Amend_1-QandA_RFP 75N96023R00009.pdf

10/24/2023

Question # RFP Reference Questions for Government Government Response

1 Section A H.15.1.e Controlled Unclassified Information page 26 What areas of the scope of work of this contract are considered to be C ontrolled Unclassified Informa on? This is a standard HHS requirement when nongovernmental IT systems are used to manage documents and materials.

Section L B (b) (1) Evaluation Factors for Award Factor 1 Experience Page 84 and 85

The criteria listed does not appear to be relevant to the scope of work and the sample protocols provided. Will the Government please clarify? This was an oversight. Revisions have been made to the RFP on pages 86‐87. Changes are in BLUE text.

3 Section M 13.1 (b) (1) Factor 1 Experience Basis of Evaluation page 112 The criteria listed does not appear to be relevant to the scope of work and the sample protocols provided. Will the Government please clarify? This was an oversight. Revisions have been made to the RFP on page

115. Changes are shown in BLUE text.

4 Section L Page 82, Section M, pg. 108

When clicking the link in the following text, "Organiza ons submi ng proposals will be required to demonstrate compliance with the established EIT accessibility standards by preparing an HHS Section 508 Product Assessment Template which can be found here:

http://www.hhs.gov/web/508/contracting/technology/vendors.html. Draft reports do not need to be Section 508 compliant. " The display is PAGE NOT FOUND. Is there another link? What evidence and/or form is required with proposal submission?

Link has been replaced with the following:

https://www.itic.org/policy/accessibility/vpat

5 Attachment 1, Formatting and Page Limitations Will the Government allow contractors to use less than 10 point font size on graphics and tables, e.g., 8 point, as long as doing so maintains readability? Items such as floor plans and large tables of data will be much easier to comprehend if they can remain on one page.

See changes to Attachment 1. These changes are captured in BLUE text.

6 Attachment 1, Formatting and Page Limitations Will the Government allow larger than 8.5x11 pages for graphics or tables (11x17) when it provides enhanced readability, e.g., floor plans? See changes to Attachment 1. These changes are captured in BLUE text.

7 Sample Protocol III ‐Page 5 of Attachment 24

The Sample Study Task III outline states that the target exposure concentra ons for PCB 11 using nose‐only exposures need to be in the range of 1 to 300 ppm. The physical properties of PCB 11 do not allow for vapor exposures at the concentrations listed in the Sample Study Task. Should the task use an aerosol instead of a vapor?

The Government would like for the contractor to capture a suggested path forward as part of the proposal.

8 Attachment 1 ‐ Page 1 of 2 Packaging and Delivery of Proposals A achment 1 denotes the proposal to be submi ed via the electronic Contract Proposal Submission (eCPS) website. Does eCPS have file size restrictions? Please review the FAQ on the eCPS website for information:

https://ecps.nih.gov/faq

9 Part III ‐ Section J ‐ List of Attachments Page 60 Attachment 7 ‐ Section K.

If an offeror has a current and completed registra on in SAMS, is A achment 7, Sec on K s ll required to be included in the proposal response? Yes. Please include Attachment 7 even if an offeror has a current registration in SAM.

10 Part III ‐ Section J ‐ List of Attachments Page 60 Attachment 14 The Government is ci ng FAR 15.406‐2 as requiring a Cer ficate of Current Cost or Pricing Data, however it is understood this is a competitive procurement. Therefore would not FAR 15.401 (1) be applicable? This is considered a completitive procurement. Please disreagard

Attachment 14. A certificate will not be required.

11 L.B.6, Enhancing Reproducibility through Rigor and Transparency

The RFP states, "Specifically, the offeror shall describe in its technical proposal the information described below:" However, there is no information provided. Will the Government please provide?

This language was inadvertantly left out of the RFP. It is now included on pages 78‐79 in BLUE.

Section L.b.3, pg. 74 vs. Factor 3 Technical Approach and Sample Research Outlines, pg. 88

Page 74 asks offerors to provide Items 1 through 4 for each SOW area, whereas pg. 88 asks Offerors to address Items 1 through 3, which are different. Will the Government clarify which format it would like offerors to use for each of the scope areas identified in Attachment 3?

Proposals should reflect on specifics stated under Factor 3 on page 90.

