RFQ Ammendment 01 SF-30.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 4

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 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, Maryland 20892-9559

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

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

RFQ No. 75N95020Q00197

9B. DATED (SEE ITEM 11)

September 30, 2020

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 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, 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.

Proposal Due Date: 3:00 p.m. (Eastern) on October 14, 2020 (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)

Joshua T. Lazarus, 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)

BY

(Signature of Contracting Officer)

October 8, 2020

Request for Proposal Amendment No. 01 75N95020Q00197 Page 2 of 4

Question 1: On page 5 of the Statement of Work it mentions “When at full capacity, the average remuneration expenses are approximately $210,000 per year or approximately $17,500 per month. However, this amount fluctuates based on the number of studies running, the number of candidates brought in for screening, and the number of study visits per day.” Is this for the base period per year or inclusive of the option quantity two tasks (i.e. A, B, C & D)?

Answer 1: As described in the Attachment 1 – Statement of Work, the average remuneration expenses are approximately $210,000 per year or approximately $17,500 per month. This total amount assumes that NIDA IRP is operating at full capacity and includes the use of approximately $100,000 in Option Quantities.

Question 2: For Option Quantities Two: A, B, C & D, are the amounts listed only ODC’s plus applied G&A or inclusive of labor or should all labor be incorporated into the base period? Also, since the government provides the funding amount is the offeror still required to provide a detailed budget for those optional quantities or can the offeror just budget for the amount identified in the RFP? Without additional information it would be difficult for the offeror to provide a detailed budget for the option quantities two. Please advise for budging purposes.

Answer 2: As stated on pages 9 and 10 of Attachment 1 - Statement of Work, “the Contractor shall provide additional funds for participant remunerations as directed by the NIDA IRP. The Contractor shall also provide for other direct costs related to participant remuneration, participant travel and meals, and other protocol or screening equipment and supplies. These costs shall be paid by the Contractor and passed through to the Government.” Therefore, all labor should be incorporated into the base period. Offerors should prepare a budget for each option quantity to identify the amount which will be directly be provided to participants as Remuneration and Other Direct Costs Support as well as any additional other direct costs which would be associated with the dissemination of the funds (if any).

Question 3: How often will a contractor staff member need to provide each, debit/gift or check payments to participants onsite (i.e. once a week, once every other week, X times a month)?

How much notice will the contractor be provided to be onsite (two weeks, one week, one month?

Answer 3: Historically, the equivalent of (1) Full-Time Employee (FTE) has been present on-site at NIDA IRP to disperse remuneration to study participants. Generally, the NIDA IRP Study teams book participants in advance and will send notification to all staff involved regarding support needs (e.g. nursing time, screening time) and will also include an approximate total payment amount for Remuneration which the Contractor will need to have available to pay participants. The scheduling is flexible to accommodate study participants, but the NIDA IRP Study team will provide approximately 2-7 business days advanced notice. In some cases, studies may schedule participants as far as 2 weeks in advance or more when possible. NIDA normally attempts to schedule participants during normal business hours however, however the Offeror should be able to provide flexible staffing to ensure coverage from time-to-time during the evenings and on weekends. Please note that Participant cancellations do occur, and when they do, NIDA will attempt to fill in the appointments with other participants if an open slot is available. As a result, bookings can be done with less than 24hrs notice and require flexibility from contracted support services.

NIDA currently uses an email notification system and electronic calendar system for scheduling participants. Most participants opt to be paid in cash unless the study is setup

75N95020Q00197 Page 3 of 4 otherwise. Therefore, it will be important for the Contractor to have enough cash on-hand to compensate participants. Cash is typically dispersed daily. If checks are provided as compensation (depending on the study), it’s possible for the Contractor to provide the checks to the NIDA Study team during the week (e.g. Friday afternoon), so that NIDA can disperse to the participant on weekend study days. Check frequency ranges from rare to multiple times per week, depending on the study and participant requests. However, with several studies starting remote procedures, checks are becoming more common and can be as often as daily. Checks can be mailed directly to participants from an offsite location with the proper procedures in place (e.g. all the remote IT compliance requirements in place to access our clinical database via VPN, to track remuneration credits and debits, etc.). Gift cards are typically handled like cash and dispersed in person.

Question 4: Is the schedule for participants’ studies mostly firm for the given year? How far in advance are participants’ schedules to participate in a study onsite at NIDA?

Answer 4: Please also refer to the response above in Answer 3. Participant scheduling will vary based on the nature of the study and its approved protocol. It is important that the Contractor be able to provide flexible staffing because each study timeline and participation requirements are different, and schedules can change due to cancellations, no shows, etc.

Some studies may require a one-time visit lasting 2-8hrs, while other studies may have multiple visits based on a set (but not rigid) timeline. The scheduling is flexible to accommodate study participants, but the NIDA IRP Study team will try to provide approximately 2-7 business days advanced notice. In some cases, studies may schedule participants as far as 2 weeks in advance or more when possible. NIDA normally attempts to schedule participants during normal business hours however, however the Offeror should be able to provide flexible staffing to ensure coverage from time-to-time during the evenings and on weekends to disperse remuneration. Upon award, NIDA will work with the Contractor to establish a process for this.

Question 5: On page 3, are the specifications listed in the sample protocol also to be used for price quote purposes. If so, the sample protocol specifications are based on 24 months, so I assume you would budget for half the quantity per year?

Answer 5: The Sample Protocol described on pages 3-5 of the solicitation should provide the framework for Offerors to develop a Sample Remuneration Plan (SRP). The SRP is not intended to be the basis for the Business Quote. The intent of the SRP is to obtain a better understanding of the Offeror’s approach and methodology to provide remuneration, travel and subsistence, and other research-related supply management support services. A complete SRP shall describe the administrative and management oversight of providing real-time payments, flexibility with methods of participant payments as well as tracking and accounting for payments made to individual participants. The SRP should also include a description of contingency planning efforts, a detailed chain of custody plan to manage all payments and the cash needed onsite to make daily cash payments, and alternative strategies to overcome potential challenges associated with provide remuneration, travel and subsistence, and other research-related supply management support services for participants. Upon award, NIDA will provide the Contractor with examples of historical strategies used and is willing to work with the Contractor to establish a process for after-hours remuneration, travel and subsistence.

75N95020Q00197 Page 4 of 4

Question 6: Given that this is a Time and Materials /Labor Hour contract, I assume that if the offeror has a GSA schedule, they can use their approved GSA labor rates along with any proposed discount?

Answer 6: As stated on page 2 of the solicitation, “NIDA anticipates the use of a Time and Materials / Labor Hour (T&M/LH) type contract as a result of this solicitation. If an award is made as a result of this solicitation, NIDA shall establish a ceiling price for the contract that the Contractor shall not exceed.” Please note that if an award is made as a result of this solicitation it will not be a GSA Task Order. However, if an offeror has a GSA schedule with approved fully loaded labor rates, they may submit quotes based on the approved GSA labor rates along with any proposed discount. If an Offeror does submit rates in accordance with the GSA schedule contract, please include the GSA Contract Number and Schedule of Contract Rates as part of the Business Quote.

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