75N91023R00001_Amendment_0001_0001.pdf

(x)

75N91023R00001 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

NCI

Bethesda, MD 20892-7511 National Cancer Institute National Institutes of Health

NCI-EXEC

Bethesda, MD 20892-7511 National Cancer Institute National Institutes of Health

01/30/20230001

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

01/30/2023

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.)

The purpose of this amendment is to answer questions posed by potential Offerors.

Solicitation due date and time are NOT changed as a result of this amendment.

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)

PAULA A. WILKISON

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 .

Request for Proposal (RFP) 75N91023R00001 Centralized Chemopreventive Agent Repository and Chemistry Support Services

Amendment #0001 – Questions/Responses

1. QUESTION: The table entitled "SECTION 2 - Initial Task Order #1 Technical Discussion" contains an entry citing a document entitled Technical Proposal Cost Summary – Initial Task Order #1 in Section J. There is no document with that name listed in Section J. Can the Government please provide the Technical Proposal Cost Summary – Initial Task Order #1?

ANSWER: This attachment was omitted in error; the link to the Technical Proposal Cost Summary document is: https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf A hard copy of this form is attached to this amendment for your reference.

2. QUESTION: The solicitation states that 3 contracts that have been completed should be included (for past performance). If the offeror is performing on a current period of performance for an IDIQ that is still active and has a task order contract under that IDIQ that was completed within the last 5 years, will the government accept description of the task order as a completed contract? (Page 72 of the RFP)

ANSWER: Yes, a completed Task Order under an existing IDIQ may be used for past performance purposes.

3. QUESTION: Does the government have a specific or preferred limit on the physical distance between the CCARS campus and the main repository and backup facility? If so, what is the limit?

ANSWER: No, the Government does not have a preference.

4. QUESTION: Per Article H.12.1, could the Government confirm that Controlled Unclassified Information will be handled as part of this program? (Page 28 of the PDF)

ANSWER: CUI is not expected to be relevant to Initial Task Order 1. However, as this is an IDIQ vehicle that will be open to all of NCI for ordering it is possible that a Task Order may be issued at some point that may involve CUI in some form.

5. QUESTION: Does the incumbent’s contract have a clause for the continuity of services based on FAR 52.217-8 Option to Extend Services?

ANSWER: Yes.

https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf

6. QUESTION: It is anticipated that one award will be made from this solicitation and that the award will be made on/about June 28, 2023, with the POP being July 1, 2023 – June 30, 2028.

Can the government please clarify the duration of the transition-in period should a new contractor be selected?

ANSWER: The transition period will be determined by tripartite meetings between the COR, incumbent, and the new contractor. It is anticipated that it will take about 60 days.

7. QUESTION: The solicitation states: "Provide copies of Standard Operating Procedures related to the task areas in the SOWs, if available". Can offerors include a table of SOP numbers and titles rather than full copies in an Appendix to save page count within the Technical Proposal? The entirety of all full SOP documents will be in the hundreds of pages. (Page 84 of the RFP)

ANSWER: It is permissible to provide a listing of all the applicable SOPs. However, during the review, the Government reserves the right to request copies of SOPs for clarity and assessment of a specific function or operation.

8. QUESTION: For increased clarity and understanding, will the government please provide example(s) of what the ad-hoc testing may entail? (Page 117 of the RFP, Page 7)

ANSWER: To support clinical trials and the PREVENT program, the COR may request testing such as MS, HPLC or characterization of incoming product using routine analytical methods such as appearance, pH and specialized testing such as NMR. Yet another instance would be to determine solubility of incoming PREVENT compounds including short- and long-term stability valuation.

9. What is the total number of items by each temperature type in the inventory that would be transferred to an offeror other than the incumbent? (Page 129 of the RFP, Page 4 of 15 of the Initial Task Order Statement of Work)

ANSWER: It is difficult to provide an ‘exact’ number of samples since there are agents added and removed depending on the needs and status of trials and different projects. The storage space specified in the SOW is sufficient for all samples and the exact inventory will be provided at the time of the contract award.

10. QUESTION: What is the current inventory management system that is being used to inventory and track the items?

ANSWER: This is proprietary information related to the incumbent and cannot be provided. The inventory management system being used by the incumbent is not Government provided equipment. Offerors may propose an inventory management system that complies with industry standards and can meet the requirements stated in the Statement of Work.

11. QUESTION: Should an offeror assume that this space is controlled ambient storage only or would this also contain cold storage space as well. If this estimate also includes cold storage space, please provide the approximate space for each type of temperature that bulk materials would need to be stored at. (Page 197 of the RFP)

ANSWER: The monitored space is for controlled ambient storage only.

12. QUESTION: The collective cubic feet does not provide the specificity needed to appropriately prepare for the quantity of storage units needed at a specific temperature. Please provide how many environmentally controlled test chambers (stability chambers) are being utilized under the current contract? (Page 197 of the RFP)

ANSWER: In item e, the delineation of total storage space needed at different temperatures is provided.

The space specified in item c is mostly ambient space with controlled test chambers for short term stability studies. These test chambers are normally found in a typical analytical lab.

13. QUESTION: The collective cubic feet does not provide the specificity needed to appropriately prepare for the quantity of storage units needed at a specific temperature. Please provide the quantity of units or square footage for each of these temperature ranges so that an offeror can adequately estimate the number of units needed for each temperature range. (Page 197 of the

RFP)

ANSWER: For estimation purpose, please consider walk-in space of approximately 2000 sq. ft.

for 2-8C, 400 sq. ft at -4C, 300 sq. ft at -30C and up to 300 sq. ft. at -80C. These are approximate numbers for guidance only. An offeror with current storage space in the above range with flexibility to add space as needed by the program will be considered.

14. QUESTION: In the Additional Business Instructions and uniform cost assumptions (agent purchases/acquisitions/synthesis), it states that the estimated amount for the initial task order for procurement of drugs/agents is $1,500,000 for PREVENT and $1,000,000 for CP-CTNet. Given that the initial task order is a base year plus 4 option years, could the Government clarify if the amounts listed are per year (e.g., $1,500,000 for PREVENT / year, and $1,000,000 for CP-CTNet / year) or if the amount is for the overall 5-year initial task order (e.g., $1,500,000 / 5 years and $1,000,000 / 5 years)? Additionally, if the Government would like the costs listed per year, should cost escalation be added or should the values remain flat year-to-year? (Page 193 of the

RFP)

ANSWER: The amounts listed are for one year and not five years. These are maximum amounts for estimation purpose only. Please include a cost escalation factor for subsequent years of the contract.

TECHNICAL PROPOSAL COST INFORMATION/SUMMARY OF LABOR

AND DIRECT COSTS

DIRECT LABOR:

Labor Category (Hours)

Year 1 (Hours)

Year 2 (Hours)

Year 3 (Hours)

Year 4 (Hours)

Year 5 (Hours)

Year 6 (Hours)

Year 7 (Hours) Total

(Title and Name - use additional pages as necessary)

Total Hours

DIRECT LABOR COST:

MATERIAL COST:

TRAVEL COST:

OTHER (Specify):

TOTAL DIRECT COST:

Specific Instructions:

1. Do not include any individual salary information

2. Do not include any indirect cost or fee.

3. Do not submit the total amount of proposal.

4. Submit this information as a portion of the Technical Proposal.

Technical Proposal Cost Information/Summary of Labor and Direct Costs 5 (1/2011)