Notice Number: NOT-OH-16-014

Key Dates
Release Date: March 3, 2016

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:

Changing 2016 Receipt Date
The application due date for PAR-16-098 "Cooperative Research Agreements Related to the World Trade Center Health Program (U01)" is April 19, 2016.

Adding Email Address for Scientific/Research Contact(s)
The email address for the Scientific/Research Contact is TKubale@cdc.gov.

Additional Review Criteria
For PAR-16-098 "Cooperative Research Agreements Related to the World Trade Center Health Program (U01)" the following items are added as Additional Review Criteria and are not Additional Review Considerations.

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.

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

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

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

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

Review of Application Type
Resubmissions. For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals. For Renewals, the committee will consider the progress made in the last funding period.

Revisions. For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Inquiries

Please direct all inquiries to:

Travis Kubale, PhD
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health (NIOSH)
Telephone: 513-841-4461
Email: TKubale@cdc.gov