United States - FDA Online Standards Search & Retrieval System

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Details

Provided by Open Opps
Opportunity closing date
27 August 2019
Opportunity publication date
17 August 2019
Value of contract
to be confirmed
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Description

Added: Aug 16, 2019 5:07 pm

FDA Online Standards Search & Retrieval System. 

Offeror Name DUNS
PART 1 - GENERAL INFORMATION
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 and 13.5 as supplemented with additional information in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price purchase order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-05 dated August 13, 2019.
The associated North American Industrial Classification System (NAICS) code for this procurement is 541990 - All Other Professional, Scientific, and Technical Services with an associated size standard of $14 Million. This requirement is being solicited full and open.
PART 2 - SUPPLIES OR SERVICES AND PRICES/COSTS
Contract Type: The Government intends to issue a firm fixed-price purchase order resulting from this solicitation.
Pricing Table:
Contract Line Item Number (CLIN) Description Quantity Price
Base Period FDA Online Standards Search and Retrieval System 1 EA $
Option Period 1 FDA Online Standards Search and Retrieval System 1 EA $
Option Period 2 FDA Online Standards Search and Retrieval System 1 EA $
Option Period 3 FDA Online Standards Search and Retrieval System 1 EA $
Option Period 4 FDA Online Standards Search and Retrieval System 1 EA $
TOTAL PRICE $
PART 3 - DESCRIPTION OF REQUIREMENT
Background
As an Agency, the Food and Drug Administration has a rich history in its use and support of standards for regulatory purposes. Several Centers in the Agency rely on standards to facilitate areas across the total product life cycles of the areas under its regulatory jurisdictions. Since, 1997 and in accordance with FDAMA of 1997, the Food and Drug Administration (FDA) established a consensus standards program recognizing all relevant medical devices standards and acquiring an annual license agreement to have full electronic access to published medical device standards. This access includes the full versions of all relevant related standards (as listed below), download capability, and continual updating of the database to provide the most current versions of standards to FDA scientists and regulatory staff for the purpose of executing FDA's regulatory responsibilities.
Objective
The objective of this contract is to acquire an online information retrieval system that provides instantaneous access to industry specifications and standards to serve the regulatory needs of the Agency where standards are utilized.
Scope
The system must contain expeditious and sophisticated research capabilities, as well as a comprehensive index that allows various types of searching and management reports, with the ability to identify specific documents then view the actual document pages. The documents must be viewable online in electronic-based PDF or HTML format, must be fully printable, and must be provided in a licensing agreement which will permit authorized downloading and temporary storage.

