MODIFICATION
R -- Manufacture of Drug Products and Matching Placebos in Capsule Form
- Notice Date
- 8/4/2016
- Notice Type
- Modification/Amendment
- 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
- HHS-NIH-NIDA-SSSA-CSS-16-489
- Archive Date
- 8/23/2016
- Point of Contact
- Lauren M. Phelps, Phone: 3014802453
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Manufacture of Drug Products and Matching Placebos in Capsule Form Request for Quotation HHS-NIH-NIDA-SSSA-CSS-16-489 INTRODUCTION This is a request for quotation for services and constitutes the only solicitation; proposals are being requested. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures. The solicitation number is HHS-NIH-NIDA-SSSA-CSS-16-489 and the solicitation is issued as a request for quotation (RFQ). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325412 with a Size Standard of 700 Employees. SET-ASIDE STATUS This acquisition is unrestricted and available for full and open competition. ACQUISITION AUTHORITY This acquisition is for a service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures. The requirement 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, dated July 14, 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 closed and alternative sourcing is now required to manufacture drug products and matching placebos needed for two clinical protocols at the National Institute of Mental Health (NIMH). These studies are being performed on a double blind basis. The first NIMH protocol is entitled "An endocrine model for postpartum mood disorders" and the second is entitled "The effects of an ER beta agonist (Lilly Compound LY500307) on estradiol-withdrawal-induced mood symptoms in women with perimenopausal depression." Purpose The purpose of this acquisition is to provide the National Institute of Mental Health with Progesterone, Estradiol, and LY500307 capsules as well as matched placebo capsules. This requirement constitutes a request for complete drug product manufacturing and control services. Project Requirements The National Institute of Mental Health requires the following: 1.The contractor shall manufacture and provide twelve-thousand 200mg capsules of Progesterone with twelve-thousand matching placebos and twenty-thousand 2mg capsules of Estradiol with twenty-thousand matching placebos. a.The Contractor must provide reports on the following for this manufacturing process: i.Assay and Impurities/Related Substances 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, detection limits and quantification limits. ii.Microbial Enumeration and Tests for Specific Organisms Suitability iii.Finished Product Release Testing on Appearance, Identification, Assay, Capsule Closure, Microbial Enumeration (USP <61>), and Testing for Specified Microorganisms (USP <62>). iv.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, 24, and 36. 2.The contractor shall manufacture and provide five-thousand 25mg capsules of LY500307 and five-thousand matched placebo capsules. a.The Contractor must provide reports on the following for this manufacturing process: i.Assay and Impurities/Related Substances 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, detection limits and quantification limits. ii.Microbial Enumeration and Tests for Specific Organisms Suitability iii.Content uniformity analysis on blend samples iv.Finished Product Release Testing on Appearance, Identification, Assay, Capsule Closure, Microbial 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, 24, and 36. 3.Capsule manufacturing will include preparation of complete formulation development, manufacturing records according to customer specifications, milling of tablets for the actives (for Estradiol), blending tablet powder with other excipients (Estradiol), blending API with other excipients (for LY500307 and Progesterone) 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 estradiol tablets and progesterone for the capsule manufacturing process. 4.All capsules shall be bulk packaged in High-Density Polyethylene (HDPE) containers. 5.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. 6.The Contractor shall ensure that all workers wear protective respirators and clothing if/as applicable for the type of compound being manufactured. 7.The Contractor will provide all Chemistry Manufacturing and Control information to the NIH Clinical Center Pharmacy Development Section (PDS) for Investigational New Drug (IND) filing. PDS will review the documents and send IND package to NIMH for IND filing with the Food and Drug Administration. 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. LY500307 API will also be provided for the manufacture of 5000 associated capsules. Delivery Requirements/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. Place of Performance Drug products and matching placebos shall be delivered to the NIH Pharmaceutical Development Section located at 10 Center Drive, Room 1C230, Bethesda, MD 20892. Contract Type The Government intends to issue a firm fixed price simplified acquisitions purchase order for this requirement. Invoicing shall be on a NET30 basis and payment shall be made via Electronic Funds Transfer (EFT). RESPONSE FORMAT Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical response and 2) a separate price quotation. The technical response should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to twenty (20) single-sided pages. The price quotation must include the requirements listed above as well as associated pricing. 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." IMPORTANT NOTE TO OFFERORS: PLEASE ENSURE THAT YOUR RESPONSE MEETS THE FORMAT REQUIREMENTS AND SPECIFICALLY ADDRESSES EACH OF THE TECHNICAL EVALUATION CRITERION AND THE EVALUATION FOCUS THAT IS INDICATED FOR EACH CRITERION. RESPONSES MUST INCLUDE BOTH A TECHNICAL DOCUMENT AND A SEPARATE PRICE QUOTATION. CONTRACTORS NOT SUBMITTING BOTH A TECHINICAL RESPONSE ADDRESSING THE EVALUATION CRITERIA AND A SEPARATE PRICE QUOTAITON SHALL NOT BE CONSIDERED. EVALUATION CRITERIA 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. APPLICABLE CLAUSES AND PROVISIONS The following FAR clauses and provisions shall apply to this solicitation: 1.All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2.FAR clause 52.213-4, Terms and Conditions-Simplified Acquisitions (Other Than Commercial Items) [March 2016] is applicable to this acquisition. 3.The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." CONTRACTING OFFICER'S REPRESENTATIVE A Contracting Officer's Representative (COR) shall be assigned to the awarded contract. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. 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 for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract The Government may unilaterally change the COR designation for this contract. CLOSING INFORMATION 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. All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-RFQ-16-489. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.
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