The Department of Veterans Affairs, VAMC Connecticut, located at 950 Campbell Avenue, West Haven, CT 06516 and our Newington Campus located at 555 Willard Avenue in Newington, CT 06111, has a requirement for the providing of Medical-Grade Bulk Oxygen and tank rental as indicated in the below Scope of Work. We are seeking if any small businesses exist in the area that can meet this requirement. If there are, please submit your capabilities, certificates, licenses, years of experience and company history to the Contracting Officer. This is informational only to determine if sufficient small business exists in the area to meet this requirement. Send information to the Contracting Officer,
[email protected] by 8/15/2013 @ 4:00pm. MEDICAL-GRADE LIQUID BULK OXYGEN Scope Of Work IMPORTANT NOTES: 1. The medical-grade oxygen being procured on this solicitation is classified as a drug and must meet USP specifications. Bulk oxygen tanks are classified as a drug delivery device, and all contractors must be registered with the Food and Drug Administration. 2. Prospective bidders are strongly encouraged to visit the bulk oxygen tank sites at the facility. Direct any questions regarding solicitation requirements or facility specifications to the contracting officer below. Please submit written questions as early as possible! 3. This solicitation is a RFQ Any exception taken to the terms and conditions of the solicitation will deem a bid non-responsive, and the bid will not be considered for award. If any changes to the solicitation are necessary, they will be made by the contracting officer by written amendment. Please keep in mind that the contracting officer is the only individual that has the authority to amend the solicitation. Contracting Officer is James Corbett (203-937-4713) e-mail:
[email protected] 1. General 1.1 The Department of Veterans Affairs, VAMC Connecticut, located at 950 Campbell Avenue, West Haven, CT 06516, as well our Newington Campus, located at 555 Willard Avenue, Newington CT 061111currently has requirement type contract for the distribution and supply of medical-grade liquid bulk oxygen that will expire 9/30/2013. 1.2 The purpose of this solicitation is to establish a committed source of supply of medical-grade liquid bulk oxygen for VAMC Connecticut. Since VAMC Connecticut does not own its own bulk oxygen tanks, the contractor shall also provide contractor-owned tanks with an appropriate back-up system. (i.e. reserve tank or cylinder bank). 1.3 The quantities shown in the solicitation schedule are estimates of VAMC Connecticut's annual requirements. There is no express or implied guarantee that these quantities will be purchased. The base contract period for a contract awarded under this solicitation will be 10/1/2013 - 9/30/2014 with four (4) one-year option periods which may be exercised by the Government. 1.4 A Contracting Officer Technical Representative (COTR) shall designated for the contract awarded from this solicitation. The COTR is responsible for local contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the COTR's specific responsibilities will be provided to the contractor and COTR at the time of contract award. Within 15 days after notification of contract award, the contractor shall meet with the COTR to ensure mutual understanding of facility requirements relating to the ordering method and specific details of any delivery instructions that are included in the solicitation schedule. If agreement cannot be reached between the contractor and COTR regarding any issue, the matter shall be referred to the Contracting Officer for resolution. 1.5 Prior to first filling, contractor must perform in-service training to include the following facets for contractor owned and government owned systems: the refill procedure, any preventive maintenance support requirements that may be needed from the medical center systems, and an explanation of all the volume alarm and low pressure set-points. The contractor will provide written procedures and training for VA staff for protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. Contractor will provide 24/7 emergency contact name(s) and telephone number(s). 1.6 Prior to first filling, and annually thereafter, alarm set-point testing and written verification must be presented through the use of a qualified third party expert per NFPA 99, 2002 Edition for contractor owned and government owned systems. Any code deficiencies in the Medical Center's existing system, as defined by NFPA 50, 1.3.3, "Bulk Oxygen System", must be identified by the contractor. A detailed explanation of these deficiencies must be presented in writing to the COTR. Receipt of this written explanation must be signed for by the COTR. 1.7 Prior to first filling, and annually thereafter, the contractor must verify, in writing, the accuracy of all gauges on contractor owned tanks. If the gauge(s) are government owned, contractor will provide, if requested after award, a written proposal with price to verify accuracy of the gauge(s). The Government may choose to exercise this option at its desire. 