AVAILABILITY OF FISH OIL TEST MATERIALS NIH GUIDE, Volume 23, Number 32, August 26, 1994 P.T. 34 Keywords: Chemicals/Materials+ National Institutes of Health This notice supplements the previous announcement published in the NIH Guide for Grants and Contracts, Vol. 19, No. 11, March 16, 1990. SUMMARY AND PURPOSE Additional Test Materials Currently Available The Fish Oil Test Materials Program announces the availability of purified EPA (approx. 90 %) and DHA (approx. 90%) in kilogram quantities to qualified applicants conducting research studies. o EPA ethyl ester, packaged in 1 gm soft gelatin capsules (contain tocopherols(1-2 mg/g) and TBHQ(.02%) o DHA ethyl ester, packaged in 1 gm soft gelatin capsules (contain tocopherols(1-2 mg/g) and TBHQ(.02%) o Placebo ethyl esters, packaged in 1 gm soft gelatin capsules (described with other products listing) Processing and Specifications of Biomedical Test Materials o EPA Ethyl Ester The ethyl ester of EPA is prepared from fish oil using transesterification, short-path distillation and urea adduction to yield an n-3 ethyl ester concentrate. The purified ethyl ester of EPA is attained by preparative chromatographic techniques. The product contains 95% ethyl esters; of the ethyl esters EPA is 95%, other n-3's are <4%, n-6's are <1% and other fatty acid esters are <1%. It contains 0.2 mg/g TBHQ as antioxidant and 2 mg/g tocopherols. o DHA Ethyl Ester The ethyl ester of DHA is prepared from fish oil using transesterification, short-path distillation and urea adduction to yield an n-3 ethyl ester concentrate. The purified ethyl ester of DHA is attained by preparative chromatographic techniques. The product contains >95% ethyl esters; of the ethyl esters DHA is 86%, other n-3's are <9%, n-6's are <3% and other fatty acid esters are <1%. It contains 0.2 mg/g TBHQ as antioxidant and 2 mg/g tocopherols. FISH OIL TEST MATERIALS PROGRAM The Fish Oil Test Materials Program is administered by the National Institute on Alcohol Abuse and Alcoholism, NIH. The program was established in 1986 through the cooperation of the National Institutes of Health (NIH), the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA), and the National Oceanic and Atmospheric Administration/Department of Commerce (NOAA/DOC). This program has been designed to provide a long-term, consistent supply of quality-assured/quality-controlled test materials to researchers to facilitate the evaluation of the role of omega-3 fatty acids in health and disease. Fish Oil Test Materials Advisory Committee A Fish Oil Test Materials Advisory Committee (FOTMAC) is chaired by scientific staff from NIH and is composed of scientists representing the funding agencies (NIH), the research community, Department of Commerce (DOC) and the Food and Drug Administration (FDA). The FOTMAC provides scientific advice to the DOC regarding the types of materials needed by research scientists, shipping procedures for the materials, and additional quality control and production issues. The committee is advisory to the Fish Oil Test Materials Program on general programmatic issues such as future directions, and has produced an information sheet on Considerations in the Study of the Effects of Dietary Fish Oils. In addition, the committee provided guidance to DOC during the production of the Drug Master File submitted to the FDA by the FOTMAC. Manuals on Analytical Methods for the Quality Assurance of Fish Oil, Production Methods/Safety and Distribution were produced by the DOC and are available to investigators. Fish Oil Test Materials Distribution Committee A Fish Oil Test Materials Distribution Committee (FOTMDC) is composed of NIH and other Federal scientists. The Distribution committee processes the applications received from investigators, advises the DOC of applicants that have fulfilled the application process, and makes recommendations regarding the distribution of requested materials. Other Test Materials Currently Available o n-3 ethyl ester concentrate, prepared from menhaden oil, bulk packed or soft-gel encapsulated (80% n-3 fatty acids including EPA and DHA) o Ethyl esters of olive oil, corn oil, and safflower oil (70% linoleic), bulk packed or soft-gel encapsulated o Deodorized menhaden oil, bulk packed or soft-gel encapsulated o Commercial preparations of corn, olive, or safflower oil, soft-gel encapsulated only o DHA Ethyl Ester and EPA Ethyl Ester in small gram quantities, bulk packed Processing and Specification of Biomedical Test Materials o n-3 Ethyl Ester Concentrate