Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health(NIOSH)

Components of Participating Organizations

National Institute for Occupational Safety and Health (NIOSH)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may differ from those used by the HHS National Institutes of Health (NIH). This document provides application guidance and links to websites with further guidance.

Funding Opportunity Title

Cooperative Research Agreements Related to the World Trade Center Health Program (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-16-098

Companion Funding Opportunity

None

Number of Applications

Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct.

See Section III. 3. Additional Information on Eligibility.

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

93.262 

Funding Opportunity Purpose

The purpose of this announcement is to help address the Zadroga Act research mandate, and in consultation with the World Trade Center (WTC) Scientific/Technical Advisory Committee, NIOSH is soliciting applications for scientifically rigorous research to help answer critical questions about physical and mental health conditions related to the September 2001 terrorist attacks. 

Key Dates
Posted Date

February 12, 2016

Open Date (Earliest Submission Date)

March 1, 2016

Letter of Intent Due Date(s)

March 1, 2016; November 1, 2016; November 1, 2017; November 1, 2018; November 1, 2019.

Application Due Date(s)

New Date April 19, 2016 April 6, 2016; December 1, 2016; December 1, 2017; December 4, 2018; December 3, 2019. (Modified March 3, 2016 per NOT-OH-16-014)

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time.

Applicant organizations are strongly encouraged to start the registration process at least 4 weeks prior to the application due date.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2016; April 2017; April 2018; April 2019; April 2020

Advisory Council Review

June 2016; April 2017; April 2018; April 2019; April 2020  

Earliest Start Date

July 1, 2016; July 1, 2017; July 1, 2018; July 1, 2019; July 1, 2020

Expiration Date

December 4, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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Table of Contents

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

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

Statutory Authority

The World Trade Center Health Program (WTCHP) is authorized under 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); Federal Regulations 42 CFR Part 52 and 45 CFR Part 75; and the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111-347; 42 USC 300mm- 300mm-61).

Background

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health (NIOSH). Information on this program is available at http://www.cdc.gov/niosh/topics/wtc/. The James Zadroga 9/11 Health and Compensation Act of 2010, Public Law 111-347 (hereafter referred to as “the Zadroga Act”) was signed by President Obama on January 2, 2011, and was re-authorized on December 18, 2015. The Zadroga Act continues monitoring and treatment activities and requires the establishment (under Subtitle C) of a research program on health conditions resulting from the September 11, 2001, terrorist attacks.

The Zadroga Act lists the following broad research areas:

  • Physical and mental health conditions that may be related to the September 11, 2001, terrorist attacks;
  • Diagnosing WTC-related health conditions for which there has been diagnostic uncertainty; and
  • Treating WTC-related health conditions for which there has been treatment uncertainty.

Research mentioned in the Zadroga Act includes epidemiologic and other research studies on WTC-related health conditions or emerging conditions among (1) enrolled WTC responders and certified-eligible WTC survivors under treatment; (2) sampled populations outside the NYC disaster area, in Manhattan (as far north as 14th Street) and in Brooklyn; and (3) control populations, to identify potential for long-term adverse health effects in less exposed populations.

The Zadroga Act specifies establishing a WTC Scientific/Technical Advisory Committee and indicates that the WTC Program Administrator shall consult with the committee in carrying out research activities related to the September 11, 2001, terrorist attacks (http://www.cdc.gov/wtc/). 

Purpose

To help address the Zadroga Act research mandate, and in consultation with the WTC Scientific/Technical Advisory Committee, NIOSH is soliciting applications for scientifically rigorous research to help answer critical questions about physical and mental health conditions related to the September 2001 terrorist attacks.

Major areas of interest include, but are not limited to, the following:

Linking 9/11 exposure to health conditions:

  • Cancers, multisystem or autoimmune, cardiovascular and neurologic disease (including age at diagnosis);
  • Characterizing patterns of illness (age, gender, comorbidities, etc.); and
  • Characterizing alterations in health and development for those exposed to 9/11 as children.

Characterizing established WTC-related diseases and comorbidities:

  • Identifying phenotypes, biomarkers, epigenetics; and
  • Care models that address complex co-morbidities and other modifiable factors.

Health services research and value-based care that addresses disaster-related injury and illness for chronic disease. (NOTE: Health services research examines how people get access to health care, how much care costs, and what happens to patients as a result of this care. The main goals of health services research are to identify the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve patient safety (Agency for Healthcare Research and Quality, 2002).

Characterizing the work-ability and occupational outcomes for those impacted by 9/11.

Lessons learned in recovery:

  • Identifying and operationalizing key elements of psychological resilience for disaster responders; and
  • Establishing comparison groups for disaster-related research for key health indicators for first responders.

(NOTE: Concepts of psychological resilience vary across disciplines with investigations addressing various outcomes ranging from reported levels of stress, burnout, compassion fatigue, and general indicators of well-being.  Also proposed are interpersonal, intrapersonal and environmental factors that suggest a more stable and enduring personality trait impacting self-regulation.

