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FBO DAILY ISSUE OF DECEMBER 04, 2008 FBO #2565
SOLICITATION NOTICE

A -- TBTC Publication of Questions and Answers

Notice Date

12/2/2008
 

Notice Type

Presolicitation
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
 

ZIP Code

30341-4146
 

Solicitation Number

TBTC-Questions_and_Answers
 

Point of Contact

Rafael A. Aviles,, Phone: 770-488-2805
 

E-Mail Address

raviles@cdc.gov
 

Small Business Set-Aside

N/A
 

Description

The following represents the questions and corresponding answers posed during the period for comments and questions as well as the pre-solicitation meeting held on November 13, 2008. The original notice was publicized in the Federal Business Opportunities website on October 10, 2008, under the title TBTC-Presolicitation. It is anticipated that a subsequent announcement will be publicized in January 2009, announcing the release of the solicitation for this requirement. Any interested party wishing to be included in the distribution of the solicitation must contact the Contracting Officer via e-mail at raviles@cdc.gov, and provide contact information. All requests for a copy of the solicitation must be received in writing and must be received by the Contracting Officer no later then 30 days prior to the closing date of the solicitation. The closing date of the solicitation has not yet been determined but is anticipated to be in April 2009. The announcement to be publicized in January 2009 will clearly specify the closing date.. Any party that participated in the pre-solicitation conference and/or requested to be included in the conference but could not participate will be included in the distribution of the solicitation and is not required to request a copy from the Contracting Officer as stated previously in this notice. TBTC Recompetition 2009 Pre-Solicitation Meeting Q&A's -- 13 November 2008 1 The technical evaluation panel must have a larger number of persons. You currently propose a small number of persons for a large number of proposals. Will this change? The TEP will have sufficient members to assure that each proposal will receive full and robust primary and secondary reviews. 2 The 2nd meeting of the TEP will re-evaluate the revised proposals. Negotiation can affect the content. How will these be evaluated? Using the same criteria and procedures as the initial review, albeit the process will be briefer since only those in the competitive range will be considered. The evaluation of revised proposals may be conducted by conference call. 3 Can the Project Officer serve on the TEP? Yes. 4 Does the 50 page limit allow for appendices? What is the limit if a proposal contains multiple sites? Will you allow extra pages for additional sites? The revised RFP will specify a lower limit. It will likely allow a maximum of 25 pages rather than 50, exclusive of appendices. If a site proposes additional clinical sites to satisfy the enrollment requirement, the proposal will likely be allowed an additional 5 pages to describe each additional clinical site. For example, site A, whose requirement is to recruit 100 patients a year, proposes to recruit 50 patients in each of 2 separate clinical sites in city X. Site A is 1 consortium site, not 2 sites. This PI will be allowed a total of 30 pages (25 +5) if both clinical sites are included in the 1 proposal. 5 Will the slides from the presolicitation conference be available on the internet? Yes, after clearance has been arranged. 6 What if a proposal includes a domestic and an international site, and only one appears strong? How can proposals allow acceptance of only some of the proposed sites? (i.e. how to "perforate") This may be done in multiple ways. --A site may submit two separate proposals (one with and one without a subcontracted 2nd site, for example). --A site may submit separate proposals for two clinical sites (one involving a subcontracted international site and one involving a domestic site). --Each clinical site may submit a separate proposal - the same PI would be the directly contracted site PI in a domestic proposal, and could be a subcontracted consultant in a proposal from a qualified international site. 7 PI's must increasingly demonstrate funding for percent effort. Proposers need guidance on what to propose. What is the minimum acceptable percent effort for PIs? It is expected that sites will assure adequate supervisory and scientific engagement from PIs. This is necessary both to assure participation in the scientific activities of the TBTC, and to assure the efficient and proper conduct of clinical and follow-up activities at the site. In most instances, this can be expected to involve 10% or more effort from PIs. At some sites, the PI may not wish to commit this extent or may be unable to do so, because of other grant support; in that case, there should be adequate engagement from other appropriately experienced staff to meet this requirement. Some sites may choose to commit greater engagement from the PI. For selected positions (i.e., chair of Steering Committee and chair of Core Science Group), additional time will be required; this will be separately funded through contract modifications as needed. 8 Will the technical proposal be evaluated before the financial proposal? Evaluation of the two proposals occurs concurrently. The TEP evaluates the technical proposal and may comment on the budget. At the same time, the Procurement and Grants Office evaluates the financial proposal. 9 What will be the composition of the Technical Evaluation Panel? The panel will be constituted in accordance with federal acquisition regulations. The program intends to assure the presence of both internal and external evaluators, with expertise in the design and conduct of clinical trials generally, and TB trials in particular, including trials in the international setting. 10 What is the page allowance if one proposes multiple sites? Does this vary by number of sites? See question #4 above. 11 What is the PI role if the clinical site is subcontracted? What is the role if the proposal includes multiple subcontracts? As the principal author of the offer, the PI remains responsible for fulfillment of the contract terms. It is up to the offeror to specify the roles and relationships of the contract and subcontract staff. 