SPECIAL NOTICE
70 -- Enterprise License - JOFOC
- Notice Date
- 6/2/2017
- Notice Type
- Special Notice
- NAICS
- 541511
— Custom Computer Programming Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, 5th Floor, Rockville, Maryland, 20852-3804, United States
- ZIP Code
- 20852-3804
- Solicitation Number
- HHS-NIH-OLAO-NOI-ORSC-2017
- Archive Date
- 6/22/2017
- Point of Contact
- Susan Cortes-Shrank, Phone: 301-402-3066
- E-Mail Address
-
cortesshranks2@od.nih.gov
(cortesshranks2@od.nih.gov)
- Small Business Set-Aside
- Woman Owned Small Business
- Description
- IRB JOFOC PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health, Office of Logistics and Acquisition Operations (OLAO), Office of Acquisitions (OA) intends to award a purchase order without providing for full and open competition (Including brand-name) to IMedRIS Data Corporation to acquire enterprise license and support of the Instituional Review Board Sorftware (IRB) assistant module. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541511 with a Size Standard $25.5. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-95 This acquisition is conducted under the procedures as prescribed in FAR 19.15 Women Onwed Small Business Program. STATUTORY AUTHORITY This acquisition is conducted under the authorities of: 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). 15 U.S.C. 637(m) under provisions of the statutory authority of FAR Subpart 6.207- FAR 6.207 - (a) To fulfill the statutory requirements relating to 15 U.S.C. 637(m), contracting officers may set aside solicitations for only EDWOSB concerns or WOSB concerns eligible under the WOSB Program (see 19.1505). (b) No separate justification or determination and findings is required under this part to set aside a contract action for EDWOSB concerns or WOSB concerns eligible under the WOSB Program. PERIOD OF PERFORMANCE From the time of award, the final purchase order will have a 12-month base period and one 12-month option periods. Place of Performance National Institutes of Health, 31Center Drive, Building 1, Basement 1C Bethesda, MD 20814 DESCRIPTION OF REQUIREMENT The Contractor shall provide enterprise license and support of the Instituional Review Board Sorftware (IRB) assistant module. The NIH Institutional Review Board (IRB) system needs to provide support for an unlimited number of users to perform the key functions outline in Figure 1: Figure 1. NIH IRB System Functional Hierarchy of Features • Pre-IRB Review - This module allows investigators to conduct reviews prior to IRB submission to determine protocol feasibility. This includes support for concept, branch, scientific, and statistical reviews. The system needs also provide the ability for IRB pre-reviews. • IRB Review - Functions within this area need to support the six IRB board reviews and operations. This includes data capture for expedited, full board, submissions types (initial, continuing, amendment) and study closure. The system must also provide functions to support data imports from the Collaborative Institutional Training Initiative (CITI) database, and central IRB reviews for multi-site studies. • Concurrent or After IRB Review - The system needs to provide features to support ethics evaluations, including Recombinant DNA advisory reviews (RAC), Institutional Biosafety Committee (IBC) reviews, radiation safety committee and radioactive drug research committee assessments (RSC/RDRC). The system should also allow the Office of Protocol Services (OPS) and Clinical Center (CC) to conduct protocol reviews after the IRB review process. Data outputs from the IRB system must also facilitate the registration of approved protocols with ClinicalTrials.gov. • Problem Report Form (PRF) Management - The NIH IRB system must also provide features for the data capture, review, and reporting functions required for serious adverse events (SAEs), protocol deviations, unanticipated problems, noncompliance reporting, and letter templates for reporting to the Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP). CLOSING STATEMENT This synopsis is not a request for competitive proposals. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Wednesday, June 7, 2017 to the Contracting Officer, Susan Cortes-Shrank, at susan.cortes-shrank@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/OoA/HHS-NIH-OLAO-NOI-ORSC-2017/listing.html)
- Place of Performance
- Address: Main Campus, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04530400-W 20170604/170602234112-befd57336da1467a4ce8b1c72d75a6d8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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