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FBO DAILY ISSUE OF AUGUST 28, 2004 FBO #1006
SOLICITATION NOTICE

99 -- Aloe Barbadensis Whole Leaf Gel-No Charcoal extract

Notice Date

8/26/2004
 

Notice Type

Solicitation Notice
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Jefferson Laboratories, National Center for Toxicological Research, Attn: Division of Contracts and Acquisitions, HFT-322 3900 NCTR Road, Jefferson, AR, 72079-9502
 

ZIP Code

72079-9502
 

Solicitation Number

222-04-2006(P)Combined
 

Response Due

9/8/2004
 

Point of Contact

Barbara Arnold, Contract Specialist, Phone (870) 543-7483, Fax (870) 543-7990, - Sandra Davis, Contract Specialist, Phone (870) 543-7469, Fax (870) 543-7990,
 

E-Mail Address

barnold@nctr.fda.gov, sdavis@nctr.fda.gov
 

Small Business Set-Aside

Total Small Business
 

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 Proposal (RFP) No. 222-04-2006(P). The solicitation clauses and provisions are those in effect through Federal Acquisition Circular 2001-24. The North American Industry Classification System (NAICS) Code is 325412 ? Pharmaceutical Preparation Manufacturing. IT IS THE GOVERNMENT?S INTENTION TO NEGOTIATE ON A SOLE SOURCE BASIS with Pangea Phytoceuticals, Inc., Harlingen, Texas, Suite 119, Harlingen, TX 78550, to provide Aloe Barbadensis (Miller) Whole Leaf Gel-No Charcoal Extract. The contract will be issued for an estimated amount not to exceed four hundred (400) kilograms of Aloe Barbadensis (Miller) Whole Leaf Gel-No Charcoal extract. FOB Destination. Contract type: Commercial Item - Firm fixed price, indefinite-delivery/quantity requirement. Subject to FAR clause 52.232-18 entitled Availability of Funds (APR 1984), funds are not presently available for this contract. The Government?s obligation under this contract is contingent upon the availability of FY-05 appropriated funds. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer. The following Far clauses shall apply to this solicitation: Far Part 52.212-1 Instructions to Offerors-Commercial Items (JAN 2004); Offer must include a completed copy of FAR provisions 52.212-3 Offerors Representations and Certifications-Commercial Items (MAY 2004); 52.212-4 Contract Terms and Conditions-Commercial Items (OCT 2003); 52.212-5 Contract Terms and Conditions Required to Implement Status of Executive Orders-Commercial Items (MAY 2004). FAR provisions can be found at the following website: http://www.arnet.gov. See numbered note 22 and 23.***** ***** BACKGROUND: Pangea Phytoceuticals, Inc. has been the sole supplier of test material for Aloe studies since 2002; any change may result in jeopardizing the scientific integrity of these studies. ***** THE CONTRACTOR SHALL PROVIDE THE FOLLOWING: Aloe Barbadensis (Miller) Whole Leaf Extract. The Aloe Vera whole leaf extract used in these studies will be the product obtained solely from mature, fresh Aloe Barbadensis leaves. The extract will be produced by grinding whole Aloe Vera leaves. The extract will then be treated with 23 mg/L Cellulase to reduce viscosity and maximize yields. This product will contain not only the inner gel but also the latex of the leaf, which is found in the bundle sheaf cells beneath the epidermis. The pulp will be removed from the extract by filtration and the product will be lyophilized to 6.0% maximum moisture content. The lyophilate will have a total bacterial plate count of less than 10,000 CFU/gram and be negative for the presence of Coliforms. The pH, alcohol precipitable hexose, malic acid and aloin content of the product will be reported for each prepared batch. Each batch will be assigned a unique lot number. The Aloe Vera test material handling, processing and preparation specifications are as followed: 1.) The Aloe Vera test materials will be the products obtained solely from mature, fresh Aloe Barbadensis (Miller) leaves. 2.) Lyophilization of the products obtained from mature, fresh Aloe Barbadensis leaves will begin within a maximum of 6 hours of harvesting the leaves. 3.) The Aloe Vera substance will be unadulterated. No stabilizers or other substances will be added to the products. 4.) The selected supplier will furnish analytical data to support the authentication of the supplied lyophilized Aloe Vera gel, whole leaf extract, and latex as unadulterated products of fresh leaves from the Aloe Barbadensis (Miller);. 5.) The prepared Aloe Vera test materials will be stored at-20degree C and shipped to NCTR on dry ice. A request for Proposal is not available. This is a 100% set-aside for small business, firm fixed price, indefinite-delivery/quantity requirement. All responsible sources may submit a quote, which shall be considered. See Numbered Note(s) 22 and 23. *****Numbered Notes: 22. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within forty-five days (thirty days if award is issued under an existing basic ordering agreement) after date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. 23. Award will be made only if the offeror, the product/service or the manufacturer meets qualification requirement at time of award, in accordance with FAR 52.209-1 or 52.209-2. The solicitation identifies the office where additional information can be obtained concerning qualification requirements and is cited in each individual solicitation.
 

Place of Performance

Address: 3900 NCTR Road, Jefferson, AR

Zip Code: 72079-9502

Country: USA
 

Record

SN00655259-W 20040828/040827093511 (fbodaily.com)
 

Source

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

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