Amendment 3.pdf

AMENDMENT #3, RFP NIAID‐DAIDS‐NIHAI2012138 1

AMENDMENT NO. 3

NIAID-DAIDS-NIHAI2012138

“SIMIAN VACCINE EVALUATION UNITS (SVEUS)”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

NIAID-DAIDS-NIHAI2012138

Three (3)

August 15, 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) Revise the titles and scope of Attachment 7, Statement of Work for Task Order #003-1, Attachment 8, Statement of Work for Task Order #003-2, and Attachment 9, Statement of Work for Task Order #003-3, to clarify that the scope of each Task Order is to reimmunize and challenge nonhuman primates which are separate non-severable tasks (revised Attachments 7, 8 and 9);

2) Revise Attachment 16: Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, Technical Proposal – Table of Contents section, the paragraph entitled Task Area 3, Conduct of Studies in Nonhuman Primates, to reduce the number of Task Orders to be issued upon award from 5 to 4 and to clarify that the purpose of the four Task Orders is for reimmunization and challenge studies;

3) Revise Attachment 17: Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3 – Uniform Cost Assumptions, paragraph 1, Technical Cost Assumptions, the paragraph entitled Task Area 3, Conduct of Studies in Nonhuman Primates, to reduce the number of Task Orders to be issued upon award from 5 to 4 and to clarify that the purpose of the four Task Orders is for reimmunization and challenge studies. Paragraph d, is revised to change the title to “Task Order for Reimmunization and Challenge of Nonhuman Primates”. Paragraph d.1, the title is revised to read “Task

AMENDMENT #3, RFP NIAID‐DAIDS‐NIHAI2012138 2

Order for reimmunization and challenge of animals for Protocol #P160 and #P162 Cost Assumptions”. Paragraph d.2., the title is revised to read “Task Order for reimmunization and challenge of animals for Protocol #P165 (GeoVax DNA/MVA) Cost Assumptions”. Paragraph d.3., the title is revised to read ““Task Order for reimmunization and challenge of animals for Protocol #P168 (NYVAC/ALVAC) Cost Assumptions”. Paragraph d.4., “Task Order for follow-up of animals for Protocol #P173 Cost Assumptions” is deleted in its entirety; and,

4) Delete in its entirety Attachment 10: Statement of Work for Task Order #003-4, [TASK

AREA 3: CONDUCT OF STUDIES IN NONHUMAN PRIMATES: CONTINUATION OF STUDY

#P173]. Attachment 10 will not be replaced and the remaining Attachments will not be renumbered.

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.

1 ATTACHMENT 7

(Revised 08/15/2012)

ATTACHMENT 7:

STATEMENT OF WORK FOR TASK ORDER #003-1

[TASK AREA 3: CONDUCT OF STUDIES IN NONHUMAN PRIMATES:

REIMMUNIZATION AND CHALLENGE OF NONHUMAN PRIMATES IN #P160

and #P162]

SIMIAN VACCINE EVALUATION UNITS (SVEUS)

RFP NIAID-DAIDS-NIHAI2012138

NOTE: These Task Orders will be issued and awarded immediately upon award of the base contract. NIAID anticipates issuing two (2) awards to accommodate two continuing studies of equal size.

1. SCOPE

The Contractor shall reimmunize and challenge nonhuman primates in Study #P160 and #P162.

2. TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work below.

Specifically the Contractor shall:

A. Operationalize the Study Plan:

1) Participate in meetings with the Contracting Officer’s Representative (COR) to develop the Study Plan.

2) Obtain IACUC approval for the study and provide the COR with documentation of

IACUC approval.

3) Obtain COR approval of the final Study Plan and initiate the study.

4) Maintain and update the Study Plan for ongoing and planned activities.

B. House, Maintain, and Conduct Studies in Nonhuman Primates

1) House and maintain seventy-five (75) Specific Pathogen Free (SPF) Indian origin Rhesus macaques (Macaca mulatta) in a BSL2/3 facility that were previously immunized with a candidate vaccine (vaccine #P160 or P162) and challenged with Simian Immunodeficiency Virus (SIV).

2) Obtain through purchase or transfer from another facility 15 naïve SPF Indian origin

Rhesus macaques (Macaca mulatta).

2 ATTACHMENT 7

3) Maintain routine health surveillance and environmental enrichment for nonhuman primates to include at least daily observation of the health status of each nonhuman primate, including weekends and holidays and on-call veterinary coverage of the nonhuman primate facility 24 hours a day, seven days a week. The Contractor shall notify the COR within two (2) business days when an nonhuman primate is sufficiently ill for the veterinarian to recommend euthanasia and euthanize nonhuman primates according to humane procedures approved by the Contractor’s Institutional Animal Care and Use Committee (IACUC).

4) For nonhuman primates that have died or been euthanized, provide information to the COR indicating the cause of death or decision to euthanize.

5) Coordinate with another facility and transfer nonhuman primates into or out of the facility as requested by the COR.

6) Quarantine and test nonhuman primates entering the facility for Mycobacterium

Tuberculosis (TB) and on a quarterly basis or as requested by the COR and maintain nonhuman primates in a TB-free facility. Accept only confirmed TB-negative nonhuman primates. Euthanize nonhuman primates that are confirmed positive for TB and notify the COR within two (2) business days.