Relevant diseases or conditions include, but are not limited to, the following:

  • Respiratory diseases
  • Cancer (including detection/diagnosis of pre-malignant changes)
  • Cardiovascular Disease
  • Psychological resilience and well-being
  • Persistent psychiatric conditions such as posttraumatic stress, anxiety and depressive disorders
  • Cognitive changes
  • Aging – the impacts of aging on those impacted by 9/11 illness and injury (e.g., premature aging, optimizing adaptation for productivity)
  • Neurological Diseases
  • Aerodigestive health
  • Multisystem or auto-immune diseases
  • Gastro-esophageal disorders
  • Gastrointestinal health
  • Chronic musculoskeletal conditions resulting from acute traumatic injury and overuse disorders

The overall objective of this announcement is to solicit meritorious and scientifically rigorous research applications that will help:

  • address the Zadroga Act research mandate;
  • answer critical questions about physical and mental health conditions related to the September 2001 terrorist attacks;
  • expand knowledge about health effects related to the September 2001 terrorist attacks;
  • improve diagnosis and treatment activities of the WTCHP; and
  • apply lessons learned from 9/11 to improve response to future disasters (see WTCHP Research-to-Care logic model at http://www.cdc.gov/wtc/researchprojects.html).

Another objective of this announcement is to help address the wide range of research needs related to the WTCHP. NIOSH will do this by considering the following types of U01 cooperative research projects:

Type of Project

Project Period

Total Cost per Year

Long term

Up to five years

Up to $600K

Intermediate-term

Up to three years

Up to $500K

Short-term

Up to two years

Up to $350K

A wide range of research needs can be addressed by each of these types of projects. Applicants must clearly identify which type of project they are proposing and provide sufficient supporting information. In 2016, NIOSH anticipates funding 2 or 3 long-term, 3 or 4 intermediate-term, and 3 or 4 short-term U01 projects.

NIOSH seeks to achieve a suitable mix of projects that help advance treatment effectiveness and the understanding of health and well-being impacts related to the September 2001 terrorist attacks.

Increased awareness of effective treatment, interactions between health conditions, patterns of illness and development, exposure-response relationships, and risk factors is critical for achieving improved treatment and intervention protocols.

Data/Resource Sharing Plan

NIOSH considers the sharing of unique data and other research resources developed through the WTCHP an important means to enhance the value, and further the advancement of, current and future research.

Investigators responding to this funding opportunity should include a plan on sharing research resources and data, or explain why such sharing is not possible. The precise content of the plan will vary depending on the data being collected and how the investigator is planning to share the data.

Factors to consider include: the expected schedule for data sharing, the format of the final dataset, supporting documentation, and whether analytic tools will be provided. Other considerations include whether a data sharing agreement will be required, whether any conditions will be placed on their use, and the mode of data sharing.

Information on data/resource sharing can be found on page II-74 (Sharing Research Tools) of the current HHS Grants Policy, which is available at: http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

HHS/CDC policy requires that grant award recipients make unique research resources and data readily available for research purposes to qualified individuals within the scientific community after publication.

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 SF424 (R&R) Application Guide.

Data Sharing and Study Recruitment

Applicants considering projects that depend on interaction or collaboration with the Data Centers, or the 9/11 Health Registry associated with the World Trade Center Health Program (see listing that follows) must coordinate in advance with the respective Directors or Administrators of the Data Centers in order to ensure access to data and/or availability of adequate numbers of potential participants are feasible to conduct the proposed research. Documentation of the study recruitment plan and agreement on this coordination must be included in the application, along with any budgetary needs for the coordination activities, by providing both a letter from the investigator to the Data Center/Health Registry/WTCHP and a response letter from the Data Center/Health Registry/WTCHP to the investigator.

Data Center and WTC Health Registry Contacts
Fire Department of New York
Director—Dr. David Prezant, 718-999-2696, david.prezant@fdny.nyc.gov
Administrator—Ms. Lara Glass, 718-999-5142 lara.glass@fdny.nyc.gov  

Mount Sinai School of Medicine
Director—Dr. Roberto Lucchini, 212-824-7052or 212-241-2131, roberto.lucchini@mssm.edu
Administrator – Jean Weiner, 212-241-2709, jean.weiner@mssm.edu

NYC Health and Hospitals Corporation
Director—Ms. Edith Davis, 212-562-4525, Edith.Davis@bellevue.nychhc.org
Administrator—Mr. Larry Chang, 212-788-0949, Lawrence.Chang@nychhc.org

WTC Health Registry
Public Affairs Liaison— Jacquelynn Osoro, 347-396-2919, josoro@health.nyc.gov    

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 funding is awarded, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIOSH intends to commit over a 5-year period about $75M in total costs (direct and indirect) to fund 60 to 70 applications. 

In 2016, NIOSH anticipates funding 2 or 3 long-term, 3 or 4 intermediate-term, and 3 or 4 short-term U01 projects.

Each year the number of new, renewal, revision, and resubmission awards and the total amount awarded will vary, depending on the number of awards that have ended; the availability of funds; the number and quality of applications; and the duration and cost of the projects proposed. Because the nature and scope of the proposed research will vary from application to application, the size and duration of each award may also vary.

Award Budget

Applicants submitting new applications may request one of the following three options: (1) a project period of up to 5 years and a total budget up to $600K per year in direct and indirect costs (total costs); (2) a project period of up to 3 years and a total budget up to $500K per year in direct and indirect costs (total costs); or (3) a project period of up to 2 years and a total budget up to $350K per year in direct and indirect costs (total costs).

