65--Labels Sheets for Study 2002

STATEMENT OF WORK (SOW) As of 02/28/2017 Contract Number: Task Order Number: IFCAP Tracking Number: 501-17-3-137-0137 Follow-on to Contract and Task Order Number: CONTRACTING OFFICER S REPRESENTATIVE (COR). Name: Section: ADMS Address: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106-4180 Phone: Cell Phone: Fax: Email Address: SUBJECT MATTER EXPER (SME). Name: Section: Address: Phone: Cell Phone: Fax: Email Address: SCHEDULE OF SERVICES AND/OR SUPPLIES. # Item/Stock# Description Est. Qty. Unit Unit Price Estimated Amount 1 Blank Sheet Labels 8-1/2 x 11 Laser Copy Stock (SPEC 18884) Sheet contains 4 labels at 4 x 2 , 1 label at 6 x 4 . Remaining section will be paper material with no adhesive. 74437/QTY = 30,000 (Sheets) 30,000 EA 2 Estimated Shipping 1 EA TOTAL ESTIMATED COST 0 CONTRACT TITLE. 2002 Label Sheets BACKGROUND. The CSPCRPCC will be using the Blank Label Sheets for the CSP #2002 clinical research trial. The four smaller labels will indicate the study number, the study title, the participant s first and last name, the date, the study drug, the bottle number, the quantity, directions for use, and a barcode. The larger label will be used as a return address label for unused drug. The paper portion will remain at CSPCRPCC as a quality record. The CSPCRPCC uses labels to identify study materials, to track study materials, to assign study materials to participants, and for inventory purposes. SCOPE. The Department of Veteran Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC), Albuquerque, New Mexico, has a requirement to purchase label stock to support the CSP #2002 clinical research trial. A total quantity of 30,000 label sheets will be needed for the Blank Label Sheets (8-1/2 x 11 ). SPECIFIC TASKS/DELIVERABLES. Vendor will provide: Blank Label Sheets These Are Custom Labels Sheet Size: 8-1/2 x 11 4 Labels at 4 x 2 1 Label at 6 x 4 Remaining section will be paper material with no adhesive. Labels Must Permanently Adhere To HDPE Bottles and Tyvek Envelopes Color: White Laser Printer Sheets For Use With Laser Printers Packaging: One Lot of 30,000 Compliant with cGMP Compliant with 21 CFR Part 211, Subpart G-Packaging and Labeling Control §211.122 Materials Examination and Usage Criteria (b) Labels Must Be Delivered To Delivery Address By 06/09/2017 PERFORMANCE MONITORING. Product will be inspected to make sure full quantity arrives in new condition, with no defects or damage by the required date of 06/09/2017. SECURITY REQUIREMENTS. Order is for product (labels) only. Vendor delivery personnel will have no access to VA IT systems, PHI, or any equipment connected to the VA network. The C&A requirements do not apply and a Security Accreditation Package is not required. GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI). N/A OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. N/A Identification of Possible Follow-on Work. None Identification of Potential Conflicts of Interest (COI). None Identification of Non-Disclosure Requirements. None Packaging, Packing and Shipping Instructions. Product will be shipped to the following address: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center ATTN: Warehouse 2401 Centre Ave., SE Albuquerque, NM 87106 Inspection and Acceptance Criteria. Upon receipt at VA Cooperative Studies Warehouse, product will be inspected to make sure full quantity arrives in new condition, with no defects or damage by the required date of 06/09/2017. PLACE OF PERFORMANCE. N/A PERIOD OF PERFORMACE. Items must be delivered on or before June 9, 2017. DELIVERY SCHEDULE. Items must be delivered on or before June 9, 2017. ACRONYMS. CO Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts. COR Contracting Officer s Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract. CSPCRPCC Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. VAMC Department of Veterans Affairs Medical Center NMAHCS New Mexico Veterans Affairs Healthcare System cGMP Current Good Manufacturing Practices. FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (cGMP) regulations. The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, packing, and labeling of a drug product. 21 CFR Part 211, Subpart G-Packaging and Labeling Control §211.122 Materials Examination and Usage Criteria (b) Any labeling or packaging materials meeting appropriate written specifications may be approved and released for use. Any labeling or packaging materials that do not meet such specifications shall be rejected to prevent their use in operations for which they are unsuitable.