Amendment 2 75N95025Q00022.pdf

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 items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE 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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

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

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

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

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 Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER 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, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Two (2)

The PURPOSE of this amendment is to 1) provide government responses to interested offeror questions and 2) make changes to the solicitation as follows.

National Institutes of Health National Institute on Drug Abuse Bethesda, MD 20892-7511

Interested Offerors

National Institutes of Health National Institute on Drug Abuse Bethesda, MD 20892-7511

75N95025Q00022

1 9

11/20/2024

11/20/2024

RFQ No. 75N95025Q00022 PROGRAM TITLE: Clinical Site and Study Monitoring for NIMH Funded Research in

Global Settings Amendment No. Two (2)

Questions and Answers (Q&A)

A. This amendment provides responses to questions received concerning the above numbered RFQ as stated below.

Offeror Question Number

Solicitation Page

Solicitation Section

Offeror Question Government Response to

Offeror Question

1 2 (vi) Please confirm if the offeror is required to provide a firm fixed price task order budget for the kickoff meeting.

Offerors shall provide a firm-fixed price task order price for evaluation purposes as the first task order is anticipated to be for a kick off meeting with a one-month period of performance effective at time of award.

2 2 Offerors must complete provisions

Please confirm that the required provisions are excluded from the combined ten-page limit for the Technical and Business Proposals

The required provisions are excluded from the combined ten-page limit for the Technical and Business Proposals.

3 3 (vii) Factor 2:

Key Personnel

Please confirm that the draft training plan and quality control plan are excluded from the combined ten-page limit for the Technical and Business Proposal

Offerors should include sufficient information for the management plan, draft training plan and quality control plan to ensure these elements can be evaluated in the technical approach per the evaluation criteria set forth in the solicitation. The management plan, Offeror Question Number

Solicitation Page

Solicitation Section

Offeror Question Government Response to

Offeror Question draft training plan and quality control plan are excluded from the combined ten-page limit for the Technical and Business Proposal.

4 5 (xi) Please confirm that Offerors are to provide a budget for the maximum number of annual monitoring visits per the RFP SOW (page 4 and 5).

Offerors should submit a budget for a sample task order on a firm-fixed price basis for price reasonableness evaluation purposes that accounts for the maximum number of clinical site and study monitoring estimated in accordance with the SOW. It is anticipated that task orders shall be issued on a as needed basis when NIMH has a need for the Clinical Site and Study Monitoring encompassing the SOW requirements in a specific global region. When needs arise the Government intends to issue a Task Order Request for Proposal (TORFP) and resultant task order.

5 5 (xi) Please confirm if Offerors should assume, for bidding purposes, that the maximum number of annual visits (12) should be evenly distributed

Offerors should submit with its offer its pricing in line with the maximum number of annual

Number

Solicitation Page

Solicitation Section

Offeror Question Government Response to

Offeror Question over the 6 regions listed in the RFP.

visits for the regions listed in the

SOW.

6 5 (xi) Does NIMH have a uniformed cost assumption for how many days on site should be estimated for each of the monitoring visits?

The number of days on site will be 3-5 days for each monitoring visit.

7 1 of 12 SOW 1. Are offerors required to submit a budget at this stage for the development of clinical site monitoring SOPs?

Please refer to government response to offeror question 4 above.

8 6 of 12 SOW C. Please confirm that no budget estimate is required at this time for any specialized clinical site monitoring visits.

Please refer to government response to offeror question 4 above.

9 7 of 12 SOW – Level of Effort

Please clarify if the 250 hours estimated for the Supervisory Program Manager are per year or are for the entire 5-year period of performance.

The 250 hours for the Supervisory Program Manager are per year. A supervisory PM shall be required for each task order issued on an as needed basis when a region is identified that requires monitoring and study site. The TORFP issued to the resultant contractor on an as needed basis during the ordering period of the IDIQ contract shall specify the Government’s estimated effort for key personnel including a supervisory PM.

For the purposes

Number

Solicitation Page

Solicitation Section

Offeror Question Government Response to

Offeror Question of price reasonableness evaluation, please quote based on 250 hours.

10 7 of 12 SOW – Level of Effort

Please confirm if Offerors are to provide a budget in our response for the estimated level of effort for the Supervisory Program Manager.

Please refer to government response to offeror question 9 above.

11 4 of 12 SOW The SOW states, “The general location of sites will be in Asia, South America, Central America, Pacific Islands, Eastern Europe, and Africa.” The expectation is that monitors will have country-specific knowledge of requirements and also be proficient in local language and dialects.

Could you please provide a list of potential countries?

Specific locations of countries depend on where the research is conducted that the government funds;

however, in the past, research has been conducted (included but not limited to) in Sierre Leone, India, Columbia, Ghana, Pakistan, Kenya, Chile, etc. TORFP issued during the 5-year ordering period shall specify the country/region when NIMH has identified a need for Clinical Site and Study Monitoring services.

