Amendment_3.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

HFT-323

FDA/OO/OFBA/OAGS/DAP

OAGS - Field Operations Branch Nick Sartain 3900 NCTR Road, Jefferson AR 72079

FDA-18-223-SOL-1196209

07/18/2018

06/21/2018

X

a. The purpose of this amendment is to revise the RFP, update Attachment A and provide answers to questions received.

b. The offer due date is hereby extended to 1:00 P.M. Central Time on July 27, 2018.

c. Extend the date for submission of Past Performance Questionnaires Attachment G to 1:00 P.M. Central Time on July 27, 2018.

Questions and answers:

Question 1. BEST 1 Amendment 2 Attachment 2, Technical Approach Factor 1: Sub-Factor 1: IDIQ Technical Approach/Capability, point A and point D suggests that we will either use an existing data platform with query tools or create one. Could the FDA please provide a description of the existing data platform and the tools and if they will be provided as GFE?

Answer, Question 1.

FDA has no direct access to data and does not own any existing platforms or query tools. The data platforms and any tools or computer programs to query and analyze the data will be identified or built and provided by the contractor. The data platforms and tools could be scientifically or commercially available or newly built to meet the specifications for the BEST requirements. The data must be accurately and easily accessed, queried, and analyzed, and the results must be easily and clearly presented to FDA. The data platform must be compatible with the rest of the surveillance infrastructure provided by the contractor and meet the requirements, specified in the RFP, to provide the capability for surveillance activities.

Question 2. BEST 1 Amendment 2 Attachment 2, Technical Approach Factor 1: Sub-Factor 1: IDIQ Technical Approach/Capability, point B suggests that the contractor must identify and have business relationships with all data providers. Has the FDA identified any of the data sources it wants to collect data from and could FDA please provide a list of the data source providers that FDA has business relationships in place?

Answer, Question 2.

FDA does not have a direct relationship or agreement with any data providers. However, FDA has requirements for data, as specified in the RFP, including administrative and claims and electronic health records in different health care settings which cover a large proportion of the US population to conduct post-market safety and effectiveness surveillance of biologic products. Therefore, the offeror is encouraged to partner with as many data sources as possible. It is the responsibility of the contractor to identify eligible and appropriate data providers, evaluate their data quality, quantity, and characteristics, and data’s availability to be provided to FDA for its surveillance activities.

Question 3. Task Order 1 asks for a considerable amount to be implemented and accomplished, with only a one year contract horizon (no option years indicated). Would new Task Orders be aimed at maintaining this capacity, or expanding it? Is it acceptable in responding to this Task Order to propose initial steps or basic building blocks that can be eventually developed into this larger capacity in later years of the IDIQ?

Answer, Question 3.

The subsequent task orders would utilize and build upon the infrastructure which is built in the first year although they would consist of different projects which may include expansion of the infrastructure built in the first year, or product-specific evaluations, or other projects.

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Question 4. Is it possible that multiple awards will be made for Task Order 1?

Answer, Question 4.

FDA may consider multiple awards for the Task Order 1 depending on the type of proposals it receives for the task order.

Question 5. Regarding Task Order 1, is it the intention to port the current query and statistical programs currently maintained by Sentinel to new healthcare data sources, or is the goal primarily to develop new and/or more flexible capacities for CBER personnel to use in their postmarket risk identification?

Answer, Question 5.

The objective of this RFP (IDIQ and Task Order) is to develop new infrastructure which provides claims as well as electronic health record data sources with computational and statistical analytic capabilities which are technologically more advanced and more flexible and have the capacity to be scaled up to a much higher level.

Question 6. When is it anticipated that Task Orders beyond #1 will be issued? Also, can the FDA provide some general guidance on their expectations of the work to be performed in the option years relative to that performed and delivered in the base year?

Answer, Question 6.

It is anticipated that there will be task orders issued beyond the first year. The new task orders would utilize and build upon the infrastructure which is built in the first year although they would consist of different projects which may include expansion of the infrastructure built in the first year, or product-specific evaluations, or other projects.

