Amendment_3_RFP_Questions_Posted_10_24_13_.pdf

Amendment 3

QUESTIONS AND ANSWERS TO RFP NO. NIHES2013180

1. Question: Sample Assignment 6C, option 2 section 4: Biological Sample

Analysis. Would the government please clarify the following:

Is it necessary to validate a method for this section?

Since this is a BMDA task and the results will be supporting a non-GLP research study, it would seem that validation is unnecessary.

Please clarify the number of samples to be analyzed. Will there be a total of 80 samples or 240 (80 x 3 dose groups) samples analyzed?

Answer: While it is correct that the BMDA assignment type does not require GLP-compliance, sample assignment 6C requires the development and validation of an analysis method for DTBBA in plasma, followed by analysis, using the validated method of 80 plasma samples. Validation of a developed method is outside the scope of the BMDA assignment type. The inclusion of the validation requires a BMDV assignment type to develop the method, followed by a BSA assignment type to analyze the samples using the validated method. Both of these assignment types require GLP compliance.

2. Question: page 45 of the RFP under Section e., Level of Effort. The RFP states that the number of hours for the base period is 31,395 per year, but in the following table the total number of hours per year is given as 32,305. Please indicate which is correct. Please also confirm that the clarified NTP estimate is the value that bidders should assume is the approximate number of hours to be bid based on the anticipated number of tasks and supporting effort that will be required for the base contract.

Answer: The original estimate has 31,395 hours total for the base contract.

3. Question: Attachment 23, Item 3, Cost Assumptions states Offerors should assume average procurement costs of $6,500 per chemical. Does this amount include just the cost of the chemical or does it include labor? Should this value also be used to estimate the chemical cost for HTS tasks? If not, what value should be used and how many chemicals would be procured in a typical HTS task under Optional Study 1?

Answer: The average estimated procurement cost of $6,500 includes the cost of the chemical and labor to procure the chemical and produce the report. HTS procurement tasks typically do not require individual reports, so the $6,500 figure should not be used to estimate HTS procurement costs. Costs for HTS chemicals in the amounts needed for the program vary widely, but for the purposes of estimating costs, Offerors should assume each chemical for a 1408-chemical plate costs $155.00 not including reporting costs and that they will be responsible for procurement of 1408 chemicals for each HTS procurement assignment. Offerors should also assume that a single procurement report would be required for each set of 1408 chemicals.

4. Question: Page 28 of the Study Specification. Under 4, Additional Requirements, the

RFP implies than an RSD of ≤ 10% is acceptable for precision of the triplicate analysis samples. On page 29 of the Study Specifications for the FPA, it says to follow the same specifications. However, on page 31 under 4. Acceptance Criteria for FPAS it says the

RSD should be ≤ 5%. Shouldn’t the acceptance criterion for precision be the same for all formulation analysis tasks? If so, which value should be used?

Answer: The %RSD requirement should be 10% for all formulation assignments.

5. Question: The study design for Sample Work Assignment 4 specifies “7-day” repeated exposure and collection of blood samples from “7 AM on Day 8”. Should we assume that we take the dosed feed away from animals (and replace with blank feed) right before

7 AM on Day 8? We believe this is what NTP intends to do since the TK profiles will get very complicated (perhaps impossible to calculate detailed kinetic constants) if animals are allowed to eat dosed feed on ad libitum basis during blood sample collections on Day 8. Please clarify.

Answer: The assumption stated in the question is correct. The dosed feed (or water) is typically removed in the morning just before the first time point is collected. The exact time would be specified in the study protocol. For the sample assignment, Offerors should assume that dosed food would be removed at 7 AM.

6. Question: Is the Level of Effort in Year 1 31,395 or 32,305 hours?

Answer: The original estimate has 31,395 hours total for the base contract.

7. Question: Options Direct Labor Hours, Solicitation, pg 45, Section L, Subsection 1.e , Level of Effort 2nd table.

For Option 2 Ancillary Studies: With 30 exercises total at up to 3/year, do the Total

Labor hours of 46,410 imply 4,610 hours per exercise?

Answer: Yes, however, the 4,610-hour estimate reflects a typical assignment. It should be understood that each exercise will have unique requirements, which will result in variance from the 4,610 hours.

8. Question: Is the submission of the Health and Safety Plan (HASP) required with the proposal or within 60 days of the start of the Contract?

a. RFP SOW Attach 3 Section 3.2.4, pg 13, States: “. . . a copy of the proposed HASP shall be included in the contract proposal”

b. Attachment 24 - Chemistry Specifications, pg 5 of Reporting Requirements, Section

4.3.2 Contract Management Reports: states: “. . . shall submit to the COR within 60 calendar days of award of the Contract”

Answer: The HASP, QMP, and IT Security plans should all be submitted with the proposal, but they do not have to be finalized for NTP review and approval until 60 days after the start of the contract. However, as the Technical Evaluation Criteria makes clear, proposals will be evaluated with the HASP, QMP, and ITS plans in mind.

