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	Cooperative Research Agreements Related to the World Trade Center Health Program (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	July 31, 2014 - See NOT-OH-14-009. The purpose of this Notice is to inform applicants about the 2014 receipt date, the 2014 Letter of Intent Date, the maximum project period and the maximum budget that can be requested, and the revised expiration date for the FOA. August 23, 2013 - See Notice NOT-OH-13-015. The purpose of this Notice is to inform applicants on changes to the 2013 receipt date, the 2013 Letter of Intent Receipt Date, the maximum project period, and budget ceilings. December 10, 2012 - See Notice NOT-OH-13-008. Clarification of Maximum Funding Period. November 21, 2012 - See Notice NOT-OH-12-008. Delay in Grant Application Submission due to the extent of the storm damage. November 2, 2012 - See Notice NOT-OH-12-006. Delay in Grant Application Submission due to Hurricane Sandy. July 26, 2012 - See Notice NOT-OH-12-001. Update to Cooperative Research Agreements Related to the World Trade Center Health Program (U01).
Funding Opportunity Announcement (FOA) Number	PAR-12-126
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.262, Occupational Safety and Health Program
Funding Opportunity Purpose	The purpose of this announcement is to support research projects and epidemiologic studies to help answer critical questions about physical and mental health conditions related to the September 2001 terrorist attacks including: biomarkers of exposures or health outcomes; epidemiologic studies; exposure-response relationships; improvements in diagnosis and treatment; patterns of illness (age, gender, etc.); risk factors for disease; and other research studies on WTC-related health conditions or emerging conditions.

Posted Date	March 23, 2012
Open Date (Earliest Submission Date)	April 21, 2012
Letter of Intent Due Date	April 20, 2012, September 24, 2012, (October 2, 2013 per NOT-OH-13-015), Originally September 24, 2013; September 24, 2014; (New Date November 2, 2014 per NOT-OH-14-009)
Application Due Date(s)	May 21, 2012, [(Extended to December 14, 2012 per NOT-OH-12-008), Originally Extended to November 30, 2012 per NOT-OH-12-001)] Originally October 24, 2012; (December 2, 2013 per NOT-OH-13-015 Originally October 24, 2013); New Date December 2, 2014 per NOT-OH-14-009 (Originally October 24, 2014); by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard dates
Advisory Council Review	Standard dates
Earliest Start Date(s)	Standard dates
Expiration Date	December 03, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This program 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 Parts 74 and 92; and the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111-347; 42 USC 300mm- 300mm-61).

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. 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 (1) among enrolled WTC responders and certified-eligible WTC survivors under treatment; and (2) in sampled populations outside the New York City disaster area in Manhattan as far north as 14th Street and in Brooklyn, along with (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/NIOSH/topics/wtc/stac/).

While the full scope of 9/11-related health problems is unknown, a growing body of evidence suggests that significant health conditions have emerged that are associated with the disaster, in particular for those exposed during the collapse of the towers and those who participated substantially in rescue, recovery, and clean-up operations.

Information on reports published about health effects in various WTC-exposed populations can be found at http://www.cdc.gov/niosh/topics/wtc/science.html. Information on research supported by the World Trade Center Health Registry can be found at: http://www.nyc.gov/html/doh/wtc/html/registry/newsletters.shtml.

Scientific reporting allows health care professionals to make earlier diagnoses of WTC conditions, which leads to more effective treatment. However, scientifically identifying the causes of health problems or conditions is typically very difficult. While it is often not 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.

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:

• biomarkers of exposures or health outcomes;
• epidemiologic studies;
• exposure-response relationships;
• improvements in diagnosis and treatment;
• patterns of illness (age, gender, etc.);
• risk factors for disease; and
• other research studies on WTC-related health conditions or emerging conditions.

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

• Aerodigestive health
• Auto-immune diseases
• Cancer (including detection/diagnosis of pre-malignant changes)
• Gastro-esophageal disorders
• Gastrointestinal health
• Mental health
• Musculoskeletal disorders
• Respiratory diseases
• Sarcoidosis

People exposed to the September 2001 terrorist attacks include responders and community members (also referred to as survivors). Responder cohorts or populations include:

• local responders (FDNY and others) who were exposed and (a) still live in the NYC area or (b) have since moved away from the NYC area, and
• responders who came from outside the NYC area to assist with the response and subsequently returned to their respective home areas.

Community members (adults and children) who were exposed include people who (a) still live in the NYC area or (b) have since moved away from the NYC area.

This research program will contribute to the CDC strategic goal, in alignment with an HHS strategic goal, to increase the number of communities that protect and promote health and safety and prevent illness and injury to improve the safety, quality, affordability and accessibility of health care.

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; and
• improve diagnosis and treatment activities of the WTCHP.