Question 7. In designing CDMs consistent with an OMOP framework, are there any requirements regarding direct compatibility with these new designs and translations into and from the Sentinel CDM?

Answer, Question 7.

FDA does not have a requirement for using or compatibility with any specific common data model. What is required, as specified in the RFP, is that the data from different sources must be accessed, queried, and analyzed the same way and the results must be provided in the same structure and format.

Question 8. Will FDA please confirm whether letters of commitment are required for Key Personnel employed by the Prime and Sub Contractors, or is this requirement just for individual 1099 contractors?

If required, do the letters of commitment count against the 50-page limit or can they be included in an appendix?

Answer, Question 8.

Letters of Commitment are required for all Key Personnel proposed for the IDIQ and Task Order. Please refer to Section 4.1 of the IDIQ SOW and Section 3.1 of Task Order #0001 SOW for a list of Key Personnel. Letters of commitment and resumes will not count towards the 50-page limit.

Question 9. Would the government consider a 10 day extension due to the response including both the IDIQ approach and the Task Order #0001 approach?

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Answer, question 9.

The Government has extended the due date.

Question 10. RFP section L.6 page 40-41. “The Government is looking for the broadest spectrum of population based data available (patient data, Electronic Health Records (EHR), inpatient claims data and medical charts or similar sources) from multiple healthcare settings providing more detailed clinical patient information than claims data alone for patients treated in outpatient and inpatient settings to conduct postmarket safety and effectiveness reviews”

How does the government define “as many data sources as possible” for the purposes of evaluating offerors? Will the quantity and quality of the data sources be a factor when determining awardees? Will the quantity of records available in each data source be considered? Are certain types of data sources better than others?

Answer, question 10.

The offeror is encouraged to partner with as many data sources as possible. Both electronic health records and claims data sources covering a large proportion of the US population that include data from all care settings are needed. It is the responsibility of the contractor to identify eligible and appropriate data providers, evaluate their data quality, quantity, and characteristics, and data’s availability to be provided to FDA for its surveillance activities as described in the solicitation. The quantity and quality of the data sources will be used to evaluate offerors. The quality and quantity of the data is dependent on how the data proposed relates to the requirements in the RFP.

Question 11. RFP section M.6 page 52. “Utilization of Small Business – Whether the Contractor provided maximum practicable opportunity for Small Businesses to participate in contract/order performance consistent with efficient performance of the contract/order. Including compliance with all terms and conditions in the contract/order relating to Small Business participation, small business participation goals, and AbilityOne goals (when required).”

The Utilization of Small Business factor will not be applicable when evaluating past performance of commercial customers. Will the government please confirm?

Answer, question 11.

The utilization of small business applies to offerors that are other than small businesses (large businesses). The past performance evaluation will assess how well the offeror complied with small business subcontracting program goals identified in the reference contracts. This would not apply to offerors who are small business concerns.

Question 12. The overall Technical Proposal instructions (L.6 Pg. 40) state “Offeror’s Proposal shall thoroughly address the BASE IDIQ SOW to include major areas of responsibility from IDIQ SOW Sections

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2.1 through 2.6 (addressed in subfactor 1) and the Task Order #0001 SOW sections 2.1 through 2.3, and

2.5 through 2.7 (addressed in subfactor 3).” In the instructions for Subfactor 3 (Pg. 42), the solicitation states “Provide a narrative description of the Offeror’s approach to performing tasks in Sections 2.1 through 2.5 in the Task Order SOW (Attachment B).” In the Technical Evaluation for Subfactor 3 (Pg. 51) the solicitation states" Demonstrates the offeror’s ability, expertise and proven technical approach to performing the tasks in Sections 2.1 through 2.3 and 2.5 through 2.7 outlined in Task Order #0001 are technically sound, logical, and likely to be effective." It is our assumption that the offeror is required to respond to all task in section 2.1 through 2.7. Will the Government please confirm?

Answer, question 12.

The RFP has been updated, see attachment with changes on pages 40, 42 and 51.

