This Notice was RESCINDED on March 21, 2018, please see NOT-HL-18-609 that replaces it.

RESCINDED

RESCINDED - Notice of Correction to Application Instructions in RFA-HL-19-008: Limited Competition: Clinical Research Sites for the MACS/WIHS Combined Cohort Study (MACS/WIHS-CCS) (U01 Clinical Trial Not Allowed)

Notice Number: NOT-HL-18-592

Key Dates
Release Date: February 13, 2018  (Rescinded March 21, 2018)

Related Announcements
RFA-HL-19-008

Issued by
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

On December 22, 2017, NHLBI and Participating ICs issued RFA-HL-19-008 "Limited Competition: Clinical Research Sites for the MACS/WIHS Combined Cohort Study (MACS/WIHS-CCS) (U01 Clinical Trial Not Allowed)". The purpose of this Notice is to alert the scientific community to an additional attachment required in the application.

Part 2. Section IV. Application and Submission Information

Current Language:

SF424 (R&R) Other Project Information

Other Attachments:  The attachments listed below must be completed or the application will not be peer reviewed. The names will be reflected in the final image bookmarking for easy access for reviewers.

1. Collaboration Plan
A Collaboration Plan must be provided as an attachment using the filename "Collaboration.pdf" and may not exceed 6 pages. The Collaboration Plan must clearly define the interactions between and integration of the MACS/WIHS-CCS, how information and resources will be exchanged, plans for communication, processes for making decisions on scientific direction, and procedures for resolving conflicts. Describe plans to enable scientific collaboration across CRS sites and with external investigators. Without repeating information from individual biosketches, describe plans to achieve synergy and interaction among key investigators to ensure efficient cooperation, communication and coordination across the CRSs. Describe communication plans for study leadership committees and science work groups.

2. Data Management Plan
A Data Management Plan must be provided as an attachment using the filename "Data Management.pdf" and may not exceed 5 pages. The Data Management Plan must describe internal and external data sharing strategies as appropriate and consistent with achieving the goals of the MACS/WIHS-CCS science interests. Where applicable, applicants are expected to describe plans for data harmonization, metadata generation, adoption/use of data standards or common data elements, and consortium-wide information technology infrastructure deployment.

3. Statistical Analysis Plan
A Statistical Analysis Plan must be provided as an attachment using the filename "Statistical Analysis Plan.pdf" and may not exceed 6 pages. The Statistical Analysis Plan should describe statistical design, power of overall study and studies restricted to subsets of participants, list outcome measures to be included in the unified science agenda, and describe innovative approaches to statistical analysis of prospective observational cohort data.

4. Biospecimen Plan
A Biospecimen Plan must be provided as an attachment using the filename "Biospecimen Plan.pdf" and may not exceed 5 pages. The Biospecimen Plan must clearly describe facilitation of biorepository access by MACS/WIHS-CCS and other investigators. The Biospecimen Plan should also describe how
study biospecimens will be collected, managed, analyzed, and stored. Applicants must include plans for maintenance and organization of existing and future biospecimens. Describe plans for adherence to Good Laboratory Practices (GLP). Opportunities to leverage institutional resources should be detailed, if applicable.

Revised Language:

SF424 (R&R) Other Project Information

Other Attachments:  The attachments listed below must be completed or the application will not be peer reviewed. The names will be reflected in the final image bookmarking for easy access for reviewers.

1. Collaboration Plan
A Collaboration Plan must be provided as an attachment using the filename "Collaboration.pdf" and may not exceed 6 pages. The Collaboration Plan must clearly define the interactions between and integration of the MACS/WIHS-CCS, how information and resources will be exchanged, plans for communication, processes for making decisions on scientific direction, and procedures for resolving conflicts. Describe plans to enable scientific collaboration across CRS sites and with external investigators. Without repeating information from individual biosketches, describe plans to achieve synergy and interaction among key investigators to ensure efficient cooperation, communication and coordination across the CRSs. Describe communication plans for study leadership committees and science work groups.

2. Data Management Plan
A Data Management Plan must be provided as an attachment using the filename "Data Management.pdf" and may not exceed 5 pages. The Data Management Plan must describe internal and external data sharing strategies as appropriate and consistent with achieving the goals of the MACS/WIHS-CCS science interests. Where applicable, applicants are expected to describe plans for data harmonization, metadata generation, adoption/use of data standards or common data elements, and consortium-wide information technology infrastructure deployment.

3. Statistical Analysis Plan
A Statistical Analysis Plan must be provided as an attachment using the filename "Statistical Analysis Plan.pdf" and may not exceed 6 pages. The Statistical Analysis Plan should describe statistical design, power of overall study and studies restricted to subsets of participants, list outcome measures to be included in the unified science agenda, and describe innovative approaches to statistical analysis of prospective observational cohort data.

4. Biospecimen Plan
A Biospecimen Plan must be provided as an attachment using the filename "Biospecimen Plan.pdf" and may not exceed 5 pages. The Biospecimen Plan must clearly describe facilitation of biorepository access by MACS/WIHS-CCS and other investigators. The Biospecimen Plan should also describe how
study biospecimens will be collected, managed, analyzed, and stored. Applicants must include plans for maintenance and organization of existing and future biospecimens. Describe plans for adherence to Good Laboratory Practices (GLP). Opportunities to leverage institutional resources should be detailed, if applicable.

5. Technical Details and Specifications of Assessments and Procedures
Technical details and specifications of assessments and procedures, grouped by listed component, must be provided as an attachment using the filename "Technical Specifications.pdf".

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Sean Altekruse
National Heart, Lung, Blood Institute (NHLBI)
Telephone: 301-435-1290
Email: altekrusesf@mail.nih.gov