Questions_answsers.doc

10-223-SOL-00082

FDA Data Management Program

Questions:

1. What is the due date for proposals? The SF1449 doesn’t mention.

The due date for proposals is May 27, 2010 by 1:00 PM eastern time.

2. Is there an incumbent? If yes, please provide the name, contract number and if they are eligible to propose on this contract The incumbent contractor is PSI International. The current contract number is HHSF223200550525G. The incumbent is not eligible to propose as a prime contractor.

3. Please advise if the set aside for this solicitation requires the contractor to be 8(A) eligible or if they MUST already be 8 (A) certified.

The contractor must be 8(a) certified in order to submit a proposal.

4. Are there any updated requirements that have not yet been posted?

At this time there are no updated requirements that have not been posted.

5. How many task orders are anticipated in the contract base year?

At this time the Government anticipates one task order in the base year.

6. The Delivery Instruction of Solicitation 1 document 10-223-SOL-00082 FINAL 1.doc uploaded on April 27, 2010, states that submissions were to be received by regular mail.

Do we have the option to e-mail both the technical and business proposals or personally deliver to the address provided?

Contractors must submit their proposals on CD per the instructions. Contractors may send the CD’s via regular mail or hand deliver by the due date for proposals answered in questions 1.

7. Is there a specific format for the budget?

Contractors should use the pricing tables used in the Base SOW and the Task 1 SOW.

8. Reference RFP, Page 87, Section 4.8, Delivery Instructions

Is it the Government’s intent to receive only one original hard copy of the Technical and Business Proposals?

It is the Governments intent to not receive a hard copy of the proposals. All proposals should be submitted on CD’s.

9. Reference RFP, Page 87, 4.9(b), Instructions for the Preparation of the Technical Proposal

Does the requirement for text to be black refer only to narrative paragraphs and lists? Can heading, tables and text boxes be in color?

Headings, tables, and text boxes can be in color.

10. Reference RFP, Attachment 1, Page 20, Compensation for Task order 1

In order for the incumbent contractors and its chosen 8(a) prime and all other offerors to have a fair and equal understanding of the current ongoing requirements, will the Government share the labor categories and the number of hours contracted in each category as specified in the extension contract between 12/31/09 and 6/30/10? The FOIA copy of the DMP contract is available, but the data has been redacted.

The labor categories are the categories in the pricing table included with attachment 1 starting on page 21.

11. Is the entire Technical Proposal intended to be double spaced? Including the resumes?

Yes the entire technical proposal is intended to be double spaced.

12. Does the 50 page limit apply to each Technical Proposal (50 pages for Base IDIQ, 50 pages for Task 1)?

Yes each technical proposal (one for the base IDIQ and one for Task 1) can be 50 pages.

13. There is a reference to our Understanding of the Requirements for Task 1 in the Technical Discussion. In section 4.8, the Delivery Instructions ask for separate for the Base IDIQ and Task 1 Business/Technical Proposals. Please clarify on whether this information should be discussed within 1 document or 2 separate Technical Proposals.

Understanding of the requirement for task 1 should be discussed in the technical proposal for Task 1.

14. What are the centers’ tolerances for unifying the computing environment (i.e. servers, networks, and storage) to achieve economies of scale?

The Government provides all hardware, software, and networking equipment with exception of the tracking software tools to be developed under task order 1. The Offeror will only be responsible for adhering to the policies and standards set by the FDA. Software maintenance is not part of the scope of work for this requirement. A separate contractor is responsible for software maintenance.

15. What are the recovery point objectives for each center?

The responsibility of backup and recovery rests with the FDA.

16. Is the system functional at all right now?

Yes, see question #2

17. Section 1 of SF1449, What is the formula for deriving the columns in the pricing table - Govt.-Site Fixed Price and Non-Govt.-Site Fixed Price? Can the Government provide the number of labor hours to multiply the rate by?

The Government expects the Offerors’ to provide in their proposal the number of hours and labor categories to accomplish the work.

