Amendment 1.pdf

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 1

Amendment No. 1

NIAID-DAIDS-NIHAI2012138

“SIMIAN VACCINE EVALUATION UNITS (SVEUS)”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

NIAID-DAIDS-NIHAI2012138

One (1)

July 24, 2012

Proposal Due Date/Time: Friday, August 31, 2012 at 3:00 pm, Local Time (Unchanged)

Issued By: Michelle L. Scala Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214 Bethesda, Maryland 20892-7612

Point of Contact PRIMARY:

prassinosca@niaid.nih.gov Callie Prassinos, Contract Specialist Phone: 301-496-0611

SECONDARY:

mscala@niaid.nih.gov Michelle L. Scala, Contracting Officer Phone: 301-451-3693

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

The purpose of this amendment is to: 1) answer questions from potential offerors regarding the solicitation; 2) to revise Attachment 1, Packaging and Delivery of the Proposal to revise the page limitation; 3) to modify Attachment 2: Proposal Intent Response Sheet to change the due date for Proposal Intent Response Sheets; 4) to set a suggested deadline for submission of questions; and 5) to amend several Attachments to correct typographical errors in the referenced Attachment Numbers and to make changes as a result of questions from potential offerors. The revised Attachments include Attachment 3: Statement of Work for the Base Contract, Attachment 13, Statement of Work for Sample Task Order #003-7, Task Area 3: Conduct of Studies in Nonhuman Primates: Virus Stock Generation and in vivo Titration, revise Attachment 14, Sample Statement of Work For Task Order #003-8, Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, and Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 2

Responses to Questions from Potential Offerors:

Question 1:

Is there a requirement that the tasks performed under the Simian Vaccine Evaluation Units (SVEUs) contracts be conducted under GLP conditions?

Response to Question 1:

No, there is not a requirement that the SVEUs studies need to be conducted under GLP conditions.

Question 2:

To respond to Task Areas 1, 2, & 3, there are to be 10 separate EXCEL presentations, one each for Task Areas 1 & 2, and to cover the eight individual Task Orders specified in Task Area 3.

The question refers to the Technical Proposal Cost Summary (pg. 43, Attachment 22) which is to be included in the Technical Proposal. Do you want the bidder to present a Technical Proposal Cost Summary for each of the 10 areas? If so, the number of pages to present the summaries will take 5-10 pages. Do these pages count against the Technical Proposal 150 page count?

Response to Question 2:

In response to your question regarding the Technical Proposal Cost Information/Summary of Labor and Direct Costs, the Offeror should include the cumulative costs of all Task Orders for which the Offeror is proposing. Thus, the Technical Proposal Cost Summary should be only 1 page. This page does count against the Technical Proposal page count.

Please note that an Offeror could potentially provide up to 12 separate EXCEL spreadsheets as part of their Business Proposal. See below:

1 EXCEL spreadsheet for Task Order #001, Core Activities 1 EXCEL spreadsheet for Task Order #002-1, Maintenance of 20 Nonhuman Primates 1 EXCEL spreadsheet for Task Order #002-2, Maintenance of 50 NHP’s 8 EXCEL spreadsheets for Task Orders #003-1 through 003-8 for the Conduct of Studies in NHPs 1 EXCEL spreadsheet for Task Order #004-1 Operation of a NHP Breeding Colony

Question 3:

For Task Order #002-1, Task Order for Maintenance of 20 SPF Nonhuman Primates/year, (Attachment 17, Additional Business Proposal Instructions, page 6), the RFP specifies a total of .27 FTEs.

For Task Order #002-2, Task Order for Maintenance of 50 SPF Nonhuman Primates/year, (Attachment 17, page 7), the RFP specifies a total of .05 FTEs.

Is the specified Task #002-2 total of .05 FTEs correct?

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 3

Response to Question 3:

The .05 FTE level of effort for Task Order #002-2 is correct as indicated in Attachment 6, Statement of Work for Task Order #002-2. Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions, paragraph b.2.A.1 incorrectly states the level of effort for Task Order #002-2 as .50 FTE. It should have stated .05 FTE.

Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions, is revised to correct this error and an updated version is included as an attachment to this Amendment.

Question 4:

The SVEU has always provided support for a certain number of FTEs, in order for the properly trained staff to be available when needed. Will this policy continue into this new contract, or will support only be provided during each task?

Response to Question 4:

Task Orders issued under Task Areas 1, 2, and 4 stipulate a specific level of effort to be delivered, which is expressed in this solicitation as full time equivalents (FTEs). The stipulated level of effort for each Task Order is the amount that will be supported under each Task Order. Offerors should budget for the stipulated amount of effort when submitting proposals. Please note, the labor mix stipulated in the solicitation is for proposal preparation purposed only and should not be considered restrictive. Please refer to Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions.

Question 5:

Regarding the listed on-going projects in the Statement of Work for Task Area 3, is it expected that the offeror provide estimates for the projects that are not located here at this time?

Response to Question 5:

There are ongoing vaccine studies being conducted at the current SVEU contract sites, and these will continue as currently planned from the present time until June 2013, when the current SVEU contracts end. However, some of these in-progress studies will not be completed when the current contracts end. Therefore, Task Area 3 Task Orders have been written to allow these studies (and the animals in them) to continue under new Task Order contracts. Offerors should submit technical and business proposals for only the projects included in the RFP.

Please note that any offeror may submit proposals for any of the Task Orders #s 003-1 through 003-4, even though an offeror did not carry out the work under the predecessor SVEU contract.

