Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise in this FOA. 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

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 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).

Background

In 2002, the Agency for Toxic Substances and Disease Registry (ATSDR) and the New York City Health Department (NYCHD) established the WTC Health Registry (http://www.nyc.gov/html/doh/wtc/html/home/home.shtml) with the goal of monitoring the health of people directly exposed to the WTC disaster. This goal included identifying long-term physical and mental health effects of the 9/11 WTC disaster; disseminating findings and recommendations to enrollees and others exposed, the public, and the scientific community; sharing information about 9/11-related resources and services; and informing healthcare policy and disaster response planning.

The Registry is an ongoing collaboration with the National Institute for Occupational Safety and Health. It is the largest post-disaster exposure health registry in U.S. history and includes a diverse cohort of over 71,000 directly affected people who performed 9/11-related rescue/recovery work or lived, worked, or attended school in lower Manhattan on 9/11/01.

To date, the Registry has completed three major health surveys (http://www.nyc.gov/html/doh/wtc/html/registry/survey-materials.shtml), and the fourth major health survey ( Wave 4 ), launched in 2015, is under way. During 2003 2004, over 71,000 persons voluntarily enrolled in the Registry by completing the first health survey ( Wave 1 ). The Registry completed its first follow-up health survey ( Wave 2 ) for adults in 2007 and for child enrollees in 2008. In 2011 2012, the Registry completed its second follow-up survey ( Wave 3 ) for adults, adolescents, and parents of adolescents. The results of these surveys will help determine to what extent physical and mental health conditions have persisted, and whether any new symptoms and conditions have emerged. Another important goal is to identify and help address gaps in physical and mental health care.

The Registry's annual reports, prepared for enrollees and the public, include information on its key activities and accomplishments, as well as details on recent findings about the health consequences of 9/11 (http://www.nyc.gov/html/doh/wtc/html/registry/newsletters.shtml).

Purpose

The purpose of this FOA is to extend and expand the WTC Health Registry developed and managed by the New York City Department of Health and Mental Hygiene in a cooperative agreement with CDC. The new project will ensure ongoing data collection for victims of the September 11, 2001, terrorist attacks on the WTC. The WTC Health Registry will continue to provide a central, unified database to assess short-term and long-term health and well-being effects among persons exposed to the WTC disaster.

As noted in the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111-347; 42 USC 300mm-300mm-61), the WTC Program Administrator shall ensure that such a registry is maintained and is as comprehensive as the WTC Health Registry in effect as of January 1, 2015, with the New York City Department of Health and Mental Hygiene for ensuring ongoing data collection relating to victims of the September 11, 2001, terrorist attacks.

A substantial amount of information about the WTC Health Registry can be found at http://www.nyc.gov/html/doh/wtc/html/registry/about.shtml. Current activities include periodic follow-up surveys, epidemiological analyses, cancer and mortality assessments, validating registry findings, identifying and investigating emerging health conditions, and facilitating independent, collaborative research with qualified researchers. There are also a variety of activities related to registry maintenance, registry outreach, dissemination, quality assurance, quality control, coordination, and collaboration.

Research Objectives

The overall objective of this announcement is to solicit meritorious and scientifically rigorous research applications that will address the Zadroga Act mandate to extend and expand the WTC Health Registry developed and managed by the New York City Department of Health and Mental Hygiene in a cooperative agreement with CDC. The new project will ensure ongoing data collection for victims of the September 11, 2001, terrorist attacks on the WTC. The WTC Health Registry will continue to provide a central, unified database to assess short-term and long-term health and well-being effects among persons exposed to the WTC disaster.

These are the specific aims of the project:

1. Maintain the Registry as a valuable public health resource to allow health professionals to track and investigate possible trends in illness and recovery.

2. Expand knowledge about the long-term health effects of 9/11 by facilitating medical, public health, or emergency preparedness research, or other scientific research relevant to the WTC Health Program with special emphasis on impacts to those who lived, worked, or attended school in the disaster area (i.e., non- responders ).

3. Conduct community activities to respond to the physical and mental health concerns and specific healthcare needs of enrollees and others exposed to 9/11.

4. Maintain the 9/11 Treatment Referral Program to help enrollees and others find care for 9/11-related health problems.

5. Collaborate with other WTC Health Program entities (Data Centers, Clinical Centers of Excellence) to explore surveillance signals and treatment outcomes as follows:

a. 9/11 linkage with uncommon health conditions, such as cancer and autoimmune and neurological disease (including age at diagnosis)

b. Treatment outcomes for selected conditions linked to 9/11

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• 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)
• Eligible Agencies of the Federal Government
• 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 NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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.

• System for Award Management (SAM): Applicants must maintain current registration in SAM (the replacement system for the Central Contractor Registration), to be renewed annually.
• Grants.gov
• eRA Commons

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

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

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

This FOA does not require cost sharing as defined in the NIH 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, 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 in the SF 424 (R&R) Application Guide. Such applications must include an introduction addressing the previous peer review critique (Summary Statement).

