Attachment3RFPNIHOD2007039.pdf

STATEMENT OF WORK

1. Background

Basic biomedical research is supported by the NIA through several programs that require animal models of the aging process. These programs include immunology, endocrinology, pharmacology, neurobiology, muscle physiology, behavior, genetics, and nutrition. Aged non-human primates (NHP) are an important model for determining how research findings from experiments in lower organisms translate to human biology and aging. From genetic, physiological and behavioral perspectives, NHP are our closest relatives in the animal world, making them a valuable tool in biomedical research.

There are many drawbacks to using NHP in research. The availability of NHP is limited and NHP are expensive to obtain and to house. And there is strong public sentiment to reduce the number of NHP used in biomedical research. The Non-human Primate Tissue Bank allows investigators to make use of NHP biospecimens at relatively little cost, and provides a mechanism for multiple investigators to share tissue from a single animal, allowing more studies to be carried out with existing resources.

2. Objective(s)

The objective of the Aged Non-human Primate Tissue Bank is to acquire, archive and distribute excess tissue from NHP that are being euthanized for research purposes at institutions around the country. Tissue will be both flash-frozen without fixation or fixed and embedded, to fit the needs of a wide-range of molecular and histochemical techniques.

3. Work to be performed

Independently, and not as an agent of the Government, the Contractor shall provide all the necessary services, qualified personnel, material, equipment, and services (except for those to be furnished by the government as specified elsewhere in this contract) to perform the work required by this contract as set forth below.

The Contractor shall receive NHP tissue from a variety of institutions around the country, solicit tissue from sources identified by the Project Officer, solicit tissue from sources identified by their own interactions with the research community upon approval of the source by the Project Officer, coordinate the transfer of the tissue to the Contractor’s facility, process and aliquot the tissue for preservation as needed, preserve the tissue and embed as needed, package, label and store the tissue, prepare a detailed inventory of the tissue, and ship tissue to investigators at the direction of the Project Officer.

Attachment 3

• Note: it is anticipated that the total number of boxes shipped, including receipt of tissue and distribution of tissue, will be approximately 50 per year.

Specifically, the Contractor shall:

A. Transfer the existing tissue bank holdings from the current contractor’s facility to the new contract facility in a safe and secure manner that prevents thawing of any frozen samples and maintains integrity and organization of all samples.

B. Interface with the Regional Primate Research Centers and investigators in the research community, as identified by the Project Officer and by the Contractor’s own involvement with the research community, to coordinate collection and transfer of excess tissue from scheduled necropsies to the Contractor. Institutional sources of tissue and the species and ages to be collected shall be approved by the Project Officer prior to receipt of the first shipment of tissue, to ensure that the tissue collected directly addresses the needs of NIA grantees. Once the source, species and age ranges have been approved, approval is not needed for individual shipments.

• Note: target tissues are brain, liver, heart, white adipose tissue (intra-abdominal), white adipose tissue (subcutaneous), muscle, serum, kidney, mammary tissue, prostate, ovaries or testes, arteries, pancreas, mammary tissue, thymus, and spleen.

It is understood that individual providers may not be able to provide all tissues for every animal. Additional tissues may be requested by the Project Officer to meet the needs of NIA grantees.

• Note: target species are primarily rhesus macaques, cynomologous macaques and the great apes, but other species such as pig-tailed macaques and lemurs may also be of interest to the NIA.

C. Provide all necessary containers, labels, fixative or medium, shipping boxes and pre-paid shipping labels for overnight shipment of the tissue to the Contractor. The contractor shall provide instructions to the tissue provider on desired sizes of tissue pieces and orientation of tissue pieces for each preservation protocol and the information desired for each animal from which tissue acquired. All costs of collecting and shipping the tissue shall be borne by this contract, including reimbursement of provider for staff time involved in collection and shipping when necessary.

D. Assign each animal from which tissue is received a unique identification number based on the provider’s institution and the institutions animal identification number.

E. Process, aliquot, and store the tissue according to the preservation protocol. For each tissue acquired, both flash-frozen and fixed aliquots shall be stored if possible. Exceptions include adipose tissue (frozen only) and serum (frozen only). In the event that only one piece of a tissue is available, the flash-freeze protocol takes priority.