Question 6:

It is our understanding that some of the animals are currently being held off-site. The per diem expenses for animals that are held off-site will need to also be accounted for in offeror’s proposals. How should these per diem expenses be incorporated in the budget for the assumed tasks described in the RFP?

Response to Question 6:

There are currently rhesus macaques being supported by SVEU contractors at off-site locations for eventual use in SVEU projects. At the end of the current contracts in June 2013, the care and maintenance of these animals will be transferred to the new

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 4

contractor under a Task Order to be issued at the time of award. Please follow the Uniform Cost Assumptions for budgeting for animal per diem costs.

Question 7:

There appear to be no indications of FTE limits for task 3, which is fairly labor intensive. Are FTEs allowed for this task? Or would personnel costs all be billed as services?

Response to Question 7:

Task Area 3 for the Conduct of Studies in Nonhuman Primates will be non-severable completion Task Orders, unlike the level of effort, severable term type Task Orders for Task Areas 1, 2, and 4. Task Orders issued under Task Areas 1, 2, and 4 will require the delivery of a specified level of effort. Task Orders issued under Task Area 3 will require the completion of specific projects. However, that does not mean that you will not budget for the labor associated with carrying out the specific projects for Task Orders issued under Task Area 3. You should budget for labor costs in the same way you budget for them in Task Areas 1, 2, and 4.

Question 8:

SOW Attachment 13 “Virus Stock Generation and in vivo Titration” calls for 18 animals, asks for a technical plan to prepare 500 ml of stock and to initiate an in vivo titration by challenging only 6 animals (2 each/each of three virus stock dilutions). The animals are to be monitored and euthanized after 60 days. No instructions for the remaining 12 animals are provided.

This attachment is referred to in Attachment 17, page 13, 4. e. as “Sample Task Order for Task Area 3: Conduct of studies in NHP: Virus titration (Attachment 11 [not 13])” in the Business Proposal section where relatively elaborate description of a technical plan using three cohorts of 6 animals (in other words all 18) for the titration arm of the study task. The budget here would far exceed the called for activity in the Technical Plan.

Response to Question 8:

The specified number of animals in Attachment No. 17, Additional Business Proposal Instructions and Uniform Cost Assumptions, is correct. Attachment 13, Statement of Work for Sample Task Order #003-7, Task Area 3: Conduct of Studies in Nonhuman Primates: Virus Stock Generation and in vivo Titration,” Paragraph 2, Technical Requirements, paragraph C, House, Maintain, and Conduct Studies in Nonhuman Primates, subparagraph 7), is revised to correct the specified number of animals:

7) Conduct an endpoint intravaginal titration of the SHIV virus stock using three (3) cohorts of six (6) nonhuman primates. The initial titration shall be conducted with three pairs of nonhuman primates which shall be exposed to stock virus at 1:2,1:5, and 1:15 dilution by the vaginal route.

Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3, Uniform Cost Assumptions, paragraph 1, Technical Cost Assumptions, subparagraph e, SAMPLE TASK ORDER for Task Area 3: Conduct of Studies in Nonhuman Primates: Virus Titration, is revised to reference Attachment 13 rather than Attachment 11. Please see the revised version of Attachment 17 that is included as an Attachment to this Amendment.

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 5

Question 9:

Page 17: under "Article G.4 item b at the bottom of the page the document indicates that “The Contractor shall bill recipients directly for the nonhuman primates provided. The charges for these nonhuman primates shall be based upon the current NIAID price list for the items listed in an Attachment in SECTION J, of this contract." No information on the NIAID price list is included in Section J or the list of attachments referred to in Section J. Please clarify how this information, if it is made available, is to be used in responding to task areas 1, 2, and 3.

Response to Question 9:

ARTICLE G.4., Recipients Reimbursement Procedures, is included in the sample contract in the event the Government determines the need to sell nonhuman primates under the contract to investigators/researchers (not to the SVEU contractors). This clause will be part of the contract when awarded. It states the guidelines for the reimbursements when selling nonhuman primates if this need arises. The price list was not included as an Attachment because it will be determined after award of the contract in collaboration with the Contractor.

Question 10:

On Page 24 of the solicitation, Article H.12., Information and Physical Access Security, and other places (e.g. p. 25, & p. 66) in the RFP refers to HHS-controlled facilities and databases.

How does this Article apply to Task Areas 1, 2, and 3? In reading the whole RFP and attachments it would appear that, one would be able to enter data into an HHS controlled database and to view data in this database which is operated by another HHS contractor.

Thus, it is not clear how to incorporate this information into the proposal

Response to Question 10:

The SVEU Vaccine Study Database is a HHS-controlled database supported by another HHS contractor, and is referenced in the Statement of Work for Task Order #001, Paragraph 2.a.5, and in Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal and Table of Contents, Section 3, I.B. Specifically, the Offeror is instructed to: “Describe the plans including available resources such as computer and internet capability for transfer of study plans, data and information to a third party and direct data entry into SVEU Vaccine Study Database. Include a description of safeguards in place to prevent and maintain unauthorized access of computers systems and records.”

Question 11:

Page 60 item 4 "resumes". Presumably an NIH biosketch will be acceptable.

Response to Question 11:

Yes, but please note the requirement in the Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal and Table of Contents, to limit CVs to 2-3 pages.

Question 12:

Page 86 under item B one of the criteria is "appropriate biocontainment for shipping of nonhuman primates". This would only seem to apply to Task Area 4. Correct?

