MODIFICATION
D -- Pharmacovigiliance COTs Software and IT Lifecycle Services - Responses to Vendor Questions - Amendment 1
- Notice Date
- 8/1/2016
- Notice Type
- Modification/Amendment
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- 16-223-SOL-00079
- Archive Date
- 8/24/2016
- Point of Contact
- Jody L. OKash, Phone: 2404024996, Sherry Solodvoka,
- E-Mail Address
-
jody.okash@fda.hhs.gov, sherry.solodvoka@fda.hhs.gov
(jody.okash@fda.hhs.gov, sherry.solodvoka@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Updated Attachment 4: Pricing Sheet Revised 16-223-SOL-00079 Redacted FACTS data sheet - supporting information in response to technical questions Government responses to vendor questions The purpose of this amendment is to upload Government responses to vendor questions, edit description details, extend the response date for quotes, and upload revised documents (16-223-SOL-00079 and Attachment 4: Pricing Sheet). i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented by Part 13 and additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. ii. The solicitation number is 16-223-SOL-00079. This is a Request for Quotation (RFQ) under Part 13. iii. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-88. iv. This RFQ is unrestricted. The NAICS code is 541519, size standard $27.5M. v. This RFQ is for the implementation of a Commercial-Off-the-Shelf (COTs) pharmacovigilance software tool that will assist the Center for Foods Safety and Applied Nutrition (CFSAN) collect and monitor adverse events associated with foods, cosmetics, and dietary supplements. Description: This Request for Quote (RFQ) is to set up an Indefinite Delivery Indefinite Quantity (IDIQ) contract vehicle to purchase a COTs pharmacovigilance software tool and obtain full IT lifecycle support services from initiation to disposition to meet CFSAN's post marketing, surveillance, and outreach objectives. It is anticipated the new COTs solution will replace the current legacy Adverse Event (AE) reporting system. This requirement includes development of a transition plan for migrating data from the legacy AE system to the new COTs solution. vi. The FAR provisions at 52.212-1, Instructions to Offerors -- Commercial, 52.212-3, Offeror Representations and Certifications -Commercial Items, and 52.209-5, Certification Regarding Responsibility Matters apply to this acquisition. As a reference, Clause 52.212-1 section (b) of which described the form and content of submissions/quotes, and which quoters shall follow, is the following: (b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show- (1) The solicitation number; (2) The time specified in the solicitation for receipt of offers; (3) The name, address, and telephone number of the offeror; (4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary; (4a) SUPPLEMENTAL INSTRUCTIONS: The quoter shall provide a technical solution demonstrating the quoter's understanding of and knowledge of the Government's requirement, objectives and tasks as defined in the attached IDIQ and Task Order SOWs. The quoter shall have separate sections in Volume I: Technical Quote demonstrating their capability to meet requirements identified in to the IDIQ and Task Order. The technical approach to the IDIQ shall not exceed 15 pages. The technical approach to the Task Order shall not exceed 15 pages. The technical solution shall demonstrate that the solution provided (including quoted products, services, and approach) meets the program and minimum requirements set forth in both the IDIQ and Task Order SOWs. General statements that the Quoters can or will comply with the requirements, that standard procedures will be used, that well-known tecniques will be used, or paraphrases of the SOW in whole or in part, will not constitute meeting the requirements set forth in the IDIQ or Task Order SOWs. (4b) SUPPLEMENTAL INSTRUCTIONS: Quoters proposing COTS pharmacovigilance software must be capable of supporting the objectives identified in section 2.1 of the IDIQ SOW and meet the mandatory product features /functionalities identified in Attachment 8. The quoters shall identify whether the features are available out of the box, require configurations, or customizations to be compliant. The quoter shall describe the expected resources, level of effort, and timeframe to conduct configurations and customizations. The quoter shall complete and submit Attachment 8, "Product Features and Functionalities.xlsx as part of their quote. (4c) SUPPLEMENTAL INSTRUCTIONS: If the proposing quoter is a large business they are required to submit a Small Business Subcontract Management plan in accordance with FAR 52.219-9 and HHS policy. Please see Attachment No. 9 for the most current HHS Small Business Subcontract plan. (4d) SUPPLEMENTAL INSTRUCTIONS: Past Performance The quoter shall identify whether they are registered in the Past Performance Information Retrieval System (PPIRS). If the contractor is registered and has evaluations stored in PPIRS, the contractor shall identify a minimum of three performance evaluations for efforts similar to this requirement, the name of the Government Agency services were provided to, contract number, dates of performance, and total dollar value. If the contractor is not registered in PPIRS they must state they have no active