18. Page 21 of task order 1, what is the formula for deriving the columns in the pricing table - Govt.-Site Fixed Price and Non-Govt.-Site Fixed Price? Can the Government provide the number of labor hours to multiply the rate by?

The Government expects the Offerors’ to provide in their proposal the number of hours and labor categories to accomplish the work.

19. If the work is to be done on contractor site, will the Government pay for the cost of the needed hardware and software?

See question #14.

20. Reference RFP, Attachment 1 (sections 4.3 and 4.4)

Will the courier services required be used to transport people, or just paper and supplies?

Does not require transport of people.

21. Reference RFP

It is our understanding that the Government will retain ownership of all future software tools developed. Will the Government make all software tools developed and in use under the existing contract available as GFE to the successful offeror at no cost?

No, the Government does not own the software in use under the current contract. However, the Government will retain ownership of all software developed under this contract.

22. Reference Page 87, 4.9(c), Instructions for the Preparation of the Technical Proposal

Based upon the fact that this proposal will include the response to the IDIQ contract and a Task Order contract, we request offerors be given the option to use the entire page count in single space to allow us to fully explain our solution.

The documents should have the “majority of the text double-spaced.” Single spacing is not acceptable.

23. Page 2 of the RFP, 5th paragraph states: "Currently, the sampling of manufacturer coding is verified by the contractor for 10% of all ICSRs received." Should the 10% metric apply to all reports submitted?

For task order 1, only electronically submitted ICSRs are sampled per the solicitation at 4.2.1 – Adverse Event Reporting Electronic Submission as described below:

i) Perform continuous quality control of manufacturer’s MedDRA coding at a 10% random sampling rate of all reports for compliance with FDA “Coding Principles for Post-marketing Adverse Event Reactions” document. Any missing MedDRA terms are to be added to the ICSRs in the AERS database.

ii) Perform quarterly quality evaluations on a 10% random sampling of Individual manufacturer’s MedDRA coding to a maximum of 50 reports to ensure compliance with the FDA “Coding Principles for Post-marketing Adverse Event Reactions”. [Reference SOP 5.3 Performing Quality Assurance of MedDRA Codes on Electronically Submitted (eSub)] In paper submissions, manufacturers do not include MedDRA codes, this is done by the Offeror.

24. Section 4.4.b.i states 100% of all Direct reports and 15 Expedited shall be "…completely processed into AERS within 7 calendar days." Can the Government please define “completely processed into AERS”?

Completely processed means all fields from the reports are committed to the database and quality control completed.

25. Section 2.4.1 Instructions for Placing and Negotiating Individual Task Orders, FDA includes the following language:

“The format and content of the work plan shall be substantially the same as the work plan that the contractor submitted with its original proposal. The work plan shall include:

A work schedule including the estimated date of commencement of work after issuance of the task order by the CO

A detailed price proposal, utilizing the rates in the contractor’s proposed cost/pricing schedule for the Base IDIQ, in addition to the total estimated price

Specific plans for dealing with anticipated problems that may be encountered”

QUESTION: Does Task Order 1 constitute the "original proposal", and does the work schedule requirement apply to Task Order 1?

The Offeror’s work plan and content should be consistent with their original proposal.

26. Ref. 2.19 352.270-5 KEY PERSONNEL (JAN 2006) - FDA indicates that "The key personnel specified in this contract are considered to be essential to work performance." However, no Key Personnel positions are included.

QUESTION: Which Key Personnel positions does FDA consider essential?

Key Personnel for Base contract: Contract Manager and Program Manager.