Specific Requirements
Specific Requirements:
1. Internet Access to Government and Commercial Standards
The system shall provide access to the following active commercial standard documents including an index with complete and unlimited access to full-text images in PDF and/or scanned images:
• AAMI Collection - Association for the Advancement of Medical Instrumentation
• ADA Collection - Americans with Disabilities Act
• ANSI Collection - American National Standards Institute
• ASA Collection - Acoustical Society of America
• ASME Collection - American Society of Mechanical Engineers
• ASQ Collection - American Society for Quality
• ASTM Collection with Redlines - American Society for Testing and Materials
• BSI Health & Safety Segment (Active and Historical) - British Standards Institution
• CLSI Collection - Clinical & Laboratory Standards Institute
• IEC Collection - International Electrotechnical Commission
• INCITS Collection - International Committee for Information Technology Standards
• ISA Network - International Society of Automation
• ISO Collection - International Organization of Standardization
• OLA Collection - Public Library Division of the Oregon Library Association
• PDA Collection - Parenteral Drug Association
• RESNA Collection - Rehabilitation Engineering and Assistive Technology Society of North America
• VC (ASC Z80) Collection - Verified Carbon Standard
• UL Collection - Underwriters Laboratories that includes:
o UL 50
o UL 50E
o UL 94
o UL 746C
o UL 796
o UL 991
o UL 1012
o UL 1310
o UL 1642
o UL 1977
o UL 2054
o UL 2089
o UL 4200A
o UL 122
o UL 2900-1
o UL 2900-2-1
o UL 2900-2-2
o UL 1998
o UL 60601-1
o UL 5500
• ISPE GAMP® 5 Guides - International Society for Pharmaceutical Engineering / Good Automated Manufacturing Practice:
o GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
o GAMP Good Practice Guide: Electronic Data Archiving
o GAMP Good Practice Guide: Testing of GxP Systems
o GAMP Good Practice Guide: Global Information Systems
o GAMP Good Practice Guide: IT Infrastructure Control and Compliance
o GAMP Good Practice Guide: Validation of Laboratory Computerized Systems
o GAMP Good Practice Guide: Risk-Based Approach to Electronic Records & Signatures
o GAMP Good Practice Guide: Legacy Systems
o GAMP Good Practice Guide: Validation of Process Controls Systems
o GAMP Good Practice Guide: Calibration Management
• ISPE Baseline Guides - International Society for Pharmaceutical Engineering
o Volume 6: Biopharmaceuticals Bound / Electronic Set
o Volume 5: Commissioning and Qualification Bound / Electronic Set
o Volume 4: Water and Steam Systems Bound / Electronic Set
o Volume 3: Sterile Manufacturing Facilities
o Volume 1, 2nd Edition: Active Pharmaceutical Ingredients
o Revision to Bulk Pharmaceutical Chemicals
In addition, the ASTM Standards must be viewable in PDF format to allow users the ability to compare additions, deletions, and other changes between the active and previous versions.
The system shall provide the capability to link from industry standards referenced in internal documents directly to the PDF document. The Contractor shall provide access to all listed standards through one site via provided username and password or IP authentication.
2. Index and Reports
The system shall provide a single index to the standard collections listed above, with access to full-text images in PDF format. The index must be able to provide the following:
• Summary that provides specific information regarding the standard document.
• Document preview or snapshot of the actual document when available.
• Ability to view and/or change view of available line item results in index.
• Ability to print index results or export for reporting.
3. Product Functionality
The system must provide the following research capabilities or methods:
A. All commercial industry standards listed above must be included in the same system using the same search engine.
B. Searching by document number or portion of a document number, including alpha prefixes and decimal points.
C. Keywords must be searchable from the index in the title of the document, scope, intended use, keyword paragraphs or summaries, and/or abstracts.
D. Searching by Preparing Organization.
E. Each search query must provide the user with a results list. The results list must identify the document number, Standards Developing Organization, and the document title.
F. The system must have an update notification feature to alert users that documents have been updated.
The system must provide the following usage reporting methods:
A. Provide usage data on the standards reviewed or downloaded from the most frequent to the least frequent upon request by FDA.
B. Capture usage data for all FDA staff using the database starting from the beginning of the license agreement. This data shall be captured using a first-time registration function whereby the user identifies which Center/Office/Division of FDA they are from and their full name. This data shall then be connected to the staff IP address. From the capture of this information, the Government shall be able to query the system to determine how different parts of the Agency are using the database to best serve its needs.
4. Document Images/Text
The system must provide the following:
A. All non-Government commercial standards must be licensed by the issuing Standards Developing Organization to allow image viewing and printing of the standard in hardcopy format.
B. Document images must include full English translation.
C. Documents must be updated in near real-time.
D. System must identify recently updated documents and provide at a minimum, a history of previously published standards that were superseded.
E. Documents must be provided via electronic media. Hardcopy delivery of documents will not be considered.
F. If a Standards Developing Organization requires Digital Rights Management (DRM) restrictions, the encryption software shall be made available at no additional charge to allow for viewing of the PDF documents. Note: DRM is currently required for AWS.
Deliverables
Description of Deliverable Due Date
1 Online Standards Search & Research System (Base Period) Daily
2 Online Standards Search & Research System (Option Period 1) Daily
3 Online Standards Search & Research System (Option Period 2) Daily
4 Online Standards Search & Research System (Option Period 3) Daily
5 Online Standards Search & Research System (Option Period 4) Daily
PART 4 - PACKAGING, MARKING and SHIPPING
As Applicable, 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 name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All delivered equipment shall be newly manufactured, not used or refurbished or previously used for demonstration.
PART 5 - INSPECTION AND ACCEPTANCE
The Government will rely on the contractor's assurances that the commercial item tendered for acceptance conforms to contract requirements. The Government inspection of commercial items will not prejudice its other rights under acceptance paragraph in FAR 12.402. The Government always has the right to refuse acceptance of nonconforming items.
PART 6 - DELIVERIES OR PERFORMANCE
Deliveries and Place of Performance
Satisfactory performance of this contract shall be deemed to occur upon delivery of services described above and/or upon acceptance by the Contracting Officer or the Contracting Officer's Representative of these products and services.
Period of Performance
The Period of Performance is:
1. Base Period: Twelve (12) Months after date of award;
2. Option Period 1: Twelve (12) Months;
3. Option Period 2: Twelve (12) Months;
4. Option Period 3: Twelve (12) Months;
5. Option Period 5: Twevle (12) Months.

