NIHAO200816responses1.pdf

NIHAO200816 Responses to Questions #1 August 8, 2008

This set of responses to questions incorporates those questions asked during the Pre- Proposal conference held for the solicitation on August 6, 2008.

Question 1:

How many awards does NIAID anticipate making in response to this solicitation?

Response:

The number of awards will be based on the technical proposals received. There is no predetermined number of awards to be made.

Question 2:

Since this is an IDIQ, offerors do not yet have a specific scope for which they can provide direct costs. Please explain how offerors should develop the list of direct costs in the absence of a specific scope of work?

Response:

Offerors are to develop their business proposal based on the application of the entire SOW to the hypothetical study included in Appendix C to the SOW.

Question 3:

Since this is an IDIQ, offerors do not yet have a specific scope for which they can project personnel level of effort requirements. Please explain how offerors should calculate the percentage of time other personnel will spend on the project in the absence of a specific scope of work?

Response:

The requirement to break down the personnel time into percentages will be eliminated from the technical proposal instructions via an amendment. Such a breakdown should be included in the business proposal.

Question 4:

A typical draft Information System Security Plan which follows a recognized standard can be approximately 100 pages long. This exceeds the allowable length for the entire Technical Proposal. Will the draft Information System Security Plan be excluded from the page count for the Technical Proposal?

Response:

Since the Draft plan will need to be tailored to specific task orders, a full draft ISSP will not be necessary with proposal submission. Draft ISSPs may be required for individual task orders as necessary.

Question 5:

Is subfactor A more important than B and C combined? If so, how much more important?

Response:

In using an adjectival rating scheme, we cannot quantify how exactly how much more important one factor or group of factors is relative to another beyond the terminology already stated in section M.

Question 6:

Will the contractor be responsible for: (a) assessing the site’s systems for identification and reporting of adverse events (AEs) and serious adverse events (SAEs) or (b) establishing and maintaining systems for identification and reporting of AEs and SAEs at the site?

Response:

Offerors will be responsible for assessing, establishing and maintaining systems for identification and reporting of AEs and SAEs at the site.

Question 7:

Will the contractor be responsible for: (a) assessing the site’s administrative and technical infrastructure to support clinical research or (b) establishing and maintaining administrative and technical infrastructure at the site?

Response:

Offerors will be responsible for assessing, establishing and maintaining administrative and technical infrastructure at the site.

Question 8:

Should it be assumed that the program site has a data management system? Or that NIH would provide a data management system?

For the purposes of the sample task, offerors should assume the site has a data management system. For task orders under the contract a data management system may or may not be present.

Question 9:

What level of statistical analysis and interpretation capacity is expected for site investigators? Does the contract envision graduate-level degree training in statistics?

Response:

At the site level, staff would need graduate-level degree training in statistics. At a data management or operations center, Ph.D. level training would be necessary.

Question 10:

Does DCR anticipate that the contractor will: (a) directly hire and manage program directors, program administrators, or financial analysts who will reside long-term in the host country to support the research program, or (b) train/build the capacity of program directors, program administrators, or financial analysts that are provided by the collaborating agency in the host country?

Response:

Offerors should propose on the sample task based on the scenario (a) where they will directly hire and manage program directors, program administrators, or financial analysts who will reside long-term in the host country to support the research program. In general, task orders will likely fall under scenario (a);

however, in some cases scenario (b) circumstances may occur.

Question 11:

Does DCR anticipate that the contractor will procure and pay for labor (in-country investigator, study coordinator, pharmacist, etc. labor) associated with the program?

Response:

Yes, the offeror will be expected to procure and pay for labor associated with the program.

Question 12:

Should offerors assume that the contractor will (a) provide the necessary servers, etc.

from its headquarters with clinical sites accessing the system remotely; or (b) work with clinical sites to purchase and set up the entire information technology infrastructure at the foreign clinical sites?

Response:

Offerors should assume that they will work with clinical sites to purchase and set up the entire information technology infrastructure at the foreign clinical sites.

Question 13:

Are offerors to assume that (a) NIAID will provide the repository for samples collected under this contract or (b) the contractor will be required to provide specimen repository services?

Response:

Offerors should assume that they will be required to provide specimen repository services.

Question 14:

Will it be the contractor’s job to identify and recruit qualified individuals to live or travel frequently to Mali for this project? Will these individuals be hired by NIH or by the contractor?

Response:

Offerors will be expected to identify and recruit individuals to live or travel frequently for task orders. Individuals are to be hired by the offeror.

Question 15:

Will responsibility for any ongoing care and treatment required from any trial-related adverse events rest with the local clinical site? Will the contractor have any responsibilities for ensuring that the clinical site provides the appropriate, ongoing care and treatment?

Response:

Yes, the offeror will have the responsibility for providing ongoing care and treatment from trial-related adverse events at the local clinical site. The offeror may be asked by NIH to provide appropriate, ongoing care and treatment; however, responsibility for that treatment will rest with the NIH.

