Amendment_0001_2018-N-67801R_PDF_Format_7.02.18.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

1 8

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

07/02/2018

4. REQUISITION/PURCHASE REQ. NO.

N/A

5. PROJECT NO. (If applicable)

6. ISSUED BY CODE 8219 7. ADMINISTERED BY (If other than Item 6) CODE

Centers for Disease Control and Prevention

(CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road

Atlanta, GA 30341-5539

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

All Vendors

9A. AMENDMENT OF SOLICITATION NO.

2018-N-67801R

9B. DATED (See Item 11)

06/13/2018

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (See Item 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers X 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 1 copy 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 ACKNOWLEGMENT

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 you 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 APPROPRIATION DATA (If required)

N/A

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

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

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to do the following:

1. Provide answers to the questions submitted by offerors. See pages 2-8.

2. Based on the answers to questions, revise Sections B and C of the RFP 2018-N-67801R, and the Appendix B. See attached revised documents.

3. As a result of this amendment, the receipt date for proposals is extended. Proposals are due no later than 2:00 PM EST, on Monday, July 30, 2018.

4. All other sections of the RFP remain unchanged.

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.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME OF CONTRACTING OFFICER

Pellumbeshe Hoxhaj

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ___________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GSA

FAR (48 CFR) 53.243

ITEM 10A.

07/02/2018

2018-N-67801R 0001

Questions and Answers

RFP-2018-N-67801R

Question 1: Page 4. The RFP states "Sponsoring program activities will independently fund contract line item (CLIN) basic award quantities for materials listed in SOW Appendix A, of the contract." However, the number of items in

Appendix A is significantly higher than the number of items shipped 2016 in the Executive Summary. For cost purposes, please confirm that all applicants should prepare a cost consistent with number of items in Appendix A or provide number of items required in base year.

Answer 1: Appendix A addresses new items and quantities for manufacture during the base year. The quantity of items shipped each year depends upon the volume of demands from registered laboratories. E.g. 400 vials are manufactured during the base year, with 100 of those vials distributed during the base year. The remaining 300 vials would be held in storage for potential distribution in subsequent options years. The number of items produced each year should not be expected to equal the number of items distributed each year.

Question 2: Page 5. Does the Incumbent need to provide a cost estimate for Optional CLIN 0101?

Answer 2: Yes, all contractors’ cost proposals should reflect a cost value for each CLIN.

Question 3: Page 19. The government states that, "Within 45 days of contract award, the new contractor will receive the

IRR website code based on a DotNetNuke framework, copies of SQL server derived databases (product catalog, SOLR indexes for searching and DotNetNuke for portal settings and user information) and copies of integration scripts that process or update systems connected to the IRR website (one way, from IRR to an outside system), to be used for establishing connectivity to their enterprise resource programs (ERP) and perform initial system testing."

What SQL Server and version is being used with the IRR website?

Answer 3: Microsoft SQL Server 2016, Enterprise Edition, v13.0

Question 4: Page 19. In order to develop a realistic estimate, would the government please provide a detailed list of enhancements and defects to all IT systems for the last two years?

Answer 4: Enhancements and defects of existing IT systems are sensitive information that cannot be shared by CDC until contract award.

Question 5: Page 19. What are the ATO/FedRAMP requirements for all IRR hosted systems?

Answer 5: ATO/FedRAMP requirements are sensitive information that cannot be shared by CDC until contract award.

Question 6: Page 20. Will the CDC provide a copy of the incumbent SOPs to the contractor to validate consistent processes?

Answer 6: Yes, CDC will distribute non-proprietary SOPs to the contractor as soon as practicable after contract award.

Question 7: Page 21. Are the current primer/probe sequences FOUO for the IRR produced reagents? In order to provide accurate costing, will the government provide all costs and sequences?

Answer 7: Primer and probe sequences are not available for public dissemination, however CDC has provided estimates of sequence length, modifications, purity and quantity. Please refer to Appendices A and B, which provide computational basis for determining cost estimates.

Question 8: Excluding surge options, what is the projected percentage escalation in storage for each option year at each storage condition/temperature for select and non-select agent material?