PART 7 - CONTRACT ADMINISTRATION DATA
The following personnel shall represent the Government for the purpose of this contract:
Contracting Officer's Representative (COR):
To be determined upon contract award
The Technical Representative is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.
Contracting Officer (CO): Contract Specialist (CS):
Anthony S. Wimbush Anthony S. Wimbush
4041 Powder Mill Road 4041 Powder Mill Road
Beltsville, MD 20705 Beltsville, MD 20705
anthony.wimbush@fda.hhs.gov Anthony.wimbush@fda.hhs.gov
Tel: (240) 402-7628 Tel: (240) 402-7628
The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to (1) Direct or negotiate any changes in the RFQ; (2) Modify or extend the period of performance; (3) Change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract.
Payment Schedule:
The Contractor shall submit invoices monthly.
FDA Three-Way Match Invoicing Procedures:
A. The contractor shall submit all invoices to:
U.S. FOOD AND DRUG ADMINISTRATION
Attn: Vendor Payments
Division of Payment Services
10903 New Hampshire Ave
WO32 - Second Floor
MAIL HUB 2145
Silver Spring, MD 20993-0002
301-827-3742
FDAVendorPaymentsTeam@fda.hhs.gov
*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.
B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:
(i) Name and address of the contractor;
(ii) Invoice date and invoice number;
(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);
(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:
(a) period of performance for which costs are claimed;
(b) itemized travel costs, including origin and destination;
(c) any other supporting information necessary to clarify questionable expenditures;
(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;
(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;
(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);
(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)
(viii) Name, title, and phone number of person to notify in event of defective invoice;
(ix) Taxpayer Identification Number (TIN);
(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);
(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;
(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, 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;
(xiii) Any other information or documentation required by the award.
C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.
D. Questions regarding invoice payments should be directed to the 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.
PART 8 - SPECIAL CONTRACT REQUIREMENTS
Section 508
Section 508 mandates that all Federal agencies eliminate the barriers in accessing electronic and information technology (E&IT). The 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. The law also helps to ensure that members of the public with disabilities have the ability to access government information and services.
FDA's goal is to properly implement Section 508 to improve the accessibility of government information and data and ensure government E&IT is accessible to Federal employees and citizens with disabilities.
The contractor should be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that documents generated as part of the tasks are fully Section 508-accessible using the available COTS tools.
508 Standard Requirements include:
1194.21 Software applications and operating systems (a - l)
1194.22 Web-based intranet and internet information and applications (a - p)
1194.31 Functional performance criteria (a - f)
All electronic and information technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitiation Act of 1973, as amended, and is viewable at http://www.accessboard.gov/sec508/508 standards.htm - Part 1194.
 
