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FBO DAILY ISSUE OF MARCH 27, 2005 FBO #1217
SOLICITATION NOTICE

R -- Critical Path Knowledge Management Database

Notice Date

3/25/2005
 

Notice Type

Solicitation Notice
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA0500037
 

Response Due

4/4/2005
 

Archive Date

4/19/2005
 

Point of Contact

Sharon Kindall , Contract Specialist, Phone 301-827-0305, Fax 301-827-7106, - Leonard Grant, Contracting Officer, Phone (301) 827-7173, Fax (301) 827-7101,
 

E-Mail Address

sharon.kindall@fda.gov, lgrant@oc.fda.gov
 

Description

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. This is a Request for Quotation (RFQ) FDA-SOL-05-00037; a written solicitation will not be issued. The Food and Drug is soliciting for an experienced consultation company to develop a critical path knowledge management database to facilitate scientific decisions made in the support of New Drug Application (NDAs), Biologic License Applications (BLAs), Investigation New Drugs (INDs), and Abbreviated New Drug Applications (ANDAs) for The Office of Pharmaceutical Science (OPS). The company must be experienced in biologic and generic drug product application review processes and knowledgeable in pharmaceutical technology. The company will be required to provide thorough and rapid assessment of business processes. Must have experience in mapping and improving manufacturing processes that recognize and capture the experiences and knowledge gained by several distinct scientific disciplines cover a wide range of therapeutic classes and manufacturing practices and regulations. This procurement is firm fixed price requirement. SCOPE OF WORK – Specific requirements are outlined below: 1. Establish a core scientific and technical decision-making process, Data collection/Initial Analysis – Select and review representative sample of New Drug Application’s (3-5 simple and 3-5 complex), Look for commonality of reviewers where possible, develop preliminary process maps. (2) Interview- develops interview questions, Schedule and conduct interview with 10-12 reviewers. (3) Develop Current Business Model – Refine as-is process maps, Document sources of scientific uncertainty (to the extent possible) (4) Determine Next Steps – Report on how things are done today, Discuss types of questions that are being asked, and if they seem to be the “right” questions, Discuss whether current process is science-based or checklist driven, Determine next steps. The company will be required to provide thorough and rapid assessment of business processes. Must have experience in mapping and improving manufacturing processes that govern federal regulations. This procurement is firm fixed price requirement. Interested offeror’s shall submit their capabilities statement along with their cost quotation. Award will be made to the vendor who submits the lowest price that meets all specifications and requirements. The Government may make its decision on the basis of initial quotations received and not have discussions. Therefore each initial quotation should contain the offeror’s best terms from both a price and technical standpoint. This is Request for Quotation (RFQ). APPLICABILITY OF FAR PROVISIONS: the following Federal Acquisition Regulation (FAR) provisions and clauses apply to this solicitation and are incorporated by references. FAR 52.212-1 Instruction to Offerors – Commercial Items. Offer must include a completed copy of FAR provisions 52.212-3 Offeror Representations and Certifications – Commercial Items with their offer. FAR provision 52.232-18 Availability of Funds. FAR Provision 52.212-4 Contract Terms and Conditions - Commercial Items. FAR 52.215-5 Facsimile Quotations. FAR 52.212-5 Contract terms and Conditions Required to Implement Statues or Executive Orders – Commercial Items, for paragraphs a, b and c, only the following clauses apply to this acquisition: 52.233-3, Protest after Award (31 U.S.C. 3553); 52.203-6, Restrictions on Subcontractor Sales to the Government, with Alternate I (41 U.S.C. 253g and 10 U.S.C. 2402); 52.219-8, Utilization of Small Business Concerns (15 U.S.C. 637(d)(2) and (3)); 52.222-21, Prohibition of Segregated Facilities (FEB 1999); 52.222-26, Equal Opportunity (E. O. 11246); 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and other Eligible Veterans (38 U.S.C. 4212); 52.222-36, Affirmative Action for Workers with Disabilities (29 U.S.C. 793); 52.222-37, Employment Reports on Special Disabled Veterans., Veterans of the Vietnam Era, and other Eligible Veterans (38 U.S.C. 4212); 52.222-19, Child Labor – Cooperation with Authorities and Remedies (E.O. 13126); 52.225-1, Buy American Act - Supplies (41 U.S.C. 10a-10d) and; 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (31 U.S.C. 3332). Offers are due in this office no later than April 4, 2005. The point of contact for this requirement is Sharon Kindall, telephone (301) 827-0305 and fax number is (301) 827-7106. Submit Offers to the Food and Drug Administration, Office of Acquisition and Grants, HFA-500, Room 2089, 5630 Fishers Lane, Rockville, MD 20857, Attention Sharon Kindall. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to finish required representation and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which shall be considered. NOTE: THIS NOTICE WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (25-MAR-2005); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/FDA/DCASC/FDA0500037/listing.html)
 

Place of Performance

Address: 5515 Security Lane, Rockville, MD

Zip Code: 20852

Country: US
 

Record

SN00776486-F 20050327/050325213407 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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