Key Personnel for Task Order 1 Contract:

Management and Administrative

Task Order Project Manager

Coders

Analyst Coder I

Analyst Coder II

Information Technology

Technology Consultant

Network Analyst/Technician

Database Management Specialist

Data Entry

Data Processing Specialist I

Data Processing Specialist II

Data Processing Specialist III

Quality Assurance

Lead Quality Assurance Specialist

Quality Assurance Specialist I

Quality Assurance Specialist II

Professional Positions

Business Writer/Editor

Subject Matter Expert I

Subject Matter Expert II

Subject Matter Expert III

Pharmacist

27. Section 4.8 Delivery Instructions: FDA indicates that offerors should submit 8 copies each of 4 proposal volumes: technical proposal for the Base IDIQ, business proposal for the Base IDIQ, technical proposal for Task 1 and business proposal for Task 1. However, instructions contained in sections 4.9 thru 4.11 indicate only 1 technical proposal and 1 business proposal.

QUESTION: Can FDA please clarify?

Section 4.8 is correct. There should be 8 CD’s for the Base IDIQ technical proposal, 8 CD’s for the Task 1 technical proposal, 8 CD’s for the Base IDIQ business proposal, and 8 CD’s for the Task 1 business proposal.

28. The RFP makes references in various areas of a 1-page CV or a 2 page resume for proposed personnel. Can FDA please clarify which of the two is the preference and if a double space format is required for these documents?

Submission of a 1 page CV that is single space is sufficient.

29. The overall percentage of eSubs to paper stated in the RFP is 80%. Can the Government please confirm this percentage?

The Government confirms the statement in the RFP: Currently, 80% of all reports are submitted electronically for task order one

30. Appendix J: Past Performance Questionnaire. Will the Government please specify the due date for the past performance questionnaire?

The past performance questionnaires are due the same date and time as the technical and business proposals

31. Section 4.8 indicates that proposals must be submitted via regular mail. Can proposals be sent via overnight service such as Federal Express?

Proposals can be sent using overnight services.

32. Section 4.9(c): Instructions indicate attachments which contain biographical information are excluded from the page count. Are letters of intent also excluded from the page count?

Letters of intent are excluded from the page count.

33. Section 4.10.6: Can the Government please clarify if descriptions of relevant experience are excluded from the page count?

Relevant experience descriptions are excluded from the page count.

34. Sections 4.10.5 and 4.11.1.6-7: What is the Government’s definition of a “major subcontractor”?

Please disregard the term ‘major sub-contractor’ and provide a list of all sub-contractors.

35. RFP Page 87, 4.9(c), Instructions for the Preparation of the Technical Proposal. The RFP requires that Offerors submit a Technical proposal with “…the majority of the text double-spaced.” Please clarify what “majority of the text” means.

“Majority of text” means that normal paragraphs should be double spaced but a table or chart for example may need to be single spaced.

36. RFP Page 87, 4.9(c), fourth bulleted item, Instructions for the Preparation of the Technical Proposal. Please clarify what “Contractor Past Performance Listing” means.

This refers to the past performance questionnaire.

37. RFP Page 91, 4.10.6(b), first bulleted item, Relevant Experience. In Section 4.10.6(b), the RFP directs that the Offeror submit the completed Past Performance Questionnaires as part of the Technical proposal. However, RFP Attachment J, “Past/Present Performance Questionnaire,” guides the evaluator to submit the questionnaire directly to the Government. Please clarify.

A lot of times offerors have evaluators fill out the questionnaire and they send it directly to the Government, however there are times when the contractor sends the forms in with their proposal. As long as the forms are received by the proposal due date the Government does not have a preference as to who sends the completed past performance questionnaire.

38. Attachment 1, Page 21, Compensation for Task Order 1. Will the Government please provide a sample staffing plan?

The pricing table on page 21 lists the labor categories the Government anticipates for Task 1.

39. Attachment 1, regarding equipment. It is our understanding that the Government will provide server hardware. Will the Government also provide networking hardware, software, and Internet connection?

Reference questions #14, #15, and #19.

40. Based on historical data, what is the length of time on average (in minutes or other value) to process (based on steps the contractor will have to take):

· Expedited-Paper

· Expedited-E submission

· Direct – paper

· Periodic – Serious-paper

· Periodic – E-submission

And, same question for the MedWatch to Manufacturer Program (10-20 per month)?

And, same question for those ICSRs with greater than 20,000 characters?

