RFP_75N91019R00016_000001.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

000001

Margo Katzper, Contracting Officer

NCI answers to questions received from the Offerors, in response to the Solicitation number stated in 9A. above.

Offerors must include a signed copy of this Amendment in their Business Proposal.

The proposal due date is extended to 4:30 PM on May 9, 2019.

National Cancer Institute Office of Acquisitions 9609, Medical Center Drive Rockville, MD 20850

75N91019R00016

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05/01/2019

04/08/2019

# Page Section Question

2 46 L‐C‐11 Travel expenses for the patients selected for the study, located in Jamaica and traveling to the US, will be on a reimbursed basis?

This requirement does not require the booking of, or payment for travel costs. The requirement is for the assistance with obtaining travel documents such as visas and passports as well as assistance with new visas/passports or visa extensions for follow‐up.

The following sections are deleted in their entirety:

4 2 SOW‐2.2.1 Can you indicate who long patients will be involved in the clinical trials?

The patient may have numerous visits over the years for therapy and monitoring. Visits may last 2‐4 days for evaluation and 1‐4 months for treatment.

6 2 Attachment 1

With a maximum of 40 pages for the technical volume and the request for information for this volume, we respectfully request that resumes are not included in the page count.

The resumes are not included in the 40 page limitation

7 29 Section L.1.d Is the Physician required to be licensed to practice medicine in the US, Jamaica or both?

The requirement is for patients in Jamaica. The Physician is required to be licensed to practice medicine in Jamaica.

8 72 Attachment 10 Are major subcontractors required to complete the Preaward Survey of Prospective Contractors?

Yes, the vendor will need to review this and submit as part of the subcontractor package for any cost reimbursement, labor hour, or time and material subcontract.

9 29,37 What level of clearance is required for key personnel and other labor categories?

It is recommended that the contractor employ personnel that can pass a basic background investigation in the country the person is working.

10 48 Section M.4.IV.a Are we required to have available and adequate clinical facilities already in place prior to award?

Yes. The contract is anticipated to begin (fully functional) on 11/1/19.

11 1 Attachment 5

How are we to treat the Travel Costs on Attachment 5? Should we estimate the cost of air travel to and from Jamaica for 10 individuals and if so for what period of time would they be based in the US?

Please see the response to question 2 above. Additional information is provided below:

The period of time that the patients will be based in the US is approximately 2‐4 days for evaluation and 1‐4 months for treatment.

12 2 Attachment 3 2.1.3

It states "Refer potentially eligible candidates (residing in Jamaica), and send their medical records

(must comply with Jamaican medical records sharing regulations) to the staff in LYMB, CCR, NCI." Since IRB prior review and approval are required for medical records review for research‐related studies and activities, will the Contractor be expected to conduct these tasks for local country/institutional IRB approval or any other scientific review processes required for these NCI protocols?

The contractor is not part of the NCI protocol. For our this requirement, the SOW states that when a patient is being referred as an eligible candidate (residing in Jamaica), the medical records are sent, after the company obtains/follows whatever the regulations in

Jamaica are regarding the sharing of medical records.

13 2 Attachment 3

Clarify administrative support. It states that the Contractor is to "contact LYMB’s Patient Care Coordinator for travel arrangements….and assisting patients with directions to and from the Clinical Center". A) Will the Contractor be expected to also provide support as a 'patient care coordinator and/or protocol navigator' for onsite support at NIH CC? B) Or is the support only for travel? C) Will the Contractor be expected to work with PI on local IRB approvals for this research?

A) No. B)The support is for the assistance in obtaining travel documents as stated in the answer to question 2 above. C)

There is no research on this requirement.

Will the PCC be expected to liaise and or support NIH protocol investigators at the CC in the US? No

It seems that information may be missing from the RFP, as no address is given for hard copies of the proposal to be sent, and the number of copies is not stated No hard copies are required.

16 I do not see the solicitation listed at the eCPS site

It is uploaded on the eCPS site

Any proposed subcontractors will need to provide a draft subcontracting plan and budget with the same detail needed to evaluate cost.

The labor categories identified in the level of effort table are correct, all hours should be within those labor categories.

5 9 Article F.3

The level of effort references a total of 1,997 direct labor hours, which appears to be distributed amongst the thre referenced labor categories, please confirm. Additionally, on page 37 #1b. References other labor categories, i.e. Single Principal

Investigator/Project Director and Other Investigators. Is the Government's intention that these personnel's hours be included in the labor categories listed on page 9 or are these separate labor categories?

(1) Page 38, Section L, B. 4 ‐ Enhancing Reproducibility through rigor and transparency.

(2) Page 14, Article H.2. NIH Policy on Enhancing Reporducibilty through Rigor and

Transparency.

1 46 L‐C.9 Does the Government expect a complete cost proposal from each subcontractor? Given the overall level of effort for this proposal, we were planning to incorporate all labor categories into the Prime's Business Proposal.

3 38 L‐B‐4

The offeror shall demonstrate compliance with the NIH Policy on enhancing Reproducibility through Rigor and Transparency as described in NIH Guide Notice NOT‐OD‐15‐103. Specifically, the offeror shall describe in its technical proposal the information described below: No information is provided. Please provide the details you require in the Technical Proposal for Enhancing

Reproducibility through Rigor and Transparency.

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