75N95023R00001_Amendment 02.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 6

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

02 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) 07/31/2023

Request for Proposal Amendment No. 02 75N95023R00001 Page 2 of 7

RESPONSE TO QUESTIONS

QUESTION 1: Given the seniority and prolific publication history of our academic SMEs, limiting the resumes of personnel to five pages will not provide NIDA with adequate background of the capability and scientific prowess of proposed personnel. Would NIDA consider removing the 5-page limit on resumes so that the depth of expertise and relevant scientific publications can be fully provided.

RESPONSE 1: Please limit the size of individual resumes. Offeror could focus on highlighting expertise that is most pertinent to the requirements of the RFP and could leverage citation links for publications.

QUESTION 2: The Small Business Subcontracting Plan template states the HHS 2022 SB Goal is 33.25%, but the RFP states the current 2023 Goal is 32%. Will the Small Business Subcontracting Plan template be revised to reflect the requirements of the solicitation?

RESPONSE 2: As stated on page 186 of the RFP, “HHS expects each procuring activity to establish minimum subcontracting goals for all procurements. The anticipated minimum goals for this RFP are as follows. (a) 32% for Small Business; 5% for Small Disadvantaged Business; 5% for Women-Owned Small Business; 3% for HUBZone Small Business; and 3% for Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small Business”. The current Small Business Subcontracting Plan Template still reflects the goals from 2022 and will not be revised. However, please refer to Section L.2.c.6.a. on page 164 of the solicitation, “An offeror's subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to the contract award. 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 must follow the instructions outlined in the SBCX Industry Guide 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.” Therefore an updated template will not be required.

QUESTION 3: Can NIDA please provide a list of Primary Sampling Units (PSU) and Secondary Sampling Units (SSU), as the solicitation did not include this data? Only the incumbent company currently managing the PATH Study will be able develop an effective sample design to meet solicitation requirements if this Primary and Secondary Sampling Unit data is not provided to all offerors, thereby creating an anti-competitive environment where only the offeror has information critical to providing an effective solution to improve the efficiency and effectiveness of PATH Study operations. Please include locations and sizes of the current PATH Study PSUs, and how heavily each PSU has already been sampled?

RESPONSE 3: As stated on page 20 of Attachment 3 Section C, “The Contractor shall ensure that the sample design includes sample-size calculations that specify the number of sampling units (e.g., for the baseline data collection, this was 156 Primary Sampling Units [PSUs]) to screen and the target number of adults and youth to recruit and retain at each wave and thereafter. The Contractor shall additionally ensure that the sample design used for cohort replenishment specified under the Period of Performance shall be capable of meeting the PATH Study analytic requirement of producing

75N95023R00001 Page 3 of 7 national-level estimates of behavioral and health measures with an average relative standard error of no more than five (5) percent and with sufficient power to stratify analyses by such factors as tobacco user status (current, former, never), type of tobacco product(s) used, race/ethnicity, age, gender, and/or other characteristics, as specified by the COR. The Contractor shall also consider rebalancing the sample as needed and specified by the COR (e.g., de-select certain participants or change the criteria or definition for oversampling) to ensure the PATH Study collects data from participants that helps meet the PATH Study objectives.” Given this information and your experience and expertise, please develop a sample design plan that will best meet the Government’s requirement.

QUESTION 4: To comply with the requirements of Section L.2.a.16.D, will the Government please confirm that to meet FedRAMP Assessment and Authorization (A&A) requirements and ensure that the information systems/service under this contract has a valid FedRAMP compliant ATO in accordance with FIPS 199, a 3PAO audit must be completed prior to an Authority to Operate (ATO) for PATH being granted and that the ATO must be obtained within 90 days of award?

RESPONSE 4: NIDA understands the complexities obtaining a FedRAMP compliant ATO and would waive the 90-day requirement. A new deadline would be established after post-award discussions between the awardee and the NIDA Information Security Team. However, the NIDA ISSO would strongly recommend the use of established FedRAMP approved hosting/application environments due to the significant delays in sponsoring a new FedRAMP authorized service.

QUESTION 5: Under Articles F.2. Deliveries Item 65 for the ATO, per FedRAMP requirements, please confirm that the government requires that a 3PAO audit be completed and that offeror’s solution is represented on the FedRAMP marketplace prior to an Authority to Operate (ATO) being obtained and that the FedRAMP representation and ATO must be obtained within 90 days of award?

RESPONSE 5: The government requires a 3PAO or independent internal assessment team to perform a full FISMA-compliant assessment, following established NIST guidance, on the offeror's solution and that it follows the guidance presented in response to Question 4.

QUESTION 6: There appears to be a difference in terminology between the Section L Instructions and the Section C Work Statement. Are data archive organization referenced in Section L and data repository organization referenced in Section C the same organization?

RESPONSE 6: These refer to the same organization.

QUESTION 7: Given that all submissions of Technical and Business Proposals are required to occur through the NIH eCPS system, will the Government confirm that the only required copies for submission are those copies submitted through the eCPS system, and therefore the requirements of the referenced narrative text are no longer applicable to PATH RFP 75N95023R00001. Please remove the requirements of the referenced section.

75N95023R00001 Page 4 of 7

RESPONSE 7: As stated in Section A of the Solicitation, “proposals as stated in ATTACHMENT 1, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website. "Proposals submitted by any other means such as facsimile, hard copy or e-mail will not be accepted.”