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

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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity 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 [email protected] 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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://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 http://grants.nih.gov/grants/forms.htm.

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

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

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

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

The letter of intent should be sent to:

Nina Turner, Ph.D.
Scientific Review Officer, CDC/NIOSH/OEP
1095 Willowdale Road, Mailstop G800
Morgantown, WV 26505-2845 USA
Telephone: 304-285-5976
Email: [email protected]

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 is limited to 75 pages. The page limits include tables, graphs, figures, diagrams, and charts.
• Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files, or 100 pages for all appendices.

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.

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

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

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

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

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 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 (http://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. Quality Assurance/Quality Control (QA/QC) Plan

18. Resource Sharing Plan(s)

19. Appendix

Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files, or 100 pages for all appendices.

*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 (http://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 instructions:

NIOSH considers the sharing of unique data and other research resources developed through the WTC Health Program 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.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as an expanded authority, but only if authorized by CDC. For more information on expanded authority and pre-award costs, see the NIH 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 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 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.

See more tips for avoiding common errors.

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 [email protected] 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.

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

Only the review criteria described below will be considered in the review process. As part of the 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.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed project to provide a central, unified database to assess short-term and long-term health effects among persons exposed to the WTC disaster; to facilitate efficient identification of potential participants for studies conducted by external researchers; and to serve as a sustained, powerful tool for the WTC Health Program and related research field(s) in consideration of the following review criteria and additional review criteria.

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

Does the project address important needs or critical barriers to help determine physical and mental health conditions that have persisted and new symptoms and conditions that 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 WTC Health Program, occupational health, or public health? Does the proposed project further develop the concept and usefulness of a WTC Health Registry? Will the proposed project further enhance access of the clinical research science community to WTC Health Program data resources? What is the potential impact of the project on emergency or disaster preparedness as it relates to occupational health and safety?

Are the PD/PIs, collaborators, and other key personnel well suited to the project? Do they have appropriate experience and training? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s), other registries, or the WTC Registry? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise? Are the leadership approach, governance and organizational structure appropriate for the project? Has the PI/PD devoted an adequate amount of time and effort to the project? Is there evidence of past collaborations with the WTC Registry or other registries?

Does the application describe how the WTC Health Registry will serve as a unique resource for researchers or practitioners? Does the application indicate how the WTC Health Registry will collaborate with other resources to further enhance its utility? Is the proposed project forward-looking with regard to registry practices, approaches or methodologies, 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 PI describe how the enhanced WTC Health Registry will serve as a unique resource for researchers and practitioners, and how the Registry will collaborate with other related resources to further enhance its utility? Does the application seek to support public health practice paradigms or approaches?

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 there methods for measuring and maximizing coverage, explaining and calculating outcome rates, or sample building and denominator estimation? Are the analytic plans clear, consistent with the research questions, and appropriate for the study design and data available? If the application is new, does it include a credible phase in plan for assuming the responsibilities of the registry? Are collaborative activities between the proposed Registry and other WTC Health Program components adequately described?

Does the application propose an adequate plan to disseminate results to state and local public health officials, community residents, and other concerned individuals and organizations? Does the applicant have experience effectively disseminating information to the community, state and local governments, and other stakeholders? Does the applicant have adequate experience working with these or similar stakeholder groups?

Does the application demonstrate an appropriate plan for community outreach and for interaction with the community? Does the proposal include outreach to enrollees to offer healthcare referrals based on survey data? Does the proposal include ways (website, reports, and direct communications) to help keep enrollees engaged? Does the applicant currently have a strong liaison component with the community, state and local governments, and other stakeholders? Does the applicant have adequate experience working with these or similar stakeholder groups?

Does the application propose adequate evaluation steps? Are measures included to assess process and outcomes? Does the applicant have adequate knowledge and experience with evaluation activities relevant to the WTC Health Registry or other registries?

Does the application propose adequate quality assurance/quality control steps for ensuring reliable operation of the WTC Health Registry? Does the applicant have experience with QA/QC activities related to the WTC Health Registry or other registries? Is there a plan to validate registry findings?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other available physical resources adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the proposed project further develop the concept and usefulness of a WTC Health Registry? Will the proposed project further enhance access of the clinical science community to WTC Health Program data resources? Does the applicant have an existing WTC Health Registry or other registry? Has the applicant addressed how it will work with the existing registry to maintain, enhance, and improve it through this new cooperative agreement? For potential collaborations, are the commitment and cooperation of other interested parties adequate, as evidenced by letters of support specifying the nature and extent of the involvement?

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.

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.

