75N95023R00001_Amendment 01.pdf

NSN 7540 - 01 - 152 – 8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48CFR) 53.243

OMB No. 0990-0115

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

1 5

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

01 See Block 16C

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

NIDA Section, Contracts Management Branch Red Office of Acquisition, NIDA c/o NIH Mail Center

NIDA 3WFN MSC 6023

16071 Industrial Drive – Dock 11 Gaithersburg, MD 20877

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

75N95023R00001

9B. DATED (SEE ITEM 11)

June 12, 2023

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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 Offer is extended is not extended.

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 Item 8 and 15, and returning 1 copies of the amendment; (b) acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED COULD 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hours and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT/ORDER NO. 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, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

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

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

PURPOSE: To respond to formal questions submitted in response to the solicitation. All other terms and conditions of the RFP remain unchanged.

PROPOSAL DUE DATE: August 9, 2023, 3:00 P.M. (Eastern Time) (UNCHANGED)

Note: The offeror should acknowledge on the cover page or first page of its business and technical proposals receipt of the RFP and this Amendment.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED

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.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Joshua Lazarus, Contracting Officer, NIDA Section

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY

(Signature of Contracting Officer)

07/19/2023

Request for Proposal 75N95023R00001

Amendment No. 01

RESPONSE TO QUESTIONS

QUESTION 1: Based on the review of the hyperlinks in the solicitation, several links are invalid.

Would the government please provide valid hyperlinks for all information/data intended to support this solicitation?

The hyperlink provided in Section J of the solicitation, which pertains to the Inclusion Enrollment Report included in the PHS Human Subjects and Clinical Trials Information Form (Study Record Form), directs to the Technical Proposal Cost Summary form:

https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf

The hyperlink provided in Section J of the RFP, which pertains to the Electronic Invoicing Instructions for NIH Contractors/Vendors is invalid.

Electronic_Invoicing_Instructions_April2020.pdf (nih.gov)

RESPONSE 1: PART III SECTION J Attachment 22 is amended as follows:

Attachment 22: Inclusion Enrollment Report included in PHS Human Subjects and Clinical Trials Information Form (Study Record Form) https://oamp.od.nih.gov/sites/default/files/DGS/HumanSubjectStudy_3_0- V3.0%20Form%20H%205-23.docx

PART III SECTION J Attachment 29 is amended as follows:

Attachment 29: Electronic Invoicing Instructions for NIH Contractors/Vendors https://oamp.od.nih.gov/sites/default/files/DGS/Invoicing%20Instructions%20With%20IP P%203-23.pdf

Attachments 22 & 29 are attached to this amendment for your reference.

QUESTION 2: The government included a list of attachments in Section J of the solicitation.

Additionally, in multiple sections of the RFP there is a link to a NIH website with an additional Section J List of Attachments. https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j. Multiple links at this website appear to be not applicable to this solicitation.

Will the Government please clarify which Section J attachments are applicable to this solicitation?

RESPONSE 2: The hyperlink “https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j” appears 3 time in the solicitation. The first occurrence is on page 23 under Section C, Article C.2(b)(3)(A)(5) Roster. The link under this sections pertains to the Roster of Employees Requiring Suitability Investigations which corresponds to Attachment 27. The link for that document is https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Foamp.od.nih.gov% 2Fsites%2Fdefault%2Ffiles%2FDGS%2Fcontracting-forms%2FSuitability%2520Roster%25202021%2520Revised.xlsx&wdOrigin=BROWSEL INK. A pdf of this document has been attached to this amendment for your reference.

The second occurrence is on page 65 under Section H, Article H.28(b)(1) Subcontracting Report. The link under this section pertains to the HHS Subcontracting Plan – HHS Industry User Guide. The link for that document is:

Amendment No. 01 https://oamp.od.nih.gov/sites/default/files/DGS/SBCX%20Industry%20Subcontracting%2 0Guide.pdf. A pdf of these instructions has been attached to this amendment for your reference.

The third occurrence is on page 184 under Section L(c)(6) Small Business Subcontracting Plan. The link under this section pertains to the HHS Subcontracting Plan – HHS Industry User Guide. The link for that document is:

https://oamp.od.nih.gov/sites/default/files/DGS/SBCX%20Industry%20Subcontracting%2 0Guide.pdf. A pdf of these instructions has been attached to this amendment for your reference.

QUESTION 3: Attachment 1, I.A.1 provides instructions for electronic submittal, but L.2.a.2 still includes instructions for hard-copy submittal. Please confirm that the electronic submittal is the only method of submittal that the government requires.

RESPONSE 3: Correct. Electronic submittal through the NIH electronic Contract Proposal Submission (eCPS) is the only method of submitting proposals to the Government.

QUESTION 4: Please confirm that 11 x 17" landscape format is acceptable for submitting detailed budgets.

RESPONSE 4: Yes, it is acceptable to submit detailed budgets using an 11” x 17” landscape format.

