Ibuprofen and Placebo
Notice Type: Combine Solicitation
Posted Date:
Office Address:
Subject: Ibuprofen and Placebo
Classification Code: 65 - Medical, dental & veterinary equipment & supplies
Solicitation Number: FA486117QB011
Contact:
Setaside: Total Small BusinessTotal Small Business
Place of Performance Country: US
Description:
Air Combat Command
99 CONS
Request for Quotations (RFQ) #: FA486117QB011 A Firm Fixed Price type contract will be awarded.
This RFQ is being issued as a 100% Small Business Set-Aside under
NAICS: 325412 - Pharmaceutical Preparation Manufacturing
CLIN 0001:
Needed Product Description :
United States Pharmacopeia (USP) grade powder Ibuprofen 800mg (#2-400mg capsules) with matching placebo, special packaging of 84 caps per bottle, regular shipping, insured, to
Requirement Specifications:
* Ibuprofen United States Pharmacopeia (USP)
* Ibuprofen 400mg capsules each x #2 caps (800mg) each dose x #3 doses per day x 14 days x #105 patients = 8,820 caps
* Matching Placebo for 400mg Ibuprofen, formulation containing United States Pharmacopeia (USP) lactose filler
* Placebo must contain United States Pharmacopeia (USP) lactose filler and shall NOT contain wheat or soy
* The Government shall NOT provide the contractor with identifiable patient information
* The contractor shall send the drugs in bulk. The Government will NOT pick it up.
* The contractor shall be able to recertify the drugs in the event that they expire before the study ends
* The study drugs must be in identical bottles that are coded so we know which is ibuprofen and which is placebo
* The study drug pills must look identical in size, shape, color, etc.
* The company must be able to provide the certificates of analysis for each component of the drugs.
*
Delivery Date: 60 Days ADC
Delivery Location:
All responsible sources may submit a quotation which shall be considered. Quotations may be emailed to TSgt Cortney Young, mailto:[email protected] no later than
A DDENDA TO 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (
Submission of offers. Submit signed and dated offers electronically to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers must include
* 1. A quote that includes a description of what is being provided, a statement that all the conditions listed above will be met, and a price.
ADDENDA TO FAR 52.212-2 - EVALUATION - COMMERCIAL ITEMS
Award will be made to the lowest price technically acceptable offeror.
The Government will organize the quotes based on the lowest price and will evaluate the lowest priced offeror for technical acceptability first. If the lowest priced offeror is technically acceptable, evaluations will cease and an award will be issued to that offeror without further consideration to any other offers.
Technical acceptability will be evaluated based on the Ratings below:
! TABLE A - Technical Ratings !
! Rating ! Description !
! Acceptable ! The quote meets all the requirements of this RFQ. !
! Unacceptable ! The quote does not meet all the requirements of this RFQ. !
!
52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (
The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site 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.
The following additional provisions or clauses are specific to this particular requirement:
! 52.204-4 ! Printed or Copied Double-Sided on Postconsumer Fiber Content Paper !
! 52.204-9 ! Personal Identity Verification of Contractor Personnel !
! 52.204-18 ! Commercial and Government Entity Code Maintenance !
! 52.209-6 ! Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment !
! 52.209-9 ! Updates of Publicly Available Information Regarding Responsibility Matters !
! 52.209-10 ! Prohibition on Contracting With Inverted Domestic Corporations !
! 52.209-12 ! Certification Regarding Tax Matters !
! 52.212-4 52.219-6 ! Contract Terms and Conditions--Commercial Items Total Small Business Set-Aside !
! 52.219-14 52.219-28 ! Limitations On Subcontracting Post-Award Small Business Program Representations !
! 52.222-21 ! Prohibition Of Segregated Facilities !
! 52.222-26 ! Equal Opportunity !
! 52.222-35 ! Equal Opportunity for Veterans !
! 52.222-36 ! Equal Opportunity for Workers with Disabilities !
! 52.222-37 ! Employment Reports on Veterans !
! 52.222-50 ! Combating Trafficking in Persons !
! 52.222-54 ! Employment Eligibility Verification !
! 52.222-55 ! Minimum Wages Under Executive Order 13658 !
! 52.223-18 ! Encouraging Contractor Policies To Ban Text Messaging While Driving !
! 52.224-1 ! Privacy Act Notification !
! 52.224-2 ! Privacy Act !
! 52.228-5 ! Insurance - Work On A Government Installation !
! 52.232-36 ! Payment By Electronic Funds Transfer'ystem for Award Management !
! 52.232-39 ! Unenforceability of Unauthorized Obligations !
! 52.232-40 ! Providing Accelerated Payments to Small Business Subcontractors !
! 52.233-3 ! Protest After Award !
! 52.233-4 ! Applicable Law for Breach of Contract Claim !