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 four years	Up to $1M
Intermediate-term	Up to two years	Up to $500K
Short-term	Up to one year	Up to $250K

There are a wide range of research needs that 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 2012, NIOSH anticipates funding 3-4 long term U01 projects, 10-14 intermediate-term U01 projects, and 8-10 short-term U01 projects.

NIOSH would like to achieve a suitable mix of projects that help advance the understanding of health impacts related to the September 2001 terrorist attacks. Increased understanding of interactions between health conditions, patterns of illness, exposure-response relationships, and risk factors is critical for achieving improved treatment and intervention protocols.

Data/Resource Sharing

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 current Data Centers are committed to making data collected available to health researchers by implementing and maintaining a comprehensive data sharing plan (DSP). Through the DSP, data will be provided for research projects that have been, or will be, funded by NIOSH.

Applicants considering projects that depend on interaction or collaboration with the Data Centers 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 needed to conduct the proposed research. Documentation of 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 and a response letter from the Data Center to the investigator.

Data Center Contacts

Fire Department of New York

Director - Dr. David Prezant, 718-999-2696, prezand@fdny.nyc.gov

Administrator - Ms. Lara Glass, 717-999-5142, glassl@fdny.nyc.gov

Mount Sinai School of Medicine

Director - Dr. Roberto Lucchini, 212-824-7052, roberto.lucchini@mssm.edu

Administrator - Mr. Matthew Cassidy, 212-241-9788, matthew.cassidy@mssm.edu

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

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

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 scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Renewal ResubmissionRevision The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIOSH intends to commit over a four-year period about $60M in total costs (direct and indirect) to fund 50-60 applications. It is expected that awards issued under this announcement will range from 1-4 years in duration. Awards issued under this FOA are contingent on the availability of funds and the submission of a meritorious application.
Award Budget	The combined total budget for a four-year project period may not exceed $4M. The combined total budget for a two-year project may not exceed $1M. The total budget for a one-year project may not exceed $250K.
Award Project Period	Allowable project periods are four years for a long-term project, two years for an intermediate term project, and one year 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.

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

Higher Education Institutions

• 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 CDC/NIOSH 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

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

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 HHS Grants Policy Statement, are not allowed.

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

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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.

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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

When multiple PD(s)/PI(s) are proposed, NIOSH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PD(s)/PI(s) and NIOSH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD(s)/PI(s). For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide, http://grants.nih.gov/grants/multi_pi

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

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

As defined in the HHS Grants Policy Statement, 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 SF 424 (R&R) Application Guide. Such applications must include an Introduction addressing the previous peer review critique (Summary Statement).

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

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

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

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

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

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

The letter of intent should be sent to:

Joan F. Karr, Ph.D.
CDC/NIOSH/OEP
1600 Clifton Road NE, MS E74
Atlanta, GA 30333 USA
Telephone: 404-498-2506
Fax: 404-498-2571
Email: JKarr@cdc.gov

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 all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

• For this FOA, the Research Strategy component of the Research Plan for a long-term (4 year) project is limited to 12 pages. Proposals for intermediate-term (2 year) projects or short-term (1 year) projects should limit their Research Strategy to 6 pages. These pages limits include tables, graphs, figures, diagrams, and charts.

Applicants should use the SF424 Research and Related Budget (Detailed Budget)

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

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://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html.

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. Information on the HHS/CDC data sharing policy is available at: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar25 and http://www.cdc.gov/od/foia/policies/sharing.htm.

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 associated with the World Trade Center Health Program must coordinate in advance with the respective Directors or Administrators of the Data Centers (see list below) in order to ensure access to data needed to conduct the proposed research. Documentation of 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 and a response letter from the Data Center to the investigator.

Data Center Contacts

Fire Department of New York

Director - Dr. David Prezant, 718-999-2696, prezand@fdny.nyc.gov

Administrator - Ms. Lara Glass, 717-999-5142, glassl@fdny.nyc.gov

Mount Sinai School of Medicine

Director - Dr. Roberto Lucchini, 212-824-7052, roberto.lucchini@mssm.edu

Administrator - Mr. Matthew Cassidy, 212-241-9788, matthew.cassidy@mssm.edu

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.

Appendix

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission. If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant 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).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov).

This initiative is not subject to intergovernmental review.

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

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

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

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the 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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Applicants should anticipate that a grantee meeting will be held at least annually. These may alternate between webinar type meetings and in-person meetings. While the location of face-to-face meetings is currently not known, applicants should budget for the meetings to be in Atlanta. These meetings will likely be 1-2 days. Applicants should budget for 1-2 people to attend the in-person meetings.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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

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).

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?

Investigator(s)

Are the principal investigators, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the investigators have a successful track record in public health research? Is there evidence of past collaborations with the proposed research team? Have previous research results provided high quality outputs and contributed to improvements in public health practice and population health?

