SOLICITATION NOTICE
B -- A Rabbit Study to Evaluate the Potential of Inorganice Contaiminants to Cause Intraccular Inflammatin for the FDA
- Notice Date
- 8/25/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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
- FDA1076531
- Archive Date
- 9/16/2010
- Point of Contact
- Mary Rose A. Nicol, Phone: 3018277183
- E-Mail Address
-
MaryRose.Nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-30. This announcement constitutes the only solicitation and a written solicitation will not be issued. This combined synopsis/solicitation, NAICS code 541690, is to notify contractors that the government intends to issue a Firm Fixed Price Contract in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. This action is designated aFull and Open Competion/Unrestricted procurement for a span of eight weeks from the time of award. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This solicitation is issued as a Request for Quotes (RFQ). The Food and Drug Administration (FDA) intends to award a Rabbit Study to Evaluate the Potential of Inorganice Contaiminants to Cause Intraccular Inflammatin. The statement of work to this solicitation are listed as follows: Statement of Work A rabbit study to evaluate the potential of inorganic contaminants to cause intraocular inflammation 1.0 Background There has been an increase in the incidence of toxic anterior segment syndrome (TASS) following cataract surgery and intraocular lens implantation in recent years. TASS is an acute sterile postoperative inflammation of the anterior segment of the eye and it is believed to be caused by toxic non-infectious substances. Many causes have been implicated in its etiology. One of the possible causes of TASS is believed to be inorganic contaminants such as heavy metals that can be introduced by fluids used during cataract surgery, including balanced salt solutions and ophthalmic viscosurgical devices (OVDs). Inorganic contaminants can also be introduced by surgical instruments that have been exposed to steam from improperly maintained steam generators during sterilization. Copper in the anterior chamber has been reported to cause anterior uveitis that includes purulent exudation and hypopyon from white blood cell infiltration into the anterior chamber. An epidemic of corneal destruction in 1998 was attributable to the degradation of brass in cannulated surgical instruments to copper and zinc by a plasma gas sterilization method in a recent publication. Alumina in polishing compounds used in the manufacturing of intraocular lenses has also been implicated in intraocular inflammation. Since inorganics can be introduced into ophthalmic surgical devices such as OVDs and intraocular lenses during manufacturing, it is, therefore, necessary to examine the potential of inorganics to cause intraocular inflammation in a rabbit model as a part of the TASS investigation such that limits on inorganics on or in ophthalmic devices can be set to ensure the safety of ophthalmic devices that are likely to have inorganic contaminants. This study is being contracted out to an outside laboratory because of space limitation at OSEL. 2.0 Description of Work The Contractor (Test Lab) shall conduct the study in the rabbit as follows: The objective of this study is to evaluate the inflammatory potential of two different inorganics. Three different doses of each of the two inorganics will be evaluated so that a dose-response effect, if any, can be examined. A total of 35 New Zealand White rabbits (male or female) weighing approximately 3 Kg each will be used in the study. Ten (10) eyes of five rabbits with normal eyes, as confirmed by pre-treatment slit lamp biomicroscopy and pachymetry, will be intracamerally injected (directly into the anterior chamber of the eye) with each of the six samples. Another 10 eyes of 5 rabbits will be injected with the vehicle control. The treated eyes will be examined for signs of inflammation by slit lamp biomicroscopy and corneal edema by pachymetry at five different time points after treatment, the last one time point being at 72 hours. Slit lamp observations should include, but not limited to, the conjunctiva, cornea, iris, cells, flare and fibrin reaction in the anterior chamber, presence of any synechia, pupil constriction, keratic precipitates, hypopyons, and fibrin clot beyond the pupillary area. Observations on the conjunctiva, cornea and iris shall be graded using the McDonald Shadduck slit lamp grading scale. Observations on cells and flare should be graded in accordance with the SUN scale (Standardization of uveitis nomenclature for reporting clinical data. Results of the first international workshop. Am J Ophthalmol 2005;140:509-516). Observations on fibrin should be grading as described in an article by R. Zarei and co-investigators (Zarei R, Azimi R, Moghimi S. et al. Inhibition of intraocular fibrin formation after infusion of low-molecular weight heparin during combined phacoemulsification-trabeculectomy surgery. J Cataract Refract Surg 2006; 32:1921-1925). The rabbits will be released from the study after the 72-hour examination. The data will be compiled/ summarized by the Contractor and a summary will be provided to FDA along with the raw data. The Contractor (Test Lab) shall:  Provide a combined total of 35 New Zealand White rabbits each weighing approximately 3.0 Kg for the study.  Adhere to its internal procedures regarding animal welfare and care.  Perform the injection and the pre-injection and the post-injection evaluation at five time points as requested by FDA using a board-certified ophthalmologist or veterinary ophthalmologist who is experienced with intracameral injection in the rabbit.  Provide adequately trained personnel to assist with surgery and pre- and post-treatment evaluation  Provide all medications needed for the study including anesthetics (ketamine/xylazine, proparacaine HCl) and medication (0.3% gentamicin drops) as needed after injection and other supplies such as injection syringes, needles and balanced salt solution.  