RFP 75N95023R00009 - Amendment 01.pdf

(x)

75N95023R00009 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT 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.

x

NIDA

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

NIDA-EXEC

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

See 16.C

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

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

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

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

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

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

03/30/2023

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

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

ORDER NO. IN ITEM 10A.

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: May 05, 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

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

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

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

JOSHUA T. LAZARUS

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

AMENDMENT 01

RESPONSES TO QUESTIONS

1. Will all ques ons/answers be shared with all bidders?

Response: Yes. All answer to ques ons from poten al bidders will be shared with the public on sam.gov via amendment to the RFP.

2. It is understood that the quan ty is not known but can historical informa on on the number of sequences (by type of submission) submi ed per year over last 5 years be shared? (Amendment 3)

Response: For es ma on purposes please use the following submissions per year by submission type:

1. Ini al INDs: 0.5

2. Protocol Amendments: 2

3. Informa on Amendments: 4

4. IND Annual Reports: 2 full reports and 5 simplified reports

5. DMF Annual Reports: 4

6. DMF Amendments: 5

7. LOAs: 7

8. Administra ve Amendments: 2

9. PIND mee ng request and packages: 0.2

3. Does every tab on A achment 8 (Breakdown of Costs) need to be completed? If not, which are required? (A achment 8)

Response: It may not be necessary to complete all the tabs. Only those relevant to the services being requested and services proposed. Please complete all relevant tabs on A achment 08.

4. How should poten al new hires be listed in A achment 8 (Breakdown of Costs)? (A achment 8) Response: Please refer to Sec on L - Instruc ons, Condi ons, and No ces to Offerors, subpart 2(b)(1)(b) Personnel on pages 60 – 62 of the RFP.

5. Given the period of performance, the current staff of the Offeror may need to change, how would we report this in A achment 8 (Breakdown of Costs)? (A achment 8)

Response: Please refer to Sec on L - Instruc ons, Condi ons, and No ces to Offerors, subpart 2(c)(3) Data Other than Cer fied Cost or Pricing Data on page 64 of the RFP.

6. Can you share the current contract award number?

Response: HHSN271201700070C

7. How many paper submissions were done under the last 5 year contract (by year)?

Response: All submissions were electronic. On average approximately 30 submissions were done per year under the previous contract.

8. SOW - "When no new informa on is available for an IND annual report during a repor ng period, the awardee will be requested to prepare a simplified version of an IND annual report informing FDA of the lack of data." Would the awardee be wri ng the annual report? (A achment 3)

Response: The awardee is expected to write IND Annual Reports. Please refer to Sec on II subpart B(3) IND Annual Report Prepara on (simplified version) on page 6 of A achment 3 – Statement of Work for addi onal details.

9. SOW - NDA Submission "One original and four copies will be required for each NDA submission applica on in addi on to one electronic copy" - How many NDA submissions during the last 5 year contract were required to provide one original and four paper copies of the submission (by year)?

(A achment 3)

Response: None, however as described in Sec on II subpart B(7) of the SOW, if there is a need for paper copies, the awardee shall provide them. If there is no need, then paper copies won’t be required.

10. How many submissions were requested to send paper copies of the submission to NIDA and/or NIDA collabora ve partners according to the COR’s specifica ons under the last 5 year contract (by year)?

(A achment 3)

Response: None. All submissions were electronic filings.

11. On the SAM webpage it says “Original Date Offers Due: May 03, 2023 03:00 pm EDT” but in the document/pdf it says the due date is May 5th (on page 1). Can you confirm or explain the difference?

Response: As stated in SAM.gov and the RFP the proposal due date is May 05, 2023 03:00 pm EDT.

12. Is this a new requirement? If not, can the agency provide the name of the incumbent.

Response: CCS Associates, Inc.

13. A achment 3, page 10 "Tasks for Technical Proposal Evalua on" The agency did not provide the volume/workload of ac vi es for items 1- 8 so it would be impossible to provide the determine the "number of hours for each of the following labor categories…" Can the agency provide the volume/workload for each tasks/items 1- 8 listed.

Response: Due to the uncertain nature of the programma c needs the exact level of effort and workload cannot be predetermined. Please refer to Sec on D Tasks for Cost Proposal Evalua on in A achment 3 Statement of Work for addi onal details.

14. A achment 3, page 10, "Tasks for Cost Proposal Evalua on" This sec on needs further clarifica on.

(a) Is the agency reques ng hourly rates for each labor cat only? What is the purpose of 880 hours?

What is the purpose of the statement "….and the number of hours each category will spend on the task" as the agency has not provide the volume/workload of ac vi es for items. (b) verify this is only for 1 IND applica on (c) verify this is only for 1 Annual Report (d) verify this only for 1 protocol amendment

Response: Please refer to Sec on L - Instruc ons, Condi ons, and No ces to Offerors, subpart 2(c)(3) Data Other than Cer fied Cost or Pricing Data on page 64 of the RFP for instruc ons on submi ng the business proposal for the individual Sample Task Orders.

NIDA requires a separate cost/price es ma on for each individual Sample Task Order Nos. 1- 4, to understand the proposed approach and costa associated with the requirement. The level of effort iden fied in subpart a. of Sec on D Tasks for Cost Proposal Evalua on in A achment 3 Statement of Work the is intended for cost es ma on and comparison. For proposal purposes, please assume 1 report each for each subsequent Sample task order.

15. A achment 16, page 1: Is the agency releasing a TO along with this RFP. Please clarify the use of this a achment for the offeror current proposal submission.

Response: As stated in Sec on L subpart 1(d)(2) on page 52 of the RFP, “The Government an cipates awarding at least one task order with contract award.”

A achment 16 is for informa onal purposes only. It is a sample of the Task Order Request For Proposal Template Form that would be issued to the awardee to establish and nego ate a new Task Order.