Questions and Answers_RFP No. NIHES 2011135_FINAL.pdf

QUESTIONS FOR RFP NO. NIHES2011135

Question 1:

Is there a description or a video we can review to show us the layout of areas that we need to provide information? In the RFP document on pages 71-80 shows the business proposal instructions...is the layout that is expected?

Answer:

As stated in the RFP, we require both a business proposal and a technical proposal. You are required to provide all business and technical information requested in the RFP and associated attachments. However, we do not require a particular format. That being said, we are requiring both hard copies and cd-roms as specified in Attachment 9-Delivery and Proposal Instructions.

Question 2:

The overall RFP reads as though you are seeking a dedicated hoster with the ability to develop a database that can take feeds from multiple locations and then store the data in one database of record. However, on page 77 with the Technical Evaluation Factors, it appears as though you are seeking a company that can provide the aforementioned services yet provide Statistical Analysis, and other hands-on services….If you could let me know which interpretation is correct I would greatly appreciate it.

Answer:

We are looking to acquire access to a hosted database which can support data collection for NTP research studies which also has the capability to perform statistical tests, has upload capability and meets NTP usability requirements as outlined in Attachment 1-Statement of Work. Please refer to the Statement of Work for more detailed specifications related to the functionality of the desired system.

Question 3:

Section III Additional Features: Item 10 states “Collect and report the calendar dates of first and last pre-mating dosing in a generation within a study.” Does this mean to report this per animal, or overall first/last for all animals in the generation (i.e. just to show 2 dates per generation)? Is there an example of the report, or more details as to what exactly is to appear on the report.

Answer:

This information is needed per group. The report should look as follows (in regard to format):

Generation 1 Group name Date of first dose Date of last dose High dose 13 June 2012 30 June 2012 Mid Dose 14 June 2012 24 June 2012 Low Dose 20 June 2012 27 June 2012 Control 5 July 2012 12 July 2012

Question 4:

Section IV Additional Study Types: The requirement states for item 1.Immunomodulation assays shall include (assay details given in Appendix 5). Please clarify the ICH guideline that is appropriate to the study type and assays referenced in this requirement?

Answer:

There is no ICH guideline that includes the comprehensive tiered testing approach used by the NTP for the conduct of Immunotoxicology studies, thus we do not reference an ICH guideline.

Question 5:

Section IV Additional Study Types: The requirement states for item 1 d. Mixed Leukocyte Response to DBA/2 Mouse Spleen Cells. Cells are cultured in the presence of 1 mCi 3H-thymidine and counted in a LKB liquid scintillation counter. Data are expressed as cpm/culture. Please clarify the ICH guideline that is appropriate to the study type and assays referenced in this requirement?

Answer:

There is no ICH guideline that includes the comprehensive tiered testing approach used by the NTP for the conduct of Immunotoxicology studies, thus we do not reference an ICH guideline.

Question 6:

Section VII-Options Which May Be Exercised After Completion of Option 1 (Year 2): This requirements states for item 2. Presentation of data from adult male and female animals on a single page in a table. Which data tables need to have data presented in this format?

Answer:

The SOW should have stated “Presentation of data from adult male and female animals without an obligatory page break in any table.” This has been amended in the Statement of Work and the amended Statement of Work will be posted to FedBizOpps.

As far as which tables need to have data presented in this format, this applies to all data tables.

Question 7:

Section VIII Reporting Requirements: The requirement states – Quarterly, the Contractor shall deliver a report summarizing the status of the system and progress made in the prior quarter. This report shall be delivered as an electronic Microsoft Word document to the COTR via e-mail. What metrics are you looking for in the system status reports?

Answer:

The report should indicate information such as the following:

-the number and nature of incidents -number and nature of help requests -if possible, a metric of average response time/time of day -time needed to assist users or answer questions -any new features developed

-any visits or training -other items of similar nature and level of granularity

Question 8:

Section VIII Reporting Requirements: For this additional requirement "The system shall convert a dead pup to an adult when the user requests this. ", can you supply more information as to this use case. Is the purpose of this to enter adult-type post-mortem data on the pup? For what end-points and for which study types?

Answer:

Yes, this is designed to permit the collection of adult post-mortem endpoints and gross observations such as organ weights and palpable masses. This would be for the MOG and RACB study designs.

Question 9:

Section VIII Reporting Requirements: For this additional requirement: "Upload retrospective data using a time by animals, an endpoint by animals, or a time by endpoint matrix entry screen (see Appendix 4, NTP- EstrousData.xlsx). ", it seems there are three means of entry desired.

1) Select a time, then enter data for all animals.

2) Select an endpoint and then enter data for all animals,

3) Have available a matrix screen with days across and animals down to entrer Estrus cycle stages.

