RFP_75N94026R00005_BTF_Amendment_3_Attachment_1_0003.pdf

RFP 75N94026R00005 Amendment 0003 – Attachment 1

Biological Testing Facility

Solicitation No.: 75N94026R00005

AMENDMENT 0003 – ATTACHMENT 1

This amendment provides answers to questions received regarding this RFP. These answers are provided for information only as guidance to potential offerors and do not supersede any terms of the RFP and do not revise or become part of this RFP.

Question #1: The Repro Task Order Statement of Work lists 17 separate types of activities that may be performed under the Repro Task Oder at the direction of the CO and COR. The RFP does not indicate which specific activities (or quantity) should be assumed for purposes of generating a budget proposal or task order response.

a. Can you please provide some guidance or specificity as to what NICHD would like the offerors to propose for the BTF Repro Task Order?

Government Response: The Repro Task Order is intended to support a diverse portfolio of preclinical development activities spanning drugs, devices, and combination products at varying stages of development.

For proposal purposes, the Offeror should consider three distinct potential products for fertility regulation per year, each at a different stage of development and representing a different product class: 1. a novel small molecule drug candidate identified from a high-throughput screen, with preliminary in vitro data suggesting potential for male contraception and no formulation or PK studies, requiring in vivo proof-of-concept studies in a rodent model to assess biological activity and reproductive tract effects, with preliminary dose-ranging to inform subsequent formulation and PK study design; 2. an antibody designed for local application to target a key protein in the reproductive tract, with some initial characterization and in vivo data, requiring a rabbit mating study to assess the effect of the locally applied biologic on fertility endpoints, including conception rate and implantation, with supporting assessment of local tissue compatibility at the site of application; 3. a drug-device combination concept that is a new design for an intravaginal ring that would deliver a well-characterized progestin and/or other validated fertility regulating compound that needs to be evaluated in 3 studies of 6 rings (1 control + 5 test article) each for drug release, systemic exposure, effects on vaginal tissue, etc.

These are samples representative of a varied and changing portfolio that includes multiple product types (e.g., small molecule drugs, biologics, medical devices, and drug-device combination products) at different stages of development (e.g., early discovery/validation, mid-stage preclinical development, and IND/IDE-enabling activities). Activities under such a portfolio may include a mix of in vitro, ex vivo, and in vivo studies; ADME and PK/PD profiling; formulation development; safety and toxicology; and other supporting activities as described in the Statement of Work. Specific quantities or study counts are only provided to suggest the potential scale of a representative project, but the scope and level of effort will vary by project. Offerors should propose a flexible approach that demonstrates the capability to support this range of activities.

b. What is the intended period of performance for the BTF Repro Task Order?

Government response: The anticipated period of performance for the Repro Task

Order is two (2) years, spanning from September 30, 2026, through September

29th, 2028.

Question #2: Will supporting documents be reviewed if attached as an Appendix to Technical

Volume 1 (which has a 30-page limit to cover the IDIQ plus 4 of the 5 requested task orders as per Attachment 1 page 2)? For example, Summary of Related Activities, evidence of Drug

Establishment Registration, Controlled Substance License, NIH Biographical Sketch Common

Form, Publication or Reference list, etc.

Government response: Supporting documents will be reviewed. However, the Government has determined it is in the best interest to amend the page limitations originally set forth in the RFP.

Below are the updated page limitations, with the intention of providing offerors sufficient space to submit informed and detailed proposals:

• IDIQ Technical Response: 30 Pages

• Administrative Task Order: 30 Pages

• Repro Task Order: 30 Pages

• Sample Tasks: 30 Pages per Sample Task

(totaling 180 pages)

Question #3: May the font size of figures and tables be smaller than required for the main body of the text?

Government response: The font size of figures and tables shall be consistent with the instructions included in Attachment 1 of the RFP entitled, Attachment 1 - Packaging and Delivery of

Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website.

Section II of this attachment indicates font size must be 10 to 12 points.

Question #4: On page 4 of Attachment 1 (Additional Proposal Instructions Attachment 1), under materials/supplies, the first bullet point states “Please include three (3) recent price quotes for all items proposed over $1000 obtained within the last 90 days…”. Is this requirement for 3 quotes per item over $1000 still required if the Offeror has a government approved purchasing system?

We find this especially onerous given that (a) 3 of the 5 task orders are sample task orders and not intended to be awarded, (b) the relatively low dollar threshold for this requirement, and (c) the limited time between RFP release and the due date.

Government response: Offerors with an approved purchasing system are exempt. However, offerors must provide evidence of their approved purchasing system as an attachment to the business proposal.

Question #5: To avoid a potential misunderstanding, will you please confirm that Technical

Volume 1, which cannot exceed 30 pages, is to include information about the IDIQ, Admin Task

Order, Sample Task Order A, Sample Task Order B, and Sample Task Order C. We are seeking confirmation that it is to be 30 pages maximum and not 30 pages per sub part for a total of 150 pages maximum? This is in reference to text on page 2 of Attachment 1.

Government response: Please refer to the Government’s response to question #2 for the revised page limitations.

ALL OTHER CONTENTS OF THIS RFP REMAIN UNCHANGED

END OF AMENDMENT 0003