SOLICITATION NOTICE
B -- Research Services - Combined Synopsis/Solicitation
- Notice Date
- 3/13/2017
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- #541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA_17-223-SOL-1180210
- Archive Date
- 4/4/2017
- Point of Contact
- Yolanda T. Peer, Phone: 8705437479
- E-Mail Address
-
yolanda.peer@fda.hhs.gov
(yolanda.peer@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- 1 Document Type: Combined Synopsis/Solicitation Solicitation Number: FDA_17-223-SOL-1180210 Posted Date: March 13, 2017 Response Date: March 20, 2017 NAICS Code: 541380 - Testing Laboratories; with a Small Business Size Standard of $15 Million Contracting Office Address FDA/OO/OFBA/OAGS/DAP National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items", as supplemented with additional information included on this notice and in conjunction with FAR Part 13.106, utilizing Simplified Acquisition Procedures. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation document will not be issued. The solicitation number is FDA_15-223-SOL-1180210. This solicitation is issued as a "Sole Source" FAR 13.106-1 (b) "Soliciting from a Single Source" Request for Quote (RFQ). This solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-94, 2005-95 dated January 19, 2017. The associated North American Industry Classification System (NAICS) Code for this procurement is 541380 - Testing Laboratories; with a Small Business Size Standard of $15 Million. This combined/synopsis solicitation is Full and Open Competition. 2 Statement of Work Research Services for: An examination of the role of advertising and promotional labeling in adult immunization disparities Part I: General Introduction Proper understanding and comprehension of health messaging is fundamental in preventing unnecessary, and otherwise avoidable, mortality and morbidity. Although culturally competent messaging is increasingly recognized as having vital importance in the health care sector, one factor that is neglected is the role of gender-specific messaging and health literacy. The goal of this proposed research is to examine gender-related health literacy and the potential lack of appropriate gender-specific messaging, particularly as a potential contributor to health disparities in older female populations. It is hoped that, as a result of this research, a best practices guide and a regulatory tool will be developed to assist regulators and policy makers in evaluating advertising and promotional labeling from a gender-sensitive and age-sensitive health literacy perspective. This addresses the Office of Women's Health Research Priority Area 6: Develop, evaluate, and use tools and methods to foster the creation and easy availability of clear and useful information about FDA-regulated products used by women to help women and their health care professionals make informed health-related decisions. A. Background Direct-to-consumer (DTC) promotion for health products and services has increased tremendously during the past decade. Recent changes in the DTC environment, particularly internet and social media, have impacted clinical encounters, risk perception, and communication. One objective for this study is to determine the rate of patient medication inquiries to healthcare providers and their influence on clinical encounters in primary care for women aged 65 and older. This includes identifying and documenting reports for the products that have disparate rates of use among elderly women; identifying gaps in the literature for health literacy pertaining to gender and age; and examining current advertising and promotional labeling for messaging that adequately targets elderly women. It is hoped that this would inform and support the implementation of best practices for gender- and age-based health literacy and increase targeted promotional messaging, ultimately increasing comprehension and awareness among elderly women. B. Scope The ultimate goal of this research is to compile and evaluate the body of literature regarding disparities in the utilization of health services and products by women 65 years of age and older and to examine the extent to which promotion impacts these disparities. Working with elderly women as stakeholders we intend to establish themes that can be used across health promotion campaigns to improve health and healthcare uptake. We will achieve this goal through various means as follows: 3 • Compile and evaluate scientific literature documenting any gender-specific disparities seen in the utilization, awareness, or comprehension of health services and/or products. • Identify themes and characteristics of successful health messaging to older women. • Delineate potential gaps in the literature, with respect to health services or products for the older female demographic group, and develop recommendations to help ameliorate these gaps. • Examine the extent to which current advertising and promotional labeling is targeted towards elderly women and other underserved populations. • Partner with federal and academic institutions to create public health outreach campaigns designed to increase awareness of vital health services in this demographic. A deliverable of this phase of the project will be a best practices guide and a regulatory tool to be used in determining whether promotional messaging conforms to gender-sensitive formats in elderly populations. Part II: Work Requirements A. Technical Requirements for Perspective Vendor: • Vendor shall be required to have access to librarians at a Health Sciences Library that are expert searchers who can support faculty investigators and students in conducting comprehensive literature searches. They shall use the correct search strategies to ensure that all relevant studies are identified in relevant databases, deliver search results into a citation management tool and set up search alerts to identify recently published literature. • Vendor shall collaborate with health professional and faith-based organizations to draw from a diverse group of participants who will be used to conduct two focus groups and provide insight on the perceptions and understanding around the promotional and advertising material. • Vendor shall develop culturally competent and outreach strategies and educational materials at the appropriate health literacy level in order to bolster awareness and decrease herpes zoster vaccination disparities among older adults. B. US Government shall conduct the following during this study: Shall perform electronic and hand searches on advertising and promotional materials published between January 2010 and December 2016, looking at promotional messaging for gender-sensitive health services and products. Evaluate the materials for cultural competence and health literacy 4 levels. This review will be done in conjunction with focus group testing (below) in order to gather information on perceptions, barriers, and comprehension of the promotional materials that have been rated for their cultural competence, gender-sensitivity and health literacy.. C. Deliverables • A full data report of the literature findings will be provided to (FDA/CBER). This report shall be completed within six-weeks of completing the literature review and analysis. • A comprehensive report of the focus group testing and findings will be provided to (FDA/CBER). This report shall be completed within six-weeks of completing the focus group testing. • The completed best practices guide and a regulatory tool (along with validation plan) to be used in determining whether promotional messaging conforms to gender-sensitive formats in elderly populations must be delivered within 4 weeks of completion. D. Place of Performance: • Literature review and analysis will be conducted at the perspective university's Health Science Library that has resources for research on female and culturally-underrepresented populations. 