SOLICITATION NOTICE
B -- Purchase of cGMP Human Growth Hormone Releasing Factor (I-44) - Package #1
- Notice Date
- 11/10/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325411
— Medicinal and Botanical Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- NIH-CC-15-001303
- Archive Date
- 12/6/2014
- Point of Contact
- Lisa L. Schaupp, Phone: 3014020735, Julius Y Tidwell, Phone: 301-496-0101
- E-Mail Address
-
Lisa.Schaupp@nih.gov, jtidwell@cc.nih.gov
(Lisa.Schaupp@nih.gov, jtidwell@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Growth Hormone Releasing Factor (GRF)( I-44), Synopsis/Solicitation. 29 pages, including SOW and evaluation factors. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, "Streamlined Procedures for Evaluation and Solicitation for Commercial Items," as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a "Request for Quotation" and being competed under FAR Part 6.1, Full and Open Competition. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-77, effective October 14, 2014. The associated North American Industrial Classification System (NAICS) code for this procurement is 325411 with a small business size standard of 750 of employees. In accordance with FAR Sub-Part 52.211-6, this is a "BRAND NAME OR EQUAL" requirement. The National Institute of Health, Office of Purchasing and Contracts, is seeking to purchase Brand Name or Equal Human Growth Hormone Releasing Factor (GRF), (1-44) as described in the Statement of Work. All interested and qualified businesses are encouraged to provide a quotation/offer. STATEMENT OF WORK The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC provides patient facilities and services for clinical investigations by the NIH Institutes, research in related areas and supervises residency and other training programs. The NIH Clinical Center Pharmacy Department provides pharmaceutical care and dispenses medications to inpatient and outpatients enrolled on clinical investigational studies. Clinical Center pharmacists provide research support to health care providers and investigators. Pharmacy staff members conduct and participate in research programs that enhance knowledge regarding optimal dosing and appropriate use of investigational and commercially available agents. The Pharmacy Department's Pharmaceutical Development Section manages investigational drug inventories through a computerized information system, prepares customized investigational drug products, and assists investigators in filing Investigational New Drug (IND) applications with the FDA. Current Good Manufacturing Practice (cGMP) Section 501 [21 U.S.C. § 351] (a) (2) (B) of the Federal Food, Drug, and Cosmetic Act requires the methods, facilities, and controls used for the manufacturing, processing, packaging, and holding of drug products to conform to current Good Manufacturing Practices (cGMPs) in order to ensure the safety, identity, strength, quality, and purity of the drugs produced. The federal Food and Drug Administration (FDA) has general rulemaking authority to issue regulations for the efficient enforcement of the act. The FDA regulates pharmaceutical manufacturing through the Code of Federal Regulations (CFR), specifically the following sections: 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR Part 600 Biological Products: General Part The FDA further discusses procedures and practices to meet cGMPs through various venues, including the publication of Guidance for Industry documents, several of which are applicable to the operations that take place in PDS. Two very relevant and important guidance documents include cGMP for Phase I Investigational Drugs and Sterile Drug Products Produced by Aseptic Processing - cGMPs. The requirement for maintenance and cleaning of pharmaceutical process systems and equipment are clear (21 CFR 211.67 Subpart D and FDA guidance and inspection documents) and linked to the regulations through these documents and venues. Regulatory Requirements for PDS Operations PDS engages in the manufacture, packaging, distribution, and holding of drugs and drug products for Phase I and Phase II clinical trials, and contributes to the submission of IND applications to the FDA. The FDA makes clear that an investigational drug for use in a Phase 1 study is subject to the statutory requirements set forth at 21 U.S.C. 351(a)(2)(B). Drugs for Phase 2 or Phase 3 study must comply with all regulations set forth by 21 CFR 210-211. As such, PDS is subject to the regulatory authority of the FDA and must operate under cGMP conditions. Additionally, vendors providing equipment or services to PDS must know, understand, and apply cGMP conditions since PDS is reliant upon the manufacturer or service provider to meet many of the required quality aspects of the goods or services provided. PURPOSE In many cases the Pharmacy is required to find a suitable source for raw materials needed to produce the drug dosage forms needed to complete the goals of approved clinical trials. The Pharmacy has made many hundreds of purchases over the years and the practices employed are, in most cases reviewed by the FDA. In effect, on hundreds of occasions, the FDA has agreed that Pharmacy has made a proper choice in this regard. The judgement, based on experience, of members of the Pharmacy who make these selections is a primary factor in the decision process. Other factors to be considered in these selections are compendial specifications and designation (inclusion in the United States Pharmacopeia or National Formulary, U.S.P./N.F. or in foreign equivalents), the issue of whether the chemical was made under current Good Manufacturing Practices (cGMP) as defined by the United States Food and Drug Administration (U.S. FDA) or, in some cases, the recognized available grade of the material, e.g. - food grade or analytical grade for example. SCOPE OF WORK • The GRF 1-44 needed must be at least 98% peptide pure. • It must be a white powder. • It must attain a solubility in water of at least 1 mg/mL. • It must have a specific rotation value at C=0.1 in water at 20 degrees C in 1% • Acetic acid of approximately -78.99 degrees. • The molecular weight must be 5040.4 • The peptide must be certified as being prepared under cGMP conditions and be labeled as such. • A reference standard must be available from the source so that analytical comparison can be made. • A certificate of analysis showing the specifications for acceptance of the provided material and the actual values found in testing must be provided. FOR ALL TERMS, CONDITIONS, AND QUOTATION INSTRUCTIONS, PLEASE SEE THE ATTACHED DOCUMENT: "Growth Hormone Releasing Factor (GRF), (I-44) Synopsis/Solicitation."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/NIH-CC-15-001303/listing.html)
- Place of Performance
- Address: National Institutes of Health, Clinical Center, 9000 Rockville Pike, 10 Center drive, Building 10, Pharmacy Department, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03570023-W 20141112/141110233921-57436d22c0e51194aab83599aab08b4a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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