7) Re-immunize (boost) nonhuman primates and challenge with SIV mac251 by the rectal route in 8 weekly exposures according to the Study Plan.

8) Challenge naïve control nonhuman primates with SIV mac251 by the rectal route in 8 weekly exposures according to the Study Plan.

9) Obtain samples from nonhuman primates including cells, tissues, mucosal secretions, blood, sera and plasma and process as specified in Contractor developed or COR provided Standard Operating Procedures (SOPs) for health surveillance and testing or shipment. Plasma load and humoral responses (from sera) shall be conducted by a separate Contractor: NIAID Core Laboratory.

10) Provide routine procedures and clinical laboratory testing including complete blood counts, parasite evaluations, bacterial culture, and serum chemistry testing and as requested by the COR additional screenings such as major histocompatibility complex (MHC) and tripartite-motif (TRIM) genotypes.

11) Maintain nonhuman primate testing and sample information including health history/status (shall include TB status, periodic weighing), treatments received, sample collection, and clinical laboratory test results for each nonhuman primate.

12) Communicate with the COR and provide health status updates and other information electronically when requested.

3 ATTACHMENT 7

13) Euthanize infected nonhuman primates as described in the Study Plan. At the termination of a study, dispose of any uninfected nonhuman primates as requested by the COR.

C. Provide support for a cost recovery program including:

1) A cost recovery program for nonhuman primates supplied by the SVEUs to research investigators or institutions may be implemented at the direction of and with the approval of the COR and Contracting Officer.

2) The COR may direct the Contractor in writing to provide nonhuman primates, with or without cost recovery from the recipient for the nonhuman primates or shipping, to non-SVEU investigators or institutions. Cost recovery for shipping shall be from the NIAID Task Order when not required from the recipient.

D. Report Study Data and Results

1) Communicate with the COR and provide study information, updates, and experimental and other information electronically when requested.

2) Provide Draft Final Study Report

3) Provide Final Study Report

E. Summarized schedule and sampling plan.

Nonhuman primates

Vaccine follow-up study

75 Rhesus macaques, 3-12 kg (plus 15 new naïve nonhuman primates)

Post-challenge follow-up Study Week 0 = first day out of quarantine (if any)

Sampling

Serum schedule

Volume = 2 ml blood for serum to be frozen Wks 4, 8, etc. (monthly until end)

Plasma schedule

Volume = 3 ml blood Wks 4, 8, etc. (monthly until end)

BOOST uninfected nonhuman primates

1.0 ml intramuscular Study Day 112

Sampling

Mucosal Schedule

Collection of rectal secretions for antibodies 4 times post-boost, prior to re-challenge

Serum schedule

Volume = 2 ml blood for serum to be frozen 5 times post-boost, prior to re-challenge

Whole blood schedule

Volume = max permitted , in heparin 5 times post-boost, prior to re-challenge

4 ATTACHMENT 7

CHALLENGE PHASE

Challenge Virus mac251 (supplied by COR) Storage -80 ⁰C Route Intrarectal, atraumatic instillation of 1.0 ml of virus dilution Delivery Study Day 224, begin 8 weekly administrations*

POST-CHALLENGE

PHASE*

Serum schedule

Volume = 2 ml blood for serum to be frozen Study Days 231, 238, then monthly through Day 370

Plasma schedule

Volume = 3 ml blood Weekly until infected, then wks +1, +2, +4, then monthly

END IN-LIFE PHASE week 53 *once a nonhuman primate is virus-positive, intrarectal exposure of that nonhuman primate ceases

[End of the Statement of Work for Task Area 3, Task Order #003-1]

5 ATTACHMENT 7

REPORTING REQUIREMENTS AND DELIVERABLES FOR TASK ORDER #003-1

[TASK AREA 3: CONDUCT OF STUDIES IN NONHUMAN PRIMATES:

REIMMUNIZATION AND CHALLENGE OF NONHUMAN PRIMATES IN STUDY #P160

and #P162]

RFP-NIAID-DAIDS-NIHAI2012138

REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one (1) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified.

A. Technical Reports

In addition to those reports required by the other terms of this Task Order, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE C.2., Reporting Requirements.

The Contractor shall submit to the Contracting Officer and to the COR technical progress reports covering the work accomplished during each reporting period. These reports are subject to technical inspection and requests for clarification by the COR. These reports shall be brief and factual and prepared in accordance with the format described below.

Format of Cover page: All reports shall include a cover page prepared in accordance with the following format:

Contract Number, Task Order Number and Project Title Period of Performance Being Reported Contractor’s Name and Address Author(s) Date of Submission Delivery Address

(1) Draft Study Report

Within 15 working days of the end of the in-life phase (i.e., Study Day 294), deliver a draft Study Report, in electronic form, to the COR for review. The contents of the Study Report are described in the Final Study Report section below.

(2) Final Study Report Within 30 working days of the end of the in-life phase, the Contractor shall submit an electronic version; One (1) copy shall be submitted to the COR and one (1) to the Contracting Officer. The report shall be factual and concise and consist of the following:

(a) The Final Approved Study Plan

(b) Documentation of IACUC and COR approval

(c) A narrative description of the study

6 ATTACHMENT 7

(d) Background information and description of the nonhuman primates and previous immunization and challenge history.

