B -- RISK ASSESSMENT AND DATABASE FOR DRUGS & CHEMICALS USED IN FOREIGN AQUACULTURE

Notice Date

May 3, 2001

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Division of Construction and Agency Support Contracting, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001

ZIP Code

20857-0001

Solicitation Number

FDA2141

Response Due

May 17, 2001

Point of Contact

Mekeba Barrett, Contract Specialist, Phone 301-827-7185, Fax 301-827-7101, Email mbarrett@oc.fda.gov

E-Mail Address

Mekeba Barrett (mbarrett@oc.fda.gov)

Description

THIS IS A SOURCES SOUGHT SYNOPSIS FOR WRITTEN INFORMATION ONLY FROM SMALL BUSINESSES. THE NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE IS 541690. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS REQUESTING A SOLICITATION WILL BE ACCEPTED. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. RESPONSES SHALL NOT EXCEED 40 PAGES AND STANDARD COMPANY BROCHURES ARE NOT DESIRED. INFORMATION SHALL FOCUS ON THE CAPABILITY TO PROVIDE SCIENTIFIC AND TECHNICAL SERVICES AS DEFINED BELOW. The Food and Drug Administration is performing a market survey to identify small businesses that have technical capabilities that can support the Center for Veterinary Medicine (CVM). Specifically, the FDA is researching the potential for issuing an 8(a) set-aside, HUBZone set-aside, or small business set-aside solicitation for the services defined in this synopsis and in the draft Statement of Work. Scope of Work: This project will be completed in two phases. The first phase will focus on building the database and beginning to gather information for the database. The second phase will consist of performing a risk assessment for each drug and chemical using the information in the database and continuing to gather information. Phase I: (A) Develop a relational database to organize the information described below. The risk assessment and supporting materials will be integrated as part of the database. (B) Obtain the information listed below (A _D) on drugs and chemicals used in aquaculture products for the countries listed. Information on the use of genetically modified aquatic species for human consumption will be included in this section. FDA defines genetically modified animals as containing drug residues and therefore regulates those animals as drugs. Information to be collected on aquaculture drugs and chemicals used in foreign countries A. For each country listed, list the aquaculture species produced in that country; B. For each species listed, provide information on the types of drugs (including transgenics) and chemicals and conditions of use in each country as follows: drug or chemical name/tradename; chemical structure of drug/chemical; CAS (Chemical Abstract Society) number; dosage form(s); dosages, frequency, duration of treatment; conditions/indications for use for each species; including lifestages ; any special conditions of use; withdrawal times [if any]; use of drug according to country's guidelines (state if drug/chemical is approved or not); copy of label(s); extent of use of drug or chemical. C. For each country listed, provide information on residue testing and analytical methods as follows: (i) Describe how (if) residues in edible tissues are measured; (ii) Describe analytical methods used to measure residues including the sensitivity of the method and extent of validation the performance of the method; (iii) Provide a copy of the documentation on methods used; and (iv) State whether the method can be adapted for use with other drugs or species. D. For each drug and chemical listed in B., provide human food safety data as follows: (i) List references citing the toxicity and other human food safety information on the drugs and chemicals and their metabolites; (ii) Summarize the toxicology/safety information for each drug and chemical and their metabolites; and (iii) Provide copies of data collected. Phase II (A) Conduct a human food safety risk assessment for each drug and chemical in the database.. Consider the extent and conditions of use and human food safety data when evaluating the risk of hazardous residues in import aquaculture products; and (B) Make modifications as needed to the database. Small businesses with the capability of providing these services are invited to submit, in writing, sufficient information within the page limitation (40 pages) which demonstrates their ability to fulfill this requirement. Responses, including the vendor's business status (e.g.: small, small dis-advantaged, minority-owned, 8(a), HUBZone, etc.) should be mailed via U.S. Postal Service to the following address: FDA; ATTN.: Mekeba S. Barrett (HFA-531); 5630 Fishers Lane Rockville, MD 20857. HAND CARRY/COURIER/OVERNIGHT CARRIER ADDRESS (FedEX, Airborne, UPS, USPS -- Express Mail): FDA; ATTN.: Mekeba S. Barrett 5600 Fishers Lane, Room 2141; Rockville, MD 20857. Capability statements shall be submitted no later than May 17, 2001.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/cgi-bin/WebObjects/EPS.woa/wa/SPF?A=R&P=FDA2141&L=3045)

Record

Loren Data Corp. 20010507/BSOL009.HTM (D-123 SN50L1N2)