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FBO DAILY ISSUE OF SEPTEMBER 18, 2005 FBO #1392
SOLICITATION NOTICE

A -- Comparative Study of Drug Application Review in Cananda and US

Notice Date

9/16/2005
 

Notice Type

Solicitation Notice
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

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

Reference-Number-1004733
 

Response Due

9/23/2005
 

Archive Date

10/8/2005
 

Description

This is a combined synopsis/solicitation for commercial items or services prepared in accordance with the format in FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ) No. 1004733. These solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The North American Classification System (NAICS) Code is 541710. The contractor shall perform a comparative study of drug application review in Canada and in the United States. The consultant will need to perform The Scope of Work, which is to include: a research organization or academic group to conduct an in depth study examining the review process of three drugs reviewed by both the Department of Health and Human Services (DHHS), Office of the Assistant Secretary for Planning and Evaluation (OASPE) and the Food and Drug Administration (FDA). The parameters the contractor shall use is 1) a drug approved by Canada?s Health Products and Food Branch (HPFB), but not by FDA, 2) a drug approved by FDA, but not by HPFB, and 3) a drug approved by both HPFB and FDA. To carry out this study, the contractor will review 1) the data packages submitted by the sponsor to both agencies, including the proposed labeling initially requested by the drug?s sponsor, 2) the decision packages (containing the analyses and recommendations of each agency?s reviewers) produced by HPFB and FDA scientists, and 3) the labeling that was finally approved (only in cases where the drug was approved). FDA will bear project management duties, including but not limited to the development of any necessary statements of work. The study would be accomplished through a contract with a research organization or academic group experienced in technological methodology and data collection. FDA agrees that an ASPE representative will be invited to serve as a participant on any Project Advisory Group (PAG). Evaluation Criteria: 1) The contractor shall have the ability to review data packages submitted by the sponsor, including (1) the proposed labeling initially requested by the drug?s sponsor, (2) the ?decision packages? (containing the analyses and recommendations of the agency?s reviewers) produced by HPFB and FDA scientists, and (3) the labeling that was finally approved ( in cases where the drug was approved), 17.5; 2) Ability to determine the similarity/differences of the data sets in the New Drug Applications (NDAs) submitted to both FDA and HPFB, including information on pre-clinical and clinical testing of the product, manufacturing specifications, stability and bioavailability data, method of analysis of each of the dosage forms the sponsor intends to market, packaging and labeling for both physician and consumer (if any), 17.5; 3) Ability to determine the primary issues for the medical, statistical, chemistry and preclinical reviewers, 10; 4) Ability to determine the substantive similarities and differences in the approaches taken by the scientists at HPFB and FDA at each critical juncture of the review process, 12.5; 5) Ability to determine the factors that were pivotal in the respective approval/non-approval decisions of HPFB and FDA, 12.5. Deliverables: 1) When the project is nearing completion, FDA/Contractor will brief ASPE representative on all analyses, analytical approaches and study design. FDA will also provide ASPE with the opportunity to review and comment on the report before it is finalized. 2) The contractor shall submit a completed study based on the Scope of Work and Evaluation criteria. Three copies of the study shall be submitted. DHHS and FDA intends to make an award immediately following this notice. The Period of Performance will be from date of contract approval through approximately four months ending approximately February 1, 2005. The following FAR Clauses shall apply to this solicitation: 52.212-1, 52.212-2, 52.212-4, 52.212-5 Instructions to Offerors-Commercial; and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by 12:00PM (noon) on the due date referenced above. All questions should be submitted in writing via e-mail to TONEILL@OC.FDA.GOV or fax to 301-827-7106. FAR provisions can be found at the following website: http://www/arnet.gov.
 

Place of Performance

Address: Food and Drug Administration, 5600 Fishers Lane, Rm. 15A55, HFG-1, Rockville, MD

Zip Code: 20857

Country: USA
 

Record

SN00897012-W 20050918/050916211733 (fbodaily.com)
 

Source

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

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