CONTRACTOR QUESTIONS AND GOVERNMENT RESPONSES 9 1 2022 2 33 PM.pdf

RFP

DOCUMENT

RFP

SECTION

TITLE

RFP

SECTIO

N #

Contractor Question Government Response

Solicitation 8 30 2022

Solicitation

: PART 2 –

SUPPLIES

OR

SERVICES

AND

PRICES/CO

STS

Pricing Table, Pages 1-

In the Description for Line Items 4, 10, 16, 22, and 28, did the FDA intend “International Pharmaceutical Market Data” instead of “US Pharmaceutical Market Data?”

That is correct. It should of stated “International” (Intl.) The table will be updated and posted to SAM.gov

Solicitation 8 30 2022

: PART 2 –

SUPPLIES

OR

SERVICES

AND

PRICES/CO

STS

Pricing Table, Pages 1-

In the Description for Line Items 4, 10, 16, 22, and 28, please specify the “three add on modules.”

Currently, the FDA is licensing the Biologic Molecule Product/Biocomparable Product, Local Product, and Local Pack add-on modules. Are these the correct modules that contractors should price?

That is correct.

Biologic Molecule Product/Biocomp arable Product, Local Product, and Local Pack

8 30 2022

: PART 2 –

SUPPLIES

OR

SERVICES

AND

PRICES/CO

STS

Pricing Table, Pages 1-

In the Period of Performance for Line Items 4, 10, 16, 22, and 28, “12 units/per year” is listed. Does the FDA mean “4 units/per year” for quarterly updates since the solicitation requests quarterly updates to international sales data?

It’s quarterly updates but because we expect to be billed monthly hence the 12 units/year

Solicitation 8 30 2022

REQ

1252383 Sales BaATTACH

MENT 1

SOW CLEAN

6 22 2022.docx updated 8 23 2022

“(REQ)”

Solicitation

: PART 8 –

INSTRUCTI

ONS TO

THE

OFFEROR

1.b

Solicitation : Part 9 – General Evaluation Informatio n, Part 9.1.b Trial Subscriptio n

PART

8 and 9, Pages 50-51

REQ:

Pages 8-

The requirement for a trial subscription was crossed out in the REQ, but references to the trial subscription as a requirement are made in the Solicitation instructions and evaluation criteria.

Please clarify whether this is a requirement

It’s not a requirement but we will require a trial subscription to aid in the evaluation

REQ REQ,

Section 11

Delivera ble Table, Under Quantity it states “NSP” but there is no reference to “MIDAS”. Should contractors add “MIDAS” to the Quantity column?

NSP in the quantity refers to “Not Separately Priced

Deliverable Table

Pages 11-12

REQ All SOW We believe that the numbering in the Statement of Work needs to be adjusted due to track changes in the document, and we want to highlight this for the Government’s attention to make evaluation easy when reading our response:

Existing Number ing

Suggest ed Number ing

Title

1.0 1.0 Description/Specificatio ns/Scope 0f Work

1.1 1.1 Background

1.2 1.2 Objectives

1.3 1.3 Scope of Work Approach

1.3.1 1.3.1 Pharmaceutical Sales Data Requirements, National Sales Data

1.3.2 1.3.2 Pharmaceutical Sales Data Requirements, International Sales Data

2 1.4 Technical Requirements and Capabilities of the Data Resources

3 1.5 Custom Programming and Analytical Support, Ad-Hoc Hours

4 1.6 Onsite Training Programs and Training Materials

5 1.7 Onsite Kick-Off and Annual Meetings

6 1.8 Technical Support

7 1.9 Disclosure Clearance for Aggregated Data outside the Agency

7.1 1.9.1 Clearance for Third Party Collaborations

Whatever the contractor thinks would be the best numbering system for their proposal is acceptable.

8 1.10 Ad-Hoc Technical Services

9 1.11 Performance Evaluation Plan

10 1.12 Anticipated Deliverables

10.1 1.12.1 Quality Control Plan and Project Management Plan

10.2 1.12.2 Monthly Usage Reports

10.3 1.12.3 Progress Reports

11 1.13 Deliverable Table

12 1.14 Advance Understanding

Suggested