RFP_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 6

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

01 1/31/2024

6. ISSUED BY CODE JTL 7. ADMINISTERED BY (If other than Item 6) CODE National Institutes of Health National Institute on Drug Abuse Office of Acquisitions c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

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

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

75N95024R00025

9B. DATED (SEE ITEM 11)

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 MAY 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: February 9th, 2024, 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)

Solicitation Number RFP 75N95024R00025 “Clinical Coordinating Center for NIDA’s Clinical Trials Network”

Amendment 01

The purpose of this amendment # 01 is to clarify the RFP requirements by responding to questions submitted. Unless specifically noted, all other terms remain unchanged.

1) Question: In the instructions to the offerors, the technical proposal is limited to 200 pages.

Please clarify if this page limit excludes appendices.

This page limit excludes appendices.

2) Article H.14.A.2.iv, p. 23 states that the contractor should “Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s).” Please confirm if the Government is willing to modify the one (1) hour requirement to a 24-hour requirement.

No, the Government is not willing to modify the one (1) hour requirement. The 1-hour response requirement is an HHS policy that is based on NIST and US-CERT guidelines.

3) Please confirm if the Government is willing to accept equivalent industry-accepted encryption standards, such as Bitlocker and Oracle TDE, and CIS configuration/hardening, as applicable.

Yes, the Government is willing to accept equivalent industry-accepted encryption standards.

4) The first bullet point requires the contractor to “Configur[e] its systems to allow for periodic HHS vulnerability and security configuration assessment scanning.” Please confirm if the Government is willing to accept modification of this requirement to allow the Contractor to conduct/provide scans without requiring granting external access for vulnerability assessment/scanning to HHS?

Yes, the Government is willing to accept modification of this requirement.

5) The general listing of FAR/HHSAR clauses appears to be missing. Can the Government please provide the full list of anticipated FAR/HHSAR clauses (understanding that the organizational structure of the successful offeror(s) will determine the specific general clause listing to be contained in the contract(s) awarded)?

The General Clauses for a Cost -Reimbursement Research And Development Contract have been incorporated by reference. As stated on page 34 of the solicitation the, The complete listing of these clauses may be accessed at: https://oamp.od.nih.gov/DGS/reference-material-prospective-offerors-and-contractors. A digital PDF of these clauses can be viewed at:

https://oamp.od.nih.gov/sites/default/files/dgs/Article%20I_1%208-NEGOTIATED%20COST-

REIMBURSEMENT%20RESEARCH%20AND%20DEVELOPMENT%20CONTRACT%2011

-23.pdf. Also, the full text of a clause may be accessed electronically as follows: FAR Clauses at:

https://www.acquisition.gov/browse/index/far. HHSAR Clauses at: https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html.

https://oamp.od.nih.gov/DGS/reference-material-prospective-offerors-and-contractors https://oamp.od.nih.gov/DGS/reference-material-prospective-offerors-and-contractors https://oamp.od.nih.gov/sites/default/files/dgs/Article%20I_1%208-NEGOTIATED%20COST-REIMBURSEMENT%20RESEARCH%20AND%20DEVELOPMENT%20CONTRACT%2011-23.pdf https://oamp.od.nih.gov/sites/default/files/dgs/Article%20I_1%208-NEGOTIATED%20COST-REIMBURSEMENT%20RESEARCH%20AND%20DEVELOPMENT%20CONTRACT%2011-23.pdf https://oamp.od.nih.gov/sites/default/files/dgs/Article%20I_1%208-NEGOTIATED%20COST-REIMBURSEMENT%20RESEARCH%20AND%20DEVELOPMENT%20CONTRACT%2011-23.pdf https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

6) Please confirm if the Contractor will be responsible for maintaining the Study eTMF for all studies under this program. Also, please confirm if these will be ‘full’ eTMF or just limited to ‘regulatory’ sections.

eTMF will be required for all studies for which support is contracted. The eTMF will include documents related to the contract’s SOW, primarily regulatory documents (e.g., copies of all IRB approved protocols and approved consent forms and intervention, human subjects and GCP training documentation).

7) Please provide an estimate of the number of IND and NDA submissions to the FDA planned per year.

For proposal purposes, NIDA estimates one new IND study per year.

8) Please provide an estimate of the number of CTN’s policies and guidance documents to be reviewed per year.

For proposal purposes, contractors may assume an annual review of the CTN policies and procedures guide, and 5 additional topic-specific guidance documents per year will be required.

9) The type of on-site visits (initiation, periodic interim and closeout) described in Task 2.a.

refer to activities typically performed by CRAs (Monitors); however, they are listed as ‘QA’ visits. Please confirm these visits are part of the regular ‘Monitoring’ responsibilities (as defined in ICH/GCP E6 (R2) – 1.38; 5.18) or if QA Auditors should be involved in these visits too?

The initiation, periodic interim and closeout visits are conducted by CRA monitors.

10) Could you please provide NIDA templates (or examples), if available, of the plans listed in

Task 6a.?

SECTION J - LIST OF ATTACHMENTS, is amended as follows:

Attachment 18: Additional templates (examples). See Attached.

11) The Government mentions the offeror must possess a DEA Research Registration for Schedules II-V controlled substances and finally must possess or demonstrate the ability to obtain a DEA registration for Schedule I controlled substances. Can the government clarify which registration would be needed for Schedule I controlled substances?

Per Article B.5, “For the duration of the contract, the Contractor agrees to maintain, at no direct cost to this contract, the required DEA Research or Chemical Analysis Registrations (Schedule I, Schedules II to V) for working with scheduled drugs”.

12) Will the government require any additional DEA registrations such as DEA Distribution Registration or DEA Analytical Registration?

