Amend_1_75F40125R00037_QR.pdf

75F40125R00037 - Access to Outpatient Longitudinal Data IDIQ

Solicitation Questions & Responses

# Reference Question Response 1 We would like to know if this is a brand new contract OR if there is (was) an incumbent performing these services.

If not brand new, could you please provide the current / previous contract number?

There are incumbents performing these services.

The current/previous contract numbers are 75F40120D00011 and 75F40120D00012.

2 Location: 2.1 PURPOSE OF THE PROJECT. Page 6. The solicitation references two different “ability to use the data” in items “d” and “e” under 2.1 PURPOSE OF THE

PROJECT.

Who is expected to provide services to conduct these analyses: the IDIQ holder, FDA, or a 3rd party?

The IDIQ holder is expected to provide the data to conduct the analyses.

3 Sol_Doc_75F40125R00037_Attachment 7 - FDA Secure Electronic Mail System

Observation: Section 2.3.2(h) of the solicitation requires the data vendor to participate in the FDA secure electronic mail system to protect any sensitive data which may be transmitted electronically between the data vendor and the FDA. In reviewing the instructions to participate in the secure electronic mail system in Attachment 7, there may be a typo in the email address.

Question: Will the government please confirm the email address in the attachment?

The correct email address is securemail@fda.hhs.gov. See amended Attachment 7, FDA Secure Electronic Mail System.

4 Sol_Doc_75F40125R00037 - Section 4.2

Page 18-19

For the HHS Mandatory Contractor Training, if the contractor employees have completed the training within the past 12 months, is it sufficient to provide the existing certification? Or do the contractor employees need to recomplete the training?

Contractor employees must complete the training every 12 months throughout the period of performance.

Contractor employees who have already completed the training within the last 12 months should not need to recomplete the training prior to their current expiration.

mailto:securemail@fda.hhs.gov

5 Sol_Doc_75F40125R00037_Attachment 14 - Task

Order Statement of Work

Observation: The Period of Performance in the IDIQ Ordering Period I is Twelve (12) months, anticipated to begin on August 22, 2025. The Task Order base period Base Period is 9 months from August 22, 2025 through May 21, 2026.

Question: Is the 9-month base period from August 2025 to May 2026 of Task Order 1 intentional?

Question: Will FDA exercise these non-concurrent IDIQ and Task Order 1 periods as defined?

Yes, the 9-month base period is intentional. The current Task Order was extended by 3 months; therefore, the fiscal year budget only allowed for a 9-month base period.

Options may be exercised any time prior to the expiration date of the IDIQ and Task Order, which will depend on the individual periods of performance, and which may not be concurrent with each other.

Refer to the amended solicitation for revised IDIQ and Task Order periods of performance.

6 Sol_Doc_75F40125R00037_Attachment 14 - Task Order Statement of Work, 6 Deliverables of Performance

Is it acceptable to provide a combined price for Deliverables # 3 and 4, Unlimited Access to Outpatient Medical Claims and Patient Level Data Extracts, given that data access and extraction are enabled through the same means?

No, Offerors shall propose separate pricing for deliverable 3 and deliverable 4 as provided in Attachment 13, Pricing Worksheet.

7 Sol_Doc_75F40125R00037 - Section 5.5.2

This section of the solicitation confirms that additional labor categories may be added to the IDIQ contract for use on task orders issued thereunder. Will the government confirm that offerors may propose new labor categories that are necessary for performance on Task Order 01 with the initial IDIQ proposal?

Yes, so long as the added labor categories are mapped to one of the Government’s IDIQ labor categories.

8 Sol_Doc_75F40125R00037_Attachment 14 - Task Order Statement of Work, Section 3.2 Task Area 2

Ad-hoc analysis is estimated and priced at 200 hours, annually. In execution, will the government allow for redistribution/ reallocation of hours across labor categories?

Yes, labor hours are not anticipated to be specified in the Task Order award, only a total ceiling price (however, Offerors shall still provide their estimated labor hours and level of effort in the proposal as specified in Attachment 13, Pricing Worksheet).

