G
1 Lot Stability - PF-5190457
Appearance: Days 0, 90, 180, 365, 730, 1095
Identity by IR: Days 0, 365, 1095
Identify by HPLC: Days 0, 90, 180, 365, 730, 1095
PF-05190457 Assay: Days 0, 90, 180, 365, 730, 1095
Chromatographic Purity: Days 0, 90, 180, 365, 730, 1095
Chiral Purity: Days 0, 90, 180, 365, 730, 1095
Water Content USP<921>: Days 0, 90, 180, 365, 730, 1095
Residual Solvents by GC USP<621>: 0, 365, 1095
Total Yeast and Mold USP<61>: Das 0, 90, 180, 365, 730, 1095
Total Aerobic Microbial Count USP<61>: Days 0., 90, 180, 365, 730, 1095
Absence of E. coli USP<62>: Days 0, 90, 180, 365, 730, 1095
1 Lot Stability Study - Oxytocin 80 U/mL Intranasal Solution
1 Lot Stability Study - Placebo for Oxytocin 80 U/mL Intranasal Solution
Time Points:
HPLC Assay: 0, 90, 180, 365, 730, 1095
USP<71> Sterility: 0, 90, 180, 365, 730, 1095
USP<791>pH: 0, 90, 180, 365, 730, 1095
USP<51>Preservative Effectiveness Category II: 0, 365, 730, 1095
#1400 PF-05190457 1 gram Blinding Blend in 120 mL amber glass vial (W216947)
#150 Oxytocin Intranasal Solution; 80 units/mL x 11 mL each
#150 Placebo Intranasal Solution; 11 mL each
#150 PF-05190457 100 mL Sterile Water for Injection, Yellow-orange
Shipping and Handling
The sole source determination is based on the National Center for Advancing Translational Sciences (NCATS) II 16-AA-0080 Protocol. Pine Pharmaceuticals will be manufacturing these medications. In order to comply with regulations of the Food and Drug Administration (FDA) and from the U.S. Pharmacopeial Convention (USP), stability monitoring is required by the company that performs the manufacturing.
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.
SATISFIED CRITERIA _____YES _______ NO
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.
ACCEPTABLE _____ UNACCEPTABLE_____
CONDITIONALLY ACCEPTABLE* ______
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.
ACCEPTABLE _____ UNACCEPTABLE_____
CONDITIONALLY ACCEPTABLE* ______
* Conditionally Acceptable - The Government finds that the Offeror meet the overall acceptability of the criteria however, conditions within its acceptability may require clarification or minor revisions before being considered fully acceptable. In the event that an offeror is considered Conditionally Acceptable and all other areas are considered equal; Acceptable will be deemed technically superior.
The proposed contract action is for drugs for which the Government intends to solicit and negotiate with only one source under authority of the 41 U.S.C. 253(c) (1), FAR 6.302.
The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors - Commercial Items; FAR Clause 52.212-2, Evaluation - Commercial Items; FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions applies to this acquisition. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.acquisition.gov/far/. Interested vendors capable of furnishing the government with the product specified in this synopsis should submit a copy of their quotation to the below address or via email to [email protected]. Offers must also be accompanied by descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all of the foregoing requirements. Quotations will be due nine (9) calendar days from the publication date of this synopsis or by September 20, 2016 at 12:00pm EST. via email or postal mail. The quotation must reference "Solicitation number" NIH-NICHD-16-168. Quotations sent by postal mail or other mailing services must be submitted to the following address: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Room 1159C, Bethesda, MD 20852. Attention: Patricia Haun, by the date and time mentioned above. Any questions must be sent via email to [email protected] and must include solicitation# NIH-NICHD-16-168 in the subject line of email. Faxed copies/responses will not be accepted.
Note: In order to receive an award, contractor must be registered and have valid certification in the SAM database @www.sam.gov.