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FBO DAILY ISSUE OF AUGUST 10, 2008 FBO #2449
DOCUMENT

A -- Evaluation of Biopharmaceutics Classification System Class 3 Drugs for Possible Biowaivers - Solicitation 1

Notice Date

8/8/2008
 

Notice Type

Solicitation 1
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

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

ZIP Code

20857-0001
 

Solicitation Number

FDA-SOL-08-00691a
 

Point of Contact

Jacqueline Richardson,, Phone: 301-827-7180, Monifa N Coleman,, Phone: 301-827-7164
 

E-Mail Address

jacqueline.richardson@fda.hhs.gov, monifa.coleman@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) has a requirement for the evaluation of Biopharmaceutics Classification System (BCS) class 3 drugs for possible biowaivers. BCS characterizes drug substances based on their aqueous solubility and intestinal permeability. These properties, in addition to dissolution, control the rate and extent of drug absorption from immediate release, solid oral dosage forms. According to BCS, drug substances may be categorized as follows: Highly soluble, highly permeable (Class 1); poorly soluble, highly permeable (Class 2); highly soluble, poorly permeable (Class 3); and poorly soluble, poorly permeable (Class 4). Currently, an FDA guidance published in August, 2000 (BCS guidance), provides for waiver of in vivo bioequivalence studies for drugs determined to have BCS Class 1 properties, provided they are rapidly dissolving and not NTI drugs. This approach has allowed the approval of numerous new and generic drugs based on in vitro data alone, with tremendous savings in resources and reduction in unnecessary human testing. It is believed, with the appropriate testing, that biowaivers may be extended to drugs belonging to BCS Class 3. Such biowaivers could also result in significant savings to the drug industry and the American health care consumer. This contract shall evaluate a number of commonly used excipients for possible impact on the permeability and absorption of several BCS Class 3 drugs. In vitro as well as confirmatory in vivo studies shall be conducted. The results could support extending biowaivers to drug products in this class. 100% Full and Open Competition The NAICS code is: 541712. It is anticipated that one (1) cost type contract is expected for a one (1) year period of performance. The solicitation and any documents relating to this requirement will only be available through the internet at: www.fedbizopps.gov. Potential offerors are responsible for monitoring Fed Biz Opps for the release of the solicitation and any subsequent amendments. Contractors are encouraged to sign-up on the fedbizopps.gov website, for email notification of all actions relevant to this solicitation, and on the interested vendors list, also listed at the bottom of this announcement. Responses to this Request for Proposal (RFP) package will be due approximately 30 days following the actual date of issuance of the RFP. Award of this requirement is anticipated by September 19, 2008. ************************PLEASE SEE ATTACHMENT FOR FULL SF 33 AND RFP ***********************
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=3f445015b27dc9710cd985980483f244&tab=core&_cview=1)
 

Document(s)

Solicitation 1
 

File Name: SF 33 AND RFP ATTACHED (FDA-SOL-08-00691a.pdf)

Link: https://www.fbo.gov//utils/view?id=94cf35cae3bdf55823b1e1dcb2a9f549

Bytes: 14,009.29 Kb
 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: 7519 Standish Place, Rockville, Maryland, 20855, United States

Zip Code: 20855
 

Record

SN01634836-W 20080810/080808221127-3f445015b27dc9710cd985980483f244 (fbodaily.com)
 

Source

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

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