This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NIH-NICHD-18-175 and is issued as a Request for Proposal (RFP). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-100. The North American Industry Classification (NAICS) Code is 424210 and the business size standard is 100. However, this solicitation is not set aside for small business. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The National Institutes of Health (NIH), National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) intends to procure on a sole source basis with Pine Pharmaceuticals, LLC, 100 Colvin Woods Pkway, Ste 300, Tonawanda, NY 14150 for intravenous stable isotopes for metabolic research. The following will be procured:

Potassium U-13C Palmitate Single Dose Vials; 2 micromoles/mL; 28 mL vial

1 Quantity:
One Time Validation: Potassium Palmitate U-13C Release Testing (Method Development and Validation Protocol; Method Development and Validation; Reference Standard; USP <71> Sterility Method Suitability; USP <85> Endotoxin Validation)

1 Quantity:
Procurement for Validation Batch: #60 Potassium U-13C Palmitate Single Dose Vials; 2 micromoles/mL; 28 mL vial

1 Quantity:
Compounding for Validation Batch: #60 Potassium U-13C Palmitate Single Dose Vials; 2 micromoles/mL; 28 mL vial

Production Batches

3 Quantity:
Procurement: #60 Potassium U-13C Palmitate Single Dose Vials; 2 micromoles/mL; 28 mL vials

3 Quantity:
Compounding: #60 Potassium U-13C Palmitate Single Dose Vials; 2 micromoles/mL; 28 mL vial

3 Quantity:
Release Testing to Include: Potency; USP<71> Sterility; USP <85> Endotoxin

D5 Glycerol single dose vials; 11.7 mg/mL; 30 mL vial

1 Quantity:
One Time Validation: D5 Glycerol Release Testing (Method Development and Validation Protocol; Method Development and Validation); Reference Standard (USP <71> Sterility Method Suitability; USP<85> Endotoxin Validation)

1 Quantity:
Procurement for Validation Batch: #65 - D5 Glycerol single dose vials; 11.7 mg/mL; 30 mL vial

1 Quantity:
Compounding for Validation Batch: #65 - D5 Glycerol single dose vials; 11.7 mg/mL; 30 mL vial

Production Batches

3 Quantity:
Procurement: #65 - D5 Glycerol single dose vials; 11.7 mg/mL; 30 mL vial

3 Quantity:
Compounding: #65 - D5 Glycerol single dose vials; 11.7 mg/mL; 30 mL vial

3 Quantity:
Release Testing to Include: (Potency; USP<71> Sterility; USP<85> Endotoxin

1 Quantity:
6,6 D2 Glucose SDV, 72.9 mg/mL, 30 mL vials
One Time Validation: (Method Development and Validation Protocol; Method Development and Validation; Reference Standard: USP<71> Sterility Method Suitability; USP<85> Endotoxin Validation)

1 Quantity:
Procurement for Validation Batch: (#65 - 6,6 D2 Glucose SDV, 72.9 mg/mL, 30 mL vials

1 Quantity:
Compounding for Validation Batch: (#65 - 6,6 D2 Glucose SDV, 72.9 mg/mL, 30 mL vials

Production Batches

3 Quantity:
Procurement: (#65 - 6,6 D2 Glucose SDV, 72.9 mg/mL, 30 mL vials

3 Quantity:
Compounding: (#65 - 6,6 D2 Gluose SDV, 72.9 mg/mL, 30 mL vials

3 Quantity:
Release Testing to Include: (Potency; USP<71> Sterility; USP<85> Endotoxin

Shipping and Handling

The sole source determination is based on that Pine Pharmaceutical is an FDA-registered 503b compounding pharmacy and 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 ten (10) calendar days from the publication date of this synopsis or by September 13, 2018 at 12:00pm EST. via email or postal mail. The quotation must reference "Solicitation number" NIH-NICHD-18-175. 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-18-175 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.

 

 

Bid Protests Not Available