5 E. Deliverables and Period of Performance: Anticipated Date of Award: 04/24/2017 The period of performance for the option periods in any resultant award will be estimated based on the date of award. If/when Option Year 1 of each CLIN is exercised; the periods of performance for all options will be firmed via bilateral modification. Base: 04/24/2017 - 04/23/2018 Option Year 1: 04/24/2018 thru 04/23/2019 6 FY 17 FY 18 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Develop protocol and study instrumentation in advance of final determination of support. Submit protocol for review and comment, contract management and any additional permissions. Conduct integrated literature reviews, focus groups, expert/in depth interviews. Submit literature analysis and initial findings for publication in identified journal. Form best practices and develop regulatory review tool. Data Management and Analysis - ongoing Final analysis Synthesis of data, final reporting, policy formulation, community education, health professional education, planning for next steps or extension, develop plan for validation of best practices, publication(s) 7 FOB Destination: Contract Type Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. CLIN DESCRIPTION SERVICE UNIT PRICE TOTAL PRICE 0001 Research Services 1 $_____________ $___________ as described in the Minimum Performance Requirements section CLIN DESCRIPTION QUANTITY UNIT PRICE TOTAL 0003 OY1 Research Services 12 $ _________ $ __________ *Option Year 1: - Service Maintenance agreement for Research Services Services as described in the Minimum Performance Requirements section above Total Price (including options): $_______________________ GSA Contract Number (If applicable): _______________________ 8 Clauses and Provisions: The full text of FAR and HHSAR provisions and clauses may be accessed electronically at http://acquisition.gov/far/index.html or https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html. CLAUSES FAR 52.212-4 Contract Terms and Conditions-Commercial Items (Jan 2017) The following FAR 52.212-4 addenda apply: The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the technical representative (TR) specified at award. If the supplies or services are acceptable, the TR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, theTR shall document the nonconforming items/services and immediately notify the contracting officer. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ The following FAR and HHSAR clauses, incorporated by reference, apply to this acquisition. FAR 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011) FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000) (a) "...within one (1) calendar day of contract expiration;.....at least 30 calendar...." (c)"...shall not exceed 1 year." FAR 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (Dec 2013) HHSAR 352.203-70 Anti-Lobbying (Dec 18, 2015) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 18, 2015) Payments Payments will not be made more frequently than monthly in arrears. Advance payments will not be made. 9 THREE WAY MATCH Invoice Submission A. THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO THE ADDRESS SPECIFIED BELOW: Attn: Division of Payment Services U.S. FOOD AND DRUG ADMINISTRATION OC/OO/OFBA/OFM/Division of Payment Services 3900 NCTR Rd., HFT-324 Bldg. 50, 6th Floor, Suite 616 Jefferson, AR 72079 nctrinvoices@fda.hhs.gov Phone: 870.543.7042 or 7446 nctrinvoices@fda.hhs.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR. The COR is (insert name and email address.) 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) Purchase order/award number; (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; 10 (d) The contractor shall include the Contract Line Item/Funding line 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; (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) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment (xi) Name and telephone number of the FDA Contracting Officer (CO) and the Contracting Officer's Representative (COR) or other program center/office point of contact, as referenced on the order/contract; (xii) Any other information or documentation required by the purchase order/award. C. An electronic invoice shall be in adobe acrobat (PDF) format. All items listed in (i) through (xii) 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 FDA Payment Office at: Attn: Division of Payment Services U.S. FOOD AND DRUG ADMINISTRATION OC/OO/OFBA/OFM/Division of Payment Services 3900 NCTR Rd., HFT-324 Bldg. 50, 6th Floor, Suite 616 Jefferson, AR 72079 nctrinvoices@fda.hhs.gov Phone: 870.543.7042 or 7446 11 nctrinvoices@fda.hhs.gov 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 (SAM) DATABASE) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN. QUESTIONS RELATING TO INVOICES SHALL BE DIRECTED TO MS. TRACI JONES or GAYLEN WILSON AT THE FDA PAYMENT OFFICE AT (870) 543-7446 OR nctrinvoices@fda.hhs.gov QUESTIONS CONCERNING TERMS OF THIS ORDER (Other than invoice-related) SHOULD BE DIRECTED TO: Yolanda Peer (870) 543-7479 or yolanda.peer@fda.hhs.gov 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 statement of work; (2) Modify or extend the period of performance; (3) Change the delivery schedule (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The Contract Officer for this order is: XXXXX, Contracting Officer 3900 NCTR Road HFT-320 Jefferson, AR 72079 Phone: (870) 543-XXXX Email: xxxxxx@fda.gov The TR is responsible for: (1) Monitoring the Contractor's technical progress, including the surveillance and assessment (2) of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the statement of work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by this contract and; (5) Assisting in the resolution of technical problems encountered during performance. The TR for this order is: 12 To be identified at time of award. 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Jan 2017) (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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015). (3) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (4) 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.) X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (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). 13 __ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C). X (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 (Jul 2013) (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. X (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 (Nov 2016) (15 U.S.C. 637(d)(2) and (3)). __ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637(d)(4)). __ (ii) Alternate I (Nov 2016) of 52.219-9. __ (iii) Alternate II (Nov 2016) of 52.219-9. __ (iv) Alternate III (Nov 2016) of 52.219-9. 14 __ (v) Alternate IV (Nov 2016) 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-Subcon-tracting 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. 