(e) Summary of the results from the study and disposition of nonhuman primates.

(f) A Table of any remaining nonhuman primate samples from the study

(g) List of nonhuman primates on study, listed by animal number and study group, showing vaccine received, virus used for challenge, and outcome of challenge.

(h) Virus load data for each infected nonhuman primate (copies/ml vs. Study Day) should be placed in an Appendix.

B. Other Reports and Deliverables

In addition, the following reports will be required:

Invention Report Requirement Source Code and Object Code IT Systems Security Reports

C. The following are the addresses to which reports should be submitted:

Contracting Officer’s Representative:

Contracting Officer’s Representative

PRDB, VPRP, DAIDS, NIAID, NIH, DHHS

6700-B Rockledge Drive Bethesda, MD 20892-7624

Contracting Officer:

Contracting Officer Office of Acquisitions

DEA, NIAID, NIH, DHHS

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

C. SECTION D - PACKAGING, MARKING, AND SHIPPING

Cannot be determined at this time Temperature controlled environment is required Shipments will be time sensitive/time critical International shipping will apply Shipping insurance is required Hazardous Materials shipping is applicable Other (list as necessary) ________________________ N/A to this solicitation

1 ATTACHMENT 8

ATTACHMENT 8:

STATEMENT OF WORK FOR TASK ORDER #003-2

REIMUNIZATION AND CHALLENGE OF NONHUMAN PRIMATES INSTUDY #P165]

NOTE: This Task Order will be issued and awarded immediately upon award of the base contract. NIAID anticipates issuing one (1) award.

The Contractor shall reimmunize and challenge nonhuman primates in Study #P165.

necessary services, qualified personnel, materials, equipment and facilities, not otherwise

2) Obtain IACUC approval for the study and provide the COR with documentation of

IACUC approval.

1) House and maintain sixty (60) Specific Pathogen Free (SPF) Indian origin Rhesus macaques (Macaca mulatta) in a BSL2/3 facility that were previously immunized with a candidate vaccine (vaccine #P165) and challenged with SIV.

2) Obtain through purchase or transfer from another facility 20 naïve SPF free Indian origin Rhesus macaques (Macaca mulatta).

3) Maintain routine health surveillance and environmental enrichment for nonhuman primates to include at least daily observation of the health status of each nonhuman primate, including weekends and holidays and on-call veterinary coverage of the nonhuman primate facility 24 hours a day, seven days a week. The Contractor shall notify the COR within two (2) business days when an nonhuman primate is

2 ATTACHMENT 8

sufficiently ill for the veterinarian to recommend euthanasia and euthanize nonhuman

5) Coordinate with another facility and transfer nonhuman primates into or out of the facility as requested by the COR.

6) Quarantine and test of nonhuman primates entering the facility for Mycobacterium Tuberculosis (TB) and on a quarterly basis or as requested by the COR and maintain nonhuman primates in a TB-free facility. Accept only confirmed TB-negative

8) Challenge naïve control nonhuman primates with SIV mac251 by the rectal route in 8 weekly exposures according to the Study Plan.

9) Obtain samples from nonhuman primates including cells, tissues, mucosal secretions, blood, sera and plasma and process as specified in Contractor developed or COR provided Standard Operating Procedures (SOPs) for health surveillance and testing or shipment. Plasma load and humoral responses (from sera) shall be conducted by a separate Contractor: NIAID Core Laboratory.

complex (MHC) and tripartite-motif (TRIM) genotypes.

3 ATTACHMENT 8

C. Provide support for a cost recovery program including:

1) A cost recovery program for nonhuman primates supplied by the SVEUs to research

Nonhuman primates

Vaccine follow-up study

60 Rhesus macaques, 3-12 kg (plus 20 new naïve nonhuman primates)

Post-challenge follow-up Study Week 0 = first day out of quarantine (if any)

Sampling

Serum schedule

Volume = 2 ml blood for serum to be frozen Wks 4, 8, etc. (monthly until end)

Plasma schedule

Volume = 3 ml blood Wks 4, 8, etc. (monthly until end)

BOOST uninfected nonhuman primates

Mucosal Schedule

Collection of rectal secretions for antibodies 4 times post-boost, prior to re-challenge

Serum schedule

Volume = 2 ml blood for serum to be frozen 5 times post-boost, prior to re-challenge

Whole blood schedule

Volume = max permitted , in heparin 5 times post-boost, prior to re-challenge

CHALLENGE PHASE

Challenge Virus mac251 (supplied by COR) Storage -80 ⁰C Route Intrarectal, atraumatic instillation of 1.0 ml of virus dilution Delivery Study Day 224, begin 8 weekly administrations*

4 ATTACHMENT 8

schedule

Volume = 2 ml blood for serum to be frozen day 231, 238, then monthly through day 370

Plasma schedule

Volume = 3 ml blood Weekly until infected, then wks +1, +2, +4, then monthly

END IN-LIFE PHASE week 53

[End of the Statement of Work for Task Area 3, Task Order #003-2]

5 ATTACHMENT 8

REPORTING REQUIREMENTS AND DELIVERABLES FOR TASK ORDER #003-2

REIMUNIZATION AND CHALLENGE OF NONHUMAN PRIMATES INSTUDY #P165]

REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one (1) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified.