Response to Question 12:

All Task Areas include a requirement for shipping of nonhuman primates due to purchase, or transfer. Therefore, this criterion applies to all Task Areas.

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 6

Question 13:

Page 86 item E refers to the adequacy, appropriateness etc. of a transition plan. However, elsewhere in the document (pp. 100-102 of the PDF, pages 2 to 4 of attachment 4) it talks about submitting a transition plan within 5 days of the effective date of a task order which would clearly be after review of applications. Can you clarify what type of information you would like to see in a transition plan for the proposal? Should there be a transition plan for each task area?

Each task order?

Response to Question 13:

Transition activities will take place under Task Area 1 and Task Area 4. The following information is included in Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal and Table of Contents, regarding what should be included in Offerors’ technical proposals about Transition:

For Task Area 1, Section 3, Paragraph I, subparagraph D, Transition, states: “Describe in detail plans and operating procedures to ensure a smooth and timely transition of activities, study data, study materials, nonhuman primates, and Government-owned equipment at Task Order initiation and at Task Order completion.

For Task Area 4, Section 3, Paragraph IV, subparagraph B, Transition, states:

“Describe in detail plans and operating procedures to ensure a smooth and timely transition of activities, study data, study materials, nonhuman primates, and Government-owned equipment at initiation and at completion of the Task Order.

Question 14:

Attachment 1, Packaging and Delivery of the Proposal, the Table on page 2, refers to page limits. Does the 150 page limit for the technical proposal and all appendices apply regardless of whether you respond to all task areas, only task area 4, or task areas 1 through 3 but not 4?

Response to Question 14:

We have given this further consideration and have revised Attachment 1, Packaging and Delivery of the Proposal, the Table on page 2, listing the page limitation as follows:

Document Number of Copies Page Limits

Technical Proposal for Task Areas 1, 2 and 3, and all Appendices

PAPER

One (1) unbound SIGNED ORIGINAL Five (5) unbound COPIES

ELECTRONIC FILES ON CD

Five (5) Compact Disks containing an electronic copy of the Technical Proposal (including all Appendices)

Not to Exceed 225 pages

Technical Proposal for Task Area 4, and all Appendices

PAPER

One (1) unbound SIGNED ORIGINAL.

Five (5) unbound COPIES

Not to Exceed 75

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 7

Question 15:

Attachment 14, page 1 item A.1.e refers to "immunization". This task order is a microbicide study and thus it would appear that the reference to "immunization" was carried over by accident and is thus, not relevant. Is this correct?

Response to Question 15:

Attachment 14, Sample Statement of Work for Task Order #003-8, Task Area 3:

Conduct of Studies in Nonhuman Primates: Microbicide Study, paragraph 2, Technical Requirements, paragraph A, Operationalize the Study Plan, subparagraph 1) e., is revised to replace "immunization" with "treatment" and shall be read as follows:

e. A summary of the treatment and specimen collection schedule to be conducted under the Study Plan;

An updated version of Attachment 14 is attached to this Amendment.

Question 16:

Attachments 3 and 16: Most references to the various other attachments in the RFP appear to be wrong. Thus, on page 3 of Attachment 3 the last sentence should refer to attachments 5 and 6 rather than attachments 3 and 4. In Attachment 16 it refers to sample task orders in Attachments 5 -12 when it should probably be Attachments 5 –14. It would be good to correct this to prevent confusion.

Response to Question 16:

Attachment 3, Statement of Work for Base Contract, and Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal and Table of Contents, currently include the incorrect referenced Attachment numbers. Attachments 3 and 16 have been revised to correct the referenced Attachment numbers, and updated versions are included as Attachments to this Amendment.

ELECTRONIC FILES ON CD

Five (5) Compact Disks containing an electronic copy of the Technical Proposal (including all Appendices)

Business Proposal PAPER One (1) unbound SIGNED ORIGINAL.

Five (5) unbound COPIES

ELECTRONIC FILES ON CD

Five (5) Compact Disks containing an electronic copy of the Business Proposal

N/A

Breakdown of Proposed Estimated Cost using Electronic Cost Proposal EXCEL Workbook

This Attachment to the Business Proposal should be submitted as a separate EXCEL file on the Business Proposal Compact Disk.

See Section J, Attachment entitled Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet to access the Excel Workbook.

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 8

Question 17:

For the continuation of studies in Task Order #003-01, 15 additional animals are to be purchased and quarantined. These additional animals will go through a standard quarantine before being placed on study. During this time, must we assume that the current 75 animals will continue to accumulate per diems while the additional animals are going through quarantine? OR, will the 75 animals be placed on study while we are waiting for the 15 animals to finish quarantine.

Response to Question 17:

As stated in Attachment 7, Statement of Work for Task Order #003-1, Offerors should assume that all 90 (75 + 15) animals will arrive after award of Task Order #003-1, and all costs associated with their care are to be charged to the contract.

Question 18:

Regarding Task Order #003-07: Attachment 13, Sample Statement of Work for Sample Task Order #003-7, specifies obtaining eighteen (18) SPF Indian Origin animals through purchase from an outside vendor. However, in Attachment 17 (Business Proposal Instructions for Uniform Costing p. 14), Sample Task Order for Virus Titration, it specifies that we are to assume that 3 cohorts of 6 animals will be available and shipped from NIAID at no cost. Can you please clarify whether proposal costs should include purchasing, transportation, and testing of the animals for Task Order #003-07?

