FDA-RFP-1227793_A1_FDA Responses.pdf

FDA-RFP-1227793

FDA Responses to Timely Vendor Questions

1.

Solicitation Section/Subsection Number: A

Question:

Please confirm if FDA-RFP-1227793 is a small business set aside or a full and open competition.

Section A of the RFP seems to be saying both.

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-05. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 541611 (Administrative Management and General Management Consulting Services). Its associated Small Business Size Standard is $15M.

This requirement is for full and open competition. All responsible offerors are permitted to submit a proposal as a result of this combined synopsis/solicitation.

Government Response

(For Government use only)

This procurement is being conducted on the basis of full and open competition. The reference to the associated Small Business size will be removed in a forthcoming amendment.

2.

Solicitation Section/Subsection Number: C.3.6 Digital Strategy

Question: Per the third bullet in Section C.3.6 Digital Strategy, “Performing testing of the digital platform with the target user groups” please confirm the government requires a feedback mechanism (e.g., survey) to gather inputs on new labeling content.

The FDA will assess the content and format of the digital platform conveying FDA product labeling information for oncology. The FDA anticipates using this information for improvements and/or to add additional public-facing content if we find it is not meeting the goals of the project to increase FDA product labeling education and awareness.

3.

Solicitation Section/Subsection Number: M.6 Technical Evaluation Criteria, Factor 2 – Project Design

Question: Under Factor 2 – Project Design, the first bullet states:

“The extent to which the Offeror provides clear goals, objectives, performance measures, and intended outcomes that align with an operational plan for identifying, supporting, developing, conducting, and coordinating the overall purpose of this grant and each of the priorities, including having resources and funds appropriately directed.”

Will the government please clarify what is meant by “…coordinating the overall purpose of this grant and each of the priorities, including having resources and funds appropriately directed.” as it relates to this RFP?

Government Response

The word “grant” shall be removed and replaced with “contract” in a forthcoming amendment. Notwithstanding the remaining elements of the Factor 2 requirements, this particular statement is meant to convey that the Contractor shall be a responsible source that clearly demonstrates the capacity to successfully complete the requirement.

4.

Solicitation Section/Subsection Number: Section L.2 Proposal Instructions

Question: The proposal instructions include page limitations but do not include font requirements. Will the government please consider adopting the following language to better allow for consistency in response requirements across offerors?

Offerors shall use only 8.5 inch by 11 inch paper, single-spaced pages with margins no less than one inch on each border; number each page consecutively; do not use a font size smaller than Times New Roman 12. Tables and illustrations may use a reduced font size, but not less than 9-point font, and may be landscape.

The Government will clarify its font requirements in a forthcoming amendment.

5.

Solicitation Section/Subsection Number: Section C.3.1.

Question: Under functions that may be included for SMEs, is “Assess and make suggestions for updates to other sections of the product label, including BOXED WARNINGS and WARNINGS AND PRECAUTIONS, based on publicly available data”. Does the FDA want the Contractor to include the FDA Adverse Events Reporting System (FAERS) Public Database as a publicly available data source to be mined independently from the FDA’s pharmacovigilance activities or will the FDA share data reports that may pertain to the up to 6 identified products?

Government Response

No, FDA does not expect the contractor to use the FAERS public database. The contractor shall be responsible for obtaining feedback from the outside community and any scientific evidence gleaned from publicly available sources, typically published literature to create recommendations on potential safety, dosing, pharmacology or other aspects of the FDA label for the FDA review team to consider in its independent review of the Contractor’s product report.

6.

Solicitation Section/Subsection Number: Section C.3.3

Question: Under this task the Contractor is asked to collect and annotate number of prescriptions written for products and ConvergeHealth Team was listed as an example. Does the FDA currently utilize ConvergeHealth data sources and tools and if so, will the Contractor have access or is it expected that the Contractor will investigate and independently procure data sources and tools to meet the requirements of the FDA?

Government Response

It is expected that the Contractor investigate and procure data sources and tools to inform current product utilization.

Solicitation Section/Subsection Number: Section M.7

7.

Question: Is the Contractor required to have a subcontracting Plan? If so, how much does HHS requires Large Business to sub out to small business to meet the minimum HHS current subcontracting goals?

Government Response

Please refer to FAR 19.704 “Subcontracting Plan Requirements” for additional information on Subcontracting Plan requirements. Solicitation Section M.7 will be revised in a forthcoming amendment.

8.

Solicitation Section/Subsection Number: Section B.7

Question: Under LABOR CATEGORIES, ESTIMATED LEVEL OF EFFORT AND PROPOSED LABOR RATES, the government list the labor categories for this SOW. Can the Government provide the years of experience and educational requirements for these positions? It is noted that under Section C.3.11 Key Personnel, information is provided including minimum experience for Position Title – Project Manager II.

Government Response

Section C.3.11 of the solicitation specifies the minimum experiential qualifications for the Project Manager II Key Personnel position. As specified in Section B.7 of the solicitation, “The Labor Categories anticipated to be required for successful performance of this effort are shown below. Offerors shall propose equal or similar Labor Categories and estimated annual hours per labor category shown below are for budgeting purposes only.” As these are anticipated Labor Categories where Offerors may propose equal or similar Labor Categories, the Government has not specified minimum experiential requirements.

9.

Solicitation Section/Subsection Number: Section C.3.9

Question: Are the six drugs listed in the table titled “Representative List of Candidate Drugs (in no priority order)”, the products that the Contractor should reference for the tasks listed in Section C.3.1 and perform the functions outlined in the sub-bullets under “For a total of up to 6 identified products (up to 3 per year):”?

a) If not, will the FDA provide a list of drugs to the Contractor for investigation or does the FDA expect the Contractor to develop a prioritized list of drugs for the FDA to select up to 6 identified products?

b) If the Contractor is to identify products to be investigated, should the Contractor include or exclude the following for investigation:

i. Supportive treatments (i.e., anti-emetics, blood stimulating factors, pain management, etc.)

ii. Drugs with an oncology indication but that are not antineoplastic agents or targeted therapies, such as glucocorticoids (e.g., prednisone)

Government Response

The six products listed in the representative list of candidate drugs are the products that the Contractor should reference for tasks in C 3.1. The Contractor will not be responsible for identifying products.

10.

Solicitation Section/Subsection Number: Section C.3.11

Question: Are there key personnel requirements regarding working on-site during the core hours?

Can you provide details around the work location requirements (location specifics), hours, and ability to complete work remotely (especially during COVID)?

Government Response

The Place of Performance under the current COVID-19 pandemic will be clarified in a forthcoming amendment.

11.

Solicitation Section/Subsection Number: Section L.2 Volume I Technical Proposal (Factors 1 -5) (Factor 5)

Question: How many relevant past performance references would the government like to see included within the Factor 5 response?

There is no specific requirement on the number of relevant past performance examples to be provided by Offerors. The Government shall adjectivally rate the Factor 5 response in accordance with the ratings described in Section M of the solicitation for Factor 5.

12.

Solicitation Section/Subsection Number: Section B.2

Question: The instructions provided to complete the pricing volume appear to be consistent with a cost-reimbursement type contract rather than a commercial item, T&M requirement as specified in Section B.2. Can the government confirm that the offeror should propose T&M rates (which are fully inclusive of all wages, overhead, general and administrative expenses) which are consistent with Commercial Item pricing in accordance with FAR 12.6?

The contract type shall be Time and Materials (T&M). Offerors shall follow the solicitation instructions for submitting their Volume II (Factor 6) Price proposal. As described in the solicitation, the Offeror shall provide cost/pricing data to the extent that enables the Contracting Officer to determine price reasonableness.