Answer 8: Since fiscal year 2011, inventory levels have been within the range of 200,000 to 270,000 reagents total. Please refer to Appendix H for estimated storage temperature conditions. The inventory does not currently contain any select agents.

Question 9: Repository temperature fluctuations are common and expected. Please confirm that CDC's intention is that all equipment be stored within the temperature range suggested by the manufacturer, especially when all equipment is operational.

Answer 9: Yes, CDC confirms that all equipment shall be stored within the temperature range recommended by the manufacturer.

Question 10: Appendix A. The ProSpecT Rotavirus Microplate Assay # 11993132 has been discontinued in North

America. Is it CDC's intention to update this item to a replacement item, or source it from Europe while it is still available?

Answer 10: CDC intends to replace the ProSpecT Rotavirus Microplate Assay with a replacement item when available in

North America, and not source it from Europe.

Question 11: Page 24. In order to assist with cost and facility estimating, please confirm CDC's requirement is to duplicate all documentation in hard copy as well as electronically? Is electronic storage and reporting acceptable if hard copies can be provided upon request?

Answer 11: Electronic storage and reporting is acceptable if hard copies can be provided upon request.

Question 12: Appendix A details the expected quantities of each deliverable to be manufactured. This does not appear to include sufficient quantities for stability testing. Please clarify if either (1) larger batch sizes will need to be produced for items targeted for stability testing, or (2) if fewer units of the items targeted for stability testing will be available for distribution.

Answer 12: Stability testing items may be pulled from the production quantities described in Appendix A. CDC understands that this will result in fewer units being available for distribution.

Question 13: Page 24. In this section, the RFP states that the "stability testing plan shall be submitted to the government within 30 days of the start of each period of performance." Is the government's intention that this starts with the end of OY1 as the Transition In period (section C.IV.A.11 requires the stability testing plan to be established within 180 days of contract award?)

Answer 13: The initial stability testing plan shall be submitted within 180 days of initial contract award, and then updated as appropriate and resubmitted for CDC review within 30 days of the start of each subsequent option year.

Question 14: Page 24. Which reagents listed in Appendix A are manufactured by the CDC that are excluded from stability studies as noted in this section?

Answer 14: Stability testing should encompass all reagents produced by the prime contractor or its subcontractors.

Reagents that may be excluded from stability testing are those items manufactured by CDC as indicated in Appendix B or purchased from commercial vendors.

Question 15: Page 25. The government notes that "reagents are divided into levels, or reagent subsets, related to their function and/or association with specific surveillance or research efforts. All IRR accounts are programmed such that registrants are only able to view the reagents in the levels to which they have been approved access." Is the government or the contractor determining and approving this access level? What are the criteria used to determine what level is appropriate for a given registrant? Will the hierarchy be provided at contract award for the tiers of reagents?

Answer 15: CDC will determine and approve registrant level access. Levels are granted based upon the requesting laboratory's role in public health surveillance. Existing level identities, the reagents contained within them, and the registrants approved for their access will be provided as soon as practicable after contract award.

Question 16: Page 25. Are XML feeds required for updates to the existing IRR Reagent Order Processing System or would any Mirth compatible format be acceptable?

Answer 16: All data communications between the website, the contractor's ERP system and CDC's reagent order processing system occur in the form of XML. CDC is not contemplating re-engineering of existing data feeds at this time.

Question 17: Page 26. The RFP states that the contractor may be involved in developing innovative ways to enhance dissemination of information for the IRR, which may include staffing booths and making presentations at scientific conferences, meetings, workshops, etc. For purposes of estimating travel costs, what has been the average number of trips, number of contractor personnel, and durations for these types of events during the current contract? Will the government provide a plug dollar figure for travel?

Answer 17: CDC anticipates that travel shall not exceed $15,000 per year, to include technical meetings with the contract

COR and subject matter experts, laboratory trainings at CDC headquarters in Atlanta, and conference presentations.

Question 18: Page 26. Will the current hotline number(s) be transferred to the new contractor as part of the transition?