A. Technical Reports

In addition to those reports required by the other terms of this Task Order, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE C.2., Reporting Requirements.

The Contractor shall submit to the Contracting Officer and to the COR technical progress reports covering the work accomplished during each reporting period. These reports are subject to technical inspection and requests for clarification by the COR. These reports shall be brief and factual and prepared in accordance with the format described below.

Format of Cover page: All reports shall include a cover page prepared in accordance with the following format:

Contract Number, Task Order Number and Project Title Period of Performance Being Reported Contractor’s Name and Address Author(s) draft Study Report, in electronic form, to the COR for review. The contents of the Study Report are described in the Final Study Report section below.

(2) Final Study Report

Within 30 working days of the end of the in-life phase, the Contractor shall submit two (2) copies of Final Study Report as described below. One (1) electronic copy shall be submitted to the COR and one (1) electronic copy to the Contracting Officer. The report shall be factual and concise and consist of the following:

(a) The Final Approved Study Plan

(b) Documentation of IACUC and COR approval

(c) A narrative description of the study

(d) Background information and description of the nonhuman primates and previous immunization and challenge history.

6 ATTACHMENT 8

(e) Summary of the results from the study and disposition of nonhuman primates.

(f) A Table of any remaining nonhuman primate samples from the study

(g) List of nonhuman primates on study, listed by animal number and study group, showing vaccine received, virus used for challenge, and outcome of challenge

(h) Virus load data for each infected nonhuman primate (copies/ml vs. Study Day) should be placed in an Appendix.

B. Other Reports and Deliverables In addition, the following reports will be required:

Invention Report Requirement

Contracting Officer’s Representative

PRDB, VPRP, DAIDS, NIAID, NIH, DHHS

6700-B Rockledge Drive Bethesda, MD 20892-7624

Contracting Officer:

Contracting Officer Office of Acquisitions

DEA, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214, MSC7612

D. SECTION D - PACKAGING, MARKING, AND SHIPPING

Temperature controlled environment is required Shipments will be time sensitive/time critical International shipping will apply Shipping insurance is required Hazardous Materials shipping is applicable

1 ATTACHMENT 9

ATTACHMENT 9:

STATEMENT OF WORK FOR TASK ORDER #003-3

REIMMUNIZATION AND CHALLENGE OF NONHUMAN PRIMATES INSTUDY #P168]

NOTE: This Task Order will be issued and awarded immediately upon award of the base contract. NIAID anticipates issuing one (1) award.

The Contractor shall reimmunize and challenge nonhuman primates in Study #P165.

necessary services, qualified personnel, materials, equipment and facilities, not otherwise

2) Obtain IACUC approval for the study and provide the COR with documentation of

IACUC approval.

1) House and maintain forty-five (45) Specific Pathogen Free (SPF) Indian origin Rhesus Macaques (Macaca mulatta) in a BSL2/3 facility that were previously immunized with a candidate vaccine (vaccine #P168) and challenged with SIV.

2) Obtain through purchase or transfer from another facility fifteen (15) naïve SPF free

Indian origin Rhesus Macaques (Macaca mulatta).

3) Maintain routine health surveillance and environmental enrichment for nonhuman primates to include at least daily observation of the health status of each nonhuman primate, including weekends and holidays and on-call veterinary coverage of the nonhuman primate facility 24 hours a day, seven days a week. The Contractor shall

2 ATTACHMENT 9

notify the COR within two (2) business days when an nonhuman primate is sufficiently ill for the veterinarian to recommend euthanasia and euthanize nonhuman

5) Coordinate with another facility and transfer nonhuman primates into or out of the facility as requested by the COR.

6) Quarantine and test nonhuman primates entering the facility for Mycobacterium

Tuberculosis (TB) and on a quarterly basis or as requested by the COR and maintain nonhuman primates in a TB-free facility. Accept only confirmed TB-negative

8) Challenge naïve control nonhuman primates with SIV mac251 by the rectal route in 8 weekly exposures according to the Study Plan

9) Obtain samples from nonhuman primates including cells, tissues, mucosal secretions (rectal), blood, sera and plasma and process as specified in Contractor developed or COR provided Standard Operating Procedures (SOPs) for health surveillance and testing or shipment. Plasma load and humoral responses (from sera) shall be conducted by a separate Contractor: NIAID Core Laboratory.

complex (MHC) and tripartite-motif (TRIM) genotypes).

