RFP 2008-N-10242 - IRR Technical Q As FINAL.doc

Technical Questions and Answers

Request for Proposals (RFP) 2008-N-10242

CDC Influenza Reagent Resource (CDC-IRR)

1. Question:

As I understand it, the CDC is looking for a vendor to supply oligonucleotide primers and probes, NOT PCR kits. Is this correct?

Answer:

The Human influenza virus Real-time RT-PCR detection and characterization kit will be composed of 8 signatures of lyophilized primers and probes and include controls as indicated in the statement of work. Controls should be applicable controls for the detection of low level viral genetic material in an appropriate medium. Template instruction manual will be provided by CDC.

2. Question:

The terminology in the solicitation is confusing, referring to the product as “real-time PCR primers and probes in a dried/lyophilized format” (page 24, paragraph 2, line 1) and “18 different types of kits” (page 24, paragraph 2, line 2). Are you looking for dried down kits, complete with PCR reagents, or dried down primers and probes only?

Kits will not include PCR reagents outside of what is listed in Appendix A and Question 1 above.

3. Question:

Reference Section C, III (Scope of Work), 4th paragraph – The first sentence refers to “Item 7 below” and “Item 15 below”. Can you please clarify where these items can be found in the solicitation?

The fourth paragraph is being modified and will be included in the addendum to clarify the level of quality for manufacture of the reagents. Only Item 1 (the Human influenza virus Real-time RT-PCR detection and characterization kit) must be manufactured at GMP level quality. All other reagents can be manufactured in GLP level laboratories.

4. Question:

To clarify the intellectual property rights requirement we assume the contractor will retain all rights to its current IP applied to delivery of the contract.

Clarification to the government to intellectual property rights has been amended in the addendum. Essentially, Section A.5.a, Intellectual Property Rights, of the RFP, will be revised to read as follows:

Intellectual Property Rights

a. Subject to the "Government Purpose License" of 35 USC 202(c)(4),the producing Party will retain sole ownership of and title to all inventions produced solely by its employee(s). The Parties will own jointly all inventions invented jointly. Inventorship shall be determined according to United States patent law.

5. Question:

Our assumption is that the intent of this contract is to ensure reagents are available as needed and directed by CDC, and not to provide reagents for general scientific research. For example, is the Web-storefront intended for designated users or to be more broadly accessible to the scientific community?

The CDC intends to provide access to all approved requestors. The CDC-IRR is intended to support public health surveillance and response: however, viruses and various panels will be available to approved researchers and commercial developers to aid in vaccine development. CDC will be working with NIAID/NIH to make various IRR products available through NIAID’s designated resource, currently BEI resources, as indicated in Section C.III of the RFP.

6. Question:

The requested quantities for the RT-PCR, HIA, MN and MN controls kits, and the volume of virus per tube (0.5ml vs. 1.0ml) differ in the Statement of Work from the quantities listed in Appendix A. Our assumption is that the quantities in Appendix A are correct.

Yes, quantities in Appendix A are correct. All volumes should be 1 ml.

7. Question:

Are the components of Kit D in Appendix A (MN Assay Viral – virus and controls) correct? They appear to be the same components as in Kit C

(MN assay).

The components in Kit D are incorrect. See modified Appendix A for the correct kit components.

8. Question:

Appendix A gives the stockage quantities for each of the reagents, but there is no indication of the distribution rate or replenishment rate of the reagents. What should we assume is the replenishment rate for the purposes of pricing?

With the exception of reagents with a quantity B as listed in Appendix A and B, the Statement of Work and Appendices provide annual production quantities of viruses and reagents. Proposed costs for viruses and reagents should be based on annual production quantities set forth in the Statement of Work and Appendices.

9. Question:

Can the CDC provide more information regarding the kits and panels referenced in RFP IV C., specifically as to either the reagent volumes or the number of tests per kit?

Appendices (SOPs) have been provided for IV.C.3-6 and 8.c to estimate volumes for 1000 reactions as indicated in Appendix A. Additional panels under IV.C.8 are to be based on 1 ml volumes of viruses and 10-100 ul of genetic material as listed in IV.C.7 of the statement of work.

10. Question:

Can the CDC clarify Appendix A Section IV D.1 in two regards. First, does the stockage quantity refer to the total from all subtypes or is it for each subtype? Secondly, Do the quantities of 25 mg@stock refer to the monoclonal antibodies? Will hybridoma cell lines be provided?