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

For renewal applications, the following factors will also be considered: Has the existing Registry made significant contributions to the WTC Health Program, as demonstrated by its accomplishments? Is there evidence of progress and achievement since the previous competitive review? Is there evidence of integration and synergy? Are collaborative activities between the existing Registry and other WTC Health Program components adequately described? Is there documentation through publications, conferences, etc., that demonstrates progress, accomplishments, and collaboration? Is there evidence that the registry has met its objectives and has been well utilized by the WTC Health Program and external researchers? Is there adequate justification for adding new projects or cores or for deleting components previously supported? Is there evidence of transfer of research findings? Have the specific commitments and plans for the Registry from the previous project period been met? Have high quality outputs contributed to improvements relevant to the WTC Health Program or broader occupational or public health practices?

Not Applicable

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

Not Applicable

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

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

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

• Will undergo a selection process in which all responsive applications will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned to the appropriate HHS/CDC Center, Institute, or Office. 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. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

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

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

All 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 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 reside 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.

Principal Investigator (PI) Rights and Responsibilities

The PD(s)/PI(s) will have primary responsibility for the following activities.

• Outreach: Planning and implementing strategies and approaches that will sustain general interest and knowledge about the WTC Registry to enhance continued participation; utilizing existing contacts with business and community groups and organizations to facilitate outreach
• Public Information Responsiveness: Supporting and maintaining a system for receiving and answering calls from the public regarding concerns and questions about the WTC Registry (NYCDOHMH call center); creating and maintaining a web site for the provision of easily accessible and up-to-date information about the WTC Registry
• Database and Analysis Infrastructure: Certifying that data are prepared for analysis within defined, optimal time frames; developing mechanisms for sharing selected and appropriate data elements with other WTC-related organizations that are also serving people who are impacted by their exposure to hazards associated with the WTC experience; verifying protocols for protecting the database from security violations and confidentiality breaches; verifying protocols for database backup and recovery
• WTC Registrant Information Updates: Establishing an infrastructure for regularly contacting WTC registrants; sending letters requesting updated contact information to a large proportion of registrants, selected on the basis of exposure category; managing staff and data system for inputting and correcting registrant contact information
• Data Dissemination: Preparing regular reports on enumeration of registrant populations, descriptive summaries, and emerging patterns of exposure or health status
• Registry Follow-Up Survey: Assessing the basis for continuing prospective analysis of the long-term health effects of the exposures associated with the WTC attacks and the aftermath
• Health Status Surveys: Matching registrants with cancer registries, hospitalization data, and vital records; performing appropriate analysis and disseminating findings
• External Registry Studies: Establishing methods and processes for permitting other researchers to use the registry; setting up a system for other bona fide researchers to obtain, under a formal request, de-identified registry data; setting up and managing a process for contacting consented registrants about other studies in which they may enroll.
• Alignment with WTC Health Program Research Agenda: Establishing a procedure that allows HHS/CDC/NIOSH staff to review proposed internal and external research projects to ensure alignment with the research needs, priorities, and goals of the WTC Health Program
• Program Evaluation: Conducting an assessment of (1) the relevance of the program’s activities to improving the health status of the cohort and (2) the impact that the program has had in reducing illness; measuring contributions of the program in terms of outputs and outcomes (intermediate or final) that are attributable to the program’s activities; using and explaining quantitative measures in such assessments
• Consultation and Collaboration: Developing science-based capacity for conducting epidemiological and demographic research related to the Registry under separate funding; attending and participating in bi-annual grantee research meetings

NOTE: 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.

HHS/CDC/NIOSH Responsibilities

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

• Developing and maintaining the infrastructure for managing and conducting outreach activities
• Developing information to be given to the public regarding concerns and questions about the WTC Registry, as well as communication materials that will inform and encourage enrollees to continue their participation
• Regularly evaluating registry information and data that describe the status of the cohort
• Consulting on the survey to evaluate prospectively the long-term health effects in this cohort associated with the WTC attacks
• Consulting on health status surveys for selected samples of registrants
• Consulting on evaluation plans for the Registry to determine its relevance to the improvement of health for the cohort and measures of impact
• Developing a system that will permit other researchers to use the registry data

Additionally, an agency program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

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.

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

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

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.

B. 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 be used to influence practices, procedures, methodologies, etc.?
• How will the findings, results, or recommendations contribute 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.

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: [email protected]
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: [email protected]
Hours: Monday - Friday, 7am - 8pm U.S. Eastern Time

CDC Technical Information Management Section (TIMS)
Telephone 770-488-2700
Email: [email protected]
Hours: Monday - Friday, 7am 4:30pm U.S. Eastern Time

There must be a contact for all participating ICs.
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: [email protected]

For PA and PAS, do not change the text shown below
Nina Turner, PhD
Scientific Review Officer, CDC/NIOSH/OEP
1095 Willowdale Road, Mailstop G800
Morgantown, WV 26505-2845
Telephone: 304-285-5976
Email: [email protected].

There must be a contact for all participating ICs.
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: [email protected]

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.

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 of 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); and 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.