3 ATTACHMENT 9

C. Provide support for a cost recovery program including:

1) A cost recovery program for nonhuman primates supplied by the SVEUs to research

Animals Vaccine follow-up study

45 Rhesus macaques, 3-12 kg (plus 15 new naïve animals)

Post-challenge follow-up Study Week 0 = first day out of quarantine (if any)

Sampling

Serum Schedule

Volume = 2 ml blood for serum to be frozen Wks 4, 8, etc. (monthly until end)

Plasma Schedule

Volume = 3 ml blood Wks 4, 8, etc. (monthly until end)

BOOST uninfected animals

Mucosal Schedule

Collection of rectal secretions for antibodies 4 times post-boost, prior to re-challenge

Serum Schedule

Volume = 2 ml blood for serum to be frozen 5 times post-boost, prior to re-challenge

Whole blood Schedule

Volume = max permitted , in heparin 5 times post-boost, prior to re-challenge

CHALLENGE PHASE

Challenge Virus mac251 (supplied by COR) Storage -80 ⁰C Route Intrarectal, atraumatic instillation of 1.0 ml of virus dilution Delivery Study Day 224, begin 8 weekly administrations*

4 ATTACHMENT 9

Schedule

Volume = 2 ml blood for serum to be frozen day 231, 238, then monthly through day 370

Plasma Schedule

Volume = 3 ml blood Weekly until infected, then wks +1, +2, +4, then monthly

END IN-LIFE PHASE week 53

[End of the Statement of Work for Task Area 3, Task Order #003-3]

5 ATTACHMENT 9

REPORTING REQUIREMENTS AND DELIVERABLES FOR TASK ORDER #003-3

REIMMUNIZATION AND CHALLENGE OF NONHUMAN PRIMATES INSTUDY #P168]

REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one (1) hardcopy of each report shall be submitted to the Contracting Officer, unless otherwise specified.

A. Technical Reports

In addition to those reports required by the other terms of this Task Order, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE C.2., Reporting Requirements.

The Contractor shall submit to the Contracting Officer and to the COR technical progress reports covering the work accomplished during each reporting period. These reports are subject to technical inspection and requests for clarification by the COR. These reports shall be brief and factual and prepared in accordance with the format described below.

Format of Cover page: All reports shall include a cover page prepared in accordance with the following format:

Contract Number, Task Order Number and Project Title Period of Performance Being Reported Contractor’s Name and Address Author(s) draft Study Report, in electronic form, to the COR for review. The contents of the Study Report are described in the Final Study Report section below.

(2) Final Study Report

Within 30 working days of the end of the in-life phase, the Contractor shall submit two (2) copies of a Final Study Report as described. One (1) electronic copy shall be submitted to the COR and one (1) electronic copy to the Contracting Officer. The report shall be factual and concise and consist of the following:

a) The Final Approved Study Plan

b) Documentation of IACUC and COR approval

c) A narrative description of the study

6 ATTACHMENT 9

d) Background information and description of the nonhuman primates and previous immunization and challenge history.

e) Summary of the results from the study and disposition of nonhuman primates.

f) A Table of any remaining nonhuman primate samples from the study

g) List of nonhuman primates on study, listed by animal number and study group, showing vaccine received, virus used for challenge, and outcome of challenge

h) Virus load data for each infected nonhuman primate (copies/ml vs. Study Day) should be placed in an Appendix.

B. Other Reports and Deliverables In addition, the following reports will be required:

Invention Report Requirement

Contracting Officer’s Representative

PRDB, VPRP, DAIDS, NIAID, NIH, DHHS

6700-B Rockledge Drive Bethesda, MD 20892-7624

Contracting Officer:

Contracting Officer Office of Acquisitions

DEA, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612

D. SECTION D - PACKAGING, MARKING, AND SHIPPING

Temperature controlled environment is required Shipments will be time sensitive/time critical International shipping will apply Shipping insurance is required Hazardous Materials shipping is applicable

1 ATTACHMENT 16

ATTACHMENT 16: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS, FORMAT

FOR TECHNICAL PROPOSAL, AND TABLE OF CONTENTS

SIMIAN VACCINE EVALUATION UNITS (SVEUs)

It is strongly recommended that offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

These additional Technical Proposal instructions reflect the requirements of the RFP and provide specific instructions and formatting for the Technical Proposal. While Section L.2.b. of the RFP provides a generic set of Technical Proposal instructions applicable to all NIH R&D solicitations, these instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used to format and prepare the Technical Proposal, and should be used as a Table of Contents for your Technical Proposal.

Offerors should follow the instructions in Section L of the solicitation, and include the information requested here.

Offerors are advised to give careful consideration to the Statement of Work for the base contract and Task Orders, all reference materials, and attachments, the Technical Evaluation Criteria in Section M, and the RFP as a whole in the development of their Technical Proposals.

Offerors proposing subcontracts to perform portions of the Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors, and the expected advantages of such an approach.

Offerors must refer to the RFP Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, formatting and layout of proposals, and prohibits the offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

Please note that offerors may submit proposals for Task Areas 1, 2, and 3, for Task Areas 1, 2, 3 and 4 or for Task Area 4 alone. The proposal submitted for Task Areas 1, 2, and 3 must be separate from the proposal for Task Area 4.

NIAID anticipates issuing Indefinite Delivery/Indefinite Quantity contracts as a result of this RFP.

Offerors must be capable of carrying out Task Orders in all three Task Areas including Task Area 1- Core Activities: Administrative and Technical Support, Task Area 2- Maintenance of Nonhuman Primates, and Task Area 3: Conduct of Studies in Nonhuman Primates. However, all offerors do not have to possess the capabilities to respond to the Task Order for the Breeding Colony to be issued under Task Area 4.

2 ATTACHMENT 16

Immediately upon award of the base 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.

