Addendum_I-Tuberculin.pdf

NOTE TO OFFEROR/PRICE SCHEDULE/

STATEMENT OF WORK/SPECIFICATIONS

I. NOTE TO OFFEROR (Checklist):

In order for an offeror to have a complete quotation package, the following must be submitted to the Contracting Officer to be considered responsive:

□ A signed copy of Form 1449 (page 1, Attachment 1) with a firm, fixed pricing filled in on the price schedule below (pages 2-4).

□ A copy of a completed provision AGAR 452.209 – 70 Representation by

Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony

Conviction (see page 20, Attachment 1).

□ A copy of a completed provision 52.212-3, Offeror Representations and

Certifications—Commercial Items. An offeror shall indicate that the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the SAM website (for NAICS code 325413), the offeror shall include a completed copy of the provision found in Attachment 1, starting on page 2).

□ A completed Federal Contractors Registration at http://www.sam.gov.

The contractor’s DUNS number should be included with the quote.

□ Past Performance References with previous contracts/POs with this agency or similar scope of work with federal/state/local entities. Up to three past performance references or contract/PO numbers should be provided, if available.

□ A statement of technical capability based on the capability to perform the requirements from the statement of work/specifications starting on page 4 below. At a minimum, the statement should include whether the offeror is already licensed by the USDA APHIS to manufacture tuberculin, the production experience with growing Mycobacterium spp. cultures or similar production experience, the willingness to provide sample product for testing if not already licensed, and the capability to meet the packaging requirements.

Quotations are due at the USDA APHIS MRPBS-ASD Contracting Team, Attn: Michael

Chiodi, Butler Square West 5 th

Floor, 100 North 6 th

Street, Minneapolis, MN 55403 no later than 3:00 pm Central Time on Tuesday, __April 16, 2013___. Faxing or emailing quotes is acceptable. The assigned Contract Specialist is Michael Chiodi. Mr. Chiodi may be reached at michael.j.chiodi@aphis.usda.gov, (612) 336-3203, or by fax, (612)

336-3550.

http://orca.bpn.gov_/ http://www.sam.gov/

II. PRICE SCHEDULE

Item No.

Schedule of Supplies NTE

Quantity

Unit Unit Price Sub-Total

Amount

BASE YEAR – Date of Award through 12 months

0001 Tuberculin, PPD Bovis Intradermic (15,000 vial order guaranteed)

15,000 10 ml vial

0002 Tuberculin, PPD Bovis Intradermic (5,000

5,000 5 ml vial

0003 Tuberculin, PPD Bovis Intradermic (5,000

5,000 1 ml vial

0004 Tuberculin, PPD Bovis Intradermic (1,000 vial order minimum, orders in 1,000 vial increments, 10,000 vial order maximum; no orders guaranteed)

