SOLICITATION NOTICE
A -- Rabbit Studies in support of TASS Investigation
- Notice Date
- 8/10/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- 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
- 1059497
- Archive Date
- 9/4/2009
- Point of Contact
- Jaclyn Stielper, , Doreen Williams , Phone: 301-827-3366
- E-Mail Address
-
jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov
(jaclyn.stielper@fda.hhs.gov, doreen.williams@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 05-33. This announcement constitutes the only full and open competition solicitation and a written solicitation will not be issued. This synopsis, NAICS code 325412, is to notify contractors that the government intends to issue a Firm Fixed Price Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. 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. Award will be made to the party whose quote offers the best value to the Government, technical, price, and past performance considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability, 2) Past Performance and 3) Price. Technical Capability and Past Performance, when combined, are significantly more important than price. This solicitation is issued as a Request for Quote (RFQ). The Food and Drug Administration (FDA) intends to award a purchase order for rabbit studies in support of TASS investigation. General Duties/Description of Work - 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 bacterial endotoxin contamination of the intraocular lens and/or surgical adjuncts such as ophthalmic viscosurgical devices (materials with viscous and/or viscoelastic properties that are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery in the anterior segment of the eye) and balanced salt solutions as well as surgical instruments used in surgery. Existing endotoxin limits for intraocular devices are not based on scientific studies on endotoxin-induced ocular inflammation. Instead, they are primarily based on experience with pharmaceutical products and devices that are intended for use in parts of the body other than the eye. Reports in the literature have shown that the eye is exceptionally sensitive to endotoxins relative to other organs. It is, therefore, necessary to develop endotoxin limits for ophthalmic devices based on the results of appropriate scientific studies to assure product biocompatibility. In 2007, FDA completed a study on the ocular reactivity of bacterial endotoxins contained in water. The results of this study have not been published. The results show that intracameral injection of water containing very low levels of endotoxins elicited transient inflammation in the rabbit eye. The results were presented at an ISO (International Standards Organization) meeting on ophthalmic implants in April of 2008. Industry representatives at the meeting questioned the applicability of this data to the presence of the same amounts of endotoxins in ophthalmic viscosurgical device (OVDs) because the physical characteristics of OVDs may limit the availability of the endotoxins to the eye. It is therefore necessary to evaluate the ocular reactivity to endotoxins contained in OVDs of various rheological properties that are currently on the market. In addition, it is necessary to examine the two different test methods currently used by industry to evaluate the inflammatory potential of OVDs. These methods are: 1) intravitreal and 2) intracameral injections in the rabbit. The intracameral injection method in the rabbit was found to be highly sensitive in detecting endotoxins in the FDA study and a similar study conducted by Japanese investigators. A manuscript on the results of the Japanese study has been submitted to the Japanese Journal of Ophthalmology. The intravitreal injection method used by some OVD manufacturers has not been adequately validated. A side-by-side comparison of the two methods would help identify the more sensitive/reproducible method of testing, which would enable FDA to establish appropriate guidance for industry in preclinical testing of OVDs. The data generated from the two studies will ultimately support U.S. and international endotoxin limit development for OVDs and other non-solid intraocular devices such as endotamponades. The two studies are being contracted out to an outside laboratory because of space limitation at the Office of Science and Engineering Laboratories (OSEL). 2.0 Description of Work The Contractor (Test Lab) shall conduct the two studies in the rabbit as follows: Study 1- Inflammation Potential of Ophthalmic Viscosurgical Devices (OVDs) The objective of this study is to evaluate the inflammatory potential of six (6) commercial OVDs, some of them are believed to contain sufficient amounts of endotoxins to elicit ocular inflammation. A total of thirty (30) New Zealand White rabbits (male or female) weighing approximately 3 Kg each will be used in the study. Five (5) rabbits will be randomly placed into each of the 6 treatment (commercial OVD) groups. Ten (10) eyes of five (5) rabbits with normal eyes, as confirmed by slit lamp biomicroscopy, will be intracamerally injected (directly into the anterior chamber of the eye) with each of the six (6) OVDs. The treated eyes will be examined for signs of inflammation by slit lamp biomicroscopy at 3, 6, 9, 24, 48 and 72 hours after injection. 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 (McDonald TO and JA Shadduck. Eye irritation. Dermatotoxicity and Pharmacology. Eds. FN Marzuli and HI Maibach. 1977;4:162-166). 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. All the raw data collected will be compiled in tables and provided to FDA as hard copies and electronically on CDs. The data sent to FDA will be sent using a trackable carrier service with a signature required upon delivery. Study 2- Comparison of Intracameral and Intravitreal Injection for the Testing of Inflammatory Potential of Ophthalmic Viscosurgical Devices (OVDs) The objective of this study is to compare two different intraocular test methods, intracameral and intravitreal injection in the rabbit, for testing of the inflammatory potential of OVDs. A total of thirty (30) New Zealand White rabbits (male or female) weighing approximately 3 Kg each will be used in the study. Five (5) rabbits will be randomly placed into each of the 6 treatment (commercial OVD) groups. Ten (10) eyes of five (5) rabbits with normal eyes, as confirmed by slit lamp biomicroscopy, will be intracamerally injected (directly into the anterior chamber of the eye) with each of three OVDs of known endotoxin concentrations. Ten (10) eyes of five (5) rabbits with normal eyes, as confirmed by slit lamp biomicroscopy, will be intravitreally injected (directly into the