The stockage refers to 30 seed stocks of the HA glycoproteins (as a group) for Influenza A (H1,2,3,4,5,6,7,9,11) and 12 seed stock for Influenza A NA glycoproteins (N1,2,7,8) hybridomas as they are developed. A total of 30 stocks will be available for all A/HA (as a group) and not specifically for A/H1 (as an example). The hybridomas will be stored at 1X107 cells/vial (same concentration as the cell lines in revised Appendix A.V.H.) Currently CDC only has 2 hybridomas available. 25 mg @ stock refers to monoclonal antibody production. CDC will provide seed stocks of the hybridomas.

11. Question:

Reference the Table in Section VII showing the delivery schedule. Items

5–8 show quantities of various panels that are different than Appendix A quantities. Are these in addition to Appendix A quantities, or are these items included in Appendix A totals?

The delivery schedule is being revised to reflect the quantities in Appendix A (see addendum for revised schedule).

12. Question:

Reference RFP Section C. IV. C. 7 – Individual Viruses. Can the CDC clarify the number of 0.5 ml samples that we should assume need to be aliquoted and stored for each virus.

Appendix A.II states 100 vials need to be made available in aliquots of 1ml. The statement of work IV.C.7 is being revised (see addendum) to indicate that all virus aliquots need to be 1ml in volume.

13. Question:

Reference: Section A, 5.a. Intellectual Property Rights. This requirement conflicts with IP rights as contained in FAR 52.227-14. Further it appears to be contrary to IP terms as included in the Appendix K, Material Transfer Agreement – Article 7. Can you please clarify the Governments expectations on IP rights?

Refer to the Answer to Question 4 above.

14. Question:

Reference: Section A, 5.c. Review of Data. Can you provide a copy of the “CDC policies and procedures” noted in the last sentence?

Clearance policies for dissemination, release, or publication of data are set by the National Center for Immunization and Respiratory Diseases of CDC. Review and approval prior to dissemination, release, or publication of data will require signatures of CDC officials to obtain clearance prior to publication. These policies and procedures will be provided following contract award.

15. Question:

Reference: Section A, 7.b. Biosafety and Security Requirements. What is the nature of the “Additional Information” noted in the last line? When will it be provided?

See Section C.III.F. for specific websites containing information on Biosafety and security requirements.

16. Question:

Reference Section C, Special Note number 2 – Quantity A Items. The note states that stock levels shall be maintained in accordance with current government priorities. How and when will the Government priorities be communicated to the Contractor? Will this be the product of the Government’s review of the noted plans?

Answer:

The government priorities will be communicated to the contractor on an ongoing basis during the performance of the contract and formalized on at least an annual basis through review and approval of the contractors acquisition, production, and manufacturing plans. For planning purposes Appendix A has been revised to indicate the level of priority for kits, panels, viruses and reagents. Below is a brief outline of this prioritization:

Priority Level Reagents identified in Tables listed below as detailed in Appendix A:

Priority Level 1:

I.

Influenza viruses live and purified

II.

Development and Evaluation Panels

III .

Other respiratory pathogens and commensal organisms

Priority Level 2

IV.

Kits A

Priority Level 3

V.

Kits B

Priority Level 4

VI.

Other Reagents

17. Question:

Reference Section C, IV, C; Section C, VII, Delivery Schedule; Section F, Deliverables Schedule; Appendix A, The quantities contained in the aforementioned references appears to contain conflicting and incomplete information. For example, SOW C.IV.c.1 requires distribution of 1000* RT-PCR kits, while Appendix A.I.A Quantity-A requires 520* kits, and section F does not specify this deliverable. Could you please explain the differences or revise the referenced quantities to be more consistent?

See addendum for clarification in statement of work. Appendix A has the correct quantities for all kits, reagents, panels, etc. Section F will also be revised to reflect the deliverable as indicated in the statement of work.

18. Question:

Reference Section C, IV, A – Develop Standard Operating Procedures.

Para 2 states: Project Officer approval of the SOP for any given task shall be obtained before the contractor shall be authorized to initiate any work under that task. SOPs shall be in full compliance with all international, federal, state and local laws and regulations; and, World Health Organization guidelines; especially in the areas of bio-safety and security. The contractor’s Institutional Biosafety Committee will be required to approve SOPs prior to release of such materials. Given the requirements for both the Project Officer and Institutional Biosafety Committee approvals who will have final approval authority?