9. Question: Is the submission of the Quality Management Plan (QMP) required with the proposal or within 60 days of the start of the Contract?

a. RFP SOW Attach 3 Section 2.3.2.2, pg 12 States: “. . . a copy of the proposed QMP must be included in the contract proposal”

b. Attachment 24 - Chemistry Specifications, pg 5 of Reporting Requirements Section

4.3.1 Contract Management Reports: states: “The QMP shall be submitted to the COR within 60 calendar days of start of the Contract” days after the start of the contract. However, as the TEC makes clear, proposals will be evaluated with the HASP, QMP, and ITS plans in mind.

10. Question: Is the submission of IT Security Plan (SSP): required with the proposal or within 60 days of the start of the Contract?

a. RFP SOW Attach 3 Section 2.2.5, pg 11, States: “. . . a copy of the proposed IT security plan shall be included in the contract proposal”

b. Attachment 24 - Chemistry Specifications, pg 5 of Reporting Requirements Section

4.3.3 Contract Management Reports: states: ”. . . shall submit to the COR within 60 calendar days of the award of the Contract” days after the start of the contract. However, as the TEC makes clear, proposals will be evaluated with the HASP, QMP, and ITS plans in mind.

11. Question: Which is the preferred terminology for proposal response: Protocols

Development, PD or Characterization Protocols Development, CPD?

a. RFP SOW, Attach. 3, Section 1.2.2 Program Management/Logistics and Handling, pg

4 uses Protocols Development (PD)

b. RFP SOW, Table 2.2.1 Attach 3, pg 18 uses Characterization Protocols Development

(CPD)

Answer: The preferred terminology is 'Protocols Development' since this assignment now includes dose formulation protocols in addition to characterization.

12. Question: For Sample Assignment 4, Preliminary Gavage Study, which is the preferred number of groups for the study: 10 animals/group/species/sex or 8 animals/group/species/sex?

a. RFP SOW Attach 3 Section 7.5.1.4, pg 26, first sentence states: “Groups of 10 rats and mice of each sex shall be gavaged…”

b. RFP SOW Attach 3 Section 7.5.1.4 pg 26 second sentence lists 8 target times: pre-dose, 5, 15, 30, 60, 120, 480, and 1440 min.

Answer: For the preliminary toxicokinetic study the Offeror should assume the number of animals is 10/group/sex/species.

13. Question: Sample Assignment 4, Toxicokinetics from the SOW, Attach. 3. For the sample chemical, deoxynivalenol, DON, is CASRN 51481-10-8 correct?

a. RFP SOW Attach 3 Section 7.1.4 pg 24, states CASRN is 51581-10-8

b. On-line the NTP document dated March 2009 is titled “Chemical Information Review

Document for Deoxynivalenol [CAS No. 51481-10-8]”

Answer: The NTP document has the correct CAS number, which is 51481-10-8, the other is a typo.

14. Question: Can the Agency provide a copy of Attachment 7 Technical Proposal Cost

Information/Summary of Labor and Direct Costs? The attachment is not included in the solicitation or available in the link provided in Section J.

Answer: Attachment 7, “Technical Proposal Cost Information/Summary of Labor and

Direct Costs” has been posted to FedBizOpps.

15. Can the Agency provide a copy of Attachment 8 Proposal Summary and Data

Record? The attachment is not included in the solicitation or available in the link provided in Section J.

Answer: Attachment 8, “Proposal Summary and Data Record” has been posted to

FedBizOpps.

16. Please clarify the Agency’s requirements for electronic submission of the Technical proposal. Attachment 1 requires 28 copies with a password of NTP246. Attachment 22, section 1.5, requests 2 copies of only the narrative with a password of NTP.

Answer: An amendment has been posted to FedBizOpps clarifying that Attachment 1, “Packaging and Delivery of Proposals” shall be followed.

17. Please confirm the Agency’s requirements for electronic submission of the Business proposal. Attachment 1 requires 5 copies with a password of NTP246. Attachment 23 provides no guidance.

Answer: Please follow the instructions provided in Attachment 1, “Packaging and

Delivery of Proposals.”

18. Does the Agency have a preference where the Technical Proposal Cost

Information/Summary of Labor and Direct Costs form is included in the proposal?

Answer: No

19. Is guidance available on what the contractor should assume when estimating travel?

Answer: The Offeror should assume 1 trip to a national meeting to present work performed under the contract, and 1 trip to NIEHS to meet with NTP staff. All meetings and travel shall be approved in accordance with the Office and Budget

Memorandum M-11-35 and NIH Guidance Related to HHS Policies on Promoting

Efficient Spending.