9 IDIQ Task 1 (FFP) Deliverables The IDIQ Task 1 (FFP) Deliverables pricing worksheet tab requires pricing for a total of 10 years with each labeled as an ordering period. Are IDIQ ordering periods 6-10 included in total evaluated price?

Refer to the amended solicitation for revised IDIQ and Task Order periods of performance.

No, IDIQ Ordering Periods III-VII (formerly IDIQ Ordering Periods VI-X) will not be included in the total evaluated price. The purpose of Ordering Periods III-VII (formerly Ordering Periods VI-X) is to establish pricing beyond the IDIQ expiration date because, as stated in the solicitation, “Individual task orders may perform up to five (5) years (inclusive of options) beyond the expiration of this IDIQ, so long as the IDIQ maximum (inclusive of Ordering Periods I- II [formerly Ordering Periods I-V]) is not exceeded.”

10 Sol_Doc_75F40125R00037 - Section 2.4.3

Will the government please specify what is "the required certification" for the Application Programmer labor category?

Technical language or platform specific programming certificates (e.g., Microsoft certified, AWS certified developer, Oracle certified Java developer).

11 Sol_Doc_75F40125R00037 - Section 2.4.2

Will the government please specify what is "the required certification" for the Senior Computer Analyst labor category?

Examples of required certificates shall include CompTIA Security+, Certified Information Systems Auditor (CISA), Certified Business Analysis Professional (CBAP) and ITIL Foundation Certification.

12 Sol_Doc_75F40125R00037_Attachment 14 - Task Order Statement of Work, Section 3.3 (h) and Section 6

Page 8, 11

The requirement to link/access additional data sources including electronic medical records is included in the ad-hoc technical services task which points to a custom programming request. However, the unlimited quantity referenced in the Section 6 Deliverables table indicates that the government is requesting a subscription model (Item 6).

Will the government confirm that access EMR should be priced as a subscription?

Yes, access to EMR should be priced using a subscription model.

13 Attachment 13 Can FDA clarify if subcontractors and consultants should be included in prime offeror's Attachment 13 - Pricing Worksheet, or if they should fill out a separate Attachment 13?

Attachment 13, Pricing Worksheet, shall include all costs, inclusive of any consultants or subcontractors, if applicable.

14 Attachment 13 Are offerors allowed to add more rows in the Attachment 13

- Pricing Worksheet "IDIQ Task 1 (FFP) Breakdown" tab?

Yes, Offerors may add additional rows to the Attachment 14, Pricing Worksheet, "IDIQ Task 1 (FFP) Breakdown" tab;

however, as stated in the solicitation, “It is the responsibility of the Offeror to ensure all calculations in the final proposal are accurate.”

15 Attachment 13 IDIQ Task 1 (FFP) Deliverables Tab and TO Task 1 (FFP) Tab:

both tabs refer to “unlimited access” for #1,2 3,4,5 and 6.

Can FDA clarify what unlimited access refers to?

Unlimited access means the FDA shall have direct, unrestricted ability to independently query and analyze all relevant data in real-time, without intermediaries or pre-approval processes.

16 Attachment 14 Section: 3.1.1 (a) states: Provide outpatient prescription longitudinal patient-level data that is currently existing and commercially available. Access to the data shall be immediate, unlimited, direct, desktop and in real-time.

Direct access shall include all upgrades, enhancements, and modifications to software and data.

Can FDA please clarify what unlimited access refers to?

Unlimited access means the FDA shall have direct, unrestricted ability to independently query and analyze all relevant data in real-time, without intermediaries or pre-approval processes.

17 Main RFP, Attachment 14 Please clarify what content should be included in the IDIQ versus the Task Order #1 proposal for requirements that are identical across both proposals, and if offerors can cross-reference sections between the two.

While content will likely be similar, the Offerors shall submit separate proposals for the IDIQ and Task Order without cross referencing. The IDIQ evaluation will be conducted first. The Task Order evaluation will be conducted second among the IDIQ awardees.

