FDA-RFP-22-1249753.pdf

COMBINED SYNOPSIS/SOLICITATION FOR ORACLE Enterprise Database and Application Server Administration Support

SOLICITATION NUMBER: FDA-RFP-22-1249753

i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

ii) The solicitation number is FDA-RFP-22-1249753.

iii) The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2022-05, Effective 7 Mar 2022

iv) This solicitation is a total small business set aside for firms certified with the socio-economic designation of 8(a) by the Small Business administration (SBA). The associated North American Industry Classification System (NAICS) Code is 541512 – Computer Systems Design Services; Small Business Size Standard of $30 Million.

v) Contract Line Items

• Labor Schedule

The Government anticipates awarding a single award Indefinite Delivery Indefinite Quantity (IDIQ) contract with an anticipated ceiling of $95,000,000.00. Award of the base period of the initial task order satisfies the guaranteed minimum for the IDIQ contract. FDA reserves the right to award Firm-Fixed-Price, Time-and-Material or Labor-Hour type task and/or delivery orders under this contract.

• Pricing Terms

Labor Rates proposed for each task order issued against the resulting IDIQ contract must be in accordance with the proposed labor categories and fixed labor rates. If a task order’s stated period of performance must be extended as a result of Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period. However, in no event shall the Contractor perform, or be paid for any work which exceeds the stated price or not-to-exceed dollar amount of a task order.

For Firm Fixed Price (FFP) task orders issued under this contract, the applicable FFP for a task order shall be based on a combination of the proposed level of effort, fixed labor rate for labor mix proposed and other direct costs (ODCs). The total FFP is the amount agreed upon by the Government and the Contractor at the time the task order is issued.

Each Labor-Hour or Time-and-Materials task order will contain a ceiling price.

vi) Contract Requirements

See Attachment 1 for the IDIQ Statement of Work for a full description of the supplies/services to be acquired and Attachment 2-4 for the Task Order Statement of Works.

vii) Deliveries, Acceptance, and Performance Dates

The resultant contract will have an ordering period of five years from the date of award. Each task/delivery order issued under this contract will specify:

• Duration of performance;

• Delivery/performance locations;

• Specific tasks to be performed (if applicable);

• Specific deliverables/deliverable due dates;

• The name of the Task Order Contracting Officer Representative responsible for inspection and acceptance;

• Acceptance terms if other than FOB Destination; and

• Invoicing Instructions

viii) Instructions to Offerors

The provision at 52.212-1, Instructions to Offerors—Commercial Items (Nov 2021), applies to this acquisition with the following addenda to the provision.

The Government intends to conduct this procurement through a phased proposal submission and a combination of oral and written submissions using an evaluation process.

1. Solicitation Questions and Comments

Questions shall be e-mailed to the CS, Peter.Lee@fda.hhs.gov, and cc’ CO, Phillip Frame at Phillip.Frame@fda.hhs.gov no later than 12:00 PM EST on Thursday, May 5, 2022. It shall be the obligation of the Offeror to exercise due diligence to discover and bring to the attention of the CS and CO at the earliest possible time, any ambiguities, discrepancies, inconsistencies, or conflicts between the statement of work (SOW) and other documents attached hereto or incorporated by reference herein. The Government reserves the right not to answer questions received after the close of the defined Offeror question submission deadline.

2. Phase I: Volume I: Proposal Submission Due Date Offerors shall submit a written response in PDF format to address the items below that is no greater than eight (8) pages excluding the cover page via email to the CS, Peter.Lee@fda.hhs.gov by DATE no later than 3:00PM EST on Monday, May 9, 2022.

Written response content that extends beyond eight (8) pages will not be considered. No other methods of submission will be accepted. Each Offeror will receive an Advisory Notification.

3. Phase II: Volume II: Proposal Submission Due Date The CO/CS will include the Phase II submission instructions on the advisory notification, including the date, time, and exact location of the Offeror’s scheduled oral presentation, as well as the due date for the Phase II submission.

No other methods of submission will be accepted.

1. Procedures This solicitation will follow the procedures under FAR 12 and 15. In so using these procedures the Government is not obligated to determine a competitive range or use any other source selection techniques associated with Subpart 15.3.

2. Instructions for Proposal Preparation Offerors are instructed to read the entire RFP document, including all attachments, prior to submitting questions and/or preparing your proposal. Omission of any information from the proposal submission requirements may result in rejection of the proposal.

(1) Offerors shall note that proposals will be evaluated, and a selection decision will be made.

