Attachment_1_-_List_of_Materials.doc

Attachment 1: Material List

Equipment/Supplies:

· iPhones

· Wall charger

· Car charger

· Stylus

· iPhone case

· Commissioning Credentials/Certificates for inspectors, Program Coordinators, and administrative personnel as appropriate (sent by FDA/DFSR to Program Coordinator to hold until appropriate time to disseminate)

· Laptops for PC and Backup PC

· PIV Cards for PC and Backup PC (necessary to log onto laptops)

Forms/Tools:

· Form FDA-415A (FDA Official Seal)

· Form FDA-482 (Notice of Inspection) carbon copies

· iPhone return form (upon request)

· Sample Monthly Report Form

· FDA Contract Invoice form (Recommended form to submit invoice info)

· Invoice Request Instructions for FDA Cost Reimbursement Type Contracts (document providing guidance for submitting invoices)

TIMS

· Required forms to complete UB and A&L compliance check inspections.

· TIMS Training Manual

LMS

· Training materials and modules Exams Equipment/Supplies:

· Digital cameras (including memory cards and batteries for cameras)

· Computers (including keyboard and mouse, if applicable) for individuals other than the PC and Backup-PC

· Printers/fax/scanner (including ink cartridges)

· Regulatory notebooks (bound)

· Ballpoint pens

· Permanent marker pens

· Resealable plastic bags

· Small labels to place on evidence

· CD-Rs for the official CD copy (for manual, digital camera process)

· CD-RWs or CD-Rs for working CD copy (for manual, digital camera process)

· Envelopes for CDs

· Boxes and/or large envelopes for inspection packages

· Secure storage for records and inspection packages

Forms/Tools*:

· Proof of insurance for minors against accidents or other injuries

· Parental consent forms for minors

· Permission slips from the school for the minors (if applicable)

· Grant of immunity from proper authorities for minors, if applicable

· Employee records for all employees, including identification verification records

· Training record/log for all employees

· Training completion certificate for “other” personnel, minors, and, if applicable, adult supervisors/chaperones

· Time and attendance records for all employees

· Inspection log or other activity tracking tool

· Time tracking tool for minors and, if applicable, adult supervisors/chaperones during inspections for reimbursement purposes

· Overnight mail service that includes tracking

· Evidence/Chain-of-Custody Log while in storage with the Contractor

Unless otherwise agreed to, the non-exclusive list of the prohibited items is as follows:

· Recording equipment (e.g., electronic surveillance or wiretapping)

· Guns or ammunition

· Purchase of vehicles. Contractors may lease vehicles or personnel may be reimbursed for mileage used on POVs.

· All documents are to be maintained by Contractor and made available to FDA upon request.