MODIFICATION
R -- National Milk Drug Residue Database
- Notice Date
- 3/1/2018
- Notice Type
- Modification/Amendment
- NAICS
- 518210
— Data Processing, Hosting, and 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
- 18-223-SOL-00007
- Response Due
- 3/5/2018 4:00:00 PM
- Point of Contact
- Mary Rose A. Nicol, Phone: 3018277183
- E-Mail Address
-
MaryRose.Nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The purpose of this Amendment for Solicitation Number 18-223-00007, "The National Milk Drug Database" is to Change Section L -Instructions, Conditions and Notices to Offerors- Paragraph A. Price, on page 50 to read as follows: The Offeror shall propose a fixed price. For proposed purposes, use the provided plug-in dollar amounts for Travel Cost for Option Year 1, and Option Year 3 are fixed at $5,000.00 for each of these option years. In Section L-3 Volume II - Business Proposal Instructions - on page 54, e. Other Considerations - delete numbers 4 and 4. In section L-11 Basis for Award and Evaluation Criteria - on page 57 Change Technical Evaluation to read as follows: The Evaluation panel will assess the Technical Proposal, assigning rating of Excellent, Highly Satisfactory, Satisfactory, and Unsatisfactory. Factors will be presented in decending order of importance. The RFP will be evaluated against the following factors: • Experience & Technical Capability • Understanding of Work & Technical Approach In addition, this Amendment includes the Questions and Answers (Q&A'S) 1-40 as shown below: Q1: Page 5 Paragraph B-2 Compensation: Since this is a fixed price contract, shouldn't there be a sub-item that addresses the amount to be compensated each quarter? And that amount included on page 2 of the SF33? For example, 25% of the [total fixed price less the withheld fee] plus a final payment of the withheld fee? A1: Because this is based upon the Quarterly Summary Progress Reports and Annual Reports, the a forementioned would not be applicable, because the Compensation is contingent based upon receipt and acceptance by the Government's Quarterly Summary Progress Reports and Annual Reports as required by Part I, Section F2 - Reports/Deliverable and Section G-, G3-Invoice Submission and in accordance with the schedule in part F. Q2: Page 8 Section C-1 a., top paragraph on the page: the 3rd and 4th lines read as follows: "The contractor shall develop a mechanism to attempt to assure that positive findings on the same lot are identified as subsequent tests." The follow-up to a positive test result is the responsibility of the dairy industry, and regulatory agency per the PMO not the NMDRD Contractor. This would be a significant change to the role of the NMDRD Contractor, and would conflict with the understanding of current roles as stated in the PMO. A2: The current contract has the same language; however, the contractor needs to be aware that they have some responsibility to issue guidelines and instructions to States and industry on how, what and when to report all testing results into the database. Q3: Page 8 Section C-1 a., top paragraph on the page: the 5th and 6th line have this sentence: "Positive results on the initial screening test of a bulk milk pickup tanker are not to be reported into the data base." Under current practice this is correct unless the milk is destroyed, based upon an initial screening test that was not confirmed. This is a decision made by industry, and the regulatory agency in accordance with the PMO. Recommend modifying the statement to match current practice. A3: Amended the RFP to add a sentence "Guidelines on how positive samples shall be reported and provided". FDA agrees that it is the industry and State's responsibility to properly report; however, we also expect the contractor to remind industry and States of that when the contractor issues guidelines and instructions for reporting into the database. Q4: Page 8 Section b. Data Elements see the list at the bottom of page No. 3. Source of sample: The listing should be clarified to show only four source definitions as used in the Annual Report, and the Data Submission Form. It is recommended that the following be used to match the NMDRD instructions: Report the source of the samples by entering the appropriate code from the following four categories: Source Code: -Bulk Milk Pickup Tanker BMP -Pasteurized Fluid Milk and Milk Products PFM -Producer Sample PS Note: Producer Samples should be reported by the permitting State, rather than by the analyzing State -Other (Silo, Over-the Road Tanker) OTH A4: The additional wording in the RFP was only meant to be added to clarify language, i.e., in addition to the word ‘raw', ‘bulk', etc., and was not meant to change any of the current four source definitions. The four sources noted in the question are correct, but are only the definition titles. The more complete definitions can be found in the most recent NMRDB annual report see (Attached NMRDB annual report in Section J). Q5: Page 10 Paragraph c. System Operations subparagraph Performance Standard: The statement that the submittal of the "(1) quarterly technical progress reports twenty (20) calender days after each quarterly reporting period" are inconsistent with the requirement of paragraph F-2 Reports/Deliverables on page 14 that states 30 calendar days. A5: Amended RFP to reflect the correct days (30). Q6: Page 15 Paragraph F-2 Reports/Deliverables C. Annual Summary Report requires some clarifications for statements in the initial paragraph. The dates, April 1, 2018 through July 30, 2018 do not represent a federal fiscal year and conflict with the Objective number 5 on page 5. Also, February 28, 2019 is not approximately 4.5 months after the end of the Government's fiscal year close date. Neither date is consistent with a December 1st due