Attachment 3 - Statement of Work (March 2023).pdf

STATEMENT OF WORK ATTACHMENT 3

75N95023R00017 March 2023

STATEMENT OF WORK

“Development and Maintenance of a Non-Human Primate Tissue Bank”

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, total body and organ/tissue-specific physiology, behavior, genetics, and nutrition.

Aged non-human primate (NHP) animals are an important model for determining how research findings from experiments in lower organisms may translate to human biology and aging. From genetic, physiological and behavioral perspectives, NHPs are human’s closest relatives in the animal world, making them a valuable tool in biomedical research.

There are many obstacles to using NHPs in research. They are expensive to obtain and house and their availability is limited. Furthermore, there is understandably strong public sentiment to reduce the number of NHPs used in biomedical research. The Non-Human Primate Tissue Bank (NHP

TB) allows investigators to make use of already available NHP biospecimens and provides a mechanism for multiple investigators to share tissue from a single animal, allowing more studies to be carried out with existing resources. This requirement is a follow-on to contract

HHSN271201800022C.

2. OBJECTIVE

The objective of the NHP TB is to acquire, archive, and distribute excess tissue and to collect clinical information from NHPs that are euthanized for research purposes or humane reasons at institutions around the country. Tissues will be flash-frozen, embedded and frozen in optimal cutting temperature (OCT) medium without fixation, or fixed and embedded in paraffin, to meet the requirements of the wide-range of molecular and histochemical techniques that will be applied to study them. Clinical information about the NHPs from which samples are collected will be shared with the NIH Primate Aging Database (PAD).

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, and equipment (except for those to be furnished by the government as specified elsewhere in this contract) to perform the work necessary to meet this requirement as set forth below.

The Contractor shall receive NHP tissues from different institutions around the country, solicit tissue from sources identified by the Contracting Officer’s Representative (COR) or from sources identified through interactions with the research community and approved by the COR, coordinate the transfer of the tissue to the Contractor’s facility, process and aliquot, embed, section the tissue

75N95023R00017 Page 2 of 5 for preservation as needed, package, label and store the tissue, request from the source or perform blood and urine analysis, prepare a detailed inventory of the stored tissues, prepare a database of tissues and clinical information on the NHPs from which tissues were obtained, provide relevant clinical information and links to the source animal’s samples to the NIA Primate Aging Database

(PAD), and ship tissue to investigators who request it at the direction of the COR.

• NOTE TO OFFERORS: For cost budgeting only, it is anticipated that the total number of boxes shipped, including receipt of tissue and distribution of tissue, will be up to 30 boxes per year.

Specifically, the Contractor shall:

A. If necessary, transfer the existing tissue biorepository 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 the integrity and organization of all samples. Time has been allotted for the transition period between the exiting contract and the follow on.

• NOTE TO OFFERORS: Offerors shall provide details about the transfer of the biorepository and database, and how the transition period will be structured.

B. Interface with the National Primate Research Centers and investigators at other NHP institutions housing NHPs, as identified by the COR and by the Contractor, 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 COR prior to receipt of the first shipment of tissue, to ensure that the collected tissue directly addresses the needs of NIA grantees. Once the source, species and age ranges have been approved, approval is not needed for individual shipments.

NOTES:

• Target tissues include, but are not limited to, brain, liver, heart, white adipose tissue

(intra-abdominal and subcutaneous), muscle, serum, kidney, mammary tissue, prostate, ovaries or testes, arteries, pancreas, mammary tissue, thymus, spleen and lymph nodes. It is understood that individual providers may not be able to provide all tissues for every animal. Additional tissues may be requested by the COR to meet the needs of the research community.

• The NIA is interested in collecting tissue primarily from rhesus macaques, cynomologous macaques, marmosets and the great apes. However, species such as pig-tailed macaques and lemurs are also of high interest to the NIA. Inclusion of tissue from additional species will be considered if valuable in meeting the needs of the research community.

• Target ages are primarily geriatric age groups; however, younger ages are also of high interest to the NIA as controls and to build cross-sectional cohorts that represent longitudinal sampling.

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• The contractor shall list prospective donor NHPs in an electronic registry containing, if available, the animals’ place of origin, a synopsis of previous research use, housing history and clinical information.

C. Provide all necessary containers, labels, medium, shipping boxes and pre-paid shipping labels for overnight shipment of tissues 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 clinical information desired for each animal from which tissue was acquired. All costs of collecting and shipping the tissue shall be borne by this contract, including reimbursement of tissue provider for staff time involved in collection and shipping, when necessary.

D. Assign each animal from which tissue is received a unique identification number (ID). The unique ID will be linked to the provider’s institution and the institution’s animal ID. For legacy samples, if available, a link shall be maintained between the unique ID assigned by the Contractor and the ID from the facility of origin, including the institution’s information.

The code key linking the unique ID assigned by the Contractor and the institution of origin of the source animals will be stored in confidential records maintained by the Contractor.

E. Process, aliquot, and store the tissue per the preservation protocol. For each tissue acquired, both frozen and fixed aliquots shall be stored if possible, with the exception of serum for which only frozen aliquots shall be stored. If only one piece of a tissue is available, the flash-freeze protocol takes priority.