Award Project Period

Allowable project periods are up to five years for a long-term project, up to three years for an intermediate-term project, and up to two years for a short-term project. Throughout the project period, CDC's commitment to continuation of awards will be conditional on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

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

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

Dun and Bradstreet Universal Numbering System (DUNS) - Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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 CDC/NIOSH support. NOTE: The CDC does not make awards to individuals directly.

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, https://grants.nih.gov/grants/multi_pi.

When multiple PDs/PIs are proposed, NIOSH requires one to be designated as the Contact, who will be responsible for all communications between the PDs/PIs and NIOSH, for assembling the application materials outlined below, and for coordinating progress reports. The Contact must meet all PD/PI eligibility requirements.

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 research proposal is scientifically distinct.

As defined in the HHS Grants Policy Statement, http: //www.hhs.gov /asfr /ogapa /aboutog /hhsgps107.pdf, applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC/NIOSH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. In addition, NIOSH will not accept any application that is essentially the same as one previously reviewed. Resubmission applications may be submitted, according to the Policy on Resubmission Applications from the SF424 (R&R) Application Guide, but must include an Introduction addressing the previous peer review critique (Summary Statement).

Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.  If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at:  TTY 1-888-232-6348.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (https://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf), except where 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.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded from https://grants.nih.gov/grants/forms.htm.

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

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 CDC/NIOSH Review 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:

Nina Turner, PhD
Scientific Review Officer, CDC/NIOSH/OEP
1095 Willowdale Road, Mailstop G800
Morgantown, WV 26505-2845 USA
Telephone: 304-285-5976
E-mail: NTurner@cdc.gov

Page Limitations

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:

  • the Research Strategy component of the Research Plan is limited to 12 pages for a long-term (5-year) project or 8 pages for an intermediate-term (3-year) or short-term (2-year) project. These page limits are the totals for all text, tables, graphs, figures, diagrams, and charts in this component.
Instructions for Application Submission

A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional. 

Required Components for This FOA 
SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Research and Related Other Project Information

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

SF424(R&R) Research and Related Senior/Key Person Profile

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

Research & Related Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Detailed budget information is required for the first budget period.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:  The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (https://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA.  As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision only) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report* (Renewal and Revision applications only)

5. Progress Report Publication List (for Continuation only)

Human Subjects Section
6. Protection of Human Subjects
7. Inclusion of Women and Minorities
8. Targeted/Planned Enrollment Table (for New Application only)
9. Inclusion of Children

Other Research Plan Sections
10. Vertebrate Animals
11. Select Agent Research
12. Multiple PD/PI Leadership Plan.
13. Consortium/Contractual Arrangements
14. Letters of Support
15. Project Dissemination Plan
16. Project Evaluation Plan
17. Resource Sharing Plan(s)
18. Appendix

*NOTE: Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (https://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf ) must be followed along with any additional instructions provided in the FOA.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following additional instructions:

NIOSH considers the sharing of unique data and other research resources developed through the WTCHP an important means to enhance the value and further the advancement of current and future research.

Investigators responding to this funding opportunity must include a plan on sharing research resources and data or explain why such sharing is not possible. The precise content of the plan will vary, depending on the data being collected and how the investigator is planning to share the data. Factors to consider include the expected schedule for data sharing, the format of the final dataset, supporting documentation, and whether analytic tools will be provided. Other considerations include whether a data sharing agreement will be required, whether any conditions will be placed on their use, and the mode of data sharing.

Information on data/resource sharing can be found on page II-74 (Sharing Research Tools) of the current HHS Grants Policy, which is available at http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf.

HHS/CDC policy requires that grant award recipients make unique research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. 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 SF424 (R&R) Application Guide.

  • Applicants considering projects that depend on interaction or collaboration with the Data Centers, or the 9/11 Health Registry associated with the World Trade Center Health Program (see listing that follows) must coordinate in advance with the respective Directors or Administrators of the Data Centers in order to ensure access to data and/or availability of adequate numbers of potential participants are feasible to conduct the proposed research. Documentation of the study recruitment plan and agreement on this coordination must be included in the application, along with any budgetary needs for the coordination activities, by providing both a letter from the investigator to the Data Center/Health Registry/WTCHP and a response letter from the Data Center/Health Registry/WTCHP to the investigator.

Data Center and WTC Health Registry Contacts

Fire Department of New York
Director—Dr. David Prezant, 718-999-2696, david.prezant@fdny.nyc.gov
Administrator—Ms. Lara Glass, 718-999-5142 lara.glass@fdny.nyc.gov  

Mount Sinai School of Medicine
Director—Dr. Roberto Lucchini, 212-824-7052or 212-241-2131, roberto.lucchini@mssm.edu
Administrator – Jean Weiner, 212-241-2709, jean.weiner@mssm.edu

NYC Health and Hospitals Corporation
Director—Ms. Edith Davis, 212-562-4525, Edith.Davis@bellevue.nychhc.org
Administrator—Mr. Larry Chang, 212-788-0949, Lawrence.Chang@nychhc.org

WTC Health Registry
Public Affairs Liaison— Jacquelynn Osoro, 347-396-2919, josoro@health.nyc.gov.