Response to Question 18:

Attachment 13, Sample Statement of Work for Sample Task Order #003-7, the statement in paragraph 2, Technical Requirements, paragraph B, Obtain, quarantine, and screen nonhuman primates, subparagraph 1) is incorrect and is revised to read as follows:

1) Obtain eighteen (18) sexually mature female Specific Pathogen Free (SPF) Indian origin Rhesus Macaques (Macaca mulata). Animals will be available and shipped from NIAID at no cost.

Please see Attachment 17, Additional Business Proposal Instructions and Uniform Cost

Assumptions, subparagraph e, SAMPLE TASK ORDER for Task Area 3: Conduct of Studies in Nonhuman Primates: Virus Titration, the fourth paragraph, describes the basis upon which budgets are to be prepared. The third bullet includes a cost assumption that “Study day 0 begins once quarantine (and acclimation to the study room) is completed.

Include in your budget costs that cover the period from arrival to Study Day 0.”

Question 19:

In Attachment 17, Sample Task Order for Virus Titration, on p. 14, the assumption is given that the final six animals (third study cohort) will not be euthanized, but transferred. However, on the next page, the instructions specify, “The in-life phase will end at Study Day 180. For costing purposes only, assume that any remaining animals will be euthanized.” Please clarify whether to transfer or euthanize the last cohort?

Response to Question 19:

Attachment 17, Additional Business Proposal Instructions and Uniform Cost

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 9

Assumptions, subparagraph e, SAMPLE TASK ORDER for Task Area 3: Conduct of Studies in Nonhuman Primates: Virus Titration, the fourth paragraph, the sixth bullet, is revised to state that the last cohort will be euthanized, and shall read as follows:

For budget preparation, assume the final 6 animals will be euthanized.

Question 20:

Should quarantine costs be included for the purchase of additional animals for Task Order 2-1 under Options 7-41?

Response to Question 20:

Yes, quarantine costs should be included in the costs for Task Order 002-1 for the purchase of additional animals under Options 7-41.

Question 21:

In Attachment 16, page 2 under Task Area 2 states, “Offerors do not have to submit proposals for both of these Task Orders. If proposals are submitted for both, the proposals must be submitted as separate documents.” Does this indicate two physically separate documents or that each task order should be developed and costed separately in the proposal? Do they both count on the 150 page limit?

Response to Question 21:

Each Task Order should be costed separately and should be submitted as a separate document. Since these are part of the Business Proposal, the Task Order cost proposals do not count towards the page limitation for the Technical Proposal.

As additional guidance in regard to the submission of proposals, the following is added to Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal and Table of Contents, Table of Contents, Task Area 2, Maintenance of Nonhuman Primates:

NOTE: The Offeror’s response must address capabilities to carry out all Task Orders under Task Area 2. If an Offeror intends to carry out both Task Orders, separate cost proposals must be submitted for each Task Order.

Question 22:

Are Offerors required to submit separate technical proposals for ALL Task Orders under Task Area 3, including Task Order #s 003-1 through 003-8?

Response to Quesiton 22:

No, Offerors do not have to submit proposals for all Task Orders under Task Area 3.

However, Offerors must submit a technical proposal that addresses capabilities to carry out Sample Task Order #s 003-5 through 003-8. Attachment 17, Section 3, UNIFORM COST ASSUMPTIONS, paragraph 1, Technical Cost Assumptions, Task Area 3, Conduct of Studies in Nonhuman Primates, is hereby revised to add the following NOTE:

NOTE: The Offeror’s response must address capabilities to carry out all Task Orders under Task Area 3. Separate Technical Proposals for each Task Order are not required.

If an Offeror chooses to respond to all Task Orders under Task Area 3, separate cost proposals must be submitted for each Task Order. Offerors must submit cost proposals for each of the Sample Task Orders (003-5 through 003-8).

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 10

Question 23:

Could you define SPF? Different organizations use different levels of stringency, requiring different tests.

Response to Question 23:

SPF is defined on page 4 of Attachment 3, Statement of Work for Base Contract, Section B.3.a.

Question 24:

One of the business attachments is not available online:

http://oamp.od.nih.gov/DGS/FORMS/pointof-contact.pdf

Response to Question 24:

The URL/link that you provided above is incorrect. In the solicitation, Section J, List of

Attachments, Attachment 28, Offeror’s Point of Contact, the URL/link is correctly cited (http://oamp.od.nih.gov/DGS/FORMS/point-of-contact.pdf ).

Question 25:

Is there a deadline for submitting clarifying questions?

Response to Question 25:

We strongly suggest that all questions regarding this solicitation be submitted by no later than August 6, 2012 so that we can provide timely responses before proposals are due.

The following changes have been made to the solicitation and the revised Attachments are attached to this Amendment.

Attachment 1: Packaging and Delivery of the Proposal, is corrected to reference the revised page number limitation and include different page limits for Task Areas 1, 2 and 3 and Task Area 4 as show in the revised table.

Attachment 2: Proposal Intent Response Sheet, is revised to change the due date by which the Proposal Intent Response Sheet must be submitted (by August 6, 2012).

Attachment 3: Statement of Work for Base Contract, paragraph 5, General Requirements for Individual Task Areas, subparagraphs A., B., C., and D., are revised to reference the correct Attachment numbers.

Attachment 13, Sample Statement of Work for Sample Task Order #003-7, paragraph 2, Technical Requirements, paragraph B, subparagraph 1) is revised to correctly state that animals will be shipped at no cost.

Attachment 13, Statement of Work for Sample Task Order #003-7, Task Area 3: Conduct of Studies in Nonhuman Primates: Virus Stock Generation and in vivo Titration,” Paragraph 2, Technical Requirements, paragraph C, House, Maintain, and Conduct Studies in Nonhuman Primates, subparagraph 7), is revised to state the correct number of animals.

