United States - Irradiated Rodent Diet Feed

Description

Added: Oct 31, 2019 3:53 pm

MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR), in acquiring certified and irradiated rodent diet feed NIH 07 and NTP 2000 in meal, pellet or wafer form.
The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) located at Jefferson, Arkansas is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.
The associated North American Industry Classification System (NAICS) Code is 311119- Other Animal Food Manufacturing; Small Business Size standards - 500 employees Small Business Size standard.
The FDA/NCTR requires certified and irradiated rodent diet feed NIH 07 and NTP 2000 in meal, pellet or wafer form. The purpose for an Irradiated, certified NIH-07 or NTP-2000 open formula diet to meet the nutritional dietary needs. NIH-07 is used during periods of pre-mating, mating, pregnancy and lactation. NTP-2000 is used during study cohorts/phases that do not include mating, pregnancy or lactation. The diets must be irradiated, and each batch of diet used shall be analyzed for contaminants, protein, fat, fiber, ash, moisture and heat-labile nutrients such as Vitamin A and thiamine. A copy of the analysis records is required with each lot of feed. It is the responsibility of the feed vendor to verify that the diet meets the enclosed standards prior to shipping.

Specifications: The rodent diet feed NIH 07 and NTP 2000 shall include the following:
• All feed shall include a copy of analysis records for each lot of feed.
• All feed shall include verification that all feed meets enclosed standards prior to shipping.
• All feed shall be manufactured in a controlled environment with quality control assessments present at multiple steps in the process.
• All feed premises shall be clean and free of dirt, trash, and other foreign material that could contaminate feed being processed or stored.
• All feed premises shall not have any domestic animal or bird that shall be confined in or have entry into the confines of the buildings housing the milling equipment, providing storage for feed ingredients, or storage for the finished food products.
• All Bagged feed ingredients and finished products shall be stored to permit inspection of the floor-wall junctures in all storage areas. There shall be no evidence of rodent-damaged bags containing feed ingredients or finished product.
• All feed premises for feed production and storage shall be effectively rodent and bird proof, with an insect control program in place.
 
• Shall include Plant sanitation methods as follows:
 Routine daily cleaning and removal of all loose feed materials lodged on the floors, walls, and ceilings.
 Removal of all insect-infected feed or raw materials as soon as detected.
 Floors, walls, ceilings, overhead and piping shall be reasonably free of all contaminating material such as rodent or bird droppings.
 All feed or raw materials shall be stored in containers or other storage facilities which prevents entry and contamination by rodents and birds.
 Milling machines used for preparation of animal feed shall not be used for any other feed product to which rodenticide, insecticide, hormones, antibiotics, or fumigants have been added.
• NTP 2000 and NIH07 shall meet the published ingredients (Table 1) and nutritional (Table 2) components see attachments.
• All diets shall meet the NTP diet limits of contamination levels as specified in (Table 3) and acceptance criteria are listed for the contamination levels (Table 4), see attachments.
• All premises before and during the effective period of the contract, shall be the subject to inspection by the COR, Quality Assurance Specialists, or other duly authorized personnel of contractor's plant, plant facilities, and milling operations. Upon request, the contractor shall inform the NCTR of the date on which the next shipment lot of feed shall be formulated.
• Shall be exact quantity of each diet per order and number of orders per performance period.
• All order(s) of feed shall be accurate and precise. The Government shall not accept more feed than ordered and the amount of each diet and feed form (meal, pellet, wafer) shipped to meet the order shall not be less than the order by more than 50 lbs. (22.7 kg).
• All orders containing NTP 2000 shall occur in meal and pellet (or wafer).
• All orders containing NIH-07 shall occur in meal and pellet (or wafer).
• All shipping lead time between order and receipt of feed shall not exceed 8 weeks.
• All feed shall NOT have a less than one-year shelf life. (A 2-year shelf life is preferred.)
• Shall keep records of each feed mixing operation including, but not limited to, ingredient quantities, raw materials lot numbers, mixing time, and calibration of scales and balances. This information shall be available to the Government upon request.
• All feed product shall be packaged to assure it arrives at the NCTR in the bacteria-free condition.
Period of Performance: Base + 4 (1 Year) Option Periods
Base Period:      07/09/2020 to 07/08/2021
Option Period 1: 07/09/2021 to 07/08/2022
Option Period 2: 07/09/2022 to 07/08/2023
Option Period 3: 07/09/2023 to 07/08/2024
Option Period 4: 07/09/2024 to 07/08/2025
FOB Point Destination. All items shall include shipping, handling and inside delivery to the destination identified herein. FOB Point of Delivery for Services and Supplies will be the FDA NCTR facility located at 3900 NCTR Road, Jefferson, Arkansas 72079.
Responses to this source sought shall unequivocally demonstrate the respondent regularly provides certified and irradiated rodent diet feed NIH 07 and NTP 2000 in meal, pellet or wafer form. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:
• Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);
• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.
• Three (3) years of past performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent.
• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.
• If a large business, identify the subcontracting opportunities that would exist for small business concerns;
• Standard commercial warranty and payment terms.
The government is not responsible for locating or securing any information, not identified in the response.
The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.
Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Additional Notes
If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the supply item would be helpful. Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before November 11, 2019 by 1:00 pm (Central Time in Jefferson, AR) at the Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, ATTN: Roosevelt Walker, 3900 NCTR Rd., HFT-320, Bldg. 50, Room 432, Jefferson, AR 72079. Reference FDA_SSN_1219270.
For information regarding this market survey, please contact Roosevelt Walker email: roosevelt.walker@fda.hhs.gov.
 
