Amendment_No_1.pdf

AMENDMENT #1, RFP NIHAO201800008 1

Amendment No. 1

NIAID-AMOB-NIHAO201800008

“Support for Specific Pathogen Free Indian-Origin Rhesus Macaque Colonies” Solicitation Number:

Amendment Number:

Amendment Issue Date:

NIHAO201800008

One (1)

December 13, 2018

Proposal Due Date/Time: Wednesday January 3, 2019, 10 AM Local Time (Unchanged)

Issued By: Callie Prassinos Contracting Officer

OA/DEA/NIAID/NIH/DHHS

Point of Contact PRIMARY:

Shivani.Patel@nih.gov Shivani D. Patel, Contract Specialist Phone: 240-669-5127

SECONDARY:

prassinosca@niaid.nih.gov Callie Prassinos, Contracting Officer Phone: 240-669-5155

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 include requirements for Live Vertebrate Animals

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.

mailto:Shivani.Patel@nih.gov mailto:prassinosca@niaid.nih.gov

AMENDMENT #1, RFP NIHAO201800008 2

Responses to Questions from Potential Offerors:

Question 1: If animals are positive for Salmonella, Shigella, Campy or Yersinia, are we allowed to treat and retest animals?

Response 1: Yes, that would be an acceptable approach, please provide details within your proposal.

Question 2: Are founder animals B+ or is there potential?

Response 2: No they have been tested negative for several years, any macaque harbors potential.

Question 3: Chagas-negative was not listed as a health requirement. Will a Chagas requirement be address per task order or is this not a consideration?

Response 3: Yes, Chagas as well as others such a zika, EEE, etc. Could be add to task orders awarded to geographical areas where there is a higher prevalence of these diseases.

Question 4: Is there a period of acclimation related to the following expectations. With animals transitioning in, will the mortality and conception standards be lowered slightly?

Response 4: No, all standards will be maintained as required.

Question 4a: Pg 64 of the RFP (SOW), #14 The Contractor shall not be responsible for animal deaths of less than ten percent (10%) unless the loss is due to negligence by Contractor staff or Subcontractors.

Response 4a: No, as stated in the RFP, contractors shall not be responsible for animal deaths of less than ten percent (10%).

Question 4b: Pg 72 of the RFP (TO 1 – SOW), #B-1 Use best efforts to achieve optimum reproduction, defined as equal to or greater than 75% conception rate with 70%-80% live progeny per year, from the females of 4 years of age and older that are identified, in conjunction with the COR, as breeders.

Response 4b: No, relocation timing would be thoroughly discussed with all parties to minimize to the greatest extent the impact to the health and wellbeing of the animals within the colony, transfers would not occur during the “breeding or birthing” seasons.

Question 5: Can we submit proposal / offer in Task Area 1 alone? Would that affect our qualification as offeror?

Response 5: According to our requirements under attachment 6 “ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS”, under ‘General Notes’ we request the offer to submit the Technical Proposal which responds to both Task areas. The instructions clarify that if an offer proposes to only 1 Task Area, they will not be considered for award.

AMENDMENT #1, RFP NIHAO201800008 3

Question 6: Task order 1: Do we need to have current capacity to house 1000 non-human primates at the time of the submission? Or can we still respond if we are scheduled to add capacity at a later date (March 2019)?

Response 6: The requirement in the Task Order is the capacity to house a 1000 NHPs as of June 2019. The proposal will need to have enough information regarding the available facility to determine its capability to meet the task order requirements.

Question 7: Can two separate entities partner up to jointly submit the response? E.g.

Company 1 would handle / perform Task Area 1 and Company 2 would handle / perform Task Area 2.

Response 7: Two separate companies can be responsible for different requirements in the contract. The government prefers one contractor propose as the prime and the other as the sub-contractor under one proposal.

Question 8: Is there any preference in the award for small business or HUBZone business?

Response 8: No, this is an full and open competition.

Requirements for Live Vertebrate Animals:

The Following revision are made to the RFP to include requirements for Live Vertebrate Animals

ARTICLE H.5. ANIMAL WELFARE is deleted in its entirety and revise as follows:

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can 142 CONTRACT Handbook 10/03/18 be accessed at:

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

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor's technical proposal, Section L – INSTRUCTION, CONDITION, AND NOTICES TO OFFERORS, 2. Instructions to Offerors b. Technical Proposal Instructions, is revised to incorporate 5. Research Involving Live Vertebrate Animals and will read as follows:

5. Research Involving Live Vertebrate Animals

It is intended that live vertebrate animals will be used during performance of this contract. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (authority derived from the Health Research Extension Act of 1985) specifies that certain information is required from offerors in contract proposals submitted to the NIH that will use live vertebrate animals.

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

AMENDMENT #1, RFP NIHAO201800008 4

The following criteria must be addressed in a separate section of the Technical Proposal titled "Vertebrate Animal Section" (VAS):

i. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Request for Proposal (RFP) Statement of Work. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.

ii. Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

iii. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

iv. Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.

A concise (no more than 1-2 pages), complete description addressing these criteria must be provided. The description must be cohesive and include sufficient information to allow evaluation by reviewers and NIH staff. For more discussion regarding the VAS, see NIH Guide Notice NOT-OD-16-006 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html.

471 RFP Handbook 10/03/18 The Contract Proposal VAS Worksheet is provided as an Attachment in SECTION J of this solicitation to assist in the preparation of the VAS as part of the Technical Proposal. It can be accessed at:

http://grants.nih.gov/grants/olaw/VAScontracts.pdf.

Attachment 6 – Technical Proposal Instructions, Section 7: Other Considerations, 1) Care of Live Vertebrate Animals is revise to incorporate the need for a Vertebrate Animal Section to be include in the Technical proposal:

Research Involving Live Vertebrate Animals

It is intended that live vertebrate animals will be used during performance of this Task Order. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (authority derived from the Health Research Extension Act of 1985) specifies that certain information is required from offerors in contract proposals submitted to the NIH that will use live vertebrate animals.

The following five points must be addressed in a separate section of the Technical Proposal titled "Vertebrate Animal Section" (VAS):

a. Detailed description of the proposed use of the animals, including species, strains, ages, sex and number to be used.

b. Justification for the use of animals, choice of species, and numbers to be used.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html http://grants.nih.gov/grants/olaw/VAScontracts.pdf

AMENDMENT #1, RFP NIHAO201800008 5

c. Information on the veterinary care of the animals.

d. Description of procedures for minimizing discomfort, distress, pain and injury.

e. Method of euthanasia and the reasons for the selection.

A concise (no more than 1-2 pages), complete description addressing these five points must be provided. The description must be cohesive and include sufficient information to allow evaluation by reviewers and NIH staff. For more discussion regarding the five points in the VAS, see NIH Guide Notice NOT-OD-10-049 at:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-049.html.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-049.html