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 11

Attachment 14, Sample Statement of Work For Task Order #003-8, Task Area 3: Conduct of Studies in Nonhuman Primates: Microbicide Study, paragraph 2, Technical Requirements, paragraph A, subparagraph 1) e., is revised to replace "immunization" with "treatment."

Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, is revised to correctly reference Attachment numbers throughout this Attachment.

Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal and Table of Contents, under Technical Proposal - Table of Contents, Task Area 2, Maintenance of Nonhuman Primates, the following Note is added:

NOTE: The Offeror’s response must address capabilities to carry out all Task Orders under Task Area 2. If an Offeror intends to carry out both Task Orders, separate cost proposals must be submitted for each Task Order.

Attachment 16, Additional Technical Proposal Instructions, Format for Technical Proposal and Table of Contents, under Technical Proposal - Table of Contents, Task Area 3, Conduct of Studies in Nonhuman Primates, the following NOTE is added:

NOTE: The Offeror’s response must address capabilities to carry out all Task Orders under Task Area 3. Separate Technical Proposals for each Task Order are not required.

If an Offeror chooses to respond to all Task Orders under Task Area 3, separate cost proposals must be submitted for each Task Order. Offerors must submit cost proposals for each of the Sample Task Orders (003-5 through 003-8).

Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions, paragraph b. Technical Cost Assumptions for Task Orders for Task Area 2: Maintenance of Nonhuman Primates, paragraph 2, Task Order for Maintenance of 50 SPF Nonhuman Primates/year, Subparagraph A. 1) is revised to correctly state 0.05 FTEs. In addition, the following NOTE is added:

proposals must be submitted for each Task Order.

Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3 – uniform Cost assumptions, Paragraph 1. Technical Cost Assumptions, subparagraph e., Sample Task Order for Task Area 3: Conduct of Studies in Nonhuman Primates: Virus Titration, fourth paragraph, sixth bullet is revised to clarify “…assume the final 6 animal will be euthanized.”

Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3, Uniform Cost Assumptions, paragraph 1, Technical Cost Assumptions, Task Area 3, Conduct of Studies in Nonhuman Primates, is revised to indicate that the Offeror’s response must address capabilities to carry out all Task Orders under Task Area 3. Separate Technical

AMENDMENT #1, RFP NIAID‐DAIDS‐NIHAI2012138 12

Proposals for each Task Order are not required. If an Offeror chooses to respond to all Task Orders under Task Area 3, separate cost proposals must be submitted for each Task Order.

Offerors must submit cost proposals for each of the Sample Task Orders (003-5 through 003-8).

Attachment 17, Additional Business Proposal Instructions and Uniform Cost Assumptions is revised to reference the correct Attachment numbers throughout the attachment.

END OF AMENDMENT No. 1, RFP No. NIAID-DAIDS-NIHAI2012138

PACKAGING AND DELIVERY OF THE PROPOSAL ATTACHMENT 1

1 (Revised 07/20/2012)

ATTACHMENT 1: PACKAGING AND DELIVERY OF THE PROPOSAL

SIMIAN VACCINE EVALUATION UNITS (SVEUS)

RFP NIAID-DAIDS-NIHAI2012138

PAPER SUBMISSION: The paper copy is the official copy for recording timely receipt of proposals.

SUBMISSION OF PROPOSALS BY FACSIMILE OR E-MAIL IS NOT ACCEPTABLE.

A. EXTERNAL PACKAGE MARKING:

In addition to the address cited below, mark each package as follows:

"RFP NO. NIAID-DAIDS-NIHAI2012138

TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

B. PAPER COPIES and CD-Rom to:

If Hand Delivery or Express Service If using U.S. Postal Service Callie Prassinos Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20817

Callie Prassinos Contract Specialist Office of Acquisitions, DEA, NIAID, NIH 6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612

NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.

NOTE: The U.S. Postal Service's "Express Mail" does not deliver to the hand delivered (20817 zip code) address.

Any package sent to this address via this service will be held at a local post office for pick-up. THE GOVERNMENT IS NOT RESPONSIBLE FOR PICKING UP ANY MAIL AT A LOCAL POST OFFICE. If a proposal is not received at the place, date, and time specified herein, it will be considered a "late proposal," in accordance with FAR Clause 52.215-1, Instructions to Offerors – Competitive Acquisition.

C. NUMBER OF COPIES:

TOTAL PAGE COUNT DOES NOT INCLUDE: Cover/Title Page and Back Page; NIH-2043; Table of Contents; Section Dividers that do not contain information other than title of Section.

PAGES THAT ARE 2-SIDED WILL COUNT AS 2 PAGES.

FORMATTING AND LAYOUT:

Use your usual word processing and spreadsheet programs to prepare and format the technical and business proposals. If documents are submitted using Adobe .pdf, the document should be submitted using a .pdf searchable format.

Type size must be 10 to 12 points.

Type spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

Print margins must be at least one inch on each edge of the paper.

Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe).

Proposals shall NOT include links to Internet Web site addresses (URLs) or otherwise direct readers to alternate sources of information.

2 (Revised 07/20/2012)

NOTE: PAGES THAT DO NOT CONFORM TO THE ABOVE FORMATTING AND LAYOUT

SPECIFICATIONS ARE SUBJECT TO REMOVAL AND MAY NOT BE FORWARDED TO THE

REVIEWERS TO BE READ OR EVALUATED.