! 252.201-7000 ! Contracting Officer's Representative !
! 252.203-7000 ! Requirements Relating to Compensation of Former DoD Officials !
! 252.203-7002 ! Requirement to Inform Employees of Whistleblower Rights !
! 252.204-7003 ! Control Of Government Personnel Work Product !
! 252.204-7011 ! Alternative Line Item Structure !
! 252.204-7012 ! Safeguarding Covered Defense Information and Cyber Incident Reporting !
! 252.209-7004 ! Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism !
! 252.219-7011 ! Notification to Delay Performance !
! 252.223-7006 ! Prohibition On Storage, Treatment, and Disposal of Toxic or Hazardous Materials !
! 252.225-7002 ! Qualifying Country Sources As Subcontractors !
! 252.225-7048 ! Export-Controlled Items !
! 252.232-7003 ! Electronic Submission of Payment Requests and Receiving Reports !
! 252.232-7010 ! Levies on Contract Payments !
! 252.232-7012 ! Performance-Based Payments--Whole-Contract Basis !
! 252.237-7010 ! Prohibition on Interrogation of Detainees by Contractor Personnel !
! 252.243-7001 ! Pricing Of Contract Modifications !
! 252.243-7002 ! Requests for Equitable Adjustment !
!
52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (DEVIATION 2013-O0019) (
(a) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (a) 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
(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.
(b)
(1) Notwithstanding the requirements of any other clause in this contract, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (b)(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,
(ii) 52.219-8, Utilization of Small Business Concerns (
(iii) 52.222-17,
(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(v) 52.222-26, Equal Opportunity (
(vi) 52.222-35, Equal Opportunity for Veterans (
(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (
(viii) 52.222-37, Employment Reports on Veterans (
(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (
(x) 52.222-41, Service Contract Labor Standards (
(xi) ___ (A) 52.222-50, Combating Trafficking in Persons (
___ (B) Alternate I (
(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (
(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (
(xiv) 52.222-54, Employment Eligibility Verification (Oct 2015).
(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (
(xvi) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (
Note to paragraph (b)(1)(xvi): By a court order issued on
(xvii) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).
(xviii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (
(xix) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (
(xx) 52.247-64, Preference for Privately-Owned
(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)
52.222-36 Equal Opportunity for Workers with Disabilities (
(a) Equal opportunity clause. The Contractor shall abide by the requirements of the equal opportunity clause at 41 CFR 60-741.5(a), as of
(b) Subcontracts. The Contractor shall include the terms of this clause in every subcontract or purchase order in excess of
noncompliance. Such necessary changes in language may be made as shall be appropriate to identify properly the parties and their undertakings.
(End of clause)
52.252-2 CLAUSES INCORPORATED BY REFERENCE (
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):
http://www.Farsite.hill.af.mil [www.Farsite.hill.af.mil]
(End of clause)
52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (
(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48
(b) The use in this solicitation or contract of any FAR (48
(End of clause)
252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (
(a) Definitions. As used in this clause-
"
"Document type" means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).
"Local processing office (LPO)" is the office responsible for payment certification when payment certification is done external to the entitlement system.
(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS "http://www.acq.osd.mil/dpap/dars/dfars/html/current/252232.htm" target="_parent"252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.
(c) WAWF access. To access WAWF, the Contractor shall-
(1) Have a designated electronic business point of contact in the System for Award Management at "https://www.acquisition.gov/" target="_parent"https://www.acquisition.gov; and
(2) Be registered to use WAWF at "https://wawf.eb.mil/" target="_parent"https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.
(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the "Web Based Training" link on the WAWF home page at "https://wawf.eb.mil/" target="_parent"https://wawf.eb.mil/
(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.
(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:
(1) Document type. The Contractor shall use the following document type(s).
Invoice Only
(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.
FM4852
(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.
!
! Pay Official DoDAAC ! F67100 !
! Issue By DoDAAC ! FA4861 !
! Admin DoDAAC ! FA4861 !
! Inspect By DoDAAC ! FM4852 !
!
(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.
(5) WAWF email notifications. The Contractor shall enter the e-mail address identified below in the "Send Additional Email Notifications" field of WAWF once a document is submitted in the system.
(g) WAWF point of contact.
(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.
mailto:[email protected]
(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.
(End of clause)
5352.201-9101 OMBUDSMAN (
(a) An ombudsman has been appointed to hear and facilitate the resolution of concerns from offerors, potential offerors, and others for this acquisition. When requested, the ombudsman will maintain strict confidentiality as to the source of the concern. The existence of the ombudsman does not affect the authority of the program manager, contracting officer, or source selection official. Further, the ombudsman does not participate in the evaluation of proposals, the source selection process, or the adjudication of protests or formal contract disputes. The ombudsman may refer the party to another official who can resolve the concern.
