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U.S. Department of Health and Human Services

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Guidance Development


Background

Summary of Comments

Considerations

Transparency Report Arrow View All Guidance Development Actions and Draft Proposals


Actions and Draft Proposals

Actions:

Action 11:

To examine suggestions for improving the guidance process, the Commissioner has formed a cross-agency working group under the leadership of the Office of Policy.  This working group is examining the current process and will identify best practices for improving the agency’s work on guidance.  Topics include streamlining guidance development, reducing the time between issuance of draft and final guidance, and making it easier to find guidance documents on the FDA Web site.

Reasoning:

The Commissioner has determined that to improve the guidance development process in a meaningful way, a broader, more in-depth review of the process is necessary.  As a result, a working group of senior regulatory policy leads from across the agency has been convened under the leadership of the Office of Policy to identify best practices for improving FDA’s efficiency at issuing final guidance documents.  The working group will summarize their review of the guidance development process and make recommendations, as appropriate, by the end of FY 2011.

Action 12:

FDA will describe the ways in which interested individuals can provide input to the agency about guidance development as part of the web-based resource, FDA Basics for Industry.  Links that provide industry with a list of guidance documents that have been withdrawn during the past year as well as possible topics for future guidance development or revision also will be made accessible in one location via FDA Basics for Industry.

Reasoning:

Based on comments the Task Force received about providing input to the agency regarding guidance development, the Task Force decided to make explanations of the different ways in which the public can participate in, and learn about, guidance development, more accessible on the FDA Web site.  As a result, FDA will provide this information on FDA Basics for Industry.

Draft Proposals:

Draft Proposal 3:

FDA will inform industry about the progress of certain high priority guidances in development by disclosing a timeline from the start of the agency’s work on a draft guidance to publication of the final guidance.

Reasoning:

FDA currently discloses a list of guidance documents the agency may work on during the next year.  But priority items are not indicated and the target date for publication of the final guidance document is not provided.  Timely, relevant guidance supports efforts by industry to comply with the law and develop novel products that may benefit the public health.

After consulting with HHS and OMB, FDA has decided to provide timelines associated with the guidance development process in an effort to provide more predictability and clarity.  FDA will track the progress of certain high priority guidance documents  and will disclose the following milestone dates (including status of the milestone):  (1) when FDA begins work on the guidance, (2) publication of the draft guidance, (3) the close of the comment period for the draft guidance, and (4) publication of the final guidance.  This information will be tracked on FDA-TRACK.  If implemented, an example of what would be provided is below.

 

fda track