CREATING AND NAMING ELECTRONIC FILES:

1. A separate CD should be submitted for the Technical Proposal and Business Proposal information.

Offerors who submit both Technical and Business Proposals on the same CD will be required to resubmit them on separate CDs.

2. Files on CDs should be named using the following format:

Company name / RFP number / technical / ** /date

** if multiple files are submitted for the technical proposal, please include the name of the section in the file name.

EXAMPLE: XYX Company/07-16/Technical/Approach/3-6-06

Company name / RFP number / business / ** / date

** if multiple files are submitted for the business proposal, please include the name of the section in the file name.

EXAMPLE: XYX Company/07-16/Business/Staffing/3-6-06

THE NUMBER OF COPIES AND APPLICABLE PAGE LIMITATIONS REQUIRED OF EACH

PART OF YOUR PROPOSAL ARE AS SPECIFIED BELOW.

PAGES IN EXCESS OF THE PAGE LIMITATION WILL BE REMOVED FROM THE PROPOSAL

AND WILL NOT BE PROVIDED TO THE REVIEWERS TO BE READ OR EVALUATED.

OFFERORS MUST CERTIFY THAT THE INFORMATION IN THE PAPER AND ELECTRONIC

COPIES IS EXACTLY THE SAME.

Document Number of Copies

Page Limits

Technical Proposal for Task Areas 1, 2 and 3, and all Appendices

PAPER

One (1) unbound SIGNED ORIGINAL Five (5) unbound COPIES

ELECTRONIC FILES ON CD

Five (5) Compact Disks containing an electronic copy of the Technical Proposal (including all Appendices and Case Studies)

Not to Exceed 225

Technical Proposal for Task Area 4, and all Appendices

PAPER

One (1) unbound SIGNED ORIGINAL.

Five (5) unbound COPIES

ELECTRONIC FILES ON CD

Five (5) Compact Disks containing an electronic copy of the Technical Proposal (including all Appendices and Case Studies)

Not to Exceed 75

Business Proposal PAPER One (1) unbound SIGNED ORIGINAL.

Five (5) unbound COPIES

ELECTRONIC FILES ON CD

Five (5) Compact Disks containing an electronic copy of the Business Proposal

3 (Revised 07/20/2012)

Document Number of Copies

Page Limits

Breakdown of Proposed Estimated Cost using Electronic Cost Proposal EXCEL Workbook

This Attachment to the Business Proposal should be submitted as a separate EXCEL file on the Business Proposal Compact Disk.

See Section J, Attachment entitled Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet to access the Excel Workbook.

PROPOSAL INTENT RESPONSE SHEET 1 ATTACHMENT 2

(Revised 07/20/2012)

ATTACHMENT 2: PROPOSAL INTENT RESPONSE SHEET

CLINICAL SIMIAN VACCINE EVALUATION UNITS (SVEUS)

Please review the attached Request for Proposal. Furnish the information requested below and return this page by August 6, 2012. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

[ ] DO INTEND TO SUBMIT A PROPOSAL

[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING

REASONS:

Company/Institution Name (print): ______________________________________ Address (print): _______________________________________________________

Project Director's Name (print): ________________________________________ Title (print): _________________________________________________________ Signature/Date: ________________________________________________ Telephone Number and E-mail Address (print clearly):

*Name of individual to whom electronic proposal instructions should be sent:

Name: ___________________________________________________ Title: ___________________________________________________ E-Mail Address: __________________________________________ Telephone Number: _______________________________________

Names of Collaborating Institutions and Investigators (include Subcontractors and Consultants) (print):

(Continue list on a separate page if necessary)

RETURN VIA FAX OR E-MAIL TO:

OA, DEA, NIAID, NIH

6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, MD 20892-7612

Attn: Callie Prassinos RFP No. NIAID- DAIDS-NIHAI2012138

FAX# (301) 496-0611

Email: callie.prassinos@nih.gov

1 ATTACHMENT 3

(Revised 7/20/2012)

ATTACHMENT 3:

STATEMENT OF WORK FOR BASE CONTRACT

1. BACKGROUND AND INTRODUCTION

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS (DAIDS), has a requirement for the provision of support services for the NIAID/DAIDS preclinical research portfolio.

The development of Human Immunodeficiency Virus (HIV) vaccines and other prevention strategies relies on the use of nonhuman primates in preclinical studies to advance the development of effective HIV and AIDS prevention approaches including vaccine candidates, topical microbicides, immune-based therapies or other prevention modalities. The NIAID Simian Vaccine Evaluation Unit (SVEU) contracts provide nonhuman primate resources that primarily support preclinical evaluation of AIDS vaccines and prevention modalities. Candidates for testing are developed by a wide range of NIH supported researchers.

The most commonly used nonhuman primate species in HIV-related research are the Indian origin Rhesus macaque (Macaca mulatta). Healthy, specific pathogen-free (SPF) nonhuman primates are required for vaccine studies because the excluded pathogens could cause immunosuppression on their own or affect the immune response to vaccines and/or infection with Simian Immunodeficiency Virus (SIV). In FY 2003, due to rising costs and decreasing availability of SPF Indian origin Rhesus macaques, NIAID established a breeding colony of SPF Indian origin Rhesus macaques at one of the current SVEU contracts with Advanced BioScience Laboratories, Inc. through a subcontract with Covance, Inc. The SPF progeny from the Rhesus colony are dedicated to the support of NIAID research studies primarily conducted under the SVEUs.