Institutional Biosafety committee will have the final authority for approval.

19. Question:

Reference Section C, IV, G – Process Requests for Viruses and Reference

Reagents from Qualified Recipients, Subject to PO Approval. Item 4 states: The contractor shall verify that transfer of virus panels to requestors are in compliance with the requirements of the Select Agents program and all international, federal, state and local bio-safety regulations. How does the government expect this to be verified? To who?

Domestic requestors must provide USDA inspection certificate and/or USDA permits upon request for select agent specimens or H5N1 reassortant virus strains. Foreign requestors must posses a Department of Commerce export license to receive select agents from the US. Specific procedures for distribution of wild type select agents are currently being negotiated with the World Health Assembly and individual countries. Specific procedures will be disseminated to the contractor upon acceptance of the final draft of virus sharing documents by CDC, WHO, and individual countries.

20. Question:

Reagents from Qualified Recipients, Subject to PO Approval. Item 6 states: The contractor shall obtain written agreements from recipient investigators and their institutions to indemnify and hold harmless the United States of America, the Department of Health and Human Services (DHHS), the Centers for Disease Control and Prevention (CDC), its contractor, their suppliers, and contributors of reference reagents from any claims, costs, damages, or expenses. The contractor shall secure and update/modify these agreements, as requested by the Project Officer. Is the noted indemnification to be established as part of the MTA with approved Recipients? If so the parties addressed for indemnification in the Appendix K MTA differ from those addressed above. Is the contractor required to revise the MTA language to include all parties noted above? Is there another method or vehicle that contractors should use?

Appendix K is only included as a template. CDC’s Technology Transfer Office is in the process of revising the MTA agreement to include the following language: The Provider and its authorized representatives will not be liable to the Recipient for any loss, claim or demand made by the Recipient, or made against the Recipient by any other party, due to or arising from the use of the Research Material by the Recipient, except to the extent permitted by law when caused by the gross negligence or willful misconduct of the Provider or its authorized representatives, and provided further that if the Recipient is an agency of the U.S. federal government or a state institution such Recipient assumes such liability only to the extent provided under the Federal Tort Claims Act, 28 U.S.C. §§ 2671 et seq. or under equivalent applicable State or foreign law.

21. Question:

Reagents from Qualified Recipients, Subject to PO Approval. Item 10 states: The contractor shall establish specific safety standards for the safe handling and use of specific viruses and reference reagents, in compliance with all federal, state and local laws and regulations. Applicable safety standards will be documented and packaged with viruses and reference reagents provided to recipients. Safety Standards will be reviewed and approved by the Project Officer prior to distribution. Are the standards noted above that are approved by the Project Officer deliverables under the contract? If so, they are not included in the deliverable table. Will these be considered formal deliverables and added to the deliverable table under the contract?

Section IV.G.9 in the statement of work indicates that the contractor shall include data sheets with technical data for each reagent distributed. Section IV.G.10 states that applicable safety standards will be documented and distributed with each reagent. The data sheets are not listed as a separate deliverable as they are considered part of each reagent.

22. Question:

Reference Section C, III (Scope of Work), 4th paragraph. The first sentence refers to “Item 7 below” and “Item 15 below”. These references appear to be incorrect. Should the references be 5 and 11(f) respectively? Please clarify the correct references.

This paragraph has been modified in the addendum. Only Item 1(the Human influenza virus Real-time RT-PCR detection and characterization kit) will be manufactured at GMP level of quality. All other reagents will be manufactured in a GLP laboratory setting.

23. Question:

Reference Section C, IV. Do the “seasonal” vaccine strains refer only to the northern hemisphere recommendations by CDC/WHO? Will panels/kits require updating following announcement of the southern hemisphere strains? Will this result in two seasonal orders per year and if so, will the government revise its estimates of required annual quantities in Appendices A and B and throughout the SOW and Section F?

No, seasonal vaccine strains include the vaccine strains as well as other predominant variant circulating seasonal strains. As indicated in Section IV.C.8 of the statement of work, seasonal panels will be reviewed quarterly for composition updates. Changes to the seasonal panel may or may not occur depending on the outcome of the quarterly review.

24. Question: With Reference to Section C., IV.

a. Are there data or recommendations from the CDC on the stability and stabilizers used for the strains, both live and inactivated?

b. With regard to stability, what is the CDC expectation for the shelf life of viral strains?

c. How will the contractor provide expiration dates prior to collection of sufficient empirical data?

d. How many months/years should stability testing for each strain persist?

e. How often will the Quantity A need to be reproduced with regard to both agent stability and utilization rate?

