Amendment 1 with Attachment RFP 75N93021R00020.pdf

AMENDMENT #1 RFP No. 75N93021R00020 1

Amendment No. 1 RFP No. 75N93021R00020

“Resources to Advance Pediatrics and HIV Prevention Science”

Solicitation Number: 75N93021R00020

Amendment Number: One (1)

Amendment Issue Date: May 16, 2022

Proposal Due Date/Time: July 7, 2022 at 3:00 PM, Local Time (Unchanged)

Issued By: Robert Corno

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY cornorj@niaid.nih.gov Robert Corno, Contracting Officer Phone: 240.669.5151

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of this Amendment is to provide responses to questions from potential offerors, regarding the solicitation.

RESPONSES TO QUESTIONS FROM POTENTIAL OFFERORS:

Question 1 Should the Small Business Plan requirement threshold be determined based on the max contract value or on the sample task order value?

Response to Question 1 mailto:cornorj@niaid.nih.gov

AMENDMENT #1 RFP No. 75N93021R00020 2

The Small Business Plan requirement should be based on the maximum amount of the contract, which is $98,878,757.

Question 2 Are you expecting costs for CUI and other IDIQ-level administrative requirements to be separately proposed, or should they be included in each individual task order? See below for specific questions:

CUI means “Controlled Unclassified Information” (RFP page 27). The RFP has considerable Information Security Requirements which will require support from our Information Security Team. This includes the requirements and reports listed in the Information Security And/Or Physical Access Security sections on RFP pages 75-85.

Regarding “IDIQ-Level Administrative Costs”, these include management and administration costs related to managing the IDIQ, rather than actions on specific task orders. This includes the support activities that are defined in Attachment 3, pages 4-12, Section C General Task Order Requirements.

Response to Question 2 The Information Security Requirements and/or Physical Access Security will be assessed at the task order level. If these requirements are applicable, then the task order will estimate/require enough effort to take into account these requirements.

Regarding “IDIQ-Level Administrative Costs”, the support activities that are defined in Attachment 3, pages 4-12, Section C General Task Order Requirements, will have effort associated with those requirements at the task order level. There are no base level IDIQ administrative costs.

Question 3 SECTION J – List of Attachments: the link to Attachment 12, the Representations and Certifications and other Statements of Offerors in the RFP is broken.

Response to Question 3 We recognize the link to Attachment 12 is not working and have provided a copy of the Attachment in this Amendment.

Question 4 Regarding Attachment 16, The HHS Section 508 Product Assessment Template (PAT) is no longer available at the link provided in section J, Attachment 16. The 508 Help desk indicated the standards have been updated. Is the 508 PAT still required (page 84, para c.), and if so, can you provide the updated template?

Response to Question 4 SECTION J – List of Attachments: Attachment 16, The HHS Section 508 Product Assessment Template (PAT), is replaced with Attachment 16, Voluntary Product Accessibility Template (VPAT). Information and form located at: https://www.section508.gov/sell/vpat/.

https://www.section508.gov/sell/vpat/

AMENDMENT #1 RFP No. 75N93021R00020 3

Question 5 Is the sample Task D for a long-acting tablet or an immediate release tablet? On page 185, it is mentioned to be an immediate release. Elsewhere in the RFP the product is mentioned to be a long-acting oral formulation.

Response to Question 5 Sample Task Order D-1 is for long-acting tablet.

Question 6 Regarding Sample Task Order B-1, while our expertise is in humanized mouse models, the Sample Task B-1 is for non-human primates. Is it necessary to provide services that include both non-human primates and humanized mice in order to be responsive to this RFP?

Response to Question 6 For an offeror to be responsive to the RFP they have to show they have the capabilities of completing all of the requirements in a given Task Area. If you do not have the in house capabilities of the Sample Task Order, you may subcontract those requirements and still be responsive to the RFP.

