MODIFICATION
65 -- Ibuprofen and Placebo
- Notice Date
- 9/14/2017
- Notice Type
- Modification/Amendment
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of the Air Force, Air Combat Command, 99 CONS, 5865 Swaab Blvd, Nellis AFB, Nevada, 89191-7063, United States
- ZIP Code
- 89191-7063
- Solicitation Number
- FA486117QB011
- Archive Date
- 10/5/2017
- Point of Contact
- Cortney C. Young, Phone: 7026529335
- E-Mail Address
-
cortney.young@us.af.mil
(cortney.young@us.af.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- Request for Quotations (RFQ) #: FA486117QB011 A Firm Fixed Price type contract will be awarded. The combined synopsis/solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-94 Effective 19 January 2017. 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 Nevada (89191) Requirement Specifications: •· Ibuprofen United States Pharmacopeia (USP) grade powder 800mg (#2-400mg) in a "0" size capsule, packaging of 84 caps per bottle •· Ibuprofen, United States Pharmacopeia (USP) grade powder 800mg (0.8gm) x #105 patients x 3 dosages per day x 14 days = 3,528gm of drug + 10% +/- waste = 3,900GM •· 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 capsules each x #2 caps (800mg) each dose x #3 doses per day x 14 days x #105 patients = 8,820 caps •· 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. •· Insured Shipping to zip code 89191 Delivery Date: 60 Days ADC Delivery Location: Nellis AFB, Nevada 89191 All responsible sources may submit a quotation which shall be considered. Quotations may be emailed to TSgt Cortney Young, cortney.young@us.af.mil no later than 20 Sep 17, 3:00 pm PST. ADDENDA TO 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JAN 2017) 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 (JAN 2017) ALTERNATE I (OCT 2014) 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 MAY 2011 52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment OCT 2015 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters JUL 2013 52.209-10 Prohibition on Contracting With Inverted Domestic Corporations NOV 2015 52.209-12 Certification Regarding Tax Matters FEB 2016 52.212-4 52.219-6 Contract Terms and Conditions--Commercial Items Total Small Business Set-Aside JAN 2017 NOV 2011 52.219-14 52.219-28 Limitations On Subcontracting Post-Award Small Business Program Representations JAN 2017 JUL 2013 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-35 Equal Opportunity for Veterans OCT 2015 52.222-36 Equal Opportunity for Workers with Disabilities JUL 2014 52.222-37 Employment Reports on Veterans FEB 2016 52.222-50 Combating Trafficking in Persons MAR 2015 52.222-54 Employment Eligibility Verification OCT 2015 52.222-55 Minimum Wages Under Executive Order 13658 DEC 2015 52.223-18 Encouraging Contractor Policies To Ban Text Messaging While Driving AUG 2011 52.224-1 Privacy Act Notification APR 1984 52.224-2 Privacy Act APR 1984 52.228-5 Insurance - Work On A Government Installation JAN 1997 52.232-36 Payment By Electronic Funds Transfer--System for Award Management JUL 2013 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business Subcontractors DEC 2013 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 252.201-7000 Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating to Compensation of Former DoD Officials SEP 2011 252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7011 Alternative Line Item Structure SEP 2011 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting OCT 2016 252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism OCT 2015 252.219-7011 Notification to Delay Performance JUN 1998 252.223-7006 Prohibition On Storage, Treatment, and Disposal of Toxic or Hazardous Materials SEP 2014 252.225-7002 Qualifying Country Sources As Subcontractors DEC 2016 252.225-7048 Export-Controlled Items JUN 2013 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports JUN 2012 252.232-7010 Levies on Contract Payments DEC 2006 252.232-7012 Performance-Based Payments--Whole-Contract Basis MAR 2014 252.237-7010 Prohibition on Interrogation of Detainees by Contractor Personnel JUN 2013 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment DEC 2012 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (DEVIATION 2013-O0019) (JAN 2017) (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 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. (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, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (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 $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17. (iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). (v) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246). (vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212). (vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (viii) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212). (ix) 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. (x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (xi) ___ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (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 E.O. 13627). (xii) 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.) (xiii) 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) (xiv) 52.222-54, Employment Eligibility Verification (Oct 2015). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658). (xvi) 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)(1)(xvi) : 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, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction. (xvii) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016). (xviii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xix) 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. (xx) 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) 52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014) (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 March 24, 2014. This clause prohibits discrimination against qualified individuals on the basis of disability, and requires affirmative action by the Contractor to employ and advance in employment qualified individuals with disabilities. (b) Subcontracts. The Contractor shall include the terms of this clause in every subcontract or purchase order in excess of $15,000 unless exempted by rules, regulations, or orders of the Secretary, so that such provisions will be binding upon each subcontractor or vendor. The Contractor shall act as specified by the Director, Office of Federal Contract Compliance Programs of the U.S. Department of Labor, to enforce the terms, including action for 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 (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): www.Farsite.hill.af.mil (End of clause) 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984) (a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause. (b) The use in this solicitation or contract of any FAR (48 CFR Chapter 1 ) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation. (End of clause) 252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013) (a) Definitions. As used in this clause- "Department of Defense Activity Address Code (DoDAAC)" is a six position code that uniquely identifies a unit, activity, or organization. "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 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 ; and (2) Be registered to use WAWF at 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/ (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. Field Name in WAWF Data to be entered in WAWF 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. Cortney.young@us.af.mil (2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988. (End of clause) 5352.201-9101 OMBUDSMAN (Mar 2016) (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 Lateef M. Hynson, USAF Deputy Director of Contracting, OL-ACC Air Force Installation Contracting Agency Joint Base Langley-Eustis VA COMM: (757) 764-5372 DSN: 574-5372 lateef.hynson@us.af.mil. 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 Air Force ombudsman, Associate Deputy Assistant Secretary (ADAS) (Contracting), SAF/AQC, 1060 Air Force Pentagon, Washington DC 20330-1060, phone number (703) 588-7004, facsimile number (703) 588-1067. (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 (JUN 1997) (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 (AUGUST 2016) (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 Air Force installation(s) cited in the contract. Contractor personnel are required to wear or prominently display installation identification badges or contractor-furnished, contractor identification badges while visiting or performing work on the installation. (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 the United States (reference FAR Clause 52.222-54, Employment Eligibility Verification ). Persons found to be undocumented or illegal aliens will be remanded to the proper authorities. (e) Effective 15 Aug 2016, the United States Air Force will implement REAL ID Act requirements IAW Public Law 109-13, 49 U.S.C., section 30301 and Code of Federal Regulations (CFR) Title 6, Part 37. (f) After 15 August 2016 contractors seeking base access will not be granted a base pass unless they have an ID card that meets the minimum standards set forth in the regulation listed above. A State ID will no longer be accepted unless it is the new updated "Real ID". A Real ID driver's license or ID card has a gold circle with a star cutout in the upper right-hand corner. (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) U.S Certificate of Naturalization or Certificate of Citizenship (Form N-550) Veterans Identification Card Veterans Health Identification Card U.S. Permanent Resident Card (Form I-551) Foreign Government issued Passport DHS issued employment authorization document that contains a photograph (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)
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- Place of Performance
- Address: Nellis AFB, NV, 89191, Nevada, United States
- Record
- SN04676938-W 20170916/170914231518-49a6cb08af6ae429e57eb293ab75f33d (fbodaily.com)
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