Answer:

a. Recommendations for storage and stabilizers required to maintain stability of live and inactivated viruses will be provided by CDC.

b. The CDC expectation for the shelf life of viral strains is approximately 2 years for reagents stored in liquid nitrogen (or -150ºC and 1 year for reagents stored at -80 ºC. However, these are only averages and certain reagents may exceed or fall short of these references. The Project Officer will provide specific details on individual reagents as handled in-house by CDC scientists.

c. CDC will provide suggested expiration dates for CDC-provided reagents.

d. Stability testing should continue while the reagents are in inventory or until the reagent’s stability declines. If stability remains unchanged, reagents can continue to be distributed as long as compositions are unchanged.

e. Quantity A of all reagents is the expected yearly production quantities. Reagents stored at suggested temperatures (as indicated by the Project Officer) should retain stability in excess of 1 year. If stability drops, reagents may need to be made more frequently and in smaller lots to maintain the least amount of loss due to instability.

25. Question:

Reference Section C., IV. Once kits/panels/reagents have been distributed, are recipient labs required to return products when new reagents are added, poor stability data is obtained, or performance of the assay has changed? Will notification and assumption of destruction be sufficient?

Return of substandard reagents is not required. Notification of destruction will suffice. Language regarding this concern will be included in the MTA.

26. Question:

Reference Section C., IV., E, items 2 and 5. Please clarify “consistency of reagent performance and integrity as defined by CDC standards”. Are there criteria aside from the 5-10% CV that is mentioned?

Consistency of reagent performance should be reproducible with only 5-10% CV.

27. Question:

Reference Section C, III, 3rd paragraph. Does the CDC intend to provide the manufacturers of the annual influenza vaccine with vaccine seed or other reagents for release testing produced by the contractor? If so, what is the required delivery time? Acceptance criteria? Will any materials produced and provided under this contract be used in the manufacture (e.g., seed stocks) or release testing of human vaccine? How will these IRR products be used in humans? If not, please clarify what is meant by “to support vaccine development”?

No, CDC will provide vaccine manufacturers with seed viruses from CDC’s in-house stocks. “To support vaccine development” refers to use of viruses and reagents for research and not for use in humans.

28. Question:

Reference Section C, III. Will panels/kits/reagents used to aid in development, evaluation, and characterization of viruses be labeled as

“Research Use Only”? What is the CDC’s understanding of the FDA regulatory obligations for these products? Which, if any, of these IRR products will be approved for human use; and what will be the contractor’s role and responsibilities for obtaining such FDA approvals?

Yes, reagents will be labeled as “Research Use Only” (RUO) unless otherwise indicated by the Project Officer. For the purposes of proposal submission, offerors should assume that all reagents will be labeled as RUO. The contractor will not be required to obtain FDA approvals.

29. Question:

Reference Section C, IV, C, item 2. Are the commercial kits described in this subsection exempt from contract requirements for quality and QC testing? Will the manufacturer’s production processes, certificates of analysis, and expiration dates be acceptable? Is there a need to secured permission for re-distribution from the manufacturers?

Yes, commercial kits are exempt from quality testing as long as the reagents are within the manufacturers’ suggested expiration date and are maintained in accordance with manufacturers’ requirements. Negotiations between the prime contractor and the kit manufacturer will need to occur to address re-distribution issues.

30. Question:

Reference Section C, III, paragraph 3 and Section C, IV, J. Will the contract provide kits/panels/reagents at no cost to recipient laboratories, or is the contractor expected to charge a fee?

Recipient laboratories will not be billed for good or services provided under the terms and conditions of this contract.

31. Question: Reference Section C.III, paragraph 4. Would the government please clarify its intended performance standards for assessing compliance with this requirement? By providing the link, http://www.fda.gov/cdrh/devadvice/32.html., in Section C, IV, E, item 6 is CDC specifying 21CFR, Part 820 as the target criteria for compliance with Good Manufacturing Practices (GMP) or GMP-like processes, in a Good Laboratory Practices (GLP) laboratory environment?

The statement of work is being modified to indicate Item 1(the Human influenza virus Real-time RT-PCR detection and characterization kit) in section III of the statement of work is the only reagent requiring a GMP level of manufacturing quality. All other reagents should be manufactured in a GLP laboratory setting. See addendum for clarification.

