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SUPPORT CONTRACT FOR THE NATIONAL TOXICOLOGY PROGRAM INTERAGENCY CENTER FOR

THE EVALUATION OF ALTERNATIVE TOXICOLOGICAL METHODS (NICEATM)

RFP # NIHES20140003

AMENDMENT #1 QUESTIONS AND ANSWERS

ADMINISTRATIVE CHANGES

AS A RESULT OF THIS AMENDMENT THE RESPONSE DATE FOR THE RECEIPT OF PROPOSALS

WHICH IS INDICATED ON PAGE 1, SECTION A, BLOCK 8, OF THE SOLICITATION HAS BEEN

EXTENDED FROM OCTOBER 10, 2014 (10/10/2014) TO OCTOBER 17, 2014 (10/17/2014).

SECTION J

Q1. Item 4 on page 56 of the RFP, and Attachment J, requests cost data in the Technical Proposal. Will the government confirm that actual cost data should be included in the Technical Proposal? If so, can contractors provide the completed Attachment J as an appendix to the Technical Proposal?

R1. Item 4 on page 56 as well as Attachment 5 of section J, clarify that 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 identified information shall be included in the Technical Proposal as indicated.

Q2. On Pages 24 and 25 of the SOW (Attachment 3), please clarify that 6.2 Contractor Provided Software and Hardware refers to the items in 6. Government Furnished Materials (GFM) and that these items will be purchased direct on the contract and added to the Government Property list.

R2. Any tools, software packages, or database products used to generate or analyze data and/or generate, maintain, or store information for Web pages not included Table 6 (Government Furnished Materials) or Table 6.1 (Contractor Furnished Materials) require prior approval. The Contractor shall have and maintains all software and hardware required to complete the efforts as described within the SOW. To achieve continuity with pre-existing efforts, the Government requires that the Contractor use certain software packages (e.g. TIBCO Spotfire, Partek Genomics Suite, GastroPlus). Approved items purchased via contract funding shall be added to the Government Property List.

Q3. On Page 1 of Attachment 14 Additional Business Proposal Instructions, Option 2 to Increase the Level of Effort indicates a 25% increase over the Base Contract. The Labor Hours table on page 54 of the RFP includes 9,500 Optional LOE hours which is approximately 47% of the Base LOE hours. Please clarify which hours should be used to calculate Option 2.

R3. The hours to be used to calculate Option 2 should equal 50% of the base or 10,170 hours.

Q4. Page 4 of Attachment 14 (also labeled Attachment 8), Effort and Cost Breakdown item (a) says, “Cost and effort for completion of sample projects 1 and 2. In the table on Pages 83 and 84 of the RFP under Technical Evaluation Factors, there is an item labeled “Response to the following task (150 Points).” Please verify that this is a sample project and identify the second sample project.

R4. Please review the amended Evaluation Criteria in Section M of the Solicitation. All pages of Attachment 14 should read Attachment 14 rather than Attachment 8 (previously listed on pages 2-4).

Q5. On page 3 of Attachment 14 (also labeled Attachment 8), the quantities in Tables II and III do not match the quantities in the last paragraph on page 4. Please clarify which information to use for costing travel and meetings.

R5. Please match the quantities in the last paragraph on page 4 with the following clarification: plan for 12 ICCVAM meetings/year – 4 face to face meeting and 8 meetings via webcast. All pages of Attachment 14 should read Attachment 14 rather than Attachment 8 (previously listed on pages 2-4).

Q6. Page 25 of the SOW (Attachment 3) says that the contractor shall provide "Web based conferencing software."

Page 17 of Attachment 3 the SOW indicates that "an NIH-approved web-based service (e.g., Adobe Connect)" will be used. Please clarify if the contractor will provide support through the NIH Adobe Connect service (to be provided by the government) or if the contractor should provide their own account for Adobe Connect or a similar service. If the contractor is to provide their own account, please provide a complete list of NIH-approved web based conferencing services.

R6. NIH prefers the use of Adobe Connect at this time for Web-based conferencing; our expectation is that the Contractor shall have the expertise to run Adobe Connect through Government services. Government-approved web-based conference packages are subject to change.

Q7. Page 7 of SOW (Attachment 3), says “On-site qualification of the subcontract laboratories by the Contractor may be required.” Please confirm that this sentence was inadvertently included in this section and should be deleted.

R7. Yes, this sentence was inadvertently included in the section on Contractor Travel. You may disregard it in this section. Its appropriate place is under 3.2.2 Coordination of Validation Studies.

Q8. Reference 3 (page 46 / paragraph J.): Attachment 8 – Additional Proposal Instructions Are the additional instructions embedded in the RFP without reference, or is Attachment 8 missing?

R8. Attachment 8 was inadvertently omitted and is attached herein.

