Amendment_FIVE_RFP_N01CN77019-18_signed.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

THIS AMENDMENT REPLACES AMENDMENTS 3 AND 4 IN THEIR ENTIRETY

Purpose: To answer offerors' questions, remove Section 508 contract requirements as described on page 4 and correct the delivery date under the applicable FAR clause 52.216-22, Indefinite Quantity.

National Institutes of Health National Cancer Institute Frederick, MD 21701

TO ALL POTENTIAL OFFERORS

N01CN77019-18

1 4

06/15/2018 belangern Typewritten Text Nicole Belanger, Contracting Officer belangern Typewritten Text 6/15/2018

RFP No. N01CN77019-18 2

Amendment Five

This amendment replaces Amendments 3 and 4 in their entirety.

This amendment answers additional questions received regarding Solicitation N01CN77019-18, removes Section 508 contract requirements as described on page 4 below and corrects the final delivery date under the applicable FAR clause 52.216-22, Indefinite Quantity.

1. I understand that we must submit a separate Excel file for each of the sample task orders and one for the Task Order 1, Kickoff Meeting. However, can we just submit one Business Proposal (PDF) combining the sample task order, Task Order 1 and all supporting documentation?

Yes, you may submit one business proposal per IDIQ pool, combining the proposed sample task order(s), Task Order 1 and all supporting documentation.

2. Should the sample budget and Task Order 1 kickoff meeting be for 5 years?

For Task Order 1 “Contract Orientation and Kickoff Meeting”, please budget for the costs of one meeting, using a period of performance of approximately 11/21/2018 -12/20/2018.

Please refer to the appropriate pool’s Base SOW(s) for the typical duration of task orders that may be issued under any resultant IDIQ contract. For proposal preparation purposes, each sample task order has a suggested period of performance of 2-3 years and is depending on the scope of the project. For each sample task order, please refer to the appropriate SOW and Technical Proposal Instructions for more information.

3. May the Gantt chart depicting our anticipated project timelines be provided in an appendix and not count against page count restrictions?

Yes. Please note total page count does not include: Title and Back Page; Table of Contents, Resumes, Appendixes & Attachments; and Section Dividers that do not contain information other than title of Section.

4. For the CGMP Pool, as the product cannot be frozen after formulation, we have assumed a pre-fill stability to test product integrity prior to the fill. Does this fit in line with what NCI is anticipating?

In general, stability of a product is its ability to retain its biological, chemical, physical and other relevant properties within specified limits. Stability testing should be seen as a continuous process from the product development through licensing to post-licensure monitoring. Thus, stability tests are generally designed to obtain information on the stability of an agent in order to determine its shelf-life and utilization period under specified packaging and storage conditions. Depending on the nature of product components, stability indication parameters and frequency of testing are expected to be carefully selected.

RFP No. N01CN77019-18 3

5. What should the small business plan be based upon? i.e., each TO/Sample TO, total of TO’s, or maximum contract value)

Please base your small business subcontracting plan on the total IDIQ maximum ceiling value of $49,995,000.

6. Since TOs are not included in the page count in the Technical Volume, would it be acceptable to include them at the end of the Technical volume instead of at the end of the Technical Approach (i.e., mid-volume)?

Yes

7. For the prime contract proposal (NO1CN77019-18), do we just submit a summary budget page? Also, are cost of individual supplies needed?

Please provide a detailed budget for each sample task order and the required Task Order 1 Kick- Off Meeting, including costs of supplies and all other categories such as labor costs and other direct costs. For the IDIQ SOW, describe any additional anticipated costs in the business proposal that are not captured in the sample task orders, including, but not limited to supplies.

For example, in the business proposal, describe additional cost information that may impact future task orders awarded under any resultant Base IDIQ contract (e.g. additional labor categories with associated labor rates, proposed escalation for labor rates, etc.) that is not already addressed in the business proposal for the sample task order(s).

8. It is clear from the NCI responses to the questions (Amendment 2) that the full validation of immunology methods is NOT required for the Efficacy protocols. Is the full GLP validation of all immunology methods (e.g., CD4 and CD8 flow cytometry) required for the GLP preclinical safety study (toxicology contract)? This may be a very costly procedure.

Full GLP validation of immunogenicity assays is not required for the safety study. However, some qualification of the assay to demonstrate that the assay is performing well is. For example, partial validation of an assay could be performed to assess assay sensitivity, specificity, and precision, with less emphasis on robustness, reproducibility, and stability.

9. Attachment 18, Technical Approach #7, states offerors shall also submit their Safety Manual on a CD. Since this is an electronic submission, does NCI want a CD of our Safety Manual? If so, I assume it is due to NCI by the submission date and time.

This submission can be electronically submitted with the proposal. It is due by the submission date and time in the solicitation.

RFP No. N01CN77019-18 4

10. Article H.19. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE HHSAR 352.239-73 (December 2015) and the entire section titled “18. Electronic and Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)” on pages 82-83 is hereby removed.

11. Under Section J, Attachment 15 HHS Section 508 Product Assessment Template is hereby removed.

12. Under Article I.4.a.5(d), the last day for final deliveries will be on/about 11/20/2028.