18 Main IDIQ RFP Anticipated Schedule of Deliverables: Please clarify the content of the Item #7-Switch Report.

A switch report is an analytical document that identifies and analyzes trends in patient or prescriber transitions between different drugs within a specific therapeutic class.

19 With the federal government holiday on Friday, July 4, 2025, please extend the proposal submission to after July 7,2025.

Due to the anticipated award date of August 22, 2025, no extensions will be granted at this time.

20 Is this solicitation a new requirement or a recompete of existing contractors?

If it is a recompete, could you please share the following incumbent contractors’ details? Firm name, whether it’s a small business concern, contract number, contract title, annual spend for every fiscal year the incumbent contract is active.

See response to question #1.

21 2.1.a. Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level and geographical/sub-national counts of outpatient prescriptions over time (page 1). 2.3.10.g Ad-Hoc Technical Services (page 13) lists geographic areas as small as counties.

Will FDA require geographic area reporting smaller than counties anticipated to meet the FDA goals and objectives (e.g. zip code, block group)?

The FDA requires granular geographic data including County, State, Metropolitan Statistical Area, as well as data at a granular level below county, such as 3-digit ZIP code level.

22 The ability to download (or obtain in a timely manner using other means) large datasets as needed. (page 2)

What is the level of data within the download dataset?

Are download anticipated to be aggregate or more granular level such as per prescription, per provider and/ or per patient?

The downloaded dataset shall be both for aggregate level data and granular level data.

23 2.3.1 REQUIREMENTS FOR OUTPATIENT PRESCRIPTION

AND PATIENT LEVEL DRUG UTILIZATION DATA

The contractor will …

d. Provide the total number of years of data available overall and the number of years available online and accessible in real-time to FDA personnel. A minimum total of ten (10) years of data (minimum of five (5) years of data available online and at a minimum an additional five (5) years of historical data that is no longer online) and propose methods to obtain historical data in a timely manner. (page 4)

What is the preferred (vs minimum) data timeframe?

The FDA requires a minimum of 5 years rolling data online and a minimum of 5 years of historical data no longer available online.The FDA prefers more than 5 years of data, if available.

24 The data shall include:

The number and percent of the total population … in the outpatient setting by healthcare professionals are available … (page 4-5)

Will FDA require each contractor to use the same outpatient setting categories?

Will FDA provide the list of outpatient setting categories for contractors to use for the proposal and query tool filters?

Contractors are expected to use general, widely recognized categories for outpatient settings in their data submission.

The FDA will not provide the list of outpatients setting categories for Offerors to use for the proposal and query tool filters.

25 The data shall include:

d. Prescription data with …. prescriber specialty,….

(page 5)

e. Medical claims with … medical specialty of the practitioner(s) involved... (page 5)

Will FDA require each contractor to use the same prescriber / provider specialty categories?

Will FDA provide the list of prescriber / provider specialty categories for contractors to use for proposal and query tool filters?

Contractors are expected to use general, widely recognized prescriber/provider specialty categories in their data submission.

The FDA will not provide the list of prescriber provider specialty categories for Offerors to use for proposal and query tool filters.

26 2.3.2 TECHNICAL REQUIREMENTS AND CAPABILITIES

OF THE DATA RESOURCES (page 6)

a. Provide outpatient prescription longitudinal patient-level data that is currently existing and commercially available. Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Direct access shall include all upgrades, enhancements, and modifications to software and data.

d. Provide access to the data resources accessible via a secure internet or network-based method permitting simultaneous, multi-user access through a user-friendly data query tool(s).

2.3.2.a requires a desktop software option and 2.3.2.d allows for an internet or network-based method. Can the software be internet based? Please clarify.

Could Offeror provide two data sources with two different query tools?

Yes, the software can be internet-based.

Yes, the Offeror can provide two data sources with two different query tools. However, user-friendliness should be a primary consideration.

27 2.3.3. CUSTOM PROGRAMMING AND ANALYTICAL

SUPPORT (AD-HOC HOURS) (page 7)

Is the 200 ad hoc hours in total or 200 hours for each of the personnel (project manager, senior computer analyst, application programmer, statistician, pharmacist, senior training specialist, survey scientist, epidemiologist)?

