, and requirements of the Fundamental Program listed above, and both of the following:

State-identified priority or topic for conducting in-depth and/or follow-back investigation activities arising from findings of surveillance data/Indicators and a description of evidence-based significance and approach. Anticipated major outputs or products, by year, should be described.

State-identified policy or standard, intervention and/or external collaborative-enhancing activities arising from findings of surveillance data/Indicators and a description of evidence-based significance and approach. Anticipated major outputs or products, by year, for either investigation or intervention major activity should be described.

3. Expanded Program

An Expanded Program award is intended for states with longer-tenure or demonstrated experience in conducting OSH surveillance or those states with a robust OSH surveillance program and history of successes. The ultimate goal is comprehensive occupational health activities for preventing and reducing occupational injuries, disease, and exposures within the state and integrating OSH into broader public health agendas. An Expanded Program will include the activities and capabilities of the Fundamental Program listed above, and will build upon that Program to include targeted surveillance efforts on selected Priority Focus Areas/Topics (PFA). Such focused surveillance is required to understand the circumstances and contributors for an OH condition, exposure, or working populations of special interest so as to formulate and develop effective preventive measures. PFAs should address significant and compelling worker health and safety problems, and consider opportunities amenable to guide evidence-based intervention efforts to improve and monitor the progress of worker health and safety.

It is expected that Expanded Programs will compile, analyze and disseminate the results of data that are not currently available from national OSH surveillance systems. The objectives are to identify work environments that place workers at high risk for occupational disease or injury; identify potential risk factors; formulate and disseminate prevention strategies to those who can intervene in the workplace and; and fill data and/or knowledge gaps in national occupational safety and health surveillance systems. An Expanded Program application must also demonstrate a high potential for implementing a balanced program that includes occupational surveillance and epidemiology, field observation of- and data collection for the state priority conditions, and the development and dissemination of prevention strategies.

An Expanded Program will include the activities, capabilities, and function of the Fundamental Program listed above, and the following:

  • Develop an OH surveillance system to enable the identification of the occupational diseases, injuries, exposures related to the PFA identified by the state.
  • Conduct in-depth analyses of OH conditions, exposures or worker populations using existing (state) data sets, and/or new case findings and case follow-up. These results may be used by states to develop, recommend or implement, and evaluate intervention and prevention activities.
  • Establish or maintain policies and procedures for performing case follow-back of selected condition(s) or working populations of special interest, including methods for identifying associated worksites.
  • Establish and implement descriptive plans for targeted activities suggested by surveillance data and information. This may include promoting the use of data by others for intervention or establishing working relationships with other agencies for case or worksite referral.
  • Collaborate with NIOSH and other participating states on projects related to a specific priority condition, population or exposure.
  • Participate actively in CDC/NIOSH- and recipient-convened meetings or conference calls of grantees for specific conditions or exposures such as FACE, occupational respiratory disease and pesticides illnesses.
  • Publish results/findings in reports, peer-reviewed journals, trade association journals and magazines, and NIOSH/CDC Alerts or MMWR or Workplace Solutions, and by posting them on websites, including the State-based Occupational Health Clearinghouse. The type of publication should be selected to achieve the best distribution to the targeted audience and the greatest impact.
  • Establish an evaluation plan to assess effectiveness and impact of 1) focused surveillance activity, including case follow-up and intervention and/or prevention procedures and outcomes, and 2) overall program.

PFAs involve more in-depth data collection and analysis, case-finding and/or case follow-up as well as assembling of new data sets. The effectiveness of an Expanded Program in meeting these goals may be facilitated, for example, through collaboration with other states and with NIOSH and through regional surveillance efforts with neighboring states. A PFA may include outcomes, exposures or worker populations that are inadequately addressed by existing national or state OSH surveillance systems (e.g., musculoskeletal disorders, immigrant workers contingent or temporary workers, evaluation of occupational health outcomes through use of electronic health records) or those historically supported by NIOSH (e.g., fatalities through state-based FACE programs, pesticides illnesses and injury, and occupational respiratory disease. PFAs may also include innovative ideas or solutions to occupational health issues. Applicants must demonstrate commitment by assigning sufficient FTEs dedicated to work on the program(s). Applicants may propose as many PFAs as desired including state-proposed de novo projects provided the total funding request is in compliance with the annual ceiling of funding for an Expanded Program (see Special Considerations section).