1) For frozen tissue (flash-frozen or embedded and frozen in optimal cutting temperature

(OCT) medium without fixation) the Contractor shall request that the provider of the tissue divide the tissue into pieces of approximately 1 gram (~1 cm3), and flash-freeze the tissue under appropriate conditions (e.g., in liquid nitrogen or on dry ice). 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 transported on dry ice and shall be stored at –80oC

• NOTE: A protocol shall be provided by the COR for dividing the brain into hemispheres and cutting each hemisphere into slabs in the coronal plane before freezing and fixing. If the entire brain cannot be provided, donations of clearly identified brain regions can be accepted.

2) For fixed tissue, the Contractor shall request that the provider of the tissue divide the tissue into pieces of approximately 1 gram (~1 cm3) and place them in 10% neutral buffered formalin. The Contractor shall provide pre-labeled containers. 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. All tissues shall be embedded in paraffin blocks. No tissue will be stored long term in fixative.

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

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F. Request the following information for each animal from the provider of the tissue: species, gender, age, animal ID, gross necropsy results, a synopsis of previous research use and significant health problems, and form of housing. If available, the Contractor shall request information on blood and urine analyses and as much clinical history as possible.

G. Establish and maintain a database for entering animal ID, health data, tissue and other related information. On a regular basis and not less than every three months, relevant clinical information from the database maintained by the Contractor shall be transmitted to the NIA

Primate Aging Database (PAD, primatedatabase.org). A code key linking the animal ID, tissue sample IDs, and clinical information shall be maintained by the Contractor.

H. Maintain a backup of the database and code key to protect against accidental loss.

I. 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 a database which shall be provided by the Contractor. The NIA NHP TB electronic inventory shall be updated whenever tissue is shipped or new tissue is added. The electronic file of the inventory or a summary thereof will be transmitted to and/or shared with the NIA COR and CO using secure protocols (e.g., Box folders, secure storage supported by the Contractor’s Institution and approved by the NIH).

J. Package and label tissues with materials that can withstand storage at –80oC and shipping on dry ice without loss of integrity or labels. Packaging and labeling materials shall be approved by the COR at the beginning of the contract and whenever changes are implemented.

K. Maintain frozen tissues in a minimum of four (4) NIH-provided freezers, each of which shall be 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 pair of NIA-provided freezers.

L. Ship tissues to investigators at the direction of the COR. All frozen tissue shall be shipped on dry ice by overnight mail unless otherwise specified. Slides with fixed sections shall be shipped at room temperature by overnight mail unless otherwise specified. Occasionally, tissue blocks might be shipped at the request/with the consent of the COR.

M. Upon direction of the COR, section fixed, embedded tissue and ship slides to investigators to fill special requests.

N. Dispose of undistributed tissue only with the consent of the COR.

O. Perform blood and urine analysis in association with collected kits. Blood analysis includes

(but it is not limited to) cell blood count (CBC) and biochemistry panel (Chem). Urinalysis includes (but it is not limited to) appearance, concentration, and content of urine.

https://primatedatabase.org/

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P. Provide to the investigator donating the animal tissues with all necessary containers/tubes, labels, shipping boxes, ice packs and pre-paid shipping labels for overnight shipment of the blood and urine.

Q. Maintain all paper (when available) and electronic records in the Contractor’s database, including data from blood and urine analyses that will be linked to the source animal ID and to vitals and health records of the animal associated with tissues collected from the same.

R. Submit blood and urine analysis data and links to the ID of the source animal to the System

Administrator of the NIA Primate Aging Database (PAD, primatedatabase.org).

S. Inform investigators of the publication policy as provided by the COR and maintain a list of all peer-reviewed manuscripts, pre-publications (e.g., BioRxiv), conference abstracts, conference posters, and conference presentations resulting from the use of tissues provided by the NHP TB. This information shall include what is reported to the Contractor by the

NHP TB users and/or what the Contractor finds through searches of PubMed and other publication databases.

T. Inform recipients of NHP TB samples about the NIA Primate Aging Database (PAD, primatedatabase.org) and how they can access through the PAD clinical and biological data collected from donor animals.

• NOTE TO OFFERORS: The PAD is currently maintained under a contract with

CleMetric, at the University of Wisconsin, Madison.

U. Advertise the NHP TB by giving virtual or in-person demonstrations at two scientific meetings per year.

• NOTE TO OFFERORS: Offerors may budget up to 2 contract personnel to travel to and attend each meeting (see Business Proposal Instructions). The Contractor shall sponsor a booth or give a platform presentation at one of the scientific sessions.

The meetings must be approved in advance by the COR and shall include, but are not limited to, the American Aging Association (AGE) Annual Meeting, the

American Society of Primatologists Annual Meeting, the Gerontological Society of

America Annual Meeting, and the Society for Neuroscience Annual Meeting. These meetings shall be attended on a rotating basis, so that the Contractor is not attending the same meetings every year.

V. Transfer the NHP TB biorepository and data and the NHP registry database to a new

Contractor at the end of the contract period of performance (if necessary).