Solicitation_75F40123Q00460.pdf

Combined Synopsis/Solicitation: 75F40123Q00460

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

75F40123Q00460 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 Purchase Order.

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

Federal Acquisition Circular (FAC) 2023-04.

The U.S. Federal Drug Administration is in need to purchase a Multi-Angle Spectrophotometer.

*********************BRAND NAME OR EQUAL************************

A. Background

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products CDRH oversees. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

The Office of Science and Engineering Laboratories (OSEL) supports the CDRH mission of protecting and promoting public health. OSEL undertakes the highest quality science to provide our customers with the best methods, tools, and expertise to: ensure readiness for emerging and innovative medical technologies; develop appropriate evaluation strategies and testing standards;

create accessible and understandable public health information; and deliver timely and accurate decisions for products across their life cycle.

Through a culture of customer first, communication, collaboration and consultancy, the Division of Imaging, Diagnostics and Software Reliability (DIDSR) participates in the Center's mission of protecting and promoting public health by identifying and investigating issues related to medical https://www.acquisition.gov/far/subpart-12.6#FAR_Subpart_12_6 imaging, computer-assisted diagnostics, and software reliability. The division accomplishes this through activities supporting the OSEL mission.

Under the FDA’s guidance, this collaboration between OSEL and DIDSR is looking to purchase a benchtop spectrophotometer (BTSP) to ensure center and agency-wide maximum, scientific research capacity. A BTSP allows for the spectral measurement of reflective and transmissive targets so that the measurement data can be used to develop colorimetrical test targets for evaluating endoscopy and dermatology devices.

B. Objective

The objective is to procure a multi-angle spectrophotometer that has the capabilities listed under salient characteristics.

C. Scope

The Contractor shall work with the COR/TPOC to meet the below requirements

D. Salient Characteristics

The benchtop spectrophotometer (“BTSP”), shall satisfy the following requirements:

a) The BTSP shall measure a spectral range between 360 nm and 700 nm or wider.

b) The spectral resolution shall be 10 nm or higher (finer).

c) The BTSP shall measure both reflectance and transmittance.

d) The reflectance measurement shall include both the specular component included

(SCI) and specular component excluded (SCE) modes.

e) The reflectance measurement geometry shall include both di:8֯ and de:8֯.

f) The selectable reflectance measurement areas shall include the small range (about φ3 mm), medium range (about φ10 mm), and large range (about φ25 mm).

g) The transmittance measurement geometry shall include both di:0֯ and de:0֯.

h) One of the transmittance measurement areas shall be in the range between φ20 mm and φ25 mm.

i) Thickness of the sample for the transmittance measurement shall be 50 mm or larger.

j) The BTSP shall conform with standard CIE 15 and ASTM 1164.

k) The inter-instrument agreement shall be less than 0.3 delta-E.

l) The repeatability shall be less than 0.05 delta-E.

m) The measurement reproducibility shall be less than 0.1 delta-E.

n) The BTSP shall provide documentation of the interface protocol.

o) The BTSP shall have memory to store previous measurement data.

p) The BTSP can be periodically calibrated internally and/or externally.

q) The BTSP shall include service support for at least one year.

r) Quote shall include all shipping and handling cost to the listed delivery location listed under delivery requirements

E. Warranty

A full 1-year manufacturer warranty shall be included.

F. Deliverables

The Contractor shall deliver the item within thirty (30) days of award and shall provide a full one

(1) year manufacturer warranty.

All deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate new, usable, and acceptable condition.

G. Section 508 Standards

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase information and communication technologies (ICT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal

Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing

Section 508 can be found at http://www.section508.gov. The third applicable regulation is the

HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable

Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable

Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable

Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

1. Must meet WCAG 2.0 A and AA;

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

3. E203 Access to Functionality (Appendix A, Application and Scoping Requirements);

4. E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements);

5. E205 Electronic Content (Appendix A, Application and Scoping Requirements);

6. E208 Support Documentation and Services (Appendix A, Application and Scoping

Requirements);

7. Chapter 6 Support Documentation and Services (Appendix C, Functional Performance

Criteria and Technical Requirements);

8. 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements);

Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-files-accessible/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or

Representative.

H. Place of Performance

U.S. Food and Drug Administration

Attention: TBD

10903 New Hampshire Ave

WO 62 RM 4120

Silver Spring, Maryland 20993

I. Period of Performance

Within thirty (30) days of award date

J. Inspection and Acceptance

All items specified in this Requirements Statement to be delivered under this order are subject to final inspection and acceptance by an authorized representative for the Government. The authorized representative of the Government is the Government’s COR, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

K. Contracting Officer Authority

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

L. Security Considerations

NOTE to Contractor/Vendor: Before the purchase order is awarded, FDA are required to get

Pre-Approval of all the IT Hardware and/or Software-Firmware-Freeware from the FDA Chief

Information Officer (CIO). For IT Hardware, this includes any device that process or stores data or controlled by data (computers/data switches, etc..) but does not include passive hardware

(rack, network cables, power supplies/cords). This will require the applicable contractor to provide a complete list of Hardware and/or Software-Firmware-Freeware that the contractor will use in fulfilling this purchase order.

This list will need to include: IT hardware: Manufacture, nomenclature and model number

Software (all types): Manufacture, nomenclature, and version number Item(s) rejected by the

CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

1) The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

2) The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

3)The Contractor (and/or any subcontractor) shall ensure that computer software developed on behalf of HHS/FDA or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The Contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS/FDA environment. No sensitive data shall be used during software testing.

4)The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS/FDA shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this award.

Line Items and Prices:

The Contractor shall provide the following deliverables:

Line Items

Item

Number

Catalog Number Quantity

(QTY)

Unit List Price

U.S. Dollars

(USD)

Subtotal

1 Spectrophotometer 1 ea $ $

2 Transmittance

Specimen Holder

1 ea $ $

3 Transmittance Zero

Cal Plate

1 ea $ $

4 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 will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will 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 (Mar 2023), applies to this acquisition.

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 11th

September 2023, 10:00 a.m. Eastern Time (ET). 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 15th September 2023 2022, 10:00 a.m. ET.

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 mailto:Iris.Johnson1@fda.hhs.gov mailto:Iris.Johnson1@fda.hhs.gov https://www.acquisition.gov/far https://www.acquisition.gov/hhsar

(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.

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 (Aug 1999)

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 time 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

Form must be received prior to making fingerprintin g appointment

**Form must be submitted by Security

Rep.

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.

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

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.

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/