Solicitation_75F40123Q00459.pdf

Combined Synopsis/Solicitation: 75F40123Q00459

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6 with FAR part 13, 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.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is

75F40123Q00459 and is being issued as a request for quotation (RFQ). The NACIS Code for this solicitation is 334516-Analytical Laboratory Instrument Manufacturing. The small business size standard is 1,000. The requirement will be awarded as Firm-Fixed Price. This requirement is

Full and Open Competition. Prospective Offeror’s are responsible for downloading the solicitation and any amendments from SAM.gov the Government reserves the right to award this order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value to the Government and discussions are not necessary.

The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2023-05.

The U. S. Food and Drug Administration (FDA) has a need to purchase a Pulsatile Pump

System.

*******************Brand Name or Equal****************************************

A. Background

To fulfill the CDRH mission statement to protect and promote public health through advancing regulatory science, CDRH is taking a regulatory science approach to develop more physiologic bench performance testing for new cardiovascular devices. This approach allows us to better understand how medical devices perform across diverse populations and to better assess the safety of emerging technologies. To accelerate patient access to innovative, safe, and effective medical devices through best-in-the-world regulatory science, the Division of Applied

Mechanics (DAM/OSEL/CDRH/FDA) is developing non-clinical test methods for evaluating cardiovascular medical devices. This procurement is a key component in building a physiologic cardiovascular bench setup for testing novel devices.

The Cardiovascular Hemodynamics group (DAM/OSEL/CDRH/FDA) plans to disseminate these test methods to industry via OSEL’s Regulatory Science Tools so that it can be used by device developers. This is aligned with CDRH Advanced Health Equity Strategic priority to advance the development of knowledge and safe and effective technologies to meet the needs of all patients and consumers. This will support consistent, least-burdensome assessment of cardiovascular devices during pre-market review while ensuring valid scientific evidence supports the performance of devices used in the care of diverse patient populations. This will inform FDA about the rigor of testing and conditions that should be evaluated for effectively evaluating new medical devices prior to clinical use.

https://www.acquisition.gov/far/subpart-12.6#FAR_Subpart_12_6

B. Objectives

CDRH is seeking an off-the-shelf cardiovascular flow model with adjustable input cardiac waveforms and built-in systemic compliance and resistance. The pump system should mimic the viscoelastic behavior of the heart and include a fluid reservoir. The system should also come with four pressure sensors, dedicated data acquisition hardware, and software to analyze cardiac pressure-flow data.

CDRH also needs to easily, and in real-time, adjust the flow through a mock circulatory loop using dedicated software that controls the stroke volume and other parameters such as heart rate for simulating different physiological hemodynamic conditions. Extensive versatility is needed for developing comprehensive test methods for the novel devices to be evaluated. Additionally, CDRH will need the pump to function as positive displacement pump to easily adjust and record physiological pressure and flow waveforms.

Expected goal: To obtain goods—in the form of a pulsatile flow pump with accessories—that meets these requirements.

Delivery: Acquisition of a pulsatile flow pump.

C. Task

The pulsatile pump system shall have the following characteristics/specifications:

The Vendor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement.

Hardware Specifications

a) Capable of generating physiological, pulsatile cardiovascular flow waveforms.

b) Achievable mean flow rate using a blood analog fluid ≥ 10 L/min.

c) Flow rate resolution ≤ 0.15 L/min.

d) Beat-to-beat repeatability ≤ 0.15 L/min.

e) Heart rate range of 40 – 210 beats per minute (bpm).

f) Maximum stroke volume ≥ 150 mL.

g) Minimum stroke volume = 0 mL.

h) Contains valves for unidirectional flow.

i) Self-priming, positive displacement pump head.

j) Compatible with 40% glycerin/60% water (blood analog) solution and water.

k) Dedicated computer and monitor screen shall be included for pump control, monitoring, and data acquisition.

l) Pump shall be powered by standard US outlet.

m) Continuous operating time > 8 hours.

n) Analog voltage control of the pump is required.

o) Data acquisition sampling rate ≥ 1 kHz.

p) System shall be capable of using a trigger signal to synchronize with other systems and/or an EKG waveform.