Question 13. RFP Section L.6 page 42, factor 1, subfactor 3. Will the Government confirm the completed task mapping matrix (Attachment F) for Task Order #0001 to identify both Key and non-Key Personnel will not be included in page limit?

Answer, question 13. Attachment F will count towards the page limit.

Question 14. RFP Section L.5 page 39 Basic Format. Will the Government confirm a submitted transmittal letter will not be included in the page limit?

Answer, question 14.

The Attachment H – Sample Client Letter for Past Performance will not be included in the page limit.

Question 15. RFP Section L.5 page 39. Will the Government confirm a submitted compliance matrix will not be included in the page limit?

Answer question 15.

This will be included in the page limit.

Question 16. RFP Section L.5 page 39. Will the Government confirm a submitted acronym list will not be included in the page limit?

Answer, question 16.

Acronym list will be included in the page limit.

Question 17. Reference Attachment A, page 26; 4. Other Requirements; 4.1 key personnel and Attachment B page 14; 3. Task order administration; 3.1 key personnel.

The IDIQ SOW states "Key Personnel at the IDIQ-Level are:

• Principal Investigator

• Program Manager

• Physician

• Epidemiologist"

The Task Order SOW states "Key Personnel for this Task Order are:

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• Principal Investigator

• Project Manager

• Physician

• Epidemiologist"

Is it the Government's expectation that the IDIQ Key personnel will be the same candidates fulfilling the Task Order Key Personnel requirements for the Principal Investigator, Physician, and Epidemiologist?

Answer, question 17.

That is dependent on each Offeror’s approach to satisfying the Government’s requirement. The Government is open to all proposals regarding key personnel.

Question 18. Reference Attachment A, page 26; 4. Other Requirements; 4.1 key personnel and Attachment B page 14; 3. Task order administration; 3.1 key personnel.

The IDIQ SOW states "Key Personnel at the IDIQ-Level are:

• Principal Investigator

• Program Manager

• Physician

• Epidemiologist"

The Task Order SOW states "Key Personnel for this Task Order are:

• Principal Investigator

• Project Manager

• Physician

• Epidemiologist"

Is it the Government's expectation that the IDIQ Key personnel Program Manager will be the same candidate fulfilling the Task Order Key Personnel Project Manager?

Answer, question 18.

Typo, this should be Project Manager vs Program Manager for both the IDIQ SOW and TO SOW. Key personnel is dependent on each Offeror’s approach to satisfying the Government’s requirement. The Government is open to all proposals regarding key personnel.

Question 19. Reference Attachment A, page 4; 2. Task order descriptions; 2.1.1 data network. "The IDIQ SOW states the Contractor shall provide access to a network of large-scale distributed databases that include near real-time (less than 4-month data lag), patient-centered, comprehensive demographic, clinical, and ancillary data from administrative and claims, and EHR data sources that are representative of the US population.

Can the FDA elaborate on what level of direct database access will be needed for queries by FDA (i.e. Is the FDA asking for a minable data source to directly access)?

Answer, question 19.

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FDA will not have direct access to the data, but the contractor will have access to de-identified individual-level data. The contractor will provide aggregate-level data in response to queries or studies to FDA.

Question 20. Reference Attachment A, page 4; 2. Task order descriptions; 2.1.1 data network. The IDIQ SOW states that the Contractor shall provide access to a network of large-scale distributed databases that include near real-time (less than 4-month data lag), patient-centered, comprehensive demographic, clinical, and ancillary data from administrative and claims, and EHR data sources that are representative of the US population. This distributed database is expected to grow every year with an emphasis on expanding access to EHR data sources and building a large network of EHR data providers.

Is it acceptable to incorporate data sources that cannot be linked to, but would be applicable and useful to required queries and studies (i.e. admin/claims and utilization data that cannot be directly linked back to EMR)?

Answer, question 20.

It is expected that both claims data sources as well as electronic health record data sources grow over time, but the more urgent need is for the expansion of the electronic health record data sources. Data sources that cannot be linked to EMR may be used but the quality and quantity of data sources will be evaluated.