657 f). X (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)). X (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). X (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Oct 2016) (E.O. 13126). X (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). X (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246). __ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212). X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). __ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212). X (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). X (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (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). 15 __ (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) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (OCT 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017). Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction. __ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (OCT 2016). __ (37)(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.) __ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693). __ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693). __ (40)(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. __ (41)(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. __ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). __ (43)(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. 16 X (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513). __ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693). __ (46) 52.223-21, Foams (JUN 2016) (E.O. 13693). __ (47)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a). __ (ii) Alternate I (JAN 2017) of 52.224-3. __ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83). X (49)(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. X (iii) Alternate II (May 2014) of 52.225-3. __ (iv) Alternate III (May 2014) of 52.225-3. __ (50) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). X (51) 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). __ (52) 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). __ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (55) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). __ (56) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). 17 X (57) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (58) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (59) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). __ (60) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (61) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(12)). __ (62)(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. (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 (May 2014) (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) (May 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). 18 __ (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). __ (11) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)). (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) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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), 19 the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iv) 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. (v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) (vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246). (vii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212). (viii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212) (x) 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. (xi) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67). (xii) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627). Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627). (xiii) 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). (xiv) 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). (xv) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989). (xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015). (xvii) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (OCT 2016) (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017). Note to paragraph (e)(1)(xvii): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction. 20 (xviii) 52.222-60, Paycheck Transparency (Executive Order 13673) (OCT 2016)). (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. PROVISIONS The following solicitation provisions apply to this acquisition: 52.212-1 Instructions to Offerors-Commercial Items applies. (Jan 2017) The following FAR 52.212-1 addenda apply: Prices shall be firm through September 30, 2017. FAR 52.204-7 System for Award Management (Oct 2016) In order for the quote to be determined technically capable, the vendor shall demonstrate that its proposed technical solution meets or exceeds the stated requirements. Price proposal must be detailed and represent the offeror's response to the schedule of items above. Technical capability will be determined and evaluated by review of information submitted by the offeror, which must provide sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above. Offerors shall specifically address the specifications stated above as well as technical specifications, 21 descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror. Past Performance will be determined and evaluated by the identification of federal, state, local Government, or private contracts for which the offeror has, in the past three (3) years, for which the offeror has sold the same system for use in same or similar applications. Provide name, telephone number, email address, contract number, past performance point of contact and dollar amount of sale. The Government is not responsible for locating or securing any information, which is not identified in the proposal, however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Offeror's shall include the firm's DUNS number with quote. The provision at FAR 52.212-2 Evaluation-Commercial Items applies. (Oct 2014) FAR 52.212-2 Evaluation - Commercial Items The Government will award the purchase order to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability (ii) Past Performance (iii) Price Technical and Past Performance, when combined, are significantly more important when compared to price in determining the best value to the Government; however, price remains a significant factor. The Government reserves the right to request additional information or conduct discussions at any time. Options: The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. 22 52.212-3 Offeror Representations and Certifications-Commercial Items (Jan 2017) The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision. FAR Provision 52.204-16 Commercial and Government Entity Code Reporting. (JUL 2016) The offer must reference solicitation FDA_17-223-SOL-1180210. Offers are due in person, by postal mail or email to the point of contact listed below on or before March 20, 2017 by 1:00 PM, (Central Time) at the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Yolanda Peer, 3900 NCTR Road, HFT-320, Building 50 - Room 420, Jefferson, AR 72079-9502 or yolanda.peer@fda.hhs.gov. For information regarding this solicitation, please contact Yolanda Peer at yolanda.peer@fda.hhs.gov.
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- Zip Code: 20993
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