D. Required Components

a) The system shall include an integrated fluid reservoir, compliance chamber, and resistance component.

b) The system shall include 4 pressure transducers for simultaneous pressure measurements at 4 locations within a mock circulatory loop.

c) The system shall include a valve performance testing model for assessing heart valve hemodynamics.

d) The pump shall include a viscoelastic impedance component adjacent to the piston to generate physiological ventricular waveforms.

E. Required Software Specifications

a) System shall include standalone software to enable full system control, real-time, digital monitoring, data collection, and post-test analysis.

b) Ability to change the input waveform in real-time among at least 3 user-defined conditions while pump is running.

c) Software control of stroke volume, heart rate, and waveform shape.

d) Software/digital control of waveform amplitude.

e) Ability to separate the data into individual beat cycles for real-time analysis of valve function.

f) Software is compatible with existing National Instruments data acquisition hardware components (i.e., NI-9178, 9403, 9263, 9237, 9201).

F. Servicing Warranty

a) Warranty of all equipment for a minimum of 1 year.

b) Technical support for the system shall be provided online and via phone.

c) Onsite servicing/calibration available.

G. Place of Performance/Period of Performance

Delivery should occur within 3-6 months of fulfilling this procurement. All equipment shall be delivered to the following address:

US FDA / Center for Devices and Radiological Health

Office of Science and Engineering Labs / DAM

Attention: TBD

10903 New Hampshire Ave

White Oak Building 62, Room 4215

Silver Spring, MD 20993

There is no need for the Vendor to perform work/installation on-site.

The device shall be installed by FDA scientific staff in the CDRH/OSEL/DAM Cardiovascular

Hemodynamics lab.

Line Items and Prices:

The Contractor shall provide the following deliverables:

Item

Number

Catalog

Number

Quantity

(QTY)

Unit Subtotal

1 Pulsatile

Pump System

1 ea $

2 Shipping $

Subtotal $

Note: The Contractor shall complete the pricing table above to be considered responsive. All

Contract Line Items are firm-fixed price.

Government Holidays

a) The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (7) Labor Day

(2) Martin Luther King's Birthday (8) Columbus Day

(3) President’s Day (9) Veterans' Day

(4) Memorial Day

(5) Juneteenth (10) Thanksgiving Day

(6) Independence Day (11) Christmas Day

b) In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c) When any such day falls on a Saturday, the following Monday is observed.

Except for designated around-the-clock or emergency operations, Contractor personnel shall not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor shall not charge any holiday as direct charge to the award.

d) It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e) Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this Contract.

INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

The provision at 52.212-1, Instructions to Offerors—Commercial Products and Commercial

Services (Sep 2023).

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete. The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1. Please follow the volume instructions or your quote may be considered non-responsive. ***

The technical volume shall provide the specifications of the equipment and the warranty. The total number of pages for the technical quote shall not exceed ten (10) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

The Offeror 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 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 to correct the document submission and the

Government will not inform the Offeror that the submission is non-responsive prior to award.

It is the Offeror’s responsibility to ensure all electronic documents are submitted without the use of macros.

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.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition. ***

EVALUATION AND AWARD

The provision at 52.212-2, Evaluation—Commercial Products and Commercial

Services (Nov 2021).

Lowest Priced, Technically Acceptable (LPTA)

Instructions to Offeror(s)

Pricing shall include shipping and installation cost.

QUESTIONS DEADLINE:

Questions Deadlines: Interested Offerors shall submit questions electronically to Contract

Specialist (CS) Iris Johnson electronically to Iris.Johnson1@fda.hhs.gov no later than September

12, 10:00 a.m. Eastern Standard Time (EST). Please include the company name, FDA

Solicitation number, and “Question(s)” in the subject line. No Phone Calls Will Be Accepted.

