N02CN75008-10_Amendment_1.pdf

N02CN75008‐10 Amendment 1 Page 2 of 9

Office of Acquisitions

National Cancer Institute

RFP Number: N02CN75008‐10

Amendment No. 1

Date of Issuance: 03/30/2018

The above numbered Request for Proposal (RFP) is amended as set forth below.

Offerors MUST acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by separate letter, telegram, or Electronic Mail which includes a reference to the RFP and

Amendment number(s).

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF

OFFERORS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

This Amendment revises the RFP as stated below:

Following are Questions received on RFP N02CN75008‐10, and answers that clarify the requirements of the RFP.

Questions:

1. Please confirm Base period and 4 Option periods (see conflicts on few pages).

The contract is intended to be a 1‐year base contract with 4 optional years.

2. Please advise on # of SAE’s (budgeting purposes) to be processed and number reportable in one years’ time.

Historically, DCP has averaged 1250 AE’s and 37 SAE’s per year.

3. Please share what other regulatory bodies SAE data will be reported.

There may be filings to Health Canada.

4. Does NCI expect contractor to provide a physician review/adjudication of AE/SAE reports/data/listings, since each study has a Medical Monitor?

The DCP Medical Monitor will provide final review and adjudication of AE’s and SAE’s with contractor support.

5. Is the contractor expected to have an SAE system outside of the Access databases or RIMS requested? If not, who manages the SAE reporting system?

The successful awardee will be expected to manage the SAE reporting program. The successful awardee should have an in‐house database system for managing SAE’s and AE’s

6. Please clarify how NCI expects to receive support for AE coding. Will contractor be given access to a specific system, Access database or simply listing reviews?

The contractor will be expected to code for regulatory reporting from CTCAE.

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7. With regard to research agreements, does “maintain” mean only document management (i.e. tracking, version control, data sharing in document library) or will contractor provide other supports?

The successful awardee will receive copies of other research agreements such as CRADA’s, MTA’s, CTA’s, CSA’s, CDA’s. The awardee will be expected to file these documents and evaluate them for accuracy if needed.

8. Is contractor expected to scan legacy IND files for electronic document maintenance or only provide storage?

The legacy IND files will need to be scanned and stored. The files may need to be queried for specific information.

9. How many IRBs participate in all active NCI trials?

DCP uses the NCI Central IRB as the primary IRB for all trials. However, each study site for DCP trials has its own local IRB’s.

10. How many total personnel throughout all NCI sponsored INDs exist to cross‐check/track required human subject’s protection training documentation?

There are no NCI personnel assigned to track Human Subject protection training. The clinical sites have personnel to gather the certifications and the contractor will be expected to track HSP training for each staff member involved in a DCP‐sponsored trial.

11. Define cross‐filing activities?

Some of DCP’s clinical trials use agents supplied by third parties. When a third party has an existing

IND, DCP will obtain a Letter of Authorization to cross‐file our IND with the collaborators IND.

12. Is the contractor expected to budget for medical writing or assume submission ready documents?

Medical writing will be a part of the new protocol review and evaluation process. The contractor should not assume submission‐ready documents.

13. If contractor finds errors or inconsistencies in regulatory documents (during review and preparation, prior to publishing), the RIMS will be utilized to route for corrections by appropriate parties/stakeholders, is this NCI’s expectation? Confirm Contractor is not expected to perform medical writing.

Many of DCP’s collaborators have no regulatory affairs resources. The awardee will be expected to prepare documentation, such as pharm/tox or CMC sections, to satisfy regulatory requirements. The awardee will be undertaking some medical writing, but the stakeholder will also be consulted before final submissions

14. Please advise on the # of DCP draft guidelines or SOPs to advise on.

The DCP draft guidelines are posted at https://prevention.cancer.gov

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15. For prospective Non‐Key personnel, will NCI accept requested details without identifying names which can be provided at award?

We will accept requested details. Letters of commitment from non‐key personnel is preferred.

16. For budgeting, please provide estimate on the number of pages/documents to be translated. Translation services usually charge by word.

It is estimated that one document per year may need translation. These documents could be up to 30 pages long with 300‐500 words per page.

17. Is there an incumbent to this contract?

Yes.

18. What was the previous contract award number, amount and incumbent name?

CCS Associates Inc.

HHSN261201100064C

$14,747,437

19. Are there current employees filling this position that might intend on remaining with a new contractor?

The Government is unable to answer this question.

20. What are the WDOL classifications for all the positions?

The service contract act is not applicable to this acquisition.