QUESTION 5: There are several tasks or activities that are or may be ongoing in each calendar year throughout the life of the contract. Potential examples include project management, biospecimen storage, certain biospecimen logistics activities, and biospecimen access. There are 9 contract periods, but the full period of performance is indicated as 13 years (2024 through 2036). Please provide direction on whether 13 years of such activities are to be included in the cost estimate and, if so, how to allocate 13 years of costs within and across the 9 contract periods.

RESPONSE 5: Please refer to Section F, Article F.1.(b) for the proposed Periods of Performance and Attachment 3 – Statement of Work, Section c. for the required and optional tasks in each of the nine (9) periods of performance. As stated on page 126 of the solicitation, “NIDA’s total anticipated need of the services described in the SOW is estimated to be 13 years. Given the progress, scope, and objectives to collect an additional four waves of nationally representative data for the PATH Study, the COR has determined that one (1) 5-year base period and eight (8) 5-year option periods may be necessary to achieve the requirements of this contract. Each option period may be exercised approximately 12 months after the preceding option period and run concurrently for the duration of the contract until completion.

The business proposal should be based on the activities needed to complete the requirements within the nine (9) option periods Given, that each Option Periods (if exercised) shall have similar tasks in each period, Offerors should describe in the business proposal how it intends to meet the programmatic requirement while effectively allocate costs for each period that will maximize cost effective and mitigate the potential risk of duplicate of effort and costs for similar tasks across the option periods.

Amendment No. 01

QUESTION 6: Please confirm that the current biorepository vendor is under subcontract to the incumbent current contract and will not be operating under a separate contract for bio-repository services under NIDA.

RESPONSE 6: The current biorepository for the PATH Study is operated as a subcontract with the incumbent. NIDA does not intend to establish and operate a separate contract for bio-repository services.

QUESTION 7: The government provided an estimated level of effort (LOE) for the 2015 solicitation but did include an estimated LOE in the 2023 PATH solicitation. This could potentially produce risk to the government evaluation of the solicitation, as only the current incumbent has accurate understanding of the Estimated LOE required to support PATH. Will the government provide an Estimated LOE for all to inform all proposal responses and ensure a fair and level competitive environment for all offerors?

RESPONSE 7: Section L - Instructions, Conditions, And Notices To Offerors, subpart (1)(l) is incorporated as follows:

l. ESTIMATE OF EFFORT

It is expected that a completion type contract will be awarded as a result of this SOLICITATION. To assist you in the preparation of your proposal, the Government estimates the maximum effort to be approximate to the hours identified in the table below. PLEASE NOTE This information is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes. The Government is requesting novel and efficient approached to complete the required work to meet the requirements, goals, and objectives.

Maximum Labor Hours, includes maximum number of all options Base Option 1 Option 2 Option 3 Option 4 Option 5 Option 6 Option 7 Option 8 Total

Required Tasks - Total

10,000 233,500 1,130,800 183,000 420,000 274,500 1,130,800 183,000 451,000 4,016,600

Option 1 (Analytic Activities)

320,000 320,000 320,000 320,000 320,000 320,000 320,000 320,000 320,000 2,880,000

Extra Small Data Collection Prep

5,100 5,100 5,100 5,100 5,100 5,100 5,100 5,100 5,100 45,900

Extra Small Data Collection

26,000 26,000 26,000 26,000 26,000 26,000 26,000 26,000 26,000 234,000

Small Data Collection Prep

12,700 12,700 12,700 12,700 12,700 12,700 12,700 12,700 12,700 114,300

Small Data Collection

65,000 65,000 65,000 65,000 65,000 65,000 65,000 65,000 65,000 585,000

Medium Data Collection Prep

19,100 19,100 19,100 19,100 19,100 19,100 19,100 19,100 19,100 171,900

Medium Data Collection

97,400 97,400 97,400 97,400 97,400 97,400 97,400 97,400 97,400 876,600

Amendment No. 01

Large Data Collection Prep

38,200 38,200 38,200 38,200 38,200 38,200 38,200 38,200 38,200 343,800

Large Data Collection

194,900 194,900 194,900 194,900 194,900 194,900 194,900 194,900 194,900 1,754,100

Extra Large Data Collection Prep

50,900 50,900 50,900 50,900 50,900 50,900 50,900 50,900 50,900 458,100

Extra Large Data Collection

259,800 259,800 259,800 259,800 259,800 259,800 259,800 259,800 259,800 2,338,200

Transition Option

800 0 0 0 0 0 0 0 800 1,600

Grand Total of Required and Optional Tasks

1,099,900 1,322,600 2,219,900 1,272,100 1,509,100 1,363,600 2,219,900 1,272,100 1,540,900 13,820,100

[End of Page Intentionally Left Blank]

PHS Human Subjects and Clinical Trials Information

OMB Number: 0925-0001 Expiration Date: 01/31/2026

Use of Human Specimens and/or Data

* Does any of the proposed research in the application involve human specimens and/or data? Yes No

Provide an explanation for any use of human specimens and/or data not considered to be human subjects research.

Add Attachment Delete Attachment View Attachment

Please complete the human subjects section of the Research & Related Other Project Information form prior to completing this form.

The following items are taken from the Research & Related Other Project Information form and displayed here for your reference. Any changes to these fields must be made on the Research & Related Other Project Information form and may impact the data items you are required to complete on this form.

