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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Procedure for Commenting on FDA Matters

Subject:
Preferred Procedure for Commenting on FDA Matters Published in the Federal Register
Area:
Operations Management
Date Revised:
September, 20 1995

 

 

PURPOSE

To provide the preferred procedure to ORA field and headquarters personnel for submitting comments on FDA matters published in the Federal Register.

BACKGROUND AND POLICY

ORA field and headquarters personnel may want to comment on FDA matters published in the Federal Register. Comments from ORA personnel acting in their official capacity may be prepared on intra-agency memoranda and submitted through their supervisor and the Director, Division of Compliance Policy (HFC-230).

Comments submitted through a supervisor and the Division of Compliance Policy will receive attention and may be forwarded to the public docket file if the Director, Division of Compliance Policy deems it appropriate.

In addition, ORA employees are encouraged to informally bring to the attention of the Division of Compliance Policy omissions and typographical errors concerning FDA matters appearing in the Federal Register.

Employees acting in their personal capacity may submit comments to the contact person identified in the announcement.