The 200 ad hoc hours is the total annual ad hoc hours anticipated across all labor categories combined.

28 2.3.10 AD-HOC TECHNICAL SERVICES/ 4.1 ANTICIPATED

DELIVERABLES/10.1.1 TECHNICAL FACTOR 1: IDIQ

TECHNICAL APPROACH

There are multiple references to the Projection Methodology.

− Projection Methodology development is an ad-hoc technical service (page 9).

− Item no. 1 contains Acceptable Projection or

Other Appropriate methodology with a delivery date at time of award/ annually (page 18).

− Section 2 contains a “detailed description of its ..

collection methodology and the project methodology.” (page 57)

− Section 5 contains describe their project methodology. (page 59)

Please clarify when the Projection Methodology description and reports are required.

Projection Methodology description is required with the proposal submission.

For the ad hoc technical service, the Projection Methodology description will be due when ad hoc service is required during the performance of the contract.

29 2.4 LEVEL OF EFFORT (page 9-10)

There are 8 labor categories listed: project manager, senior computer analyst, application programmer, statistician, pharmacist, senior training specialist, survey scientist, epidemiologist.

There is no anticipated level of effort in hours or FTEs per labor category to support the non-ad-hoc statement of work. Please clarify.

No anticipated level of effort is being provided as part of the solicitation for the non-ad hoc (Firm-Fixed-Price) portion of the requirement. Offerors shall propose a labor mix and level of effort that they believe will satisfy the Government’s requirements.

30 4.1 Anticipated Deliverables (pages 17-18)

For “2. Unlimited access to National Level counts of unique patients (100 users)”

Is this deliverable a report or function of the query tool?

How many users will be using the “National Level counts” at the same time?

This deliverable is a function of the query tool, not a report.

The FDA requires 100 seat licenses and the tool shall be able to accommodate multiple users at the same time.

31 6.3. CONTRACTOR PERSONNEL SECURITY CLEARANCE

STANDARDS AND RESIDENCY REQUIREMENTS, DATED

OCTOBER 2017 (Solicitation pages 36-39 / Attachment 14 pages 25-28)

The Place of Performance is at Contractor’s site (Solicitation page 25).

Will the contractor be required to conduct background checks including finger printing for contractor employees and subcontractors that will be located at the contractor’s site?

Can contractor employees and subcontractors work outside of US and its territories as long as the person had resided in the U.S. for a total of at least three (3) of the past five (5) years? (Solicitation pages 39 / Attachment 14 pages 28)

The Contractor Personnel Security Clearance Standards and Residency Requirements are not applicable to contractor or subcontractor employees who will not develop, have the ability to access, use, or host and/or maintain Government information and/or Government information system(s), including instances of remote access to or physical removal of such information beyond agency premises or control; or contractor or subcontractor employees who will not have regular or prolonged physical access (routine physical access to an FDA-controlled facility, logical access to an FDA-controlled information system, access to government information, whether in an FDA-controlled information system or in hard copy, or any combination of circumstances) to a “federally-controlled facility,” as defined in FAR Subpart 2.1.12.

There are no known restrictions regarding contractor or subcontractor employees, not subject to the Contractor Personnel Security Clearance Standards and Residency Requirements, working outside of the United States and its territories.

32 IDIQ INSTRUCTIONS, CONDITIONS, AND NOTICES TO

OFFERORS OR RESPONDENTS (page 55)

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”.

Are Microsoft Office table of contents, footnote / endnote, and cross-reference within the Word and Excel links permissible in the proposal?

Yes, Microsoft Office table of contents, footnotes/endnotes, and cross references within Word are acceptable. Excel links should not be included. As stated in the solicitation, Volume I, Technical Proposal, is limited to 50 pages, not including key personnel resumes, cover pages, table of contents, dividers, glossaries, bibliographies, or Data Characteristics Table (Attachment 1).

