75N93022R00037 - Amendment No. 1.pdf

AMENDMENT OF SOLICITATION

Solicitation Number: 75N93022R00037 Amendment Number: 1

AMENDMENT ONE (1)

Issued by: National Institute of Allergy and Infectious Diseases (NIAID)

Office of Acquisitions 5601 Fishers Lane Rockville, MD 20852

Solicitation Number: 75N93022R00037

Date of Solicitation Issuance: May 4, 2023

Date of Amendment No.1 Issuance: May 31, 2023

Number of Pages: 3 Pages

NIAID Point of Contact: PRIMARY:

Mary Smith, Contract Specialist Email: mary.smith@nih.gov Phone: (240) 627-3377

Offerors MUST acknowledge receipt of this amendment, by Amendment number(s) and date of the amendment.

FAILURE OF YOUR ACKNOWLEDEMENT AT THE PLACE DESIGNATED FOR THE

RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT

IN REJECTION OF YOUR OFFER.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

Purpose of Solicitation Amendment:

The purpose of Amendment No. 1 is to respond to questions received regarding the solicitation.

ALL OTHER TERMS AND CONDITIONS OF THE SOLICITATION REMAIN

UNCHANGED.

End of Amendment 1 mailto:mary.smith@nih.gov

Single Institutional Review Board (sIRB) RFP 75N93022R00037 Questions and Responses

Issued By NIAID May 31, 2023

Number Question Government Response 1 What is the anticipated timeline/dates of service? As stated on page 41 of the RFP, award is anticipated on/about

February 2024. It is anticipated that the award from this solicitation will be an Indefinite-Delivery/Indefinite-Quantity (IDIQ) parent contract with a term of 7 years, with Firm Fixed-Price type task orders awarded from the parent contract to be fully funded for the base period and subsequent option quantities/periods, if exercised.

• The period of performance of the Task Area A Task Order is anticipated to be 7 years (Base period and Options 1 – 6 are anticipated to be 1 year each, as per page 75 of the RFP).

• The period of performance of the Task Area B Task Order is dependent on the number of annual continuing reviews required for the protocols being reviewed under the Task Order. As stated on page 86 of the RFP, assume sample task order 2 includes standard review for ten (10) protocols, with the parameters outlined on page 87.

2 Can you provide an estimate of the number of potential studies, and breakdown of anticipated submission type (Exempt/Full Board)?

20 full-board reviews per year are anticipated.

3 Please provide clarification on the request for a Genetic Advisory Committee, including scope.

NIAID may request this additional service to fully explore any human subjects protections concerns for clinical trials involving human genetic testing, if not clearly delineated in NIH policies. We anticipate this service may be needed once or twice during the length of the contract, if at all. Note, Offerors will not be evaluated on their ability to provide for a Genetic Advisory Committee.

4 Do you anticipate the need for ethics or biosafety review for any sites:

• In Canada?

• Outside of the US and Canada?

• Yes, we anticipate the need for ethics/biosafety reviews for sites in Canada.

• No, we do not anticipate ethics/biosafety reviews for sites outside of US and Canada.

5 Section 4 of the table of contents: Please provide clarification on the CV requirement. Would this be the CV for the head of IRB operations and regulatory at Advarra?

Or something else?

A CV is required for the person responsible to lead and direct the activities to be carried out under the contract. A CV should also be provided for key personnel that will provide project management and technical oversight.

6 Attachment 8, section 3, 1D (Ad hoc meetings) – Are these related to IRB review meetings, or operational in nature?

These ad hoc meetings refer to meetings with the Sponsor to discuss and resolve unanticipated events.

7 Attachment 8, section 3, 1E – contractor site visits – would this be a governance meeting, or something else?

The meeting is to tour the contractor’s facility, meet with key personnel, and discuss contract issues and statuses.

8 Attachment 8, section 3, 2C – how many sites per protocol should we consider in this example?

Assume review for a typical protocol with parameters as described in Sample TO 2.