(2) Offerors are expected to follow the detailed proposal preparation instructions fully and carefully. The Government will rely on the information provided by the Offerors to evaluate the proposals. It is therefore imperative that Offerors carefully follow the instructions set forth below and submit their proposals in the format and with the content specified below, providing all requested information.

(3) The Offerors are responsible for the accuracy and completeness of its proposal.

Proposals shall be valid for 120 days from the RFP’s submission due date.

3. Page Size and Font

All electronic submitted PDF documents shall use no smaller than 12-point font. Text in graphics and charts shall be no smaller than 9-point font, and text in tables shall be no smaller than 9-point font.

Each submitted file of the electronic copy of the proposal shall be compatible with Microsoft Office 2013 or later version. It is the sole responsibility of the Offerors to ensure that the electronic media submitted is virus-free and can be opened and read by the Government. The deadline for submission of the electronic copy of the proposal is firm. As the closing date and time draws near, heavy traffic on the web server may cause delays. Offerors are strongly encouraged to plan and leave ample time to prepare and submit their proposals. Offerors bear the risk of web site inaccessibility due to heavy usage, which may occur during the final days/hours before the RFP closing time. The electronic copy of the proposal will constitute the official copy for timely receipt.

For the electronic copy of the proposal, each file shall be submitted in an unlocked format readable by Microsoft Office 2013 and searchable PDF, except Pricing Excel Workbook, which is required to be in Excel.

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

4. Proposal Content

The CS, identified in Section II, is the point of contact for this acquisition. The required elements of proposal submission are provided in Table 1 below. The Cover Letter and Resumes will be in PDF format, the PowerPoint presentation will be in PDF format, and the Pricing Worksheet will be in Excel format.

5. Advisory Down-Selection Notification After the Government completes the evaluation of Phase I, Offerors will receive an advisory notification via e-mail from the Government. This notification will advise the Offeror of the Government’s advisory recommendation to proceed or not to proceed with Phase II submission. Offerors who are rated most highly in Phase I will be advised to proceed to Phase II of the proposal submission process. Offerors who were not among the most highly rated will be advised that they are unlikely to be viable competitors, along with the general basis for the Government’s advisory recommendation. The intent of this advice is to minimize proposal development costs for those Offerors with little to no chance of receiving an award.

The Government intends to provide no more than three (3) Offerors with an advisory notification to proceed to Phase II. However, the Government’s advice will be a recommendation only, and those Offerors who are advised not to proceed may elect to continue their participation in the procurement.

Failure to participate in Phase I of the procurement precludes further consideration of an Offeror. Phase II submissions will not be accepted from Offerors who have not submitted Phase I proposals by the due date and time stated in this solicitation. For those Offerors that are highly rated and advised to proceed to Phase II of the proposal submission process, the CO/CS will include the date, time and exact location of the Offeror’s scheduled oral presentation. The Phase II written submission due date will be approximately 2 weeks from the date of the advisory notification, and oral presentations will be scheduled after the submission of written Phase II proposals. The Government recommends Offerors begin preparation of Phase II proposals only after receipt of the Phase I advisory down-select notice.

Table 1.

Naming Convention Tab Title

Volume I: Prior Experience (Phase I) Tab A (Document)

Prior Experience Criteria (8-page limit)

Tab B (Document)

Contractor Information and Confirmation

Volume II: Key Personnel and Oral Presentation (Phase II) Tab A (Document)

PowerPoint Slides for Oral Presentation (35 Slide Limit) – NOT

EVALUATED

Oral Presentation Proposed Solution for IDIQ (see Attachment 1-4)

Volume III: Business & Pricing

Tab A (Document)

Proposal Cover/Transmittal Letter

Tab B (Document)

Pricing Excel Workbook (Attachment A)

Tab C (Document)

Proposal Assumptions, Exceptions and Dependencies

• Information contained in each volume shall be complete to the extent that evaluation of each tab may be accomplished independently of, and concurrently with, evaluation of the others.

Your responses must demonstrate that both your firm and personnel can successfully complete this project. Offerors shall strictly adhere to the page limits.

• NO PRICE INFORMATION IS TO BE INCLUDED IN VOLUME I or VOLUME II

ix) Basis of Award & Evaluation Criteria

The provision at 52.212-2, Evaluation—Commercial Items (Nov 2021), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government intends to award an IDIQ and three (3) task orders to the Offeror whose proposal conforms to the solicitation and represents the best value to the Government using tradeoffs to the Government, price and other factors considered. Evaluation Phase II and I are listed in descending order of importance and, when combined, are significantly more important than Volume III Cost. The evaluation will be based on the demonstrated capabilities of the Offeror in relation to the needs of the project as set forth in the RFP. The proposals will be evaluated carefully in accordance with the aforementioned confidence ratings to determine the best value to the Government. It is important the Offeror’s proposal be submitted initially with the most favorable terms, and include details to support the completed pricing in the Attachment A – PRICING SHEET because the Government intends to award without negotiation in accordance with FAR 52.215-1. However, the Government reserves the right to hold discussions, if the Government determines discussions are necessary.