Optional Components for this FOA
PHS 398 Cumulative Inclusion Enrollment Report
R&R Subaward Budget Attachments Form 5 YR 30 ATT

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

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement.

Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC. For more information on expanded authority and pre-award costs, go to http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf.

Funds relating to the conduct of human subjects research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.   

6. Other Submission Requirements and Information

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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters “FWA” before the number. 

If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http:// grants.nih. gov/grants/ Electronic Receipt /avoiding _errors.htm or http:// grants. nih.gov/grants/ Electronic Receipt/submit _app.htm.

Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the CDC/NIOSH Scientific Review Officer by email at NTurner@cdc.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants should anticipate and budget accordingly for a required 2-day meeting for research grantees, held bi-annually in New York City (NYC). These may alternate between webinars and in-person meetings.

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
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the CDC mission http:// www.cdc.gov/ about/ organization/ mission.htm, all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system. In addition, as part of the NIOSH mission (http://www.cdc.gov/niosh/about.html), all applications submitted to NIOSH in support of occupational safety and health research are evaluated for scientific and technical merit through the NIOSH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority 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

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

Significance

Does the project address important needs or critical barriers to help determine physical and mental health conditions which have persisted, and new symptoms and conditions which have emerged, in people exposed to the 9/11 disaster? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practices be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventive interventions used in the World Trade Center Health Program, occupational health, or public health? What is the potential impact of the project on occupational health and safety or public health?

For Renewal Applications: Has the project made significant contributions to new knowledge about diseases, conditions, treatments or other areas relevant to responder or community member cohorts impacted by the WTC disaster? 

Investigator(s)

Does the project address important needs or critical barriers to help determine physical and mental health conditions which have persisted, and new symptoms and conditions which have emerged, in people exposed to the 9/11 disaster? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practices be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventive interventions used in the World Trade Center Health Program, occupational health, or public health? What is the potential impact of the project on occupational health and safety or public health?

For Renewal Applications: Has the project made significant contributions to new knowledge about diseases, conditions, treatments or other areas relevant to responder or community member cohorts impacted by the WTC disaster? 

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? 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 application challenge and seek to shift current public health practice paradigms or approaches?   

Approach

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?  

Are the overall strategy, methodology, feasibility, and rationale well-reasoned and appropriate to accomplish the specific aims of the project? Does the proposed project timeline include clearly established objectives for which progress will be measured objectively by defined methods? Are potential problems, alternative strategies, and benchmarks for success presented? Are the analytic plans clear, consistent with the research questions, and appropriate for the study design and data available? Does the application propose use of evidence-based interventions or strategies in the research plan? Are outputs identified and measures/metric to assess outcomes included? Does the application describe how the results from the research will be disseminated and ultimately used?

If the project involves collaboration with the current Clinical Centers of Excellence, Data Centers, or the WTC Health Registry, are appropriate letters of support included in the application? 

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? For planned or potential collaborations, is the commitment and cooperation of other interested parties adequate as evidenced by letters of support specifying the nature and extent of their involvement? 

Additional Review Criteria

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

Protections for Human Subjects

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

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

Dual Use Research of Concern

Reviewers will identify whether the project involves one of the agents or toxins described in the US Government Policy for the Institutional Oversight of Life Sciences Dual Use Research of Concern, and, if so, whether the applicant has identified an IRE to assess the project for DURC potential and develop mitigation strategies if needed.

For more information about this Policy and other policies regarding dual use research of concern, visit the U.S. Government Science, Safety, Security (S3) website at: http://www.phe.gov/s3/dualuse. Tools and guidance for assessing DURC potential may be found at: http://www.phe.gov/s3/dualuse/Documents/durc-companion-guide.pdf.

Additional Review Considerations

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.

Limitations of Currently Available Data

Health effects related to the September 2001 terrorist attacks are considered to be primarily a result of exposure during the attacks, while responding to the resulting disaster, or while living in the area during the disaster response, remediation, and cleanup efforts. Scientifically identifying the causes of health problems or conditions is typically very difficult because of independent factors unrelated to the September 2001 terrorist attacks that may contribute to the onset of specific diseases. Likewise, health conditions existing prior to exposures related to the September 20011 terrorist attacks may also be contributing factors.

Reviewers should consider that a standardized body of pre-existing medical data for all potential study subjects may not exist. In addition, the paucity of reliable, comprehensive environmental measurements could make quantifying exposures very difficult.

Although often it may not be possible to determine the specific cause of an individual's illness or condition, it is critical to promote scientifically rigorous studies and reviews of potential health problems or risk factors among the affected population. Reviewers should consider how well applicants acknowledge and address the limitations in currently available data.

Review of Application Type

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.

Project Dissemination Plan

Reviewers will assess whether the proposal includes an adequate plan for summarizing and disseminating results. The dissemination plan should include:

  • Publication of results in peer-reviewed scientific journals;
  • Presentation of results at scientific conferences (specify the target conferences);
  • Presentation of findings/progress at the Bi-annual WTC Research Grantee meetings;
  • Presentation of results to interested groups (unions, WTCHP committees, and responder or survivor stakeholder organizations.

