MODIFICATION
B -- HUMAN FIBROBLAST IN VITRO - Amendment 1
- Notice Date
- 5/21/2013
- Notice Type
- Modification/Amendment
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Other Defense Agencies, TRICARE Management Activity, USUHS CONTRACTING OFFICE, 4301 JONES BRIDGE ROAD, Bethesda, Maryland, 20814-4799, United States
- ZIP Code
- 20814-4799
- Solicitation Number
- HT9404-13-Q-0660
- Archive Date
- 6/18/2013
- Point of Contact
- Christina Johnson, Phone: 3012953069, Zamora Olin, Phone: 301-295-3922
- E-Mail Address
-
christina.johnson@usuhs.edu, Zamora.Olin@usuhs.edu
(christina.johnson@usuhs.edu, Zamora.Olin@usuhs.edu)
- Small Business Set-Aside
- Total Small Business
- Description
- Responses to contractor's questions. The purpose of this amendment is to address the following questions: The purpose of this amendment is to address the following contractor's questions: 1) As an FDA approved drug manufacturer, we are not a certified clinical testing laboratory. The solicitation requests information on certifications and other control rules for clinical labs have not been applied to our operation by FDA. Instead, all analytical method validation (per ICH guidance), controls and test specification justifications have been reviewed by FDA as part of our license. We believe this is a more rigorous review of out method reliability and reproducibility. Will such an explanation permit our filing in lieu of these certifications? All controls requested are in place as part of our quality system. RESPONSE: The vendor does not need to be a certified clinical testing laboratory. Rather it needs to have processes in place to ensure that its product is manufactured in compliance with FDA guidelines and ICH guidance and can be used for autologous transplantation. 2) In order to provide a cross-reference letter in the submittal, we typically require the IND number to provide access to the reference. Is the intent to have the actual letter included in the submission, or that the company agrees to supply a letter? RESPONSE: The cross-reference letter is not required with your offer. The cross-reference letter will be included in the government's IND application. This letter will allow the government to reference the CMC section of the vendor and avoid having to generate a completely novel CMC section. The government wishes to take fibroblasts from a donor and perform an autologous transplant to a different skin site. It does not wish to develop and have FDA review of the process for expanding the fibroblasts. 3) The Sponsor is requesting adventitious agent testing for autologous fibroblast lots. FDA has waived our need for such testing under 21 CFR 1271.90(a)(1). If the government would still like to have this testing perform, we will add the cost to the per lot pricing, but we would need to know the target virus categories in order to price. If HIV/HEPB/HEPC is acceptable, I will add as optional testing. Sterility, endotoxin, and mycoplasma are tested for each lot as required by our license. RESPONSE: It was assumed that human subjects would be tested for HIV/Hep B/Hep C prior to fibroblast collection and expansion. Therefore, this testing would not need to be duplicated by the vendor. 4) In the solicitation, an as yet to be approved IND for the clinical use of the cells being cultured is mentioned and the CMC section of that document is referenced to contain certain pertinent information related to the proposals to be submitted. Will we have access to that IND/CMC information prior to our submitting a proposal? If not could specific parts of the CMC section be made available? RESPONSE: A draft CMC section for the government's IND for this project exists as the government has already met with the FDA. However, it will not be made available at this time as the decision has been made to contract the fibroblast expansion component of the project to a commercial vendor. However, the government will share the final CMC section that references the cross-reference letter from the vendor prior to submission to the FDA. The vendor will have adequate time, as determined by the government, to review the CMC of the government's IND prior to submission. 5) In the information given it is stated that "The Government has generated a protocol to expand autologous human fibroblasts in vitro for re-introduction into human donors. This protocol is specific for an autologous fibroblast product and is being developed under an open Investigational New Drug (IND) Application with the Food and Drug Administration (FDA)". Information in this protocol would be very helpful in understanding the costs and timing related to the performance of this protocol. Would the soliciting agency make this protocol or the pertinent elements of this protocol available to submitting entities? RESPONSE: No components of the government's IND application will be forthcoming at this time. The government's expectation is that the vendor has experience expanding human fibroblasts for re-introduction to the donor via autologous transplantation. The government is willing to adapt its protocol and IND to accommodate the vendors existing FDA approved process. 6) In the solicitation there is a requirement for CAP and CLIA certification for the laboratory performing any testing related to the cell characterization required for lot release. Can this requirement be fulfilled by outsourcing these activities to a CAP and CLIA certified contract organization? RESPONSE: Absolutely. In fact, outsourcing to an independent lab is encouraged. 7) For past job references, we not a contract manufacturer. We can provide a summary of clinical trial campaigns and FDA approval/inspections as evidence of continued performance. Please let me know if this would be acceptable. RESPONSE: Contractors should provide any relevant and similar experiences that demonstrate their capabilities to fulfill the requirements outlined in the synopsis. 8) Are attachments permitted, or 15 page maximum for all summaries on technical capabilities? RESPONSE: Contractors are authorized to address all the Evaluation Factors within 30 pages including any attachments.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/1deca848f9c496505cfdd54a4164a03c)
- Place of Performance
- Address: BETHESDA, MD, United States
- Record
- SN03068335-W 20130523/130521235356-1deca848f9c496505cfdd54a4164a03c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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