Answer 18: No, the existing hotline number is proprietary to the current incumbent.

Question 19: Page 26. What is the government estimate on the number of Development, Modernization and Enhancement

(DME) releases each year and the level of effort for each release? Will the government provide the historical number of major and minor software releases, and applicable patch only releases?

Answer 19: The IRR website and associated infrastructure (except for proprietary contractor ERP systems) requires approximately 10-20% DME on an annual basis. The CDC Reagent Order Processing system has required 40-50% DME for the last two years, but CDC anticipates that the level of DME required for this systems will decrease in future years.

Additional information regarding software releases and patches is considered sensitive information that may be provided upon request at contract award.

Question 20: Page 27. What is the required or historical average timeframe from submission of IRR registration paperwork to COR approval?

Answer 20: The historical average timeframes from registrant submission to COR approval are:

Domestic labs, BS2 or below, 5 days

Domestic labs, BL2+ or above, 8.5 days

International labs, BL2 or below, 7.8 days

International labs, BSL2+ or above, 7.8 days

Question 21: Page 27. What is the communication and technology used to exchange data between the IRR Reagent Order

Processing System and the contractor internal ERP system?

Answer 21: Since one of the contract requirements will be to provide an ERP system (see Section C.IV.F.3), the contractor shall be responsible for determining and developing services that will allow interoperability between the IRR Reagent

Order Processing System provided by CDC at the time of contract award and the contractor's ERP system. Therefore, the communication and technology used will be dependent upon the contractor’s own internal system.

Question 22: Page 28, 30. For the contractor staff located on-site at the CDC Atlanta Headquarters, will the Government provide office space, phones, computers, and other necessary equipment as well as assist in access to the facility?

Answer 22: Yes, CDC will provide contractor personnel with an office environment typically provided to CDC personnel including workstations, telephones, and computers with access to the internet. On-site staff will be required to complete appropriate security and background clearances and shall only receive access to specific facilities necessary to complete this contract's tasks.

Question 23: Page 29. Per CDC/USDA Select Agent Regulations, electronic records should not be stored off site. Please clarify CDC's intentions regarding the phrase "electronic copies are stored off-site."

Answer 23: The Responsible Official should keep backup copies of all records documenting entity select agent activities and store the records in a manner that reduces the risk of loss. The contractor must comply with any CDC/USDA Select

Agent Regulations or policies for maintaining a system of records and data bases. CDC is not aware of any CDC/USDA

Select Agent Regulations policies prohibiting backup electronic records storage off site.

Question 24: Page 30. Delivery within 96 hours for some international destinations is not feasible due to customs and transit delays. Will CDC consider updating requirement to: If delivery is not possible within 96 hours, cold chain will be maintained by a courier able to re-ice shipments?

Answer 24: Yes, CDC will update the SOW to reflect that cold chain should be maintained by the courier if delivery is not possible within 96 hours. See attached revised solicitation.

Question 25: Page 30. The RFP states "IRR reagents shall ship door-to-airport whenever possible." Is the intent of this requirement for all shipments or just international shipments?

Answer 25: The door-to-airport requirements relates to international shipments only. This information will be updated in the contract's SOW. See attached revised solicitation.

Question 26: Page 30. The RFP states "the contractor shall have one logistics specialist assigned to CDC Atlanta

Headquarters full time." Is this person in addition to the one mentioned in Section C.IV.H.7 or is this the same position?

Answer 26: The contractors' proposal should anticipate two personnel to be assigned to CDC headquarters in Atlanta, GA.

One to support daily IT operations of the IRR website and IRR Reagent Order Processing System (section C.IV.H.7) and a second to support coordination of shipments and customer service support (C.IV.I.16).

Question 27: Page 34. To understand the different storage requirements, is the current government provided list of equipment sufficient storage space for base year storage requirements?