Question 21. Reference Attachment A, page 4; 2. Task order descriptions; 2.1.1 data network. The IDIQ SOW states the Contractor shall provide access to a network of large-scale distributed databases that include near real-time (less than 4-month data lag), patient-centered, comprehensive demographic, clinical, and ancillary data from administrative and claims, and EHR data sources that are representative of the US population.

Is it acceptable to incorporate datasets for which portions meet the 4 month “data lag” criteria, while other portions operate on a five month lag (i.e. some data will meet that criteria of no more than 4 months, but a proportion of N~900 hospitals will not)? What is an acceptable threshold or proportion of the dataset that should meet the data lag requirement?

Answer, question 21.

FDA may evaluate and consider data sources with a longer lag than 4 months but certainly with a lag shorter than 6 months.

Question 22. RFP Section L.5, page 39. Does the Government have a preference on which version/year of Microsoft Office programs (Word, Excel) the offeror shall use to submit their response?

Answer, question 22.

The Government is currently using 2016 Microsoft Office programs.

Question 23. RFP section G.5, key personnel, page 18, Attachment A, Section 4.1 key personnel. The key personnel listed in Attachment A the IDIQ Order Statement of Work (SOW) document are as follows:

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• Principal Investigator

• Program Manager

• Physician

• Epidemiologist

There are labor category descriptions for all of the labor categories listed above, with the exception of Program Manager.

Will the FDA provide a labor category description for the program manager labor category or is it up to the vendor to provide a description for this role?

Answer, question 23.

Attachment A Section 4.1 key personnel is a typo. The reference for “Program Manager” should be deleted and replaced with “Project Manager”.

Question 24. Task descriptions, Section 2.1 and subsections. RFP Section L.6 page 40. The RFP states, “Offeror’s Proposal shall thoroughly address the BASE IDIQ SOW to include major areas of responsibility from IDIQ SOW Sections 2.1 through 2.6 (addressed in subfactor 1) and the Task Order #0001 SOW sections 2.1 through 2.3, and 2.5 through 2.7 (addressed in subfactor 3)”

Question: As listed in the SOW, there are select technical sections in the Task Order SOW that map directly back to the IDIQ SOW, which include:

Task Order Section Equivalent IDIQ Order Section

2.1 Task 1, Data Network

Requirements

Section 2.1.,Task 1: Data sources, Tools, Methods, and Related Infrastructure

2.2 Task 2, Conduct Queries and

Epidemiologic Studies

Section 2.2, Task 2: Queries and Epidemiologic Studies

2.2.1 Simple Queries Section 2.2, Task 2: Queries and Epidemiologic Studies

2.2.2 Complex Queries Section 2.2, Task 2: Queries and Epidemiologic Studies

2.2.3 Complex Epidemiologic Studies Section 2.2, Task 2: Queries and Epidemiologic Studies

2.3 Task 3 Methods, Infrastructure, and Linkage Tools Requirements

Section 2.1.,Task 1: Data sources, Tools, Methods, and Related Infrastructure.

Since these sections will contain the same technical approach response information, and in order to conserve pages for other content and avoid inserting redundant sections, is it acceptable to put our technical approach for these sections in the sample task order IDIQ section and just cite the sections within the technical proposal approach of the IDIQ (or vice-versa?)

Answer, question 24.

Yes, this is acceptable. It must be clearly marked and identified to aid in the evaluations.

Question 25. RFP, section L.7 page 43. The RFP states, “…any finalized, applicable Contractor Performance Assessment Reports (CPAR) may be provided in lieu of the Past Performance Questionnaire and Sample Client Letters.”

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Is it the contracting office’s expectation that the CPARS and the first section of the questionnaire form be included in the Volume II proposal response or should it be forwarded to Nick Sartain prior to the RFP submittal deadline?

Answer, question 25.

If the offeror is using CPARS in lieu of the past performance questionnaire (PPQ) it must be submitted with volume II proposal response.

Question 26. RFP, section L.7 page 43. The RFP states, “…any finalized, applicable Contractor Performance Assessment Reports (CPAR) may be provided in lieu of the Past Performance Questionnaire and Sample Client Letters.”

