NHLBI-ECB-HB-2016-09-JB_02.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICAITON NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicble)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICIATION NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a)By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPIRATION DATA (If required)

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IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

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Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

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PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

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16B. UNITED STATES OF AMERICA

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NSN 7540-01-152-8070

Previous edition unusable

RFP # NHLBI-HB-2016-09-JB

Production Assistance for Cellular Therapy (PACT) - Cell Processing Facilities

Questions and Answers

1. Is Program Director(s) a required title?

Response: This information is furnished for the Offeror's information only and is not to be considered restrictive for proposal purposes.

2. If an Offeror has demonstrated a successful alternative approach can the Offeror split it into an Administrative Program Director and a Technical Program Director, and/or provide alternative titles to cover these responsibilities, together with the PI?

Response: Per Item V. “Estimated Level of Effort” on page 6 of the Attachment 3-

Statement of Work (SOW), “This information is furnished for the Offeror's information only and is not to be considered restrictive for proposal purposes. Offerors must provide justification for proposed FTE levels and when applicable why it differs significantly from the amount listed above.”

3. Are Program Directors and/or individuals with equivalent responsibilities expected to have effort on both Task Area 1 and Task Area 2?

Response: Each task order requirement shall have its own SOW and evaluation factors for award. An Offeror’s response to Task Area One, Task Order 00001 and the proposed sample tasks should demonstrate capability for each criterion to be evaluated in Section M, “Evaluation Factors” on pages 110- 116. Also, see Article

G.3. “Task Order Procedure” on pages 17 through 19 of the RFP for more information.

4. Is it anticipated that sites might also participate in the design of these studies and use funds to conduct the preclinical animal studies themselves, including the cost of animals and effort of personnel to conduct these studies as well as collect and analyze data?

Response: Task Order requirements under Task Area 2 WILL NOT include the conduct of preclinical animal studies. However, in addition to manufacturing and supplying cell products for preclinical animal studies in Task Area 2, it is expected that the CPF will provide expert opinion to the investigator(s) in regards to the conduct of the preclinical studies to support IND submission. This activity may include participation in the design of, and/or analysis of preclinical animal studies.

5. Will all projects be limited specifically to Heart, Lung, and Blood indications, excluding any areas outside of these? Are diseases that affect multiple organs, including lung and heart but not specific to these organs in line with NHLBI interests?

Response: The objective of the PACT program is to develop novel cellular therapies in the area of heart, lung, and blood cellular therapy research; however, task requirements funded by other ICs or federal partners may extend beyond heart, lung and blood indications. See Item 1.6 in Attachment 3- SOW which allows for the inclusion of work that is relevant to other NIH ICs.

6. Is the RFP targeting only CPFs that have professional accreditation (e.g. AABB, FACT…) and FDA master files?

Response: The PACT CPFs shall serve investigators within the scientific community as performance centers for translational research related to cellular therapies and manufacturers of cellular therapy products. The mission of the PACT program is to provide assistance for cellular therapy translational research and the manufacture of cellular therapy products for IND-enabling studies and validation runs prior to the initiation of a clinical trial. The proposed CPF will be assessed on the availability and adequacy of the facilities and resources necessary to meet the objectives of the

PACT program. Professional accreditation and FDA master files are supporting information to demonstrate qualifications.

7. Currently we are conducting product development work for novel cellular therapies in preparation for Phase I/II clinical trials for parties that are external to our organization.

Since these projects are already in the pipeline at our site, will they be eligible to submit a

Request for Service Application (RSA) to the coordinating center?

Response: Yes, assuming the projects meet the PACT program requirements for a

Request for Service Application (RSA), the PI of the project(s) can submit a RSA and will be considered for support by the PACT program. RSAs may be submitted for projects that have undergone earlier developmental steps at a designated PACT

CPF, using non-PACT funding. A prior working relationship between the requestor and the PACT-CPF for the specific project will not disqualify the RSA.

8. Please confirm on how to address the Subcontractors section under the Business Proposal

Instructions (page 108). The “subcontractors” our facility would use are fee for service vendors and not true subcontractors.

Response: Please conform to your organization’s standard business practices and policies.

9. On page 68, item 7. Alternate Proposals, it states, “You may, at your discretion, submit alternate proposals, or proposals which deviate from the requirements; provided, that you also submit a proposal for performance of the work as specified in the statement of work.” It is unclear if this reference to “proposals” is different or synonymous to the sample task orders (1-4, Attachment 5, pages 6-7). I am interpreting the solicitation as requiring we address each of the four sample task orders and not change them to other types of cell processing that we more regularly perform.

Response: A potential CPF Offeror must include with its technical proposal information on at least one or up to the four sample tasks listed in the Attachment 5-

Additional Proposal Instructions to be considered responsive.

Per the solicitation:

For proposal purposes, the technical evaluation team will evaluate each Offeror’s capability to perform the specific requirements described for Task Area One (1) and the four sample tasks to be performed under Task Area Two(2).

Using the sample tasks No. 1-4, as appropriate, identify the types of cellular therapy manufacturing services and translational services that could be provided.

You may, at your discretion, submit alternate proposals, or proposals which deviate from the requirements; provided, that you also submit a proposal for performance of the work as specified in the statement of work. Such proposals may be considered if overall performance would be improved or not compromised and if they are in the best interests of the Government. Alternative proposals, or deviations from any requirements of this RFP, shall be clearly identified.

Documentation of experience and past performance in the manufacturing of other types of cell processing may be included. See Question #11 for additional information.

