Amendment__8_RFP-NIAID-DMID-NIHAI2016059.pdf

RFP-NIAID-DMID-NIHAI2016059 Page 1 of 3

AMENDMENT #8

RFP-NIAID-DMID-NIHAI2016059

“PRE-CLINICAL MODELS OF INFECTIOUS DISEASES”

AMENDMENT No. 8

This Amendment provides notification of the replacement of language in Section L.2.b.5. Research Involving Live Vertebrate Animals and Section M.3. Live Vertebrate Animals Evaluation.

Amendment Number: Eight (8)

Amendment Issue Date: July 06, 2016

Proposal Due Date: Wednesday, July 13, 2016 5:00 PM EST

(UNCHANGED)

Issued By:

Brian A. Madgey

Contracting Officer Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane, Room 3D47

MSC 9821

Rockville, Maryland 20852-9821

Point of Contact:

Brian Madgey., Contracting Officer

Email: madgeyba@mail.nih.gov.

Offerors must acknowledge receipt of the final posting of Amendment #8, on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals HAS NOT been extended.

THE CUTOFF DATE FOR QUESTIONS IS JULY 6, 2016.

SECTION L.2.b.5 Research Involving Live Vertebrate Animals, is hereby revised and shall 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 mailto:madgeyba@mail.nih.gov.

RFP-NIAID-DMID-NIHAI2016059 Page 2 of 3 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 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-10-006 at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html.

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 .

Section M.3. Live Vertebrate Animals Evaluation, is hereby revised and shall read as follows:

3. LIVE VERTEBRATE ANIMALS EVALUATION

The offerors proposal must include, as a separate section of the Technical Proposal titled "Vertebrate Animal Section," (VAS) a complete, concise (no more than 1-2 pages) description addressing the following criteria. (See NIH Guide Notice NOT-OD-16-006 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html ):

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

RFP-NIAID-DMID-NIHAI2016059 Page 3 of 3 animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.

b. 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).

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

d. 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.

As part of the overall technical evaluation of proposals, the reviewers will consider the acceptability of the offeror's description in the VAS of the technical proposal. The discussion of all criteria will be addressed and evaluated. Based on the evaluation of this Section, the VAS may be rated "unacceptable" (i.e., concerns are identified as to the adequacy of the description addressing each of the criteria, or no discussion can be found regarding the VAS), or "acceptable." If the reviewers find that this Section of the technical proposal is "unacceptable" they will provide a narrative supporting their findings.

If the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to address the concerns raised by reviewers. You will be able to further discuss and/or clarify your position until submission of your Final Proposal Revision (FPR). Once discussions are closed with the submission of your FPR, if your proposed description under the VAS is still found to be unacceptable, then your proposal may not be considered further for award.

ALL OTHER TERMS AND CONDITIONS OF THE RFP REMAIN UNCHANGED