Quotes Due: Interested Offerors shall submit their RFQ to Iris Johnson (CS) electronically to

Iris.Johnson1@fda.hhs.gov no later than September 15, 10:00 a.m. EST.

Provisions and Clauses

FAR 52.252‐2 Solicitation Provisions 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):

https://www.acquisition.gov/far and https://www.acquisition.gov/hhsar.

HHSAR

352.211-3 Paperwork Reduction Act (Dec 2015)

352.222‐70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec

2015)

352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

HHSAR 352.232-71 Electronic Submission of Payment Requests

(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 identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or mailto:Iris.Johnson1@fda.hhs.gov mailto:Iris.Johnson1@fda.hhs.gov https://www.acquisition.gov/far https://www.acquisition.gov/hhsar successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting

Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the

Contracting Officer's written authorization with each payment request.

FAR

The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial

Items; FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-3 Offeror Representations and

Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions Commercial

Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or

Executive Orders--Commercial Items; FAR 52.204-19 Incorporation by Reference of

Representations and Certifications; FAR 52.204-24 Representation Regarding Certain

Telecommunications and Video Surveillance Services or Equipment; FAR 52.204-25

Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or

Equipment; FAR 52.204-26 Covered Telecommunications Equipment or Services-

Representation; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor--Cooperation with

Authorities and Remedies; FAR 52.223-18, Encouraging Contractor policies to Ban Text

Messaging While Driving; FAR 52.222-21, Prohibition of Segregated Facilities; FAR 52.222-

26, Equal Opportunity; FAR 52.222-36, Affirmative Action for Workers with Disabilities; FAR

52.232-33 Payment by Electronic Funds Transfer—System for Award Management.

52.204-27 Prohibition on ByteDance Covered Application (Jun 2023)

(a) Definitions. As used in this clause—

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by

ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)—

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a

Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023

(Pub. L. 117-328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M-23-13, dated February 27, 2023, “No TikTok on Government Devices” Implementation Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees; however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an exception has been granted in accordance with OMB Memorandum M-23-13.

(c) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for the acquisition of commercial products or commercial services.

52.211-6 Brand Name or Equal

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 before contract/award expiration.

FDA

FDA 1335 Personnel Security Clearance Requirements

1. BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and

Human Services (DHHS), requires that DHHS employees and contractor employees

(including subcontractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or lease space for less than thirty

(30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all times while in DHHS-owned or leased space.

2. GENERAL

The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

a. Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security

Operations, Policy and Planning, Personnel Security Staff.

b. "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in paragraph a. above.

With the exception of costs associated with fingerprinting Contractor employees outside of the

FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees will be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation

Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required, vary with the position risk levels for the contract.

The position risk levels for this contract are Level 1. There are two (2) potential position risk levels, which are:

Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge will be required to provide additional security information for a background investigation as specified in Paragraph 5 below.

b. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by

CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

CHART A

Mandatory for all on-site contract employees

NON-

SENSITIVE

POSITIONS -

LEVEL 1

FORM NAME

OBTAIN

FROM

WHEN

REQUIRED

SUBMIT TO DATE

REQUIRE

D

FDA Form 3391

- FDA

Security Card

Access Request

Contractin g Officer’s

Representativ e (COR).

Sponsorshi p must be provided by

FDA COR.

All positions on DHHS property or leased space

Food and Drug

Administration Attn:

Badging and

Credentialing Office

10903 New

Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD

20993

**Form must be submitted by Security

Rep.

Form must be received prior to making fingerprint appointmen t.

