SOLICITATION NOTICE
65 -- Bosentan (Tracleer) Tablets and Services
- Notice Date
- 7/28/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Attn: Department of Veterans Affairs National Acquisition Center, (= 049A1), P.O. Box 76, Building No. 37, Hines, Illinois 60141
- ZIP Code
- 60141
- Solicitation Number
- 797-NC-03-0023
- Response Due
- 8/12/2003
- Archive Date
- 9/11/2003
- Point of Contact
- Point of Contact - Ronald Jenkins, Contract Officer, (708) 786-492= 9, Contracting Officer - Ronald Jenkins, Contract Officer, (708) 786-4929
- E-Mail Address
-
Email your questions to Ronald Jenkins
(ron.jenkins2@med.va.gov)
- Description
- This is a combined synopsis/solicitation for commercial items prepare= d in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.=20 The VA National Acquisition Center is issuing Request For Proposal (RFP) 797-NC-03-0023 for the Department of Veterans Affairs=92 (VA) requirements for Bosentan (Tracleer) 62.5mg and 125mg tablets and related services. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2001-14 and VA Acquisition Circular 97-9. The North American Industrial Classification System (NAICS) code for this procurement is 325412, the small business size standard is 750 employees and the procurement is being conducted on an unrestricted basis. The provision at Federal Acquisition Regulations (FAR) 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition and the following clauses are applicable to this acquisition and are incorporated by reference as addenda to this clause: 52.233-2 Service of Protest, 852.233.70 Protest Content, 852.233-71 Alternate Protest Procedures, 52.214-34 Submission of Offers in the English Language and 52.214-35 Submission of Offers in U.S. Currency. Offerors are advised to include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer.=20 The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition and the following clauses are applicable to this acquisition and are incorporated by reference as addenda to this clause: 52.216-21 Requirements (Oct 1995); last sentence to read, =93provided, that the Contractor shall not be required to make any deliveries under this contract after 30 days of contract=92s expiration,=94 52.217-5 Evaluation of Options (July 1990), 52.217-9 Option to Extend the Term of the Contract (Mar 2000); first sentence to read, =93The Government may extend...within 30 days; provided that the Government gives the Contractor a preliminary notice of its intent to extend at least 60 days before the contract expires,=94 52.216-18 Ordering (Oct 1995) (orders may be issued from____through____), 52.232.17 Interest and 852.270-4 Commercial Advertising (Nov 1984). =20 The clause at FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and the additional FAR clauses cited in this clause are applicable to the acquisition as follows: 52.203-6, Restrictions on Subcontractor Sales to the Government, with Alternate I (41 U.S.C. 253g and 10 U.S.C. 2402), 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 1999) (if the offeror elects to waive the preference, it shall so indicate in its offer), 52.219-8, Utilization of Small Business Concerns (15 U.S.C. 637 (d)(2) and (3)), 52.219-9 Small Business Subcontracting Plan; 52.219-23 Notice of Price Evaluation Adjustment for SDB Concerns (Alternate 1), 52.222-3 Convict Labor, 52.232-34 Payment by EFT-Other than CCR, 52.222-21, 52.232-36 Payment by Third Party, Prohibition of Segregated Facilities (Feb 1999), 52.222-26, Equal Opportunity (E.O. 11246), 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (38 U.S.C. 4212), 52.222-36, Affirmative Action for Workers with Disabilities (29 U.S.C. 793), 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (38 U.S.C. 4212), 52.222-19, Child Labor-Cooperation with Authorities and Remedies (E.O. 13126), 52.225-5, Trade Agreements (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note), and 52.225-13, Restriction on Certain Foreign Purchases (E.O. 12722, 12724, 13059, 13067, 13121, and 13129). The purpose of this solicitation is to establish a supply source to the Department of Veterans Affairs (VA) for Bosentan (Tracleer) tablets and related services. The contract type will be a fixed price, indefinite delivery, requirements contract. The contract will be for a base year, plus four one-year option periods that will be exercised at the discretion of the Government. The estimated number of VA patients currently receiving Tracleer is 20. Due to United States Food and Drug Administration (FDA) requirements for patient monitoring, Bosentan (Tracleer) tablets, manufactured by Actelion are only dispensed through FDA approved specialty distributors (SD). The Tracleer Access Program (TAP) is a restricted distribution network for Bosentan (Tracleer) tablets, in conjunction with a patient database that follows patients treated with Tracleer. This program provides a mechanism to assist with two primary risk management goals for Tracleer therapy, pregnancy prevention and prevention of hepatic injury. The requirements of the TAP program can be viewed by accessing the FDA approval letter to Actelion (NDA 21-290) dated November 20, 2001. This letter may be downloaded from the following website: www.fda.gov/cder/approval/index.htm.=20 The Department of Veterans Affairs will purchase Tracleer and related services from an authorized SD. Only VA physicians will be authorized to prescribe Tracleer and register patients with the SD to receive Tracleer. The SD must provide the following services: 1.