FDA Responses to Vendor Questions_FDA_RFP_1228764.pdf

FDA-RFP-1228764

FDA Responses to Vendor Questions Received

1.

Solicitation Section/Subsection Number: Section C3.2 Question:

The RFP states, “These drug categories shall include, but shall not be limited to, the following drug categories:

Antismoking products, female contraceptives, oral pain products, weight loss products, cannabis/hemp products, acne products, ear care products, motion sickness/anti emetic products.”

Question: Many of these categories are currently included in FDA’s model through the TSV Health Dept, but not at a UPC or ingredient level – will the FDA need ingredient level detail?

Government Response

(For Government use only)

Yes, the FDA requires ingredient level detail.

2.

Question:

The RFP states, “These drug categories shall include, but shall not be limited to, the following drug categories:

Antismoking products, female contraceptives, oral pain products, weight loss products, cannabis/hemp products, acne products, ear care products, motion sickness/anti emetic products.”

Question: If E-Cigarettes are of interest, this is categorized in Tobacco for IRI, and if it is necessary to include this category, we would need to expand the geography to MULO-C given the high % of sales within Convenience for these products. Can the FDA confirm this is their request for the project?

Government Response

(For Government use only)

The FDA identified antismoking products in this section of the solicitation, not tobacco.

3.

Question:

The RFP states, “These drug categories shall include, but shall not be limited to, the following drug categories:

Antismoking products, female contraceptives, oral pain products, weight loss products, cannabis/hemp products, acne products, ear care products, motion sickness/anti emetic products.”

Question: CBD/Hemp is a separate attribute – is this a “must include” for the FDA?

The proposed solution shall capture cannabis/hemp products and be made available when needed under the Time and Materials CLIN if it is not already coded as part of the dataset under the Firm-Fixed Price CLIN.

4.

Question:

The RFP states, “These drug categories shall include, but shall not be limited to, the following drug categories:

Antismoking products, female contraceptives, oral pain products, weight loss products, cannabis/hemp products, acne products, ear care products, motion sickness/anti emetic products.”

Question: Acne is part of Beauty/Skin Care in TSV, so not included in current Health Dept – is this a “must include” for the FDA?

The proposed solution shall capture acne products and be made available when needed under the Time and Materials CLIN if it is not already coded as part of the dataset under the Firm-Fixed Price CLIN.

5.

Question:

The RFP states, “These drug categories shall include, but shall not be limited to, the following drug categories:

Antismoking products, female contraceptives, oral pain products, weight loss products, cannabis/hemp products, acne products, ear care products, motion sickness/anti emetic products.”

Question: Are the categories listed in C3.2 (cited above) “must haves” in both the POS ingredient report and

CSIA?

No. The categories listed in C3.2 shall be included in the POS ingredient report if already coded as part of the Firm-Fixed Price CLIN. If not, they will be requested as needed by the Government under the Time and Materials CLIN.

6.

Question:

The RFP states, “These drug categories shall include, but shall not be limited to, the following drug categories:

Antismoking products, female contraceptives, oral pain products, weight loss products, cannabis/hemp products, acne products, ear care products, motion sickness/anti emetic products.”

Question: Is the FDA aware that the addition of the categories listed above (Section C3.2) add to the scope/price to the current deliverable set?

The FDA is only responding to questions relevant to the current solicitation.

References to other contracts are not relevant to this solicitation.

7.

Solicitation Section/Subsection Number: Section C3.3, f. ; Section C3.6 Question:

The RFP states in C3.3 (f.), “Configuration of user interface tool – optimize configuration of user interface tool to provide FDA staff the ability to select drugs and perform data reports by active ingredient, generic and brand name, and any other data elements that may become available, and download in a timely manner and without or with minimal intervention by the Contractor.“

AND

The RFP states in C3.6, “Technical requirements - The Contractor shall provide OTC drug utilization data that is currently existing and commercially available. Access to the data shall be via either monthly or quarterly reports in excel format.”

Question: The two points in Sections C3.3 (f.) and in Section 3.6 (above) seem in conflict – the FDA is asking for a user interface tool, but there is also a request for monthly or quarterly deliverables in excel? Can the FDA provide clarification on these requirements? Additionally, if an interface tool is to be used to access the data, please specify the number of users Government Response

(For Government use only)

No interface is required. FDA is requesting access to the data via either monthly or quarterly reports in excel format only. Section C.3.3(f) will be revised and removed in a forthcoming amendment.

8.

Solicitation Section/Subsection Number: N/A Question:

Has the FDA considered the impact of removing IRI’s CSIA? If the future proposal excludes subscription of CSIA, there are several implications:

o Subscription allows for the tool to be organized in such a way that one can easily access critical levels such as ingredient o With the removal of the tool, there would be less structure and more need for configuration of the data on an ad hoc basis o This would impact lead times and customization costs for ad hoc requests Government Response

(For Government use only)

The FDA is only responding to questions relevant to the current solicitation.

References to other contracts are not relevant to this solicitation.

9.

Solicitation Section/Subsection Number: Section B.2;Section C.3.10 Question:

Section B.2 states that “The period of performance shall consist of one (1) 12-month Base Period and two (2) 12-month Option Periods for a total of 36 months if all options are exercised.”

Section C.3.10 states that “After Year 5 the FDA shall notify the Contractor of the aggregated data release and accept the Contractor’s requested revisions, but shall not require formal approval for release.”

Question: Did the FDA intend to say “After Year 3” instead of “After Year 5” in Section C.3.10?

Section C.3.10 will be revised from “After year 5” to “After Year 3” in a forthcoming amendment to the solicitation.

10.

Solicitation Section/Subsection Number: Section F Question:

“Section F” – this is referenced in the solicitation, but accesses a SharePoint site within the FDA .

Question: Can the FDA provide a copy of “Acceptable Projection or Other Appropriate Methodology”?

Government Response

(For Government use only)

Please see the solicitation Attachment 1 (Glossary) for further information on the term “Acceptable Projection or Other Appropriate Methodology”. The hyperlink in Section F will be removed in a forthcoming amendment to the solicitation.

11.

Solicitation Section/Subsection Number: Factor 3 (pg. 64) Question:

Will the FDA please allow responders to provide the trial subscription agreement in an appendix, outside of the page limit?

As stated in solicitation Section L.3.1, attachments are not included in the Volume I Technical Proposal page count.

12.

Solicitation Section/Subsection Number: Volume II – Past Performance Proposal (factor 6) Question:

The RFP document requests, “To the maximum extent practicable, provide two corporate or Government past performance references that are attainable through the Past Performance Information Retrieval System

(PPIRS).”

Question: If responders are citing past performances references that have current CPARS reports (PPIRS merged with CPARS), why do they have to have their customers also fill out a questionnaire?

The evaluation of Past Performance is not limited to CPARS/PPIRS. As stated in the solicitation, independent investigations may also be made with regard to Past Performance.

13.

Solicitation Section/Subsection Number: Attachment 1 – Glossary of Terms Question:

The RFP States, “Attachment 1 – Glossary of Terms: De-identified data - Data that has had key patient information removed, e.g., name, address, social security number, and date of birth, so that any user or audience shall not purposefully or inadvertently discover a patient’s identity. However, the capability of tracking a single individual (e.g. patient A) across multiple encounters over time and of differentiating that individual from another individual (e.g. patient B) shall be required.”

Question: We are confirming that we cannot track individuals, but households. We believe the FDA is already aware of this, but just confirming this is acceptable.

Government Response

Yes.

FDA Responses to Vendor Questions Received