Q9. Page 46 / paragraph J, Attachments 7 and 19. Are we correct in assuming that Attachment 7 and 19 are available for download from the HHS site with file names “vpatinstructions.docx” and “sflll.pdf”, respectively?

R9. Attachments with web-links are available for download. Should you encounter difficulty accessing the attachments please feel free to contact the Contracting Officer as indicated for the solicitation. Also note that Attachment 13 was repeated as Attachment 19 therefore disregard Attachment 19 as only one disclosure is required.

SECTION K

Q10. Page 48 of the RFP, Section K, indicates that offerors must go to the System for Award Management (SAM) and complete the Representations and Certifications. Is this required in advance of proposal submission? Does completing the Representations and Certifications online preclude the need to submit the Representation and Certifications as part of the Business Proposal? Or are both required?

Do we need to complete the Reps and Certs or can we certify via ORCA and fill out only Section (b) per usual?

R10. Completion of the Representations and Certifications in the SAM website is required in advance of proposal submission. Submission of the Representations and Certifications online does not preclude the need to submit them as part of the Business Proposal. Both are required.

SECTION L

GENERAL:

Q11. Section 13a on page 59 states, “Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a ‘major subcontract’ is defined as: Any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime contractor or another subcontractor in an amount greater than 50% of the total contract.” Since this is a small business set-aside, no subcontractor will be allowed to furnish supplies and services in excess of 50% of the total contract. We suggest the government consider removing the last sentence further defining a major subcontract as greater than 50% of the total contract.

R11. Agreed. The language defining a “major subcontract” should be disregarded.

Q12. Section 13a on page 59 states that Past Performance Information should be included in the Business Proposal. However, in Section M on page 88, Past Performance is listed separately. Will the government confirm that the Past Performance section should be included in the Business Proposal and will be evaluated as part of the Business Proposal?

R12. Past Performance shall be included in the Business Proposal. Section M identifies the Evaluation Factors for Award. Past Performance Information will be evaluated by the Government as stated in Section M.

Q13. Under Section 7e on page 80, the RFP states, “You are cautioned that omission or an inadequate response to this very important RFP requirement could have a negative effect on the overall selection process.” Will the government confirm that this clause refers to Section 7 as a whole and not just Section 7e, as some bidders may not have pertinent grants to report?

R13. The last paragraph in section 7 refers to the entire section.

Q14. Section 6 on page 68 states that Section 508 Compliance should be addressed in the Technical Proposal.

However, in Section M on page 87, Section 508 is listed separately outside of the Technical Evaluation Factors. Will the government confirm that the Section 508 section should be included in the Technical Proposal?

R14. 508 Compliance shall be addressed in the Technical Proposal as stated. Section M identifies the Evaluation Factors for Award. Evaluation of Electronic and Information Technology accessibility – Section 508 shall be evaluated as stated in Section M.

Q15.A. Page 56 of the RFP states, “Proposals will be typewritten, paginated, reproduced on letter size paper, printed/copied double-sided, on at least 30 percent post consumer fiber paper, as required by FAR 4.302(b), and will be legible in all required copies. In addition, accessible copies of your proposal will be prepared in electronic format on encrypted compact discs (CD), all copies will be legible and 508 accessible.” Will the government confirm that only the electronic copies of the proposal need to be 508 accessible?

Q15.B. Authorized Official and Submission of Proposal (page 56 / paragraph 2.2). Do proposals have to be 508 compliant or only post-award deliverables?

R15.A. Only electronic copies of the proposal need to be 508 accessible. Unless otherwise stated in the solicitation.

R15.B. The deliverables shall be 508 compliant as stated in the Solicitation and Statement of Work and Attachments.

Q16. If a prime enters into T&M agreement with a subcontractor, does the subcontractor need to provide a sealed package to the government?

R16. If the prime enters into any subcontract, the prime shall include the information identified on page 80 of the solicitation, subparagraph 8, subcontractors.

Q17. In Section 8f on page 80, the RFP states the requirement for subcontractors to provide “a complete cost proposal in the same format as the offeror’s cost proposal.” Does this apply only to subcontractors that will perform major or critical aspects of the requirement?

R17. This applies to all subcontractors.

Q18. The Labor Hours table on Page 54 of the RFP includes Optional LOE hours for three (3) Technical Professional Support positions. Page 86 of the RFP, Optional Technical Professional Support, indicates “additional Toxicologists (up to 2; as described above).” Please verify whether two or three positions should be included for Optional Technical Professional Support. Also, for costing purposes, please clarify whether these additional positions should be Toxicologists or specifically Computational Toxicologists.

R18. The hours to be used to calculate Option 2 should equal 50% of the base or 10,170 hours.

Also, please review the amended Evaluation Criteria in Section M of the Solicitation.

Q19. Section L of the RFP does not provide page restrictions for the technical proposal. Is there a required page allocation for the technical proposal and/or any sections within it?