2. Acronyms 2.1 This section lists acronyms that are used in this Statement of Work and other parts of the solicitation. BOP - Federal Bureau of Prisons CCF - 100 cubic feet CF - Cubic feet CGA - Compressed Gas Association CGMP - Current Good Manufacturing Practices CO - Contractor owned COTR - Contracting Officer Technical Representative DOD - Department of Defense DOT - Department of Transportation FDA - U.S. Food & Drug Administration GO - Government owned IHS - Indian Health Service NFPA - National Fire Protection Association OGA - Other Government Agency (Other than VA) OSHA - U.S. Department of Labor, Occupational Safety and Health Administration USP - United States Pharmacopeia VA - Department of Veterans Affairs 3. Government-Furnished Property 3.1 The solicitation hereby identifies the bulk oxygen storage tank(s) at VAMC Connecticut as being CO (Contractor Owned). Government owned bulk oxygen storage tanks and appurtenances will be maintained by and at the expense of the Government in a manner that will insure compliance with applicable regulations, standards and normal good practices. 3.2 The solicitation hereby identifies that VAMC Connecticut requires installation of contractor owned equipment and shall provide a suitable location and foundation for the installation of the contractor owned bulk oxygen tank(s). Additionally the facility shall provide access to an electrical power source and hook-up to a facility-maintained alarm system. The contractor shall perform the hook-up of contractor owned equipment to the facility-maintained alarm system. 4. Contractor-Furnished Equipment 4.1 If the facility has contractor owned tanks, the contractor shall provide, install and maintain bulk oxygen tank(s) with appropriate back-up system(s). Through the duration of the contract, the contractor shall be liable for the integrity, suitability, and safety of contractor owned tank(s) that will insure compliance with applicable regulations, standards and normal good practices. The tank capacity and reserve system shown in the schedule are minimum capacities required by the using facility Manifold, cylinders for the reserve supply, liquid converter, alarm switch, regulator, valves, level indicator, and any other devices or connections required for proper tie-ins with the facility's gas system shall be furnished by the contractor, without cost to the Government. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container shall have an outlet that allows access for testing the purity of the oxygen. 4.2 All equipment and materials required to perform on the contract (other than what is specifically listed in section 3, Government-Furnished Property) shall be provided by the contractor. Contractor owned equipment shall be installed, inspected and maintained by the contractor without additional cost to the Government. (i.e., all installation, inspection and maintenance costs shall be included in the contract's monthly equipment rental fee for the applicable facility.) Contractor owned equipment shall be kept in good operating condition and appearance, in accordance with applicable regulations, standards and normal good practices. The contractor shall be provided reasonable access to the bulk oxygen systems for this purpose. 5. Installation of Contractor-Owned Equipment 5.1 Unless otherwise directed by the using facility, contractor owned equipment shall be installed by the effective date of the contract and shall be connected to the medical gas system on that date; provided: that the contractor shall be allowed a maximum of ninety days after receipt of notice of award to complete installation. If the contractor's equipment replaces equipment already in use, the exchange of equipment shall be accomplished without interruption of gas supply to the using facility. Contractor installed equipment shall remain the property of the contractor and shall be removed upon termination of the contract, when directed by the ordering facility and in full cooperation with the succeeding contractor so as to avoid interruption of gas supply. 5.2 To permit orderly transition from one contractor to another, the contractor shall continue to honor the contract's monthly equipment rental fee and bulk oxygen contract price for a maximum of ninety days beyond the scheduled expiration of the contract period, unless transition from one contractor to another is completed prior to the ninety day transition period. For any partial month, the contractor shall prorate the monthly equipment rental fee accordingly. The contractor shall continue to provide and maintain its equipment during this transition period. 5.3 No guarantee is given or implied that data included in the schedule regarding contractor owned equipment currently located at the facilities is complete and accurate as to the factors affecting the cost of furnishing and installing the required contractor owned tanks and appurtenances. Offerors are strongly encouraged to visit the facility sites prior to submitting a bid and take other steps as may be reasonably necessary to ascertain the nature and location of the work, and the general and local conditions which can affect the work or the cost thereof. Failure to do so shall not relieve offerors from the responsibility of estimating properly the difficulty and cost of successfully performing the work. Site visits may be arranged by contacting the COTR designated in the solicitation schedule. 5.4 All contractor owned equipment shall be installed in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001, NFPA 99 Standard for Health Care Facilities, 2002 Edition, and FDA's Current Good Manufacturing Practices (CGMP) Regulations. The contractor shall comply with all OSHA standards and applicable safety requirements, including proper signage and use of personal protective equipment. 