=09The filling of the initial prescription for authorized VA patients to be shipped within 24 hours to the patient=92s home, VA pharmacy or other location as designated by the VA physician and the shipment of refills within 48 hours.=20 2.=09Inserting two patient reminders in the monthly prescription, first, the approved Patient Medication Guide and second, a liver function test (LFT) and pregnancy testing reminder card. These will remind the patient to have LFTs checked; and, for child bearing potential females, testing for pregnancy checked on a monthly basis and the prevention of pregnancy using appropriate birth control methods. In addition, patients are reminded to contact their physicians if they experience adverse events or have questions. The SD must make a database entry to verify completion of this contact. 3.=09Generating a letter to the prescribing physician indicating that the initial prescription for Tracleer has been filled, with date and patient name. The letter will contain the name of the SD with a contact number for the physician to call if there is any need to alter the dosage of Tracleer. The letter will also remind the physician to check the LFTs monthly and that female patients should not become pregnant, or take Tracleer during pregnancy, and should have monthly pregnancy testing performed. The physician will also be reminded to report any adverse events to the Actelion Drug Safety Reporting Line (1-866-228-3546) and/or the FDA (1-800-FDA-1088). 4.=09Calling patients prior to scheduled shipments of the next month=92s medication and asking them if they are continuing on Tracleer. If they are, patients should be reminded of the need for liver function tests and asked if they have had a blood draw in the last month for reasons other than checking blood thinning. Female patients should be asked if they have had a pregnancy test within the last month and be reminded that they should not become pregnant while on Tracleer. 5.=09If patients have not had liver and/or pregnancy tests within the last month, the SD will communicate this immediately to the physician and remind the physician of the need for liver and/or pregnancy monitoring. The call to the patient and the contact with the physician must be logged. 6.=09If a planned refill does not occur, the SD TAP administrator will determine why. If there is a medical reason, the physician will be contacted to determine what the medical reason is, and if the issue is related to LFT elevation or change in pregnancy status. This information will be entered into the TAP database. Adverse events will be forwarded to the Actelion Director of Drug Safety for follow-up and reporting. 7.=09Delivery of Tracleer to patients shall be within 24 hours for initial prescriptions, within 48 hours for all refills, and shall be in accordance with all FDA regulations and TAP requirements. =20 Bosentan (Tracleer) tablets are to be sold to the Government at prices no greater than Federal Ceiling Prices (FCP) as established on the Department of Veterans Affairs Federal Supply Schedule (FSS) 65IB. The SD receiving a contract award as a result of this solicitation will provide the Bosentan (Tracleer) tablets at no greater than the FSS FCP price. The SD will include a flat fee, which is separate from and not included in the FCP price of the drug, for providing all of the above listed related services required by the FDA and this solicitation, as a separate line item.=20 This fee will be applied on a per prescription basis. Option year pricing will be determined by the current FCP price and offerors shall purpose a firm, fixed price, flat fee for services for the Base Year and each of the individual option years. However, FCP prices may change at anytime during the term of the contract and the changed price will immediately become the new price for Tracleer. Contractor will be required to provide quarterly sales reports to the NAC detailing the number patients receiving Tracleer, the amounts received and the prices charged. Contractor shall provide these quarterly sales reports 30 days after the end of each calendar quarter ending March, June, September and December. The Government will award a contract resulting from this solicitation to the lowest price, technically acceptable, responsible offeror whose offer conforms to the solicitation. SD must provide the listed services to VA patients within the scope of their qualifications and licensure and in accordance with generally accepted professional standards. Contractor must warrant that all pharmacy personnel employed by them, or otherwise providing listed services to VA patients, are and shall remain licensed or certified and supervised. In addition, personnel must be qualified by education, training and experience to perform their professional duties. =20 Offers will be due by 4:00 pm Central Standard Time on August 12, 2003. Offers can be mailed to: Department of Veterans Affairs, National Acquisition Center, PO Box 76, 1st Avenue One Block North of Cermak Road, Hines, Illinois 60241. Offers can be faxed to Attn: Ronald E. Jenkins (708) 786-5256. If a paper copy of this solicitation is desired please fax written requests to Ronald E. Jenkins at (708) 786-5256 or e-mail Ron.Jenkins2@med.va.gov. If there are any questions please call Ronald E. Jenkins at (708) 786-4929. See numbered note 12. =20
- Web Link
-
RFP 797-NC-03-0023
(http://www.bos.oamm.va.gov/solicitation?number=3D797-NC-03-0023)
- Record
- SN00384501-W 20030730/030728213409 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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