13 Section L.b, Personnel, pg. 75 vs. Factor 4, Personnel, page 88

Will the Government clarify whether informa on should be provided in accordance with page 75 or page 88, and if the la er, will the Government confirm that page limits of 1 page for additional critical personnel and 1/2 page for other professional personnel are per each person named and not overall page counts?

Proposals should reflect on specifics stated under Factor 4 on page 91.

14 Factor 6, Small Business Utilization, pg. 91 Will the Government confirm that only the information contained in Attachment 27 (SB Subcontracting Plan) is submitted into SBCX and that the information requested in Attachment 26 should be provided within the Technical volume of the proposal?

Please disregard attachment 27. The Geovernment requests that offerors use link as specified in H.14 and substitute the link for any reference to Attachment 27 in this RFP.

15 A.H.15, pg. 25, Privacy Compliance Could the Government clarify what por on of the scope of work on this contract will contain PII?

The request/receipt of CVs for new professional staff during the conduct of the contract is considered PII.

Question # RFP Reference Questions for Government Government Response

Attachment 12 Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet

The RFP is clear that the nih.gov/content/breakdown‐proposed‐estimated‐cost‐plus‐fee‐and‐labor‐hours excel spreadsheet is to be submitted with the Prime proposal, however TAB "Subcontracts" states " A complete breakdown and summary sheet for each proposed subcontract must be included with the prime proposal. The same format should be used for both the prime and subcontract proposals."

Question: As a standard practice, most subcontractors will not fully disclose their rates to a Prime contractor so is the Government requesting a fully disclosed sealed subcontractor package? If so how does the subcontractor submit the package?

Yes, we are requesting the package. If a proposed subcontractor is unwilling to submit a proposal to the prime, the subcontractor should submit through eCPS system.

Attachment 24, Sample Protocol Outline number VI, pg. 27, Table 1, Animals Required for each Test Agent, footnote b.

Footnote b states “Five animals/sex/species shall be used for disease screening prior to quarantine release and resampled at 4 weeks.

The 4‐week time point shall include dried blood spot, blood, fur wipe, feces, and necropsy.” Is “blood” a typographical error? Yes, "blood" is an error and has been removed from Attachment 24.

Questions for RFP 75N96023R00009 Conduct of Toxicological Evaluations for the Division of Translational Toxicology (DTT)

Attachment 24, Sample Protocol Outline number VI, pg. 28, Section 3, Internal dose Assessment, second paragraph, specifically sentence 3

The paragraph states that “Blood collections shall occur at 2 hours after gavage dosing for each animal, and all collections shall occur within a 2‐hour period. Blood shall be processed to plasma, stored on wet ice prior to processing, and all samples processed to plasma within 1 hour of collection. Isolated plasma and urine shall be stored in 250µL aliquots at ≤ ‐70°C. Is “urine” a typographical error?

Yes, " urine" is an error and has been removed from Attachment 24

Question # RFP Reference Questions for Government Government Response

Section B ‐ Evaluation Factor for Award Para (1) Factor 1‐ Experience, Pg. 85 and Section 11‐ Qualification of the Offeror Para (d) Pertinent Contracts Pg.104

Section B ‐ Evaluation Factor for Award Para (1) Factor 1‐ Experience Page 85, indicates the Offeror should include recent and relevant contracts completed within the last 5 years preceding the release date of the solicita on. However Sec on 11‐ Qualifica on of the Offeror Para (d) Pertinent Contracts Pg.104 states that Offerors should provide all relevant contracts completed within the last 3 years and currently in process.

Question: In order to be consistent and demonstrate complete experience and qualification can the Government verify that the contracts provided in the Experience Section (Factor 1) may include ongoing projects? Can the Government also verify that the contracts provided in Section 11‐Qualification of the Offeror Para (d) Pertinent Contracts may include contracts completed within the last 5 years versus 3 years?

Please include contract actions completed within the last five years.

Page 107.