The SVEUs will use state-of-the-art approaches in evaluating AIDS prevention strategies in nonhuman primate models and will incorporate new and improved techniques and technologies throughout the contract period.

The Contractor shall be required to carry out, directly or through subcontractors and/or consultants, the activities defined below for Task Areas 1, 2, and 3; 1, 2, 3, and 4; or 4 alone.

Task Area 1 - Core Activities: Administrative and Technical Support Task Area 2 - Maintenance of Nonhuman Primates

2 ATTACHMENT 3

Task Area 3 - Conduct of Studies in Nonhuman Primates Task Area 4 - Operation of a Nonhuman Primate Breeding Colony

Immediately upon award of the contract, the Government intends to award Task Orders in Task Area 1- Core Activities: Administrative Management and Technical Support, Task Area 2- Maintenance of Nonhuman Primates, Task Area 3- Conduct of Studies in Nonhuman Primates, and Task Area 4- Operation of a Nonhuman Primate Breeding Colony.

2. SCOPE

The Contractor shall provide the facilities, nonhuman primates and the scientific and technical expertise necessary to conduct: 1) pilot studies of new vaccines; 2) immunogenicity and/or efficacy studies of candidate vaccines; 3) efficacy studies of passively administered antibodies, microbicides, and other anti-virals; 4) in vivo generation of Simian-Human Immunodeficiency Virus (SHIV) and SIV challenge stocks; and 5) pilot studies of antiviral drugs and/or immunotherapy regimens.

Nonhuman primates will be provided by the Government through transfer of the animals from existing contractors, as needed.

Facilities requirements include: 1) BSL2/3 facilities (BSL2 with BSL3 practices) capable of housing from 200 to 400 nonhuman primates on Study Plans; 2) BSL2 facilities capable of housing 50 to 100 nonhuman primates not assigned to a Study Plan; and 3) facilities for housing a breeding colony of 550 SPF Indian origin Rhesus macaques.

This contract will NOT provide funds to support facility construction costs.

3. GENERAL DESCRIPTION OF TASK AREAS

A. Task Area 1 - Core Activities: Administrative and Technical Support: Under this

Task Area the Contractor shall support work that will be performed on a regular, on-going basis including (i) general administration, coordination, and management of financial and veterinary activities; (ii) project planning (iii) receipt, storage and shipment of vaccines; virus stocks; samples including cells, tissues, mucosal secretions, blood, sera, and plasma, herein referred to as study materials; (v) reporting and maintenance of data; and (vi) transition activities.

B. Task Area 2 - Maintenance of Nonhuman Primates: Under this Task Area the

Contractor shall provide support to obtain, transport, quarantine, house, care and maintain nonhuman primates.

C. Task Area 3 - Conduct of Studies in Nonhuman Primates: Under this Task Area the

Contractor shall (i) initiate Contracting Officer Representative (COR)-approved studies;

3 ATTACHMENT 3

(ii) obtain, transport, quarantine, house, care and maintain nonhuman primates; and (iii) conduct studies as described in the scope of the Task Orders.

D. Task Area 4 – Operation of a Nonhuman Primate Breeding Colony: Under this Task

Area, the Contractor shall provide support for the operation and maintenance of a SPF Indian origin Rhesus macaque (Macaca mulatta) breeding colony dedicated to the support of NIAID research studies primarily conducted under the SVEU.

4. GENERAL REQUIREMENTS FOR TASK ORDERS

The following requirements shall apply to every task order issued in each of the respective Task Areas.

A. Maintain full and continuous accreditation of nonhuman primate facilities by Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), [http://www.aaalac.org/accreditation/index.cfm], Office of Laboratory Animal Welfare (OLAW) Assurance [http://grants.nih.gov/grants/olaw/olaw.htm] and compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, including environmental enrichment [http://grants.nih.gov/grants/olaw/references/phspol.htm].

B. Maintain appropriate security measures for controlled access to nonhuman primate facilities and study materials.

C. Maintain security against unauthorized access and use of computer systems and records.

D. Maintain compliance for shipment of study materials and nonhuman primates with International Air Transport Association (IATA) Dangerous Goods Regulations for shipment by air transportation or with Department of Transportation (DOT) regulations for shipment by ground transportation (www.iata.org/ps/publications/dgr). All shipping procedures, conditions, and containers shall be appropriate for preserving study materials.

E. Maintain appropriate Biosafety Level procedures for activities defined in the Statements of Work for the Task Areas.

5. GENERAL REQUIREMENTS FOR INDIVIDUAL TASK AREAS

A. Task Area 1 - Core Activities: Administrative and Technical Support

Immediately upon award of a base contract, NIAID will issue a Task Order for this Task Area. Attachment 4 is the Task Order for this initial award and includes all general requirements.

B. Task Area 2 - Maintenance of Nonhuman Primates

1. Immediately upon award of the base contract, NIAID will issue Task Orders to provide support for transport, quarantine, housing, care and maintenance of Government-owned nonhuman primates. Attachments 5 and 6 are the Task Orders for these initial awards.

4 ATTACHMENT 3

2. All shipping costs for nonhuman primates shall be incurred by the supplier for nonhuman primates transferred within the SVEUs. Shipping costs for nonhuman primates purchased from outside vendors shall be incurred by the recipient SVEU.