PART 9 - CONTRACT PROVISIONS AND CLAUSES
FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://acquisition.gov/far/
(End of clause)
FAR 52.204-13 - System for Award Management Maintenance (Oct 2018)
FAR 52.204-18 - Commercial and Government Entity Code Maintenance (Jul 2016)
FAR 52.212-4 - Contract Terms and Conditions - Commercial Items (Oct 2018)
FAR 52.232-39 - Unenforceability of Unauthorized Obligations (Jun 2013)
FAR 52.232-40 - Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)
FAR 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (May 2019)
Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Aug 2019)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
[Contracting Officer check as appropriate.]
(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).
(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).
(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)
(4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).
(5) [Reserved].
(6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
(8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).
(9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).
(10) [Reserved].
(11)
(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C.657a).
(ii) Alternate I (Nov 2011) of 52.219-3.
(12)
(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).
(ii) Alternate I (Jan 2011) of 52.219-4.
(13) [Reserved]
(14)
(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C.644).
(ii) Alternate I (Nov 2011).
(iii) Alternate II (Nov 2011).
(15)
(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).
(ii) Alternate I (Oct 1995) of 52.219-7.
(iii) Alternate II (Mar 2004) of 52.219-7.
(16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
(17)
(i) X 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637(d)(4))
(ii) Alternate I (Jan 2017) of 52.219-9.
(iii) Alternate II (Nov 2016) of 52.219-9.
(iv) Alternate III (Nov 2016) of 52.219-9.
(v) Alternate IV (Aug 2018) of 52.219-9
(18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).
(19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C.637(a)(14)).
(20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).
(22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).
(23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).
(24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).
(25) X 52.222-3, Convict Labor (June 2003) (E.O.11755).
(26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2018) (E.O.13126).
(27) X 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(28)
(i) X 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).
(ii) Alternate I (Feb 1999) of 52.222-26.
(29)
(i) X 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
(ii) Alternate I (July 2014) of 52.222-35.
(30)
(i) X 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).
(ii) Alternate I (July 2014) of 52.222-36.
(31) X 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).
(32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
(33)
(i) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O. 13627).
(ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(34) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)
(35)
(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
(36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).
(37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun2016) (E.O. 13693).
(38)
(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).
(ii) Alternate I (Oct 2015) of 52.223-13.
(39)
(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).
(ii) Alternate I (Jun 2014) of 52.223-14.
(40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).
(41)
(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).
(ii) Alternate I (Jun 2014) of 52.223-16.
(42) X 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).
(43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).
(44) 52.223-21, Foams (Jun 2016) (E.O. 13693).
(45)
(i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).
(ii) Alternate I (Jan 2017) of 52.224-3.
(46) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).
(47)
(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
(ii) Alternate I (May 2014) of 52.225-3.
(iii) Alternate II (May 2014) of 52.225-3.
(iv) Alternate III (May 2014) of 52.225-3.
(48) 52.225-5, Trade Agreements (Aug 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
(49) X 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).
(50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).
(52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).
(53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).
(54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).
(55) X 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).
(56) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).
(57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C.3332).
(58) X 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
(59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).
(60)
(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
(ii) Alternate I (Apr 2003) of 52.247-64.
(iii) Alternate II (Feb 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
[Contracting Officer check as appropriate.]
(1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).
(2) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).
(3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
(4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
(5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
(6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).
(7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
(8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
(10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
(e)
(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C.637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.
(vii) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(viii) 52.222-26, Equal Opportunity (Sept 2015) (E.O.11246).