Project Evaluation Plan

Reviewers will assess whether the proposal includes an adequate plan for evaluating outputs, outcomes, and impacts. The evaluation plan should:

  • Identify members of the research team responsible for the evaluation of study activities and the quality of collected data;
  • Describe how the data collected will be assessed for quality and accuracy;
  • Describe how individuals responsible for gathering and analyzing data (such as conducting surveys and laboratory tests) will be trained and supervised; and
  • Describe how often study team members will meet to (1) review progress in recruitment goals, (2) review preliminary results, and (3) identify and resolve emerging problems.

Resource Sharing Plans

NIOSH considers the sharing of unique data and other research resources developed through the WTCHP an important means to enhance the value and further the advancement of current and future research.

The reasonableness of the resource sharing plan, or the rationale for not sharing research data, will be assessed by the reviewers. The reviewers will not, however, factor the proposed plan into the determination of scientific merit or the impact score.

As applicable, reviewers will assess whether the following Resource Sharing Plans, or the rationale for not sharing these 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. The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:  http://www.cdc.gov/grants/interestedinapplying/applicationresources.html.

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).

Applications from Foreign Organizations

Not Applicable

2. Review and Selection Process

Applications for this FOA will also be evaluated for scientific, technical, and educational merit in accordance with CDC/NIOSH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review process, 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/priority score. All applications will receive a written critique.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA.

Following initial peer review, the NIOSH Secondary Review Council (SRC) will provide a second level of review for programmatic relevance and balance. Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by initial peer review.
  • Relevance to WTCHP priorities.
  • Contribution toward development of guidelines for improved treatment, intervention, or healthcare for populations covered by the WTCHP.
  • Contribution to a blend of studies to advance understanding of health impacts on populations covered by the WTCHP.
  • Commitment of the applicant institution to collaborative efforts.
  • Adequacy of resource-sharing plan.
  • Administrative/managerial capability of the applicant institution.
  • Availability of funds.
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 HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ogapa/aboutog/ hhsgps107.pdf).

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, HHS/CDC/NIOSH will request "just-in-time" information from the applicant. HHS grants policies as described in the HHS Grants Policy Statement http:// www.hhs.gov/ asfr/ogapa/aboutog/ hhsgps107.pdf.

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.

2. Administrative and National Policy Requirements

Overview of Terms and Conditions of Award and Requirements for Specific Types of Grants

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://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf.

Awardees must comply with the administrative requirements (AR) outlined in 45 Code of Federal Regulations (CFR) Part 75, as appropriate, as well as any additional requirements included in the FOA.

Specific requirements that apply to this FOA are the following:

AR-25: Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data-sharing agreement will be released as follows:

a. In a timely manner

b. Completely, and as accurately as possible

c. To facilitate the broader community

d. In accordance with CDC policy on Releasing and Sharing Data.

Applications must include a copy of the applicant's Data Release Plan. Applicants should provide appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for an award. An award can be made when reviewing officials have approved an acceptable Plan. Successful applicants and the Program Official will determine the documentation format. Information on data/resource sharing can be found on page II-74 (Sharing Research Tools) of the current HHS Grants Policy (http:// www.hhs.gov/ asfr/ogapa/aboutog/ hhsgps107.pdf).

The following are additional policy requirements relevant to this FOA.

HHS Policy on Promoting Efficient Spending:  Use of Appropriated Funds for Conferences and Meetings, Food, Promotional Items and Printing Publications

This policy supports the Executive Order on Promoting Efficient Spending (EO 13589), the Executive Order on Delivering and Efficient, Effective, and Accountable Government (EO 13576) and the Office of Management and Budget Memorandum on Eliminating Excess Conference Spending and Promoting Efficiency in Government (M-35-11).  This policy apply to all new obligations and all funds appropriated by Congress.  For more information, visit the HHS website at:  http:// www.hhs.gov/ asfr/ogapa/acquisition/ effspendpol_memo.html.

Federal Funding Accountability and Transparency Act of 2006

Federal Funding Accountability and Transparency Act of 2006 (FFATA), P.L. 109–282, as amended by section 6202 of P.L. 110–252, requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single, publicly accessible website, www.usaspending.gov. For the full text of the requirements, please review the following website: https://www.fsrs.gov/.

Plain Writing Act

The Plain Writing Act of 2010, Public Law 111-274 was signed into law on October 13, 2010. The law requires that federal agencies use "clear Government communication that the public can understand and use" and requires the federal government to write all new publications, forms, and publicly distributed documents in a "clear, concise, well-organized" manner. For more information on this law, go to: http://www.plainlanguage.gov/plLaw/index.cfm.

Tobacco and Nutrition Policies

The CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and to promote healthy nutrition.  CDC encourages all awardees to implement the following optional evidence-based tobacco and nutrition policies within their organizations. These policies build on the current federal commitment to reduce exposure to secondhand smoke, which includes The Pro-Children Act, 20 U.S.C. 7181-7184 that prohibits smoking in certain facilities that receive federal funds.

Tobacco:

Tobacco-free indoors – no use of any tobacco products (including smokeless tobacco) or electronic cigarettes in any indoor facilities under the control of the applicant.

Tobacco-free indoors and in adjacent outdoor areas – no use of any tobacco products or electronic cigarettes in any indoor facilities, within 50 feet of doorways and air intake ducts, and in courtyards under the control of the applicant.

