Amendment_1_(RFP_No._N01DA-15-2243).pdf

“Clinical Research Coordinating Center for NIDA’s Clinical Trials Network”

AMENDMENT OF SOLICITATION NO.: RFP N01DA-15-2243

AMENDMENT NO.: 01

EFFECTIVE DATE: March 5, 2015

DUE DATE: March 30, 2015, 3:00 P.M. EST

ISSUED BY:

National Institute on Drug Abuse, NIH

NIDA R&D Contracts Management Branch

Office of Acquisitions

6001 Executive Boulevard

Room 4211, MSC 9559

Bethesda, MD 20892-9559

Point of Contact: Lisa Bielen, Contract Specialist (Changed)

E-Mail: lisa.bielen@nih.gov (Changed)

Phone: 301.443.6677

FAX: 301.443.7595

The above numbered solicitation is amended as set forth below. All other terms and conditions of the RFP remain unchanged.

DESCRIPTION OF AMENDMENT

PURPOSE: To answer questions regarding the RFP

Questions & Answers:

1. RFP Section M.3 (pg. 76) states the mandatory qualification criteria of offerors’ possession of a DEA

Research Registration (for Schedules II to V), and either possession/or the ability to obtain registration for Schedule I. Please clarify: can the registration be possessed by a subcontractor, or must it be held by the prime contractor?

The DEA License must be held by the entity that will be receive, store, and distribute DEA scheduled medications. In the past, sub-contractors have been the holder of the DEA license.

This arrangement will be acceptable for the upcoming contract.

2. As specified in Article G.2, “Key Personnel,” the term “key personnel” is used to contractually designate personnel that cannot have their commitment be changed to the project or moved off the project without approval from NIDA. However, page 64 of the RFP states that resumes for all key personnel are required. Does NIDA require resumes for only contractually designated key personnel or do you require resumes for personnel who we feel are important to the contract? In addition, page 63 of the RFP states that a letter of commitment is required for proposed personnel who are not members of the offeror’s staff, e.g., subcontractors, and that a resume does not meet this requirement. Does NIDA require resumes for all proposed subcontractor personnel in addition to a letter of commitment or resumes for only subcontractor personnel who we feel are important to the contract, e.g., those in leadership positions?

NIDA is requiring resumes for all personnel deemed by the Offeror to be important to the contract. NIDA is requiring resumes and letters of commitment for all non-offeror staff members who are deemed by the offeror to be key personnel (important to the contract).

mailto:lisa.bielen@nih.gov

3. The cover letter of the RFP states that the offeror must submit one original (1) and ten (10) copies of the technical proposal; whereas Attachment 1 of the RFP, “Packaging and Delivery of the Proposal,” states that the offeror must submit one original (1) and fifteen (15) copies. How many copies of the technical proposal does NIDA require for this RFP?

NIDA is requiring fifteen (15) copies of the technical proposal.

4. Would the Government consider amending Attachment 1 to the RFP (Packaging and Delivery of the

Proposal) and accept proposal submissions via email?

No, NIDA will not accept email submissions.

5. In Task 7.a. of the Statement of Work, it states that one senior staff member will represent the Clinical

Coordinating Center (CCC) on the CTN Steering Committee and participate in all Steering Committee meetings. Should offerors assume that the 3-4 Steering Committee meetings per year are face-to-face, via conference call, or a combination of both?

The CTN Steering Committee typically holds a 2½ day meeting meets face-to-face annually and meets 2-3 times per year via conference calls and webinars.

6. Does the Government assume the $300,000 per year for the purchase of medication/placebo (page 6 of the Statement of Work) will cover all of the costs associated with the delivery of the Task 4 services?

Similarly, does the Government assume the $300,000 per year for the purchase of laboratory supplies

(page 7 of the Statement of Work) will cover all of the costs associated with the delivery of the Task 5 services?

Per the SOW, “offerors should assume $300,000 in other direct costs for medication/placebo purchases for Task 4 each year of the contract.”

7. Does the Government expect Regulatory submissions to be in electronic or paper format?

To date, the CTN’s FDA submissions have been paper-based.

8. Can the Government clarify how many NDAs vs. INDs will need to be submitted?

Task 1 g indicates, “the offeror may assume that in any given year, two (2) CTN studies will be involved in an IND or NDA.” To date, all FDA submissions have been INDs.

9. Can the Government clarify Task 5.i. of the Statement of Work as far as whether the CCC would need to coordinate/send analysis results to the Data and Statistical Center?