21. The proposal specifies a font with spacing of “no more than 15 cpi,” such as Arial 11. Can tables and charts be in a smaller font such as Arial 10 [point font]?

Yes

22. The proposal can’t include links to URLs; however, is it acceptable to provide hyperlinks within the document?

Yes, hyperlinks to items within the electronic proposals are acceptable?

23. In various places the RFP refers to 5 option years (see page 4) or 4 option years (see page 14). Please clarify the number of option years.

Contract will be Base + 4 options years for a total of 5 years.

24. Attachment 9 states that the offeror’s technical proposal shall include copies of Standard Operating

Procedures (SOPs) relevant to the Task Areas in the Statement of Work. Do these SOPs need to be submitted with the proposal or within 120 days of contract award?

Draft SOP’s need not be submitted with proposals. Draft SOP’s shall be submitted within 60 days of award. However, final SOP’s must be available no later than 120 days after the contract award.

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25. Section L lists NAICS 541690 small business size standard as $7 million. Is this amount correct?

Size standard for NAICS 541690 is $15 million.

26. Page 9 of the RFP states that an independent assessment of security and privacy controls in place for system(s) is due 90 days after contract award; the RFP then states that the POA&M, the end product of this independent assessment, is due 30 days after contract award. Please confirm the due dates for these deliverables.

The POA&M shall be delivered as part of the SA&A, which is required 90 days after contract award.

27. The IND annual reports and DMF annual updates are due on the anniversary date of each contract year. Is this correct?

The IND annual reports and DMF updates are due on the anniversary dates of their respective submission dates.

28. Article B.3 states that certain items are prohibited and then proceeds to list of items that may be included if the contracting officer approves. What is the likelihood of any of these listed items being included?

Further, are there any other associated restrictions if so directed? For example, if meals are to be included will customary per diem restrictions apply? See also Article H.19, These items are approved on a case‐by‐case basis. Contractors will be required to comply with

Government Travel Regulations.

29. Article C.1 identifies the SOW as a January 2018 document; this does not match the SOW attached as attachment 3, which one is correct?

Attachment 3 is the latest and correct SOW.

30. Article C.2 requires all electronic reports to be Section 508 compliant. Section 508 requires that all website content be accessible to people with disabilities. These two statements do not appear to relate to one another, could the government address this perceived disconnect.

It is the expectation of NCI that electronic reports be 508 compliant and accessible to people with disabilities.

31. Page 5, Draft SOPs – are there any draft SOPs already in existence as a part of the services provided by the incumbent? If so, can these be made available?

The final SOP’s themselves are proprietary and cannot be shared.

32. Page 8, Transition Plan – it is not clear which transition is at issue. Is the government concerned with

“Transition In” under a new award generated from this RFP, or “Transition Out” at the end of the period of performance of the new contract?

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The Transition Plan deliverable is concerned with the Transition out at the end of the period of performance of the new contract.

33. Page 9, which positions are Level 5 and which are Level 1?

The government has not defined any specific labor categories/positions for this acquisition, as it is up to the Offeror to propose appropriate labor categories/labor mix to fulfill the requirements under the

SOW. Determinations will be made based on labor categories Offeror proposes.

34. Page 10 as it relates to compliance with HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)‐12, ‐‐ will all contractor employees have access to government electronic systems?

All contractor employees will not have access to government electronic systems. Requests for use of government electronic systems will be made to the contract Project Officer who will decide the request suitability.

35. Page 11, the links in paragraph 6 and F do not appear to be active, could the government provide the pdfs referenced?

The links appear to be working. Please try manually copy & pasting the links.

36. Page 12, paragraph 13. If this contract does not require website development, does this paragraph apply?

Yes, a Section 508 Annual Report will be a required deliverable.

37. Page 14, table of personnel, has the government determined any of the categories of labor to be inherently Exempt from the Fair Labor Standards Act?

The government has not determined any labor categories to be inherently exempt from the Fair Labor

Standards Act.

38. Page 24, the link in paragraph 6 does not appear to be active, could the government provide the pdfs referenced?

The links appear to be working. Please try manually copy & pasting the links.

39. Page 26 requires contractor employees to be trained prior to working on the contract, but the linked website requires a code to access the training. When will that code be provided?

Codes shall be provided after award.

40. Page 26 also requires role‐based training for certain positions, can the government identify which roles and which training will be required?

The roles shall be identified by the program manager after contract award.

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41. Page 26, Rules of Behavior‐‐the first link does not exist.