As such Section L.2.a.2. is amended as follows:

“The proposal must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this RFP. Your proposal shall be submitted in accordance with Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, Part III, Section J hereof. To expedite the proposal evaluation, all documents required for responding to the SOLICITATION should be placed in the following order:”

QUESTION 8: Given the need to consider rebalancing the sample and ensure that the sample is capable of meeting the PATH Study analytic requirements, including sufficiently powered analyses within strata of age, please confirm that in addition to replenishment of a shadow sample (Section 4.2.2.1) and a youth sample (Section 4.2.2.2), offerors may propose replenishment of an adult sample.

RESPONSE 8: Yes, offerors may propose innovative approaches and solutions in addition to the requirements defined in the SOW. As stated in Section L.2.a.5. Alternate Proposals, “You may, at your discretion, submit alternate proposals, or proposals which deviate from the requirements; provided, that you also submit a proposal for performance of the work as specified in the statement of work. Such proposals may be considered if overall performance would be improved or not compromised and shall clearly identify why the acceptance of the proposal would be advantageous to the Government. Any deviations from the terms and conditions of the solicitation, as well as the comparative advantage to the Government, shall be clearly identified and explicitly defined. The Government reserves the right to amend the solicitation to allow all offerors an opportunity to submit revised proposals based on the revised requirements.”

QUESTION 9: If existing PATH Study participants engage in follow-up data collection waves that use collection modes beyond those described in their original consent form (e.g., computer, telephone), will reconsenting be required?

RESPONSE 9: Government expects the offeror to use their organization’s IRB guidance on when reconsenting will be required.

QUESTION 10: In order to propose data collection methods that are complementary to the prior PATH Study main waves (as described in Section 4.3), is there a current reconsenting process established and is reconsenting required?

RESPONSE 10: Please refer to the response above in Question 9.

QUESTION 11: Please confirm that Task 1.5 does not include activities related to the development and implementation of standardized procedures for the receipt and review of applications from independent researchers to require data from the data repository.

75N95023R00001 Page 5 of 7

RESPONSE 11: Task 1.5 activities do not involve independent researchers to deposit data. Task 1.5 solely refers to coordination of the PATH Study Contractor with a Data Repository Organization.

QUESTION 12: Given the historical support of ExamOne as the biospecimen collection organization and Fisher BioSciences as the biorepository organization, to avoid risk to the PATH study and support seamless continuity of PATH Study operations, will the Government direct the use of ExamOne and Fisher Biosciences? If so, will the Government provide Government estimated cost for each vendor for proposal purposes.

RESPONSE 12: Government does not direct the use of any particular organization or subcontractor to meet the Task 9 requirement. Offerors should identify and propose potential subcontractors and their related costs in their proposal.

QUESTION 13: Considering the critical PSU and SSU information and details are absent from the solicitation as released, would the Government consider extending the due date by 3 weeks (to 1 SEPT) and provide the PSU and SSU information to ensure all offerors are able to maintain the integrity of the cohort in their sample design

RESPONSE 13: Please refer to the response in Question #3. Government is unable to extend the due date for this solicitation.

QUESTION 14: Is it acceptable for subcontractors to submit proprietary pricing packages directly to the Government? The solicitation as released does not provide language that allows separate submission of fully disclosed subcontractor pricing and subcontractors may not wish to share fully disclosed pricing with Prime contractors. If separate submission of proprietary pricing by subcontractors is acceptable, please provide instructions and format on how subcontractor proprietary pricing should be submitted to NIDA.

RESPONSE 14: Please refer to Section A of the Solicitation, “proposals as stated in ATTACHMENT 1, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website. "Proposals submitted by any other means such as facsimile, hard copy or e-mail will not be accepted.”

Additionally, please refer to Section L.2.c.3.b.3 on page 181 of the solicitation, “Subcontracted Items Include parts, components, assemblies, and services that are to be produced or performed by others in accordance with offeror's design, specifications, or direction and that are applicable only to the prime contract. For each subcontract over $750,000, the support should provide a listing by source, item, quantity, price, type of subcontract, degree of competition, and basis for establishing source and reasonableness of price, as well as the results of review and evaluation of subcontract proposals when required by FAR 15.404-3.” Please also refer to Section L.2.c.12. on page 192 of the solicitation, “If subcontractors are proposed, please include a commitment letter from the subcontractor detailing:

a. Willingness to perform as a subcontractor for specific duties (list duties).

b. What priority the work will be given and how it will relate to other work.

c. The amount of time and facilities available to this project.

d. Information on their cognizant field audit offices.

e. How rights to publications and patents are to be handled.

f. A complete cost proposal in the same format as the offeror's cost proposal.”

75N95023R00001 Page 6 of 7

QUESTION 15: we understand that there will be substantial overlap between periods of performance. We also understand that all costs will need to be segregated by period of performance and by task as to not duplicate costs. The provided Excel spreadsheet (Attachment 13) does not provide an effective way to segregate costs by task or show overlapping periods of performance. Given this, is it acceptable to provide pricing in the contractor’s own format, ensuring all costs are detailed at the level described in Section L.2.C.1?

RESPONSE 15: As stated in Section L.2.c.1, “The business proposal must contain sufficient information to allow the Government to perform a basic analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price. These elements will include, as applicable, direct labor, fringe benefits, travel, materials, subcontracts, purchased parts, shipping, indirect costs and rate, fee, and profit.

Offerors should include the detailed cost information for all required tasks and all optional tasks in for each period of performance.”

Additionally please reference Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website.

If the provided Excel spreadsheet (Attachment 13) does not provide an effective way to segregate costs by task or show overlapping periods of performance, then the offeror should submit a format that complies with the requirements and detail requested.

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