33 10.4. VOLUME IV: IDIQ SUBCONTRACTING PLAN

PROPOSAL INSTRUCTION

For an Offeror that is an SBA -certified small business entity, What information will be required of the VOLUME IV:

SUBCONTRACTING PLAN PROPOSAL?

Refer to IDIQ solicitation Section 10.4, Volume IV: IDIQ Subcontracting Plan Proposal Instructions, and Attachment 9, HHS Subcontracting Plan, for proposal requirements.

34 Sol_Doc_75F40125R00037.pdf Section 4.3, Page 19 of 63 and Attachment 14, Section 7, Page 12 of 36

The period of performance is listed for the IDIQ as five years beginning on August 22, 2025 and ending August 21, 2030.

The Task Order is listed as beginning August 22,2025 and ending May 21, 2030. Will FDA please confirm the period of performance is different for the IDIQ and Task Order?

Refer to the amended solicitation for revised IDIQ and Task Order periods of performance.

The IDIQ and Task Order will have difference periods of performances. See response to question #9 for further explanation.

35 Sol_Doc_75F40125R00037 Section 10.1.2, Page 58 of

Is Attachment 6 (part of Technical Factor 2) included within the 50 page limit of Volume I: IDIQ Technical Proposal?

No, see amended IDIQ solicitation Section 10.

36 Sol_Doc_75F40125R00037.pdf Section 2.3.1.c, Pages 3&4 of 63 Solicitation Reference Text: 'For each health care setting, the Contractor shall estimate the proportion captured in the data source out of the entire market and provide this estimation to FDA, updated at least semi-annually.'

Will FDA please define 'health care setting' in more detail?

For example, is Offeror segmenting by claim type (Ex.

pharmacy, office, hospital etc.) or is this by facility place of service and/or pharmacy channel type?

Is the 'semi-annual' component referring to a post-award requirement or is Offeror to provide database counts for this line item spanning 6-month intervals over a specific time period? For example, can Offeror provide 2023 database statistics throughout the entire IDIQ / Task Order response as a base period if multiple years required? If so, how many years should be covered (Ex. 1, 5, 10, etc.)?

Healthcare setting refers to the facility place of service and/or pharmacy and channel type.

The semi-annual component in this section refers to the time of award. The FDA requires the Contractor to provide an updated estimate of the proportion captured in the data source out of the entire market at least semi-annually post-award. The FDA requires a minimum of 5 years of rolling data online and a minimum of 5 years of historical data.

37 Sol_Doc_75F40125R00037.pdf

Section 2.3.1.c, Page 4 of 63 Solicitation Reference Text: 'Characteristics shall minimally include: number of individual patients or covered lives per calendar quarter;'

Is it acceptable for Offeror to provide the 4 quarters of 2023 as the "calendar quarters' required for this component?

- If not, will FDA please provide the total calendar quarters required?

Yes, Offerors can provide the four quarters of 2023 as the “calendar quarters,” but Offerors will also be evaluated on the number of years of historical data they have available as outlined in the Statement of Work.

38 Sol_Doc_75F40125R00037.pdf Section 2.3.1.c, Page 4 of 63 Solicitation Reference Text: 'number and percent of patients or covered lives with at least two years of continuous activity;'

Will FDA please define 'two years of continuous activity' in more detail? For example, can Offeror identify patients that have any prescription OR medical / hospital claim over an 8 quarter period such as 2023/2024?

Two years of continuous activity refers to the number of patients with two years of continuous activity on a prescription, e.g. Jan 2022 to Dec 2024 or eight quarter periods from first quarter 2022 to fourth quarter 2024.

39 Sol_Doc_75F40125R00037.pdf Section 2.3.1.c, Page 4 of 63 Solicitation Reference Text:

'FDA (including children [ages ≤ 17 years], females of child-bearing age, and elderly [ages ≥ 65 years]);'

There is reference to '10 year patient age buckets' listed on Page 1 of the Data Characteristics, Attachment 1. Should Offeror also provide the specific three age categories in addition?

- If so, is it acceptable to use ages 15-44 as the exact definition of 'females of childbearing age'?