A research plan must be provided for each proposed project/priority focus area (PFA).

State Initiated/Priority Topic: up to 10 states
NIOSH is interested in sponsoring priority topics/areas that are a major OH concern in the state or other significant OSH initiative.

Exposures:
Pesticides: up to 5 states

Health Outcomes:
Fatality assessment, control & evaluation (FACE): up to 9 states
Occupational Respiratory Disease: up to 7 states
Musculoskeletal disorders (MSD): up to 5 states

Target worker population:
The PAR addresses worker populations in the U.S. including youth, older age workers, immigrant workers, temporary workers, and workers who work in high-risk industries or occupations. Much of the research is accomplished using secondary, de-identified data; however, some programs conduct active case finding or follow-back research methods for select projects i.e., Expanded Program.

Collaboration and Partnerships
An applicant should describe meaningful, productive collaborations and partnerships in the conduct of surveillance. Examples include state and other agency data holders, state-county-city agencies or departments, non-governmental organization (NGO), workers or worker protection organizations, state and federal OSHA, and other agencies and organizations addressing worker protections and health promotion. Advisory members to the surveillance program may serve as important intermediaries for these entities.

Evaluation & Performance
An applicant organization is expected to perform basic or targeted program evaluation including measurement commensurate with level of NIOSH funding including appropriate accessible data sources and other administrative or feasibility considerations. The overall goal is for continuous quality improvement of the grant funded program. Grantees are expected to use findings to recommend and report how evaluation/performance improvement leads to OH surveillance program or organizational capacity building. This process may involve the participation of a new or existing Advisory body for public health epidemiology and surveillance. Hence, the application should describe whether and how the program interfaces with a higher-level Advisory group. An applicant is encouraged to consider the CDC Evaluation Framework. Compliance with this component is expected for the prime institution and flow down sub grantee. In accordance with an approved plan, summary qualitative and quantitative measures should be tracked and reported in the grant progress report and Closeout Report. When appropriate, an OH surveillance sub evaluation plan may be embodied in a comprehensive state public health/labor evaluation plan provided that OH surveillance evaluation/performance data and information can be captured, queried, and reported to NIOSH on an annual basis.

Translation Plan
To maximize the translation of OH surveillance findings, an applicant is strongly urged to utilize trans-disciplinary strategies and approaches and conduct audience-specific translation and dissemination activities. Examples include public health impact and economic burden of work related illnesses and mortality, how and why surveillance data informs policy/legislation, advance and inform best practices in surveillance and epidemiology, contribution to workplace solutions (i.e., research to practice) or total worker health protection and promotion e.g., interaction of occupational and personal risk factors for worker health and safety.

Grantee Meetings
An objective is to increase the dissemination and use of state surveillance information for decision-making regarding research and intervention activities (see Intermediate goal 2.2 at http://www.cdc.gov/niosh/programs/surv/goals.html. As such, recipients of this cooperative agreement are expected to set aside funds to attend and actively participate in relevant CDC/NIOSH-convened meetings.

Recipients are expected to attend, and include funds in their annual budgets for two representatives, including the PI or designee, to attend two NIOSH-convened grantee (Partner) meetings per year. These one-day meetings will be organized and convened by NIOSH officials with input from the grantees and others. One of these meetings will be held each November-December, usually in conjunction with the CSTE OH Subcommittee meeting. Another meeting will possibly coincide with the CSTE Annual Conference (typically in June) during which grantees attend the OSH sessions at the CSTE Conference. For budget preparation for all years of requested support, assume the November meeting will be held in Washington D.C. and the June meeting in Denver, CO unless notified otherwise.

In addition to the meetings described above, applicants for the FACE program must budget for up to two personnel to attend a two day annual meeting. Applicants for the pesticide illness related project should budget for one person to attend an annual one and one-half day meeting. Applicants for the work-related lung/respiratory project are expected to attend an annual two to two and one-half day meeting for up to two people. For budget preparation, assume these meetings will be held in Washington D.C. unless specified otherwise.