If the expectation is that it should be included in the proposal, can it be excluded from the page count requirement in the past performance volume? If vendors submit 5 past performances, they will quickly go over the 20 page limit established.

Answer question 26.

CPARS records submitted in lieu of the PPQ will not count towards the page limits.

Question 27. RFP Section L.7, past performance, page 43. The RFP states, “Past Performance proposal shall consist of a copy of each Client Letter and the “Contract Identification” information set forth in Item #1 of the questionnaire completed sent by the offeror to the client.

Can the contracting office remove the client letter and contract information portion within item #1 of the questionnaire from the page count limitation within the Past Performance volume? Vendors who opt to use 5 references will go over the 20 page limit established.

Answer, question 27. The client letter and contract information portion within item #1 Attachment G – Past Performance Questionnaire will not count towards the 20-page limit.

Question 28. Attachment F: Task Order Mapping Matrix. Will the contracting office consider removing the task order mapping matrix document (attachment F) from the page count limit?

Answer, question 28.

Attachment F will count towards the page limit.

Question 29. Attachment H: Sample Client Letter. To confirm: the sample client letters are to use to tailor letters to our customers who have agreed to complete questionnaires and it is not necessary to provide copies of our client letters to the CO or include in the proposal…correct?

If copies are required, can the contracting office consider not including them within the page limit?

Answer, question 29.

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Sample client letters Attachment H should be tailored for each client. A copy of the client letters are to be included in the proposal. The client letters Attachment H will not count towards the volume II page limit.

Question 30. Attachment I: Sample Commitment Letter. Will the contracting office consider removing the Commitment letter from the page count limitation?

Answer, question 30.

Letters of commitment and resumes will not count towards the 50-page limit.

Question 31. IDIQ SOW Attachment A, section 2.1.1 page 6. Request Clarity of “Develop a quarterly report to present the results of the data quality assurance plan for each database”. Do you mean a quarterly report based on the quarterly test study?

Answer, question 31.

The databases are expected to be updated with new data on a quarterly basis. Every quarter when the databases are refreshed, the contractor shall perform quality checking of the new version of databases to ensure the accuracy of the data. The result of the quality checking of the data shall be provided to FDA in the form of a report every quarter.

Question 32. IDIQ SOW Attachment A, section 5, page 29-31. There does not seem to be an equivalency matrix for the Labor Categories. Does an advanced degree not provide a decrease in years of experience? Example: Research Analyst/Programmer II states “Bachelors of Science or Master’s Degree in related field with 10 years of experience”. Does a Master’s Degree require less years of experience than a Bachelors?

Answer, question 32.

The Government will keep the years of experience requirement as is for all degree levels.

Question 33. IDIQ SOW and TO #1 SOW. Attachment B section 2.4 page 8. Paragraph 1 identifies medical/billing code specialists, but this labor category is not defined within the IDIQ SOW.

Will the FDA provide a labor category description for this labor category?

Answer, question 33.

Below, please find the labor category description for medical billing/code specialist with the job title:

medical record technician.

Medical Record Technician - (Medical Record Administrator) maintains medical records of hospital and clinic patients, reviews medical records for completeness and accuracy, codes diseases, operations, diagnoses and treatments, compiles medical care and census data for statistical reports, and maintains indexes on patient, disease, operation, and other categories. The Medical Record Technician directs routine operation of medical record department, files, or directs Medical Record Clerk to file, patient records, maintains flow of medical records and reports to departments, and may assist medical staff in

FDA-18-223-SOL-1196209 Amendment 3 10 of 11 special studies or research. The Medical Records Technician should have at least Two years above high school with a minimum of 12 semester hours directly related to MRT work (e.g., courses in medical terminology, anatomy & physiology, and introduction to health records) Position is entry level and requires 0-3 years’ experience, preferably in a medical office setting.

Question 34. In order for vendors to have time to recover our proposals based on the clarifications provided by the FDA, will the contracting office provide a modest 1 week extension on the submittal due date?

Answer, question 34.

The Government has extended the due date.

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