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

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 to use 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 clinical research, are the 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?

If the project involves collaboration with the current Clinical Centers of Excellence or Data Centers, are there 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 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?

Dissemination Plan

Does the application propose an adequate plan to summarize findings and disseminate results?

Evaluation

Does the proposal include adequate evaluation steps to validate process and outcomes?

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/priority score, but will not give separate scores for these items.

Limitations of Currently Available Data

Health effects related to the September 2001 terrorist attacks are considered to be primarily a result of being exposed during the attacks, while responding to the resulting disaster, or 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 which may contribute to the onset of specific diseases. Likewise, existing health conditions 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.

While it often may not 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.

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 HHS/CDC Requirements under AR-1 Human Subjects Requirements (http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1).

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the policy on the Inclusion of Women and Racial and Ethnic Minorities in Research (http://www.cdc.gov/OD/foia/policies/inclusio.htm).

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.

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/priority 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

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.

Applications will be evaluated for scientific and technical merit by an appropriate peer review group, in accordance with CDC/NIOSH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review process, 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/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, recommended applications will receive a second level of review for programmatic relevance and balance. The following will be considered in making funding decisions:

Scientific and technical merit as determined by scientific peer review.

• Availability of funds.
• Relevance to WTCHP priorities.
• Contribution to a blend of studies to advance understanding of health impacts on populations covered by the WTCHP.
• Contribution toward development of guidelines for improved treatment, intervention or healthcare for populations covered by the WTCHP.
• Commitment of the applicant institution to collaborative efforts and.
• Adequacy of resource sharing plan.
• Administrative/managerial capability of the applicant institution.

After the peer review of the application is completed, the PD(s)/PI(s) 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://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

Any applications awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements. If the application is under consideration for funding, NIOSH will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) and 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.

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).

Applicants should review the information on additional requirements available at the following internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

The following additional requirement is of particular importance for this announcement:

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. Developed 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 CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. Successful applicants and the Program Official will determine the documentation format.

Information on the HHS/CDC data sharing policy is available at the following websites: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar25. http://www.cdc.gov/od/foia/policies/sharing.htm.

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://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html.

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 (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other 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 in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and HHS/CDC as defined below.

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

• 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 based on the defined sampling strategy; conducting appropriate data management procedures.
• Analyzing data and disseminating findings in peer-reviewed journals and presentations at scientific conferences and other meetings.
• Participating in one reverse site visit with CDC in Atlanta on an annual basis.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and 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, the activities described below:

• Assisting in review of research protocols (e.g., for sampling, recruitment, assessment, and data management)
• Advising on, or participating in, analysis, interpretation, and dissemination of study findings.
• Participating in reverse site visits with grantees in Atlanta on an annual basis.
• Monitoring and evaluating the scientific and operational accomplishments of the project through conference calls, site visits, 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 notice of grant award.

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 notices of grant awards. 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:

• 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 non-competitive continuation of the award.
• Recommending corrective actions as needed.
• Carry out administrative and technical related duties e.g., grant cycle or funding information, programmatic approvals and recommendations, consultation or technical assistance pertaining to administration requirement of award, monitor performance of the recipient, process Just-In-Time (JIT) information for research projects, approve final reports before release and distribution, communicate guidance and policy, facilitate budget recommendations, program/site visit, dissemination of grantee information and research reports.
• Provide guidance or information for addressing recipient inquiries.

Participate in grantee meetings, and facilitate development of goals and agenda for these 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 the NIOSH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the awardee, one NIOSH designee, and a third 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.

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

The web site includes information on each Federal financial assistance award and contract over $25,000, including such information as:

1. The name of the entity receiving the award

2. The amount of the award

3. Information on the award including transaction type, funding agency, etc.

4. The location of the entity receiving the award

5. A unique identifier of the entity receiving the award; and

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

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the Central Contractor Registry; and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the Federal Funding Accountability and Transparency Act of 2006, please review the following website: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) (http://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 Grant Progress Report (HHS/PHS 2590; http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (HHS/PHS 2590). The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (HHS/PHS 2590)

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required when for closeout an award is relinquished, as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Travis Kubale, Ph.D.
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

Joan F. Karr, Ph.D.
CDC/NIOSH/OEP
1600 Clifton Road NE, MS E74
Atlanta, GA 30333 USA
Telephone: 404-498-2506
Fax: 404-498-2571
Email: JKarr@cdc.gov

Ruben Cruz
Centers for Disease Control & Prevention
Procurement and Grants Office, Field Branch V
626 Cochrans Mill Road
P.O. Box 18070
Pittsburgh, PA 15236-0070
(412) 386-6724
Fax: (412) 386-6429
Email: rcruz@cdc.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 HHS Grants Policy Statement.

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.