Amendment 2_Questions and Responses_5.31.2024.pdf

SOLICITATION QUESTIONS AND GOVERNMENT RESPONSES

May 17, 2024

QUESTION 1: In section M - Evaluation Factors for award there is a pass/fail table. Under part D, GLP compliance it states that we must provide the most recent FDA GLP inspection of our lab. We are capable of GLP work, and have completed GLP PK studies for other clients, but we have not been audited by the FDA. Is this going to prevent us from any possible award for this opportunity?

GOVERNMENT RESPONSE: If no audit has been conducted, please just state that no audit has been conducted. The offerors should understand that if an audit is conducted while on an NIH contract, a copy of the inspection report must be provided to NIH. The offerors should provide details on the compliance standards appropriate for the work they can perform and descriptions of past GLP-compliant work conducted in their proposal.

QUESTION 2: In the mandatory qualification criteria pass/fail table, can you clarify the DEA Research Registration requirement? Can we submit a response to this proposal while we are in the process of getting DEA registered? The final sentence of that criteria reads " In addition, the successful offeror must either possess, or demonstrate the ability to obtain a DEA registration for Schedule II-V controlled substances."

GOVERNMENT RESPONSE: Offerors who are in the process of obtaining a DEA Research Registration should provide details on the current timeline for getting registered. Any paperwork provided during the registration process can be offered as demonstration that the offeror is in the process of obtaining a DEA registration. All offerors should recognize that they will not be able to bid on work requiring a DEA registration if a current registration lapses or they are unable to obtain a DEA registration.

QUESTIONS 3: I would like to understand what is being asked from us. I didn’t see a specific project, with a specific molecule to write a proposal for. Pricing and timelines are dependent on knowing which molecule and what requirements are needed. Could you let me know when we will receive that information? Or what would be the next step?

GOVERNMENT RESPONSE: While responses related to the base contract should address all modalities that could potentially be handled, responses related to the sample task orders should be specific to the modality in that task order (i.e. AAV or ASO). The sample task orders include specific modalities which allows offerors to prepare a detailed response include pricing and timelines. Although they are sample task orders, responses related to the sample task orders should demonstrate the offeror’s approach and ability to handle the tasks outlined. Please see RFP Attachment 8, Additional Technical Proposal Instructions.

RFP No. 75N95024R00050 Amendment No. 2

May 31, 2024

QUESTION 4: If a subcontractor performing the nonclinical studies has AAALAC accreditation, will the AAALAC accreditation requirement as described in the proposal be satisfied? Is it a requirement that prime and the subcontractor each have their own AAALAC accreditation?

GOVERNMENT RESPONSE: All proposed animal facilities must have AAALAC accreditation. The prime is not required to have AAALAC accreditation if all animal facilities and activities using animals are in subcontracted facilities.

Please note: the prime contractor must have an OLAW Animal Welfare Assurance even if all animal facilities and activities using animals are in subcontracted facilities. In that case, an Interinstitutional Assurance is required. Please see the PHS Policy on Human Care and Use of Laboratory Animals at https://olaw.nih.gov/policies-laws/phs-policy.htm and information on Interinstitutional Assurances at https://olaw.nih.gov/resources/documents/interinstitutional-assurance.htm.

QUESTION 5: Please confirm that certified cost and pricing data is not required in accordance with FAR 15.403-1 as the Government is anticipating adequate competition, and this effort is anticipated to be under the $2,000,000 threshold delineated in FAR 15.403-4.

GOVERNMENT RESPONSE: Certified cost or pricing data is not required. FAR 15.403-4 states that certified cost or pricing data shall be obtained only if none of the exceptions in FAR 15.403-1(b) apply. An exception in FAR 15.403-1 applies and therefore certified cost or pricing data is not required.

QUESTION 6: Please confirm the due date for proposal submissions.

GOVERNMENT RESPONSE: The due date for proposal submissions is 2:00pm ET on July 8, 2024.

RFP No. 75N95024R00050 Amendment No. 2 https://olaw.nih.gov/policies-laws/phs-policy.htm https://olaw.nih.gov/resources/documents/interinstitutional-assurance.htm