This RFP does not commit the Government to pay any cost for the preparation and submission of a proposal. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. The Government reserves the right to make administrative price/technical trade-offs that are in the best interest and to the advantage of the Government.

The Government will evaluate proposal for award purposes by adding the total price for all options (including the option to extend services) to the total price for the basic requirement. The Government may determine that a proposal is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

A written notice of award or acceptance of a proposal, emailed or otherwise furnished to the successful Offeror within the time for acceptance specified in the proposal, shall result in a binding contract without further action by either party. Before the Offeror’s specified expiration time, the Government may accept a proposal (or part of a proposal), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

x) The Provision at FAR 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial Services (Nov 2021), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal.

xi) The clause at 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services (Nov 2021), applies to this acquisition with the following addenda:

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

https://www.sam.gov/portal https://www.sam.gov/portal http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

- Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

- Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

- Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

- Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

- Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

- Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

- Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

xii) The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (May 2022), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition:

• 52.219-06 Notice of Total Small Business Set-Aside (Nov 2020)

• 52.222-21 Prohibition of Segregated Facilities (Apr 2015)

• 52.222-26 Equal Opportunity (Sept 2016) (E.O. 11246)

• 52.222-35 Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212)

• 52.222-36 Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793)

• 52.222-50 Combating Trafficking in Person (Nov 2021) ( 22 U.S.C. chapter 78 and E.O. 13627)

• 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Jun 2020) (E.O. 13513)

• 52.232-33 Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C.

3332)

xiii) Additional contract requirement(s) or terms and conditions

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

FAR 52.216-18 Ordering (Aug 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from Date of Base Contract Award__ through __Five years (TBD at time of award).

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of clause)

FAR 52.216-19 Order Limitations (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than _$1,000.00______, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor --

(1) Any order for a single item in excess of $10,000,000.00.

(2) Any order for a combination of items in excess of $95,000,000.00; or

(3) A series of orders from the same ordering office within _____14____ days that together call for quantities exceeding the limitation in subparagraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within __10___ days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

FAR 52.216-22 Indefinite Quantity (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the

Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after the stated period of performance end date of the contract.

FAR 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time before the contract expires.

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

FAR 52.219-14 Limitations on Subcontracting (Sep 2021)

(a) This clause does not apply to the unrestricted portion of a partial set-aside.

(b) Definition. Similarly situated entity, as used in this clause, means a first-tier subcontractor, including an independent contractor, that—

(1) Has the same small business program status as that which qualified the prime contractor for the award (e.g., for a small business set-aside contract, any small business concern, without regard to its socioeconomic status); and

(2) Is considered small for the size standard under the North American Industry Classification System (NAICS) code the prime contractor assigned to the subcontract.

(c) Applicability. This clause applies only to—

(1)Contracts that have been set aside for any of the small business concerns identified in 19.000(a)(3);

(2)Part or parts of a multiple-award contract that have been set aside for any of the small business concerns identified in 19.000(a)(3);

(3)Contracts that have been awarded on a sole-source basis in accordance with subparts 19.8, 19.13, 19.14, and 19.15;

(4)Orders expected to exceed the simplified acquisition threshold and that are—

(i)Set aside for small business concerns under multiple-award contracts, as described in 8.405-5 and 16.505(b)(2)(i)(F); or

(ii)Issued directly to small business concerns under multiple-award contracts as described in

19.504(c)(1)(ii);

(5)Orders, regardless of dollar value, that are—

(i)Set aside in accordance with subparts 19.8, 19.13, 19.14, or 19.15 under multiple-award contracts, as described in 8.405-5 and 16.505(b)(2)(i)(F); or

(ii)Issued directly to concerns that qualify for the programs described in subparts 19.8, 19.13, 19.14, or

19.15 under multiple-award contracts, as described in 19.504(c)(1)(ii); and

(6)Contracts using the HUBZone price evaluation preference to award to a HUBZone small business concern unless the concern waived the evaluation preference.

(d) Independent contractors. An independent contractor shall be considered a subcontractor.

