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Communicating Information About Agency Procedures


Background

Summary of Public Comments

Considerations

Transparency Report Arrow View All Communicating Information About Agency Procedures Actions and Draft Proposals


Actions and Draft Proposals    

Actions:

Action 1:

FDA will develop a web-based resource called FDA Basics for Industry that will provide basic information online about the regulatory process governing FDA-regulated products, and include information that is frequently requested by industry.

Action 2:

FDA will update the agency organizational charts and senior leadership personnel changes on the FDA Web site on at least a quarterly basis and ensure that the level of detail provided on the organizational charts is consistent across the agency.

Action 3:

Each Center has a process for industry to submit general regulatory questions, and for directing inquiries to individuals with additional expertise, if necessary.  Links to these processes will be made available on FDA Basics for Industry.

Action 4:

If a general question about an existing policy, regulation, or the regulatory process is submitted to any of the email addresses specified below, whenever practicable, FDA should provide a response within 5 business days or acknowledge receipt of the inquiry and provide an approximate timeframe for response.  This will be tracked on FDA-TRACK.

Read the Reasoning for Action 4

Action 5:

In September 2010, FDA issued its “Strategic Priorities FY 2011-2015” in draft form for public comment.  FDA will issue a final version of the “Strategic Priorities FY 2011-2015” by March 2011.

Action 6:

FDA will post on the FDA Web site slide presentations that are delivered by FDA employees to external audiences at events sponsored by, or co-sponsored by, the agency.

Draft Proposals:

Draft Proposal 1:

FDA should maintain on the FDA Web site a list of presentations given by FDA employees to external audiences.

Draft Proposal 2:

When the Office of the Commissioner (OC) receives a request to reconsider a scientific decision of an FDA employee from an interested person outside the agency pursuant to 21 C.F.R. § 10.75, OC should inform the submitter within three weeks whether OC will review the request, and should inform the submitter when a decision or an update on the status of the review may be expected.