12 May one site submit multiple proposals? Yes 13 What guidance can you provide concerning indirect costs to propose? Offerors should use the most applicable indirect cost rate which is consistent with U. S. federal contracting law and institutional policy. Within these parameters, offerors are encouraged to utilize the most advantageous indirect cost rate. Each budget proposal will be evaluated based in part upon its overall total cost to the government, with all cost elements included. 14 Is it CDC's intent to continue support for the Community Research Advisory Group (CRAG)? Should funding for CRAG members be included in each proposal? CDC intends to continue support for CRAG, but through mechanisms distinct and separate from this RFP. However, site proposals are encouraged to include mechanisms for community engagement. 15 Should use of the CDC Central IRB be prioritized for domestic sites? Yes; this will be considered in the evaluation criteria, since it promises increased efficiency in protocol preparation. 16 What are instructions for estimation of travel budgets? Instructions are needed so sites can know what travel to budget, for what locations, etc. Budgets should include travel funds to allow attendance for 3 days by 1-4 persons from each site at the semiannual TBTC meetings (i.e., twice a year). The budgets proposed should include travel funds as deemed necessary by the offeror; it is the offeror's decision regarding how many persons to send to each meeting. To standardize budgets, proposers should assume that one meeting will be held in Atlanta. The other meeting will alternate between Chicago IL and Brussels BELGIUM. 17 Is it desired that proposals include the potential to perform studies of diagnostics? Will this capacity for diagnostics studies be given consideration in evaluation of proposals? Potential for diagnostics studies should be noted briefly if present, and will be considered under evaluation criterion #5. Also see answer to question #26 below. 18 How will the potential for scientific contribution be evaluated? Through such standard measures as prior performance in similar research consortia, consultations, peer-reviewed publications, etc. 19 In considering the group's scientific agenda, what capacities should be included - ability to do PK, phase 2, phase 3, LTBI studies? What populations are desired, and should their availability be flagged? On what type of study should the detailed cost proposal be focused? All these capacities are desirable, but each offeror is not expected to have all of them. Those which are present should be described, as requested in the call for proposals. The populations of interest are described in the RFP, in the appropriate sections. The detailed cost proposals should be based on a phase 3 study with 6 months of active treatment and 2 years of follow-up after treatment. A detailed example of a phase 3 study for use in preparation of budgets will be included in the call for proposals. Enrollment will thus be occurring simultaneous with follow-up of earlier studies. 20 What consideration will be given in evaluation for the capacity to mentor young professionals? Will this be specified in the RFP? Consideration of this capacity will be included as part of the evaluation element #4 Scientific Contribution Potential. 21 Is the basis for estimation of incidence at sites the WHO estimate of incidence of smear positive TB? Yes 22 How specifically will the number of sites be counted? The total unit needed to satisfy the enrollment requirement (of 10, 30 or 100 patients per year) will be counted as 1 TBTC site. If a PI proposes both a domestic and a subcontracted international site, will this represent 1 site or 2 sites? Two (2) TBTC sites. If the PI submits 2 separate proposals, then each proposal would be allowed 25 pages. Separate proposals might be desirable if the technical approach, organization and details of process will be very different at the 2 sites. 23 The Core Science Group has suggested establishment of a repository for specimens. Will the RFP specify what types of specimens are to be collected, stored and shipped? Sites should plan to collect, store and ship isolates from enrolled and relapsed/failed patients, sera from enrolled patients, sera or plasma from PK patients, and buffy coats from PK patients. 24 Will it be possible to shift funds from one category to another within the awarded site budget, if the TBTC requirements change? Yes, if and only if approved by the Contracting Officer. 25 How should diagnostics capacity be addressed in the proposals? The capacity of the site for conducting diagnostic studies should be highlighted in the same manner as other special capacities (for example, access to MDR-TB populations, access to children, or ability to perform pharmacokinetic studies; see question #17 above) 26 How should the laboratory staff and microbiologist be included in the site staff and as part of the TBTC team? Is there a standard structure for this? Does this imply some engagement other than the standard use of the site lab for cultures and smears? There is no standard for how to include the laboratory staff and microbiologists in the TBTC team. The quality and quantity of the involvement is up to the offeror and contingent on local conditions. However, it is desirable to name specific laboratory personnel, the percent effort, and the costs to be charged to the contract to support, for example, special laboratory tests, completion of study case report forms, or travel by these (lab) staff to TBTC meetings. 27 Can you include examples of laboratory report forms in the RFP, so that site lab microbiologists can understand well what is required? Yes, these will be added as appendices to the RFP 28 Can the RFP specify a minimum level of support for the site PI? See question #7 above 29 Is there overlap among any of the evaluation criteria? If so, will this be corrected? We are aware of some areas of duplication, as a result of the editing process. We will review and revise the document to eliminate any such overlap.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=b6bb107b0e4997193dab1d2b60803ca9&tab=core&_cview=1)
 

Place of Performance

Address: 2920 Brandywine Rd., Atlanta, Georgia, 30341, United States

Zip Code: 30341
 

Record

SN01712396-W 20081204/081202215603-b6bb107b0e4997193dab1d2b60803ca9 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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