SOURCES SOUGHT
B -- Laboratory Survey of Diethanolamine (DEA) in Cosmetic Products - Package #1
- Notice Date
- 5/20/2014
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- 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-SS14-1133823
- Archive Date
- 6/18/2014
- Point of Contact
- Christopher R. McGucken, Phone: 2404027599
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- 'Determination of Diethanolamine in Shampoo Products Containing Fatty Acid Diethanolamides by Liquid Chromatography with a Thermal Energy Analyzer' by Chou: Journal of AOAC International Vol. 88, No. 2, 2005. FDA-SS14-1133823 Sources Sought notice in Word format. TITLE: Laboratory Survey of Diethanolamine (DEA) in Cosmetic Products OPDIV: FDA, Center for Food Safety and Applied Nutrition (CFSAN) This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the work described below. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. This is not an invitation for bid, request for proposal, or other solicitation, and in no way obligates the Food and Drug Administration (FDA) to award a contract. BACKGROUND FDA is responsible for providing regulatory oversight of the safety and proper labeling of cosmetics. FDA is interested in the use of diethanolamides, such as cocamide DEA and lauramide DEA, in cosmetic products because they may contain residual diethanolamine (DEA) that can react to form nitrosamines, which have been shown to be carcinogenic. Diethanolamides, such as cocamide DEA and lauramide DEA, are commonly used as ingredients in cosmetic products for their function as thickening and cleansing agents, foam boosters, and stabilizers. Although most commonly found in detergent formulations like shampoos, bubble baths, and liquid body cleansers, their properties also make them useful in products such as creams and lotions. FDA does not have any information on the current levels of DEA present in cosmetic products. This DEA content is needed to set regulatory priorities. CONTRACTOR REQUIREMENTS The work to be performed by the contractor encompasses the following: •The Contractor shall conduct a laboratory analysis of diethanolamide containing cosmetic products for diethanolamine (DEA) using a specific method. The Contractor shall perform the following test method on each sample: o"Determination of Diethanolamine in Shampoo Products Containing Fatty Acid Diethanolamides by Liquid Chromatography with a Thermal Energy Analyzer" by Chou: Journal of AOAC International Vol. 88, No. 2, 2005. (A copy of this method is attached in the Appendix below). •Every product will be analyzed in triplicate. •CFSAN has a list of 159 specific diethanolamide containing products to be purchased and used by the Contractor for its analysis. oThe following represents the government's intent as to the breakdown of what is to be analyzed: 5 hair products, 6 shaving preparations, 14 bath additives, 30 shampoos, 50 liquid soaps, and 54 shower products. •The Contractor shall also purchase and analyze 6 diethanolamide-free cosmetic products consisting of 1 hair product, 1 shaving preparation, 1 bath additive, 1 shampoo, 1 liquid soap, and 1 shower product. •Before conducting analyses of the 159 diethanolamide-containing cosmetic products, the Contractor shall first demonstrate its ability to perform accurate analyses by conducting recovery studies on 6 diethanolamide-free cosmetic products purchased by the Contractor. This is required in order to address any possible matrix effects. oThis will be accomplished by spiking these products with a characterized reference DEA. oEach product shall be tested at 5 different concentration levels, including one at the zero level or blank. oEach analysis must be conducted in triplicate Capability statements must demonstrate the minimum requirements outlined below. Please address each in the order listed below. Personnel - Offeror shall demonstrate that it employs the requisite personnel to perform the analyses as described above. The offeror shall name the participating personnel, identify their qualifications and experience, and for each person listed indicate the percentage of time that they would be devoting to this contract. Technical Experience - Offeror shall demonstrate experience relevant to DEA analysis in cosmetic products. Experience analyzing cosmetic products using the referenced test method is highly desirable. Offeror shall also list any laboratory accreditations and certifications it has received that relate to its ability to perform these analyses. Technical Approach - Offeror shall identify the specific instrumentation it plans on using to analyze for DEA in cosmetics. Offeror shall describe method performance criteria which should include method precision, limit of detection, range, and accuracy for DEA determined by the method. Offeror shall identify any required method modifications it will employ in these determinations. Offeror shall further provide instrument specifications on stability and sensitivity. Offeror shall also provide any directly relevant Standard Operating Procedures (SOPs). The quote shall also include a sample quarterly report that will show the formatting that the Contractor intends to utilize in its quarterly report. Project Management - Offeror shall provide information relevant to the administration of the project. This should include management plans for oversight of the project, procedures for implementing quality control and quality assurance systems, procedures for assuring that samples are not compromised (i.e. maintenance of a chain of custody paper trail, lock-up of samples when unattended, etc.), and cost control procedures. ADMINISTRATIVE INFORMATION Please provide the follow Business information on your cover sheet: 1.DUNS Number 2.Company Name 3.Company Address. 4.Company Point of Contact, phone number and email address 5.Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. 6.Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7.Current GSA Schedules appropriate to this Sources Sought 8.Current Government Wide Agency Contracts (GWACs) 9.Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses shall be limited to 11 pages (inclusive of coversheet). Responses must be received not later 3:00 PM EST, June 3rd, 2014. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Christopher.McGucken@fda.hhs.gov
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