View the file

Other files

Show all 19

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

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

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

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

b. The offer due date is hereby extended to 1:00 P.M. Central Time on July 31, 2018.

c. Extend the date for submission of Past Performance Questionnaires Attachment G to 1:00 P.M. Central Time on July 31, 2018.

HFT-323

FDA/OO/OFBA/OAGS/DAP

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

9A. AMENDMENT OF SOLICITATION NUMBER

FDA-18-223-SOL-1196210

07/19/2018

9B. DATED (SEE ITEM 11)

06/22/2018

X

Questions and answers:

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

Answer, question 1.

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

2. If an applicant receives an award for Task Order 1 from IDIQ 2 (FDA-18-223-SOL-1196210), but not for IDIQ 1 (FDA-18-223-SOL-1196209), what should this contractor assume about the data structuring, coding and access requirements and tools availability requested in IDIQ 1 (FDA-18-223- SOL-1196209) and its Task Order 1?

Answer, question 2.

The offeror for IDIQ2 (FDA-18-223-SOL-1196210) TO1, must provide independent capability to provide data in a structured, accessible and analyzable format. IDIQ 1 (FDA-18-223-SOL- 1196209) is independent and has a different scope than IDIQ 2 (FDA-18-223-SOL-1196210).

3. 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 3.

FDA will issue additional Task Orders based on the needs of the program. The timing and content of these TASK Orders cannot be predicted, however it is anticipated that the general nature of the work will involve expansion of similar work to a wider range of products regulated by CBER.

4. 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 4.

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.

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

Answer, question 5.

FDA-18-223-SOL-1196210 Amendment 2 2 of 13

The Government has extended the due date.

6. RFP section G.5, Attachment A section 5.1 key personnel and Attachment B section 8.1. The IDIQ and TO1 SOWs (Attachments A and B) indicate only two key personnel, the Program Manager and Principal Investigator, but the RFP Instructions and Attachment F mapping matrix also lists the Physician and Epidemiologist as Key. Can the government clarify the key personnel?

Answer, question 6.

Key personnel include the Principle Investigator, Senior Software Engineer, Project Manager, and Physician.

7. RFP section L.6 says “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 of biologic products which we encourage the offeror to partner with as many data sources as possible.”

Section M.5.A.I.1 The IDIQ Technical Proposal Subfactors in Section L reference that the government is looking for offerors to provide data. However, the Evaluation Factors for Award in Section M only state that the offeror must demonstrate the capability and expertise of using the data. Will provision of data sources be considered as an evaluation for award?

Answer, question 7.

Offerors are expected to make available large volumes (millions) of validated patient data for use within the program as described in the RFP.

8. RFP section M.5.A.I.1. Demonstrates capability and expertise with developing methods such as AI, NLP and others to identify and data mine adverse event or health outcome information, product effectiveness and AE reporting for all CBER regulated products from EHR sources using case definitions, EHR or computable phenotypes, codes, unstructured text data and other text information.

In the evaluation criteria in Section M, the government asks the offeror to demonstrate expertise in mining AE information for EHR sources. However, the subfactors in Section L.6 list other types of data. Will experience mining these other data sources be factored into the evaluation?

Answer, question 8.

All directly relevant capability and expertise stated by the applicant will be considered in the evaluation.

FDA-18-223-SOL-1196210 Amendment 2 3 of 13

9. RFP section M.5.A.I.1. Identify and discuss the methods and approaches to be used to conduct quality control and validation to ensure valid, accurate identification of transfusion-associated adverse events from EHRs of >90%, and conduct analyses to ensure accurate, timely submission of automated reports to MedWatch.

Can the government provide clarification on how it will evaluate whether a submission is timely?

Answer, question 9.

Serious adverse event reports are generally required to be submitted to FDA within a 15 day or 45-day period after observation, therefore a 15-day target is appropriate.

10. RFP section M.6. “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 10.

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.

11. Reference Attachment A, page 4; 2. Task 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 or equal to a 3-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 11.