12 3 of 73 RFP overall document

The RFP states, “The Contractor’s proposal shall provide a management plan detailing the proposed management approach as well as a draft training plan and quality control plan.”

Can you please confirm that these plans are excluded from the 10-page maximum

Please refer to government response to offeror question 3.

Number

Solicitation Page

Solicitation Section

Offeror Question Government Response to

Offeror Question for the Technical and Business Volume?

13 32 Additional Clauses Included in Full Text

A clause starts at #3 (“Information Security Categorization”) at the beginning of p. 32; the first part of the clause appears to be missing. Please confirm if these requirements from p.

32-39 are intended to be included and, if so, please amend the RFP to include the full clause

Please refer to the changes set forth in this amendment

(no. 2) for the missing language.

See B.1. below.

14 32 #4, Controlled Unclassified Information

Section 4, “Controlled Unclassified Information” outlines a number of security requirements applicable to CUI. Please advise what type of CUI will be delivered to the contractor under this contract

The type of CUI that shall be delivered to the contractor under this IDIQ contract/task orders issued is Personal Health Information (PHI).

15 33 #7, Internet Protocol Version 6 (IPv6)-

Please confirm if the government is willing to accept equivalent industry-accepted internet protocol standards?

IPv6 is required for any IT system associated with this contract.

16 34 #10, Standards for Encryption

Please advise if industry-equivalent standards for encryption, such as Bitlocker and Oracle TDE, and CIS configuration/hardening will be accepted

Encryption is required for all digitally stored and transmitted PHI information.

17 36 D, Incident Response

Item 3 states the contractor must, “Report all suspected and confirmed information security and privacy incidents and breaches to the NIH Incident Response Team (IRT) via email at IRT@mail.nih.gov , COR, CO, the NIH Office of the SOP (or his or her designee), and other stakeholders, including

One-hour is the HHS/NIH policy for reporting incidents.

mailto:IRT@mail.nih.gov

Number

Solicitation Page

Solicitation Section

Offeror Question Government Response to

Offeror Question incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour.” Please advise if the government will accept a 24-hour reporting timeline.

18 36 D, Incident Response

Item 4 requires the contractor to “Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and HHS/NIH and NIH privacy breach response policies when handling PII breaches.”

Please confirm

Confirmed.

19 38-39 G, CONTRACT

INITIATION

AND

EXPIRATION

This clause includes various general security requirements for Enterprise Performance Life Cycle and HHS System Development Life Cycle. Please confirm if the government will accept equivalent industry-accepted standards?

The security clauses in accordance with the solicitation must remain as written.

20 1 of 12 SOW1 Are offerors required to submit a budget at this stage for the periodic review (e.g., every two years or as needed) of clinical site monitoring SOPs?

Each TORFP shall specify the government’s requirements that shall include the estimated number of periodic reviews required for Clinical Site and Study Monitoring;

however, Offerors should submit with its offer a budget that includes a sample task order on a firm-fixed price basis for price

Number

Solicitation Page

Solicitation Section

Offeror Question Government Response to

Offeror Question reasonableness evaluation purposes that accounts for the maximum number of clinical site and study monitoring estimated in accordance with the SOW.

21 1 of 12 SOW1 Are offerors required to develop the 4 SOPs listed for this task from scratch or are there currently effective SOPs that could be revised/updated?

Offerors are required to develop new SOPs.

22 We just became aware of the opportunity for Clinical Site and Study Monitoring with NIMH. _____ would love an opportunity to submit a proposal and we kindly request an extension on the current due date.

As a result of this amendment (no. 2) that includes solicitation changes and government responses to interested offeror questions, the solicitation shall be extended until 2 PM EST on 11/25/2024. See B.2. below.

(End of answers to questions to the RFQ) B. This amendment revises the above numbered RFQ as stated below.

1. RFQ Attachment 2 – Additional Terms and Conditions, page 32 is hereby amended to delete in its entirety the first incomplete paragraph “under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.” and is replaced to incorporate the missing Information Security and/or physical access security language above paragraph d. as follows:

INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

A. Baseline Security Requirements mailto:fisma@hhs.gov

1. Applicability- The requirements herein apply whether the entire contract or order (hereafter "contract"), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor)will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar

2. Safeguarding Information and Information Systems- In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

• Confidentiality , which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity , which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability , which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less , bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

2. RFQ Section (xii) is hereby amended to extend the hour and date specified for receipt of offers as follows:

All offers must be received by 2:00 P.M. Eastern Time, on 11/25/2024, and reference Solicitation Number 75N95025Q00022. Responses must be submitted electronically to Cassandra Conley, Contract Specialist, at cassandra.conley@nih.gov.