As stated in SECTION M on page 78 of the Mandatory Qualification Criteria, “This project involves the use of scheduled drugs under the Controlled Substances Act of 1970. Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess a DEA Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970. In addition, the successful offeror must either possess, or demonstrate the ability to obtain a DEA registration for Schedule I controlled substances.” Specifically, the Contractor must posses the DEA registrations necessary to support the work described in Task 4 of the Statement of Work.

13) Can the government provide clarification as to why a DEA Research Registration is required versus a DEA Distribution Registration?

Please refer to the response above to question 12.

14) What is the government’s estimate for adequate storage space of the study products? Will the study material require any other storage conditions outside of ambient climate controlled?

For proposal purposes, please assume that storage space will vary depending on new study requirements but is expected to include secure ambient and temperature-controlled settings.

15) The government mentions that packaging of the study product will be needed. Is this secondary or primary packaging of study material? What type of secondary packaging will be required?

For proposal purposes, please assume the Contactor may be required to package individual study participant kits from bulk supplies, package components for single-use, label packaging for study use per protocol, etc.

16) Can the government clarify the qualitative and quantitative confirmatory analyses desired for the study product?

The Contractor may be required to evaluate the presence of (qualitative) and how much of (quantitative) a study drug is present in study medications.

17) Under the Section H.14.1 “standards for encryption” is listed, “Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.” Please clarify the operations related to this requirement, in terms of any required vendor (CRO) IT support or ownership.

Use of HHS PIV cards or COR distribution of keys would not be required for this system.

However, use of a key recovery mechanism should be incorporated into the contractor/vendor operations for their own key management purposes.

18) H.14.1.C.2.v, p. 26. This section requires the contractor to “Provide full access and cooperate on all activities determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents.” Can the Government please clarify what is considered “full access” and whether the Government is willing to accept modification of this requirement to allow the Contractor to conduct/provide scans without requiring granting external access for vulnerability assessment/scanning to HHS?

In this context, “Full access” is not physical or logical access to system components but that all materials deemed pertinent to incident responses are provided (or are accessible) to Federal Government personnel responsible for the oversight and management of the security and privacy of the systems information. The Contractor may conduct/provide scans without having to grant external access to HHS.

19) Please confirm if the Government is willing to accept patch releases within 30 days of vendor release for workstations and internet-facing systems and 90 days of vendor release for all other systems (with severe/immediate/imminent threat patches applied immediately).

Yes, the Government is willing to accept patch releases within 30 days of vendor release for workstations and internet-facing systems and 90 days of vendor release for all other systems (with severe/immediate/imminent threat patches applied immediately).

20) Attachment 3 - Statement of Work, page 9, C. Task Orders for Proposal Evaluation. For

Sample Task Order A (Administrative and Concept Support Services), please confirm the budget should only be 4,000 hours of effort in Year 1. Or alternatively, does the Government want to see 4,000 hours of effort budgeted in each of Years 1 through 5?

For proposal purposes, the budget for Sample Task Order A should be based on 4,000 hours of effort in Year 1 only.

For Sample Task Order A (Administrative and Concept Support Services) and Sample Task Order B (Research Protocol Development), please confirm that labor hours associated with subcontractors and vendors for Task 4 and Task 5 (e.g., pharmaceutical services/investigational product depot; drug testing/analytical laboratory; etc.) do not count towards the 4,000 labor hours (Sample Task Order A) and 9,000 labor hours (Sample Task Order B)

This is correct, the labor hours for Task 4 and Task 5 do not count towards the 4,000 labor hours and 9,000 labor hours, respectively.

21) Attachment 3 - Statement of Work, pages 3-8, Tasks 1, 2, and 6.

1. Will the CCC be responsible for product safety services, such as monitoring

SAEs/medical monitoring, safety reporting, DSMB coordination and support, etc.?

Yes, the CCC will be responsible for product safety services, such as monitoring SAEs/medical monitoring, safety reporting, DSMB coordination and support.

2. Should offerors propose a Safety Database that can integrate with the NIDA CTN Data and Statistics Center’s EDC system?

The Contractor should anticipate working with the CTN Data and Statistics Center to maximize efficiency and effectiveness. This may involve the use of a contractor proposed safety database or obtaining access to the DSC’s EDC system.

3. Can NIDA please specify the EDC system deployed by the NIDA CTN DSC?

The DSC uses Advantage eClinical.

22) In the event a non-incumbent offeror is chosen as the successful awardee for the NIDA CCC, please confirm NIDA’s expectations for the “Transition Period” of the 15-20 simultaneous studies from the incumbent contractor to the new contractor (e.g., 3 months, 5 months, 6 months, etc.). Also, how quickly after award does NIDA expect to receive the successful awardee’s Draft Transition Plan and subsequent Final Transition Plan?

The RFP has been updated to clarify the expectation that transition of work would be expected to happen within 90 days. The following RFP sections have been updated:

1. Section L, INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, subpart 2.b.1.a.1., Objectives (page 60 of the RFP) is amended as follows:

“Provide a schedule for completion of the work and delivery of items specified in the statement of work to include activities necessary for the orderly transition of services being provided by the predecessor Contractor within 90 days of contract award.”

2. SECTION M – EVALUATION FACTORS FOR AWARD, subpart 6. 2. , Technical Evaluation Factors – Management Plan (page 79 of the RFP) is amended as follows:

“Evaluate the proposed management plan on its ability to effectively conduct, manage, and coordinate the resources to ensure successful operation of the technical plan to carry out the proposed project to include plans for the transition of services being provided by the predecessor Contractor (if applicable).”

Contractors should address transition activities within their technical plan.