6. Delivery of Medical Liquid Bulk Oxygen 6.1 Bulk oxygen is ordered by and delivered to VAMC Connecticut. 6.2 The contractor shall deliver medical-grade liquid oxygen within the time-frame specified in the schedule for the facility. The time-frame identified may be either the number of calendar days after receipt of the Government's order, the specific days of the week for delivery, the specific time intervals between deliveries, a specified reorder point, or other specified ordering and delivery methods. If the time frame for contractor delivery is not identified in the facility requirements, the contractor must provide 24-hour notice prior to delivery or upon mutual agreement between the facility and contractor, alternate ordering/delivery methods such as pre-scheduled deliveries, calling for tank level readings, installing a telemetry unit, etc. may be arranged. If for any reason the contractor is unable to delivery at the agreed upon day or time, the contractor will provide 24-hour notice to the COTR, so that the facility can initiate an alternate backup action. In accordance with VHA Patient Safety Alert dated April 5, 2004, all deliveries must be monitored by a qualified and trained technical representative that will be designated by each facility. Contractor will be provided with names and contact information of primary and back-up facility representatives. This applies to all deliveries regardless of time or day of execution. 6.3 Tanks(s) will be filled to maximum functional capacity at each refilling procedure unless otherwise specified in the facility requirements or as agreed upon in a written document signed and dated by the COTR. 6.4 At the time of each delivery, contractor must provide a legible signed and dated written document that identifies the tank level prior to fill, the level after fill, and the quantity delivered. This document must be counter-signed by the facility representative supervising the delivery. 6.5 Emergency delivery will be provided within 24 hours after receipt of Government notification. Contractor must respond to the facility by either telephone or email within one hour to confirm receipt of emergency notification to ascertain the nature of the emergency. Emergency status is determined by the Government when conditions warrant, such as an actuated main bulk tank low level alarm, imminent alarm condition, or system leak. Failure of the contractor to remain current with agreed delivery schedule and requirements does not constitute an "emergency" for purposes of charging an emergency delivery fee. 7. Quality Assurance Specifications and Requirements 7.1 All medical gas manufacturers and fillers of medical gases must be registered with FDA as drug manufacturers. All oxygen shall be manufactured, processed, packed, transported, and stored according to FDA's Current Good Manufacturing Practices (CGMP) regulations, and all labeling shall comply with FDA's labeling regulations (21 CFR Part 201). 7.2 All liquid bulk oxygen delivered under the contract shall be medical-grade and shall meet or exceed the standards cited in the current edition of the United States Pharmacopoeia/National Formulary (U.S.P.). 7.3 A valid certificate of analysis shall be provided with each delivery of liquid oxygen. The certificate shall include, at a minimum: a) Supplier's name and complete address b) Name of the Product (i.e. Oxygen U.S.P.) c) An Air Liquefaction Statement where appropriate d) Lot number or other unique identification number e) Actual analytical results for full U.S.P. monograph testing. (A statement that only states that the product meets the minimum purity of 99.5%, etc. is not acceptable.) f) Test method used to perform the analysis. (A statement such as "Meets U.S.P. specifications" is not acceptable; nor would "Tested via Servomex" be acceptable since the specific model number is not provided.) g) Signature of authorized supplier representative and date. 7.5 Material Safety Data Sheets shall be provided to the facility COTR upon request. 7.6 A copy of all inspection reports shall be provided to the facility COTR upon the completion of any contractor owned or government owned bulk oxygen system inspections that are required by regulation. 7.7 All contractor owned equipment shall be maintained or repaired in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 and FDA's Current Good Manufacturing Practices (CGMP) Regulations. 8. Applicable Regulations & Standards The following is a list of some of the regulations and standards that are applicable to this contract. The list is not comprehensive, and the contractor is responsible for ensuring that all products, equipment and services provided under the contract are in compliance with applicable Federal, state, and local regulations. If applicable, the editions in effect as of the date of this solicitation are listed. Contractor is responsible for remaining compliant with any future revisions that are effective at the time of contract performance. Title 21, Code of Federal Regulations, Parts 210 & 211 - CGMP regulations for supplying medical grade oxygen. 