Technical and Business Proposal Q A 9-10-12.docx

REMINDER: The cut-off for submitting questions regarding this solicitation is 3:00 pm October 5, 2012.

Questions and Answers to RFP No. NIHES2012154 Title: Support of the Research Effort to Evaluate Toxicity Following Early Life Exposure to Test Articles For the National Toxicology Program (NTP)

1) Based on several questions received regarding the costing of the base work and options, the following general response is provided:

It appears that there is confusion about how to cost the base contract and options, especially with regard to the level of effort estimates provided in the chart on pages 44 and 45 of the RFP. We would like to clarify that this chart is provided for helpful guidance to Offerors in understanding the way in which the final contract award will be structured and also to inform the Offeror that the laboratory must have adequate capacity for the amount of work that is expected to be performed in this contract. This chart is not to be used for purposes of developing a cost estimate and the number of labor hours given are estimations only and are not to be considered restrictive. Offerors must estimate cost and level of effort for the base and options by using the Additional Business Proposal Instructions on pages 75 and 76 of the RFP. These instructions provide the information needed to develop a business proposal for this solicitation. Offerors shall provide costs in a format identical to or similar to Attachment 12. It is acceptable if Offerors choose to use a slightly different format as long as the major cost categories are included.

2) Attachment 3, Statement of Work, page 9 – Electronic deliverables must be compliant with Section 508 regarding accessibility. What is the NIEHS criteria for “accessibility” as it applies to the current solicitation.

Response: See Section C.2. Reporting Requirements:

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Helpful Resources."

See 6. REPORTING AND SUBMISSIONS in the SOW:

6. REPORTING AND SUBMISSIONS

Electronic deliverables must be compliant with Section 508 regarding accessibility. In some cases, there may be accommodations for which the COR will provide information annually.

The current accommodation applies to the prestart chemistry report and final study reports and requires that these PDF be OCRed, tagged, have the language set to English, and have the tab order set. Accommodations are renewed annually. For costing purposes, assume that the accommodation will be renewed annually.

3) RFP Cover Page (Section A.2) and page headers – The RFP number on the solicitation cover page and the RFP number in the headers is not the same. Please verify the correct RFP number.

Response: This was an oversight. The correct RFP number is NIHES2012154 found on the cover page.

4) Water analysis - please clarify the frequency of water analysis for cost purposes.

Response: For cost purposes, assume facility water analysis is conducted once yearly.

5) Can the NTP provide a potential location for shipments of biological samples or animals for cost purposes regarding shipping?

Response: For costing purposes, assume that each time biological samples or animals must be shipped, the cost for shipping these samples is $1,000 to any potential location.

6) RFP Page 76, Item 7 (Overall Cost estimates) – Item 7b (MOG), what cohorts are to be included for the cost estimate? Response: 13-week, Teratology and Fertility cohorts. Item 7c, what is the route of administration? Response: oral gavage.

7) RFP page 75 – Number 5 on the mouse toxicity studies. Can an Offeror assume that the same formulations will be used on the rat and mouse studies such that all chemistry support cost should be included in the rat cohort and not for the mouse cohort?

Response: Yes.

8) Study Assignment #1 (RACB), page 8 indicates that F0 dams that do not deliver pups shall be examined internally on the expected GD 24. Is this correct? Since the females will be mated 3 times and high dose females are also required for a crossover mating should we assume that all F0 females will be kept until all matings are complete?

Response: For costing purposes, assume that all F0 females will be kept until all matings are complete. The last sentence of the first full paragraph on page 8 of Study Assignment #1 is in error.

9) Study Assignment #1 (RACB) page 11 - Is the necropsy of the non-selected F1 offspring to be included in the cost estimate for phase 3?

Response: Yes, include this in phase 3.

10) Study Assignment #1 (RACB) page 11 – Should Offerors assume that the section on F1c mating and F2 assessment is phase 5?

Response: Yes

11) Study Assignment #3 (MOG) Fertility cohort - Section 8.4 specifies evaluation of vaginal cytology on the F2 females; however no age is defined. Do Offerors assume starting at PND 77 +/- 3 days and continuing for 16 days?

Response: Yes

12) Study Assignment #3 (MOG) Fertility cohort - Section 8.5 requires costing of a crossover mating; however, the study assignment says to euthanize F1 females after weaning of the F2 offspring. For costing purposes, should Offerors assume that all F1 females are retained until the crossover mating is complete? The crossover only requires the high dose females.

Response: For costing purposes, assume to perform crossover mating with high dose F1 females, retaining all F1 females until the crossover is complete and euthanize all F1 females in the same timeframe.

13) Study Assignment #3 (MOG) Neurobehavioral cohort - Section 9.2 states weekly body weights and cage feed consumption until evidence of mating. Is this an error?

Response: For cost purposes, assume that the neurobehavioral cohort animals will NOT be mated.

14) Study Assignment #3 (MOG), Prenatal cohort - Section 7.3 - Is there a gross exam on pregnant females that would require the presence of a pathologist?

Response: For costing purposes there is no gross exam on pregnant females requiring the presence of a pathologist for Sample Study Assignment #3.

15) Study Assignment #3 (MOG) Neurobehavioral cohort – Should there be costing for any abbreviated functional observations on the dams or pups during lactation?

Response: Sample Study Assignment #3 does not require any abbreviated functional observations on the dams or pups during lactation.