We have questions about type 2) - Does this mean you would select an estrus stage, for example "diestrus" and then select an animal and then enter all days on which this one selected estrus cycle stage occurred? Can you explain the use case where this method 2 would be used in preference to method 1 or 3?

Answer:

While given in the SOW in the context of estrous data, these methods would be used for any endpoint, for example, loading data from an assay with either fluorescent or radioactive readout. The assay results would be collected using a spectrophotometer or scintillation counter not directly linked to the database, and then the results uploaded into the database.

Question 10:

In the section “Additional features” “A. System Usability Features” there is this requirement:

9. Collect data from ovarian follicles, including 7 sections through the tissue and counts for four types of cells, 20 – 40 counts per slide. The matrix entry screen in item (8) above can also be used for this process.

Questions – Is the desired matrix entry to be animals down the page and the four types of cells across the page? Is each section made into a separate slide, and during the cell counting the results from all slides are combined into one number per cell type for each animal? Is it the desire for the actual counting to be done in the application being delivered or is a mechanical counter separately used?

Answer:

Correct, the matrix data entry screen can be used for this requirement.

Example of raw data for upload:

Animal Section Cell A Cell B Cell C Cell D 1 1 2 14 17 4 1 2 2 8 15 5 1 3 4 11 14 3 1 4 3 13 14 6 1 5 5 12 16 4 1 6 3 18 15 4 1 7 4 16 17 5 2 1 2 15 17 7 2 2 3 13 18 3 2 3 1 14 13 4 2 4 0 16 14 5 2 5 2 15 15 6 2 6 3 19 14 7 2 7 3 13 16 8 3 1 4 15 13 2 3 2 5 16 16 4 3 3 7 14 15 3 3 4 6 15 17 5 3 5 3 14 16 4 3 6 4 14 18 5 3 7 2 13 16 3 4 1 5 14 15 3 4 2 1 13 16 6 4 3 5 12 17 4

The system would provide a means to compute the mean for each animal, for each of the four cell types. The raw counts would be obtained using a device outside of the database, and the results uploaded into the system.

Question 11:

Historical Control Database: “This control database shall contain data on the incidence of histological, fetal pathology and other findings”. Please describe which other findings should be included. For example is this required to include all ante-mortem and post-mortem data, for adults, pups and fetuses or just post-mortem fetal and adult histological findings? Similarly, the availability to view the historical control data, is this limited to fetal and adult histological findings. If not, which other measurements and end-points need to have this information viewable.

Answer:

The database should have the capability for the user to select from any ante-mortem and post-mortem endpoint within the system for inclusion in the historical control report. The most frequent use will be to view adult and fetal post-mortem findings data in order to adjust the anomaly grade of the finding, however, it is also possible that reproductive fertility endpoints such as gestation length, number of pups per litter, and other indicators of fertility and fecundity will be of interest. Finally, developmental markers such as day of attainment of balanopreputial separation may also be required by the end user. Thus we specify that any endpoint associated with animals in the control group should be available for reporting and analysis using the control database functionality

Question 12:

Historical Control Database: “The historical control database shall be available to use as an analysis group in statistical tests.” Please describe which other findings should be included in this function of using the control database as an analysis group in statistical tests. For example is this required to include all ante-mortem and post-mortem data, for adults, pups and fetuses or just post-mortem fetal and adult histological findings?

Answer:

The database should have the capability for the user to select from any ante-mortem and post-mortem endpoint within the system for inclusion in a statistical test analysis group.

Question 13:

“I.A.3. Once the validation is complete and the system is ready for use to collect data, the Contractor shall provided 40 hours of training in the data collection and data review/reporting processes supported by the system within 30 days of data collection capability being deployed.” Is this training restricted to the RACB and MOG designs or should it include the additional designs in the RP? i.e. Immunomodulation Assays, Sensitization Study Designs, Neurotoxicology and/or Carcinogenicity Study Designs.

Answer:

This training is for RACB, MOG and Immunomodulation and Sensitization Study Designs.

Question 14:

Will all the dates in the various documents be amended so they remain relative to the actual Award Date?

Answer:

Yes, an amendment will be posted reflecting updated periods of performance in Section IV-Additional Contract Requirements.

Question 15:

General-Pricing and Cost: For the optional functional requirements (not the options for users, sites, training, etc.)

is there an expectation that these will be priced as “one off” costs or annualized and added to the on-going subscription fee for the remaining period of the award.

Answer:

In Section II of the RFP, you will find these optional functional requirements listed as separate contract line item numbers (CLINs). As such, the Government expects these optional functional requirements to be separately priced on a fixed price basis and not annualized.