The CCC is responsible for coordinating drug testing and analytical laboratory services; which may include on-site testing or central laboratory services. The CCC will need to collaborate with the DSC to establish a process through which the results of these tests may be entered into the

DSC’s EDC system.

10. Will the CCC be responsible for product safety services? Can the Government provide an estimate of the number of SAEs both expedited and non-expedited offerors should assume?

The CCC will be responsible for monitoring SAEs. A projected number of SAEs is not available as they vary based on the type of trial conducted (medication vs behavior) and the expected number of participants.

11. Regarding SOW Task 1 c., this task seems to overlap with the ones under Task 2. Please clarify.

Task 1 c indicates the overall responsibility for a clinical trial’s regulatory compliance; while

Task 2 details more specifically the expected activities of trial monitoring and monitoring visit activities.

12. For SOW Task 1 d., does the contractor need to maintain hard copies, e-copies, or both? Will the contractor receive any hard copy or e-files of regulatory documents? Does the contractor need a fire suppression file room?

The contractor will be responsible for maintaining electronic copies of required regulatory documents.

13. For SOW Task1 g., are FDA submissions currently paper-based on electronic? If eCTD, is a publishing tool in place that will transfer with the contract for use by a successor contractor?

To date, the CTN’s FDA submissions have been paper-based.

14. For SOW Task 1 g., would this task include writing Investigator’s Brochures and CMC sections?

Yes, this task would require the Contractor to collaborate with Study Lead Investigators and

NIDA on the preparation of the on the Investigator’s Brochure and CMC sections.

15. For SOW Task 1 g., how many IND submissions are anticipated per year?

Task 1 g indicates, “the offeror may assume that in any given year, two (2) CTN studies will be involved in an IND or NDA.”

16. For SOW Task 1 i., are all protocol deviations (including violations) reported through the DSC EDC system or should the contractor assume that we provide a reporting tool?

Yes, all protocol deviations are reported through the DSC’s EDC system.

17. For SOW Task 1 m., please clarify the difference between Task 1m and Task 1k, as they seem to be duplicates.

Yes, they are duplicates.

18. Is there an SOP Reading Room?

The tasks/responsibilities of the CCC are included in the SOW included in N01DA-15-2243 and the roles/responsibilities of the CTN Node are included in the terms and conditions section of

RFA-DA-15-008.

19. For SOW Task 3 a., are the closeout meetings referenced in this task the QA closeout visits? What kind of training does NIDA require to be developed for closeout meetings?

The Contractor will be expected to participate in study orientation and study closeout meetings.

Study-specific training will take place primarily at the Orientation meeting and while, formal training will not be scheduled in conjunction with QA Monitoring visits, the Contractor should anticipate the need to reinforce training at these visits

20. For SOW Task 3 c., is the development, maintenance, and hosting of the training tracking database in the scope of this contract or will this be done by the DSC?

The CCC Contractor will have primary responsibility for tracking CTN training. Coordination with the DSC will be required only to the extent needed to gain information on the CTN staff participating in in on-going studies and the status of the ongoing studies and their sites.

21. For SOW Task 4 n., for costing purposes, should we assume that the ECG machines and cardiologist consultation are considered part of the stated cost assumptions for Task 8 (i.e. 4 x $60,000 per year)?

Yes.

22. For Article F.3, Level of Effort (pg. 14): the RFP states that the labor hours “exclude subcontractor labor hours.” However, under Section L.1.e, Instructions to Offerors – Level of Effort (pg. 46), that exclusion does not appear. Please confirm if the LOE is exclusive of subcontractor labor hours.

LOE is exclusive of subcontractor labor hours.

23. Regarding Article F.3 Level of Effort (and Section L.1.e): Because most of the activities described under Tasks 4 and 5 are usually provided and priced on other than a labor-hour basis (e.g. fixed unit price, by subcontractors), can NIDA confirm that those activities and their cost is not encompassed in the stated LOE hours?

NIDA confirms, those activities and their costs is not and will not be encompassed in the stated

LOE hours.

24. Attachment 1 – Packaging and Delivery of the Proposal – for the technical proposal, states: “If submitting CD ROMS, include with the original and each copy.” We found no other reference to electronic copies of the technical proposal in the instructions – please confirm if CD ROMS are desired.

CD ROMS are optional – they are neither desired nor undesired.

25. Are there any preferences in terms of formatting of the technical proposal (font/size/margins)?

NIDA does not have any preference in terms of formatting the technical proposal.