NOT-HL-18-609: Revision: 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)

Revision: 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)e

Notice Number: NOT-HL-18-609

Key Dates
Release Date: March 21, 2018

Related Announcements
NOT-HL-18-592 Rescinded
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)". This Notice replaces NOT-HL-18-592 to alert the scientific community to a correction in the list of attachments required for the application.

Part 2. Section IV. Application and Submission Information

Current Language:

SF424 (R&R) Other Project Information

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

Other Attachments: The attachment listed below must be completed and attached or the application will not be peer reviewed.

Clinical Research Site History

A description of the Clinical Research Site's history and research program must be provided as an attachment using the filename "Clinical Research Site History.pdf" and may not exceed 4 pages. Provide details for each bullet below:

Document the Clinical Research Site's ability to implement a diversified portfolio of research protocols including ancillary research projects.
Document key CRS personnel leadership of HIV-related comorbidity research, through publication and accepted manuscripts, as first or last author.
Describe the purpose, frequency and methods of previous CRS interactions with community advocacy groups.

Revised Language:

SF424 (R&R) Other Project Information

1. Clinical Research Site History
A description of the Clinical Research Site's history and research program must be provided as an attachment using the filename "Clinical Research Site History.pdf" and may not exceed 4 pages. Provide details for each bullet below:

Document the Clinical Research Site's ability to implement a diversified portfolio of research protocols including ancillary research projects.
Document key CRS personnel leadership of HIV-related comorbidity research, through publication and accepted manuscripts, as first or last author.
Describe the purpose, frequency and methods of previous CRS interactions with community advocacy groups.

2. 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".

Inquiries

Please direct all inquiries to:

Sean Altekruse, DVM, MPH, PhD
National Heart, Lung, Blood Institute (NHLBI)
Telephone: 301-435-1290
Email: [email protected]