RFP_Amendment_01.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Purpose: To distribute RFP questions and answers.

National Institutes of Health National Institute on Drug Abuse Office of Acquisition NCATS Section

75N95023R00029

1 6

06/20/2023

05/26/2023

RFP Number 75N95023R00029 Amendment Number 01

RFP Questions and Answers

1. Would a computational toxicology approach be responsive to the RFP?

If Offerors wish to include a computational toxicology approach as one of their capabilities in response to the RFP, they may do so. However, a purely computational approach alone would not be responsive to the RFP.

2. Page 1 of Attachment 4, under “Task1: In Vitro Toxicity Assessments” states that the assays listed there can be performed in a non- GLP environment. However, page 79 of the Solicitation, under “4. Mandatory Qualification Criteria” says that the offeror’s laboratory facility must be in compliance with the Food and Drug Administration’s GLP regulations. Is a non-GLP environment acceptable for the assay formats listed in page 1?

That is correct. A non-GLP environment is acceptable for the assay formats listed in Task 1 (In Vitro Toxicity Assessments). However, please note that Task 2 (Genotoxicity Testing) lists assays that are to be performed under GLP.

3. Regarding the In Vitro hERG assay, Attachment 4 mentions Cloned hERG Potassium Channels Expressed in Human Embryonic Kidney Cells as the format. We can offer hERG assay using a different assay format: hERG Fluorescence Polarization Assay. The assay would be performed in our facility in a non-GLP environment. Would this assay be acceptable for your purposes?

The Government prefers the conventional assay (hERG Potassion Channels Expressed in Human Embryonic Kidney Cells) as the format for generating data to be used in support of regulatory submissions, which must be performed in compliance with GLP as indicated in the Sample Task Order. However, Offerors may propose different assay formats, provided there is a strong demonstrated concordance between the conventional assay and the proposed alternative assays.

4. Regarding Task 1: In Vitro Toxicity Assessments, can samples be provided in 100% Dimethylsulfoxide (DMSO)?

Potentially yes, but certain specific technical details, such as solvents, would be determined at the level of the individual task order, contingent upon scientific feasibility and need.

5. Regarding Task 1: In Vitro Toxicity Assessments, for any resultant Task Order, what is the expected cadence of sample shipments (ie. Weekly, bi-weekly, monthly)?

As this is an Indefinite Delivery, Indefinite Quantity (IDIQ) contract, the Government currently does not know the precise cadence of sample submission.

However, it would be reasonable to expect a monthly schedule.

6. Regarding Task 1: In Vitro Toxicity Assessments, what is the estimated number of samples to be shipped per month?

As this is an Indefinite Delivery, Indefinite Quantity (IDIQ) contract, the

Government currently does not know the precise number of samples to be shipped per month. However, it would be reasonable to consider approximately 10 compounds monthly.

7. Regarding Task 1: In Vitro Toxicity Assessments, are samples able to be formatted into 96-well plates and/or 384-well LDV plates?

For the purposes of the technical response, Offerors may consider that samples will be in 384-well plates. However, certain technical details, such as sample plating format, would be determined at the level of the individual task order, in consideration of an awardee’s need / technical capabilities.

8. Attachment 6 – Section 3 – Subsection 3.A. – Technical Area 1, states, “If you are not proposing on Technical Area 1, include Subsection 3.A. in your proposal and include a statement that you are not proposing on this technical area…” Would this rule also apply if a contractor were to propose a subsection of a Technical Area? For example, in Attachment 4, a contractor plans to respond to Technical Area 1 but only has capabilities to achieve items 1-4 in Task 1: In Vitro Toxicity Assessments. Would the contractor be able to include a statement that we are not proposing subsections 5-16.

No. Offerors may choose to propose on only Technical Area 1 or 2, or on both Technical Areas, depending upon their expertise and capabilities. However, Offerors must propose on all elements (subsections) under a given Technical Area being proposed on.

9. Article B.2.b includes the following text: The minimum guarantee will be satisfied by the issuance of a task order to each IDIQ awardee. The task order will be issued concurrently with the IDIQ contract and will require a kick-off meeting. Subsequent task orders will be issued in accordance with Article G.3. TASK ORDER PROCEDURE. Question: The RFP does not include a task order for the kick-off or other management activities. Is this something the government would like offerors to propose?

No, Offerors do not need to propose on the kick-off meeting task order and should not propose on it.

10. Article G.2 – does the government’s language that Key Personnel are “To be determined at the task order level” mean that we do not have to designate key personnel at the IDIQ level?

