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D -- Imports and Systems Inspection, Regulatory Compliance, and Enforcement (SIRCE)

Notice Date
Notice Type
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
Solicitation Number
Archive Date
Point of Contact
Justin Cole, Phone: 2404027579, Sherry Solodkova,
E-Mail Address
justin.cole@fda.hhs.gov, sherry.solodkova@fda.hhs.gov
(justin.cole@fda.hhs.gov, sherry.solodkova@fda.hhs.gov)
Small Business Set-Aside
Amendment 2 ****STATUS UPATE**** As a result of the Sources Sought, the FDA anticipates going forward with a full and open, single award IDIQ. The FDA intends to release the RFP in the 2nd quarter of the fiscal year. This information is subject to change. For informational purposes only, no response is needed. Amendment 1 Questions and Answers for FDA-17-040917 TITLE: FDA Office of Regulatory Affairs (ORA) Imports and Systems Inspection, Regulatory Compliance, and Enforcement (SIRCE) Sources Sought Number: FDA-17-040917 Notice Type: Sources Sought Classification Code: 70 -- General purpose information technology equipment NAICS Code : 541519 The purpose of this request for information is to obtain technical and/or business information and input from the marketplace for the Imports and SIRCE requirement. The U.S. Food and Drug Administration's Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products, and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with its state, local, tribal, territorial and foreign counterparts. The FDA Office of Information Management and Technology (OIMT) supports ORA through the design, development, and application of information technologies to facilitate ORA operations and provide capabilities to meet ORA's mission to safeguard the foods, drug, devices, biologics, veterinary, and tobacco products that the Agency regulates. The field users of the ORA systems work in 20 district offices, more than 150 resident posts and border stations, 13 laboratories, and several international offices. Other system users work in ORA headquarters organizations and in the compliance offices of every FDA Center. The daily work of these users includes field work, import operations, compliance actions, and laboratory operations, as well as overarching needs to plan and manage their workload and to manage the shared information about the firms that FDA regulates. Users external to the FDA also use certain ORA systems, to support collaboration and communication between federal, state, and industry participants to achieve FDA's public health mission. ORA systems are amongst FDA's most heavily used, with over 6,000 total users and as many as 600+ concurrently. The Mission Accomplishment and Regulatory Compliance Services (MARCS) Investment was initiated to upgrade and replace many of ORA's legacy systems. In 2016, MARCS was divided into the two current investments: 1) Imports and 2) Systems for Inspection, Regulatory Compliance, and Enforcement (SIRCE), to better manage ongoing efforts to maintain and enhance the 25+ applications and components within ORA's portfolio of transactional systems. Together, these systems support the operational work of ORA in the Agency's imports and domestic regulatory responsibilities. The import program staff in the field require applications to support import entry review including Prior Notice review, fieldwork assignment, and compliance decision making for the millions of import entry lines that are received each year. The ORA systems also support the domestic business processes for planning and conducting inspections, federal/state partnerships, workload management, investigative operations, laboratory analysis, compliance work, and other mission-critical activities. In accordance with FAR Part 10 Market Research the FDA will use the results of the market research to determine if sources capable of satisfying the agency's requirements exist based on its response to the questions contained in this notice. This Sources Sought is being issued by the Food and Drug Administration (FDA) for services related to Imports and SIRCE requirement. FDA welcomes responses from all interested parties. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION. Telephone inquiries will not be accepted or acknowledged, and no feedback, discussions, or evaluations will be provided to companies regarding their submissions or information received. FDA does not intend to make a selection decision or award a contract on the basis of responses. Interested vendors shall provide the following information: Questions Provide a brief corporate profile of your company to include the following: Organization's official name and dba name, if applicable; Length of time the Organization has been in business; Types of services provided by your Organization; Types of clients by industry (i.e. Federal, Commercial, Local Government, etc.); Whether the Organization is U.S. based or International; If the Organization is a subsidiary of another Organization; DUNS number and CAGE number; Organization's website address; Main point of contact name, phone number, and email address; SBA size designation information and small business concern type (if applicable); Number of employees in the organization; Organization's most recent annual receipts amount as defined by the SBA. Tax Identification Number Any applicable Socio-Economical Classification(s): 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, Women-Owned and Small Disadvantaged Business. • 2. Verify whether the requirement can be met by one source or if your company would need to enter into multiple partnerships or teaming arrangement to complete the work. •a. What task areas can your company perform as the prime? •b. What task areas would need to be