Question 16:

How long will the period of performance for the sample task be?

Response:

5 years.

Question 17:

How many clinical trials will be supported as part of the sample task?

Response:

2 clinical trials will be supported.

Question 18:

How many research projects will be supported as part of the sample task?

Response:

1 research project will be supported.

Question 19:

Should offerors budget for travel for Malian personnel to the NIH? If so, how many trips/year? What is the average duration of the trips? For contractor personnel posted in Mali, please confirm that offerors should propose the allowances specified by the Department of State (cost of living allowance, post differential, transfer costs, education allowance, living quarters allowance). Which personnel will be NIH personnel, and which will be contractor personnel?

Response:

Offerors should assume 2 trips per year for Malian personnel to the NIH each one week in duration. Offerors should propose overseas allowances based on their standard practices. State Department or Military overseas compensation standards are acceptable. The offeror will not be required to handle travel arrangements for NIH employees.

Question 20:

Is the contractor responsible for managing renovation of the laboratory facilities? If so, since offerors may have very different assumptions about the renovation requirements, please provide an estimated cost of renovations.

Yes, offerors should assume they are responsible for renovations with a ceiling amount of $300,000.

Question 21

Is the contractor responsible for equipping the laboratory facilities? If so, since offerors may have very different assumptions about the equipment requirements, please provide an estimated cost of equipment or a list of equipment to be purchased and installed.

Response:

Yes, the contractor is responsible for equipping the laboratory. The laboratory to be used should be a standard lab set up for HIV clinical trials. Offerors are expected to develop their own estimate of the equipment requirements based on their understanding of the requirement and the nature of the laboratory required.

Offerors are to assume there is no pre-existing equipment present.

Question 22:

Should offerors budget for development and airing of radio and television recruitment commercials for any of the studies in the sample task order? If so, for how many studies?

Response:

No, offerors should not budget for recruitment commercials as part of the sample task.

Question 23:

How many specimens should offerors budget for shipment each year? Please provide information on an illustrative specimen so offerors can develop comparable quotes for these specimen shipments? Should offerors assume specimens are being shipped to the

US?

Response:

The two clinical trials anticipated would each have 200 patients as would the one research study. Offerors should base their estimate for specimens on those patient numbers. The studies to be performed will be HIV studies. Offerors are to assume no shipments to the US will be necessary.

Question 24:

Should offerors budget for all the meeting and conference support services listed in Item

1.59 (page 5) of the SOW?

Response:

Yes, offerors should budget for all meetings and conference support services.

Question 25:

Are the trials to be performed in the sample task observational or interventional?

Response:

The two clinical trials are to be observational. The one research study will be interventional.

Question 26:

How many Data Safety Monitoring Boards (DSMB) will be required for the program?

Response:

One DSMB will be required for the sample task.

Question 27:

How many desktop and notebook computers should be purchased for the site?

Is the contractor responsible for procuring all the software required by the research program?

Response:

Offerors should estimate the IT requirements based on their understanding of the requirement to operate one clinical site as part of the sample task. The offeror is responsible for procuring all of the software and IT hardware for the site.

Question 28:

What office equipment, clinical equipment, and medical supplies are required for the site? Is the offeror responsible for procuring office equipment, clinical equipment and medical supplies?

Offerors should base their proposal on their understanding of the requirement for the sample task. The offeror is responsible for all office equipment, clinical equipment, and medical supplies.

Question 29:

Will the contractor be responsible for study drug supply?

No, the contractor will not be responsible for the sample task study drug supply.

Question 30:

For budget preparation is there an expectation that funds will included for administrative and management support of the contract (other than the program director) outside of the specific task orders?

Response:

The solicitation includes a guaranteed minimum amount for each contract award.

No funds will be obligated on the basic contract for administrative and management support beyond the guaranteed minimum.

Question 31:

Will these proposals be peer reviewed as an N01?

Response:

No, this solicitation will not be peer reviewed as an N01.

Question 32:

Should offerors assume they hold all regulatory responsibility for the interventional project?

Response:

Yes, offerors should assume they hold all regulatory responsibility for the interventional project.

Question 33:

Should the offeror develop one website where the general public will access information and include links with restricted access for DCR and site staff or separate websites?

Response:

Two separate websites should be developed, one for study staff access and another for public access.

Question 34:

Should the offeror develop a database where site staff can practice using a DM system or a database to track the types of training that the site staff has completed?

Response:

Neither type of database is required; however, offerors are at liberty to utilize any of their standard business practices for this requirement.

Question 35:

The study PI will not be responsible for submitting the paperwork to their IRB?

Response:

The study PI will be responsible for submitting the paperwork to their IRB.

Question 36:

For IND studies, who will be the official sponsor?

Response:

Please assume the sample task treatment study is not an IND study.

Question 37:

Is there a projected range of funding for this total program across all tasks for all awardees?

Response:

NIAID does not release that type of information at this stage in the acquisition process.