N01CP71015-82_Amendment_0002.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

PURPOSE: Provide response to contractor questions.

Proposal Due Date: April 3, 2017; 3:00 PM EST (Unchanged)

National Institutes of Health National Cancer Institute Office of Acquisitions 9609 Medical Center Dr Rockville, MD 20850

N01CP71015-82

N/A

1 4

03/24/2017

03/03/2017

1. Question: Would the Government please identify the sites vendors are expected to use and/or the number of sites and locations anticipated?

Response: The location is as specified, Costa Rica. The number of clinical sites and site vendors is to be determined by the offeror and will be evaluated for capabilities to meet procurement requirements.

2. Question: Please elaborate on the scope of responsibilities for vendor selection of sites.

Response: The vendor is responsible for selection of sites and should ideally have extensive prior experience at selected sites to allow for initiation of the work shortly after contract award.

3. Question: Based on the answer to the above questions, are there uniform cost assumptions related to the sites that vendors should use to develop pricing?

Response: The Randomized Controlled Trial (RCT) will comprise 20,000 and the survey component will comprise 4,000- please refer to Attachment 27, table 2, page 38 of 61 for details related to study time points and activities at each time point. In addition, the RFP specifies the requirement of continued follow-up of 1000 women currently enrolled in an NCI-sponsored longitudinal study (see Attachment 28). As part of this effort, two home visits with blood draw and a brief questionnaire are envisioned. This information should be used to develop pricing.

4. Question: Would the Government provide details on the sites’ internet capabilities, in particular the current performance and historical reliability?

Response: As part of the response to this RFP, the offeror should propose a plan for providing internet and associated capabilities. These will not be provided by the US government.

5. Question: Are vendors to establish a biobank as part of the scope of this project, or will vendor be required to use NCI’s biobank as described in the sample task order? If NCI’s biobank, are costs associated with the biobank assumed by the vender.

Response: The offeror should establish a temporary biorepository with appropriate accreditations to operate on site. For purposes of pricing, the offeror should assume that samples will reside at the temporary local biorepository for approximately six months, and then be shipped to the NCI Biorepository located in Maryland for long-term storage. The offeror should budget for the cost of local storage and shipments.

6. Question: Is there an incumbent for this work; if so, would the Government please identify.

Response: A component of the RFP envisions extended follow-up of women in previously recruited into an NCI study. The incumbent for the work leading to this extension phase is Fundacion

INCIENSA.

7. Question: Will the task order response be evaluated as a stand-alone section, or may vendors cross reference to the IDIQ response?

Response: Vendors may cross reference to the IDIQ response as part of their response to the Sample Task Order.

8. Question: Please elaborate on the scope of statistical programming and analysis support.

Response: The US government will assume the responsibility for all statistical analyses and programming.

9. Question: Please confirm whether the vendor is expected to maintain study data in STDM format or use NCI’s Common Data Elements and map to SDTM for FDA submission.

Response: The vendor is not expected to maintain study data in STDM format or use NCI’s Common Data Elements and map to SDTM for FDA submission.

10. Question: Is Sample Task Order 001 expected to be awarded upon issuance of the umbrella IDIQ contract? Since the Sample Task Order and the IDIQ have the same title, what other task order does the government anticipate awarding under this IDIQ?

Response: Yes, the Government anticipates awarding sample Task Order 0001 upon issuance of the umbrella IDIQ contract. A second Task Order for work described in Task Area 2 will be awarded at a later date.

11. Question: Is the Government expecting separate Firm Fixed Price quotes for each of the 10 Activities in the Sample Task Order, or a single Firm Fixed Price quote for the entire Sample Task Order?

Response: A single Firm-Fixed Price quote for the entire sample task order is expected. However, sufficient detail should be provided to allow the Government to perform appropriate cost analysis.

12. Question: Will cell phones/tablets be provided to the sites by the vendor, or do the sites have existing cell phones/tablets for use for the study?

Response: The Government will provide cell phones/tablets for use for the study.

13. Question: Will the vendor be responsible for site payment?

Response: The offeror must provide the site and is responsible for site payment.

14. Question: Would NCI be willing to expand the items excluded from the page count to the following:

• Cover letter

• Title page

• Section dividers that do not contain information other than title of Section

• Project objectives

• Government notice for handling proposals

• Proposal summary and data record

• Table of contents

• The Facilities and Equipment section

• The Information security section and 508 compliance table

• Key SOPs or a list of SOPs

Response: Yes, the above-listed items will be excluded from the page count.

15. Question: The RFP states that CVs are included in the page count. Even with key personnel CVs limited to 3 pages each and non-key personnel CVs limited to 1 page, should we take this to mean only key personnel should receive CVs, or would the government be willing to exclude CVs from the page count so we can include them for all personnel?

Response: The government will exclude CVs from the page count.