Are Human Subjects Involved? Yes No

Is the Project Exempt from Federal regulations? Yes No

Exemption number:

If No to Human Subjects

654321

Skip the rest of the PHS Human Subjects and Clinical Trials Information Form.

If Yes to Human Subjects

7 8

Add a record for each proposed Human Subject Study by selecting ‘Add New Study’ or ‘Add New Delayed Onset Study’ as appropriate. Delayed onset studies are those for which there is no well-defined plan for human subject involvement at the time of submission, per agency policies on Delayed Onset

Studies. For delayed onset studies, you will provide the study name and a justification for omission of human subjects study information.

Add Attachment Delete Attachment View Attachment

Other Requested Information

Click here to extract the Human Subject Study Record Attachment

Study Record(s)

Attach human subject study records using unique filenames.

1) Please attach Human Subject Study 1 Add Attachment Delete Attachment View Attachment

Delayed Onset Study(ies)

Study Title Anticipated

Clinical Trial?

Justification

Add Attachment Delete Attachment View Attachment

Updated on March 21, 2023

Invoice and Payment Provisions (Vendor has Transitioned to IPP)

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the

Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS:

Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a Contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing

Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Approving Official: Contracting Officer Name- Email Address-

Contracting Officer Representative Name- Email Address-

II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or Contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the Contractor for supplies delivered or services performed, the amount was not subject to further https://www.ipp.gov/ settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (Mar 2023).

(a)

(1) In accordance with 31 U.S.C. 3903 https://www.govinfo.gov/link/uscode/31/3903 and 10

U.S.C. 3801 https://www.govinfo.gov/link/uscode/10/3801 , within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of clause).

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022).

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801 http://www.ipp.gov/

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of clause).

ROSTER OF EMPLOYEES REQUIRING SUITABILITY INVESTIGATIONS

CAN: Contractor:

RFP/Contract #: Contractor Contact:

Contract Title: Contractor E-mail:

Project Officer:

Contract Specialist:

TO BE FILLED OUT BY PROJECT OFFICER and ISSO: TO BE FILLED OUT BY CONTRACTOR:

TO BE FILLED IN BY CONTRACTOR: PROJECT OFFICER and ISSO:

Suitability Level

Investigation Type Questionaire Required

Existing Clearance or Application

Last Name First Name e-mail Position

Non-Disclosure Agreement Submitted

(mm/dd/yyyy)

Security Awareness Training Completed

(mm/dd/yyyy) Tier 1, 2, 3, 4, or 5

Tier 1; Tier 2S;

Tier 2SR; Tier 3;

Tier 3R; Tier 4;

Tier 4R; Tier 5;

Tier 5R Estimated

Cost

SF85, SF85P,

or SF86

Questionaire Submitted

(mm/dd/yyyy)

HHS Credit Release

Submitted (mm/dd/yyyy)

OF 306

Submitted

(mm/dd/yyyy)

Fingerprinting Completed

(mm/dd/yyyy) Agency Clearance

Level Date Comment

Page 1 C:\Users\lazarusjt\Downloads\Suitability Roster 2021 Revised (1)

HHS Industry User Guide for Subcontracting Plan Reviews

Table of Contents

Introduction

Navigation

Completing Subcontracting Plans

Evaluation

Introduction

When vendors receive notification from HHS to submit their subcontracting plans for review, the invited vendor(s) will login to the Subcontracting Plan Review page within their registered SBCX account.

Navigation

Subcontracting Plan Review responses are located in the Industry Information section.

The Subcontracting Plan Review page displays the Subcontracting Plan(s) available to the user. Click the title link to view more information.

The SBCX Subcontracting Plan Reviews link contains the following sections.

1. Summary: The project information entered by the HHS Contracting Officer.

2. Subcontracting Goals: The requirements for the type of Subcontracting Plan.

3. Documents: Upload, view, and delete supporting documentation.

4. Notes: Communicate with the Contracting Officer (CO) and Small Business Specialist (SBS) within the system.

* The Notes feature is only available for Subcontracting Plan Reviews In Progress.

A publicly available Subcontracting Plan will only show the Summary. Only users with the authority to submit Subcontracting plans should click Create Subcontracting Plan.

Completing Subcontracting Plans

Step 1. Identify the type of subcontracting plan and report the eligible subcontracting dollars.

* A publicly available Subcontracting Plan may require the pricing information.

Step 2. Provide all required information referred to as Subcontracting Goal Data.

Step 3. Identify the Subcontracting Program Administrator and their duties. For a commercial plan, only supporting documentation is required.

Step 4. Describe the efforts utilized to include small businesses in subcontracting plans and acknowledge the assurances.

Step 5. Certify the completion and compliance of the subcontracting plan. Submit for approval before the deadline.

A PDF version of the Subcontracting Plan is available after submission.

The Contracting Officer may request a clarification and return the subcontracting plan for revision.

Evaluation

The Subcontracting Plan Review process involves three approvers.

1. Evaluation CO

2. Evaluation SBS

3. Evaluation SBA PCR

If you still need technical help, contact us at client.support@apexlogic.com.