Contractor’s

Commitment to

Protect Non-Public

Information (NPI)

Agreement form

Contractin g Officer

All positions with access to non-public privileged, proprietary, or trade secret information

Contracting Officer for retention in contract file

Ten (10) calendar days prior to commence ment of work

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair

Credit Reporting

Act Release

Contractor generated

All positions, including intermittent, per diem or temporary

*Food and Drug

Administration Attn:

Badging and

Credentialing Office

10903 New

Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD

20993

(301) 796-4592

Ten (10) calendar days prior to commence

SF 85 -

Questionnaire for

Non-Sensitive

Positions

Online via

OPM’s e-QIP system

Non-

Sensitive

Positions -

Level 1

Clearance

*Submit to OPM online via the e- QIP system

Ten (10) calendar days upon request of the

Contracting

Officer

FD 258 -

Fingerprint Chart

(2 Charts

Required)

Fingerprinting services available by appointment only. Call (301)

827-9527

Contractin g Officer

Non-

Sensitive

Positions -

Level 1

*Food and Drug

Administration

Fingerprinting &

Personnel Security

Office

10903 New

Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD

(301) 796-4607 days prior to commence

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of

Contracting Officer.

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.*Food and Drug Administration

Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m.

10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

No appointment necessary

(301) 796-4592

CHART B

Public Trust

Positions - Levels

5 or 6

FORM NAME

OBTAIN

FROM

WHEN

REQUIRED

SUBMIT TO DATE

REQUIRE

D

SF 85P -

Questionnaire for

Public Trust

Positions

Online via

OPM’s e-

QIP

system

Public Trust

Positions -

Level 5 or 6

*Submit to OPM online via the e- QIP system

Ten (10) calendar days prior to commencem ent of work

FD 258 -

Fingerprint Chart

(2 Charts Required)

Fingerprinting services available by appointment only.

Call (301) 827-

Contracti ng Officer

Public Trust

Positions -

Level 5 or 6

Clearance

*Food and Drug

Administration

Fingerprinting &

Personnel Security

Office

10903 New

Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD

(301) 796-4607 days prior to

FDA Form 3391

- FDA

Security Card

Access Request

COR.

Sponsorsh ip must be provided by

FDA

COR.

All positions on DHHS property or leased space

Food and Drug

Administration Attn:

Badging and

Credentialing Office

10903 New

Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD

20993

**Form must be submitted by Security

Rep.

Form must be received prior to making fingerprintin g appointment

Contractor’s

Commitment to

Protect Non-Public

Information (NPI)

Agreement form

Contracti ng Officer

All positions with access to non-public privileged, proprietary, or trade secret information

Contracting Officer for retention in contract file

Ten (10) calendar days prior to

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair

Credit Reporting

Act Release

Contracto r generated

All positions, including intermittent, per diem or temporary

*Food and Drug

Administration Attn:

Badging and

Credentialing Office

10903 New

Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD days prior to

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

*Food and Drug Administration Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m.

10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

No appointment necessary

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of

Contracting Officer.

In order to access the e-QIP system, Contractor employees must provide the appropriate

Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth;

(f) email address; and (g) phone number. The Personnel Security Specialist will use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each

Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The Contracting Officer’s Representative (COR) for the contract will provide the name of the appropriate Personnel Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in the

Contractor’s employees being denied access to FDA property until all security processing has been completed.

3. BADGING PROCESS

The FDA identification badge (PIV) is a multi-purpose badge that includes a magnetic strip

(for card access) and a barcode (for employee identification programs). The FDA has implemented the Monitor Dynamics, Inc. (MDI) Network Security System for access control at approximately 98 FDA facilities nation-wide. This system uses the magnetic strip badges and card readers to control access.

The purpose of the FDA badge is to ensure that only authorized personnel gain access to FDA facilities. The badges are encoded to limit an individual's access to designated security areas.

Card readers are grouped into "classes" that define the areas that individuals have access to. The

"class" is determined by your security representative.

If an individual is an FDA Headquarters or contract employee and need a security identification/access badge:

Complete HHS Form-745, HHS ID Badge Request. This form is available through the

Contracting Officer’s Representative (COR), or in the FDA Badging Office at:

Food and Drug Administration, Fingerprinting and Personnel Security Office, 10903 New Hampshire Avenue, Building 1, Room 1201, Silver Spring, MD 20993.

Contact the Contracting Officer’s Representative; have them assign the "class" and sign the

HHS Form 745 in the designated blocks. Please, make sure that all appropriate information is completed before arriving at the badging office.