Correct. Offerors do not need to designate Key Personnel at the IDIQ level, pursuant to Article G.2. Key Personnel. However, the Additional Technical Proposal Instructions (Attachment 6), specify the requirements for identifying relevant personnel and describing their experience and qualifications within the Technical Discussions at the level of the Technical Area. Per the Technical Evaluation Factors (Section M), these proposed personnel will be evaluated with respect to their appropriateness to carry out the overall technical approach and accomplish the work described. After award of the IDIQ contract, successful Offerors would be required to identify the specific Key Personnel proposed to carry out any issued Task Orders.

11. Are the Technical Area 1 and Technical Area 2 task orders awardable?

No. These are sample Task Order Requests for Proposals (TORFPs) and will not result in actual task order awards. The responses to the sample TORFPs are used to assess the Offeror’s understanding of the types of requirements that the Government might have in future task orders, and the overall soundness, feasibility and completeness of the proposed approach to achieve the stated requirements.

12. Are CVs included in the 50 pages per technical area or should they be part of the attachments?

Resumes must be no longer than two pages each and should be provided in Section 4: Attachments. Per the Additional Technical Proposal Instructions (Attachment 6), these attachments shall not exceed a total of 50 pages per Technical Area.

13. Is it the intention of NCATS to have samples collected for Plasma Drug Level and Metabolite ID Determination analyzed onsite at the Contractor’s lab or shipped to an offsite vendor?

It is preferable to have these samples analyzed onsite, but this is not required.

These samples can be shipped to an offsite vendor for analysis, if needed. If an Offeror expects to utilize an offsite vendor / subcontractor for such work, this arrangement should be clearly described, as outlined in the Additional Technical Proposal Instructions (Attachment 6).

14. Required task order deliverable to include progress meeting agendas and minutes?

Meeting agendas and minutes are not contract deliverables under the contract or task orders.

15. May we submit our small business subcontracting plan in our business/cost proposal rather than electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system?

No. In accordance with ARTICLE H.13. SUBCONTRACTING PROVISION of the RFP, the small business subcontracting plan must be submitted electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https://osdbu.hhs.gov. The offeror shall follow the instructions outlined in the SBCX Industry Guide at:

https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j to successfully submit their subcontracting plan by the proposal submission deadline.

16. What is the contract value to be used on the Small Business Subcontracting Plan (SBSP) to be submitted with each Sample Task Order as part of the proposal response?

Use the maximum contract limit of the resulting IDIQ contract of $48,622,546.

https://osdbu.hhs.gov/ https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j

a. Should Offerors use the total value of the proposed Sample Task Order or should Offerors use the maximum contract limit of the resulting IDIQ contract of $48,622,546 or some other dollar amount for this proposal submission?

Use the maximum contract limit of the resulting IDIQ contract of $48,622,546.

b. If the former, would a SBSP still be required for submittal with the proposal should the Sample Task Order be below the $750,000 threshold a SPSP to be required for a contract?

Use the maximum contract limit of the resulting IDIQ contract of $48,622,546.

17. On page 18, Article H.13., a.3., it directs the Offeror to submit the Small Business Subcontracting Plan (SBSP) electronically in SBCX. Are Offerors to also include an additional copy of the same SBSP with the Business Proposal in pdf format via the Contract Proposal Submission (eCPS) website?

No. See answer to question 15.

18. On page 52 of the RFP, the reference to “Attachment 11: FAR Clause Deviation Acknowledgement Form” is listed as a Technical Proposal attachment. That form does not appear to be technical in nature. Should this form be submitted with the Technical Proposal or the Business Proposal?

Submit RFP Attachment 11: FAR Clause Deviation Acknowledgement Form with the Technical Proposal.

19. On Attachment 14, “HHS Subcontracting Plan Template”: The Fiscal Year is stated as “2022”. In addition, the version is identified in the footer as “Subcontracting Plan Template (Rev. March 2022).” Please confirm this is the version of the form, along with the correct/current goal percentages, to be utilized for the proposal submittal. Alternatively, please provide the form and goal percentages to be used.

The subcontracting goal percentages for reference in preparing your proposal are the following HHS fiscal year 2023 goals:

https://www.sba.gov/sites/sbagov/files/2023-01/FY23_Final_Goals_508_0.pdf

Small Business: 32.00%

SDB: 05.00%

WOSB: 05.00%

SDVOSB: 03.00%

HUBZone: 03.00%

RFP Attachment 14: HHS Subcontracting Plan Template is included only as a preparatory aid. The small business subcontracting plan is only to be submitted electronically through the HHS SBCX system and is not to be included in the technical or business proposals submitted through eCPS (see answer to question 15).

https://www.sba.gov/sites/sbagov/files/2023-01/FY23_Final_Goals_508_0.pdf

20. Attachment 18, Section K: As this includes specific areas to be certified by the Offeror, should a signature block be included at the end of this form in order to certify?

Include a completed copy of RFP Attachment 18: Section K within your business proposal. It does not need to be signed and a signature block does not need to be included at the end of the form.