10,000 10 ml vial

0005 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

0006 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

OPTION YEAR ONE – 12 months

0007 Tuberculin, PPD Bovis Intradermic (10,000 vial order; no order guaranteed)

0008 Tuberculin, PPD Bovis Intradermic (5,000

0009 Tuberculin, PPD Bovis Intradermic (5,000

0010 Tuberculin, PPD Bovis Intradermic (1,000 increments, 10,000 vial order maximum; no

0011 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

0012 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

OPTION YEAR TWO – 12 months

0013 Tuberculin, PPD Bovis Intradermic (10,000

0014 Tuberculin, PPD Bovis Intradermic (5,000

0015 Tuberculin, PPD Bovis Intradermic (5,000

0016 Tuberculin, PPD Bovis Intradermic (1,000 increments, 10,000 vial order maximum; no

0017 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

0018 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

OPTION YEAR THREE – 12 months

0019 Tuberculin, PPD Bovis Intradermic (10,000

0020 Tuberculin, PPD Bovis Intradermic (5,000

0021 Tuberculin, PPD Bovis Intradermic (5,000

0022 Tuberculin, PPD Bovis Intradermic (1,000 increments, 10,000 vial order maximum; no

0023 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

0024 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

OPTION YEAR FOUR – 12 months

0025 Tuberculin, PPD Bovis Intradermic (10,000

0026 Tuberculin, PPD Bovis Intradermic (5,000

0027 Tuberculin, PPD Bovis Intradermic (5,000

0028 Tuberculin, PPD Bovis Intradermic (1,000 increments, 10,000 vial order maximum; no

0029 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

0030 Tuberculin, PPD Bovis Intradermic (1,000 increments, 5,000 order maximum; no

MAX TOTAL

I CERTIFY THIS QUOTE IS VALID FOR A PERIOD OF ____________ DAYS

PRINTED NAME: ___________________________________

SIGNATURE: _______________________________________

III. STATEMENT OF WORK/SPECIFICATIONS

MYCOBACTERIUM BOVIS PURIFIED PROTEIN DERIVATIVE TUBERCULIN

1. SERVICE REQUIREMENTS

The PPD Tuberculin specified herein is required by the U.S.

Department of Agriculture (USDA), Animal and Plant Health

Inspection Service (APHIS), National Veterinary Services

Laboratories (NVSL), Ames, Iowa, for use in determining whether animals are infected with bovine tuberculosis. The

Mycobacterium bovis Purified Protein Derivative Tuberculin

(Tuberculin, PPD, BOVIS, hereinafter referred to as PPD

Tuberculin), must be of current production. In order to meet program requirements, the delivery requirements specified must be met. It is highly important that the PPD Tuberculin possess the maximum uniformity possible from the standpoint of specificity and potency. Therefore, exacting compliance with uniform methods and materials in preparing, storing, diluting, testing, bottling, and shipping is essential.

Any facility that is not already licensed and/or inspected and approved by the USDA for production of PPD Tuberculin shall be inspected and accepted and have product tested and licensed before a contract can be awarded to them.

Product must be available for specified multiple fill volumes (10 ml, 5 ml, 1 ml) for consideration.

In addition, the USDA, APHIS, VS must have the option to purchase bulk quantities of the tuberculin PPD prior to dilution to 1.0 mg/ml. Bulk quantities may vary but typically the amount ranges from 250.0 mls to 1000.0 mls per request.

2. SPECIFICATIONS

QUALITY: The product shall be approved by the USDA, APHIS, Veterinary

Services (VS), and shall be produced and tested in accordance with appropriate sections of 9 CFR (Code of Federal

Regulations) or other approved potency tests available for release of product.

1. EXPIRATION DATE: The final product shall bear an expiration date not to exceed 36 months from the date of satisfactory potency test by the producer. All PPD Tuberculin shall be delivered at least 24 months prior to the expiration date.

2. BOTTLING:

(a) BOTTLES: The final product shall be bottled in 10 ml, 5 ml, and 1 ml quantities in sterile amber borosilicate glass serum bottles which meet the requirements of the Pharmacopeia of the United States for Type 1 glass.

(b) CLOSURES: Each bottle of the final product shall be closed with “B” corkage rubber stopper and sealed with a “B” corkage one piece aluminum seal. The stoppers shall be rinsed with distilled water before sterilization and use.

3. LABELING: Labels placed on final containers of PPD Tuberculin must comply with the applicable provisions of 9 CFR 112, except Parts 112.2 (2) and 112.2 (5) and shall be submitted to

USDA, APHIS, Veterinary Services, for review and approval before being placed in use.

Labels shall be produced in a manner to ensure adherence to all vials and prevent printing to become illegible or removed.

Labels shall contain no trademark or similar identification. In general, labels of the final product containers shall provide the following:

a. True name of the product: TUBERCULIN, PPD BOVIS, INTRADERMIC

b. U.S. Veterinary License Number

c. Serial Number

d. Expiration date: Use before (month, day, year):

e. Contents: Specific fill volume (10 ml, 5 ml, or 1 ml)

f. Dosage: 0.1 ml

g. Storage: Store at 2-8 degrees C. Do not freeze.

h. Usage Statement: For Veterinary Use Only.

i. Distributor Statement: Produced for U.S. Department of Agriculture, Animal and Plant Health Inspection

Service.

4. PACKAGING AND MARKING: Bottles of the labeled final product shall be packaged in solid bleached sulfate (SBS) paperboard containers or similar containers of suitable stability. Each container shall be partitioned to ensure proper packaging and shipment of product to avoid damage to bottles. When these partitions interlock, bottles should be securely packaged and not allow for excessive movement of bottle and allow for efficient packaging and shipment of final product. Containers should close securely utilizing a tuck top closure lid or similar closure.

