FDA's Adverse Event Reporting System (FAERS) II

Added: Jun 06, 2018 11:55 pm Modified: Jun 22, 2018 3:30 pmTrack Changes The purpose of Amendment No. 0001 is to:

1) Post Questions and Answers (Q&A)

2) Provide updated documents:
RFP Attachment 1: IDIQ Terms and Conditions
RFP Attachment 2: IDIQ SOW
RFP Attachment 3: FAERS II DME SOW
RFP Attachment 4: FAERS II Requirements
RFP Attachment 6: FAERS II Pricing Sheet

3) Provide new RFP Document:
RFP Attachment 13: VPAT 2.1

4) Extend proposal due date until 3pm Eastern Time, July 9, 2018


(i) This is a combined synopsis/solicitation for commercial services prepared in accordance with the FAR part 12, 15, and 16.5 procedures. In order to Streamline this requirement FAR part 12 procedures were used to the maximum extent possible. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is FDA-SOL-18-1192468 and is being issued as a Request for Proposal (RFP).

(iii) This solicitation and incorporated provisions are those in effect through Federal Acquisition Circular 2005-97.

(iv) The NAICS code is 541512, Computer Systems Design Services. The small business size standard is $27.5M. The Government intends to issue a single award Indefinite Delivery Indefinite Quantity (IDIQ) Contract with a five year ordering period and concurrent one task order resulting from this Request for Proposal (RFP) to the single responsible Offeror whose proposal is determined to be the best value to the Government. Additional task orders will be issued in the future.

At the discretion of the Contracting Officer, the government may use Labor Hour, Time and Materials, Firm Fixed Price contract types, or a combination thereof, for the task orders. Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government's determination of contract type.

(v) The FDA requires the purchase and implementation of a suite of Pharmacovigilance Commercial Off the Shelf (COTS) products that is Brand Name or Equivalent to the products listed in the RFP Attachments. The purpose is to replace the FDA's Legacy Adverse Event Reporting System (FAERS) with a new suite of Pharmacovigilance COTs products; obtain configuation / integration / implementation / and O&M support services for the new system, and ultimately improve Adverse Event case management, case processing, data analytics, and signal management.

(vi) This is a Brand Name or Equal to Solicitation.  Please see RFP Attachments for more detail on the brand name pharmacovigilance COTS products the Government is seeking to obtain.

(vii) PERIOD OF PERFORMANCE: (est) 09/15/2018 - 09/14/2023

(viii) The provision at FAR 52.212-1 titled, "Instructions to Offerors -Commercial" (JAN 2017), applies to this acquisition and is available at website: http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P257_45709.

(ix) The provision at FAR 52.212-2, titled, "Evaluation of Commercial Items" (OCT 2014), is applicable to this acquisition.

This evaluation will be conducted using a combination of best value methodologies (See RFP Attachment 1 for more detail). The Government reserves the right to establish a competitive range and award without discussions. Technical merit will more important than price in evaluating proposals (Please see RFP Attachment No. 1: IDIQ Terms and Conditions for Instructions to Offerors and Evaluation Criteria)

(x) In accordance with 52.212-3 all Offerors shall complete annual Representations and Certifications in the System for Award Management.

(xi) FAR clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition.

(xii) FAR clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition.

(xv & xvi) All questions must be emailed to jody.okash@fda.hhs.gov, with cc to Tzeleong.Chang@fda.hhs.gov no later than Thursday, June 14, 2018 at 1pm ET. Please note the FDA solicitation number (FDA-SOL-18-1192468), project title (FAERS II), company name, and topic (Questions) must be identified in the subject line of all correspondence and submittal of questions. Answers to all questions will be posted as an amendment to the solicitation on Federal Business Opportunities. Technical and Business Proposal are due no later than Tuesday, June 26, 2018 at 12pm ET. See attached IDIQ Terms and Conditions, Section 4.1 for general instructions on proposal submissions.

Added: Jun 06, 2018 11:55 pm (i) This is a combined synopsis/solicitation for commercial services prepared in accordance with the FAR part 12, 15, and 16.5 procedures. In order to Streamline this requirement FAR part 12 procedures were used to the maximum extent possible. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is FDA-SOL-18-1192468 and is being issued as a Request for Proposal (RFP).

(iii) This solicitation and incorporated provisions are those in effect through Federal Acquisition Circular 2005-97.

(iv) The NAICS code is 541512, Computer Systems Design Services. The small business size standard is $27.5M. The Government intends to issue a single award Indefinite Delivery Indefinite Quantity (IDIQ) Contract with a five year ordering period and concurrent one task order resulting from this Request for Proposal (RFP) to the single responsible Offeror whose proposal is determined to be the best value to the Government. Additional task orders will be issued in the future.

At the discretion of the Contracting Officer, the government may use Labor Hour, Time and Materials, Firm Fixed Price contract types, or a combination thereof, for the task orders. Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government's determination of contract type.

(v) The FDA requires the purchase and implementation of a suite of Pharmacovigilance Commercial Off the Shelf (COTS) products that is Brand Name or Equivalent to the products listed in the RFP Attachments. The purpose is to replace the FDA's Legacy Adverse Event Reporting System (FAERS) with a new suite of Pharmacovigilance COTs products; obtain configuation / integration / implementation / and O&M support services for the new system, and ultimately improve Adverse Event case management, case processing, data analytics, and signal management.

(vi) This is a Brand Name or Equal to Solicitation.  Please see RFP Attachments for more detail on the brand name pharmacovigilance COTS products the Government is seeking to obtain.

(vii) PERIOD OF PERFORMANCE: (est) 09/15/2018 - 09/14/2023

(viii) The provision at FAR 52.212-1 titled, "Instructions to Offerors -Commercial" (JAN 2017), applies to this acquisition and is available at website: http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P257_45709.

(ix) The provision at FAR 52.212-2, titled, "Evaluation of Commercial Items" (OCT 2014), is applicable to this acquisition.

This evaluation will be conducted using a combination of best value methodologies (See RFP Attachment 1 for more detail). The Government reserves the right to establish a competitive range and award without discussions. Technical merit will more important than price in evaluating proposals (Please see RFP Attachment No. 1: IDIQ Terms and Conditions for Instructions to Offerors and Evaluation Criteria)

(x) In accordance with 52.212-3 all Offerors shall complete annual Representations and Certifications in the System for Award Management.

(xi) FAR clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition.

(xii) FAR clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition.

(xv & xvi) All questions must be emailed to jody.okash@fda.hhs.gov, with cc to Tzeleong.Chang@fda.hhs.gov no later than Thursday, June 14, 2018 at 1pm ET. Please note the FDA solicitation number (FDA-SOL-18-1192468), project title (FAERS II), company name, and topic (Questions) must be identified in the subject line of all correspondence and submittal of questions. Answers to all questions will be posted as an amendment to the solicitation on Federal Business Opportunities. Technical and Business Proposal are due no later than Tuesday, June 26, 2018 at 12pm ET. See attached IDIQ Terms and Conditions, Section 4.1 for general instructions on proposal submissions.