Attach_1_Materials_List[1].pdf

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

Attachment 1: Material List

Provided by FDA to Contractor

Provided by FDA to Contractor via the TIMS Database

Provided/Purchased by Contractor

Equipment/Supplies:

• iPhones (built-in camera) o 2 levels of passwords o Battery pack o Wall charger o Car charger o Stylus (upon request) o iPhone case

• Commissioning Credentials for inspectors and Program Coordinator (sent by FDA/DFSR to Program Coordinator to hold until appropriate time to disseminate)

• Commissioning Certificates for administrative personnel (sent by FDA/DFSR to Program Coordinator to hold until appropriate time to disseminate)

Forms/Tools:

• Form FDA-415A (FDA

Official Seal)

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

• iPhone return form

• Narrative Report

Templates

• Sample Quarterly Report

Form

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

• Invoice Request Instructions for FDA

Forms/Tools:

• Undercover buy compliance check inspection form

• Advertising and labeling compliance check inspection form

• Other required forms to be filled out during inspections

• Training Manual

Equipment/Supplies:

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

• Computers (including keyboard and mouse, if applicable)

• 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

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

Provided by FDA to Contractor

Provided by FDA to Contractor via the TIMS Database

Provided/Purchased by Contractor

Cost Reimbursement Type Contracts (document providing guidance for submitting invoices)

Training Materials:

• Training manual and other resource materials

• Exam 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.