R19. Attachment 8, Additional Technical Proposal Instructions, contains page limitations for some of the individual areas of the technical proposal.

Q20. Page 63 of the RFP, item 4 Schedule, states “performance or delivery schedules shall be indicated for phases or segments of work, as applicable, by contract year as well as for the overall contract.” Is a schedule for the base year sufficient? Can bidders provide the schedule as an appendix to the Technical Proposal?

R20. The Technical Proposal Instructions, item 4, the first sentence, instructs all offerors to “Provide a schedule for completion of the work and delivery of items specified in the Statement of work”.

Q21. Item 2 on page 56 of the RFP specifies that bidders must provide electronic copies of the proposal on encrypted CD’s using the password, NICEATM2014. Attachment 1 states electronic copies must be encrypted using the password NICEATM20140003. Please clarify which password is preferred.

R21. All references to CD encryption should read NICEATM2014.

SECTION M

Q22. Section M, page 82 of the RFP, states that all Contractor Staff will be required to be co-located (i.e., same physical location). While we understand that the core team must be co-located, certain activities in the solicitation (e.g., peer review, expert panels) likely will be conducted outside of the co-located facility. Can the government confirm that it is acceptable for some activities to be performed within the physical walls of the co-located facility?

R22. Special approvals are required to conduct meetings at other than Federal Facilities. The Government prefers that meetings be conducted at Federal Facilities. If Federal Facilities are not available, meetings may be conducted at alternate facilities which meet Government Requirements. Meetings between Contract Staff and the COR may be located at either the Contract organization or at the COR’s location. The Contractor is required to have sufficient space for the COR to occasionally meet with all Contract staff assigned to this effort.

Q23. Page 86 of the RFP (Section M) aligns 25 points each for ‘Optional Technical Professional Support’ and ‘Optional Technical and Administrative Support’ resources. Can the government confirm if named resources and resumes are required for each of these categories?

R23. Please review the amended Evaluation Factors for Award at Section M.

Q24. Page 86 of the RFP (Section M) aligns 25 points each for ‘Optional Technical Professional Support’ and ‘Optional Technical and Administrative Support’ resources. The text seems to imply the desire for two specified resources in the first category. If we assume the same (2 resources) for the ‘Optional Technical and Administrative Support’ category, the evaluation points per resource (25/2 or 12.5) would exceed the evaluation points per resource for the non-optional ‘Technical and Administrative Support’ resources (30/3 or 10). Please confirm the desired number of resources for each category and evaluation point allocation.

R24. Please review the amended Evaluation Factors for Award at Section M.

Q25. Section M details eight factors for evaluation. The section details how all of these factors will be evaluated, except cost. Since the Business Proposal requires much more than just the bid cost, will the government designate how it will evaluate the Business Proposal as a whole?

R25. The business portion of each contract proposal will be subjected to a cost and price analysis, management analysis, etc. (See page 58 of the solicitation). The Business Proposal Instructions (page 70 of the solicitation) identify the information to be provided and how it shall be analyzed. Cost/price information will be used for such purposes as ensuring that the offeror fully understands the requirement and for determining that the indirect rate(s) are being applied correctly. It does not preclude obtaining more comprehensive information. Note: Please review the amended/updated information in Section M.

Q26. Has the incumbent contractor supported the sample task defined at the bottom of page 83 of the RFP Evaluation Factors (related to endocrine disruption)? If so, will the government provide any related documentation or background materials?

R26. Endocrine disruptors are a priority issue for NICEATM and several of the ICCVAM agency partners and the incumbent is involved in several projects related to endocrine disruptors. However, this generic task was provided so that the Offeror can demonstrate their understanding of the validation process. Guidance documents cited within the SOW include Validation and Regulatory Acceptance of Toxicological Test Methods: a report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods and Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods

Q27. In Section M6.5.g on Page 87, should the Conflict of Interest Plan be included as an appendix to the Technical Proposal or should it be included directly as part of the Quality Management Plan section?

R27. The Conflict of Interest Plan should be included as part of the Quality Management Plan section.

ADDITIONAL QUESTIONS

Q28. Pages 9-11 of the RFP specifies a number of Information Security reporting requirements including requirements for development of an IT Security Plan, IT Risk Assessment, FIPS 199 Assessment, IT Security C&A, and Vulnerability Scans. Can the Government validate the target network and/or systems associated with these plans and reports? Is it meant to address the networking environment of the contractor’s facility? Furthermore, can the government specify the determined risk level of the data associated with the contract? In other words, are we to assume a ‘low’, ‘moderate’, or ‘high’ risk environment?

R28. Refer to page 24 of the RFP ARTICLE H.11, INFORMATION AND PHYSICAL ACCESS SECURITY for the position sensitivity levels as well as links to policy documents regarding submission of the various IT Reports required.

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