If government provided equipment does NOT provide sufficient storage space for current inventory, then please address the following:

a. Total Storage Space Requirements for non-select agents at each of the following temperatures:

i. Cubic feet requirements for inventory @ 2-8C

ii. Cubic feet requirements for inventory @ -10 to -20C

iii. Cubic feet requirements for inventory @ -70 to -90

iv. Cubic feet requirements for inventory in LN2

v. Cubic feet requirements for inventory @ room temperature

b. Additional Storage Space Requirements for select agents

i. Cubic feet requirements for inventory @ 2-8C

ii. Cubic feet requirements for inventory @ -10 to -20C

iii. Cubic feet requirements for inventory @ -70 to -90

iv. Cubic feet requirements for inventory in LN2

v. Cubic feet requirements for inventory @ room temperature

Answer 27: The government furnished materials listed in Section C.VI does not reflect all of the equipment necessary for performance of the contract's technical requirements. Additional equipment and storage space may be necessary to operate and maintain the IRR depending upon the building facilities and existing equipment of the contractor. Please refer to

Appendices A, B, and H, which provide computational basis for determining total storage space needs.

Question 28: Page 34-35. For the government furnished materials that are available for transfer upon request:

a. Are preventative maintenance agreements in existence and/or current for all equipment?

b. Should equipment need repair, who is responsible for repair?

c. Should faulty equipment be deemed un-repairable, is there a process for replacement?

Answer 28: Yes, preventative maintenance agreements are currently in place for all equipment listed in the section C.VI, Government Furnished Materials. All equipment will be provided in working order. If upon inspection, any equipment is determined to be unusable the contractor shall follow instructions set forth in FAR 52.245-1, Government Property.

Question 29: Page 81. Do the resumes count towards either of the page limit totals (60 Technical + 50

Appendices/References)?

Answer 29: No, the resumes do not count towards either of the page limit totals (60 Technical + 50

Appendices/References). Note that each resume shall not exceed 4 pages.

Question 30: Can facility floor plans include a font size less than 10pt as long as it remains legible?

Answer 30: Yes, as long as facility floor plans remains legible.

Question 31: Page 84. Will an ODC CLIN be added?

Answer 31: Yes, an ODC CLIN will be added as required to cover travel and software licenses needed to meet the performance requirements of the contract. See attached revised solicitation.

Question 32: Page 85. For each major subcontractor, would the government allow for up to three (3) contracts completed during the past three years and the last (up to 3) contracts awarded currently in progress that are similar in nature to the solicitation work scope, in addition to the Prime?

Answer 32: Yes. For each major subcontractor CDC will allow for up to three (3) contracts completed during the past three years and the last (up to 3) contracts awarded currently in progress that are similar in nature to the solicitation work scope in addition to the prime contractor.

Question 33: Page 88. Will the government allow a more detailed transition plan discussion to address the requirements of

M.2.e to be included as an Appendix.

Answer 33: Yes, CDC will allow a transition plan included as an appendix so long as it does not exceed 20 pages and adheres to formatting requirements in section L.4.

Question 34: Appendix B, Page 3-4. There appears to be a conflict between the specification that the titer must be greater than or equal to the CDC seed stock and the required Ct value range. Will CDC consider revising the requirement to ≤ 28

Ct value.

Answer 34: CDC does not agree that these are contradictory requirements. The required Ct value range addresses purity while the titer requirement addresses quantity.

Question 35: Appendix B, Page 17 and 22. Our understanding is that 21 CFR 820 allows for certified and validated packaging. Will CDC update language to include both.

Answer 35: Appendix B, specifications #13 and #17 refers to validation of the shipping process to ensure maintenance of storage cold chain. This information will be updated in the contract's SOW. See the attached revised solicitation.

Question 36: Appendix B, Page 23-24. All of the Panels listed in Appendix B # 18 list included components. The quantities of components for the Panels do not match quantities of deliverables listed in Appendix A. Will the panels include only the deliverables listed in Appendix A; or will they be provided by CDC; or are they in addition to the deliverables listed in Appendix A.

Answer 36: Panels may be composed of a combination of reagents from the existing IRR inventory, new IRR inventory manufactured in accordance with Appendix A quantities, or items provided by CDC to the contractor in bulk or final vial format depending upon the panel. This information will be added to the Appendix B for clarity. See attached revised

Appendix B.

