RFQ_75F40126Q00408_Final.docx

75F40126Q00408 - Port Linear Smoking Machine This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR), Revolution FAR Overhaul (RFO) Part 12.2 (UPDATE: April 20, 2026), as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-1, 3/13/2026.

This announcement constitutes the only solicitation and a separate solicitation will not be issued. The solicitation number is 75F40126Q00408. This solicitation is issued as a Request for Quotes (RFQ).

The associated North American Industry Classification System (NAICS) code for this acquisition is 541990 - All Other Professional, Scientific and Technical Services; the applicable Small Business Size Standard is $16.5 Million. This requirement is solicited for full and open competition. This requirement is being solicited as an open market. Prospective offerors are responsible for downloading the solicitation and amendments from SAM.gov. The Government reserves the right to award a contract without discussion if the Contracting Officer determines that the initial offer provides the best value and discussions are not necessary.

The U.S. Food and Drug Administration (FDA) is requesting quotes for a service agreement and a qualification service for the CERULEAN SM450i Linear Cigarette Smoking Machine at TPL. This instrument is an integral component that support the Food and Drug Administration (FDA) Office of the Chief Scientist/Office of Analytical and Regulatory Laboratories (OCS/OARL) to meet the legislative requirements and the sample workload that are an integral part of the Agency response to the legislation. This instrument is needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under the Food and Drug Administration (FDA) regulatory jurisdiction and to establish expertise in the analyses of tobacco products.

Interested Offerors shall submit any questions concerning the solicitation at the earliest time possible to enable the Government to respond. Questions shall be submitted directly by email to Pamela.Lee@fda.hhs.gov. No phone calls. Questions not received by the question submission deadline of: Monday, September 21, 2026, at 3:00 PM ET may not be considered.

The deadline for receipt of offers for this requirement is: Wednesday, September 23, 2026, at 3:00 PM ET. Proposal submissions must be submitted by email only to Pamela Lee at: Pamela.Lee@fda.hhs.gov. Subject line of the email should be titled: “Proposaal Submission: 75F40126Q00408_Port Linear Smoking Machine”.

Part 1.0: Proposal Submission Instructions

1.1 Offerors shall submit a firm-fixed price proposal, including details of all prices supporting the required deliverables.

1.2 The offeror shall complete the pricing chart below. Pricing shall include all applicable fees including FOB destination shipping and handling. Any charges presented after contract will not be considered.

1.3 Proposals shall be in two volumes: Volume I shall be Technical and Volume II shall be Price. The volumes shall be separate and complete, so the evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in Volume I.

1.4 Proposals shall clearly reference the solicitation, date of offer, company proposing and point of contact.

1.5 Proposal shall be valid for at least 60 days after close of solicitation.

1.6 Offerors shall include in the proposal:

· a point of contact (name, telephone number, and email address),

· proposed firm-fixed-prices,

· business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.),

· Unique Entity ID (UEI) number,

· certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current.

Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote.

1.7 EVALUTION FACTORS, CRITERIA, AND DECISION FOR AWARD

The Government intends to award a single Firm Fixed Price contract as a result of from this solicitation to the responsive quote that represents the best value after evaluation in accordance with the factors identified in the solicitation.

The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit cost or prices offered, unless the Offeror specifies otherwise in the proposal. While not currently anticipated, the Government reserves the right to make multiple awards if, after considering the additional administrative costs, it is in the Government's best interest to do so.

The Government is not responsible for locating or securing any information, which is not identified in the proposal. However, the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

1.7.1 52.212-2 Evaluation—Commercial Products and Commercial Services (April 20, 2026)

(a) Evaluation factors. The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate offers: technically acceptability and price.

(b) Options (if applicable). The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. The evaluation of options does not obligate the Government to exercise the option(s).

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

(End of provision)

Offerors’ initial proposals should contain their most favorable price and technical terms.

Price Evaluation - Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

In considering the price of the base period and any option periods, the Government will consider that if the extension of service clause (FAR 52.217-8) is exercised, it will be on the exact same rates and terms, other than length of performance, as the base or option period being extended. Prior to making an award, the Government shall determine that the price, inclusive of all options (including the options available under FAR 52.217-8), is fair and reasonable, and that the price of the base period and all option periods (including any potential option(s) represented by FAR.

1.7.2 Basis of Award

"Award will be made to the responsible offeror whose quotation/offer is technically acceptable and represents the lowest evaluated price, in accordance with FAR Part 12 (as restructured under the Revolutionary FAR Overhaul, Solicitation, Evaluation and Award subpart), using Lowest Price Technically Acceptable (LPTA) source selection procedures for commercial acquisitions at or below the applicable simplified acquisition threshold of $7.5 million (or $15 million for emergencies/major disasters)."