date. Further, a required submittal of the Annual Summary Report on December 1 would risk compromising the integrity, and usefulness of the Report due to lag times in reporting of data from some important states. Please clarify for consistency. A6: Amended RFP with the following paragraph: The annual report includes data received by the Contractor during federal fiscal years (October 1 through September 30). The annual report is due on December 15th of each calendar year. Q7: Page 23 Section H.1.A 4) Information Security Categorization. We question the determination that the solicitation and contract involves Personally Identifiable Information PII. At present, there are no data in the NMDRD that meet the PII criteria. The agreement with NCIMS requires that the data in the NMDRD not be identifiable back to a specific dairy or company, and therefore by definition are Not personally identifiable information. There are no "personal" data in the NMDRD. The contact information maintained by the Contractor contains only public information for contact via US Mail, email or phone. No other data such as birthday, health information or social security numbers are known to or used by the Contractor. Having to meet all the PII requirements in Section H of the RFP would incur increases in cost from the current levels. Changing the information classification means that much of Section H may not be required at all. We are not a party to the FDA process of test kit approval. Our information comes directly from FDA or NCIMS after new Tests are approved for use, and are to be added to the NMDRD. We do not receive or access any known non-public information from the FDA. A7: Amended RFP showing "No PII". Q8: Page 33 Section H.4 paragraph 2. GENERAL, middle of page 33 is the statement: "The Risk Designation(s) for this contract is Tier(s): 2". We question the designation as Sensitive Moderate Risk (Tier 2) since the definition for Tier 1 more closely represents the actual. A8: Amended RFP showing "Tier 1". Q9: When will the existing National Milk Drug Residue Database, and relevant source code, scripts and documentation as described per Section C paragraph l be provided to the successful contractor awarded this contract? Will that occur on the day the contract is signed? A9: The documentation and raw data except the existing database will be provided to a new contractor as soon as award is made. Q10: How will the database and related source code information, etc. as described in paragraph l is provided to the successful contractor? A10: Information will be provided via email. Q11: Is the existing database, related scripts and data currently used to manage the data and prepare the reports the property of the government? A11: The data is the property of the government, but not the existing database. Q12: L-3 - Volume II - proposal expiration date states September 30, 2013, please provide the correct date. A12: L-3 Volume II - page 50 is changed to read: Date submitted & Proposal expiration date shall remain valid thru September 30, 2018. Q13: What is the total number of users who currently access the database? A13: There are 53 reporting organizations via a multi-user data collection interface. Q14: Please provide the type of database and the version of Microsoft Sequel Server that is used with the database. A14: dBase III-type DBF. Q15: In what format will the fiscal year to date data records be provided if they are not yet entered into the existing database when it is transferred to the new contractor? A15: Excel. Q16: What version of Microsoft Sequel Server is being used for the current Milk drug database? A16: There is no Server, stand alone, single user PC. Q17: Does a letter from our accounting firm need to be provided to verify that the accounting program utilized for our small business is acceptable by government. Please clarify? A17: In accordance with SAM (System for Award Management System) in the Representations and Certifications, a self-certification of your firm is required as a small business concern. Also, confirm in K-2,-52.204-8, Annual Representations and Certifications (Jan 2017), page 43 of the Solicitation. Q18: Is a letter from our accounting firm verifying acceptable practices of accounting needed for the proposal submission? A18: No, it's not mandatory. Q19: Is it necessary to submit a paper copy as well as digital - (see page 48 3a)? We thought this might be an error or older text that is no longer relevant as most agencies accept digital and desire digital to meet sustainability targets and reduce impact on the environment by going paperless? A19: There is no need to submit paper copy, digital version is acceptable copy. Q20: The documentation states: "...launch for "live" use a database system within thirty (30) calendar days after receipt of the contract award..."Does this mean, a production-ready piece of technology? Or does it mean: 1. This solution can utilize already developed software 2. It does not take into an account user testing, technology testing, or iteration. A20: The new contractor must be able to develop a data management system from scratch without any inherited portion beside raw data from existing system such as software (need to purchase needed software for the development), and launch (meaning participants can enter their data into the newly development system) within 30 days after receipt of the award. Q21: I would like to know some questions about the specific objectives stated on page 4 under Objectives 1) Design, Develop and launch for live use a database system.... It appears the government does have a database system - what is the reason you are looking to design a new system - is there a deficiency in the current database system? Please describe. A21: The existing database is not the property of