Changes to Funding Opportunity Announcement RFA-CA-15-022 "Proteogenomic Translational Research Centers for Clinical Proteomic Tumor Analysis Consortium (U01)"

Notice Number: NOT-CA-16-004

Key Dates
Release Date:   December 9, 2015

Related Announcements
NOT-CA-16-016
RFA-CA-15-022   

Issued by
National Cancer Institute (NCI)

Purpose

This Notice modifies the recent Funding Opportunity Announcement by the National Cancer Institute (NCI): RFA-CA-15-022 entitled "Proteogenomic Translational Research Centers for Clinical Proteomic Tumor Analysis Consortium (U01)".

This FOA is a part of the NCI program for Clinical Proteomic Tumor Analysis Consortium (CPTAC).
The major change for RFA-CA-15-022 is the delayed application due date (now May 11, 2016) and accordingly updated matrix of other dates. This change is meant to give prospective applicants the additional time that they will likely need for the complicated arrangements and collaborations associated with the required studies using human tumor biospecimens from the NCI-supported clinical trials.

There are also some clarifications regarding the nature of documentation that applicants must provide to document that they will have a proper access to clinical biospecimens for the proposed studies and an update to scientific contacts.

The following sections of RFA-CA-15-022 are revised as shown below.

 

1) The Section "Key Dates" is modified to read as follows.

Part 1. Key Dates

The FOA currently reads:

Posted Date

November 2, 2015

Open Date (Earliest Submission Date)

December 27, 2015

Letter of Intent Due Date(s)

30 days prior to application due date

Application Due Date(s)

January 27, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

April - May 2016

Advisory Council Review

August 2016

Earliest Start Date

September 2016

Expiration Date

January 28, 2016

Due Dates for E.O. 12372

Not Applicable

The FOA is modified to read:

Posted Date

November 2, 2015

Open Date (Earliest Submission Date)

April 11, 2016

Letter of Intent Due Date(s)

30 days prior to application due date

Application Due Date(s)

May 11, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October-November 2016

Advisory Council Review

January 2017

Earliest Start Date

April 2017

Expiration Date

May 12, 2016

Due Dates for E.O. 12372

Not Applicable

2)The"Research Objectives and Main Requirements for this FOA" are being revised to clarify the need for documented commitment for access to clinical trial specimens.

Part 2. Section I. Funding Opportunity Description

Research Objectives and Main Requirements for this FOA

Under the subheading "Human Biospecimens", the text currently reads:

At the time of application submission, research projects must have access (written approval) to characterize such specimens from NCI-sponsored clinical trials at the start of the program.

The FOA is modified to read:

At the time of application submission, applicants must have appropriately documented commitment for access to clinical trial specimens to be used in the proposed research. This documentation should follow the guidelines for letter(s) of support in obtaining specimens from ETCTN and NCTN studies, listed at http://proteomics.cancer.gov/aboutoccpr/fundingopportunities/current/Reissuance-of-Clinical-Proteomic-Tumor-Analysis-Consortium. For details, see Section IV. Research Plan under “Letters of Support”.

3) The instructions for Letters of Support are being revised to clarify the need for documented commitment for access to clinical trial specimens.

Part 2. Section IV.2 Instructions for Application Submission

PHS 398 Research Plan

The text currently reads:
Letters of Support: In addition to standard items, provide letter(s) of commitment for access to clinical trial specimens to be used in the proposed research. These letter(s) must clearly state that applicants will have access to clinical specimens needed for the research projects proposed and specify the following parameters:

  • Expected number of such specimens and amounts that will be available to the PTRC applicants;
  • Timing of the availability (listed by relevant categories, such as tumor type, treatment type, etc.);
  • Specimen nature (including whether pre-treatment, post-treatment, or both);
  • Types of accompanying data (medical, genomic, etc.);
  • Any other critical information about specimens must have access (written approval) to characterize such specimens from NCI-sponsored clinical trials at the start of the program.

The text is modified to read:
Letters of Support: In addition to standard items, provide letter(s) of support for access to clinical trial specimens to be used in the proposed research. For this FOA, please refer to the guidelines for letter(s) of support in obtaining specimens from ETCTN and NCTN studies, listed at http://proteomics.cancer.gov/aboutoccpr/fundingopportunities/current/Reissuance-of-Clinical-Proteomic-Tumor-Analysis-Consortium.  For other NCI-sponsored clinical trials, please describe the required approval process for obtaining clinical specimens collected during the trial and the investigator’s commitment to fulfill these requirements.  In addition, letter(s) must at least specify the following parameters:

  • Expected number of such specimens and amounts that will be available to the PTRC applicants;
  • Timing of the availability (listed by relevant categories, such as tumor type, treatment type, etc.);
  • Specimen nature (including whether pre-treatment, post-treatment, or both); and
  • Types of accompanying data (medical, genomic, etc.)."

4) Section VII, the names under Scientific/Research Contacts are updated to read:

Scientific/Research Contact(s)

For general aspects of the entire Clinical Proteomic Tumor Analysis Consortium, contact:
Henry Rodriguez, MS, PhD, MBA
National Cancer Institute (NCI)
Telephone: 301-451-8883 
Email: rodriguezh@mail.nih.gov

For issues related to proteomics/genomics research, contact:
Emily Boja, PhD
National Cancer Institute (NCI)
Telephone: 301-451-1079
Email:  bojae@mail.nih.gov

For issues related to clinical research, contact:
Mehdi Mesri, PhD
National Cancer Institute (NCI)
Telephone: 301-451-2149
Email:  mesrim@mail.nih.gov

For issues related to CPTAC public resources, contact:
Tara Hiltke, PhD
National Cancer Institute (NCI)
Telephone: 301-451-8511
Email:  hiltket@mail.nih.gov

For issues related to National Clinical Trials Network (NCTN), contact:
Elise Kohn, MD
National Cancer Institute (NCI)
Telephone: 240-276-7163
Email: kohne@mail.nih.gov

For issues related to Phase I Experimental Therapeutics Clinical Trials Network (ETCTN), contact:
S. Percy Ivy, MD 
National Cancer Institute (NCI)
Telephone: 240-276-6565
Email: ivyp@ctep.nci.nih.gov

For issues related to Phase II Experimental Therapeutics Clinical Trials Network (ETCTN), contact:
Jeffrey Moscow, MD 
National Cancer Institute (NCI)
Telephone: 240-276-6565
Email: jeffrey.moscow@nih.gov

For issues related to Diagnostic Biomarkers and Technology, contact:
James Tricoli, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5725
Email: tricolij@mail.nih.gov

All other aspects of RFA-CA-15-022 remain unchanged. Likewise, the companion CPTAC FOAs,(RFA-CA-15-021 and RFA-CA-15-023) remain unchanged.

Inquiries

Please direct all inquiries to:

Henry Rodriguez, MS, PhD, MBA
National Cancer Institute (NCI)
Telephone: 301-451-8883 
Email: rodriguezh@mail.nih.gov