(ix) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C.4212).
(x) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).
(xi) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C.4212)
(xii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.
(xiii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).
(xiv)
(A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O 13627).
(B) Alternate I (Mar 2015) of 52.222-50(22 U.S.C. chapter 78 and E.O 13627).
(xv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).
(xvi) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
(xvii) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).
(xviii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xix) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
(xx)
(A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (Jan 2017) of 52.224-3.
(xxi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.
(xxiii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.1241(b) and 10 U.S.C.2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
52.217-8 Option to Extend Services.
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 within one (1) day of contract expiration.
(End of clause)
52.217-9 Option to Extend the Term of the Contract.
Option to Extend the Term of the Contract (Mar 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor anytime prior to the contract expiration date; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least one (1) day before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed sixty-six (66)months. j
(End of clause)
HHSAR Clauses:
HHSAR Clauses and Provisions can be viewed in full text at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html
352.203-70 Anti-Lobbying (Dec 2015)
352.208-70 Printing and Duplication (Dec 2015)
352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)
352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)
352.239-74 Electronic Information and Technology Accessibility (Dec 2015)
Special Notice and Agreement Regarding Software EULAs/TOS
Computer software and services are often subject to license agreements, referred to as End User
License Agreements (EULA), Terms of Service (TOS), or other similar legal instruments or
agreements. Many of these agreements contain indemnification clauses that are inconsistent
with Federal law and unenforceable, but which could create a violation of the Anti-Deficiency
Act (31 U.S.C. 1341) if agreed to by the Government.
Therefore, by submitting a quotation the Contractor shall agree that the inclusion of any Limitation of Liability, Indemnification, and any other clauses that conflict with Federal law or regulation in any EULA or TOS are NULL AND VOID. The vendor agrees that any EULA/TOS clauses conflicting with Federal law or regulation and are not agreed to by the Government if included with the submission of a quotation. Additionally, by submission of the quotation the Contractor must agree to the inclusion of FAR 52.232-39 Unenforceability of Unauthorized Obligations in any resulting contract or order, if awarded.
FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)
This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): www.acquisition.gov/far
(End of provision)
FAR 52.212-1 - Instructions to Offerors - Commercial Items (Oct 2018)
• See Part 10 below
FAR 52.212-2 - Evaluation - Commercial Items (Oct 2014)
• See Part 11 below
FAR 52.204-7 - System for Award Management (Oct 2018)
• All offerors shall be registered in the SAM database with completed representations and certifications.
FAR 52.204-16 - Commercial and Government Entity Code Reporting (Jul 2016)
FAR 52.204-18 - Commercial and Government Entity Code Maintenance (Jul 2016)
FAR 52.212-3 - Offeror Representations and Certifications -- Commercial Items (Oct 2018)
• If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.212-3 with this offer
FAR 52.219-1 - Small Business Program Representations (Oct 2014)
• If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.219-1 with this offer
PART 10 - INSTRUCTIONS TO THE OFFEROR
The provision at FAR 52.212-1 incorporated above is tailored as follows. Quotes shall be submitted no later than 12:00 p.m. (Eastern Time) on August 22, 2019. Quotes shall be submitted via email in native MS Word or Excel or PDF format to the Contract Specialist, Anthony S. Wimbush at anthony.wimbush@fda.hhs.gov.
The Offeror shall submit a completed pricing table in Part 2 for a firm fixed-price order. The Contractor shall provide the price and all detailed documentation to support the total cost of the quote. The firm fixed-price proposed shall be inclusive of all shipping and any other costs associated with meeting all the requirements listed in Part 3 - Description of Requirements. If an offeror has not completed annual representations and certifications in the SAM database, offerors shall also include a completed copy of the provisions at 52.212-3 and 52.219-1.
PART 11 - GENERAL EVALUATION INFORMATION
The FDA intends to award a firm-fixed price purchase order resulting from this solicitation. The FDA will evaluate offers/quotes received in response to the RFQ on using low-price-technically acceptable (LPTA) methodology. To be determined "technically acceptable" the offeror/quoter must adhere to all the requirements stated in the SOW. FDA determines the evaluated price by adding up all base and option years.
This RFQ does not commit the Government to pay any costs incurred in the preparation of the submission of the quotation or to contract for the supplies or services.

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Opportunity closing date
27 August 2019
Value of contract
to be confirmed

About the buyer

Address
Department of Health and Human Services Office of Acquisitions and Grants Services - Rockville United States

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