Question # RFP Reference Questions for Government Government Response

Section B ‐ EVALUATION FACTORS FOR AWARD, Subsection (6) Pg 91‐ Factor 6, Small Business Utilization Section M EVALUATION FACTORS FOR AWARD. Subsection 12. Subcontracting Program Evaluation Factors Ratings, Pg. 110‐ Table 4. Small Business Rating Method

The two areas of the RFP contradict. Factor 6 states "work to be performed by small business as the prime and/or subcontractors is 20% of the contract value" and Subsection 12. Subcontracting Program Evaluation Factors Ratings, Pg. 110‐ Table 4. Small Business Rating Method states " Outstanding is 8% or more". Question: Can the Government clarify which is correct?

Language has been updated to a minimum of 2% since that is the minimum for an acceptable rating in the evaluation factors. Pg 94.

RFP Attachment 24 III. Conduct of Studies to Evaluate the Respiratory Toxicity of 3,3’ Dichlorobiphenyl (PCB 11) by Short‐term Nose‐only Inhalation in Rats and In Vitro Exposure of Air‐liquid Interface (ALI) Rat and Human Test Systems. Section E. Phase 3‐ Repeat (Three‐day) In Vitro Exposure of ALI Human and Rat Airway Test Paragraph 2 Exposure Pg. 9

Does the proposed 3‐day repeat exposure include histology sample collec on a er each repeat exposure OR a er conclusion of all 3 exposure days?

The offeror should propose what they think is appropriate. None of the endpoints in this section are prescriptive related to timing.

Question # RFP Reference Questions for Government Government Response

RFP ARTICLE H.14. SUBCONTRACTING PROVISIONS b, Subcontracting Reports Pg. 22 RFP Attachment 27 Small Business Subcontracting Plans (SBCX)

RFP ARTICLE H.14. SUBCONTRACTING PROVISIONS b, Subcontracting Reports Pg. 22 states "An offeror is to submit their respective subcontracting plan 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."

Question: Please clarify when Attachment 27 Small Business Subcontracting Plans should be submitted. Is submission required by proposal submission deadline or when vendors receive notification from HHS to submit?

Please see response to question 14. Attachment 27 can be disregarded.

The plan shall be submitted by the Proposal Submission Deadline as specified in H.14.

Attachments_75N96023R00009_Tox RFP 10.02.23; Sample Protocol Outline IV.

Conduct of Studies to Evaluate the Subchronic Toxicity of Test Agent X in Rats and Mice Following Whole Body Inhalation Exposure; page 17 (PDF page 53)

Page 17 states "Blood for Micronuclei Rats and Mice (as appicble). No micronuclei collection listed in Outline. Is this applicable?

The offeror can disregard this in the output requirements table.

Attachments_75N96023R00009_Tox RFP 10.02.23; Sample Protocol Outline V.

Conduct of Studies to Evaluate Chronic Toxicity of Test Agent Y Administered in Feed to Rats (Following Perinatal Exposure) and Adult Mice; page 24 (PDF page 60)

Page 24 states "Samples shall be collected and distributed as described in section V.D.5". There is no V.D.5. Is this the table?

V.D.5. is the 3‐Month Extramural Research header:

V. Sample Protocol Outline for the study.

D. Phase 2‐ Chronic (6‐month) Study (In‐life)

5. 3‐Month Extramural Research

Attachments_75N96023R00009_Tox RFP 10.02.23; Sample Protocol Outline V.

Conduct of Studies to Evaluate Chronic Toxicity of Test Agent Y Administered in Feed to Rats (Following Perinatal Exposure) and Adult Mice; page 25 (PDF page 61)

Page 25 states deliverables as "Submissions of Preliminary Chemistry and Generator and Chamber Characterization" and "Submissions of Prestart Inhalation Report". No inhalation in Outline. Typos for " Generator and Chamber Characterization" and "Inhalation"?

The first item under Prestart Submissions in the left hand column can be disregarded. It has been corrected to read “Submission of Prestart Chemistry Report”

Attachments_75N96023R00009_Tox RFP 10.02.23; Sample Protocol Outline V.

Conduct of Studies to Evaluate Chronic Toxicity of Test Agent Y Administered in Feed to Rats (Following Perinatal Exposure) and Adult Mice; page 26 (PDF page 62)

Page 26 states deliverables as "Clinical Pathology Data (unaudited)". No Clinical Pathology in Outline. Typo? “Clinical Pathology Data” in the output requirements table can be disregarded.