2011-71. FDA Transparency Initiative: Improving Transparency to Regulated Industry

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability; request for comments.

SUMMARY:

As part of the third phase of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled “FDA Transparency Initiative: Improving Transparency to Regulated Industry.” The report includes 19 action items and 5 draft proposals to improve transparency to regulated industry. FDA is seeking public comment on the content of the draft proposals, as well as on which draft proposals should be given priority.

DATES:

Submit electronic or written comments by March 8, 2011.

ADDRESSES:

Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets at the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Ann Witt, Office of Policy, Planning, and Budget, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 32, rm. 4226, Silver Spring, MD 20993, 301-796-7463, FAX: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background on the FDA Transparency Initiative

In January 2009, President Obama issued a memorandum on Transparency and Open Government calling for an “unprecedented level of openness in Government” and directing the Director of the Office of Management and Budget (OMB) to issue an Open Government Directive instructing executive departments and agencies to take specific actions to implement the principles of transparent, collaborative, and participatory government. The Open Government Directive was issued December 8, 2009. Under the leadership of Secretary of Health and Human Services, Kathleen Sebelius, the U.S. Department of Health and Human Services has also prioritized transparency and openness. In June 2009, the Commissioner of Food and Drugs (the Commissioner), Dr. Margaret Hamburg, launched FDA's Transparency Initiative to implement these efforts at FDA.

The initiative is overseen by a Task Force representing key leaders of FDA. The internal Task Force is chaired by the Principal Deputy Commissioner of FDA and includes five of the Agency's center directors, the Chief Counsel, the Associate Commissioner of Regulatory Affairs, and the Chief Scientist. The Task Force is charged with submitting a written report to the Commissioner on the Task Force's findings and recommendations.

The Task Force has held two public meetings,^[1] launched an online blog (http://fdatransparencyblog.fda.gov/​), and opened a docket. The online blog and the docket received over 1,500 comments. The blog, which is ongoing, has offered an opportunity for exchange about specific ideas for transparency at the Agency.

The Task Force is proceeding with the Transparency Initiative in three phases:

• Phase I: FDA Basics.
• Phase II: Public Disclosure.
• Phase III: Transparency to Regulated Industry.

Phase I is intended to provide the public with basic information about FDA and how the Agency does its work. In early January 2010, FDA launched a Web-based resource called FDA Basics (http://www.fda.gov/​fdabasics). The resource now includes (1) 158 questions and answers about FDA and the products that the Agency regulates, (2) 9 short videos that explain various FDA activities, and (3) 14 conversations with FDA officials about the work of their offices. Each month, senior officials from FDA product centers and offices host online sessions about a specific topic and answer questions from the public about that topic. FDA uses the feedback provided by the public to update this resource.

Phase II relates to FDA's proactive disclosure of information the Agency has in its possession, and how to make information about Agency activities and decisionmaking more transparent, useful, and understandable to the public, while appropriately protecting confidential information. On May 19, 2010, FDA released a report that contains 21 draft proposals about expanding the disclosure of information by FDA while maintaining confidentiality for trade secrets and individually identifiable patient information.

The Task Force solicited comment on the content of the proposals, as well as on which draft proposals should be given priority, for 60 days. The Task Force is reviewing the comments received and will recommend specific proposals to the Commissioner for consideration. The Task Force's recommendations will consider feasibility and priority, considering other Agency priorities that require resources. Not all of these proposals will necessarily be implemented. Some may require changes in law or regulation; some may require a substantial amount of resources.

Phase III is the subject of this document and is described in more detail in section II of this document.

II. Phase III: Transparency to Regulated Industry

The third phase of the Transparency Initiative addresses ways FDA can become more transparent to regulated industry to foster a more efficient and cost-effective regulatory process.

Regulated industry provides the public with food, drugs, medical devices, cosmetics, and other widely used and important consumer products. FDA's mission is to protect and promote the public health through oversight of these products.

In order to succeed, FDA must clearly communicate standards and expectations to industry. Communicating requirements and expectations to industry in a more accessible manner promotes understanding of, and compliance with, rules set up to protect the supply of food and medical products.

In response to a request for input from FDA on this topic in March 2010 (75 FR 11893, March 12, 2010), regulated companies requested additional transparency about the standards to which their products are held, the process for soliciting guidance from the Agency, and the progress of regulatory efforts at the Agency. In the report, FDA outlines 19 action items and 5 draft proposals to improve transparency to regulated industry.

The Task Force is soliciting comment on the content of the five draft proposals, as well as on which draft proposals should be given priority, for 60 days. After considering public comment on the draft proposals, the Task Force will recommend specific proposals to the Commissioner for consideration. FDA will begin to implement the action items in the report in 2011.

III. Request for Comments

FDA is interested in receiving comments from the public about the content of the five draft proposals as well as on which draft proposals should be given priority. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Identify the draft proposal which your comment addresses by the number assigned to that proposal. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: January 1, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

Footnotes

1.  Transcripts and the webcast from both public meetings are available on the FDA Web site, http://www.fda.gov/​transparency.