The Offeror is not required to provide specific three age categories; however, the Offeror may inform the FDA of the age buckets or categories they have available.

40 Sol_Doc_75F40125R00037.pdf Section 2.3.1.f, Page 5 of 63 Solicitation Reference Text:

'Direct access to weekly data with the capability of providing current and historical national-level and sub-national level counts of prescriptions and unique patients over time, delivered weekly with no more than an eight calendar (8) day lag.'

In addition to the ability to provide 'counts' on the 'weekly' delivery schedule as noted, could Offeror interpret the weekly cadence request at a more granular level to provide access to updated patient transaction level data on a weekly basis in which additional counts could be extracted?

Yes, the Offeror can provide a more granular level to provide access to updated patient transaction level data on a weekly basis in which additional counts could be extracted.

41 Sol_Doc_75F40125R00037.pdf

Section 2.3.2.f, Page 6 of 63 Solicitation Reference Text:

'Provide FDA with a fourteen (14) calendar day trial subscription. The Contractor shall provide a live virtual web-based training session that lasts a maximum of two (2) hours at the start of the trial subscription period. The trial subscription shall include direct access, documentation, and technical support for a maximum of seven FDA users. The FDA will not pay for this subscription as access will be used solely to assess whether the contractor meets the data requirements, and not for any analyses, public disclosure, or regulatory decision making. '

Will FDA please clarify the response type expected for this line item? For example, does Offeror need to acknowledge this is acceptable in general terms or are more specifics required such as providing specific documentation, user ids and offering overviews for the trial subscription period components?

The Government expects more specific documentation such as User IDs for the FDA users, ability for the users to log into the Offeror’s interface to use the data to perform analyses over the 14-day period.

The Offeror is expected to provide a two-hour training about their interface to the FDA users as part of the trial subscription. The FDA will assign each Offeror a date and time for the trial subscription training after proposals are received.

42 Sol_Doc_75F40125R00037.pdf Section 4.1, Item 7 Page 18 of 63 Solicitation Reference Text:

"Switch Report - Customized Analysis'

Please clarify what the requirements of the 'Switch Report' should specifically contain. The IDIQ has this additional line item that does not appear to be in the Task Order.

See response to question #18. The Switch Report is on the IDIQ, but not on the Task Order, because the FDA may not require the Offeror to provide a Switch Report during the period of performance of the Task Order. A subsequent Task Order may be issued for the Switch Report if the FDA has a need for it.

43 Sol_Doc_75F40125R00037.pdf Section 2.3.7, Page 8 of 63 Solicitation Reference Text:

MONTHLY PROGRESS REPORTS

Will FDA please confirm the only required cadence for the progress report is monthly (Ex. no weekly or quarterly views)?

Correct, the cadence of the progress report will be monthly.

44 Sol_Doc_75F40125R00037.pdf

Section 4.1, Item 6 Page 18 of 63 Solicitation Reference Text:

'Unlimited Access to Electronic Medical Records (EMR) (10 users) - Unlimited - 12 Months - As needed ' and Attachment 14, Section 3.3.h, Page 8 of 36 Solicitation Reference Text:

The Contractor shall provide additional quantities of Services including, but not limited to:

h. Ability to link/access additional data sources including electronic medical records within the vendor’s data suite to provide a comprehensive view of the drugs being analyzed.

Will FDA please clarify the 'unlimited access' to EMR data need?

- Is this for a therapeutic area or patient subset or for all linkable/non-linkable patients available in an EMR repository?

- Do the 5 and 10 years data availability periods apply here as well as monthly update capability?

- Are there specific EMR fields of interest since 'drugs' was mentioned (Ex. lab results, tests, vitals, etc.)?

Please clarify the response type expected for 'additional data sources'. For example, would Offeror provide what types of data would potentially be accessible or is the response that Offeror has the 'ability' to do this type of work, but details are not needed?

See response to questions #15 and #16.

The FDA expects access to EMR data that covers all therapeutic areas.

Yes, the 5- and 10-year data availability periods apply to the monthly update capability.