Note for budget preparation: An applicant may not propose use of grant funds to host and expend funds for a rented venue for a regional or multi-state scientific meeting or conference without a prior approval from CDC NIOSH. An applicant may also request a reduced-cost CDC grantee SAS statistical software license. However, only one SAS PC-compatible base type license per project/PFA may be requested, subject to CDC availability and policy and based on availability of funds. If the license(s) application is approved by CDC, NIOSH will reduce (offset) the annual award amount by the cost of the SAS license(s). Allow 1-2 months for CDC processing of a state request, immediately after award, in coordination with the CDC SAS support program. Reduction of Award funds may vary by year over the grant 5-year project period due to possibly fluctuation in annual SAS license cost.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
Resubmission e.g., A1
Competing Revision e.g., expand the scope of work

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications, and NIOSH programmatic considerations. Estimated $32,500,000 for the entire five year project period. Estimated $6,500,000 total funding (direct and indirect costs) for the first year (12 month budget period). Approximately 25 awards will be made depending upon the number and types of applications received in 2014.

Award Budget

Annual ceiling of funding is $130,000 total costs for a Fundamental Program Application; $140,000 total costs for a Fundamental-Plus Program Application; and $675,000 total costs for an Expanded Program Application. NIOSH is also considering the provision of additional funding to selected, qualified applicants/recipients for yearly follow-back/intervention activities for work-related adult blood lead cases, with additional total costs funding of $5,000, $10,000, or $20,000 total costs based on quantitative criteria in Part 2, Section I., sub section 1.

Award Project Period

The maximum project period is 5 years. The initial budget period, July 1, 2015 through June 30, 2016 and for all-inclusive awards. The project period will start on July 1, 2015 and end of June 30, 2020. The budget period is 1 July through 30 June for each year.

HHS grants policies as described in the HHS Grants Policy Statement http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

1. Eligible Applicants

Eligible Organizations

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession

Other

State Controlled Institution of Higher Education

  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via Grants.gov.
  • Nonprofit institutions not acting as bona fide agents for government agencies
Foreign Institutions

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.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the PHS 398 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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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 PHS 398 Application Guide. A Contact PI must be designated.

For each sub project, a Project Director/PI must be identified in the application along with his/her institutional affiliation e.g., subcontract. The project director will be responsible for leading and managing scientic, technical, reporting, and research protections related activities which also should be reflected in the his/her time commitment in the application. A biosketech and Other Support document is required.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 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.

Letter of Intent

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 NIOSH 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:

Name, address, and telephone number of the Applicant Organization
Descriptive title of proposed surveillance program
Total amount of funds requested for entire project and initial year budget periods
Name, address, and telephone number of the PD(s)/PI(s)
Name and address of all participating institutions/agencies, by subproject. Names of key personnel, by subproject

The letter of intent should be sent to:

Steven Inserra
CAPT, USPSH
Scientific Program Official
Office of Extramural Programs
National Institute for Occupational Safety & Health
1600 Clifton Road, NE Mailstop E74
Atlanta, GA 30333
sinserra@cdc.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional signed paper copies of the application and all copies of the Appendix files must be sent to:

Price Connor, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road
Mailstop E-74
Atlanta, GA 30329-4018
404-498-2530
Fax 404-498-2571
Overnight mail address:
2400 Century Parkway NE (4th floor)
Atlanta, GA 30345
spc3@cdc.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section for each sub project/component of the application.

  • Overall: 12 pages
  • Research Project: 12 pages
  • Indicators/OHI: 12 pages
Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall (Required).
  • Sub Projects (Required). OH Indictors/OHI (required) plus up to 4 sub projects will be allowed.
Overall Component

All instructions in the PHS398 Application Guide must be followed.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: 1 page limit

Research Strategy: 12 page limit

Resource Sharing Plan:Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Project or Priority Focus Area/Topic (PFA)

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Project)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Project)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Project)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period Project)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Project)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Project)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Project)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: 1 page limit

Research Strategy: 12 page limit

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Foreign Institutions

Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the GPS http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html.

Pre-award costs are allowable only as described in the GPS http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and for responsiveness by NIOSH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact the NIOSH Program Official at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS 398 Application Guide.

Post Submission Materials

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

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

1. Criteria

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.
For this PAR, CDC NIOSH will conduct the external peer review in accordance with CDC NIOSH policies.

Overall Impact - Overall

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).

Scored Review Criteria - Overall

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.

Significance

Does the overall program address an important problem or a critical barrier to progress in the field? If the aims of the program 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?