subcontracted out? •c. Please explain how your company would select teaming arrangements / partnerships to successfully support all Imports and SIRCE task areas identified by the Government? •d. If your company is a small business would you be able to support a contract of this size and complexity while maintaining compliance with 52.219-14, Limitation on Subcontracting (Jan 2017) • i. If so, please explain how you will maintain compliance. • ii. If not, do you recommend part of this acquisition be set aside for small businesses? • 3. What contract vehicle do you recommend for this requirement? •a. GSA Single Award BPA •b. Multiple Single Award BPAs •c. GSA Multiple Award BPA •d. Single Award IDIQ •e. Multiple Single Award IDIQs. •f. Multiple Award IDIQ •g. Other: Please explain • 4. Are the scopes of the draft IDIQ SOW and the Assignments DME SOW clearly defined? •a. If not, what information needs to be added, changed, and/or reworded to clarify the Government's requirements? •b. Do you have sufficient information in the SOW and attachments to propose on this effort? •c. Has FDA omitted any critical information in the associated Statement of Work that is needed? 5. Does your organization have an existing GSA schedule for these types of services outlined in the draft SOW? The FDA is considering awarding an IDIQ/BPA up to 10 years. Will your organization's existing GSA schedule have enough option years to cover the entire Period of Performance? If so, please provide the ultimate completion date of your firm's GSA Schedule. 6. What is your Organization's experience relevant to the Task Area Requirements described in draft SOW? Please list any Federal Government, State and/or Local Government, and/or Commercial customers for projects that you have worked on that are similar in scope, size, and complexity. Development, Modernization, and Enhancement: describe your capabilities to develop new systems, modernize existing mission critical systems, and to enhance those systems without disruption to business operations. Operations and Maintenance: describe your capability to provide support to a program with many mission-critical interdependent systems. • i. Describe your experience in supporting a Tier 2 or Tier 3 24x7 help desk while simultaneously engaging in software development and maintenance. • ii. Describe your experience providing support to 24x7 systems that are comparable to the systems in the draft SOW. • iii. Describe your experience in reducing the cost of O&M for a complex environment such as the one in the draft SOW with legacy and modernized systems. •d. Integration: describe your capability to integrate systems, including those developed by multiple contractor teams, in a complex environment like that at FDA. •e. What is the estimated dollar value of these projects? •f. Please complete the capability matrix (template attached) to provide an overview of your company's experience developing and maintaining systems using some of the technologies used by ORA systems. 7. Describe the most complex production technology environment (i.e., Operating System, DBMS, architecture, application server, middleware, number of databases and sizes, size of application system, number of transactions a day, number of internal vs. external interfaces etc.) your company has provided O&M service for? What is the length of this service? 8. Transition: describe your capability to rapidly assume responsibility for a project of the size and scope in this contract. How long of a transition period do you recommend in seamlessly transitioning O&M services for complex systems such as those in the draft SOW from an incumbent contractor. • 9. What NAICS codes would your company recommend for this action? 10. What resources (i.e. labor categories, skill sets) have you used in your relevant experiences to perform these types of services outlined in the draft SOW? Are the resources for performing the SOW tasks currently available? Describe the qualifications and certifications of the key personnel you have used/would use to fulfill the requirements of the type of work in the draft SOW. The FDA has included suggested labor categories in attachment J. • i. What additional labor categories do you recommend for the attached work? • ii. What labor categories, if any, are unnecessary or redundant? How would your company recruit for the positions necessary to accomplish the work under this requirement (both O&M and any DME)? 11. Do you suggest any particular evaluation criteria that would effectively allow FDA to discriminate between offerors? SUBMISSION INSTRUCTIONS Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email. Responses shall be limited to 15 pages; graphics, tables and diagrams do not count toward the page limit. The document(s) shall be prepared using Times New Roman 12-point font style for printing on 8.5 X 11 inch paper. Each page shall identify the submitting respondent and page number. Page Margins shall be no less than 0.5" on all sides. A complete response to the Sources Sought should include answers to all of the questions. Please note that a respondent's failure to provide a complete response to a question may be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide O&M support"). All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Capability statements will not be returned and will not be accepted after the due date. Documentation shall be emailed to: Justin Cole at justin.cole@fda.hhs.gov. Attachment: Draft IDIQ SOW Draft Assignments Module Enhancements DME SOW Draft Key Capabilities Matrix
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SN04817596-W 20180210/180208231900-5f3449fdae048220c05f4dfff6dabc52 (fbodaily.com)
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