Hand carry the original (copies or faxes will not be accepted) HHS Form-745 and the old identification badge to the following location for photographing:

Food and Drug Administration, Fingerprinting and Personnel Security Office, 10903 New Hampshire Avenue, Building 1, Room 1201, Silver Spring, MD 20993.

Hours of service: Monday - Friday, 8 a.m. - 11 a.m. and 1 p.m. to 3 p.m.

You are required to wear your identification badge at all times while in FDA facilities. The badge must be displayed at or above the waist in plain view. If you do not have your badge when you attempt to enter an FDA facility a temporary visitor's badge will be issued to you on a daily basis.

If you lose your badge, immediately contact the Contracting Officer’s Representative (COR) so that it can be deactivated in the network security system to prevent unauthorized use. Before a replacement badge will be issued, you must wait three working days, and then submit a new completely signed off HHS-745 form, FDA Security Card Access Request. Hand-carry your

HHS-745 form to the FDA Badging Office during normal hours of operation.

FDA Badges are issued for 5 years for employees and up to 1 year (contingent upon duration of contract) for contractors. To replace an expiring badge, complete an HHS- 745 form within 30 days of expiration. If you have any questions or problems contact the Contracting Officer’s

Representative (COR).

FDA Badges must not be given or loaned to any person other than the original recipient.

Badges are used for security purposes only and must not be used as identification for personal or other business purposes. Badges must be surrendered to the issuing office when you retire, transfer, terminate FDA employment, etc. Lost or stolen badges must be immediately reported to the security office.

All non-FDA employees and contract employees who work on site or are required to have access to non-public information while working under an FDA contract for 30 calendar days or longer, must have a satisfactory preliminary check prior to being issued a security identification/access badge. Any questions or problems regarding these preliminary background checks should be directed to the Contracting Officer’s Representative (COR).

4. BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract.

1. Required background investigations may include, but not be limited to:

2. Review of prior Government/Military personnel records;

3. Review of FBI records and fingerprint files;

4. Searches of credit bureaus;

5. Personal interviews; and

6. Written inquiries covering the subject’s background

Background investigations shall be conducted by the Office of Personnel Management

(OPM).

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of contractor employees.

The Contractor shall submit the information required for e-QIP access and other requisite forms for the risk levels(s) specified. In addition, the contractor shall provide a cover letter which includes: the Contractor’s name, the contract number, the name of the Contracting Officer administering the contract, the names of all Contractor employees’ for whom background check is required and those employees’ social security numbers, date of birth, and former names.

The contractor shall advise its prospective employees that all standard forms submitted to the

FDA shall be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

Personnel Security Staff shall resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise

Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a Contractor employee for who security forms have been submitted is terminated or otherwise ceases work under the contract, the contractor shall immediately notify

Personnel Security Staff in writing, with copies to the respective FDA Contracting Officer’s

Representative (COR) and Contracting Officers.

The OPM background investigation will take approximately 120 days. The Contracting

Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract. Those who are not cleared must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the contractor shall notify the Contracting Officer, and the Government will make a determination whether an additional security clearance is required.

In the event that a cleared individual is replaced, the contractor shall notify the Contracting

Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual.

The Contractor shall be responsible for the return of any Government issued security badges to the Contracting Officer’s Representative (COR).

FDA Invoice Submission Instructions

352.232-71 Electronic Submission of Payment Requests

(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 identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall 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) The Contractor may submit payment requests using other than IPP only when the Contracting

Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the

Contracting Officer's written authorization with each payment request.

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).

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

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.

1. 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;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other

Indirects)- show rate, base and total amount;

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

4. 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;

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

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

7. 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.

***NOTE TO VENDOR***

Parties responding to this solicitation may submit their offer in accordance with the company’s standard commercial practices (e.g. on company letterhead, formal quote form, etc.) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Unique Entity Identifier 4) Taxpayer ID number;

5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer.

Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. A company may register by going to www.sam.gov.

http://www.sam.gov/