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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Field Distribution of Hardcopy Reports to Headquarters Units

Subject:
Field Distribution of Hardcopy Reports to Headquarters Units
Area:
Operations Management
Date Revised:
September, 5 1995

 

 

PURPOSE

To provide a general reference for packaging and mailing hardcopy reports from field offices to headquarters units.

BACKGROUND

Compliance Programs, Compliance Program Circulars, and assignments (CPs and assignments) provide instructions for field submission of hardcopy reports (EIRs, Worksheets, Sample Summaries, etc.) to headquarters to meet specific needs. This FMD provides general instructions for submitting hardcopy reports to headquarters.

Note: Electronic reporting (LMS, COMSTAT, etc.) in lieu of hardcopy reporting is encouraged.

PROCEDURES

All copies of a report destined for headquarter unit(s) shall be clear, legible and signed by the investigator, inspector, and/or analyst, and by the endorsing official.

Districts will in all cases retain the original EIR, Worksheet, or other hardcopy records.

A. ROUTING

1. Hardcopy Reports Specifically Identified in the Field Reporting Requirements Section of the Compliance Program

Send one copy of each required document as directed in the reporting section. The Centers will make additional copies for distribution to their own offices. If the report covers more than one program within the Center, clearly identify the Programs and the Program Assignment Codes (PACs) in the "Reason for Referral" block on the EIR, coversheet, optional Form 41, or other routing slip.

If hardcopy reports cover more than one Center, a separate copy must be sent to each Center.

2. Additional Routing for EIRs
a. EIRs Classified "Official Action Indicated"

Submit a separate copy of each EIR with exhibits to:

- The Administrative Files - Records Section, HFA-224

- When the report involves an injury or illness

-- Division of Emergency and Epidemiological Operations, ORA, HFC-160 (As of October 1, 1995 this office will merge with Division of Field Investigations to become Division of Emergency and Investigational Operations), and

-- the respective Center inspection & surveillance unit.

b. EIRs Classified "No Action Indicated" or "Voluntary Action Indicated"
Always submit a separate copy of each Computer Generated Coversheet (FD 481CG) to: The Administrative Files - Records Section, HFA-224. Only the Computer Generated Coversheet needs to be submitted for EIRs showing a correction of previously violative products or firms.
c. EIRs Classified "Out of Business" or "Not Official Establishment Inventory"

Submit only the Computer Generated Coversheet (FD-481CG) to:

- The Administrative Files - Records Section, HFA-224 and

- The Center unit(s) responsible for registration if the inspection relates to a registered firm (see FMD No. 92).

d. EIRs Classified "Referred to Center"
Submit one copy of each report temporarily classified as "Referred to Center," including all necessary exhibits, to the appropriate Center unit. After final classification, route reports according to the final classification.

B. IDENTIFYING and PACKAGING PROCEDURES

1. Establishment Inspection Reports

- Assemble and route EIRs with the Endorsement (FD 481(E)-CG) on top making sure the routing symbol(s) are properly, entered on the endorsement sheet and the FD 481(A)-CG.
- Circle the routing symbol of the headquarters unit for which that copy of the report is intended.
- All documents (inspection reports, photographs*, exhibits, labeling) relating to the same EIR must be stapled or banded together, or preferably, put in a single U.S. Government Messenger Envelope (Standard Form 65-B). Do not use paper clips, since other records can easily become attached to the clips and be misrouted.
*Do not routinely submit photographs unless directed by the CP, or assignment.
- Multiple copies of EIRs being mailed to different headquarters unit(s) (Centers, ORA, etc.) must be separately identified and separately packaged (U.S. Government Messenger Envelope, box, etc.) so the mail rooms can make distribution to each unit indicated.

2. Collection Reports, Worksheets, etc.

Staple an Optional Form 41 or other routing slip on top of the package. Do not use paper clips since other records can easily become attached to the clips and cause misrouting.

Designate the headquarters unit and the program requiring the submission. Date and legibly sign the routing slip so that any questions may be directed to the responsible individual.

C. MAILING

To ensure efficient handling by mail room personnel, all mailing containers (envelopes, boxes, etc.) shall be identified with the proper headquarters address and mailing symbol, even if the envelopes are being sent to different offices within the same Center. Staff Manual Guide f:2280.2 requires adequate protection of privileged information in transit.

D. SPECIAL INSTRUCTIONS

When an initial report on an establishment is submitted to the Records Section, the following items are important to establish a headquarters' file: legal status, including subsidiary, parent and/or related firms (show CF Number); correct spelling and precise firm names; and length of the time the firm has been in business.


DISTRIBUTION:             Regional Food and Drug Directors and District Directors; FDA Headquarters Offices

ISSUED BY:                  ORA/ORO/Division of Emergency and Investigational Operations (HFC-130)

AUTHORITY:                  ORA

PUBLICATION DATE:  8/96