The n-3 ethyl ester concentrate is prepared from vacuum-deodorized menhaden oil using transesterification, urea adduction and short-path distillation. The concentrate contains >90% ethyl esters, of which approximately 80% are n-3 fatty acid ethyl esters (44% EPA, 24% DHA, 10-12% other n-3 fatty acid ethyl esters), 3% C18 (other than n-3), 6% C16 and the remainder as other esters. It contains 0.2 mg/g TBHQ as antioxidant, 2 mg/g tocopherols and 2.0 mg/g cholesterol. The concentrate is available in 1 g soft-gel capsules (100 capsules/bottle) or packaged in bulk in quantities suitable to investigators' needs. o Placebo Ethyl Esters The olive, corn and safflower ethyl esters contain >85% esters. The olive oil ethyl esters contain approximately 70% oleic acid, 10% C16, and 6% C18 (<6 mg/g n-3) fatty acid ethyl esters. The corn oil ethyl ester contains approximately 50% linoleic, 23% oleic acid and 10% C16 (>6 mg/g n-3) fatty acids. The safflower ethyl esters contain approximately 72% linoleic, 8% oleic and 6% C16 (>2 mg/g n-3) fatty acids. The preparations are available in 1 g soft-gel capsules (100 capsules/bottle) or packaged in bulk in quantities suitable to investigators' needs. o Deodorized Menhaden Oil Deodorized menhaden oil is prepared from oil that has been winterized and alkali refined; it is processed through a two stage wiped-film evaporator to remove cholesterol, volatile oxidation products and any traces of organic contaminants. The oil contains approximately 30% n-3 fatty acids in the triglyceride form; 14% EPA, 8% DHA, 8% other n-3. It contains 0.2 mg/g TBHQ as antioxidant, 2 mg/g tocopherols and 2.0 mg/g cholesterol. The deodorized oil is available in 1 g soft-gel capsules (100 capsules/bottle) or is packaged in bulk quantities suitable to investigates needs. Special requests for antioxidants-free oil will be considered, e.g., for studies involving varying levels of antioxidants. o Placebo Oils Commercial preparations of corn, olive, and safflower oil have been soft-gel encapsulated to serve as placebos for studies involving encapsulated menhaden oil. These oils contain 0.2 mg/g TBHQ as antioxidant and 2 mg/g tocopherols. The major fatty acids for each oil are: corn (58% 18:2n-6, 26% 19:1n-9) olive 17% 18:2n-6, 57% 18:1n-9), safflower 80% 18:2n-6, 9% 18:1n-9). They are available in 1 g soft-gel capsules (100 capsules/bottle). Although vegetable oils will not be supplied in bulk form, investigators may request analysis of antioxidants and tocopherol levels in vegetable oils that they purchase for their studies. APPLICATION PROCEDURES To qualify to receive materials described in this announcement the applicant must: (1) have peer-reviewed research indicating the need for the requested materials, and (2) submit a correctly completed application form and a signed waiver of liability. The committee will not be responsible for assessing the scientific merit of the application. Regulations on human subjects and animal research apply. In accordance with federal regulations, an IND number will be required for the use of these materials in human studies. The FOTMAC has established a drug master file at the FDA that includes manufacturing, chemical composition, and toxicological data relevant to these products. Investigators approved for the use of NOAA/DOC materials may reference this file in order to expedite their IND requests. Availability of materials are contingent on DOC/NOAA production capabilities. When prioritization is necessary, the order will be: (1) NIH funded, (2) other U.S. government funded, (3) peer-reviewed, other funded, (4) NIH approved, not funded, and (5) other. Kilogram quantities of purified EPA ethyl ester and DHA ethyl ester are available for research purposes. The awarded materials are provided free of charge (Researchers are asked to pay shipping costs). For further information, contact Dr. Patricia Fair at (803) 762-1200. Additional information will be provided to the investigator including extensive quality assurance data for each lot of test material shipped, stability data and storage instructions. INQUIRIES Investigators may obtain further information and apply for available fish oil test materials for relevant studies by requesting an application form from: Fish Oil Test Materials Program Program Coordinator National Institute on Alcohol Abuse and Alcoholism DANAC #4, Room 55C 12501 Washington Avenue Rockville, MD 20852 Telephone: (301) 443-2393 FAX: (301) 594-0035 .
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