3. Subsequent to the base contract award, NIAID anticipates issuing additional Task

Orders in this Task Area as needed to obtain, transport and provide for quarantine, housing, care and maintenance of nonhuman primates. Below are general requirements for Task Orders to be issued under this Task Area:

Specifically, the Contractor shall:

a. Provide support to obtain, quarantine, house, care and maintain specific pathogen free (SPF) nonhuman primates through purchase or transfer from another facility. SPF nonhuman primates shall include Rhesus macaques (Macaca mulatta) of Indian origin and may include Chinese origin macaques. All purchases or transfers from non-SVEU contracts of nonhuman primates shall require Contracting Officer authorization. For the purposes of this contract SPF is defined as free of infection with Simian immunodeficiency virus (SIV), Type D Simian Retroviruses (SRV), and Simian T-lymphotropic virus (STLV-1). SRV and STLV-1 shall be negative by PCR and serology. Additional pathogens may be added to this definition as approved and/or recommended by the COR.

Nonhuman primates obtained may also include species, such as pig-tail macaques (Macaca nemestrina), cynomolgus monkeys (Macaca fascicularis), and African green monkeys (Cercocebus atys), as specified by the COR.

1) Ascertain and record Simian Herpes B virus (Cercopithecine herpes virus-1, hereinafter referred to as B virus) infection status.

2) Provide support for repeated testing for SPF viruses and Mycobacterium tuberculosis (TB).

b. Provide support for appropriate housing, care and maintenance of nonhuman primates. Task Area 2 encompasses the following categories of housing:

1) A BSL-2 facility with BSL-3 practices (BSL 2/3), as described in Biosafety in Microbiological and Biomedical Laboratories, (BMBL), 5th edition [http://www.cdc.gov/biosafety/publications/bmbl5/] to hold nonhuman primates awaiting assignment to a Study Plan or nonhuman primates post-study awaiting re-assignment to a subsequent Study Plan.

2) A BSL-2 facility, as described in BMBL 5th edition [http://www.cdc.gov/biosafety/publications/bmbl5/[, to hold nonhuman primates awaiting assignment to a Study Plan.

c. Provide general health surveillance and health services such as sample collection, processing, and immunologic testing.

5 ATTACHMENT 3

C. Task Area 3 - Conduct of Studies in Nonhuman Primates

1. Immediately upon award of the base contract, NIAID will issue Task Orders to provide support for transport, quarantine, housing, care, maintenance and follow-up of COR approved nonhuman primate Study Plans in progress. Attachments 7-10 are the Task Orders for these initial awards. In addition, subsequent to the award of the base contract, NIAID anticipates issuing additional Task Orders for this Task Area to provide support to obtain, transport, quarantine, house, care, maintain and conduct COR approved nonhuman primate studies (Attachments 11-14).

2. All shipping costs for nonhuman primates shall be incurred by the supplier for nonhuman primates transferred within the SVEUs. Shipping costs for nonhuman primates purchased or transferred from outside sources shall be incurred by the recipient SVEU.

3. Studies under this Task Area may include:

a. immunogenicity and/or efficacy of candidate vaccines such as larger-scale studies of vaccines that have already demonstrated promise in nonhuman primates;

b. immunogenicity of candidate HIV vaccines (or immunogenicity and efficacy of SIV vaccines which parallel HIV vaccines in approach) in anticipation of Phase I human clinical trials;

c. in vivo and in vitro titrations of SIV/SHIV stocks and infection of nonhuman primates to generate and/or evaluate SIV/SHIV virus stocks;

d. route of immunization or route of infection, or other preliminary studies needed for subsequent vaccine study;

e. efficacy of passively administered antibodies, microbicides, or other anti-viral substances;

f. pilot studies of antiviral drugs and/or immunotherapy regimens;

g. pilot studies of new vaccines;

h. comparative studies of vaccines and/or adjuvants from multiple sources; and

i. studies with topically administered microbicides or other anti-virals to block infection of nonhuman primates with virus administered vaginally or by other mucosal routes.

4. Upon award of a specific Task Order in this Task Area, the Contractor shall:

a. Participate in meetings with the COR and collaborating vaccine investigators to develop and implement the Study Plan. The Study Plan shall include proposed timelines to:

1) Identify and obtain nonhuman primates for the specific study.

2) Obtain nonhuman primates through purchase or transfer from other NIAID facilities, transport and quarantine (if required for the specific study).

3) Develop an Animal Immunization and Sample Collection Schedule.

4) Prepare and submit an Institutional Animal Care and Use Committee (IACUC) protocol.

6 ATTACHMENT 3

5) Confirm IACUC approval.

6) Prepare an Animal Randomization and Study-arm Assignment Table.

7) Maintain study-specific data.

8) Plan study specific laboratory assays.

9) Provide other relevant documents as required by the Study Plan.

10) Initiate studies following COR approval.

b. As required by the Study Plan:

1) Freeze and store pre-study samples.

2) Administer immunogens, adjuvants, and/ or other study materials.

3) Collect study materials according to the Animal Immunization and Sample

Collection Schedule.

4) Process and store samples.

5) Challenge nonhuman primates with infectious virus.

6) Perform laboratory assays such as in vitro immunologic and virologic assays.

7) Perform necropsies.

8) Provide clinical, laboratory and protocol information to other researchers as identified by the COR.

c. At the end of the study:

1) Provide to the COR a complete study report, including at a minimum: a final

Animal Immunization and Sample Collection Schedule containing actual calendar dates of the study as performed, all laboratory data generated, inventory of all samples stored from the study, record of shipments made (date, number of samples, destination), account of any nonhuman primates sacrificed or that died during the study.

2) Provide/Enter study-specific data into the SVEU Vaccine Study Database.

3) Dispose of nonhuman…