Question 37: Appendix B, Page 33. The expected results for the concentration for Bacterial Pathogen Reference Strains is listed as "≥ 1 x 106 colony forming units per mL". Please confirm this is supposed to be "≥ 1 x 10^6 colony forming units per mL".

Answer 37: ≥ 1 x 10^6 colony forming units per mL is correct. This information will be updated in the contract's SOW.

See attached revised solicitation.

Question 38: Appendix B, Page 34. Please clarify if poliovirus sensitivity testing is a QC test expected of the contractor? If required by the Contractor, please confirm CDC will provide the Positive Control?

Answer 38: CDC will perform poliovirus sensitivity testing.

Question 39: General. Only the incumbent contractor will have visibility into non-consistent costs. Please provide the current historic spend on an annual basis per contract year for non-consistent costs such as shipping? Alternatively provide a plug number for these costs?

Answer 39: Total historical shipping costs for non-pandemic years are:

2010-2011 - $418,530

2011-2012 - $432,320

2012-2013 - $546,485

2013-2014 - $472,560

2014-2015 - $530,476

2015-2016 - $487,122

2016-2017 - $383,350

Question 40: Please provide a current staffing profile and level of effort for resources supporting the current contract.

Answer 40: The contractor's proposal should reflect their estimate of the appropriate staff and level of effort to complete the work as described in the statement of work.

Question 41: Will the government limit the required language for developed materials to English? If no, which languages are required?

Answer 41: Website documentation, including certificates of analysis and product specifications, will be provided in

English. Specialized documentation to facilitate customs import may require occasional translation into Spanish or French as available resources permit.

Question 42: How many out going shipments (percentage of total shipments) require validated shippers with temperature monitoring devices (i.e., data loggers)?

Answer 42: The contractor should anticipate that they shall need to validate the integrity of any new shipping processes

(including changes to outer shipping packaging) with temperature monitoring devices. Routine shipments after validation will not require temperature monitoring devices.

Question 43: To provide accurate annual shipping cost estimates, please provide 12-months (e.g., 2017-18) any of the historical shipment data available with details on:

a) Total shipments:

i) domestic vs international

ii) select agents vs regular samples

iii) temperature conditions

iv) dangerous goods vs non dangerous

b) Shipments of non-select agents

i) Estimated number of shipments to domestic and international labs

ii) How many at room temperature, e.g., how many 2 mL vials per shipment per month

iii) How many at refrigerated temp. e.g., how many 2 mL vials per shipment per month

iv) How many on dry ice. e.g., how many 2 mL vials per shipment per month

v) How many using Dry Shipper (for LN2). e.g., how many 2 mL vials per shipment per month

c) Shipments select agents

i) Estimated number of shipments to domestic labs ii). Are there any international shipments of select agents? If so, the list of destination countries

iii) How many at room temperature, e.g., how many 2 mL vials per shipment per month

iv) How many at refrigerated temp. e.g., how many 2 mL vials per shipment per month

v) How many on dry ice. e.g., how many 2 mL vials per shipment per month

vi) How many using Dry Shipper (for LN2). e.g., how many 2 mL vials per shipment per month

Answer 43: During the 12 month time period from June 1, 2017 to May 31, 2018, IRR sent 1,645 shipments containing

10,923 items to 123 countries. Of these, approximately 70% were domestic and 30% were international shipments. No select agents were shipped during this time period. Percentage of total items shipped at each temperature were 64% frozen on dry ice, 6% at 2-8°C, and 30% at room temperature. Cell lines were shipped frozen on dry ice. Approximately 33% of all shipments contained a total of 2318 items considered to be dangerous goods. CDC is unable to provide data in requested format of terms of 2ml vials per shipment per month.

Question 44: Are there any dry ice sensitive materials that need to be handled without exposing to dry ice?

If yes, how many (%) of in coming and out going shipments need to be handled this way?

Answer 44: There are no dry ice sensitive materials.