29 CFR 1910.104 Applies to the installation of bulk oxygen systems on industrial and institutional consumer premises 49 CFR - Transportation Federal Food, Drug, and Cosmetic Act NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 Edition NFPA 99: Standard for Health Care Facilities, 2002 Edition U.S.P. 23 Density data and volume measurement equivalents published in Compressed Gas Association Pamphlet No. P-6, titled "Standard Density Data, Atmospheric Gases and Hydrogen," shall be used when necessary to convert measurement of gases from one form to another. For example, the following conversion factor shall apply for conversion from gallons to cubic feet. Calculation based on data in CGA P-6 1 ft³ liquid O2 = 860.6 ft³ gas (Table 1) 1 ft³ liquid O2 = 7.48052 gal ((Table 2) Therefore: 7.48052 gal (1 ft³) liquid O2 = 860.6 ft³ gas 1 gal liquid O2 = 860.6 ft³ gas 7.48052 1 gal liquid O2 = 115.05 ft³ gas or more commonly quoted as 1 gal liquid O2 = 115.1 ft³ gas 9. Contractor Owned Cylinders 9.1 This section applies to all contractor owned cylinders that are provided under this contract as a back-up system to a primary bulk oxygen system. 9.2 Laws and Regulations: Cylinders and other containers for gaseous and liquid forms of gases shall comply with the Department of Transportation specifications and shall be maintained, filled, marked, labeled, and shipped to comply with current and subsequent updates to DOT regulations (Title 49-Transportation, Code of Federal Regulations). Packaging, labeling, etc., for medical gases shall also comply with the Federal Food, Drug, and Cosmetic Act. 9.3 Marking: In addition to marking required by the aforementioned laws and regulations, marking shall comply with American National Standards Z48.1-1954 (R 1971), "Method of Marking Portable Compressed Gas Containers to Identify the Material Contained." 9.4 All unauthorized or inapplicable markings, tags, and labels shall be removed. When shipment is by commercial carrier, shipping tags complying with Federal Standard 123F dated 5/15/91 shall be attached to each cylinder so as to be protected by the valve protection cap. The contract data markings required by the applicable standard shall be applied to one side of the tag and the identification markings on the reverse side. Consignee markings may be omitted when shipment is by contractor's truck. 9.5 Valves: Valves shall comply with Compressed Gas Associates Standard CGA-V-1 (11th Edition, 2003), "Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections." Valve protection caps for cylinders designed to receive such caps shall be securely attached to the cylinders in a manner to protect the valves from injury during transit and delivery to the purchaser's receiving area. Refer to 49 CFR 173.301(g)). 9.6 Color Coding: All cylinders shall be color coded in accordance with the Compressed Gas Association Pamphlet CGA C-9-1988, "Standard Color Marking Of Compressed Gas Containers Intended For Medical Use." 9.7 The contractor shall be responsible for all testing required by regulation of contractor owned cylinders at no additional cost to the Government. 9. Contractor Owned Cylinders (continued) 9.9 The bidder's price for the oxygen shall include the furnishing of, at no additional cost, all services which are required at each and every filling of a cylinder to comply with applicable regulations, specifications, and normal good practices. Such services are of the type normally provided in the supply of medical cylinder gases, and shall include, but not be limited to: tags indicating cylinder is "Full," In Use," or "Empty"; inspection, testing, evaluation, and cleaning services required at each and every filling; pin-indexing, when required, and attachment of Government-furnished warning tags, when required. Attaching of oxygen cylinders to manifold systems, when required, shall also be performed by the contractor at no additional cost. In addition to services listed in this paragraph, the contractor is responsible for all maintenance and testing of contractor-owned cylinders. 10. Government Owned Cylinders 10.1 Individual Agency Ownership of Cylinders: Government owned cylinders shall remain the property of the individual ordering (owning) agency and shall not be exchanged for other cylinders, either government-owned or contractor-owned, without authorization of the Contracting Officer Technical Representative (COTR) at the ordering agency. INSTRUCTIONS FOR SOLICITATION PREPARATION 1. Please do not submit prices that extend past two decimal points. Any prices submitted past two decimal points will be rounded. (e.g. A price of $0.334 will be rounded to $0.33; a price or $0.335 will be rounded to $0.34) If an award is made, it will be at the rounded price. 2. All prices for bulk oxygen shall be submitted by hundred cubic feet (CCF). The estimated annual usage for VAMC Connecticut is shown in CCF. 3. Any equipment rental fees shall be submitted as a monthly rental fee. (The schedule shows estimated requirements of 60 months since this is the number of months over the anticipated 5 year period of the contract.) 4. The schedule indicates the capacity of the bulk oxygen tank in cubic feet and provides information regarding the type of back-up system (RST - reserve tank (cubic feet) or CYL - cylinder bank.) The ownership of the main tank and back-up system is shown as either GO (government owned) or CO (contractor owned). 