For All Renewal Application: Does the application show progress in program development and capacity addressing occupational epidemiology and surveillance? Did the program show successes in OSH consultation, OSH outreach and education, and more intensive collaboration across agencies and departments? Did the program show major accomplishments including dissemination of Indicator data and reports for 2010-2014? Is there evidence of surveillance findings knowledge transfer by stakeholders? For

Renewal Expanded Program Application: Is there evidence of successful advances in methods and procedures, data acquisition and data management, and communication for individual projects? Were there project-specific major outputs and possible beneficial intermediate outcomes? Any user/stakeholder feedback for the utility of the program and/or project outputs e.g. medium or small business feedback?

Does the application describe whether there are elevated incidence and/or prevalence rates for OH fatalities, diseases, or exposures compared to national or regional estimates? Does it describe a critical barrier to state-led progress in occupational epidemiology and surveillance or research translation? If the aims of the proposed program are achieved, how will scientific knowledge, program and technical capability, and/or clinical practice be improved? How and to what degree will successful completion of the program aims change preventative interventions and outreach?

Does this application describe available, accessible data within the state? Are important occupational problem(s) addressed? Are the needs and approaches to connect surveillance and prevention activities well-described?

Does the application describe the need and anticipated development of the new or improved OH surveillance program? Are program capacity and capability goals articulated?

Is there access and use of multiple data sources for advancing OH surveillance?

Are outreach, partnership development, and OSH/surveillance consultation addressed and resourced?

What is the potential or actual impact of the research on workers, employers, and public health in state and the U.S.? If successful, do the research results have the potential to be scalable or adaptable to reach at-risk worker population(s)?

Will the work be influential in that it will lead others to investigate the problem, open new areas or topics of surveillance research, or improve the scientific approach or public health practice?

Regarding an Expanded Program Application, are there state-proposed priority research topics of an important, impactful nature? Is the need or magnitude of the issue adequately described?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program and/or projects? 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?

For All Renewal Application: do the investigators have a successful track record in public health research? Is there evidence of past internal & external collaborations for the proposed research team?

Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Is there evidence of relevant publications and presentations or other honors?

For the PI/PD and Key Personnel, is the level of effort in person-months appropriate for the time commitment required by the proposed OH surveillance program?

Have previous research results provided high quality outputs and contributed to improvements in public health practice and worker health and safety?

For Fundamental and Fundamental-Plus Program Application, does PD/PI and key personnel provide evidence of appropriate training, skills and experience in support of a surveillance program?

For Expanded Program Application, is the knowledge and experience of the PD/PI and co-investigators conducive for active and passive surveillance and epidemiology research methods?

Does the investigative team bring complementary and trans-disciplinary expertise to the particular project (if applicable)?

Regarding possible Multiple PI/PD Plan, does each PD/PI have measurable effort (greater than zero) and level of effort adequate to achieve the proposed goals? Does the plan summarize the decision-making process including scientific and technical direction and allocation of resources?

Innovation

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?

Does the program and/or projects have the potential to overcome any stated administrative barriers for data sharing or use?

For Expanded Program Application, are there novel strategies for minimizing the time for data acquisition, release of data, data incompatibility, or technologies or systems for interface with programs-specific data? Are there opportunities for collecting new data or incentive for collaboration with external data stewards?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program and/or projects? 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?

Are the purpose, goals, and objectives of the program adequately described?

Are the overall strategy, assessment and methodology, and analyses well-reasoned and appropriate to accomplish specific aims? Are there adequate descriptions regarding data, data sharing and data management and protections?

Does the overall approach describe linkage for prevention, intervention, translation, outreach, education, and evaluation?

For Fundamental-Plus Application: Did the applicant describe the nature and approach for an in-depth investigation as well as for an intervention recommendation planning?

For Expanded Program Application: For an individual project, is there a statement of the problem/challenge, clear objectives, a project design and methods, and a realistic schedule? Are there appropriate outreach and partnership and translation components? Are there project-specific outputs and anticipated outcomes? If the project involves clinical research, are there plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed

Is there an indication the program will strive to affect change in policy, standards and practice using data, data management, investigation findings and staff expertise, as appropriate?

Will the first 13 Indicators be completed and disseminated? Are all or most of Indicator number 13 through 20 proposed to be completed?

Does the applicant acknowledge potential problem areas including access to data, data limitations, and possible yet-developed communication channels and networks? Does the applicant describe active and/or passive communication strategies for program development and improvement, and for developing outreach and partnerships?