Labels on boxes shall be of black printing or similar clearly visible color on solid white paper and shall contain the same information as stated in Item 3 except that 3e shall read as follows: “Contents: “Number Enclosed” 10 ml bottles”, or

“Contents: “Number Enclosed” 5 ml bottles”, or “Contents:

“Number Enclosed” 1 ml bottles”.

6. PACKING AND SHIPPING: Packages of the final product shall be packed in containers for shipping so as to withstand shock, pressure changes, temperature changes and other conditions incident to ordinary handling in transportation.

PPD Tuberculin that is lost because of breakage and/or leakage during shipment and any that has deteriorated due to exposure to heat or cold, shall be replaced by the successful contractor.

METHOD FOR PRODUCTION OF M. BOVIS PURIFIED PROTEIN

DERIVATIVE TUBERCULIN (TUBERCULIN, PPD BOVIS,

INTRADERMIC)

** WARNING **

HEAT RESISTANT, BOROSILICATE GLASS, WHICH MEETS THE

REQUIREMENTS OF THE PHARMACOPEIA OF THE UNITED STATES

FOR TYPE I GLASS SHALL BE USED THROUGHOUT FOR THE

PRODUCTION OF PPD. PPD TUBERCULIN MAY ADHERE TO

GLASSWARE. ROUTINE WASHING AND STERILIZATION

PROCEDURES MAY NOT BE ADEQUATE FOR PREVENTING

ANTIGENIC CONTAMINATION OF SUCCESSIVE LOTS. THEREFORE,

GLASSWARE SHOULD BE PERMANENTLY IDENTIFIED FOR USE

WITH ONLY ONE MYCOBACTERIAL STRAIN. THE GLASSWARE

SHOULD BE CLEANED BY ROUTINE METHODS FOLLOWING

HARVEST, THEN CLEANED AGAIN BY ACCEPTABLE METHODS

SPECIFIED IN THE APPROVED PRODUCTION OUTLINE ON FILE

WITH APHIS. THE SPECIFIED PROCEDURE SHOULD PROVIDE FOR

THE REMOVAL OF ANTIGENIC CONTAMINATS.

*Anionic detergent is a wetting agent which is completely soluble in hot or cold water and is noncorrosive and biodegradable.

Although the USDA mentions examples of product brand in this contract, the USDA does not claim any product superiority or endorsement.

Alconox, Inc. 30 Glenn Street, Suite 309 White Plains, NY

10603 USA

3. PREPARATION OF CULTURE FILTRATE

1. MICROORGANISMS: Only Mycobacterium bovis Strain AN-

5 shall be used. Cultures on this strain may be furnished to the

Contractor by the Veterinary Services Laboratories, APHIS, at the beginning of the contract period and at other times upon request given an advance notice of 6 months. The purity and identity of the cultures shall be maintained at all times and these records will be made available to the Veterinary Services

Laboratories, APHIS when requested .

2. SEED CULTURES: Stock cultures, frozen in Dubos Broth or equivalent grown on Middlebrook’s or equivalent.

7H-10 medium slants or frozen stock cultures shall be provided by the Veterinary Services Laboratories. Seed cultures shall be prepared by inoculating heat resistant, borosilicate flasks containing 250 ml – 300 ml of Modified Reid’s Synthetic Fluid

Medium with a loopful of culture grown on Middlebrook’s 7H-

10 medium slants. The mouth of each seed culture flask shall be closed with a sterile gauze-covered cotton plug or sterile plastic foam stopper and then covered with aluminum foil, which extends over the neck area of the flask. Seed cultures shall be grown by incubating at 36.5 degrees C to 38.5 degrees C for about 2 to 8 weeks in a constant temperature incubator equipped with a device to increase the relative humidity.

No species or strains of mycobacteria, other than M. bovis

Strain AN-5, shall be permitted in any incubator or room that is used to prepare M. bovis Strain AN-5 seed cultures.