Per Attachment 9, Additional Technical Proposal Instructions, it states Offerors will be evaluated on their ability to address all technical requirements in the general Task Area SOW, as well as the technical requirements in each Task Order. Offerors lacking the expertise to address all of the technical requirements are encouraged to identify collaborations and partnerships that, through combined expertise, can address all of these technical requirements. Please note when identifying a partner/collaborator, it is important for the offeror to explain how a partner/collaborator will support certain activities rather than just providing a letter of support.

Question 7 The Task Area B seems to require proficiency in both nonhuman primates as well as humanized mouse models to prevent HIV. Humanized mouse models for HIV prevention need to recapitulate human mucosal transmission and the models that exist such as the bone marrow/liver/thymus (BLT) transplant models of immunodeficient mice require both aborted fetal tissues and special surgical skills. These are specialized models that cannot be produced commercially and rely on consistent sources of aborted human fetal tissues which are difficult to obtain in some regions. Further, our expertise and resources at a National Primate Research Center emphasize nonhuman primate research, and we are discouraged from performing murine studies at these centers. Unless there is a direct path to NHP studies. We could contract out murine humanized mouse studies if necessary, or perform PK and other basic safety studies in CD34 transplanted humanized mouse models in house, but we would like to know which humanized mouse model is desired for this task order and how much of the work is expected to involve humanized mouse models?

Response to Question 7 As indicated in Attachment 9 (Additional Technical Proposal Instructions), Offerors lacking the expertise to address all of the technical requirements are encouraged to identify collaborations

AMENDMENT #1 RFP No. 75N93021R00020 4 and partnerships that, through combined expertise, can address all of these technical requirements. Since NIAID has no preferred humanized mouse model, the Offeror is encouraged to identify a partnership/collaboration in which a relevant humanized mouse model can be used for PK, safety, and efficacy studies to support product development and fulfill the requirements of Task Area B. Please note when identifying a partner/collaborator, it is important for the offeror to explain how a partner/collaborator will support certain activities rather than just providing a letter of support.

Question 8 The Task Area B requires production and characterization HIV/SIV/SHIV strains and other pathogens. We have limited strains of SIV and relies on other sources for most strains such as NIH, George Shaw of University of Pennsylvania, SVEU’s viral cores, etc. Will it be acceptable for RAPPS to use resources other than offeror site?

Response to Question 8 Yes, it is acceptable for the Offeror to identify a partnership/collaboration for the production and characterization of HIV/SIV/SHIV strains and other pathogens that may not be available in-house. Please note when identifying a partner/collaborator, it is important for the offeror to explain how a partner/collaborator will support certain activities rather than just providing a letter of support.

END OF AMENDMENT NO. 1, RFP No. 75N93021R00020

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS

Update per FAC 2022-03 Last updated: 01/2022

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

52.204-8 Annual Representations and Certifications.

As prescribed in 4.1202(a), insert the following provision:

ANNUAL REPRESENTATIONS AND CERTIFICATIONS (JAN 2022)

(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is__________________ [insert NAICS code].

(2) The small business size standard is _____________ [insert size standard].

(3) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition—

(i)Is set aside for small business and has a value above the simplified acquisition threshold;

(ii)Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii)Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) (1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The Offeror shall indicate which option applies by checking one of the following boxes:

https://www.acquisition.gov/far/4.1202#FAR_4_1202 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7

(i) □ Paragraph (d) applies.

(ii) □ Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c) (1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless–

(A) The acquisition is to be made under the simplified acquisition procedures in part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that-

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.204-26, Covered Telecommunications Equipment or Services- Representation. This provision applies to all solicitations.

https://www.acquisition.gov/far/52.203-2#FAR_52_203_2 https://www.acquisition.gov/far/part-13#FAR_Part_13 https://www.acquisition.gov/far/52.203-11#FAR_52_203_11 https://www.acquisition.gov/far/52.203-18#FAR_52_203_18 https://www.acquisition.gov/far/52.204-3#FAR_52_204_3 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-5#FAR_52_204_5 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26

(vii) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations- Representation.