evaluations. (4e) SUPPLEMENTAL INSTRUCTIONS: 508 Product Assessment Template. The HHSAR Provision at 352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015). (a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. (b) Accordingly, any quoter responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards. (c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility. In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, quoters must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows quoters or developers to self-evaluate their supplies and document-in detail-whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508. In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, quoterss must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues. (d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a quoter claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense. (End of provision) (5) Terms of any express warranty; (5a) SUPPLEMENTAL INSTRUCTIONS: Terms of any express warranty shall cover software and software licenses provided by this IDIQ. This discussion of warranty shall be included in the technical solution described in instruction 4 and 4a. (6) Price and any discount terms; (6a) SUPPLEMENTAL INSTRUCTIONS: The quoter shall fill out and return Attachment 4: Pricing Worksheet as the means of providing their pricing for the products and services required. Please note in tab 3, titled, "Labor", of the pricing workbook the Government has recommended Labor Categories that are deemed necessary for successful performance of the task areas identified in the IDIQ SOW (see Attachment No. 7 for labor category descriptions). The Government has also provided level of effort per labor category for each IDIQ contract year. The contractor shall not change the recommended labor categories or level of effort as it is used to show a basis for the Government's IDIQ ceiling amount. Quoters shall map their labor categories to the Government's labor categories should their titles differ. (7) "Remit to" address, if different than mailing address; (8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically); (8a) SUPPLEMENTAL INSTRUCTIONS: Per FAR 52.212-3(b), by submission of a quote to this solicitation, the quoter verifies that the representations and certifications currently posted at sam.gov are current accurate complete and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), with exceptions, if any, identified by paragraph. Therefore, quoters shall not submit documentation of their representations and certifications in response to this quote, excluding exceptions. (9) Acknowledgment of Solicitation Amendments; (10) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration. Quote Submission Instructions Quotes shall consist of the following documents, delivered electronically, to the Point of Contact for this solicitation: 1) Signed and dated quote, containing at a minimum the information from instructions 1, 2, 3, 7, 8, 9 and 11 (if instruction 11 is applicable). 2) A technical solution per instruction 4. This shall include the warranty information per instruction 5. 3) List of three Performance Evaluation stored in Government Performance Evaluation System (if applicable) 4) Completed Attachment No. 4: Completed Pricing Worksheet with cells unlocked 5) Completed Attachment No. 6: Non-Disclosure Statement for Key Personnel. 6) Completed Attachment 8: Product Features and Functionalities 7) Completed Attachment No. 9: Small Business Subcontracting Plan (large businesses only) 8) 508 Product Assessment Template vii. FAR Provision 52.212-2 - Evaluation - Commercial Items applies to this solicitation. (a) The Government will award a contract resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation provides the best value to the Government. (b) Price: The Government will evaluate the total evaluated price of the IDIQ and task order. All Quoters providing quotations must clearly state the overall cost to the Government and complete pricing on Attachment No. 4: Pricing Sheet with cells unlocked. Pricing should be in alignment or discounted from the quoter's commercial pricing for similar services. As necessary to determine prices are fair and reasonable, the Government may conduct cost analysis as described in FAR 15.404-1(c) or use other methods of price reasonableness as described in FAR 13.106-3(a)(2). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful quoter within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision) The following factors shall be used to evaluate offers: 1. Factor 1 - Technical Capability Volume 1 - a. Section 1: Approach to IDIQ SOW - Page Limit: 15 pages 1. Appendix 1 to Section 1: Completed Attachment 8: Product Features and Functionalities 2. Appendix 2 to Section 1: Completed Attachment 9: Small Business Subcontracting Management Plan (if applicable - large businesses only). 3. Appendix 3 to Section 1: List of three Past Performance references stored in PPIRS(if applicable). 