The Medwatch to Manufacturer program and ICSR are very small in volume and do not add appreciably to the work load

Estimates on minutes of labor spent per report can be derived from information given in attachment one of the contract that estimates worker productivity

(1) ICSRs shall be entered into AERS at or above the following performance targets:

(a) Processing Step and ICSRs per hour:

(b) 5-6 ICSRs per hour per employee

(c) Initial Data Entry 25-30 per hour

(d) Supplemental Data Entry 5-7 narratives per hour

(e) Data entry quality control 10-15 reports per hour

(f) MedDRA Coding 10-15 reports per hour

(g) MedDRA Coding Quality Control 25-30 reports per hour

You might need to add a small amount of additional labor for the triaging of reports. Note that two full time equivalents are now assigned to this duty.

The Government expects the Offerors’ to provide in their proposal the estimated length of time needed to process the above.

41. Based on historical data, what is the length of time to process a Drug Quality report?

The Government expects the Offerors’ to provide in their proposal the estimated length of time needed to process the above.

42. Page 7, based on historical data, what is the length of time for the Contractor staff to complete 4.21. sections i through v? Then, what is the length of time to perform, on average, vi?

The Government expects the Offerors’ to provide in their proposal the estimated length of time needed to process the above.

43. Within the MedDRA processing component, who will provide the Medical Review – FDA or Contractor? And, please describe what the Government’s description of Medical Review includes.

The Offeror is responsible for the Medical Review. See Appendix A – Glossary for description under MedDRA Coding.

44. Page 19: FDA will have three senior staff onsite to ‘facilitate day-to-day operations.’ Please provide more details on what this role entails.

Quality control, triaging of initial receipt of paper reports and acts as Subject Matter Experts (SMEs). Knowledge and expertise in electronic submissions. Resolve problems with individual or group of records that require subjective determinations.

45. On average, how many records are found to have inadequate coding and thus need to be escalated to the next step?

I assume the question is that under electronic submission how many electronic records need manual intervention before they can be loaded into the database? About 60% of all electronic records will go directly into the database. In 40% of electronic records issues like drugs not being in the FDA drug dictionary causes the report to stop and need manual correction by data entry staff.

46. Will the government provide the contractor staff (i.e., data entry specialists and coders) with any initial training? If yes, what is the estimated number of days or hours?

On site staff is available to answer questions during normal operations. During the initial months they will be available to train staff up to 15 hours per week.

47. Page 9, what are the paper acknowledgment letters acknowledging? And, what is the estimated weekly volume?

In AERS voluntary reports (consumers and health care providers) are thanked for reporting with a form letter

In DQRS reports are received and then letters are set out to FDA field office to give them the opportunity to inspect manufactures in the reports DQRS and AERS

AERS 200 per week

DQRS 250

48. Page 9, what is the estimated volume of rejection letters?

DQRS and AERS

AERS 2 or 3 a month

DQRS 0

49. For some ICSRs the Contractor will review the MedDRA coding already provided to ensure accuracy and for other ICSRs the Contractor will actually perform the initial coding (i.e., 4.5 – page 12) – is this accurate?

This is accurate.

50. What are the anticipated project hours or shall the Contractor establish the hours during the week?

The Offeror shall establish the hours required to perform the services as stated in the RFP.

51. How do the volumes on page 40 differ from those posted on page 3 of attachment 1?

The task order should have stated received and processed. That is the numbers in the task order breakdown do not include non –serious AERS reports which are now not entered into the system The following adverse event reporting metrics provide a glimpse of the scale, complexity, and timeframes in the FDA adverse event reporting data entry and quality control effort:

Total number of reports received in CY 2009 by type

Average number of MedDRA terms per ICSR in CY 2008*

Average narrative length (bytes used) per ICSR in CY 2008*

*The 2009 metrics are not available at this time. These reports are expected to remain approximately the same as 2008 metrics.

Then it agree’s with the agency wide contract numbers Table 1. Adverse Event Report 2009 Estimates