Please refer to https://ocio.nih.gov/InfoSecurity/IncidentResponse

42. Article H.10, can the government quantify how many cubic feet of records are likely to transfer from the incumbent as well as an estimate of how many cubic feet of storage will be generated each year.

Approximately 2,000 cubic ft. of records will likely transfer. Most documentation is now saved electronically and future storage requirements are anticipated to be minimal.

43. Page 81, Past Performance: is this something more than the Corporate Experience factor on Page 80?

The Pertinent Corporate Experience factor will have a 15% weight as a technical evaluation factor. The past performance factor will be evaluated subsequent to the technical evaluation and is defined on page 81.

44. Attachment 3, page 5 of 6, notes an existing government information management system and requires the new contractor to integrate such system with its own. Can the government provide the details of the existing system and future systems?

Government information systems utilize XML, JSON and CSV based interfaces. The contractor may use any system as needed for effective data interchange.

45. Task 10 of the SOW contains a Transition Out requirement to a successor contractor, is there a transition plan available from the incumbent to better understand the Transition In expectations?

The transition plan from the incumbent contractor is not available at this time.

46. Page 50 states that the proposals must be printed double‐sided on 30% post consumer fiber paper.

Please confirm if both electronic and hard copy submissions are required and clarify.

A hard copy proposal is not required. Please refer to Attachment 1 for proposal submission instructions.

47. Please define which positions are key persons and what resumes are required and if resumes are included in the page count.

The contract PI and any other co‐PI’s will need complete resumes. These resumes will be included in the page count.

48. Please confirm if SOPs are required to be submitted with the technical proposal, as per the requirement on page 7, when they are a required deliverable due within 60 days of contract award. Are SOPs included in the total page count if they are required to be submitted with the proposal?

The government rescinds the requirement to submit Draft SOP’s with the proposal. Draft editions of the SOP’s for program review should be submitted within 60 days of contract award. Final editions of the draft SOP’s are required within 120 days of the award.

49. Attachment 3, what current system is being used for 24 hour 7 day notification?

The contractor will notify the DCP Medical Monitors and FDA by e‐mail as appropriate.

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50. The term “salient results” is used a couple of times in the RFP, does this equate to “accomplishments?”

Yes, salient results are the most meaningful accomplishments related to the item requested.

51. Could the government clarify the following, note specifically the text in red?

Draft Standard Operating Procedures

5. The Contractor shall prepare and submit draft SOPs for all functions described in the SOW and submit to DCP for review and approval within 120 days of contract award. SOPs shall be updated as needed and submitted to DCP for review and approval.

Final SOP Manual

6. Upon receipt of NCI approval of the draft standard operating procedures, the Contractor shall create a Standard Operating Procedures Manual in PDF format and submit to DCP for review and approval.

BUT

Deliverable Table states the following:

8. Draft Standard Operating Procedures Within 60 calendar days of award

9. Final Standard Operating Procedures Manual WIthin 120 calendar days of award

The government rescinds the requirement to submit Draft SOP’s with the proposal. The SOP’s should be operational within 120 days of contract award. The draft SOP’s should be available for Program Officer commentary within 60 days of award. The Project officer will evaluate the draft SOP’s after receipt of the draft SOPs so that any revisions can be made final within 120 days of award. The final SOP’s must be operational within 120 days of contract award.

52. Similarly, could the government clarify the delivery requirement for Roster Updates, note specifically the text in red?

Roster: 1. A. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change.

Deliverable Table: 23 Reporting of New and Departing Employees Within 5 working days of staffing changes

Any staffing changes must be submitted within 7 days (5 working days) of the change.

53. Attachment 8 discusses Key Personnel and it appears that the proposed Principal Investigator/Project Manager should be considered as “key.” That attachment also mentions “Other Key Technical Personnel.” Do all of the requirements associated with “Key” apply equally to “Other Key Technical?”

Does the government consider all “Professional” staff as “Key” or “Other Key Technical Personnel?”

The PI is the only Key personnel for the contract. At this time, there are no “Other Key Personnel”.

54. Throughout the RFP the term “research” is used, for example in the evaluation factors on page 66, “2. Other Considerations d. Other factors you feel are important and support your proposed research” Do we correctly understand that this RFP supports DCP’s efforts to manage research, but does not extend to the conduct of research?

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No original research will be undertaken by this contract. Some literature searching may be required.

55. Article F.3, the table states “Professional” and “Professional Support,” can the government provide its understanding of the differences between these two terms?

It is up to the Offeror to propose appropriate labor categories/labor mix to fulfill the requirements under the SOW. The government has provided approximate/broad labor categories to provide offerors with a basis to determine the level of effort.