FDA is seeking databases without patient identifiers that can be analyzed by multiple approaches, including text mining by both contractor and FDA staff.

FDA-18-223-SOL-1196210 Amendment 2 4 of 13

12. Reference Attachment A, page 4; 2. Task 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 or equal to a 3-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 12.

FDA continually seeks access to expanded administrative datasets to support active surveillance for CBER products including administrative datasets that cannot be directly linked back to an EMR. However, the availability of large scale EHR data suitable for application of AI methods, including text mining, is necessary for completion of Task Orders to be performed under the resultant award.

13. Reference Attachment A, page 4; 2. Task 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 or equal to a 3-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 3 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 3 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 13.

FDA is targeting a data lag period of no longer than three months to allow timely assessment of any unanticipated adverse events. In the event a particularly large or valuable dataset is available for which a slightly longer data lag period is anticipated, FDA will weigh the specific advantages and disadvantages of accepting these data.

14. RFP section L.6 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 14.

FDA-18-223-SOL-1196210 Amendment 2 5 of 13

The Attachment F – task mapping matrix will be included in the page limit.

15. RFP section L.5 Basic Format. Will the Government confirm a submitted transmittal letter will not be included in the page limit?

Answer, question 15.

A submitted transmittal letter (Attachment H) will not be included in the page limit. Any other transmittal letter will count towards the page limit.

16. RFP Section L.5 Basic Format. Will the Government confirm a submitted compliance matrix will not be included in the page limit?

Answer, question 16.

A submitted compliance matrix will be included in the page limit for volume I.

17. RFP Section L.5 Basic Format. Will the Government confirm a submitted acronym list will not be included in the page limit?

Answer, question 17.

A submitted acronym list will be included in the page limit.

18. Attachment A section 5.1 key personnel and Attachment B section 8.1 key personnel. The IDIQ SOW states ""Key Personnel at the IDIQ-Level are:

• Principal Investigator

• Program Manager""

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

• Principal Investigator

• Project Manager""

Is it the Government's expectation that the IDIQ Key personnel will be the same candidate fulfilling the Task Order Key Personnel requirements for the Principal Investigator?

Answer, question 18.

This was a typo. Key personnel include the Principle Investigator, Senior Software Engineer, Project Manager, and Physician. See RFP amendment for updates. The Program Manager is a typo and should be Project Manager throughout the IDIQ SOW and TO SOW. The IDIQ Project Manager is anticipated to function at a broader level than the Task Order Project Manager, however there is no specific contraindication to these roles being filled by the same person as long as the key FTE allocations are maintained.

FDA-18-223-SOL-1196210 Amendment 2 6 of 13

19. Attachment A section 5.1 key personnel and Attachment B section 8.1 key personnel. The IDIQ SOW states Key Personnel at the IDIQ-Level are:

• Principal Investigator

• Program Manager""

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

• Principal Investigator

• Project Manager""

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 19.

This was a typo. Key personnel include the Principle Investigator, Senior Software Engineer, Project Manager, and Physician. See RFP amendment for updates. The Program Manager is a typo and should be Project Manager throughout the IDIQ SOW and TO SOW. The IDIQ Project Manager is anticipated to function at a broader level than the Task Order Project Manager, however there is no specific contraindication to these roles being filled by the same person as long as the key FTE allocations are maintained.

20. RFP Section L.5, Basic Format. 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 20.

The Government is currently using 2016 Microsoft Office programs.

21. RFP Section F.1 and Attachment A section 5.4. The Solicitation shows the Ordering Period 1 starting 09/03/2018 and the IDIQ SOW shows the Ordering Period 1 starting 09/10/2019. Will the government please clarify the total period of performance as well as the start date for Ordering Period 1?

Answer question 21.

Section F.1 of the RFP is correct. If award is made later than identified, then the periods will be adjusted accordingly.