4. Appendix 4 to Section 1: 508 Product Assessment Template b. Section 2: Approach to Task Order SOW - Page Limit: 15 pages 1. Appendix 1 to Section 2: Key Personnel Resumes (not included in Page count for Task Order / individual resumes shall not exceed 3 pages) 2. Appendix 2 to Section 2: Completed Attachment No. 6: for Key Personnel identified in Attachment 2: Task Order SOW Volume 2- 2. Factor 2: Price - Shall be submitted on Attachment No. 4: Pricing Sheet with cells unlocked. Technical Capability is more important when compared to price. The Government will evaluate technical capability adjectivally as Excellent, Highly Satisfactory, Satisfactory, or Unsatisfactory. Although the Government reserves the right to open discussions if the Contracting Officer deems it appropriate, offerors are apprised that the Government intends to issue an award without discussions. Supplemental information regarding the evaluation: Technical Capability: The Government's evaluation of Technical Capability will assess the quality of the quote's technical solution; determine the quoter's understanding of and knowledge of the Government's requirement, objectives and tasks as defined in the attached IDIQ and Task Order SOWs. The evaluation will also consider the degree to which the quote provides assurance that the solution (including proposed products, services, and approach) will meet the program and minimum requirements set forth in the IDIQ, Task Order SOW, and Product Features / Functionalities identified in attachment 8. In addition, if the company is a large business the Government will evaluate the extent their Small Business Subcontracting Management Plan assist in meeting FDA's small business goals. An acceptable plan must, in the determination of the Contracting Officer, provide the maximum opportunity for small business concerns and small business concerns owned and controlled by socially and economically disadvantaged persons to participate in the performance of the contract. If the apparently successful quoter fails to negotiate a subcontracting plan acceptable to the contracting officer within the time limit prescribed by the contracting officer, the quoter will be ineligible for award. Key Personnel Resumes: The Government will evaluate the likelihood of the experience and skill set of proposed key personnel to result in successful delivery of products and services identified in Task Order. Past Performance (Risk Assessment): The Government shall also evaluate a quoter's past performance as part of the overall risk assessment, not as a weighted factor. Past Performance will be given a rating of Positive, Negative, or Neutral. Quoter's that do not have past performance information stored in PPIRS will be given a risk assessment score of "neutral". Please note the Government will review the evaluations identified by the quoter as similar to this requirement but also reserves the right to use any performance evaluation associated with the quoter that is stored in PPIRS. Performance risks are those associated with an Offeror's likelihood of success in performing the acquisition requirements as indicated by that Offeror's record of past performance. The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an Offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information. viii. FAR Provision 52.212-3, Offeror Representations and Certifications apply to this solicitation. ix. The following FAR Provisions are incorporated by reference and apply to this solicitation: 52.209-7 Information Regarding Responsibility Matters. (Jul 2013) 52.204-7 System for Award Management (Jul 2013), 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certifications (Oct 2015) 52.233-2 -- Service of Protest. (Sep 2006) (a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from Jody O'Kash,5630 Fishers Lane, Rm. 2084 Rockville, MD 20854. (b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. (End of Provision) x. Please see the document titled, 16-223-SOL-00079 for a list of FDA, HHSAR, and FAR clauses that apply to this action. xi. Questions - It shall be the obligation of the Quoter to exercise due diligence to discover and to bring to the attention of the Contracting Officer (CO) at the earliest possible time, any ambiguities, discrepancies, inconsistencies, or conflicts between the statement of work and other documents attached hereto or incorporated by reference herein. Questions shall be e-mailed to jody.o'kash@fda.hhs.gov, with cc to sherry.solodkova@fda.hhs.gov no later than 05:00pm Eastern Time (local), July 21, 2016. The closing date will not be extended for the purpose of responding to questions received after this date. xii. Quoters shall provide a quotation to the FDA comprised and separated into individual technical and price (business) volumes. The quotations shall contain a statement indicating the period of time the quotation is in effect; not less than 120 calendar days from the RFQ due date. The quotations shall be submitted electronically via email to jody.o'kash@fda.hhs.gov, with cc to sherry.solodkova@fda.hhs.gov by Tuesday, August 9 at 5pm Eastern time (local). Electronic versions of the technical quotation shall be formatted in both Microsoft Word 97 or greater or Adobe Portable Document Format (PDF) and electronic versions of the cost/price quote shall be formatted in Microsoft Excel 97 or greater or in a spreadsheet convertible to Microsoft Excel.
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FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/16-223-SOL-00079/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
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