government, a new contractor who wins the contract must develop a new database for participants to enter their data. There is no deficiency in the current database. Q22: How will the database system be provided to the contractor? For example, will this be on disk, via mail or email or will there be travel required to FDA offices to secure the database system? A22: The existing database will not be transferred to a new contractor. Q23: Can you provide the list of voluntary participants and confirm if the contractor is required to recruit new participants from each state. ON Page 5 item 10 there is a requirement about communicating with Participants. How many participants are there and what forms of communications are expected with the participants? A23: The contractor does not need to recuit new participants. The participants are State agencies and industries. Q24: Is the data entry part of the SOW? As the document says, there could be data from print material. If so, what could be the approximate amount of hard copy data that may need potential manual entry into the system? A24: Yes, only if there are hard copies received. It's rare. All current participants are submitting their data electronically. Q25: Does the work need to be on site at FDA Office or it can be done remotely from our office? A25: The work does not need to be on site at FDA Office. Q26: Is there an incumbent contractor for this project, or is it a brand new project? A26: This is not a brand new solicitation; we currently do have a contractor managing the contract. Q27: Is there a minimum team size required by this contract? A27: There is no minimum team size required as long as the work can be carried out as required in the Statement of Work. Q28: Will FDA Provide a Development/ Stage environment or it needs to be provided by the contractor? A28: FDA will not provide a Development/Stage environment. Q29: The Statement of work is descriptive, but does not have distinct tasks enumerated. However, in Section L-3 Price, The offeror is expected to provide costing for the provided line item tasks for each item in the SOW, "The proposed fixed price for each task in the SOW must be supplied in such a way and in such detail as to identify all costs that derive the fixed price of each effort,". Section B-1. B Objectives does, however, have a more concrete list of tasks. Should we be costing that list or derived tasks from the descriptions in Section C? A29: Yes. Q30: What technology will be used? A30: The technology is to be determined by the contractor. Q31: What are the Data feeding options? A31: The data feeding options are determined by the contractor in coordination with the reporters. Q32: Security (Internal or External) A32: Security requirements are stated in the RFP Section H. Q33: Expected database size A33: The data set is currently approximately 21 MB in size. It can be reduced to approximately 2MB in a zip file for electronic transmission Q34: No. of users and concurrent users A34: There are currently 53 reporting organizations via a multi-user data collection interface; the contracted database is single user for generating the reports specified in the RFP and maintaining the data. Q35: No. of environments. A35: The operating environment consists of a data collection interface, an information website and a reporting environment. Q36: Approximately how many of the testing report data entries will have to be entered manually on a monthly basis? A36: Currently there are none. Q37: Will the FDA be providing a list of authorized contacts? Or will the FDA vet account requests? A37: The new contractor shall be able to obtain the contact list from the FDA. Q38: What does it means on page 9 of the solicitation when referring to Validated and non-validated Samples? A38: The term, "validated test "is a test used for the screening of raw milk for drug residue, which has been evaluated by FDA in accordance with the standards established for the evaluation of these types of tests and found acceptable by the NCIMS in accordance with Appendix N of the PMO. In addition, FDA validated drug residue detection procedures for screening and quantification of drug residues in milk may be used." The term "non-validated test" then means the opposite. It is a test that industry has decided to use, but has not gone through evaluation by FDA and acceptance by the NCIMS. Q39: There is an objective stated in section B that the system should be "Designed, Developed, and Deployed within 30 days of award", With the Security requirement to protect the PII and Non Disclosed data. I wouldn't recommend rushing the database to be exposed to the public internet without proper Verification and Validation Testing. Is there a hard requirement that the database be deployed within 30 days, this would trump security concerns. A 30 day deployment schedule only allows for 2 weeks of actual development. Is there more detail that can be provided as to which features are needed at which times such that they could be rolled out with a phased approach? A39: The security requirements have been amended in the RFP which should address the concerns. The 30 days requirement for having the database in place is an important timeline to avoid data entry delay. Regarding the features of the database, please refer to Q & A from 30 to 35 above. Q40: Is the defined content for the intermittent data summary reports or a sample available? A40: Not at this time. The Proposal due date remains unchanged.
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- Place of Performance
- Address: 8630 Fishers Lane, Rockville, Maine, 20875, United States
- Zip Code: 20875
- Zip Code: 20875
- Record
- SN04839869-W 20180303/180301231536-475168e796b3f49ef2b6fee1098e8e0d (fbodaily.com)
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