 
 
 
 
 
 
 

(Attachments)

Table 1.
Ingredients and composition of NTP-2000 and NIH-07 open formula non-purified diets1
Ingredient NTP-2000 NIH-07
g/100 g diet
Ground corn 22.18 24.5
Ground wheat 22.26 23.0
Wheat middlings 15.0 10.0
Soybean meal (49% protein) 5.0 12.0
Fish meal (60% protein) 4.0 10.0
Dried skim milk 0.0 5.0
Corn gluten meal (60% protein) 0.0 3.0
Alfalfa meal (17% protein) 7.5 4.0
Oat hulls 8.5 0.0
Purified cellulose 5.5 0.0
Corn oil (without preservatives) 3.0 0.0
Soy oil (without preservatives) 3.0 2.5
Dried brewer's yeast 1.0 2.0
Dry molasses 0.0 1.5
Sodium chloride 0.3 0.5
Calcium phosphate dibasic (USP) 0.4 1.25
Calcium carbonate (USP) 0.9 0.5
Choline chloride (70% choline) 0.26 0.092
Methionine 0.2 0.0
Vitamin premix 0.53 -4
Mineral premix 0.55 0.256

1 Adapted from Rao (1994 and 1996).
2 Included in the vitamin and mineral premix.
3 Vitamin premix of the NTP-2000 diet contained the following (per kg): vitamin A (stabilized palmitate or acetate) 4000 IU; vitamin D (activated animal sterol) 1000 IU; vitamin K (menadione sodium bisulfite complex), 1 mg; all-rac-α-tocopheryl acetate (vitamin E), 100 mg; folic acid, 1.1 mg; niacin 23 mg; d-pantothenic acid (d-calcium pantothenate), 10 mg; riboflavin, 3.3 mg; thiamin (thiamin mononitrate), 4 mg; vitamin B-12, 52 μg; pyridoxine (pyridoxine hydrochloride), 6.3 mg; d-biotin, 0.2; with wheat middlings as carrier.
4 Included with the mineral premix.
5 Mineral premix of the NTP-2000 diet contained the following (per kg): magnesium (oxide), 514 mg; iron (sulfate), 35 mg; zinc (oxide), 12 mg; manganese (oxide), 10 mg; copper (sulfate), 2 mg; iodine (calcium iodate), 0.2 mg; chromium (acetate), 0.2 mg; with calcium carbonate as carrier.
6 Vitamin and mineral premix composition of the NIH-07 diet was given by AIN (1977).