Task Area 1, Core Activities: Administrative and Technical Support:

Up to three (3) Task Orders will be awarded as term/level of effort type contracts for a period of 1 year with options to extend the term of the Task Order on an annual basis for a maximum period of performance of 7 years. It is anticipated that up to 3 Task Orders will be issued to up to 3 separate contractors. The performance requirement will be the delivery of 1.30 full time equivalents per year.

Task Area 2, Maintenance of Nonhuman primates:

Up to three (3) Task Orders will be issued for maintenance of 20 nonhuman primates in BSL2/3 facilities. These Task Orders will be awarded as severable term form task orders including a performance requirement for delivery of 0.27 full time equivalents (FTEs) plus 7,300 nonhuman primate days (20 nonhuman primates for 365 days) per Task Order per year. The Task Orders will be awarded for a 1 year period with options to extend the period of the Task Orders annually for a maximum performance period of 7 years. In addition, options to purchase additional nonhuman primates when existing nonhuman primates supported by this Task are used for studies conducted under Task Area 3 will be included in the Task Order. The purpose of the Options is to replenish the number of nonhuman primates in order to keep availability of the nonhuman primates at 20 on a continual basis. If an option is exercised, the contractor shall be required to purchase five (5) nonhuman primates. These options may be exercised up to five (5) times per year. It is anticipated that up to 3 Task Orders will be issued to up to 3 separate contractors.

One (1) Task Order will be issued for maintenance of 50 nonhuman primates in a BSL2 facility. This Task Order will be awarded as severable term form task order including a performance requirement for delivery of 0.05 FTE plus 18,250 nonhuman primate days (50 nonhuman primates for 365 days) per year. The Task Order will be awarded for a 1 year period with options to extend the period of the Task Order annually for a maximum performance period of 3 years. It is anticipated that 1 Task Order will be issued to 1 contractor.

Future Task Orders will be issued as the need for maintenance of additional nonhuman primates arises.

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.

Task Area 3, Conduct of Studies in Nonhuman Primates Four (4) Task Orders will be awarded for reimmunization and challenge studies in nonhuman primates. These Task Orders will be awarded as nonseverable completion form task orders including a performance requirement for completion of the reimmunization and challenge and submission of a final study report. These studies will have a period of performance of approximately 6 to 12 months each and will be fully

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funded at initiation. It is anticipated that 4 Task Orders will be issued to up to 3 separate contractors.

In addition, it is anticipated that six (6) to twelve (12) Task Orders will be issued per year for Task Area 3, Conduct of Studies in Nonhuman Primates, as nonseverable completion form task orders with a performance requirement for completion of studies and delivery of a final study report.

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).

Task Area 4, Operation of a Nonhuman Primate Breeding Colony One (1) Task Order will be issued to provide support for appropriate housing, care and maintenance of 550 SPF nonhuman primates per year including breeding harems to achieve a production rate of 60-100 live births per year. This Task Order will be awarded as a severable term form task order including a performance requirement for delivery of 0.50 FTEs and 200,750 nonhuman primate days per year (550 nonhuman primates for 365 days). The Task Order will be awarded for a 1 year period with options to extend the period of the Task Order annually for a maximum performance period of 7 years. It is anticipated that 1 Task Order will be issued to 1 contractor.

SECTION 1:

A. PROPOSAL TITLE PAGE Include RFP title and number, name of organization, DUNS number, and identify if the proposal is an original or a copy.

B. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

C. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043)

D. TABLE OF CONTENTS

SECTION 2: TECHNICAL PROPOSAL OVERVIEW

Provide a brief overview of the Technical Proposal, including the following:

A. A brief description of the activities to be performed by the Offeror and all proposed subcontractors, including identification of all proposed subcontractors and a list of key personnel for the Offeror and the proposed subcontractors with degrees, titles and role in the project.

B. By area of expertise, provide the total number of staff, the number available to be assigned to the contract for the Offeror and all proposed subcontractors, and total number of additional staff to be hired and trained.

C. A brief description of the facilities and equipment to be made available by the Offeror and all proposed subcontractors.

SECTION 3: TECHNICAL PLAN

In addition to the information provided in Section L, offerors should demonstrate their capabilities to fulfill the activities specified in Task Areas 1, 2, and 3 indicated in the Statements of Work (SOW) and/or Task Area 4, if applicable.

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The capability of the Offeror to fulfill the requirements of the Task Area SOWs will be assessed based on the Offeror’s response to the Task Orders and sample Task Orders (listed in attachments 3-15). The Technical Plan should be sufficiently organized to clearly identify the specific responses to each of the Task Areas and Task Orders or sample Task Orders within that area. Responses to the Task Orders and sample Task Orders should be well integrated; any area that is not relevant or applicable to the proposed effort should not be included and likewise, in those cases where an effort has already been described for a previous Task Order or sample Task Order, it is not necessary to repeat all of the information for a subsequent Task Order or sample Task Order response. The responses should be organized by Task Area, as indicated below:

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

A. Administrative and scientific management of Task Order activities

1. Describe in detail the proposed processes and procedures for coordination, oversight, planning, implementation and management of Task Order activities and integration of personnel and resources needed including conduct of multiple activities and studies such as the ones to be conducted in the Task Orders issued under the base contract.