(b) Before consulting with an ombudsman, interested parties must first address their concerns, issues, disagreements, and/or recommendations to the contracting officer for resolution. Consulting an ombudsman does not alter or postpone the timelines for any other processes (e.g., agency level bid protests, GAO bid protests, requests for debriefings, employee-employer actions, contests of OMBC A-76 competition performance decisions).
(c) If resolution cannot be made by the contracting officer, concerned parties may contact the Center/MAJCOM ombudsmen, Lt Col
Deputy Director of Contracting, OL-ACC Air Force Installation Contracting Agency Joint Base Langley-Eustis VA COMM: (757) 764-5372 DSN: 574-5372 [email protected]. Concerns, issues, disagreements, and recommendations that cannot be resolved at the MAJCOM/DRU or ARISRA level, may be brought by the concerned party for further consideration to the
(d) The ombudsman has no authority to render a decision that binds the agency.
(e) Do not contact the ombudsman to request copies of the solicitation, verify offer due date, or clarify technical requirements. Such inquiries shall be directed to the Contracting Officer.
5352.223-9001 HEALTH AND SAFETY ON GOVERNMENT INSTALLATIONS (
(a) In performing work under this contract on a Government installation, the contractor shall:
(1) Comply with the specific health and safety requirements established by this contract;
(2) Comply with the health and safety rules of the Government installation that concern related activities not directly addressed in this contract;
(3) Take all reasonable steps and precautions to prevent accidents and preserve the health and safety of contractor and Government personnel performing or in any way coming in contact with the performance of this contract; and
(4) Take such additional immediate precautions as the contracting officer may reasonably require for health and safety purposes.
(b) The contracting officer may, by written order, direct Air Force Occupational Safety and Health Standards (AFOSH) and/or health/safety standards as may be required in the performance of this contract and any adjustments resulting from such direction will be in accordance with the Changes clause of this contract.
(c) Any violation of these health and safety rules and requirements, unless promptly corrected as directed by the contracting officer, shall be grounds for termination of this contract in accordance with the Default clause of this contract.
(End of clause)
5352.242-9000 CONTRACTOR ACCESS TO AIR FORCE INSTALLATIONS (
(a) The contractor shall obtain base identification and vehicle passes, if required, for all contractor personnel who make frequent visits to or perform work on the
(b) The contractor shall submit a written request on company letterhead to the contracting officer listing the following: contract number, location of work site, start and stop dates, names of employees and subcontractor employees needing access to the base, as well as the specific times these employees require access to the base. The letter will also specify the individual(s) authorized to sign for a request for base identification credentials or vehicle passes. The contracting officer will endorse the request and forward it to the issuing base pass and registration office or Security Forces for processing. When reporting to the registration office, the authorized contractor individual(s) should provide a valid driver's license, current vehicle registration, valid vehicle and insurance certificate.to obtain a vehicle pass.
(c) A background check [e.g., National Crime Institute Center (NCIC)] may be conducted on each employee and vehicle prior to issuance of a pass and/or during the performance period of the contract. Adverse information or failure to consent to such check may result in such individual being prevented from entering the installation.
(1) It is contractor's responsibility to employ personnel and subcontractors that have the ability to obtain installation access. Employees/subcontractors that are denied installation access does not affect contractor's performance period.
(d) Contractors are required to ensure their employees and those of their subcontractors have the proper credentials allowing them to work in
(e) Effective
IAW Public Law 109-13, 49 U.S.C., section 30301 and Code of Federal Regulations (CFR) Title 6, Part 37.
(f) After
(g) Personnel who don't possess REAL ID compliant credentials will have to provide acceptable alternative forms of ID. Some of the more common acceptable credentials are:
(h) United States Passport Personal Identification Verification (issued by the Federal Government) PIV-I cards (issued by non-Federal Government entities)
(Form I- 766)
(i) The contractor shall not be entitled to any compensation for delays or expenses associated with complying with the provisions of this clause.
(j) During performance of the contract, the contractor shall be responsible for obtaining required identification for newly assigned personnel and for prompt return of credentials and vehicle passes for any employee who no longer requires access to the work site.
(k) When work under this contract requires unescorted entry to controlled or restricted areas, the contractor shall comply with AFI 31-101, Integrated Defense, and AFI 31-501, Personnel Security Program Management as applicable.
(l) Upon completion or termination of the contract or expiration of the identification passes, the prime contractor shall ensure that all base identification passes issued to employees and subcontractor employees are returned to the issuing office.
(m) Failure to comply with these requirements may result in withholding of final payment.
(End of clause)
Link/URL: https://www.fbo.gov/spg/USAF/ACC/99CONS/FA486117QB011/listing.html
Security camera installation
Q– Copy of 581-18-1-6811-0001 Johnson Assoc (VA-17-907964)
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