Table 2.
Nutrient concentrations of NIH-07 and NTP-2000 nonpurified diets1
Nutrient NIH-07 NTP-2000
Protein,2% 22.92 ± 0.44 14.56 ± 0.91
Fat,2% 5.42 ± 0.26 8.24 ± 0.50
Fiber,2% 3.43 ± 0.39 9.31 ± 0.81
Carbohydrates,3% 51 52
Energy,4kcal/g 3.44 3.40
Vitamins5
A,2IU/kg 6263 ± 581 6823 ± 1524
D IU/kg 4450 ± 13826 10007
E 35.2 ± 8.58 83.8
K7 3.0 1.0
Thiamin2 18.1 ± 3.27 11.1
Riboflavin 7.8 ± 0.92 6.9
Niacin 98.7 ± 23.2 75.8
Pantothenic acid 32.9 ± 8.92 27.7
Pyridoxine 9.3 ± 2.49 12.1
Folic acid 2.6 ± 0.7 1.9
Biotin 0.27 ± 0.046 0.28
B-12 (ppb) 41.6 ± 18.0 48
Choline 2955 ± 382 2950
Minerals5
Sodium 3160 ± 310 1820
Potassium 8860 ± 590 6820
Calcium2 11,800 ± 700 9400 ± 600
Phosphorus2 9400 ± 400 5800 ± 400
Magnesium 1650 ± 100 1880
Iron 348 ± 84 163
Manganese 93.3 ± 5.6 53
Copper 11.6 ± 2.46 5.8
Zinc 59.4 ± 9.7 48.7
Iodine 3.5 ± 1.14 0.6
Selenium 0.34 ± 0.11 0.23 ± 0.13
Chromium 1.57 ± 0.53 1.2
1 From the National Toxicology Program data base.
2 Mean ± SD of 15 contemporary lots.
3 Other than crude fiber, average value calculated by difference including the correction for moisture and ash.
4 Average physiological fuel value, with no energy value for fiber.
5 As ppm, means ± SD for 12 lots of NIH-07 diet analyzed during 1985-1996, and average for two lots of NTP-2000 diet analyzed in 1995 and 1996, unless stated otherwise.
6 Mean ± SD of four lots.
7 Added concentration, not analyzed.

Table 3.
NIH-07 or NTP-2000 DIET - LIMITS OF CONTAMINANT LEVELS
 
 
AFLATOXINS
(Maximum PPB) Total 5
B1 2
NITROSAMINES
(Maximum PPB) Total 15
(Volatile)
N-nitroso Dimethylamine 10
HEAVY METALS
(Maximum PPM) Lead 1.00
Cadmium 0.15
Mercury 0.05
Arsenic 0.50
Selenium 0.50
CHLORINATED HYDROCARBONS
(Maximum PPM) BHC
Alpha 0.02
Beta 0.02
Delta 0.02
Lindane 0.02
Heptachlor 0.02
DDE 0.02
DDD 0.02
DDT 0.03
HCB 0.08
Mirex 0.02
Methoxychlor 0.05
Dieldrin 0.02
Endrin 0.02
Telodrin 0.02
Chlordane 0.05
Toxaphene 0.10

ORGANOPHOSPHATES
(Maximum PPM)
Chloropyrifos-methyl 0.10
Ronnel 0.03
Ethion 0.02
Trithion 0.05
Diazinon 0.20
Methylparathion 0.03
Ethylparathion 0.03
Malathion 0.50
Endosulfan I 0.02
Endosulfan II 0.02
Endosulfan Sulfate 0.03
PCB'S
(Maximum PPM) 0.20
MISCELLANEOUS
(Maximum Limits)
Nitrate (N PPM) 20
Nitrite (N PPM) 5
BHA (PPM) 10
BHT (PPM) 5
Total Bacterial Plate Count (CFU/Gm) 1000
Coliform (MPN/Gm) 10
E. Coli (MPN/Gm) 10
Salmonella (/Gm) ...................... Neg

Table 4.
RATING OF THE FEED FOR CONTAMINANTS

Maximum Points -100
95 to 100 - use the feed
91 to 94 - May use it but replace with a new batch within four weeks
90 and below - reject the feed
1. If all contaminants are at less than the specifications, rating for that batch of feed will be 100.
2. Aflatoxin - Deduct 1 point for each PPB above the specification. If the aflatoxin level is more than 10 PPB, the feed shall not be used.
3. Nitrosamines - Deduct 1 point for each 2 PPB above the specifications.
4. Heavy Metals:
Lead, Arsenic, and Selenium - Deduct 1 point for each 0.2 PPM above the specifications. Cadmium and Mercury - Deduct 1 point for each 0.02 PPM above the specifications.
5. PCB's - Deduct 1 point for each 0.02 PPM above the limit.
Pesticides - Deduct 1 point for each increase equivalent to the maximum allowable level.
6. Miscellaneous contaminants - Deduct 1 point for each increase equivalent to the maximum allowable level. If microbiological contaminants are 2X the limits, a new sample is to be tested for possible contamination during sampling. If the repeat sample confirms the original results and the total bacterial count is > 5000 cfu/gm, the product was not irradiated properly and cannot be accepted as an irradiated product.

Opportunity closing date

11 November 2019

Value of contract

to be confirmed