3. PRODUCTION CULTURES: Production cultures shall be prepared by inoculating heat resistant, borosilicate flasks containing Modified Reid’s Synthetic Fluid Medium with M.

bovis mycobacterial pellicle obtained from seed cultures prepared as described above. The mouth of each production flask shall be closed with a sterile gauze-covered cotton plug or sterile plastic foam stopper and then covered with aluminum foil, which extends over the neck of the flask. Production cultures shall be observed weekly and those that show contamination shall be removed, autoclaved, and discarded.

No species or strains of mycobacteria other than M. bovis

Strain AN-5 shall be permitted in any incubator room that is used to prepare M. bovis Strain AN-5 seed cultures for use in the preparation of production cultures.

4. STERILIZATION OF PRODUCTION CULTURES: After incubating for 8 to 12 weeks, all production culture flasks are inspected before sterilization for contamination, discoloration, insufficient growth, or any other abnormalities. Cultures showing any abnormality must be removed and destroyed separately by autoclaving. The final production cultures shall be sterilized in their original unopened production flasks by autoclaving with steam under pressure at 121 degrees C for 30 minutes. The autoclave shall only contain M. bovis AN-5 production cultures and be kept clean and free of toxic materials such as disinfectants.

5. SEPARATION OF PELLICLE FROM FLUID MEDIUM: The pellicle material shall be removed from the sterilized production cultures by filtering through sterile gauze or sterile stainless steel wire mesh into a sterile heat resistant, borosilicate glass container. The pellicle material shall be discarded.

6. PRESERVATON OF CULTURE FILTRATE: A five percent phenol stock solution shall be prepared from reagent grade phenol in advance. The volume of culture filtrate combined with the five percent phenol solution must create a final culture filtrate product that contains a final phenol concentration of one-half percent. This is accomplished by adding the five percent phenol solution to the culture filtrate while gently agitating.

7. STORAGE OF CULTURE FILTRATE: The culture filtrate preserved with one-half percent phenol shall be placed in sterile heavy walled bottles that are phenol resistant and stored at 4-8 degrees C. Avoid exposure to freezing and light by using amber bottles, covering the bottles, or storing in the dark.

4. PREPARATION OF A LOT OF PPD TUBERCULIN CONCENTRATE

A lot of PPD Tuberculin Concentrate shall be prepared by taking a quantity of culture filtrate and processing according to a protocol that has been approved by the contractor and the USDA, NVSL.

There are several methods of tuberculin PPD precipitation, and the following section outlines the general process

1. CLARIFICATION: The culture filtrate shall be clarified by microporous filtration using sterile membrane filters with a 0.6 micron pore size or smaller. The culture filtrate shall be retained in a sterile container for further processing.

If the culture filtrate runs through the microporous filtration system too slowly, it may be necessary to prefilter the culture filtrate through sterile filter pads with a pore size larger than

0.6 micron or precede filtration by high speed centrifugation.

2. CONCENTRATION: The culture filtrate shall be concentrated to approximately two percent of the original volume by ultra filtration (using a molecular filtration membrane with a nominal molecular weight retention value of

10,000).

3. PRECIPITATION: Protein shall be precipitated from the concentrated culture filtrate by slowly adding a precipitating agent, while constantly stirring. The supernatant fluid is discarded and the precipitate is retained for further processing.

4. PURIFICATION: The precipitate shall be washed and dissolved in a minimum amount of solvent buffer according to the appropriate protocol. While washing, the product volume should remain constant.

5. CENTRIFUGATION: The concentrate may be clarified by centrifugation as described in the specific processing protocol.

6. STERILIZATION: Each lot of PPD Tuberculin Concentrate shall be sterilized by filtration using a 0.2 micron filter and filtering into a sterile container.

7. PROTEIN DETERMINATION: The micro kjeldahl method shall be used to determine the protein concentration of each lot.

8. BOTTLING: Each lot of PPD Tuberculin Concentrate shall be placed in one or more heavy walled bottles that are phenol resistant and light resistant.

9. LABELING: Each lot of PPD Tuberculin Concentrate shall be identified with a label that contains the product name, lot number, and production date (day when concentration step 2 was started).

10. STORAGE: PPD Tuberculin Concentrate shall be stored at

2-8°C in phenol resistant and light resistant bottles. Avoidance of light may be maintained by using amber bottles, covering the bottles, or storing in the dark.

