Responses to Questions Received Solicitation 10.doc

Responses to Questions Received Solicitation 10-250-SOL-00079DM 5th Cohort

1. Reference: Section L - Instructions, Conditions, and Notices to Offerors or Quoters Subparagraph C. Business Proposal Instructions and Attachment H, Certificate Of Current Cost Or Pricing Data, FAR 15.406-2 (RFP pg 40) Question: The Government is procuring items in an environment with many qualified offerors and many competing bids are expected. Adequate price competition appears to exist. Will HRSA consider using FAR 15.403-1, and modify the RFP to state that offerors must submit "information other than cost or pricing data" by completing the forms provided in the RFP. Solicitation Attachment H would not be applicable. All other portions of the RFP would remain unchanged.

RESPONSE: The Government is still uncertain about the competitive market place for these units. Therefore, we are asking for cost and pricing data to determine the reasonableness of an offerors proposed price.

2. Reference: G.2 Key Personnel, Key Personnel clause (HHSAR 352.242-70) (RFP pg 16) Question: Will the Key Personnel clause remain in effect for only the 3 year period of performance associated with Line Items 1, and 4-8, or will it remain in effect for the full 10 year period associated with Line Items 2 and 3."

RESPONSE: The Key Personnel clause will remain in effect for the full 10 year period of performance.

3. Reference: Section L.1.C.1 Cost and Pricing Data subparagraph b. (RFP pg 40)

Question: This subparagraph requires offerors to provide the cost recovery fees or fair market value charged to transplant centers or registries for CBU shipped for transplant. How will this information be used in evaluation of offeror's business proposal?"

RESPONSE: HRSA's reason for requesting this information is that cord blood unit sales are a potential source of revenue for banks, which contributes to overall financial stability.

4. Reference: Section L - Instructions, Conditions, and Notices to Offerors or Quoters, L.1 Proposal Instructions: Format and Contents, A. General Instructions subparagraph 12. (RFP pg 28)

“The Technical Proposal should not exceed 20 pages, excluding any attachments and resumes. …Contractors are requested to use double-sided printing for the entire Technical Proposal including attachments, resumes and supplementary material.”

Question: Is it the Government’s intent that the proposal is 20, double-sided pages?

RESPONSE: The technical proposal should not exceed 20 pages in length. As a double-sided document, only ten pieces of paper, at most, would be utilized.

5. Reference: c. Technical Requirements, 1. Corporate Capability and Experience, d.

"The Offeror must have obtained all required Federal and State licenses including: Biological License Application (BLA) or investigational new drug applications (INDs) as required by the FDA; … " and M.4 Evaluation Criteria, subparagraph 3. (RFP pages 33 and 49/50) Question: Is BLA submission a requirement or preference on the part of HRSA? Will this requirement/preference of BLA submission be evaluated as part of the 25 points for “Other Aspects of Capability and Experience” or as part of the 29 points for “Other Aspects of Technical Approach”?

RESPONSE: HRSA will evaluate offerors ' preparations and readiness to apply for BLAs on time under the Corporate Capability and Experience section (included in the 25 points for "other aspects of capability and experience").

6. Reference: M.4 Evaluation Criteria, subparagraph 3. (RFP page 49/50) Question: Please provide the specific sub-elements of the evaluation criteria that the Government will use to award the following points:

Other Aspects of Capability and Experience 25 points Other Aspects of Technical Approach 29 points RESPONSE: Other Aspects of Capability and Experience : 25 points: These will be assessed as described in the RFP pages 33-34 1. a-b, and Other Aspects of Technical Approach: 29 points: These will be assessed as described in the RFP pages 34-37, 2a-t

7. Reference: C.1 Business Proposal Instructions, 3) Past Performance Information (RFP page 42) Question: Are offerors allowed to use a collection site and the collection agreement as a previous client/contract?

RESPONSE: Yes

8. Reference: c. Technical Requirements, 2. Technical Approach, u.

“. … The Technical Evaluation Factors in Section M.4. provide up to 3 additional points to Offerors proposing HLA typing at additional loci or higher resolution.” (RFP page 37) Question: Will HLA typing on mother’s blood be eligible for the additional 3 points instead of additional loci or higher resolution due to recent NIMA implications on clinical outcome as shown by Van Rood et al in PNAS?

RESPONSE: Up to 3 additional points will be added to scores for typing at additional loci or higher resolution, specifically. Maternal HLA typing could be beneficial in light of the new NIMA research, but it is still too early to know. Offerors should describe any unique characteristics of their program, including NIMA initiatives, however the bonus points being referenced apply only to typing at additional loci or at higher resolution.

9. Reference: C. Business Proposal Instructions, Section M - Evaluation Factors for Award, M.1 Award Criteria, first paragraph, third sentence. [reads :( Because of the Legislative restrictions, no subcontracting opportunities exist).], Section I - Contract Clauses 52.203-6, Restrictions on Subcontractor Sales to the Government, SEP 2006 (RFP pages 19, 40, 42, 47. More)

Question: Please explain M.1 Award Criteria, first paragraph, third sentence. Is subcontracting allowed for this effort?

RESPONSE: Award(s) will be made to prime contractors. Organizations interested in only performing specific identified tasks within the Statement of Work and not the entire Statement of Work, may not apply independently under this solicitation, but may do so as subcontractors to applicant offerors.

10. Question: Is there a budget cap for the solicitation, and if so are indirect costs included in that amount or in addition to the direct costs?

RESPONSE: This is a best value solicitation and offerors are encouraged to be prepared to offer and negotiate at discounted prices (see reference on the bottom of page 5 of the Solicitation, “Note to Offeror”).

QUESTION 11. We are looking at Attachment D table D.2. Based on the 5 columns in year one are you restricting the number of CBU we may request funding for to a total of 1,500? We had planned to bank considerably more than that.

RESPONSE: No. This attachment was prepared as a tool to assist offerors in organizing their requests for funding. Columns may be added if an offeror proposes to bank more than the numbers represented by the table.