Answers to Questions.docx

Questions:

Questions/Answers

1. Section 1-General & 5.1.2.-NAICS CODE 621111 Orthopedic physicians’ offices It is stated that the Offeror should verify that they are SAM Registered as NAICS Code 621111.

Is this correct? This limits the Offerors to physician’s offices.

Response: Ignore the NAICS Code. This was the closest. FDA is not allowed to use multiple codes. Simply mention the project title: Clinical Support to Aggregate Patient Data at Patient Care Facilities

1. Section 3.3 SCOPE/TASKS-‘Contractor shall provide de-identified patient/device related data’, but in 2)a)-‘data shall include DOB, and in 4) Date of implant surgery:

Supplying DOB and dates of service are protected health information that could potentially identify a patient.

Can you clarify whether we should pursue a HIPAA safe harbor de-identification approach (eg: eliminating month and day from the DOB and service dates) or secure an expert determination?

Response: Yes, we could have Year and remove MONTH and DAY. For implants/explants we would need to know the Year and age of the patient at the time of either surgeries.

1. Section 3.3 SCOPE/TASKS-Note under 8)c) says ‘This SOW is focused on the first task of gathering clinical/epidemiological information relevant to metal-based implanted devices.’

Is the scope of the RFP just limited to the information gathering which will subsequently be used in later tasks in addition to and/or separate and apart from this RFP?

Response: The scope of the RFP is to gather information, organize the information such that data are reported with each of the requested variables in the same order (i.e. DOB, race, sex, date of device implant, date of device explant, medical allergies etc.… are all organized similarly).

1. 3.10.A) FORMAT OF DELIVERABLES-‘using the current FDA version of Microsoft Office products’.

Which version does the FDA have of Microsoft Office?

Response: Microsoft Offices 365 pro plus.

1. 3.15., the Period of Performance is 9/15/2020 THRU 9/14/2021.

What date range of coverage is required for the clinical data collection?

What duration of clinical data is required for each case before and after the implant date?

Is there a minimum number of implant cases required to meet the study objectives?

Response:

What date range of coverage is required for the clinical data collection?

15 to 20 years in at least 15 year blocks Examples of date ranges include

1. year 2000 to 2015

1. 1997- 2012

1. 2004- 2019.

What duration of clinical data is required for each case before and after the implant date?

1 year to 2-weeks prior to the implant date.

1. - And, 3-5 years prior to the year of implant surgery.

Up to 5 to 7 years after the implant date

Is there a minimum number of implant cases required to meet the study objectives?

Minimum: there should be no less than 1200 completed cases

1. 4.3 FAR 52.217-8- Option to Extend Services.

Because this is a Firm Fixed-Price (FFP) Contract, what ‘rates specified in the contract’ are this referring to? If this contract is extended 6 months, how is the fee adjusted?

Response: FAR 52.217-8 may be used to extend the period of performance of the contract if the need arises to complete work under the contract at the fixed rates/price of the contract as agreed. If additional work is involved, that will be negotiated with the Vendor.

1. 5.6 EVALUATION FACTORS/Factor 2: Relevant Past Experience: The Offeror shall detail its previous experience with conducting animal research studies and preclinical contract research of the type required by this solicitation.

We assume the ‘animal research studies’ portion of this sentence is a mistake.

Can you clarify the intent of this sentence?

Response: There should not have been animal evaluation criteria in the Adverse Health Events Announcement, this may have been a carry-over from a different SOW. This sentence should be deleted.

1. Enclosures:

Attachment i, Non-Disclosure Form The listed attachment was not included in the email that we received. Can you provide this form?

Response (3398 Form),. For convenience, see attachment.

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