2. Describe the processes that will be used for the general management and oversight of the veterinary services to be provided for the nonhuman primate facility and of the nonhuman primates in Task Orders issued under the base contract.

3. Describe the processes and systems in place to track activities and maintain up-to-date records of nonhuman primates.

4. Provide plans for the process and procedures followed for a cost recovery program of nonhuman primates.

5. Describe the procedures in place for providing oversight of subcontractor activities.

6. Provide a description of the responsibilities and level of effort for all personnel broken out by category, who will be assigned to this Task Order.

7. Provide an organization chart indicating clear lines or authority and responsibility for all proposed personnel.

B. SVEU Vaccine Study Database Support: Transfer and Entry of Study Plans, Information, and Data into the SVEU Vaccine Study Database The SVEU Vaccine Study Database is an Oracle-based database, maintained by a separate NIAID contractor and accessed by the internet via a website that is password protected. The Database shall be used to centralize data collection for the studies conducted under this Task Order and as a source of information to monitor study progress.

1. 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.

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C. Receipt, Storage and Shipment of study materials

1. Describe the proposed plans and procedures for the receipt, storage, packaging, and shipping of vaccines, study samples, virus stocks, and other study-related materials as described in the SOW.

2. Describe procedures for shipment of biohazardous material (virus stocks and blood and other samples from SIV- or SHIV-infected nonhuman primates).

3. Describe storage capabilities, including freezer and liquid nitrogen facilities, and monitoring and security systems in place.

D. Transition 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.

E. Personnel Provide a staffing plan and describe all relevant information to document individual training, education, experience, qualifications and expertise necessary for the successful completion of the SOW for the Administrative and Technical Support Core Activities.

Clearly identify who is to be assigned as Key Personnel. Limit CVs to 2-3 pages and provide selected references for publications relevant to the scope of the RFP, and include experience with projects of similar scope, size and complexity carried out by the offeror and any proposed subcontractors over the past 5 years.

1. Principal Investigator (PI): include experience and qualifications of the PI to plan, manage, and direct the activities to be carried out under this Task Order including experience managing contracts with similar scope and complexity.

2. Scientific and Technical Personnel: include experience and expertise with respect to conduct of the aspects of the SOW.

3. Veterinary and nonhuman primate facility staff: include experience, training and qualifications of the veterinarian and nonhuman primate facility staff to plan, manage, and direct the activities to be carried out under this Task Order including experience managing contracts with similar scope and complexity.

4. Administrative and financial staff: include experience and expertise with respect to

F. Facilities

1. Provide the location, features, and the availability of facilities, equipment, and other resources necessary for the conduct of this project. Include the floor plan of the proposed facility and list equipment resources necessary for the conduct of the project. Confirm that the facility will be available at the time of Task Order award and during the performance of the Task Order.

2. Describe plans and procedures to be utilized for compliance with all safety guidelines and regulations related to the conduct of activities under this Task Order.

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II. Task Area 2, Maintenance of Nonhuman Primates

A. Transfer, Acquisition, Care, Maintenance, and Testing of Nonhuman Primates.

1. Provide a description of experience coordinating with other facilities for transfer of nonhuman primates into your facility.

2. Discuss your procedures for identifying and obtaining nonhuman primates through transfer or purchase from outside sources. Describe and document your past experience in obtaining nonhuman primates from the proposed sources. If you propose to acquire nonhuman primates from your own facility, provide a description of the process for transferring nonhuman primates onto the SVEU.

3. Discuss the macaque species available to you and your experience with these species. Primary emphasis will be on Rhesus macaques (Macaca mulatta) of Indian origin. However, SVEUs may be requested to house and conduct studies utilizing Chinese origin Rhesus macaques or other nonhuman primate species as described in the SOW. Indicate which species of nonhuman primates you will have access to and describe your experience in housing the various nonhuman primate species.

Discuss plans for, and any relevant issues associated with, housing more than one macaque species concurrently in your facility.

4. Describe procedures and facilities for quarantine and routine testing of the nonhuman primates as they arrive at your facility

5. Describe procedures used to obtain and provide nonhuman primates that are Specific Pathogen Free (SPF) defined as free of infection with Simian immunodeficiency virus (SIV), Type D Simian Retroviruses (SRV), and Simian T-lymphotropic virus (STLV-1). Provide your procedures for requiring virus testing of nonhuman primates before purchase and receipt and for repeat testing once the nonhuman primates are received in your facility to ensure that the nonhuman primates are free of these infections. Provide similar information on your testing procedures for assuring that the nonhuman primates are free of tuberculosis.

6. Describe your nonhuman primate husbandry practices, environmental enrichment procedures, standard procedures for health surveillance and routine clinical care of nonhuman primates, procedures for taking blood samples for clinical and testing purposes, performance of surgical procedures and post mortems, criteria for recommending euthanasia, and procedures for euthanasia as described in the Task Order Statements of Work.

7. Provide a description of and relevant documentation for your facility procedures, including biocontainment procedures as appropriate for the SOW, for the housing and care of nonhuman primates under both BSL2 and BSL2/3.

8. Provide plans for maintaining 20 nonhuman primates in BSL2/3 housing and 50 nonhuman primates in BSL2 housing and accommodating multiple concurrent Task Orders should the maximum capacity of 200-400 nonhuman primates in BSL2/3 housing and 50-100 nonhumans in BSL2 be required.

