Amendment2_75N95022R00050.pdf

OMB No. 0990-0115

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

1 2

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

NIDA Section, Contracts Management Branch Blue Office of Acquisitions, NIDA National Institute on Drug Abuse, NIH 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.

75N95022R00050

9B. DATED (SEE ITEM 11)

June 15, 2022

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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 ACKNOWLEDG- MENT 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, x 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 amend the Request for Proposal (RFP) to answer questions to the solicitation.

Proposal Due Date: August 15, 2022, 2:00 PM EST (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.

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)

Khurram Shaikh, Contracting Officer, NIDA Section, CMB Red

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

16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

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

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48CFR) 53.243

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.

1. Article H.34. specifies that the contractor shall provide NARA-certified document storage for this contract. Should storage be included in the Performance Area A fixed price, 5-year budget for up to 15 studies total or if it should be included under each Task Order budget (Performance Area B)?

Answer: Requirements of storage or records will be at the TO level and will be on a as needed basis.

2. Specific to the Level of Effort table on page 66; Can you provide a full version of the table?

Answer:

Labor Category

Base Period

Labor Hours

Sample Task Order A - Protocol Development and Study

Preparation 1,000

Sample Task Order B - Study Implementation 9,000

3. For Performance Area A fixed price budget, should the vendor budget for 1,000 hours per year for 5 years (5,000 total hours)?

Answer: Yes (see attachment 1, page 1)

4. For Performance Area A (Overall Clinical Operations Support) can the government advise budget type?

Answer: NIDA anticipates a fixed price type but vendors may propose alternative contract types if they prefer.

5. For Performance Area B (study implementation), should the vendor budget for 9,000 hours over 12 months (1-year)?

Answer: No, task order of this nature will require an estimated 9,000 hours of effort in the base period of one year, with an additional four 1-year option periods to support a trial (see attachment 1, page 1)

6. For Performance Area B (study implementation), can the government advise budget type?

Answer: NIDA anticipates a cost plus fixed fee type but vendors may propose alternative contract types if they prefer.

7. For Performance Area B (study implementation), should the 9,000 hours be broken up into the following total cost components:

1. Base Requirement: Protocol Development and Study Preparation

2. Quantity Option: Study Implementation

Answer: Yes

8. Can the Government provide a study protocol, protocol synopsis, or additional specifications and assumptions for the medical device study that will be conducted for 9,000 hours?

Answer: Yes (see Sample Task Order B; attachment 1 page 1)

9. Does the CV/Resume have a page limit?

Answer: No, the CV/Resume count toward part of the 200 page Technical Proposal limit.

10. Is the Technical Proposal Cost Summary exempt from the 200 page Technical Proposal page limit?

Answer: The cost summary should be included in the Business Proposal

11. Is the Summary of Related Activities exempt from the 200 page Technical Proposal page limit?

Answer: No, the Summary of Related Activities count toward part of the 200 page Technical

Proposal limit.

12. Is the Section 508 VPATS exempt from the 200 page Technical Proposal page limit?

13. For following two (2) separate budgets in standalone Excel workbooks, would the government prefer separate budgets in standalone excels?

1. Performance Area A - 5-year fixed price budget (see attachment 1 page 1)

2. Performance Area B - 1-year cost reimbursement budget for 9,000 hours + 4 option years (see attachment 1 page 1)

14. Article H.32.1.1.a.i.a.iv (p.34) 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). Is the Government be willing to modify the one (1) hour requirement to a 24-hour requirement?

15. Article H.32.3.1.d.i and ii (p. 40) outlines a number of configuration standards for COCO systems.

Is the Government be willing to accept equivalent industry-accepted encryption standards, such as Bitlocker and Oracle TDE, and CIS configuration/hardening, as applicable?

16. The first bullet point under Article H.32.3.1.d.v requires the contractor to “Configur[e] its systems to allow for periodic HHS vulnerability and security configuration assessment scanning.”

Is the Government 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?

17. Would a bid submitted on a firm fixed price commercial basis be eligible for consideration under the RFP proposal instructions?

Answer: NIDA anticipates a Cost reimbursement type contract however if a vendor submits a firm fixed price contract, NIDA will consider the proposal.

A. Task Orders for Proposal Evaluation

1. For purposes of proposal preparation, offerors are to provide a technical proposal and cost estimates for each of the two types of task orders described below. The types summarized below are general descriptions of task orders that BPMT anticipates ordering under the contract. However, throughout the ordering period of this contract, task orders may involve one or more of the tasks described in the Clinical SOW and are not limited by the types described below.

a. Sample Task Order A – Protocol Development and Study Preparation

This sample task order requires services as described in Performance Area B, Base Requirement in the SOW to support preliminary clinical study protocol development and study preparation. It will also include support for administrative tasks such as report writing, invoicing, maintaining certifications, and other tasks necessary to meet the needs of the contract. The offeror will demonstrate their understanding of this task by describing the work needed to be performed in preparation for a clinical study.

For proposal preparation purposes, offerors may assume that a task order of this nature will require an estimated 1,000 hours of effort over a period of one year, with an additional four 1-year option periods.

b. Sample Task Order B – Study Implementation

The contractor shall provide for implantation of the clinical study as described in Sample Task Order A above. This includes clinical study implementation and management from initiation through closeout. The offeror will demonstrate their understanding of this task by describing the work needed to be performed from the information in Performance Area B, Quality Option.

For proposal preparation purposes only, offerors may assume that a task order of this nature will require an estimated 9,000 hours of effort in the base period of one year, with an additional four 1-year option periods to support a trial with the following characteristics:

Study Design: Participants will be undergoing medical device testing with a randomized active-sham crossover study.

Population: A total of 80 participants will be randomized from among 5 study sites.

Device: Fully implanted neural stimulation system.

Testing: Pre- and post-op imaging with MRI and CT. Standard pre- and post-op bloodwork.

Study Timeline: 36 months (study start-up = 8 months, recruitment phase (ongoing) = 12 months, treatment phase = 6 months per participant, follow-up phase = 6 months per participant, and 4 months study closeout)

NIDA intends to award a Task Order of Type A at the time of contract award. Task Order Type B will be awarded upon successful completion and review of the information from

Sample Task Orders Attachment 1

TO Type A. Additional Task Orders will be awarded as program needs arise.

Sample Task Orders Attachment 1