Does the applicant list anticipate major outputs of the program and individual projects? For outputs, is the intended audience(s) identified for increase in the likelihood of comprehension, knowledge, attitude formation, and behavioral intent?

Regarding evaluation and translation plans, are major outputs/products identified and are measures/metrics included? Does the translation plan describe the degree and how program outputs (including findings and recommendations) will be translated (e.g., audience-specific), disseminated including channels and marketing, and/or diffused for select worker groups. Will the Advisory body be involved/review in any of these activities?

Environment

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?

Will the project benefit from any unique arrangements of the scientific/technical environment or departments or participating institutions?

Is the environment conducive for partnership and collaboration development including administration-supported access or arrangements? Does the environment support integrative and multi-departmental access and working groups?

Does the institutional environment offer any leverage or influence of OH surveillance outputs including integration of data & outputs with other program/department portals, websites/repositories, information dissemination systems, or electronic referral or reporting or with participating institutions data systems, portals and/or websites?

Additional Review Criteria - Overall

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CDC NIOSH, in accordance with CDC NIOSH 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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 appropriate national Advisory Council or Board. 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.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

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.

2. Administrative and National Policy Requirements

All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award (http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf).

Awardees must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate, as well as any additional requirements included in the FOA.

Specific requirements that apply to this FOA are the following:

Generally applicable Administrative Requirements:

AR-1: Human Subjects Requirements
AR-2: Inclusion of Women and Racial and Ethnic Minorities in Research
AR-3: Animal Subjects Requirements
AR-7: Executive Order 12372 Review
AR-9: Paperwork Reduction Act Requirements
AR-10: Smoke-Free Workplace Requirements
AR-11: Healthy People 2010
AR-12: Lobbying Restrictions
AR-13: Prohibition on Use of CDC Funds for Certain Gun Control Activities
AR-14: Accounting System Requirements
AR-16: Security Clearance Requirement
AR-17: Peer and Technical Reviews of Final Reports of Health Studies ATSDR
AR-21: Small, Minority, And Women-owned Business
AR-22: Research Integrity
AR-24: Health Insurance Portability and Accountability Act Requirements
AR-25: Release and Sharing of Data
AR-26: National Historic Preservation Act of 1966
AR-28: Inclusion of Persons Under the Age of 21 in Research
AR-29: Compliance with EO13513, Federal Leadership on Reducing Text Messaging while Driving , October 1, 2009
AR-30: Information Letter 10-006, - Compliance with Section 508 of the Rehabilitation Act of 1973
AR 31 - Distinguishing Public Health Research and Public Health Nonresearch
AR 32 FY 2012 Enacted General Provisions

Cooperative Agreement Terms and Conditions of Award
3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the HHS Grants Policy Statement at http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html.

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 GPS at http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html.

Also required will be an Annual Report of Major Outputs, Accomplishments and Outcomes. The report will be written in a style and semi technical content for uptake by professionals. A 3-4 PDF-type page limit will apply including a page for publications, citations and other product descriptions. The author is fully responsible for its content, and NIOSH does not intend to substantially proof or edit the submission. NIOSH may post the report on its website for public viewing.

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 GPS at http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html for additional information on this reporting requirement.

Section VII. Agency Contacts

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

Application Submission Contacts

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Scientific/Research Contact(s)

CAPT Steven Inserra, MPH
Captain, USPHS
Scientific Program Official
Office of Extramural Programs
National Institute for Occupational Safety & Health
1600 Clifton Road, NE Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2552
sinserra@cdc.gov

Peer Review Contact(s)

Price Connor, PhD
Scientific Review Official
Office of Extramural Programs
National Institute for Occupational Safety & Health
1600 Clifton Road, NE Mailstop E74
Atlanta, GA 30333
Telephone: (404) 498-2530
spc3@cdc.gov

Financial/Grants Management Contact(s)

Sharon Cassell
Centers for Disease Control & Prevention (CDC)
Telephone: 770-488-2703
Email: scassell@cdc.gov

Section VIII. Other Information

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 HHS GPS at http://www.hhs.gov/asfr/ogapa/aboutog/grantsnet.html.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. This program is described in the Catalog of Federal Domestic Assistance and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. Awards are made under the authorization of the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670), Federal Mine Safety and Health Act, Section 501(a), 30 USC 951 (a); Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

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