The FDA expects access to EMR data that covers all prescription drugs.

Additional data means if the Contractor’s data can be combined with additional data resources

45 Sol_Doc_75F40125R00037.pdf Section 4.2, Page 18 of 63 Solicitation Reference Text:

'The U.S. Department of Health and Human Services (HHS) mandates that all prime contractors and sub-contractors that are performing work under a government contract regardless of having direct access to the agency’s network are required to complete annually the HHS mandated contractor training courses within three (3) business days after contract award; and any other newly mandated training as required by the FDA within ten (10) business after training notification as follows...'

Will FDA please clarify the personnel requirements for this line item to allow Offeror to properly assess the annual work effort required?

- Does this training apply only to the day-to-day direct customer facing team and/or all of the underlying Contractor support personnel aligned to the engagement?

- Please clarify that upon a potential contract award on or near August 22, 2025, the Contractor's identified team would need to complete the 2025 annual training within three business days from the award date?

The Government expects all support personnel and the direct customer facing team performing work under this contract to complete the Mandatory Trainings within three days of the award and annually thereafter.

The training link(s) will be emailed to the Contractor upon award.

46 Sol_Doc_75F40125R00037.pdf

Section 10.1.3., Page 58 of 63 Solicitation Reference Text:

“At least two (2) examples shall have been performed for a federal Government agency.”

In order for the Offeror to provide the best examples of relevant experience, would FDA consider experience performed for a state Government agency in lieu of a federal Government agency? Alternatively, would it be acceptable to provide only one (1) example where relevant experience was performed for a federal Government agency and the other two (2) examples are for Commercial customers?

The Government will only accept relevant experiences from federal government agencies. State governments or commercial customers will not be accepted in place of federal experience.

47 Sol_Doc_75F40125R00037.pdf Section 1, Page 1 of 63 Solicitation Reference Text:

“This RFP is unrestricted; however, the Government will reserve a minimum of one (1) additional award for a small business concern who is determined to be technically capable and who is determined to have proposed a fair and reasonable price, in accordance with the evaluation criteria set forth in this solicitation.”

The solicitation states that it is unrestricted; however, on the other hand, FAR clause 52.219-6, Notice of Total Small Business Set-Aside is included in the contract. Can you confirm that the contract is unrestricted?

Yes, as stated in the IDIQ solicitation Section 1, “This RFP is unrestricted; however, the Government will reserve a minimum of one (1) additional award for a small business concern who is determined to be technically capable and who is determined to have proposed a fair and reasonable price, in accordance with the evaluation criteria set forth in this solicitation.”

48 Sol_Doc_75F40125R00037.pdf Section 10.4, Page 60 of 63 Solicitation Reference Text:

“In accordance with FAR 52.219-9, Small Business Subcontracting Plan Alternate II (NOV 2016), proposals submitted in response to this solicitation shall include a subcontracting plan that separately addresses subcontracting with small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns.”

The solicitation requires the submission of a small business subcontracting plan. However, the solicitation is unrestricted. Further, the solicitation does not include any targets for subcontracting to small businesses. Can you confirm that all offerors must submit small business subcontracting plans?

As stated in the IDIQ solicitation Section 10.4, “In accordance with FAR 19.702(b)(1), subcontracting plans are not required from small business concerns.”

Subcontracting goals for Fiscal Year 2025 were provided on page 1 of Attachment 9, HHS Subcontracting Plan.

49 Will you please confirm how the FDA is classifying

Solicitation 75F40125R00037 with respect to NAICS code applicability and small business size standards. Specifically:

• Will this RFP be evaluated under the NAICS code

541519 as an IT Value-Added Reseller (VAR), or is it considered a non-IT services solicitation under 541519?

This clarification impacts our business size classification:

• If it is not considered an IT VAR procurement, we qualify as a small business (revenue under $34M) and may not need to subcontract.

• If it is considered an IT VAR procurement, then employee count is the size standard (150 employees), and we would be considered a large business.

This solicitation is not considered as an IT VAR procurement.