Question 45: Would the government please provide:

1) List of countries where the non-select agents are sent. 2) Anticipated number of shipments, number of vials in each shipment, shipping temperature

Answer 45: Reagents may be sent to any registered laboratory from any country, subject to permit requirements and government sanctions if applicable.

During the 12 month time period from June 1, 2017 to May 31, 2018, IRR sent shipments to Albania, Algeria, Angola, Argentina, Armenia, Azerbaijan, Bahrain, Bangladesh, Belarus, Belize, Bhutan, Bolivia, Bosnia-Herzegovina, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chad, Chile, China, Colombia, Costa

Rica, Cote d'Ivoire, Czech Republic, Democratic Republic of Congo, Denmark, Dominican Republic, Ecuador, Egypt, El

Salvador, England, U.K., Estonia, Ethiopia, Fiji, France, Gambia, Georgia, Ghana, Greece, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Lebanon, Libya, Lithuania, Macedonia, Madagascar, Malawi, Maldives, Mali, Malta, Mauritania, Mexico, Mongolia, Montenegro, Morocco, Mozambique, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, USA, Qatar, Republic of Moldova, Russia, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, South Africa, South Korea, Spain, Sri Lanka, Suriname, Sweden, Taiwan, Republic of China, Tanzania, Thailand, Timor-Leste, Togo, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, Uruguay, USA, Uzbekistan, Venezuela, Vietnam, Zambia.

The number of items and shipping temperatures varies based on regional demand and response to fluctuating infectious disease surveillance and outbreaks. During the period from June 1, 2017 to May 31, 2018, shipments varied in size from 1 to 133 items per shipment, with an average shipment size of 7 items. Percentage of items at each shipping temperature were provided by CDC in the answer No. 43.

Question 46: Would the government please provide:

1) List of countries where the select agents are sent. 2) Anticipated number of shipments, number of vials in each shipment, shipping temperature.

Answer 46: No select agents were shipped during either the 2017 or ongoing 2018 fiscal years. However this does not preclude select agent shipments in future years. The number of shipments will be dependent upon reagent demand in response to fluctuating infectious disease surveillance and outbreaks. The government estimates the number of select agent shipments per year will not exceed 1% of the total annual shipments.

Question 47: Would the government please clarify the current export and import permits status? Are they currently in place and will the information be transferred?

Answer 47: Existing permits are not transferrable from the incumbent to a new contractor. Please refer to section C.IV.I.12

Question 48: Will the government provide an estimate for any incoming materials (or procured materials, e.g., vaccines, cell banks, virus) that are not manufactured by the contractor that need incoming receipt inspections?

Answer 48: Contractor will be responsible for the inspection and acceptance of all incoming materials. Please refer to

Appendices A and B which provide computational basis for determining these estimates.

Question 49: Given the number of vendors identified for purchasing ancillary reagents in Appendix A there is insufficient time to negotiate purchase agreements with costs that would be comparable to the incumbent negotiated rates. Thus, will the government provide a single plug value for all ancillary agents to be used in all offerors proposals and allow time to negotiate rates during the transition in period?

Answer 49: The contractor's proposal should reflect their best estimates of ancillary reagent costs.

Question 50: May subcontractors submit sealed pricing direct to the government?

Answer 50: Yes. The prime contractor must clearly articulate all subcontract and total costs in the prime contractor’s proposal. The subcontractor’s cost proposal must include sufficient information that meets the requirements of detailed cost and pricing data in accordance with the Federal Acquisition Regulations (Table 15-2).

Question 51: To allow for more detailed matrices, floor plans, diagrams, equipment, list of SOPs, will the government increase page count for appendices?

Answer 51: No, CDC is satisfied with the current page count requirements as described in section L.4.

Question 52: As the detailed logistical and technical requirements for the IRR solicitation were not previously disclosed, a

30 day submission deadline is not enough time for respondents not already familiar with all the elements of the Statement of Work to submit a proposal in a timeline manner.

We request that the government extend the due date an additional 45 days to ensure that submissions are technically compliant and of the best value to the customer.

Answer 52: CDC will extend the due date to Monday, July 30th, which gives offerors 28 calendar days to prepare proposals.