5. Bidders are strongly encouraged to arrange a site visit prior to submitting their bid. Visits may be arranged by contacting the individual listed as the contact for the facility. AS1311 LOSS OF CONTRACTOR-OWNED CYLINDERS (APR 1984) Both the Contractor and using Government Agency should keep accurate records of receipt and return of Contractor-Owned cylinders. In case of loss or damage of Contractor-Owned cylinders due to negligence on the part of the using Government Agency, a mutually agreeable settlement should be made by the parties involved. If a settlement cannot be reached between the involved parties, the matter shall be referred to the Contracting Officer for a decision to be made under the Dispute Clause of the Contract General Provisions. AS1313 CONTRACTOR'S LIABILITY (APR 1984) (a) Responsible for Government Property: The Contractor assumes full responsibility for and shall indemnify the Government for any and all loss or damage whatsoever kind and nature to any and all Government property, including any equipment, supplies, accessories, or parts furnished while in custody and care for storage, repairs, or services to be performed under the terms of this contract, resulting in whole or in part from the negligent acts or omissions of Contractor, any subcontractor or any employee, agent, or representative of Contractor or subcontractor. (b) Hold Harmless and Indemnification Agreement: The Contractor shall save and hold harmless and indemnify the Government against any and all liability, claims, and cost of whatsoever kind and nature for injury to or death of any person or persons and for loss or damage to any property occurring in connection with or in any way incident to or arising out of the occupancy, use, service, operations, or performance of work under the terms of this contract, resulting in whole or in part from the negligent acts or omissions of Contractor, any subcontractor, or any employee, agent or representative of Contractor or subcontractor. (c) Damage to Government Property From Causes Other than Contractor's Negligence: Nothing in the above paragraphs shall be considered to preclude the Government from receiving the benefits of any insurance the Contractor may carry which provides for indemnification for any loss, or destruction or damage to Government property. The Contractor shall do nothing to prejudice the Government's right to recover against third parties for any loss, destruction of or damage to Government property and upon the request of the Contracting Officer shall, at the Contractor's expense, furnish to the Government all reasonable assistance and cooperation (including assistance in prosecution of suit and the execution of instruments of assignment in favor of the Government) in obtaining recovery. AS1345 RECALLS (MAY 1999 Update) If at any time during the term of the contract awarded as a result of this solicitation, the Food and Drug Administration (FDA) or the individual contractor initiates a drug recall or FDA withdraws their approval to manufacture a drug, the following steps will immediately be taken by the appropriate contractor: a. Important notices not requiring immediate attention may be mailed to: Mr. Arnold B. Bierenbaum, Director, Safety and Technical Services (10NB) Veterans Health Administration 810 Vermont Avenue NW Washington, DC 20420 or Mr. Ezra R. Safdie Director, Healthcare Engineering (10NB) Veterans Health Administration 810 Vermont Avenue NW Washington, DC 20420 b. Drug product hazard alerts, recalls and product notices requiring immediate attention and dissemination should be sent via overnight express to: Mr. Arnold B. Bierenbaum, Director, Safety and Technical Services (10NB) Veterans Health Administration 810 Vermont Avenue NW Washington, DC 20420 or Mr. Ezra R. Safdie Director, Healthcare Engineering (10NB) Veterans Health Administration 810 Vermont Avenue NW Washington, DC 20420 c. Forward one copy of any notification along with any pertinent information to: Assistant Director, National Contracts Division (049A1N2PH) P.O. Box 76 Hines, IL 60l41 AS213 MANUFACTURING FACILITIES (AUG 2002) (I) Only offers from contractors and/or suppliers that have on record with the Dept. of Veterans Affairs, Pharmacy Benefits Management, a Quality Assurance Evaluation that has found those facilities, listed below, to be in compliance with the laws that FDA enforces and capable of marketing all currently manufactured products that meet applicable quality standards, will be accepted. Where FDA does not perform quality assurance testing, the VA reserves the right to perform its own quality assurance evaluation or to hire a contractor to perform this task. (II) Arrangements for a Quality Assurance evaluation are obtained by contacting the office specified in paragraph (I) above. Evaluations will be performed by FDA in accordance with Paragraph V.4 of the VA-FDA Interagency Agreement, by which the FDA is responsible for providing quality assurance for drugs, biologics, chemicals, and/or reagents being offered. Quality Assurance evaluation must have been received by the VA prior to the effective date of the contract as shown within this solicitation. (III) For any Nutritional/Dietary Supplements being offered, documentation of clinical studies that were performed on the offered products pertaining to the therapeutic treatment of patients may be required as a quality assurance measurement. (IV) If at any time during the life