FBO Notice Date 02/20/18
BIDS Reference Number 378
Document Type: Modification
Professional, Administrative, And Management Support Services

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 20857-0001

R -- National Milk Drug Residue Database SOL 18-223-SOL-00007PRESOL DUE 030518 POC Mary Rose A. Nicol, Contract Specialist, Phone 3018277183, Email MaryRose.Nicol@fda.hhs.gov

The purpose of this Amendment is to revise Solicitation Number .18-223-SOL-00007, The "National Milk Drug Residue Database "to include the changes 1-6 as noted below: Please note: The Revised Solicitation datedFebruary 20, 2018 is attached in its entirety.
1. Please insert the hightailed sentence on page 8, under Section - C1 Scope of Work, paragraph-a: (Description of the National Milk Drug Residue Database)
Sentence: Guidelines on how positive samples shall be reported and provided.
2. Page 10: under "Performance Standard:" please change (from: 20 calendar days to: 30 calendar days); and change the annual report due date (from: December 1st to: December 15th)
3. Page 15: under C. Annual Summary Report: please replace the entire existing 1st paragraph with what is highlighted.
From: The annual report includes data received by the Contractor during federal fiscal years (April 1, 2018 throughJuly 30, 2018). The reports shall be submitted after the end of the fiscal years by February 28, 2019 which is approximately 4.5 months after the end of the Government's fiscal year close date. for the federal fiscal year. The annual report is due on December 1st of each calendar year.
To: 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.
4. Page 22: Paragraph 4) Information Security Categorization on page 23:change "Overall Risk Level" from: high to: Moderate.
5. Page 22: Paragraph4) Information Security Categorization on page 23: change the Checked box of "Yes PII" to: "No PII. "
6. Page 32: Change Paragraph 2 - Background Investigation change the Risk Designation(s) on page 33 for this contract from: 2 to: 1.

This Amendment also includes the Questions and Answers (Q&A'S) to date Reference: National Milk Drug Residue Database RFP 18-223-SOL-00007, Dated Feb 05, 2018

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 aforementioned would not be applicable, because the Compensation is contingent based upon receipt and acceptance by the Government's QuarterlySummary Progress Reports and Annual Reports as required by Part I, Section F2 -Reports/Deliverable and Section G-,G3-Invoice Submission and in accordance withthe 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 theunderstanding 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 resultsinto 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 screeningtest 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 befound 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 progressreports twenty (20) calender (sp) 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 notbe 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 notbe 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 asdescribed 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 toa new contractor as soon as award is made
Q10: How will the database and related source code information, etc. as described in paragraph l be 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 thegovernment, but not the existing database.
Q12: L-3 - Volume II - proposalexpiration date states September 30, 2013, please provide the correct date.
A12: L-3 Volume II - page 50 is changed to read: Date submitted & Proposalexpiration 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 users

Q14: Please provide the type of database and the version of Microsoft SequelServer 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 accountingprogram 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 accountingneeded for the proposal submission?
A18:

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 deficiencies in the current database.
Q22: How will the database system be provided to the contractor? For example, will this beon 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 areexpected with the participants?
A23: the contractor does not need to recuit new participants. There are 53 participants, they are State agencies and a fewindustries.
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 needs 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 newproject?
A26: This is not a brand new solicitation; we currently do have acontractor managing the contract.

Q27: Is there a minimum team size required by this contract?
A27: Thereis 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. Shouldwe be costing that list or derived tasks from the descriptions in Section C?
A29: Yes

The request for proposal date remains unchanged.

CITE: https://www.fbo.gov/spg/HHS/FDA/DCASC/18-223-SOL-00007/listing.html

SET-ASIDE: Total Small Business