9. Include a description of your experience using off-site holding facilities for nonhuman primates until the initiation of a study plan and coordination/transport to on-site facilities.

10. Provide documentation of Office of Laboratory Animal Welfare (OLAW) assurance and your assurance number, documentation of Association for the Assessment and Accreditation of Laboratory Nonhuman primate Care (AAALAC) accreditation, and information about the composition, expertise, experience, and regulations of your organization’s Institutional Nonhuman Primate Care and Use Committee (IACUC

11. Describe procedures in place to provide compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Nonhuman Primates as described at

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http://grants1.nih.gov/grants/olaw/references/phspol.htm.

12. Describe procedures for provision of (on-call) veterinary coverage of the nonhuman primate facility 24 hours a day, seven days a week, and for provision for at least daily observation of the health status of each nonhuman primate, including weekends and holidays.

B. Personnel training, education, experience, qualifications and expertise necessary for the successful completion of the SOWs for Task Area 2: Maintenance of Nonhuman Primates. Clearly identify who is to be assigned as Key Personnel. Limit CVs to 2-3 pages and provide selected references for publications relevant to the scope of the RFP, and include experience with projects of similar scope, size and complexity carried out by the offeror and any proposed subcontractors over the past 5 years.

2. Scientific staff and technical laboratory personnel: include experience and expertise with respect to conduct of the relevant aspects of the SOW

3. Veterinary and nonhuman primate facility staff: include experience, training and qualifications of the veterinarian and nonhuman primate facility staff to plan, manage,

4. Nonhuman primate technician and nonhuman primate care staff: include experience and expertise with respect to conduct of the relevant aspects of the SOW.

C. Facilities

a. Describe available facilities including BSL2 and BSL2/3 housing for nonhuman primates required as described in the Task Order SOWs.

b. Provide the location, feature, and the availability of facilities, equipment, and other resources necessary for the conduct of this project. Include, as appropriate, the floor plan of the proposed facility and list equipment resources necessary for the conduct of the project. Confirm that the facility will be available at the time of Task Order award and during the performance of the Task Order.

c. Describe the facility security system and procedures to prevent unauthorized entry into the nonhuman primate care facility.

III. Task Area 3, Conduct of Studies in Nonhuman Primates These instructions apply to Task Orders and Sample Task Orders contained in Attachments 7-14:

A. Operationalization of Study Plans

1. Provide relevant documentation of your experience in development/design of Study Plans for :

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a. Monitoring of nonhuman primates from an ongoing vaccine studies

(efficacy and/or immunogenicity);

b. SIV, SHIV, or HIV vaccine studies (efficacy) in nonhuman primates;

c. Evaluation of the immunogenicity SIV, SHIV, or HIV vaccines in nonhuman primates;

d. In vivo titrations of virus challenge stocks;

e. Microbicide studies in nonhuman primates; and

f. Other relevant studies described in the Task Order SOWs.

2. Describe your experience in coordinating and conducting nonhuman primate studies, including multiple ongoing studies at one time as described in Task Order SOWs.

3. Describe your experience in collaborating with investigators in the design and conduct of Study Plans.

B. Conduct Studies in Nonhuman Primates

1. Discuss your procedures for, and experience with, the conduct of vaccine efficacy studies, immunogenicity studies, in vivo virus titrations, route of immunization/route of infection studies, microbicide studies, generation of virus stocks, antiviral therapy, and immunotherapy studies in nonhuman primates, including:

a. immunization by various routes (e.g. intramuscular, subcutaneous, intranasal, electroporation);

b. application of microbicides or other antiviral agents (e.g. vaginal administration);

c. sample collection (e.g. whole blood, serum, and plasma samples, mucosal tissue and secretions, biopsies, BAL); and

d. virus challenges by various routes (e.g. repetitive intrarectal, intravaginal, intravenous).

When discussing procedures for and experience with the conduct of studies, offerors should respond with attention to the elements of the relevant Task Order and sample Task Order SOWs provided in Attachments 7-14.

2. Provide a description of and relevant documentation for your facility BSL2/3 biocontainment procedures for the housing and care of SIV-infected nonhuman primates. Provide descriptions of biocontainment procedures and safety precautions to be observed during virus inoculation, blood and tissue collection, transfer of biohazardous samples for storage or shipment, disposal of biohazard waste, etc.

3. Provide descriptions of procedures for clinical and monitoring of virus-infected (including SIV/SHIV) nonhuman primates in the studies. Provide a description of criteria for euthanasia.

4. Provide a description of your procedures for obtaining and processing blood samples and obtaining and freezing plasma samples for shipping for assessment of plasma levels of viral RNA, using the nucleic acid sequence based amplification (NASBA) assay.

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5. Describe your methods for determining major histocompatibility complex (MHC) and tripartite-motif (TRIM) genotypes.

6. Describe methods and experience with expanding SHIV on primary Rhesus macaque cells.

7. Describe the aliquot scheme, freezing and storage procedures for optimally archiving a challenge virus stock that will be used for multiple years by multiple investigators.

8. Describe methods and experience with, determining TCID50 on…