of the contract, the contractor's facility, or the source from which the contractor obtains any of the item(s) listed under this contract, fails to meet Current Good Manufacturing Practice Regulations (CGMPRs)(21 CFR Part 210 and 211), and/or a negative Food and Drug Administration Quality Assurance Evaluation is received, the contracting officer may apply the procedures outlined in paragraph (V). (V) Any products manufactured during this period of CGMPRs deficiencies shall not be shipped without written authorization from the contracting officer, and material which has been received without this authorization shall be returned as rejected goods at the contractor's risk and expense. The contractor will have 30 days in which to correct the deficiencies that caused the negative evaluation and notify the VA National Acquisition Center to have a reevaluation completed by the Food and Drug Administration. If upon reevaluation results are still negative, the contract shall be terminated by the contracting officer in accordance with 52.212-4(m). The failure or inability of the contractor or contractor's source to correct CGMPR deficiencies in a timely fashion shall not constitute or give rise to an "excusable delay" in performance pursuant to 52.212-4(f). (VI) Offeror must indicate in the spaces below and/or by attachment, if additional space is needed, (a) exact product(s) offeror desires to furnish to the Government, (b) whether the offeror manufactures ( ) the product(s) and/or the offeror is a distributor ( ) of the product(s) manufactured by another firm. The contractor will only be able to utilize the manufacturer(s) provided in response to this clause for the duration of the contract, unless a substitution of the manufacturing facility is approved by the VA. ITEM FACILITY LOCATION PERSON TO BE NO. NAME, ADDRESS, CITY, CONTACTED or COUNTY, STATE & ZIP CODE INCLUDING PHONE SIN (Do Not Include Distributors) NUMBER PLEASE COMPLETE ATTACHMENT "A" _____ ____________________________________ ____________________ _____ ____________________________________ ____________________ _____ ____________________________________ ____________________ AS213 MANUFACTURING FACILITIES (AUG 2002) (continued) Notes: A. If the product(s) are to be manufactured at more than one location, each location should be identified and product(s) manufactured at the facility should be identified. Also list the names and locations of all subcontractors (packager, labelers, etc.,) who participate in the production of product(s) to be furnished to the Government. B. Products may be identified by the solicitation item number or Special Item Number (SIN) as listed on the Standard Form (SF) 1449 or Continuation Sheet(s) of the SF 1449. C. In addition, when the finished product to be offered is of foreign manufacture, the complete name and address of the manufacturer shall also be listed. (VII) In case of any facility relocation, the contractor agrees to notify the contracting officer of the change and request approval to supply contract items from the new location. AS1961 MEDICAL DEVICE AMENDMENTS OF 1976 (MAY 1995) The product(s) included in this solicitation is/are considered medical devices by the U.S. Food and Drug Administration, Bidders and/or subcontractors must comply with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. AS2116 AVAILABILITY OF STANDARDS AND REGULATIONS (APR 1984) Standards and regulations in this Solicitation are available from the organization responsible for their preparation, maintenance or publication: " American National Standards: * American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018 * Compressed Gas Association, Inc. 1235 Jefferson Davis Highway, Arlington, VA 22202 " Compressed Gas Association Pamphlets: * Compressed Gas Association, Inc., 1235 Jefferson Davis Highway, Arlington, VA 22202 " National Fire Protection Association Pamphlets: * National Fire Protection Association, Battery March Park, Quincy, MA 02269 " U.S. Department of Commerce and Department of Transportation Publications: " Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. AS1108 CONTACT FOR CONTRACT ADMINISTRATION (MAY 1992) (Tailored) Offerors are required to designate a person to be contacted for prompt contract administration. NAME: ________________________________________ TITLE: ________________________________________ ADDRESS: ________________________________________ Street Address __________________ ______ _______ City State Zip Code (______) ____________________ (_______)____________________ TELEPHONE NUMBER: FACSIMILE NUMBER ____________________________ EMERGENCY CONTACT (______) ____________________ (_______)____________________ TELEPHONE NUMBER: FACSIMILE NUMBER ___________________________________ e-mail address AS1115 ORDERING ADDRESS (MAY 1994) (Tailored) Bidders are requested to indicate below the address(es) to which orders should be forwarded: (List on an attachment to the solicitation if more space is required.) __________________________________________________ Contractor's Name __________________________________________________ Address ___________________________________________________ City, State, Zipcode ___________________________________________________ Emergency Contact ___________________________________________________ Emergency Phone Number Note: Ordering Addresses may be submitted on Attachment "B"