FDA-SOL-1224068 BEST 3 IDIQ Amendment A00001_QnA.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE PAGE OF PAGES

1 6

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

A00001 07/13/2020 1224068

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

CODE

FDA/OO/OFBA/OAGS/DAP

SUZANNE MARTELLA

3900 NCTR ROAD

BUILDING 50, RM 430, HFT-320

JEFFERSON AR 72079

Same as Block 6

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, county, State and ZIP: Code) (X) 9A. AMENDMENT OF SOLICITATION NO.

ALL PROSPECTIVE OFFERORS

FDA-SOL-1224068

9B. DATED (SEE ITEM 11)

06/24/2020

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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.

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 one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram 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 DATA 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. 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 NO. IN

ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, 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)

E. IMPORTANT: Contractor is not, is required to sign this document and return __1_ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this Amendment is to post Solicitation Questions and Answers. See page 2 of this document.

The closing date for this solicitation is not extended; responses are still due NLT 12pm Central Time on 07/23/2020.

SEE THE FOLLOWING SF30 CONTINUATION PAGES

Except at 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.

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

Nick Sartain, Contracting Officer

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

(Signature of person authorized to sign)

BY _____________________________________________

(Signature of Contracting Officer)

NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.243

A00001

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

Final Questions and Answers

Clinical Site Monitoring for FDA-funded Human Subject Research Studies

Form-33 SOLICITATION, OFFER AND AWARD Page 1

Since the FDA will complete the Name and Address of Offeror Q15a CODE and FACILITY items

Question 1: Should we complete the Name and Address of Offeror and phone?

Answer 1: Yes

Question 2: Can the signature be electronic?

Answer 2: Yes

B.3.1. FIVE YEAR ORDERING PERIOD OF PERFORMANCE Page 3

There are budget formats for the staff in Years 1 – 5. But no format for computer infrastructure, web based, secure portal staff and infrastructure, or travel.

Question 3: Where do we submit the budget for the web-based, secure portal staff and costs per year?

Answer 3: Please refer to section L.8. There is no preferred budget format except that each offeror shall use excel for their business proposal.

Question 4: Where do we submit the budget for computer infrastructure costs (servers, data storage) per year?

Answer 4: Yes. (see response to Question 3)

Question 5: Should the travel for Quarterly and Annual meetings be added to each yearly budget?

Answer 5: Yes. (see response to Q3)

Question 6: Do you want all 5 years of budget in RFP response?

Answer 6: Yes. (see response to Q3)

B3.2 Seed Task Order 1: Healthcare Data Partner Page 6

Question 7: Should the Seed Task Order include the beginning server, and data storage or should it be in year one budget?

Answer 7: The seed task order should include those costs.

G.5. HHSAR 352.237-75 KEY PERSONNEL (DEC 2015) Page 16

“The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual.”

But the B.3.1. FIVE YEAR ORDERING PERIOD OF PERFORMANCE Page 3-5, the Staff Hours are provided and are not full-time.

Question 8: Is it permissible for staff to work on other projects?

Answer 8: Staff can work on other projects than BEST projects as long as there will be no conflict of interest introduced between the BEST projects and other projects they will be working on and that determination should be made in consultation with CBER.

Question 8a: If no, when will the additional task orders be issued to assure staff are in full-time positions?

Answer 8a: CBER can only provide you information about the task orders that are already released which is the current task order with a one-year period of performance. The current IDIQ has a base year with 4 optional years. Those 4 optional years are truly optional; that means CBER, on an annual basis, will determine whether it will exercise the option.

G.8. TRAVEL COSTS AND OTHER DIRECT COSTS

Question 9: What is included in Other Direct Costs (ODC)? Does ODC include the computer infrastructure?

Answer 9: Yes, and any other costs required for successful contract performance.

Question 10: Is there a budget format for ODC?

Answer 10: Please refer to section L.8. There is no preferred budget format except that each offeror shall use excel for their business proposal.

Question 11: Travel costs for quarterly and annual meetings will be estimated in this proposal. All staff will be traveling from outside Washington DC to the FDA White Oak campus offices in Silver Spring, MD. Will travel costs will be resubmitted prior to the specific meeting?

Answer 11: At this time the Government does not anticipate future changes to travel costs.