1.8 52.252.-1 Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

Provisions Number Title

(End of provision)

1.8.1 Authorized Deviations in Provisions (Nov 2020)

(a) The use in this solicitation of any Federal Acquisition Regulation (48 CFR Chapter 1) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the provision.

(b) The use in this solicitation of any ______________ [insert regulation name](48 CFR Chapter______) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of provision)

Part 2: Schedule of Services (all shipping and handling shall be included in the price)

CLIN

DESCRIPTION

QTY

UNIT OF ISSUE

PRICE

Extended Price

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

EA

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

Total:

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

Total:

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

Total:

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

Total:

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

Total:

Grand Total (All Periods)

Part 3: Statement of Work (SOW)

Service Agreement and Qualification Service CERULEAN SM450i Linear Cigarette Smoking Machine Background The Center for Tobacco Product (CTP) Tobacco Products Laboratory (TPL) located in Atlanta, Georgia has a requirement for a service and qualification agreement for one of its Cerulean SM450i Linear Cigarette Smoking Machines.

This instrument is an integral component that supports the Food and Drug Administration (FDA) Office of the Chief Scientist/Office of Analytical and Regulatory Laboratories (OCS/OARL) to meet the legislative requirements and the sample workload that are an integral part of the Agency response to the legislation. This instrument is needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under the Food and Drug Administration (FDA) regulatory jurisdiction and to establish expertise in the analyses of tobacco products.

Salient Characteristics The Contractor shall be capable of providing both the Service Agreement and Qualification Service for all systems specified in the Statement of Work “Brand Name or Equal” to that provided in a Cerulean service contract to ensure uninterrupted performance within manufacturer’s specification as well as complying with local qualification assurance and ISO 17025 certification.

All the following are minimum requirements.

Preventative Maintenance

· Maintenance of the Linear Cigarette Smoking machine shall include a one (1) year full manufacturer’s warranty on all parts, travel and labor, including software and hardware and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum of 72 hour response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications.

· The contractor shall perform one (1) preventative maintenance inspection (PMI) for the SM450i Linear Cigarette Smoking Machine during each one (1) year period of performance.

· The contractor shall perform one (1) operation qualification/performance verification (OQ/PV) for the SM450i Linear Cigarette Smoking Machine during each one (1) year period of performance. The OQ/PV must include all supplies needed to perform that service.

· The contractor under the service agreement shall repair or replace any part or parts which prove to be defective at no additional charge to the government.

· The contractor shall make arrangement for the fastest delivery and will resume work upon receipt of parts within 72 business hours (3 days) or a mutually agreed upon timeframe.

· The contractor shall be responsible to obtain all new parts required for all repairs and maintenance.

· The Contractor Officer Representative (COR) or Point of Contact (POC) shall contact the Contractor to schedule a mutually acceptable date and time for the preventive maintenance visit. All visits must be scheduled in advance with the COR or POC.

· Documentation of preventative maintenance duties performed must be provided.

· The PM service shall be performed by a Cerulean trained and certified engineer and must provide documentation that the instrument is functioning according to the manufacturer’s specifications.

Service Calls

· The Contractor shall respond within 2 business days after receipt of a service call.

· The Contractor shall provide unlimited telephone and email access to instrument technical support Monday – Friday between the hours of 9-5 p.m. EST.

· All repairs must result in the instrument(s) serviced meeting the manufacturer specifications and must use factory new manufacturer replacement parts.

· Any parts or components removed for replacement shall become the property of the Contractor unless otherwise agreed to by the parties. The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information that the FDA may return the parts to the Contractor at the Contractor’s cost within 3 days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments.

· The Contractor shall perform a diagnostic test results or narrative summary demonstrating that the instrument is meeting the manufacturer’s specifications.

Qualification Service The Qualification service for each system shall include OQ/IPV to be performed after the planned preventative maintenance (PM) and in the event of a critical repair and shall include:

· The contractor shall provide documentation for calibrations and an instrument performance run.

· The OQ/IPV service shall be performed by a Cerulean trained and certified engineer and must provide documentation that the instrument is functioning according to the manufacturer’s specifications.

· Removal of any packaging materials shall be the responsibility of the Contractor.

Service Conditions

· To the maximum extent practicable, service must be rendered on-site at the FDA.

