Key Dates

Related Announcements

PAR-20-280 - Cooperative Research Agreements Related to the World Trade Center Health Program (U01)

Issued by

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)

Purpose

The updated requirements, guidance, instructions, and other information for PAR-20-280 are effective with the publication date of this notice.

Length of the Award Project Period

Applications are now limited to a maximum project period of four years. NIOSH will consider the following types of U01 cooperative research projects for 2021 due date/FY2022 funding.

The Research Strategy component of the Research Plan is limited to 12 pages for a long-term (up to 4 years) project. Proposals for intermediate-term (up to 3 years) or short-term (up to 2 years) projects shall limit their Research Strategy to 8 pages. These page limits are the totals for all text, tables, graphs, figures, diagrams, and charts in this component.

Note to Applicants

Please follow carefully "Content and Form of Application Submission" for forms package associated with this FOA and "Other Submission Requirements and Information" in Section IV. Application and Submission Information. As stated, you must include a Data Management Plan (DMP) in the Resource Sharing Plan(s) of the PHS 398 Research Plan Component of the application for each proposed collection of public health data. Additionally as noted, the following components are required for this FOA, and must be included as attachments in the "12. Other Attachments" section of the "R&R Other Project Information" section of the application. When uploading documentation into this application package, clearly label the documents for easy identification.

1. Project Dissemination Plan

2. Project Evaluation Plan

3. WTC Subpopulation(s) under study and Primary Diseases/Conditions (please also include the study design of your proposed study) as attachment "Study Information"

4. Risk Assessment Questionnaire (include form and supporting documentation)

5. Duplication of Efforts (required if this application will result in programmatic, budgetary, or commitment overlap with another application or award submitted to another funding source in the same fiscal year. Write "No Overlap" if no overlap.)

If the subpopulation you propose to study includes only WTC Survivors, you are strongly encouraged to submit your application to the FOA RFA-OH-22-004 for funding consideration by the NIOSH WTC Health Program (see Section I. Target Population for descriptions of allowed WTC subpopulation).

Section I. Funding Opportunity Description

Statutory Authority

The World Trade Center (WTC) Health Program is authorized under the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111–347, as amended by Public Laws 114–113 and 116–59); codified in Title XXXIII of the Public Health Service Act at 42 U.S.C. §§ 300mm – 300mm–61, 124 Stat. 3623).

Section IV. Application and Submission Information

Data Management Plan (DMP): CDC requires recipients for projects and programs that involve data collection or generation of data with federal funds to develop and submit a Data Management Plan (DMP) for each collection of public health data.

Applicants that plan to collect public health data must submit a DMP in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• A description of the data to be generated in the proposed project;
• Standards to be used for the collected or generated data;
• Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);
• Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and
• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

CDC OMB approved templates may be used (e.g. NCCDPHP template). Other examples of DMPs may be found at USGS.

Expanded Authority:

For more information on expanded authority and pre-award costs, go to the HHS Grants Policy Statement and speak to your Grants Management Specialist.

All CDC/NIOSH awards are subject to the federal regulations, in 45 CFR Part 75, terms and conditions, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

Public Health Data:

CDC requires that mechanisms for, and cost of, public health data sharing be included in grants, cooperative agreements, and contracts. The cost of sharing or archiving public health data may also be included as part of the total budget requested for first-time or continuation awards.

Data Management Plan:

Fulfilling the data-sharing requirement must be documented in a Data Management Plan (DMP) that is developed during the project planning phase prior to the initiation of generating or collecting public health data and must be included in the Resource Sharing Plan(s) section of the PHS398 Research Plan Component of the application.

Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds (for example, privacy and confidentiality considerations, and embargo issues).

Recipients who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance (for example, reduction in funding, restriction of funds, or award termination) consistent with 45 CFR 74.62 or other authorities as appropriate. For further information, please see revised AR-25.

Human Subjects

Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board (IRB) approvals are in place. Copies of all current local IRB approval letters and local IRB approved protocols (and CDC IRB approval letters, if applicable) will be required to lift restrictions.