10. Will a proposal to manufacture and distribute a human cell-derived biological reagent or a cell line that can be used in the manufacturing process of a cell product be responsive to this RFP?

Response: On page 68 of the RFP NHLBI-ECB-HB-2016-09-JB, “Production

Assistance for Cellular Therapies (PACT) - Cell Processing Facilities” there is language addressing alternate proposals. See Question #9 above.

11. Is it acceptable to include letters of support from previous collaborators on work that exemplifies the focus of this solicitation? I was thinking this would help demonstrate track record.

Response: Experience and past performance are factors which are relevant to the ability of the Offerors to perform and are considered in the source selection process.

Refer to the solicitation on page 72, “Past Performance Information”, pages 108-

109, “Qualification of the Offeror” and pages 115-116, “Past Performance Factor.”

12. On page 68, item #6, the document states to “not exceed 40 single-sided pages or 20 double-sided pages” for the Technical Plan (including the substudy proposal which I presume is the same as the sample tasks outlined in Attachment 5, pages 6-7). However, further into the paragraph, it references a 30 page limit. Is that a typo? And, finally, the substudy proposal section “shall not exceed 8 single-sided or 4 double-sided pages”. If the substudy section references the sample tasks, that would mean an average of 2 pages per task if all 4 tasks are included.

Response: The page limitation of the technical plan shall not exceed 40 pages, a total of 8 pages for all sample tasks (4 tasks at 2 pages per task), and 32 pages for the remainder of the technical plan. Reference to a “30 page limit” was an administrative error and corrected in Amendment #01 of the solicitation.

13. It seems that we submit budgets that include proposals for making the 4 sample products

(MSC, CD34, IPS cells and T cells) and that we rate each product at 2.04 FTE. When we assemble the budget do you want us then to estimate the number of each of these products (as examples) that we would make each year and then include technical staff salaries on the cost of making each product?

Response: The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions. Offerors must separately identify in its proposal costs associated with Task Area One, Task Order 0001 and each proposed sample task under Task Area Two. See Attachment 7: Technical Proposal Summary on page 56, and Questions #14 and #15 below.

14. Do we say that we would need, for example 5 FTEs to cover all anticipated PACT manufacturing in a year, add them to the annual budget as a Personnel line item, and submit product manufacturing costs that do not specify the FTE and salary required to make each product? This would be much more like other past contract programs in which

"infrastructure" costs are built in to maintain the salaries and costs of maintaining the facility operations, independent of the cost for manufacturing each specific cell product.

Response: Infrastructure costs shall be task order specific for this requirement.

For example, “infrastructure costs to maintain salaries” were included in the

“ESTIMATE OF EFFORT” for Task Area 1, Task Order 00001 and the four sample proposals under Task Area 2. Offerors must separately identify in its proposal all “infrastructure costs” associated with Task Area One, Task Order

00001 and each proposed sample task under Task Area Two.

The technical proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the Offeror's understanding of the project may be evaluated (See SECTION J, Attachment 7 entitled, TECHNICAL PROPOSAL

COSTSUMMARY.) However, the technical proposal should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any), and total costs. The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions.

15. Regarding the 2.04 FTE for the technical proposal, is this for the entire technical proposal or per each task within the technical proposal of which there should be 4 making it 8.16

FTE’s total? Please clarify.

Response: If an Offeror submits a proposal that includes all the sample tasks at

2.04 FTEs each, the combined FTE amount would equal 8.16 for Task Area 2. The

Offeror’s proposal must include effort for Task Area One, Task Order 00001 and any or all of the proposed sample task(s) under Task Area Two. See page 65, “ESTIMATE OF EFFORT.”

16. Is there a specific table of contents format to be used?

Response: No, there is no format specified for the table of contents in the RFP.

17. Is the newly formatted NIH biosketch acceptable for the required resumes of key personnel?

Response: There is no standard format for resumes referenced within the RFP. The newly formatted NIH biosketch is acceptable as long as it contains information specified for resumes, i.e., “indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.” (See

Item 4. “Resumes” on page 85 of the RFP.)

18. Is there a fillable form for the HHS Section 508 standards?

Response: On page 98 of the RFP instructions for preparing the HHS Section 508

Product Evaluation Template may be found on the HHS Web site

(http://www.hhs.gov/web/508/contracting/technology/vendors.html). Fillable forms can be found at this link.

19. This RFP clearly excludes GMP clinical product manufacturing, but what is less clear is whether it includes manufacturing process development, since this is part of the IND enabling work (technically this should be done before submitting the IND), which does necessitate GMP production, preclinical safety testing and efficacy validation. Can you confirm that this product characterization would be included?

Response: Yes. This product characterization will be included. The mission of the

PACT program is to provide assistance for cellular therapy translational research and the manufacture of cellular therapy products for IND-enabling studies and validation runs prior to the initiation of a clinical trial.

http://www.hhs.gov/web/508/contracting/technology/vendors.html

20. Is there not a scientific program officer with whom I could have a brief discussion about the PACT RFP?

Response: This requirement will be funded with a contract (RFP), not a grant

(RFA). As such, communications with other officials may compromise the competitiveness of this acquisition and result in cancellation of the requirement.

Potential Offerors shall direct all communications to the attention of the

Contracting Officer cited at the bottom of the face page of the solicitation.

Rockledge II Building 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892-7902

-Responses to the questions received.

All other terms and conditions of the solicitation remain unchanged.