22. Attachment B, task 7 communication and outreach, 7.1 training. Will the Government please clarify, or provide for estimation purposes, the number of the training session that will occur during the period of performance for this Task Order?

Answer, question 22.

FDA-18-223-SOL-1196210 Amendment 2 7 of 13

The frequency of training sessions will depend on the anticipated needs of the program, however a proposal for quarterly training sessions would be typical.

23. Attachment B, task 7 communication and outreach, task 7.4 prepare abstracts and reports. Will the Government please clarify, or provide for estimation purposes, the number of abstracts and reports that will be required during the period of performance for this Task Order?

Answer, question 23.

The frequency of abstracts and reports will depend on the anticipated needs of the program, however a proposal for 4-6 reports/year would be typical.

24. Attachment B, task 7 communication and outreach, task 7.5 prepare presentations and manuscripts. Will the Government please clarify, or provide for estimation purposes, the number of presentations and manuscripts that will be required during the period of performance for this Task Order?

Answer question 24.

The frequency of presentations and manuscripts will depend on the anticipated needs of the program, however a proposal for 4 publications and 4 presentations/year would be typical.

25. Does the FDA plan to issue additional RTOPs during the first year of the IDIQ contract, as the additional task orders would overlap with this task order?

Answer, question 25.

The FDA may issue additional RFTOP’s during the base year if a new need arises.

26. Reference the RFP, section B.3.1, Order Period 1. Do the hours shown in the table represent FDA’s estimates of maximum per labor category for task order 1? If not, what are these hours an estimate of?

Answer, question 26.

These are estimated hours per labor category, per each ordering period that will be used for evaluation purposes of the IDIQ contract.

27. Reference the RFP, section G.5. An Epidemiologist is listed as key personnel but not listed in section B.3.1. Please explain this difference.

Answer, question 27.

This is a typo. The key personnel have been updated in the RFP, IDIQ SOW, and TO SOW.

FDA-18-223-SOL-1196210 Amendment 2 8 of 13

28. It would be helpful for bidders to have information on the results of the current BEST contract. Are there materials from the current contract that FDA can share with contractors who are bidding on this RFP, such as an interim report or some other document that shows progress and achievements to date and lessons learned?

Answer, question 28.

See attachment titled “BEST ISH Poster”.

29. Has the current contractor created or extended a CDM that incorporates data for blood products?

If so, can the FDA share additional information?

Answer, question 29.

The current contractor makes use of the OHDSI OMOP common data model which has been modified to include 1) ISBT-128 blood labeling codes as a reflection of blood component exposures as well as 2) computable patient phenotypes from NLP data mining of EHR text notes reflecting timing and details of blood transfusion administration and 3) computable phenotypes reflecting post-transfusion adverse events, such as Transfusion Associated Circulatory Overload (TACO), and post-transfusion bacterial sepsis. See attachment titled “BEST ISH Poster”.

30. Reference task 3.1 in task order 1, Develop, implement, and Validate New, innovative Methods to Address Automated Reporting of Adverse Events for CBER Regulated products in the task order SOW, "The Government anticipates up to ten (10) users accessing the database on a weekly basis" is mentioned. Could the FDA clarify which database this is in reference to and who the users are?

Most data providers have strict onboarding and access requirements even for de-identified data.

Answer, question 30.

The requirement for database access by multiple users (est n=10) is a key element of the proposed work. 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.

31. Would FDA consider the deletion of FAR 52.227-17 Rights in Data – Special Works be deleted as it is not applicable? Pursuant to FAR 27.409(i) and 27.405(a), deliverables required hereunder are not considered Special Works.

answer question 31. FAR 52.227-17 remains in the solicitation.

32. Will FDA please confirm that this link is the correct link to the OPM Federal Executive schedule

Salary Level and that the Schedule 5 Executive Level II with a salary of $189,600 is the correct level?

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/pay-executive-order-2018-adjustments-of-certain-rates-of-pay.pdf. If this is not the correct link, would FDA be willing to provide the correct link?

