SOLICITATION NOTICE
R -- Manufacture of Finished Drug Products and Matching Placebos in Capsule Form
- Notice Date
- 11/8/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- NIH-NIDA-SSSA-CSS-17-032
- Archive Date
- 12/3/2016
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Manufacture of Finished Drug Products and Matching Placebos in Capsule Form Competitive Combined Synopsis/Solicitation NIH-NIDA-SSSA-CSS-17-032 INTRODUCTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items. The solicitation number is NIH-NIDA-SSSA-CSS-17-032 and the solicitation is issued as a request for proposal (RFP). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325412 with a Size Standard of 1,250 Employees. SET-ASIDE STATUS This acquisition is unrestricted. Businesses of any size classification may respond. ACQUISITION AUTHORITY This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures and FAR Part 12-Acquisition of Commercial Items, and IS NOT expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-89-2 dated November 1, 2016. The resultant contract will include all applicable provisions and clauses in effect through this date. DESCRIPTION OF REQUIREMENT Background The NIH Clinical Center Pharmacy Development Section recently discontinued its internal drug capsule manufacturing services and alternative sourcing is now required for manufacture of drug products and matching placebos needed for a clinical protocol at the National Institute of Mental Health (NIMH). NIMH protocol "A controlled double blind study trial of citalopram added to methylphenidate in youth with severe mood dysregulation" currently requires manufacture of drug products and matching placebos. This protocol will test the efficacy of citalopram plus methylphenidate vs. placebo plus methylphenidate in decreasing irritability in youth with severe mood dysregulation. Purpose The purpose of this acquisition is to provide the National Institute of Mental Health with citalopram capsules as well as matched placebo capsules. This requirement constitutes a request for complete drug product manufacturing and control. Scope of Work: The National Institute of Mental Health requires the following: 1.The contractor shall manufacture and provide seven-thousand (7,000) 5mg capsules of Citalopram with seven-thousand (7,000) matching placebos. a.The Contractor must provide reports on the following for this manufacturing process: i.Assay and Impurities/Related Substances Method Qualification of HPLC ready filter compatibility, system suitability, linearity (detection and quantification limits), accuracy and range (bracketing the intended strength), specificity from the diluent, mobile phase and placebo, as well as standard and sample solution stability over 7 days, detection limits and quantification limits. ii.Microbial Enumeration and Tests for Specific Organisms Suitability iii.Homogeneity Analysis on blend samples iv.Finished Product Release Testing on Appearance, Identification, Assay and Degradants, Capsule Closure, Aerobic Microbial Enumeration (USP <61>), Yeast and Mold Enumeration (USP <61>), and Testing for Specified Microorganisms (USP <62>). v.Stability Assessment to ensure stability in the following storage conditions: Storage condition must include the following combination: 25°C/60% RH. Storage duration will include the following number of months: 3, 6, 12, 18, 24, and 36. 2.Capsule manufacturing will include preparation of complete formulation development, manufacturing records according to customer specifications, milling of tablets for the actives, blending tablet powder with other excipients as per manufacturing records, filling of the powder into capsules, capsule weight monitoring, cleaning the room, and inspection of capsules. The contractor shall be responsible for procuring Citalopram for the capsule manufacturing process. 3.All capsules shall be bulk packaged in High-Density Polyethylene (HDPE) containers. 4.All drug and placebo capsule manufacturing must be performed in a facility licensed by the US Food and Drug Administration as a Good Manufacturing Product (GMP) facility. 5.The Contractor shall ensure that all workers wear protective respirators and clothing if/as applicable for the type of compound being manufactured. Government Furnished Property The Government shall provide the successful offeror with the formulas for the necessary drug products. Additionally, the Government shall provide the capsules to be used for the drug product and matching placebo manufacture. The Government will arrange for the capsules to be shipped to the Contractor. Place of Performance: Drug products and matching placebos shall be manufactured at the contractor's site and delivered to the Department of Pharmacy, IDMRS located at 10 Center Drive, Room 1C230, Bethesda, MD 20892. Period of Performance: Delivery of the manufactured drug products and associated documentation shall be made within twelve (12) weeks following contractor receipt of the drug formulas and capsules provided by the Government. Contractor delivery of the manufactured drug products and associated documentation shall be made on a FOB Destination basis and any cost associated with this must be included in any quotation submitted. Contract Type: A firm fixed price purchase order within the Simplified Acquisition threshold is anticipated. Invoicing Procedures: Invoicing procedures shall be identified at time of award. NET30 invoicing with payment via Electronic Funds Transfer (EFT) is anticipated. Question and Answer Period: Interested contractors may submit questions relating to this requirement. Questions shall be submitted to the contract specialist, Lauren Phelps, via email at lauren.phelps@nih.gov by or before 11/14/2016 at 11:00 AM EST. Late questions shall not be accepted. Questions will be anonymized and answered and the answers will be provided as soon as possible after the question deadline via solicitation amendment. Should no questions be received, no amendment shall be posted. EVALUATION CRITERIA In accordance with FAR 52.212-2: Evaluation - Commercial Items (October 2014), the Government will award a purchase order resulting from this solicitation on the basis of best value, technical factors and price considered. Technical factors shall be considered more important than price. Factor 1: Federal Food, Drug, and Cosmetic Act Section 503B Compliance (MANDATORY CRITERION) The contractor must confirm in its proposal that it is a Food and Drug Administration-Approved Human Drug Compounding Outsourcing Facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. Additionally, a copy of the most recent/current FDA inspection report must be submitted. The report must indicate a "pass" rating. Contractors not confirming their Section 503B compliance and providing a copy of their current FDA inspection report shall not be further considered for award. Factor 2: Technical Approach: The contractor shall detail in its technical proposal how it shall meet each of the project requirements. The Government shall evaluate the Contractor's proposed approach to manufacturing the drug products per the requirements of this solicitation. The Government shall specifically evaluate for effectiveness and efficiency. Factor 3: Delivery Schedule: The Government shall evaluate offers for ability to meet and exceed delivery schedule requirements. Proposals must include a manufacturing and delivery lead time. Exceeding the delivery requirements shall be viewed favorably. Factor 4: Past Performance: The Contractor shall provide a list of two (2) contracts or purchase orders completed during the past five (5) years, similar in size and scope to the drug product and matching placebo manufacturing requirements outlined in this Statement of Work. Experience shall include the following information for each contract or purchase order listed: a.Name of Contracting Organization b.Total Contract Value c.Description of Requirement and Specific Responsibilities of the Offeror d.Contract Period of Performance Past Performance shall be evaluated for relevance to the current requirement. EVALUATION METHOD Technical proposals will be evaluated using a summary adjectival rating based on the following scale: Excellent, Very Good, Good, Fair, Poor. Award shall be made to the contractor offering the greatest value in consideration of both technical factors and price. Award shall not be considered for proposals evaluated to be "Poor." RESPONSE FORMAT Responses to this requirement must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. Each evaluation criterion must be addressed in a technical proposal. A separate price quote must be provided and include associated pricing for the requirements listed above. Please ensure that optional tasks are quoted separately from the required tasks. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." APPLICABLE CLAUSES AND PROVISIONS The FAR clauses and provisions below shall apply to this solicitation. Please note that any clauses requiring fill-ins shall be completed at time of award. 1.All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2.The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (October 2016), applies to this acquisition. 3.A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (October 2016), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4.FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) is applicable to this acquisition. 5.FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (November 2016) apply to this acquisition. The following clauses shall be checked/included in this clause: FAR 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) FAR 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). FAR 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) FAR 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) FAR 52.222-3, Convict Labor (June 2003) FAR 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016) FAR 52.222-21, Prohibition of Segregated Facilities (Apr 2015). FAR 52.222-26, Equal Opportunity (Sept 2016) FAR 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) FAR 52.222-50, Combating Trafficking in Persons (Mar 2015) FAR 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) FAR 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) FAR 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) 6.The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 7.In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. NOTE Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. CLOSING STATEMENT All responses must be received by the closing date of this announcement and must reference solicitation number NIH-NIDA-SSSA-CSS-17-032. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/NIH-NIDA-SSSA-CSS-17-032/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04323369-W 20161110/161108234751-2a224b3a76372b0971e42fb7d127bad0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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