32. Question:

Reference Section C.III, last paragraph. “Products in the Influenza

Reagent Resource will be provided to qualified persons and institutions as determined by criteria provided by the project officer. …”; Section C.IV.C.7, page 12, “Individual Viruses: The contractor shall prepare or otherwise acquire, aliquot and store 117* influenza viruses, to be made available to the CDC, public health partners, developers and researchers, as approved by the Project Officer.”; and Section C.IV.G.1., page 17, “All requests for viruses, panels and/or reference reagents shall be approved by the Project Officer for shipment and delivery to qualified recipients only.” As with Section C, IV, C, item 7 and Section C,IV,G, item 1, several instances indicate that the Project Officer will approve each shipment, while Section C, III indicates that the Project Officer will provide criteria that the contractor will apply in determining whether to honor a request for shipment. Would the government please clarify whether the Project Officer will approve each request for shipment; and if so, what is the government’s estimate of how many hours or days will be required to obtain such approvals?

The Project Officer must approve all requests. Depending on the request, approvals may take from a few days to a couple of months. If the request does not require a MTA, approvals should take only 1-2 days. Requests that require a pre-approved MTA may only take 1 week to obtain approvals. Requests that require a regular MTA may take several months for both agencies to agree to the language. For the purposes of proposal development, an average of five business days from request to approval may be assumed.

33. Question:

Reference Section C,III, last paragraph. “In addition, the CDC Project Officer will periodically request transfer of selected products from the Influenza Reagent Resource to the National Institute of Allergy and Infectious Diseases (NIAID/NIH) for inclusion in the Biodefense and Emerging Infections Research Resources Repository (http://www.beiresources.org/).” To support uniformity in pricing assumptions, would the government please provide annual estimates of the types, numbers and frequency of such transfers?

Quantities for transfer to NIAID’s repository, currently the Biodefense and Emerging Infections Research Resources Repository (BEI), are included in the Quantity A estimates provided in the RFP.

34. Question:

Reference Section C, IV, G items 9 and 10. Both items have a requirement for Project Officer approval. To support uniformity in scheduling assumptions, would the government please provide estimates of the numbers of days required for Project Officer approvals?

For the purposes of proposal development, an average of five business days from request to approval may be assumed.

35. Question:

Reference Section C,IV, H. To support uniformity in pricing assumptions, would the government please provide a listing of annual estimates of specific locations (city and country) and frequency for the required panel distributions?

As stated in Section C, IV, H, proficiency testing is anticipated for laboratories in the U.S. and abroad. For the purposes of proposal development, offerors may assume an annual distribution of 1) 150 blinded panels using the cost estimates of providing proficiency testing to a hypothetical laboratory in St. Louis, MO., and 2) 50 blinded panels using the cost estimates of providing proficiency testing to a hypothetical laboratory in Bangkok, Thailand.

36. Question:

Reference Section C, IV, J, item 4 - To support uniformity for offerors’ pricing, would the government please provide either an estimated not to exceed total direct cost per year or annual estimates of numbers and lengths of publications, frequency and length of newsletters, as well as scientific conferences, meetings, workshops, etc. locations and durations?

No pre-determined approach is provided. Enhancing dissemination is desirable but is not the primary purpose of the contract.

37. Question:

The RFP/SOW mentions several computer systems that would be provided by the contractor, however the RFP contains no requirements to comply with the provisions of Section 508 of the Rehabilitation Act (29 USC § Partd), the Accessibility Standard (36 CFR 1194), and the FAR Final Rule (48 CFR Parts 7,10,11,12,and 39), nor is there an exemption cited (FAR Part 39). We respectfully request clarification that either:

1. Section 508 applies (with the requisite information, as per FAR);

2. Section 508 does not apply pursuant to exception;

3. This procurement does not contemplate the purchase of electronic and information technology falling under the definition of EIT provided in the Rehabilitation Act or Accessibility Standard.

In the event that Section 508 applies to this procurement, and no exemption is applicable, the Contractor must be advised of the DHHS/CDC compliance strategy, as provided for under the Rehabilitation Act and FAR Final Rule (48 CFR Parts 7,10,11,12,and 39):1. selection of applicable Accessibility Standards;2. selection of technologies to be used based upon the requiring activity’s market research, and; 3. listing of interoperability requirements (if applicable),in order for contractors to appropriately develop and cost a technical approach that is responsive to the Section 508 requirements of the RFP/SOW.