FDA-18-223-SOL-1196210 Amendment 2 9 of 13 https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/pay-executive-order-2018-adjustments-of-certain-rates-of-pay.pdf https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/pay-executive-order-2018-adjustments-of-certain-rates-of-pay.pdf

Answer, question 32.

link appears to be correct.

33. It would be helpful for bidders to have information on the contract that was awarded in 2017. How many FTEs are on the contract that was awarded for solicitation 181185B, Biologics Effectiveness and Safety (BEST) Initiative, Develop New, Innovative Methods for Automation of Blood Product Adverse Event Reporting?

Answer, question 33.

The obligated ceiling amount on the 2017 contract is $2,494,837.00 under contract HHSF223201750070A. The FTEs are dependent on your approach to satisfying our requirement.

34. Confirm, the required key personnel for the IDIQ are: 1) Principle Investigator; 2) Program Manager and for the Task Order: 1) Principle Investigator, Project Manager?

Answer, question 34.

This was a typo. Key personnel include the Principle Investigator, Senior Software Engineer, Project Manager, and Physician.

35. 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 35.

This was a typo. Key personnel include the Principle Investigator, Senior Software Engineer, Project Manager, and Physician.

36. Question: there are select technical sections in the Task Order SOW that map directly back to the IDIQ SOW, which include (but not limited to):

Task Order Section Equivalent IDIQ Order Section

2.1 Task 1, Data Sources, Tools, Methods, and Related Infrastructure (and associated subsections)

1.1.2.1 Identify, develop, tools, methods, capabilities and capacities….

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?)

FDA-18-223-SOL-1196210 Amendment 2 10 of 13

Answer, question 36.

Yes, this is acceptable. It must be clearly marked and identified which sections apply to each.

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

Question: 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 37. If the offeror is using CPARS in lieu of the past performance questionnaire (PPQ) it must be submitted with volume II proposal response.

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

Question: 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 38. CPARS records submitted in lieu of the PPQ will not count towards the page limits.

39. 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.

Question: 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 39. The client letter (attachment H) and contract information portion within item #1 Attachment G – Past Performance Questionnaire will not count towards the 20-page limit.

40. Will the contracting office consider removing the task order mapping matrix document (attachment F) from the page count limit?

Answer, question 40.

See response to question # 14.

FDA-18-223-SOL-1196210 Amendment 2 11 of 13

41. 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? Vendors who provide 5 references will go over the 20-page limit established.

Answer, question 41.

Sample client letters Attachment H must 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.

42. Will the contracting office consider removing the Commitment letter from the page count limitation?

Answer, question 42.

Letters of commitment (Attachment I) and resumes will not count towards the 50-page limit in volume I.

43. IDIQ SOW. Request Clarity on “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 43.

The data quality assurance plan report should be a running report that identifies results from the quarterly test study, as well as results from any other data quality assurance findings as specified in the established data quality assurance plan.

The Quality Assurance plan is due once versus quarterly and has been updated in the SOW.

Table 1: Task 1 Deliverables/ Work Products

Task Deliverable Due Date Quantity / Frequency

Delivered To

Task 1.1 Develop a data quality assurance plan for each database with respect to all coding systems used in the database such as

ICD9, ICD10, HCPCS, CPT, ISBT-

128, and others.

Plan due NLT 2 weeks after task order award date

Once COR

FDA-18-223-SOL-1196210 Amendment 2 12 of 13

44. IDIQ SOW. 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 44.

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

45. IDIQ SOW and TO #1 SOW. 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 45.

Medical/Billing code specialists is not included in BEST IDIQ #2 RFP.

46. 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 46.

The due date for proposals has been extended.

Task 1.1 Develop a quarterly report to present the results of the data quality assurance plan for each database. Develop an action plan to correct any deficiencies or missing data based on the quarterly report results.

1st report due within 90 days of task order award date

Quarterly COR

FDA-18-223-SOL-1196210 Amendment 2 13 of 13

File details come from the government source that posted it.