(e) Limitations on subcontracting. By submission of an offer and execution of a contract, the Contractor agrees that in performance of a contract assigned a North American Industry Classification System (NAICS) code for—

(1)Services (except construction), it will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor's 50 percent subcontract amount that cannot be exceeded. When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract;

(2)Supplies (other than procurement from a nonmanufacturer of such supplies), it will not pay more than 50 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor's 50 percent subcontract amount that cannot be exceeded. When a contract includes both supplies and services, the 50 percent limitation shall apply only to the supply portion of the contract;

(3)General construction, it will not pay more than 85 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities.

Any work that a similarly situated entity further subcontracts will count towards the prime contractor's 85 percent subcontract amount that cannot be exceeded; or

(4)Construction by special trade contractors, it will not pay more than 75 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor's 75 percent subcontract amount that cannot be exceeded.

(f) The Contractor shall comply with the limitations on subcontracting as follows:

(1) For contracts, in accordance with paragraphs (c)(1), (2), (3) and (6) of this clause—

[Contracting Officer check as appropriate.]

□ By the end of the base term of the contract and then by the end of each subsequent option period; or

□ By the end of the performance period for each order issued under the contract.

(2) For orders, in accordance with paragraphs (c)(4) and (5) of this clause, by the end of the performance period for the order.

(g)A joint venture agrees that, in the performance of the contract, the applicable percentage specified in paragraph

(e) of this clause will be performed by the aggregate of the joint venture participants.

FAR 52.219-17 Section 8(a) Award (Oct 2019)

(a) By execution of a contract, the Small Business Administration (SBA) agrees to the following:

(1) To furnish the supplies or services set forth in the contract according to the specifications and the terms and conditions by subcontracting with the Offeror who has been determined an eligible concern pursuant to the provisions of section8(a) of the Small Business Act, as amended ( 15 U.S.C.637(a)).

(2) Except for novation agreements, delegates to the Office of Acquisitions and Grants Services the responsibility for administering the contract with complete authority to take any action on behalf of the Government under the terms and conditions of the contract; provided, however that the contracting agency shall give advance notice to the SBA before it issues a final notice terminating the right of the subcontractor to proceed with further performance, either in whole or in part, under the contract.

(3) That payments to be made under the contract will be made directly to the subcontractor by the contracting activity.

(4) To notify the U.S. Food and Drug Administration Contracting Officer immediately upon notification by the subcontractor that the owner or owners upon whom 8(a) eligibility was based plan to relinquish ownership or control of the concern.

(5) That the subcontractor awarded a subcontract hereunder shall have the right of appeal from decisions of the cognizant Contracting Officer under the "Disputes" clause of the subcontract.

(b) The offeror/subcontractor agrees and acknowledges that it will, for and on behalf of the SBA, fulfill and perform all of the requirements of the contract.

FAR 52.219-18 Notification of Competition Limited To Eligible 8(a) Participants (Mar 2020)

(a) Offers are solicited only from small business concerns expressly certified by the Small Business Administration (SBA) for participation in the SBA’s 8(a) Program and which meet the following criteria at the time of submission of offer-

(1) The Offeror is in conformance with the 8(a) support limitation set forth in its approved business plan;

and http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

(2) The Offeror is in conformance with the Business Activity Targets set forth in its approved business plan or any remedial action directed by the SBA.

(b) By submission of its offer, the Offeror represents that it meets all of the criteria set forth in paragraph (a) of this clause.

(c) Any award resulting from this solicitation will be made to the Small Business Administration, which will subcontract performance to the successful 8(a) offeror selected through the evaluation criteria set forth in this solicitation.

(d) The [insert name of SBA’s contractor] will notify the Food and Drug Administration’s Contracting Officer in writing immediately upon entering an agreement (either oral or written) to transfer all or part of its stock.

The following HHSAR clauses and provision apply and can be obtained at the following website:

https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

By reference:

• 352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)

FDA provisions – Language for Insertion in Acquisition Documents Based on the Change to Disable Macros in Microsoft Office Documents from Outside Sources The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

(End of Provision)

In full text:

• 342.239-74 Electronic and Information Technology Accessibility (Dec 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section- 508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E207 Software (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and

Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical

Requirements)

• Electronic content must be accessible to HHS acceptance criteria.

• Accessibility checklists for various formats are available at the HHS site. Materials that are final items must be compliant with Section 508 at time of delivery, except upon approval of the Contracting Officer or Representative.

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards.

Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

xiv) All responsible sources may submit a proposal, which if timely received, shall be considered. The proposal for Phase I shall reference solicitation number FDA-RFP-22-1249753. The proposal is due by email to the point of contact listed below on or before May 9, 2022 by 3:00 pm EST.

xv) Point of Contact: Peter Lee at (240) 402-4278 or email at Peter.Lee@fda.hhs.gov.

mailto:Peter.Lee@fda.hhs.gov