Tobacco-free campus – no use of any tobacco products or electronic cigarettes in any indoor facilities and anywhere on grounds or in outdoor space under the control of the applicant.

Nutrition:

Healthy food service guidelines that at a minimum align with Health and Human Services and General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations for cafeterias, snack bars, and vending machines in any facility under the control of the recipient organization and in accordance with contractual obligations for these services. The following are resources for healthy eating and tobacco free workplaces:

http://www.gsa.gov/graphics/pbs/ Guidelines_for_Federal_Concessions_and_Vending_Operations.pdf
http://www.cdc.gov/nccdphp/dnpao/hwi/toolkits/tobacco/index.htm
http://www.cdc.gov/obesity/strategies/food-serv-guide.html

Applicants should state whether they choose to participate in implementing these two optional policies. However, no applicants will be evaluated or scored on whether they choose to participate in implementing these optional policies.

Pilot Program for Enhancement of Employee Whistleblower Protections

All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award and requires that grantees inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C. 4712.

Copyright Interests Provision

This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipient must obtain prior approval from the CDC for any exception to this provision.

The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved by CDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports for this award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS identification number for up to three (3) months after the publication date and the PubMed Central identification number (PMCID) thereafter.

Language Access for Persons with Limited English Proficiency

Recipients of federal financial assistance from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. Recipients of federal financial assistance must take the reasonable steps to provide meaningful access to their programs by persons with limited English proficiency.

Dual Use Research of Concern

On September 24, 2014, the US Government Policy for the Institutional Oversight of Life Sciences Dual Use Research of Concern was released.  Grantees (foreign and domestic) receiving CDC funding on or after September 24, 2015 are subject to this policy.  Research funded by CDC involving the agents or toxins named in the policy, must be reviewed to determine if it involves one or more of the listed experimental effects and if so, whether it meets the definition of DURC. This review must be completed by an Institutional Review Entity (IRE) identified by the funded institution.

Recipients also must establish an Institutional Contact for Dual Use Research (ICDUR). The award recipient must maintain records of institutional DURC reviews and completed risk mitigation plans for the term of the research grant, cooperative agreement or contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation.

If a project is determined to be DURC, a risk/benefit analysis must be completed. CDC will work collaboratively with the award recipient to develop a risk mitigation plan that the CDC must approve.  The USG policy can be found at http://www.phe.gov/s3/dualuse.

Non-compliance with this Policy may result in suspension, limitation, restriction or termination of USG funding, or loss of future USG funding opportunities for the non-compliant USG-funded research project and of USG funds for other life sciences research at the institution, consistent with existing regulations and policies governing USG funded research, and may subject the institution to other potential penalties under applicable laws and regulations.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) 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 HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an “assistance” mechanism (rather than an “acquisition” mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients’ activities by involvement 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 HHS/CDC as defined below.

The PDs/PIs will have primary responsibility for the following:

  • Designing and conducting research to address the described research objectives of this cooperative agreement
  • Partnering effectively with any outside entities expected to participate in the proposed research. Such partnerships should be well-defined and documented by letters of support detailing the nature and extent of involvement or memoranda of understanding.
  • Establishing goals and objectives that are realistic, measureable, and time-oriented for all phases of the project
  • Developing a research protocol involving human subjects for Institutional Review Board (IRB) review and approval by all cooperating institutions participating in the research project, including CDC if applicable
  • Collaborating with CDC in design and implementation of research and the analysis, interpretation, and dissemination of study findings
  • Developing, designing, and piloting research protocols and instruments; recruiting participants according to the defined sampling strategy; and conducting appropriate data management procedures
  • Analyzing data and disseminating findings in peer-reviewed journals and presentations at scientific conferences and other meetings
  • Attending and participating in bi-annual grantee research meetings.

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 HHS, PHS, and CDC policies.

NIOSH staff with relevant subject matter expertise may have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. These include, but are not limited to, these activities:

  • Assisting in review of research protocols (such as for sampling, recruitment, assessment, and data management)
  • Advising on or participating in analysis, interpretation, and dissemination of study findings
  • Attending and participating in bi-annual grantee meetings
  • Monitoring and evaluating the scientific and operational accomplishments of the project through conference calls, site visits, grantee meetings, and review of technical reports.

Specific substantial involvement activities for NIOSH project scientists will be negotiated further with each grantee as part of the pre-award process. This will include adding special terms and conditions in the NOA.

NIOSH Program Official (PO)

Additionally, the Scientific/Research Contact named in this announcement will serve as the Program Official (PO) for all awards. This person will be responsible for the normal scientific and programmatic stewardship of these awards and will be named in the NOAs. The PO will have programmatic involvement during the conduct of this activity through approval of progress reports, human subjects protection, and advice and coordination commensurate with normal program stewardship for grants. Other PO responsibilities include these:

  • Ensuring that all requirements are met prior to issuance of an initial award
  • Objective and independent evaluation of progress toward specific aims or objectives
  • Approving noncompetitive continuation of the award
  • Recommending corrective actions as needed
  • Carrying out administrative and technical duties such as giving grant cycle or funding information, programmatic approvals and recommendations, consultation or technical assistance pertaining to administration requirements of award; monitoring performance of the recipient; processing "just in time" information for research projects; approving final reports before release and distribution; communicating guidance and policy; facilitating budget recommendations; visiting programs/sites; attending grantee meetings; and disseminating grantee information and research reports
  • Providing guidance or information addressing recipient inquiries
  • Participate in and facilitate development of goals and agenda for grantee meetings, as necessary.

