Amendment 0001-Final_signed.pdf

RFP- NIHAI75N93021R00010 Page 1 of 2

AMENDMENT #0001

RFP- NIHAI75N93021R00010

“REGULATORY AFFAIRS SUPPORT”

Amendment Number: 0001

This Amendment provides a lists questions submitted by interested parties and the responses provided by the National Institute of Allergy and Infectious Diseases (NIAID).

AMENDMENT ONE (0001)

Issued by: National Institute of Allergy and Infectious Diseases (NIAID) Office of Acquisitions, MSC 9821 5601 Fishers Lane Rockville, MD 20852

Solicitation Number:

Date of Solicitation Issuance:

Date of Amendment No.0001 Issuance:

Number of Pages:

NIAID Point of Contact:

NIHAI75N93021R00010

April 29, 2021

June 22, 2021

2 pages

PRIMARY:

Ignacio Reyes, Contract Specialist Email: ignacio.reyes@nih.gov Phone: 301-435-7574

SECONDARY:

Charles H. Jackson, Jr. Contracting Officer Email: Charles.Jackson@nih.gov Phone: 240-669-5175

Offerors must acknowledge receipt of the final posting of Amendment #0001, on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

All additional questions must be submitted by 3:00 PM EST on July 1, 2021.

The hour and date specified for receipt of proposals remains unchanged.

RFP- NIHAI75N93021R00010 Page 2 of 2

AMENDMENT #0001

THE FOLLOWING PAGES PROVIDE ANSWERS CONCERNING A NUMBER OF INQUIRIES

WE HAVE RECEIVED FOR THE ABOVE NUMBERED SOLICITATION:

Question No.

Question / Response

1 Question: When is the last day offerors can submit Questions on the RFP.

Response: Previously there was no timeline for question submissions. Submit all additional questions prior to 6/28 to allow the government time to review and provide a response via an amendment.

2 Question: Clarification on the Place of Performance. Please specify if the staff are going to be performing work from contactor offices or DMID offices in Bethesda or a combination of both?

Response: Contractors staff works from contractor offices, however, 1 or 2 staff will come to DMID offices in Bethesda one day per week.

3 Question: Are other direct cost (ODCs) allowed on this RFP or should the offeror provide only labor cost based on the # of labor hours (28,252 per yr) specified in the RFP.

Response: Other direct costs are allowed in accordance with FAR Part 32. Additionally, see ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS.

4 Question: Does DMID have its own Regulatory Submission Information Management System (e.g eCTD system) or should the offeror provide their own for the performance of the SOW.

Response: No, DMID doesn’t have its own Regulatory Submission Information Management System (e.g. eCTD system), therefore the offeror provides their own off the shelf system to perform the requirements of the Statement of Work.

5 Question: Per page 94 #7 - please provide the location (city & state) where the regulatory audits will take place, if DMID intends that offerors should include this in travel cost.

Response: On page 94 under the uniform assumptions, section B. number 7) Regulatory Audits: The locations (city/state) for the 8 two-day audits/site visits per year may vary depending on which non-clinical/clinical study DMID decides to audit. For estimating purposes only, use Atlanta GA; Columbus OH; San Francisco CA; and Frederick MD.

*Note-Use each city twice for your travel estimate. *

6 Question: Can DMID please provide more information for travel, such as, is there a "Limit To Not Exceed" for Travel per contract year?

Response: Uniform travel assumptions have been provided to identify projected travel for this level of effort contract and all offerors should proposed based on the cited assumptions. This is a cost-plus fixed fee contract with option years.

7 Question: This is a SB set-aside, is a small business Joint venture (the JV comprises of 2 small businesses) eligible to apply?

Response: One of the small business needs to be identified as the prime contractor.

Comment: On page 46, the offerors need to log into SAM.gov and provide a copy of your reps and certs.

Additionally, offerors are required to complete and submit the attached reps and certs document with your business proposal as described in Part IV of the solicitation.

Untitled

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS

Update per FAC 2021-03 Last updated: 02/2021

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:

1. ANNUAL REPRESENTATIONS AND CERTIFICATIONS (Mar 2020), FAR Provision 52.204-8

(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 which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(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:

(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 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.203-2#FAR_52_203_2 https://www.acquisition.gov/far/part-13#FAR_Part_13

(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.

(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.

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 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

(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 award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(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 $83,099, the provision with its Alternate II applies.

(D) If the acquisition value is $83,099 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.

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 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

(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.

(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, https://www.acquisition.gov/far/52.225-20#FAR_52_225_20 https://www.acquisition.gov/far/52.225-25#FAR_52_225_25 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 title, date]. 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 (MAR 2020). 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 which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture (i.e., nonmanufacturer), is 500 employees.

(End of provision)