1) For flash-frozen tissue, the Contractor shall request that the provider of the tissue document the location of the tissue piece within the organ should be noted, divide the tissue into pieces of approximately 1 gram (~1 cm3), and flash-freeze the tissue in liquid nitrogen or dry ice-cooled isopentate. The Contractor shall provide freezing vessels and pre-labeled storage containers so that the tissue does not have to be re-packaged when received by the contractor. Frozen tissue shall be stored at –80o.

• Note: it is unlikely that the NIA Non-human Primate Tissue Bank will be the recipient of an entire brain, but if such an opportunity presents itself, a protocol shall be provided by the Project Officer for dividing the brain into hemispheres and cutting each hemisphere into slabs in the coronal plane before freezing and fixing.

2) For fixed tissue, the Contractor shall request that the provider of the tissue document the location of the tissue piece within the organ should be noted, divide the tissue into pieces of approximately 1 gram (~1 cm3), and placed in 10% neutral buffered formalin. The Contractor shall provide pre-labeled containers containing the fixative solution. Upon receipt of the fixed tissue and after it has been fixed for a minimum of 48 hours, the Contractor shall trim the tissue and embed it in blocks of paraffin. If multiple pieces of the same tissue were received, at least one piece shall remain stored in fixative without embedding.

• Note: the size of the tissue will vary depending on the organ.

F. Request the following information for each animal from the provider of the tissue: species, gender, age, animal identification number, gross necropsy results, a synopsis of previous research use and significant health problems, and form of housing. The Contractor shall enter this data into the NIA NHP Tissue Bank Database (provided by the NIA).

G. Maintain an inventory of tissue received, organized by species, gender and age, that includes information on the number of each tissue received under each preservation protocol, the number shipped to investigators, the number on inventory, and the location.

The inventory format shall be the NIA NHP tissue Bank Database, developed in Microsoft Access, which shall be provided by the government. The NIA NHP Tissue Bank Database inventory shall be up-dated whenever tissue is shipped or added.

H. Maintain frozen tissues in two freezers, each of which is equipped with an independent alarm system and back-up generator. Approximately half of each sample cohort of tissue (same species, age, gender) shall be maintained in each freezer.

I. Use packaging materials and labels for the tissue that are able to withstand storage at

–80oC and shipping on dry ice without loss of integrity or labels. Packaging and labeling materials shall be approved by the Project Officer prior to use.

J. Ship tissues to investigators at the direction of the Project Officer. All frozen tissue shall be shipped on dry ice by overnight mail unless otherwise specified, and fixed tissue and tissue blocks shall be shipped at room temperature by overnight mail unless otherwise specified. The Contractor shall invoice the investigator for the cost of shipping the tissue and a nominal fee, currently $10.00 per individual tissue. All proceeds from the sale of tissues shall be applied to the cost of the contract. Proceeds from the sales of tissues shall be shown on a separate line on the monthly invoices.

K. Upon direction of the Project Officer, section fixed, embedded tissue and ship slides to investigators to fill special requests.

L. Dispose of unsold tissue only with the consent of the Project Officer.

4. Required Reports/Deliverables

A. An inventory up-date shall be provided to the NIA after each shipment or addition of tissues, or weekly at most.

B. Semi-annual progress reports shall be delivered to the Project Officer (1 copy) and the

Contracting Officer (1 copy) within thirty (30) calendar days of the end of the period covered by the report. The initial report shall be submitted for the first full six months of the contract performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of six full calendar months. A semi-annual report will not be required for the period when the final report is due. Progress reports shall detail the species, gender, and ages of animals from which tissue was received for banking, the number of samples of each tissue type received from each animal, the number of orders filled listed by institution, and the number of each tissue type delivered.

C. A final report shall be submitted to the Project Officer (1 copy) and the Contracting Officer

(1 copy) on or before the expiration date of this contract. The final report shall include a summation of the work performed under the entire contract period of performance, including number of tissue collected and number of tissues shipped to investigators.