Section 508 does apply. Refer to Section “C.A. Section 508” of the Acquisition of Communications Products of U.S. Department of Health and Human Services website: http://www.hhs.gov/web/policies/508contractlang.html

38. Question:

Reference Section C, IV, C, Item 8b (development panel). The RFP states that approval from the Project Officer is required before distribution of the development panel? Will the process permit the Project officer to assign a delegate authority for approval?

For the purposes of proposal development, offerors should assume that all approvals must be routed through the Project Officer. Appropriate delegation of authority will be determined following award of the contract.

39. Question:

Reference Section C, IV, G, item 2. The requirements specify that the contractor retain written documentation to support 6 sub-items. Will an automated audit system with the appropriate data and login information support this requirement, or is paper documentation absolutely necessary?

An automated audit system with the capability for report generation is acceptable. However, reports generated from the automated system must be updated and kept on file to safeguard against system failure and data loss.

40. Question:

Reference Section C, IV, G, item 11. The RFP refers to a secure package and delivery system and written verification of receipt. If the secure package system can utilize user authentication (or signature) with barcode confirmation, will it address this requirement or is written documentation absolutely necessary?

User authentication with barcode confirmation is acceptable. However, paper reports must be generated from the tracking software and kept on file to safeguard against data loss.

41. Question:

Reference Section C, IV, G, item 11. The RFP refers to a “secure package and delivery system”. Can you define “secure” in terms of general standards such as NIST e-authentication guidelines?

System’s developed under this contract must undergo a Certification and Accreditation (C&A) in compliance with the E-Government Act of 2002, Federal Information Management System Act (FISMA), OMB Circular A-130 and the National Institute of Standards and Technology (NIST) publications. The NIST publications provide definitive guidelines in the following publications: NIST Special Publication 800-37, 800-60 (Volumes 1 & 2), 800-53 (Volumes 1 & 2), and NIST Federal Information Processing Standards (FIPS) 199 and 200 (http://csrc.nist.gov under Federal Information Processing Standards (FIPS) and Special Publications). The C&A process must be initiated and completed by CDC’s Information Technology Group (ITSO/OSCO). Once the systems’ vulnerabilities are mitigated or resolved and C&A has been completed, the Authority To Operate (ATO) is signed by CDC’s Chief Information Security Officer and forwarded to the contractor.

Access to the CDC protected data by external users requires the system to comply with OMB and NIST guidelines (OMB M-04-04 and NIST SP 800-63). The first determination is whether the data category/types are low, moderate or high. This is based on data content, system function and system integration. To determine this, CDC Information Technology Groups will use FIPS 199/200 and FIPS NIST SP 800-60 to determine the system category. Once the category/type is assessed, the E-Authentication rating can be determined to allow external users to access CDC information.

42. Question:

Reference Section C, IV, I, item 2. The RFP mentions sample data that might be stored in the inventory data. Is there an existing database that stores this information? If so, can you provide the database schema? Will any data migration activities be required?

Currently the sample data on site at CDC for reagents is housed in a variety of databases and a variety of platforms managed by different groups within the influenza division. The specific details of the sample data will be provided with the shipment of government furnished property. Data migration activities will not be required.

43. Question:

Reference Section C, IV, I, item 3. The RFP requires a tracking system capable of reading colored barcodes. Is the RFP referring to Microsoft’s implementation of the High Capacity Colored Barcode (HCCP)?

“Colored barcodes” is not referring to any specific software application.

44. Question:

Reference Section C, IV, I, item 4. The RFP refers to a “data mirror”.

Is this a requirement for real time data duplication or scheduled interval synchronization?

Scheduled interval synchronization should occur daily at a minimum.

45. Question:

Reference Section C, IV, I, item 6. The RFP requires up-to-date inventories be kept in electronic databases and on paper. Can the paper copies be an output/report of the database or is it required to be a separate unrelated account of the inventory?

Reports generated from the database will suffice. However, frequent report generation of paper copies is required to minimize potential data loss.

46. Question: Reference Section C, IV, J, item 1. The RFP indicates that the “storefront” will be password-protected. Does this requirement align with a specific e-Authentication level as established by OMB Memorandum 04-04, E-Authentication Guidance, and NIST SP 800-63?

Answer:

Refer to the Answer to Question 41.

47. Question:

Reference Section C, IV, J, item 2 - The RFP indicates that the storefront” will be password-protected. Will there be any areas in the website that should be available for viewing without a password?

