Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF OCTOBER 1,1999 PSA#2445

National Institutes of Health, Division of Research Contracts, OCM/OA/OD, 6100 Executive Blvd., MSC 7540, Room 6E01, Bethesda, Maryland 20892-7540

A -- CALORIE RESTRICTED AND LONGEVITY IN RHESUS MONKEYS SOL NIH-AG-99-01 DUE 101999 POC Donna M. Spicer, Contracting Officer, phone:301-496-4487, e-mail:Spicerd@od.nih.gov E-MAIL: Donna M. Spicer, Spicerd@od.nih.gov. The National Institute on Aging, National Institutes of Health, is seeking small business sources capable of performing the requirements synopsis below. This requirement is classified under SIC Code 8731 (Commercial Physical and Biological Research). The size standard is 500 employees. The specific qualification data (including capability statements) will be analyzed by the National Institute on Aging staff in order to determine if there are qualified sources using SIC Code 8731. The Gerontology Research Center, National Institutes on Aging, NIH, is seeking qualified sources to conduct a long-term study (10 years) of the effects of calorie restricted (CR) on life span and selected biological markers related to aging in rhesus monkeys. The study will consist of approximately equal number of male(70) and female(70) control (ad libitum-fed, AL) and CR monkeys. CR will be initiated in young adult animals that have attained puberty but are not older than 8 years of age. Animals must be isolated at feedingtime to permit adequate control over food intake. At all other times monkeys will be housed in small social groups. In addition to life table analyses, other relevant data will be collected from colony animals including body weight and composition (fat, lean and bone mass), health status, reproductive cycling and fecundity. Blood samples and other biological materials including DNA, urine, and feces shall also be collected for additional studies or for banking. This study is intended to be an expansion of existing NIA-supported studies in CR in Poolesville, MD. As such, the proposed study shall be conducted at a site within one and one-half hours driving distance from Poolesville or Baltimore, Maryland. Experimental intervention will be minimized to permit accurate estimation of life span effects. The work shall be done in the following two phases: Phase I Procure 140 monkeys (70 males and 70 females) prior to initiation of CR. Duration of Phase I will not exceed three years and it is expected that all animals necessary for the study will be procured. As monkeys are procured, preparations for Phase II should begin and will include monitoring of tuberculosis and health status, formation of social groups and development of feeding and housing strategies. On reaching the required number of monkeys, no more animals will be added to the colony. Phase II Activities in Phase II are subdivided into the following sections: housing, feeding, health monitoring, data collection, database, banking of biologicals, data summary and reporting, additional studies. Phase II will be subdivided into 2 periods. Period one will involve randomization of monkeys into control and calorie restricted (CR) experimental groups. Also, during period one adjustment of intake levels for CR monkeys will be completed. Period two constitutes the long-term CR portion of the study. Housing All monkeys must be housed and all husbandry practices must follow established regulatory guidelines including NIH, USDA, and NRC published guidelines. The contractor must be AAALAC accredited and all experiments conducted under the terms of the contract. Feeding On entry into the colony and during conditioning all animal will be fed ad libitum (AL). All monkeys will receive the same diet. Monkeys will be randomly assigned to either AL or CR groups that will consist of approximately equal numbers of animals. Die formulation is to remain constant over the course of the study. Monkeys shall receive two meals per day, one in the early morning, and one in the early afternoon. For feeding, monkeys will be trained to go to their respective individual feeding stations within the group-housing area. Prior to delivery of food allotment, animal caretakers shall confirm that each animal is in its correct feeding station. Each animals morning and afternoon meal will be individually weighed each day. Monkeys shall remain in their individual feeding stations a maximum of 90 minutes after the meal is delivered. After 90 minutes, all uneaten food is removed from the feeding stations and the group-housing configuration of the room reestablished. Health Monitoring/Environmental Enrichment Details on the health-monitoring program are provided for daily, monthly, quarterly, and annual basis. The contractor will maintain a computerized animal record system. In additional to clinical/treatment notes, the animal record for each monkey will contain body weight and blood chemistry data over the course of the study. Each animal will be carefully examined visually for signs of illness and/or injury daily. Once a month the facility veterinarian shall accompany the primary technician on health check rounds. Quarterly animals will undergo tuberculosis (TB) testing, body weight, waist circumference, hip circumference, height, body temperature, and systolic and diastolic blood pressure. Every six months blood samples will be obtained and blood count chemistry analyses completed. On an annual basis each animal will receive a "hands on" examination. Exam will include general body inspection, dental exam, and radiographics of the spine. Spinal x-rays for evaluation of osteoarthritis. Monitor bone/and reproductive health as follows: Annual evaluation of body composition and bone mass will be conducted using dual energy x-ray absorptiometry (DXA). Total body scans for body composition, bone density scans of the lumbar spine, and radius. Obtain data on reproductive hormones (testosterone, estrogen, progesterone, lutenizing and follicle stimulating hormone), bone turnover (osteocalcin and collagen cross-links). The contractor will develop a regular program of environmental enrichment that is in accordance with NIH and USDA regulations. Data Collection Similar to health monitoring, data collection requirements can be broken down into convenient time intervals such as daily, quarterly, and annually. The contractor will be required to maintain both hard copy and computerized versions of all data collected. Data Storage/Retrieval The contractor shall develop a database to maintain project data. The database shall be accessible by the NIA Project Officer over the Internet. Data Summary and Reporting Monthly reports on animal health status will be provided to the NIA Project Officer and will include a summary of all animals under treatment, those being observed for possible treatment and any relevant behavioral or other observations. Quarterly reports containing similar information will also be provided and an annual report. Pathology All animals dying of natural causes or euthanized by the veterinarian should have a full pathological work up completed. Space Requirements Animal housing space shall be designed such that all applicable regulations are satisfied. Individual feeding stations must meet USDA size requirements based on animal weight. It is estimated that animal housing will require approx. 90 square feet per social group of shared space. Assuming 15 monkeys per social group, the total group housing area is expected to be between 850 and 1000 square feet with an additional 620 square feet for feeding stations. Animal housing will consist of social housing in a group area and 16 individual feeding stations connected to the social area with sliding lockable door. Top and bottom on each side. All are interconnected via lockable, sliding doors to permit individual feeding at mealtime and left open the remainder of the time (housing design is available upon request). This announcement is not a request for proposal and does not commit the National Institute on Aging to award a contract now or in the future. No Request for Proposal is available at this time. Interested parties are requested to respond to this announcement by forwarding sufficient information to demonstrate technical approach, background and experience of staff, management approach, and facilities and equipment capabilities. Requesters should limit their capability statements to 15-20 pages. Four (4) copies of this document must be submitted within 20 days of the date of publication of this announcement. Copies of the capability statements should be forwarded to Donna M. Spicer, Contracting Officer, Division of Research Contracts, Office of Contracts Management, National Institutes of Health, 6100 Executive Blvd., Room 6E01, MSC 7540, Bethesda, Maryland 20892-7540. See Note 1. Posted 09/29/99 (W-SN386342). (0272)

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