5. PREPARATION OF A SERIAL OF PPD TUBERCULIN

A serial of the final product (Tuberculin, PPD bovis, Intradermic) shall be prepared from one or more lots of PPD Tuberculin

Concentrates. It is essential that sterile equipment and aseptic procedures are used in every step.

1. DILUTION: Each serial shall be prepared by diluting the blended PPD Tuberculin Concentrate with an appropriate diluent to create a protein concentration of 1.0 ± 0.1 mg/ml. A

50 ml sample of the diluted product shall be placed into a sterile container and centrifuged at an appropriate time and speed to separate the sediment from the supernatant. The sediment shall be examined microscopically for the presence of acid-fast bacteria or other microorganisms before bottling.

2. BOTTLING AND LABELING: Each serial shall be bottled and labeled as required in Items 4 and 5 of the Specifications.

3. STORAGE: Bottles of the final product shall be stored at 4-

8˚C.

4. PACKAGING AND MARKING: Bottles of the labeled final product shall be packaged and marked as required in Item 6 of the Specifications.

6. TESTING EACH SERIAL OF PPD TUBERCULIN

Each serial shall be tested and pass testing for purity, safety, potency and special chemical characteristics in accordance with the conditions prescribed in 9 CFR, Parts 113.409, Section V of the approved outline of production and any parts that are applicable, which are on file with the

USDA,APHIS, Veterinary Services. As an option, other guinea pig potency testing procedures may be acceptable by review with the Center for

Veterinary Biologics and the National Veterinary Services Laboratories.

IV. SPECIAL CONTRACT REQUIREMENTS

PACKAGING AND MARKING

1. PACKING FOR DOMESTIC SHIPMENT

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with the Interstate Commerce regulations, Uniform

Freight Classification Rules, or regulations of other carriers as applicable to the mode of transportation.

2. PACKING SLIP

Each shipment shall include a packing slip enclosed in a protective pouch and attached to the outside of one box and a packing slip placed inside one of the shipment boxes.

The packing slip shall identify the following:

A. Contract Number

B. Required Delivery Date:

C. Quantity Shipped

D. Invoice Number

V. MEASURABLE PERFORMANCE STANDARDS

DELIVERIES OR PERFORMANCE

1. PERIOD OF PERFORMANCE

The period of performance of this contract is from date of award through 5 years and 6 months, unless extended or terminated.

2. DELIVERY LOCATION

Shipment of deliverable items, other than reports, shall be to:

USDA

National Veterinary Services Laboratories

Brucella and Mycobacterium Reagents Team c/o Randy Capsel/Teresa M. Sigafoose-Grimm

1920 Dayton Road

Ames, Iowa 50010

3. TIME OF DELIVERY

The Government desires delivery to be made according to the following schedule:

REQUIRED DELIVERY

QUANTITY (LOT SAMPLES) DELIVER BY

20 – 10, 5, and/or 1 ml vials To be negotiated

QUANTITY (CONTRACT QUANTITY) DELIVER BY

2 to 4 production lots totaling 45 days after approval of the total vials relating to each lot sample contract quantity of product

(Production lots may be created and delivered throughout the contract year.)

The Contractor shall provide twenty (20) 10 ml, 5 ml, or 1 ml lot samples for testing in accordance with the delivery requirements indicated. Lot samples may be shipped up to 30 days earlier than the due date if the testing lab is notified 30 days in advance.

The foregoing delivery requirements are based on the assumption that the successful offeror will receive the notice of award 12 weeks prior to the first lot sample. The Government will extend the delivery date in the delivery schedule set forth by the number of calendar days after the above date that the Contractor receives notice of award, if the Contractor promptly acknowledges receipt.

VI. USDA TECHNICAL POINT OF CONTACT

USDA National Veterinary Services Laboratories

Brucella and Mycobacterium Reagents Team

Teresa M. Sigafoose-Grimm and Randy Caspel

1920 Dayton Road

Ames, Iowa 50010

Telephone: 515-337-7317

VIII. INVOICE INSTRUCTIONS:

Invoice instructions: See 52.212-4(g). The Contractor shall submit the original invoice to the address listed above at or after the time of delivery. Payment is to be made within

30 days after receipt of the invoice.