If the proposed research project involves more than one institution and will be conducted in the United States, awardees are expected to use a single Institutional Review Board (sIRB) to conduct the ethical review required by HHS regulations for the Protections of Human Subjects Research, and include a single IRB plan in the application, unless review by a sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy or a compelling justification based on ethical or human subjects protection issues or other well-justified reasons is provided. Exceptions will be reviewed and approved by CDC in accordance with Department of Health and Human Services (DHHS) Regulations (45 CFR Part 46), or a restriction may be placed on the award. For more information, please contact the scientific/research contact included on this FOA.

Note: The sIRB requirement applies to participating sites in the United States. Foreign sites participating in CDC-funded, cooperative research studies are not expected to follow the requirement for sIRB.

Section VI. Award Administration Information

Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please visit here and here for more information.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see link.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please visit here and here.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please visit here and here.

Additions to the Generally applicable ARs

AR-34: Accessibility Provisions and Non-Discrimination Requirements

AR-37: Prohibition on certain telecommunications and surveillance services or equipment for all awards issued on or after August 13, 2020

Additional Policy Requirements

Language Access for Persons with Limited English Proficiency

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see here and LEP website. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care here.

Final Reports

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

• Research Aim/Project Overview: The PI should describe the purpose and approach to the project, including the outcomes, methodology and related analyses. Include a discussion of the challenges, successes and lessons learned. Describe the collaborations/partnerships and the role of each external partner.
• Translation of Research Findings: The PI should describe how the findings will be translated and how they will be used to inform policy or promote, enhance or advance the impact on public health practice. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers and other potential end users. The PI should also provide a discussion of any research findings that informed policy or practice during the course of the Period of Performance. If applicable, describe how the findings could be generalized and scaled to populations and communities outside of the funded project.
• Public Health Relevance and Impact: This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project related beyond the immediate study to improved practices, prevention or intervention techniques, or informed policy, technology or systems improvements in public health.
• Publications; Presentations; Media Coverage: Include information regarding all publications, presentations or media coverage resulting from this CDC-funded activity. Please include any additional dissemination efforts that did or will result from the project.
• Final Data Management Plan: Applicants must include an updated final Data Management Plan that describes the data collected, the location of where the data is stored (example: a repository), accessibility restrictions (if applicable), and the plans for long term preservation of the data.

Specific guidance for the final report and annual outcome update is available on the NIOSH OEP website under Grant Closeout.

Termination

CDC may impose other enforcement actions in accordance with 45 CFR 75.371- Remedies for Noncompliance, as appropriate.

The Federal award may be terminated in whole or in part as follows:

(1) By the HHS awarding agency or pass-through entity, if the non-Federal entity fails to comply with the terms and conditions of the award;

(2) By the HHS awarding agency or pass-through entity for cause;

(3) By the HHS awarding agency or pass-through entity with the consent of the non-Federal entity, in which case the two parties must agree upon the termination conditions, including the effective date and, in the case of partial termination, the portion to be terminated; or

(4) By the non-Federal entity upon sending to the HHS awarding agency or pass-through entity written notification setting forth the reasons for such termination, the effective date, and, in the case of partial termination, the portion to be terminated. However, if the HHS awarding agency or pass-through entity determines in the case of partial termination that the reduced or modified portion of the Federal award or subaward will not accomplish the purposes for which the Federal award was made, the HHS awarding agency or pass-through entity may terminate the Federal award in its entirety.

Section VIII. Other Information

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

Awards are made under the authorization of Sections of the Public Health Service Act as amended and under the Code Federal Regulations. Awards are made under the authorization of the Section 301 of the Public Health Service Act as amended (42 U.S.C. 241); Federal Regulations 42 CFR Part 52 and 45 CFR Part 75; and the James Zadroga 9/11 Health and Compensation Act of 2010 (Public Law 111–347, as amended by Public Laws 114–113 and 116–59; codified in Title XXXIII of the Public Health Service Act at 42 U.S.C. §§ 300mm – 300mm–61, 124 Stat. 3623). All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Inquiries

Please direct all inquiries to:

James Yiin, PhD
Scientific Program Official
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention (CDC)
Telephone: 513-841-4271
Email: [email protected]