Attachment 1 IDIQ Statement of Work (SOW).pdf

Contractor Personnel Security Clearance Standards and Residency Requirements (October 2017) Page 17-22

Question 12: Are sections 1. Background through 8. Non-public data protection only related to contractors on DHHS-owned or leased space?

Answer 12: This is for contractor staff that requires a PIV card and the Government does not anticipate the need for this at this time.

Question 12a: If no to Q12, describe what “all employee security information” refers to in the 2nd bullet, page 18.

Answer 12a: Confirmation all individual employee security information has been submitted properly; If contractor staff requires regular access to the FDA campus then this information will need to be provided.

Question 12b: If no to Q12, will staff be required to ger a PIV card (page 20) to attend the quarterly meetings at the FDA White Oak campus?

Question 12b: Not required for quarterly and annual meetings.

4.1. KEY PERSONNEL page 24

The Research Analyst/ Programmer II and Research Analyst/ Programmer I descriptions (page 24) list both experience and education. We have senior computer programmers who have not completed a Bachelor’s degree.

Question 13: Are staff required to meet both education and years of experience? (For example, 25 years’ experience and some college credits.)

Answer 13: Yes

Attachment 2 Task order 1 SOW.pdf

2.3.4 Secure portal page 11

This request for proposal may be awarded to multiple organizations.

Question 14: Does each awardee set up their own secure portal or can a neutral secure portal be create / used by all awardees?

Answer 14: That decision will have to be made after it is determined how many awardees there will be and how the awardees will be structured. However, a secure portal by each awardee is usually necessary for communication and exchange of sensitive information with FDA.

Attachment 3 Personnel Security Clearance Requirement.pdf

This request for proposal does not include contractors Access (Physical or Logical) to Government Information or Operation of a Federal System Containing Information.

Question 15: Is Attachment 3 applicable to BEST #3?

Answer 15: It is not required at this time for BEST 3, as we don’t anticipate contractor staff needed regular access to the FDA Campus.

Question 15a: If yes, which sections?

Answer 15a: N/A

Attachment 5 Wage Det 2015 4281 Rev 16 dated 04.23.2020.pdf

The personnel working on this contract are not listed positions on Wage Detail. All personnel are exempt and with be all be paid more than minimum wages. In the Volume III - Business / Price Proposal, we will include a Labor Rate Card.

Question 16: How do I use the Wage Determinations if we will not use any of the labor categories?

Answer 16: Please refer to the labor categories listed on page 3-6. Further, annotate which personnel are exempt from the SCA; if all personnel are exempt, no Wage Determination will be included upon award.

Attachment 6 Task Order Mapping Matrix.xls

Question 17: Is the Labor Mapping Matrix due in the RFP response or after the contract is awarded?

Answer 17: This is due with your response to the RFP.

Attachment 6 has Physician as key personnel but not Senior Computer Programmers/Research Analysts. FDA-SOL-1224068+CBER+BEST+3+IDQI+(RFP).pdf G.5. HHSAR 352.237-75 KEY PERSONNEL (DEC 2015) page 16 has Senior Computer Programmers as key personnel but not Physician. Attachment 1 IDIQ Statement of Work (SOW).pdf (page 22) Computer Programmers/Research Analysts as key personnel but not Physician.

Question 18: Is a Physician as key personnel?

Question 19: Are the Computer Programmers/Research Analysts as key personnel?

Question 20: Are Computer Programmers/Research Analysts and Senior Computer Programmers the same personnel?

Answers to Qs 18-20:

Key Personnel for this contract are:

Program Manager Principle Investigator Epidemiologists Senior Computer Programmers

Question 21: Within Task Order 1, understand there is both a (1) Data and an (2) Analytics Capabilities component. The question is: is CBER open to working with a data-neutral analytics partner, to consistently apply validated methodology across data sources? i.e., would CBER entertain an RFP response that focuses on (2) above, with the understanding that other partners would provide (1)?

Answer 21: The primary purpose of this RFP is to gain access to large-scale claims administrative data sources. In addition, the data provider needs to have some level of analytic capability, including on-demand ad-hoc programming, excluding pre-packaged computer programs with limited flexibility such as what is called ‘a modular program’. A coordinating center will provide some support with respect to analytic capabilities.

Question 22: On Task Order 1, re: (1) Data, is CBER interested in consultation on/vetting of datasets to inform decisions on dataset fitness relative to the research needs?

Answer 22: The primary purpose of this RFP is to gain access to large-scale claims administrative data sources.

End Questions & Answers.