Dispose the study animals at the end of the study either by re-assigning them to other studies or have the rabbits humanely euthanized.  Compile/ summarize the data and provide FDA with a data summary and all the raw data upon completion of each study.  Allow FDA technical staff to observe treatment and post-treatment examination of the study rabbits and make study modifications as deemed necessary, provided that the total number of rabbits used and the number of post-treatment slit lamp examinations specified in the contract remain unchanged. The Contractor must have and will be technically evaluated on the following factors:  Prior experience and expertise in ophthalmic surgical studies directly relevant to the type of work needed and the appropriate infrastructure to conduct this type of study.  Access to a board-certified ophthalmologist or veterinary ophthalmologist with prior experience in intracameral injection in the rabbit, slit lamp biomicroscopy and pachymetry.  Current AAALAC accreditation.  A non-portable slit lamp biomicroscope with camera attachment and equipment to measure corneal thickness. The Contractor must not have:  Received any kind of research funding on ophthalmic product development from industry 3.0 Deliverables and Milestones Deliverables Due Date Perform Study Within 2 months of contract signing Compile/summarize data and provide summary along with all raw data to FDA Within 2 weeks of study completion Criteria for Acceptance FDA will review study data to determine if the study was performed in accordance with the protocol provided to the Contractor and recommendations, if any, made by the Project Officer or a designee during the course of the study. Only the Project Officer that initiated the contract has the authority to accept or reject the deliverables. The acceptability of deliverables shall also be based on the timeliness and accuracy of the deliverables. Materials and Resources to be supplied by FDA FDA will provide samples of all six samples and the vehicle control to be evaluated in 10 ml sterile and endotoxin-free glass vials with screw caps. The identities of the samples will be masked. The samples will be sent by FDA to the Contractor via an overnight courier. The samples shall be refrigerated upon arrival at the test lab. All remaining samples are to be returned to FDA. 4.0 Period of Performance Eight weeks from award date. 5.0 Location, Work Schedule and Travel No traveling is required by the Contractor. Work schedule will be dictated by the study design as described in the protocols provided by FDA. 6.0 Security and Privacy It is not anticipated that the Contractor will be exposed to sensitive Agency information or data. Nevertheless, the Contractor shall agree that the study personnel will not divulge or release information or data developed or obtained in connection with performance of this contract, unless made public by FDA or upon written approval by the Project Officer. The data generated from these studies shall not be used in any publications by the Contractor or its study personnel. 7.0 Payment Terms Contractor will be paid 50% of the total study costs upon signing of the contract. 50% of the cost of the individual studies will be paid upon FDA acceptance of the deliverables. Request for Information (RFI) In order that the FDA may determine vendor qualifications, please submit your company's capability statement including information that addresses the following: 1. What is your company name, mailing address, e-mail address, telephone and fax number, web address (if available)? Please provide a name, e-mail address, and telephone number of a point of contact that has authority and knowledge to clarify responses with Government representatives. 2. What is your company's core business capability, experience, and/or ability with as it relates to the statement of work for this requirement. 3. What is your company's experience as it relates to NAICS codes 541690, 4. What is your company's business size for NAICS Code 541690 with each size limitation standard? 5. Is your company qualified as an 8(a) firm (must be certified by SBA), small disadvantaged business (must be certified by SBA), woman-owned business, HUBZone firm (must be certified by SBA), service-disabled veteran-owned business (must be listed in VETBiz vendor information pages)? 6.Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 7. Identification of any GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 8. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation, such as letters or certificates to indicate the firm's status. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested offerors should submit their capability statement not exceeding five (5) pages in length. Phone calls will not be accepted or returned. Interested firms or individuals may submit the requested information to: maryrose.nicol@fda.hhs.gov. US Food and Drug Administration Mary Rose A. Nicol 5630 Fishers Lane / HFA-500 OAGS/DAO Rm 2089 Rockville, MD 20857 QUESTIONS DEADLINE: All questions are to be submitted via email to maryrose.nicol@fda.hhs.gov no later than August 27, 2010 5:00 PM pm EST. QUOTATIONS DUE: All quotations are due, via email to: maryrose.nicol@fda.hhsg.gov, no later than 2:00 pm, EST on September 1, 2010. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33, FAR 52.217-9 Option to Extend the Term of the Contract. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to maryrose.nicol@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1076531/listing.html)
- Place of Performance
- Address: Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN02254708-W 20100827/100825235631-d6794328d918b6597f0f3bd24474d733 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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