· In the event a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping, and transportation costs as well as liability for the shipment to and from the FDA, 1777 Hardee Ave. SW Atlanta, GA. 30310. The Contractor shall be responsible for providing a “Return Authorization Number” or other information authorizing return of the shipment to their facility prior to the shipment. The Contractor shall also provide a shipping account number to pay for the shipment.

· The Contractor shall only employ tools, parts, instruments, test apparatus, methodologies, techniques, and practices approved for use by the manufacturer.

Instruments for Preventative Maintenance and Qualification Service

Description/Serial Numbers

(1) SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

Warranty All labor, replacement parts and components (excluding consumables) shall be warrantied.

Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

Deliverables

CLIN

DESCRIPTION

QTY

UNIT OF ISSUE

PRICE

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

· SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454)

Place of Performance Food and Drug Administration Tobacco Products Laboratory 1777Hardee Ave. SW Atlanta, GA 30310 POC: Robert Walker

Period of Performance The period of performance shall be for a base period of one year with four one-year option periods for Preventative Maintenance and Operation Qualification Services BASE YEAR - 12 Months OPTION YEAR 1 – 12 Months OPTION YEAR 2 – 12 Months OPTION YEAR 3 – 12 Months OPTION YEAR 4 – 12 Months Unless otherwise specified, services shall be performed Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

Government Holidays Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather.

January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day) June (Juneteenth) December (Christmas Day) July (Independence Day) Part 4: Contract Clauses

4.0 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 at any time before contract completion.

(End of clause)

4.1 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 prior to contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at 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 undefined.

(End of clause)

4.2 52.252-2 Clauses Incorporated By Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

Clauses Number Title

(End of clause)

4.2.1 Authorized Deviations in Clauses (Nov 2020)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any HHSAR clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

4.3 Department of Health and Human Services Acquisition Regulation (HHSAR) Clauses:

4.3.1 Contractor Compliance with Defending Women and Protecting Children Requirements – Certification (MARCH 2025) (DEVIATION)

(a) Certification. By submission of this offer and during performance of this contract, including the obligation, expenditure, or drawdown of funds, the contractor certifies that: [Offeror shall check each item.] ___ (1) It is compliant with Title IX of the Education Amendments of 1972, as amended, 20 U.S.C. §§ 1681 et seq., including the requirements set forth in Presidential Executive Order 14168 titled Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, and Title VI of the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq., and Contractor will remain compliant for the duration of the contract.

___ (2) The above requirements are conditions of payment that go the essence of the contract and are therefore material terms of the contract.

___ (3) Payments under the contract are predicated on compliance with the above requirements, and therefore the Contractor is not eligible for funding under the contract or to retain any funding under the contract absent compliance with the above requirements.

___ (4) This certification reflects a change in the Government’s position regarding the materiality of the foregoing requirements and therefore any prior payment of similar claims does not reflect the materiality of the foregoing requirements to this contract.

____ (5) Submitting a knowing false statement relating to Contractor’s compliance with the above requirements and/or eligibility for the contract may subject Contractor to liability under the False Claims Act, 31 U.S.C. § 3729, and/or criminal liability, including under 18 U.S.C. §§ 287 and 1001.

(b) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

(End of provision)

4.3.2 352.209-2 Contractor Compliance with Defending Women and Protecting Children Requirements (March 2025) (DEVIATION)

352.232-71 Electronic Submission of Payment Requests (APR 2026) (RFO DEVIATION)

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements in FAR 32.905(b), and the applicable payment clause included in this contract.

(b) Submission instructions. Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) Alternate submission procedures. The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing.

(d) Submission of alternate payment procedures authorization. If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

4.3.3 352.239-79 Information and Communication Technology Accessibility (Feb 2024) (Deviation)

(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 information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)

4.3.4 Contract Administration

a. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is: Name: Madeline Bryant, Contracting Officer Phone: 240-402-7611 Email: Madeline.Bryant@fda.hhs.gov

The contact information for the Contract Specialist is:

Name: Pamela Lee, Contract Support Specialist Phone: 240-402-3847 Email: Pamela.Lee@fda.hhs.gov

b. The COR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The following COR will represent the Government for the purpose of this contract: Name: (To be completed at time of award) Email:

Phone:

4.3.5 Inspection/Acceptance

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the COR specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

4.3.6 Payment Terms

Net 30 days after government acceptance of a proper invoice which shall only be submitted after services have been performed. In accordance with the “Advance Payment Statute” at 31 U.S.C § 3324: Advance payments will not be made.

4.3.7 Invoice Submission

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.

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.

4.3.8 Notice Regarding the Use of Macros in Submitted Documents Be advised that FDA does not accept documents which contain the use of macros. When submitting documents 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). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.