Introductory web pages describing the IRR, available products, and providing instructions and enrollment to new users will be needed.

48. Question: Reference Section H.3 Security Auditing and Testing. The RFP indicates that the government has the right to conduct security auditing, penetration testing. What are the guidelines under which such testing would occur? What level of security is required to pass such tests? Will the contractor be provided with the requirements specific to security to perform their own testing as part of Quality Control?

System’s developed under this contract must undergo a Certification and Accreditation (C&A) in compliance with the E-Government Act of 2002, Federal Information Management System Act (FISMA), OMB Circular A-130 and the National Institute of Standards and Technology (NIST) publications. The NIST publications provide definitive guidelines in the following publications: NIST Special Publication 800-37. This NIST special publication provides guidelines for security auditing and testing.

49. Question: Reference Section C, IV, F item 12. Will the computer systems be required to be compliant with NIST security requirements categorization under FIPS 199 and require CDC/OCISO Certification and Accreditation (C&A) authorization to operate (ATO)?

Refer to the Answer to Question 41.

50. Question:Reference Section C, IV, I, item 1. The SOW states that the system will be maintained on a "personal computer (PC)-compatible system". Are there any hardware/software specific platform requirements other than compliance with CDC/HHS Federal Enterprise standards?

There are no specific hardware/software requirements other than the compliance mentioned in question 50.

51. Question:

Reference Section C, IV, I, item 4. Are there any classification levels or guidelines, such as 'sensitive but unclassified', identified with this data yet (other than those already established for Select Agent Data)?

There are no classification levels for the data managed by the contractor. Specifics on the requirements of select agent data can be found in Section C.IV.F of the RFP. .

52. Question:

Reference Section C, IV, J, item 1. The requirement identifies an electronic "storefront", elsewhere, there is a requirement for separate electronic system for Select Agent data (F.12), would this storefront need to be able to connect and appropriately filter that Select Agent information or should it be excluded?

The purpose of the electronic storefront is to facilitate ordering of reagents. A listing of available products will be accessible to potential requestors via the web storefront. This list will indicate that select agents are available to qualified requestors; however, this list does not require any connection to databases managing inventory of select agents. Management of inventory and distribution (Section C, IV, I) is a separate function where appropriate controls required for Select Agent information are applicable.

53. Question:

Reference Section E.1. How does the Government plan to “accept” what is delivered? What method or approach does the government intend to employ to determine acceptance of the articles (inventory of kits, panels, agents?)

Contractor-supplied reagents must perform in a similar manner as those of CDC in-house reagents. Reagents will be tested using specific standard assays for serological, diagnostic, and pathotype testing to determine performance. Standard operating procedures for specific assays are included in the Appendices for the serological assays. Other assays are listed in IV.E.2 but may include Western blot, in vitro and in vivo infectivity, and other methods.

54. Question:

Reference Appendix A. What is meant by “stocks”? Individual tubes of reagent? Individual products?

Appendix A reference to “seed stocks” is referring to individual aliquots of virus and reagent provided to the contractor for storage and/or propagation.

55. Question:

Reference Appendix A, Other Reagents, D.3 and E.1. indicates that antisera will be made for each virus in Appendix A.II, for each animal listed. Does the CDC require multiple animal versions of the same polyclonal, or one set of antisera as listed made in the best suited animal?

Required animal sera are typically limited to the best suited animal and will be indicated by the Project Officer. However, there may be instances where antigens need to be prepared from more than one species of animal as indicated by the Project Officer. For the purposes of the proposal, offerors should estimate using production of one set of antisera in the best-suited animal.

56. Question:

Reference Appendix A, Other Reagents, C.1: Antigens. Protein expression, protein purification, hybridoma construction, animal inoculations, antibody harvesting, and column purification is a standard but long duration set of processes that can’t be initiated (according to SOW C.IV.A) prior to SOP approvals by the Project Officer. Is it possible to receive baculovirus clones upon award to ensure the 12-month delivery of the first round of IRR products?

Yes, the clones that are available can be provided to the contractor within 30 days of the approval of the Standard operating procedures. These reagents can also be purchased commercially.

57. Question:

In regards to the performance and delivery schedule as outlined on page

25 of the SOW, it appears that the only deliverables needed for the first year are 20 of each of these panels: development, proficiency, specificity and independent. Is this a correct assumption? What are the delivery dates for the other deliverables (i.e. antigens, antibodies)?

