Updates for PAR-16-098 "Cooperative Research Agreements Related to World Trade Center Health Program (U01)"

Notice Number: NOT-OH-16-022

Key Dates
Release Date: August 15, 2016

Related Announcements
PAR-16-098

Issued by
Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH)

Purpose

The following changes are hereby made to the announcement:

Section 1. Funding Opportunity Description

Length of the Award Project Period for "Long Term" Projects
The project period for Long Term projects is up to 4 years with a total cost per year up to $600K.

Data Center and WTC Health Registry Contacts
Fire Department of New York
Administrator Jessica Weakley, 718-999-0412, Jessica.weakley@fdny.nyc.gov

Mount Sinai School of Medicine
Co-Deputy Director and Administrator Andrew C. Todd, PhD, 212-824-7053, andy.todd@mssm.edu

Major areas of interest
Specific Collaboration Requirement for Research Proposal Involving Children Exposed to the 9/11 Disaster

Only a small number of children exposed to 9/11 were enrolled in either the 9/11 Health Registry or the WTC Health Program. In the 15 years that have passed since 2001, many of these children have now advanced in age thus further reducing the number of children available for recruitment as research subjects. To maximize the likelihood of success of future research efforts, and minimize the recruitment burden to this small cohort, NIOSH will only accept applications when proposed research activities reflect collaborations by multiple institutions to achieve an integration of physical, behavioral and mental health of children/youth and adequately address recruitment challenges to provide adequate statistical power.

Section IV. Application and Submission Information because the application package has been updated by NIH please refer to the following revised application instructions

2. Content and Form of Application Submission

Instructions in the SF424 (R&R) Application Guide
Applicants responding to PAR-16-098 "Cooperative Research Agreements Related to World Trade Center Health Program (U01)" are to use the SF424 (R&R) Application Guide for "Forms Version D" updated on March 25, 2016.

Required Components

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

Research Related Budget
All instructions in the SF424 (R&R) Application Guide (Forms Version D) must be followed. The Research Related Budget must be provided for all proposed budget periods.

Project Performance Site Locations(s)
All instructions in the SF424 (R&R) Application Guide (Forms Version D) must be followed.

Research and Related Senior/Key Person Profile (Expanded)
All instructions in the SF424 (R&R) Application Guide (Forms Version D) must be followed.

PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide (Forms Version D) must be followed.

PHS 398 Research Plan
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. Progress Report Publication List (for Continuation only)

Human Subjects Section
5. Protection of Human Subjects
6. Data Safety Monitoring Plan
7. Inclusion of Women and Minorities
8. Inclusion of Children

Other Research Plan Sections
9. Vertebrate Animals
10. Select Agent Research
11. Multiple PD/PI Leadership Plan.
12. Consortium/Contractual Arrangements
13. Letters of Support
14. Resource Sharing Plan(s)
15. Authentication of Key Biological and/or chemical Resources

Research and Related Other Project Information
All instructions in the SF424 (R&R) Application Guide (Forms Version D) must be followed.
Please note: The Project Dissemination Plan and the Project Evaluation Plan should be included in the "Research and Related Other Project Information" form; line #12. "Other Attachments."

PHS Inclusion Enrollment Report
All instructions in the SF424 (R&R) Application Guide (Forms Version D) must be followed.

Appendix

Optional Component

R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT
All instructions in the SF424 (R&R) Application Guide (Forms Version D) must be followed.

5. Funding Restrictions
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.

Section V. Application Review Information

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

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

Section VII. Agency Contacts

Financial/Grants Management Contact(s)
Kerwin A. Lawrence
Grants Management Specialist, CDC/OCOO/OFR/OGS
2960 Brandywine Road, Mailstop E-01
Atlanta, GA 30341
Telephone: 770-488-1120
Fax: 770-488-2640
Email: KLawrence2@cdc.gov

Inquiries

Please direct all inquiries to:

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