The NIH is seeking a qualified and experienced contractor(s) capable of providing contamination control cleaning supplies including at least, but not limited to those listed in Exhibits 1. The Contractor must be capable of delivering ordered supplies within 72 hours of receipt of orders to the National Institutes of Health, 9000 Rockville Pike, Bethesda, MD. The cGMP Cleaning Supplies will be for use in the NIH biologics manufacturing sites and aseptic processing cleanrooms It is vital that the Contractor provides Certificates for Analysis (COA), Certificates of Certifications and Packing Inserts in each packaged case of supplies. It is critical to adequately clean these rooms with the needed Government approved cleaning supplies to be able to pass the Joint Commission and FDA Certifications for cGMP pharmaceutical development practices. See the attached Statementof Work, with Exhibits 1.
The vendor responses must demonstrate their expertise in the areas describedabove. Please note that failure to specifically demonstrate capability to provide the required services in your response to this market survey may affect the Government's review of industry's ability to perform these services. The vendor'sresponse shall be in sufficient detail to allow the Government to assess the capability of your firm.
The vendor response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the company to perform the specialized requirements described in this synopsis. Interested organizations must demonstrate and document in any response submitted to this market survey extensive experience with and the ability to perform all of the specialized requirements elsewhere described.
This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. THIS IS NOT A REQUEST FOR PROPOSALS. The Government will not award a Purchase Order or Contract based upon Vendor responses to this announcement. The Government shall notassume any costs for preparing or submitting any information in response to themarket survey or the Government's use of the information. Any proprietary information should be clearly identified as "proprietary information".
In addition to addressing the requirements in the attached SOW, the Government requests that your capability statement address the following requests for information, if relevant.
1) Please provide the full company/entity name, address including points of contact (phone number and e-mail address), DUNS numbers, and type/size of the company/entity by NAICS code.
2) If your company/entity is a dealer or service-provider, and not a manufacturer of the end items/products contemplated by the SOW, please identify your company as such and identify the end item/product manufacturers that you would be obtaining goods from in order to perform the contract, and where the manufacturers are geographically located.
3) According to the small business limitations on subcontracting standard provided by the amended Small Business Act at 15 U.S.C. § 657s, the requirement for a small business supplier is that the small business prime contractor "may not expend on subcontractors more than 50 percent of the amount, less the costof materials, paid to the concern under the contract . . . ." 15 U.S.C. § 657s(a)(2). However, "[c]ontract amounts expended by a covered small business concern on a subcontractor that is a similarly situated entity [(i.e., another small/small disadvantaged business of the same type)] shall not be considered subcontracted for purposes of determining whether the covered small business concern has violated [limitations on subcontracting.]" 15 U.S.C. § 657s(b). If you are a small business, please address your ability to adhere to limitations on subcontracting at 15 U.S.C. § 657s. To ascertain if you are a small business,use the size standard provided by NAICS Code 325612 (Polish and Other Sanitation Good Manufacturing), with a size standard of no more than 750 employees.
As part of this, if you are a small business that is a dealer/service-provider and not a manufacturer, please so state, and address whether you meet the following requirements from 13 C.F.R. § 121.406(b). Specifically, your company/entity:
(1) Does not exceed 500 employees (notice that the employee standard under the non-manufacturer rule is more restrictive than for NAICS Code 325612);
(2) Is primarily engaged in the retail or wholesale trade and normally sells thetype of item being supplied;
(3) Takes ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; and
(4) Will supply the end item of a small business manufacturer, processor, or producer made in the United States.
NIH must receive written capability statements no later than December 6, 2017 at 9:00 a.m. Eastern Time. E-mail the written capability statement to Lisa Schaupp, the Contract Specialist, at the e-mail address Lisa.Schaupp@nih.gov.
Respondents will NOT be notified as to the results of the Government's market research.