Delivery schedule is being updated and will be included in the addendum.

58. Question:

The SOW states: “With the exceptions of WHO Influenza Reference

Reagent Kits (Item 7 below), and Animal Antisera against Influenza Viruses (Item 15 below), all viruses and reagents will be manufactured (to the maximum extent practicable) in accordance with Good Manufacturing Practices (GMP) or GMP-like processes, in a Good Laboratory Practices (GLP) laboratory environment; see Section IV.E.6 of the Statement of Work (SOW).”

If GLP is the maximum extent practicable that we can manufacture the reagents then would this be acceptable for this contract?

Yes, with the exception of Item 1: RT-PCR Detection and Characterization kit. The statement of work is being modified as noted in the attached addendum to reflect this change.

59. Question:

The RFP reflects a Base Period of only 1 year. Since the nature of this program is that where the initial start up will be important to the successful outcome of this nationally critical program we believe a longer base period would be more favorable to the Government. Would the Government consider increasing the base period to three to five years, with up to five additional option years?

Section C.II, Special Notes indicates that "Contractor inventories shall be fully stocked by the end of Year 1, and maintained thereafter in accordance with current government priorities". The purpose of the CDC-IRR, as part of the government's overall pandemic influenza plan, is to have critical reagents available to vaccine and diagnostic developers and laboratories in the event of an influenza pandemic. The government believes the Statement of Work requirement is both reasonable and attainable within the 1 year time frame.

60. Question:

Paragraph three of Section L.8(b).II.B requires the offerors to demonstrate its technology transfer compliance and operations plan for resolving potential conflicts of interest if a commercial organization were to propose to acquire potentially valuable reagents through this contract. One of the objectives in Section C.II is to improve access to these materials to developers of influenza vaccines, antiviral drugs, and influenza virus diagnostic products. Assuming a commercial entity requests a reagent consistent with this purpose, please clarify the potential conflicts that could arise in this situation.

CDC-IRR reagents will be released to authorized recipients for purposes set forth in the RFP statement of work and documented in Materials Transfer Agreements (MTAs), which will be negotiated with recipient institutions. MTAs are legally binding agreements; and, use of materials for other purposes set forth in the agreement would be unauthorized. This is an example of the type of “conflict” that should be addressed in the offeror’s technical proposal submission.

61. Question:

Section C.II "Special Notes" requires the Quantity A inventories to be fully stocked by the end of year 1. Does 'fully stocked by the end of Year 1' include all components (e.g., viruses, bacteria, sera, and diagnostic reagents such as PCR primers)? Will the CDC provide a list of prioritized components for Year 1?"

The government priorities will be communicated to the contractor on an ongoing basis during the performance of the contract and formalized on at least an annual basis through review and approval of the contractors acquisition, production, and manufacturing plans. For planning purposes Appendix A has been revised to indicate the level of priority for kits, panels, viruses and reagents. Below is a brief outline of this prioritization:

Priority Level Reagents identified in Tables listed below as detailed in Appendix A:

Priority Level 1:

I.

Influenza viruses live and purified

II.

Development and Evaluation Panels

III .

Other respiratory pathogens and commensal organisms

Priority Level 2

IV.

Kits A

Priority Level 3

V.

Kits B

Priority Level 4

VI.

Other Reagents

62. Question:

Section C. Ill "Scope of Work". The fourth paragraph references "(Item 15 below)". This section does not appear to contain Item 15. Please clarify.

The fourth paragraph is being modified and will be included in the addendum to clarify the level of quality for manufacture of the reagents. Only Item 1 must be manufactured at GMP level quality. All other reagents can be manufactured in GLP level laboratories.

63. Question:

Section C.F/."Detailed Technical Requirements", Paragraph E.6.

references "(Section III, Item 15 of the SOW)". It is not clear what reference this is to since there is not anything numbered 15 in this section.

Similar to Question 88 above, this paragraph will be modified as noted in the addendum to reflect the clarification that only Item 1 needs to be manufactured at GMP level quality. All other reagents can be manufactured in GLP level laboratories.

64. Question:

Please provide a draft copy of the MTA to be signed at contract award referenced in Section A.7(d) and Section C.IV.B(l).

Appendix A is a template of our current MTA agreement. CDC is currently working on a draft version of an MTA agreement that can be used by the contractor for reagent requests from the CDC-IRR.

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