vitreous of the eye) with each of the same three OVDs. The treated eyes will be examined for signs of inflammation using slit lamp biomicroscopy at 3, 6, 9, 24, 48 and 72 hours after injection. The grading of the slit lamp observations will be the same as what is described for Study 1. The rabbits will be released from the study at the end of the 72-hour examination. All the raw data collected will be compiled in tables and provided to FDA as hard copies and electronically on CDs. The data sent to FDA will be sent using a trackable carrier service with a signature required upon delivery. The Contractor (Test Lab) shall: 1.Provide the necessary number of rabbits for use in the two studies. Each study requires that 30 New Zealand White rabbits weighing approximately 3 Kg be successfully injected with the test materials (with no surgical trauma that could confound the study findings) and monitored for the duration of the study. Purchase an additional six (6) animals to hold on reserve in the event that any of the study animals expire unexpectedly during the term of the study. 2.House the animals in the facility at least 1 week prior to the procedures and during the entire term of the study. 3.Prepare an animal care and use protocol for conducting the studies listed above and obtain approval to conduct the studies. 4.Adhere to the laboratory’s internal procedures regarding animal welfare and care. 5.Perform the injection and the pre- and post-injection evaluation at 3, 6, 9, 24, 48 and 72-hours in accordance with the technical protocol provided by FDA using a board-certified ophthalmologist or veterinary ophthalmologist who is experienced with intracameral and intravitreal injection of OVDs in the rabbit. 6.Provide adequately trained personnel for animal husbandry, food and water and daily care of the rabbits during their assignment to the study protocol and to assist with all stages of the surgery and pre- and post-treatment evaluation. 7.Provide all housing and husbandry needs, including food and water and health care needs for the animals during the acclimation and study period. 8.Provide all medications needed for the studies including anesthetics (ketamine/xylazine, proparacaine HCl) and medication (0.3% gentamicin drops) as needed after injection and all other surgical supplies, such as injection syringes and needles as needed. 9.Humanely dispose of the study animals at the end of the two studies either by re-assigning them to other studies with approved protocols or have the rabbits humanely euthanized in accordance with the current guidelines for euthanasia of rabbits. See guidelines provided in: AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) June 2007 (http://www.avma.org/resources/euthanasia.pdf). 10.Compile the data and provide FDA with all the raw data (including animal records, lab notebooks, and animal room environmental data) and summary data upon completion of each study. 11.Allow FDA technical staff to observe treatment and post-treatment examination of the study rabbits and make study modifications as deemed necessary. FDA requires a minimum of five (5) rabbits per group per study as described above. The total number of rabbits to be successfully treated and the number of slit lamp examinations specified in the contract will remain unchanged. The Contractor must have: 1. Prior experience with humane care and use of New Zealand White rabbits 2.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. 3.Access to a board-certified ophthalmologist or veterinary ophthalmologist with prior experience in intracameral and intravitreal injection of OVDs in the rabbit and slit lamp evaluation. 4.Current AAALAC accreditation. 5.A non-portable slit lamp biomicroscope with camera attachment 6.An operating microscope, which is needed for intracameral and intravitreal injection The Contractor must not have: 7.Received any kind of research funding on ophthalmic product development from industry 3.0 Deliverables and Milestones Deliverables Due Date Prepare animal care and use protocol for Study 1 and 2 in accordance with study procedures provided by FDA Within 1 month of contract signing Provide plan for providing raw data and summary tables of the data for the study Within 1 month of contract signing Perform Study 1 Within 2 months of contract signing Compile/summarize data from Study 1 and provide summary along with all raw data to FDA Within 2 weeks of study completion Perform Study 2 Within 3 months of contract signing Compile/summarize data from Study 2 and provide summary along with all raw data to FDAWithin 2 weeks of study completion Criteria for Acceptance FDA will review the animal care and use protocol prior to starting the study. FDA will review the plan for the submission of the raw data and summary compilation prior to starting the study. FDA will also review the 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 who 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 Contractor with a copy of the protocol for each of the two studies. FDA will provide samples of all nine OVDs (six for the first study and three for the second study) for each of the rabbits in each treatment group. The OVDs to be evaluated will be provided in sterile syringes. The identities of the samples will be masked. The OVD samples will be sent by FDA to the Contractor via an overnight courier. A direct signature will be required for the package. The samples shall be refrigerated upon arrival at the test lab. Specific handling, documentation and tracking instructions will be provided in the FDA protocol. All remaining samples are to be returned to FDA in a pre-determined manner described in the FDA protocol. 4.0Period of Performance September 1, 2009 to January 31, 2010 5.0Location, 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. 6.0Security and Privacy Included with the quote must be the Contractor’s NIH Full Domestic Assurance Number. 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. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Jaclyn.Stielper@fda.hhs.gov no later than August 17, 2009 at 4:30 PM EST. QUOTATIONS DUE: All quotations are due, via email to: Jaclyn.Stielper@fda.hhs.gov, no later than 4:30 PM EST on August 20, 2009. 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 52.217-9, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to Jaclyn.Stielper@fda.hhs.gov. Telephone calls will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1059497/listing.html)
- Place of Performance
- Address: Contractor's Facility, United States
- Record
- SN01906326-W 20090812/090811002506-ff4d2f85ed0efdb82600deb9c9333e4a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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