(viii) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(ix) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(x) 52.214-14, Place of Performance-Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(xi) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xii) 52.219-1, Small Business Program Representations (Basic, Alternates I, and II). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(C) The provision with its Alternate II applies to solicitations that will result in a multiple-award contract with more than one NAICS code assigned.

(xiii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiv) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xvi) 52.222-38, Compliance with Veterans’ Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract https://www.acquisition.gov/far/52.209-2#FAR_52_209_2 https://www.acquisition.gov/far/52.209-5#FAR_52_209_5 https://www.acquisition.gov/far/52.209-11#FAR_52_209_11 https://www.acquisition.gov/far/52.214-14#FAR_52_214_14 https://www.acquisition.gov/far/52.215-6#FAR_52_215_6 https://www.acquisition.gov/far/52.219-1#FAR_52_219_1 https://www.acquisition.gov/far/52.219-2#FAR_52_219_2 https://www.acquisition.gov/far/52.222-22#FAR_52_222_22 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-25#FAR_52_222_25 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-38#FAR_52_222_38 award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial products or commercial services.

(xvii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA–designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xviii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA–designated items.

(xix) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals-Representation. This provision applies to solicitations that include the clause at 52.204-7.)

(xx) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xxi) 52.225-4, Buy American-Free Trade Agreements-Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225-3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $92,319, the provision with its Alternate II applies.

(D) If the acquisition value is $92,319 or more but is less than $100,000, the provision with its Alternate III applies.

(xxii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan-Certification. This provision applies to all solicitations.

(xxiv) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certifications. This provision applies to all solicitations.

https://www.acquisition.gov/far/52.223-1#FAR_52_223_1 https://www.acquisition.gov/far/52.223-2#FAR_52_223_2 https://www.acquisition.gov/far/52.223-4#FAR_52_223_4 https://www.acquisition.gov/far/52.223-22#FAR_52_223_22 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.225-2#FAR_52_225_2 https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 https://www.acquisition.gov/far/52.225-4#FAR_52_225_4 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-6#FAR_52_225_6 https://www.acquisition.gov/far/52.225-5#FAR_52_225_5 https://www.acquisition.gov/far/52.225-20#FAR_52_225_20 https://www.acquisition.gov/far/52.225-25#FAR_52_225_25

(xxv) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.]

__ (i) 52.204-17, Ownership or Control of Offeror.

__ (ii) 52.204-20, Predecessor of Offeror.

__ (iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

__ (iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment- Certification.

__ (v) 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification.

__ (vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA–Designated Products (Alternate I only).

__ (vii) 52.227-6, Royalty Information.

__ (A) Basic.

__ (B) Alternate I.

__ (viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically in SAM website accessed through https://www.sam.gov. After reviewing the SAM information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date].

https://www.acquisition.gov/far/52.226-2#FAR_52_226_2 https://www.acquisition.gov/far/52.204-17#FAR_52_204_17 https://www.acquisition.gov/far/52.204-20#FAR_52_204_20 https://www.acquisition.gov/far/52.222-18#FAR_52_222_18 https://www.acquisition.gov/far/52.222-48#FAR_52_222_48 https://www.acquisition.gov/far/52.222-52#FAR_52_222_52 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 https://www.acquisition.gov/far/52.227-6#FAR_52_227_6 https://www.acquisition.gov/far/52.227-15#FAR_52_227_15 https://www.sam.gov/ https://www.acquisition.gov/far/4.1201#FAR_4_1201

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause # Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of provision)

Alternate I (SEP 2021). As prescribed in 4.1202(a), substitute the following paragraph (a) for paragraph (a) of the basic provision:

(a)(1) The North American Industry Classification System (NAICS) codes and corresponding size standards for this acquisition are as follows; the categories or portions these NAICS codes are assigned to are specified elsewhere in the solicitation:

NAICS Code Size standard

[Contracting Officer to insert NAICS codes and size standards].

https://www.acquisition.gov/far/4.1202#FAR_4_1202

(2) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce, (i.e., nonmanufacturer), is 500 employees if the acquisition—

(i) Is set aside for small business and has a value above the simplified acquisition threshold;

(ii) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.