Areas of Joint Responsibility

Responsibilities are divided between awardees and NIOSH staff as described above. Substantial involvement responsibilities of NIOSH project scientists will be collaborative, consultative, and facilitative, not proscriptive, in nature.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and NIOSH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened and will have three members: a designee of the awardee, a NIOSH designee, and a designee with expertise in the relevant area who is chosen by the other two. 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 regulations 42 CFR Part 50, Subpart D, and HHS regulations 45 CFR Part 16.

3. Reporting

Federal Funding Accountability and Transparency Act of 2006.  Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds, including grants, contracts, loans, and other assistance and payments, through a single, publicly accessible website, www.USASpending.gov (http://www.usaspending.gov/).

The website includes the following information on each Federal financial assistance award and contract over $25,000:

1. The name of the entity receiving the award

2. The amount of the award

3. Information on the award, such as transaction type and funding agency

4. The location of the entity receiving the award

5. A unique identifier of the entity receiving the award

6. Names and compensation of highly compensated officers (as applicable)

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: (1) information on executive compensation when not already reported through the System for Award Management (SAM) and (2) similar information on all subawards/subcontracts/consortiums over $25,000. For the full text of the requirements under the Federal Funding Accountability and Transparency Act of 2006, please review the following website: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) (https://grants.nih.gov/grants/guide/url_redirect.htm?id=11160) annually and financial statements as required in the HHS Grants Policy Statement. Program staff will evaluate the effectiveness of resource sharing as part of the administrative review of each Non-Competing Continuation Grant Progress Report (HHS/PHS 2590; https://grants.nih.gov/grants/funding/2590/2590.htm).

The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Continuation Grant Progress Report (HHS/PHS 2590). A final progress report, an invention statement, and the expenditure data portion of the Federal Financial Report are required when for closeout an award is relinquished, as described in the HHS Grants Policy Statement (http:// www.hhs.gov/asfr/ ogapa/aboutog/ hhsgps107.pdf).

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Submission of Reports

The Recipient Organization must provide HHS/CDC with an original, plus one hard copy of the following reports:

1. Yearly Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, www.grants.gov and at http:// grants.nih.gov/grants/ funding/2590/ 2590.htm), is due 90 to 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application. Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

2. Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons within 90 days after the end of the calendar quarter in which the budget period ends.

3. A final progress report, invention statement, equipment/inventory report, and the final FFR are required 90 days after the end of the project period.

Content of Reports

1. Yearly Non-Competing Grant Progress Report

The grantee’s continuation application/progress report should include:

  • Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the PHS 2590 http:// grants1.nih.gov/ grants/funding/ 2590/2590.htm  http:// grants.nih.gov/grants/ funding/2590/2590.htm: Detailed narrative report for the current budget period that directly addresses progress towards the Measures of Effectiveness included in the current budget period proposal.
  • Research Aims: list each research aim/project

a) Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned

b) Leadership/Partnership: list project collaborations and describe the role of external partners.

  • Translation of Research (1 page maximum). When relevant to the goals of the research project, the PI should describe how the significant findings may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public health policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that were translated into public health policy or practice and how the findings have been or may be adopted in public health settings. Or, if they cannot be applied yet, this section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:
    • How will the scientific findings be translated into public health practice or inform public health policy?
    • How will the project improve or effect the translation of research findings into public health practice or inform policy?
    • How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?
    • How will the findings advance or guide future research efforts or related activities?
  • Public Health Relevance and Impact (1 page maximum). This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project relate beyond the immediate study to improved practices, prevention or intervention techniques, inform policy, or use of technology in public health. Questions to consider in preparing this section include:
    • How will this project lead to improvements in public health?
    • How will the findings, results, or recommendations been used to influence practices, procedures, methodologies, etc.?
    • How will the findings, results, or recommendations contributed to documented or projected reductions in morbidity, mortality, injury, disability, or disease?
  • Current Budget Period Financial Progress: Status of obligation of current budget period funds and an estimate of unobligated funds projected provided on an estimated FFR.
  • New Budget Period Proposal:
    • Detailed operational plan for continuing activities in the upcoming budget period, including updated Measures of Effectiveness for evaluating progress during the upcoming budget period. Report listed by Research Aim/Project.
  • Project Timeline: Include planned milestones for the upcoming year (be specific and provide deadlines).
  • New Budget Period Budget: Detailed line-item budget and budget justification for the new budget period. Use the CDC budget guideline format.
  • Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. If no publication or presentations have been made at this stage in the project, simply indicate “Not applicable: No publications or presentations have been made."
  • IRB Approval Certification: Include all current IRB approvals to avoid a funding restriction on your award. If the research does not involve human subjects, then please state so. Please provide a copy of the most recent local IRB and CDC IRB, if applicable. If any approval is still pending at time of APR due date, indicate the status in your narrative.

2. Annual Federal Financial Reporting

The Annual Federal Financial Report (FFR) SF 425 is required and must be submitted through eRA Commons within 90 days after the end of the calendar quarter in which the budget period ends. The FFR should only include those funds authorized and disbursed during the timeframe covered by the report. The final FFR must indicate the exact balance of unobligated funds and may not reflect any unliquidated obligations. There must be no discrepancies between the final FFR expenditure data and the Payment Management System's (PMS) cash transaction data.

Failure to submit the required information in a timely manner may adversely affect the future funding of this project. If the information cannot be provided by the due date, you are required to submit a letter explaining the reason and date by which the Grants Officer will receive the information. All CDC Financial Expenditure data due on/after October 1, 2012 must be submitted using the FFR via the eFSR/FFR system in the eRA Commons. All Federal Reporting in the Payment Management System is unchanged. All new submissions should be prepared and submitted as FFRs.

CDC's implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 1/30/2012, the annual FFR is due 6/30/2012 (90 days after the end of the calendar quarter of 3/31/2012). Due dates of final reports will remain unchanged. The due date for final FFRs will continue to be 90 days after the project period end date.

Grantees must submit closeout reports in a timely manner. Unless the Grants Management Officer (GMO) of the awarding Institute or Center approves an extension, grantees must submit a final FFR, final progress report, and Final Invention Statement and Certification within 90 days of the end of grant period. Failure to submit timely and accurate final reports may affect future funding to the organization or awards under the direction of the same Project Director/Principal Investigator (PD/PI).

FFR (SF 425) instructions for CDC grantees are now available at http:// grants.nih.gov/ grants/forms.htm. For further information, contact GrantsInfo@nih.gov. Additional resources concerning the eFSR/FFR system, including a User Guide and an on-line demonstration, can be found on the eRA Commons Support Page: https://era.nih.gov/registration_accounts.cfm.

FFR Submission: The submission of FFRs to CDC will require organizations to register with eRA Commons (Commons) (https:// commons. era.nih.gov/ commons/). CDC recommends that this one time registration process be completed at least 2 weeks prior to the submittal date of a FFR submission.

Organizations may verify their current registration status by running the “List of Commons Registered Organizations” query found at: https://era.nih.gov/registration_accounts.cfm. Organizations not yet registered can go tohttps:// commons. era.nih.gov/ commons/ registration/ registration Instructions. jsp for instructions. It generally takes several days to complete this registration process. This registration is independent of Grants.gov and may be done at any time.

The individual designated as the PI on the application must also be registered in the Commons. The PI must hold a PI account and be affiliated with the applicant organization. This registration must be done by an organizational official or their delegate who is already registered in the Commons. To register PIs in the Commons, refer to the eRA Commons User Guide found at: http:// era.nih.gov/ commons /index.cfm.

3. Final Reports

Final reports should provide sufficient detail for CDC to determine if the stated outcomes for the funded research have been achieved and if the research findings resulted in public health impact based on the investment. The grantee’s final report should include:

  • Research Aim/Project Overview: The PI should describe the purpose and approach to the project, including the outcomes, methodology and related analyses. Include a discussion of the challenges, successes and lessons learned. Describe the collaborations/partnerships and the role of each external partner.
  • Translation of Research Findings: The PI should describe how the findings will be translated and how they will be used to inform policy or promote, enhance or advance the impact on public health practice. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers and other potential end users. The PI should also provide a discussion of any research findings that informed policy or practice during the course of the project period. If applicable, describe how the findings could be generalized and scaled to populations and communities outside of the funded project.
  • Public Health Relevance and Impact: This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project related beyond the immediate study to improved practices, prevention or intervention techniques, or informed policy, technology or systems improvements in public health.
  • Publications; Presentations; Media Coverage: Include information regarding all publications, presentations or media coverage resulting from this CDC funded activity. Please include any additional dissemination efforts that did or will result from the project.
Section VII. Agency Contacts

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

Application Submission Contacts
Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov
Hours: 24 hours a day, 7 days a week; closed on Federal holidays

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues, FFR submission)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
Hours: Monday - Friday, 7am - 8pm U.S. Eastern Time

CDC Technical Information Management Section (TIMS)
Telephone 770-488-2700
Email: PGOTIM@cdc.gov
Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time

Scientific/Research Contact(s)

Travis Kubale, PhD
CDC/NIOSH/OEP
1600 Clifton Road NE, Mailstop E74
Atlanta, GA 30329-4018
Telephone: 513-841-4461
Fax:  404-498-2571
Email: TKubale@cdc.gov

Peer Review Contact(s)

Nina Turner, PhD
Scientific Review Officer, CDC/NIOSH/OEP
1095 Willowdale Road, Mailstop G800
Morgantown, WV 26505-2845
Telephone: 304-285-5976
Email: NTurner@cdc.gov.

Financial/Grants Management Contact(s)

Brandis Belser
Grants Management Officer, CDC/OCOO/OFR/OGS
2960 Brandywine Road, Mailstop E-01
Atlanta, GA 30341
Telephone: 770-4882-2676
Fax: 770-488-2640
Email: BBelser@cdc.gov

Section VIII. Other Information

Other CDC funding opportunity announcements can be found at www.grants.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.

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 Part 75.

Awards are made under the authorization of Sections of the Public Health Service Act as amended and under the Code Federal Regulations. 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); the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111-347; 42 USC 300mm – 300mm-61); 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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