E9-12902. Food and Drug Administration Transparency Task Force; Public Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public meeting to solicit recommendations from interested persons on ways in which FDA can make useful and understandable information about FDA activities and decisionmaking more readily available to the public.

Dates and Times: The public meeting will be held on June 24, 2009, from 8 a.m. to 5 p.m. Persons interested in attending the meeting must register by June 17, 2009. Submit written or electronic comments by August 7, 2009.

Location: The public meeting will be held at the National Transportation Safety Board (NTSB) Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594.

ADDRESSES:

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number found in brackets in the heading of this document. Submit electronic registration via e-mail to [e-mail] by close of business on June 17, 2009. Transcripts of the meeting will be available for review at the Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 30 days after the meeting.

For Registration to Attend and/or to Participate in the Meeting: If you wish to attend public meeting and/or make an oral presentation at the meeting, you must register by e-mail (see ADDRESSES) by close of business on June 17, 2009. When registering, you must provide the following information: (1) Your name, title, company or organization (if applicable), address, phone number, and e-mail address and (2) if you wish to make a presentation, the specific topic or issue to be addressed and the approximate desired length of your presentation. There is no fee to register for the public meeting and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. Registration on the day of the public meeting will be permitted on a space-available basis beginning at 7:30 a.m.

We will do our best to accommodate all persons who wish to make a presentation at the meeting. FDA encourages persons and groups having similar interests to consolidate their information for presentation through a single representative. After reviewing the requests to present, we will contact each participant prior to the meeting with the amount of time available and the approximate time the participant's presentation is scheduled to begin. Presenters must then send the final electronic copies of their presentations in Microsoft PowerPoint, Microsoft Word, or Adobe Portable Document Format (PDF) to [e-mail] by June 22, 2009.

If you need special accommodations due to a disability, please inform the contact person (see FOR FURTHER INFORMATION CONTACT) by June 17, 2009.

FOR FURTHER INFORMATION CONTACT:

Afia Asamoah, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., rm. 2208, Silver Spring, MD 20993, 301-796-4625, FAX: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

Transparency promotes accountability and provides information to the public about government activities and initiatives. For FDA, providing information to the public in a timely, user-friendly manner is important to enhance the work of the agency.

Government transparency and accountability is a priority for the Obama Administration. On January 21, 2009, President Obama issued two memoranda to the heads of executive departments and agencies regarding openness in government.¹ In the memorandum on Transparency and Open Government (“Transparency and Open Government memorandum”), the Administration has pledged to take appropriate action, consistent with law and policy, to disclose information to the public rapidly, and in a form that is easily accessible and user friendly. Executive departments and agencies have been charged with harnessing new technologies to make information about agency operations and decisions available online and readily available to the public. Further, executive departments and agencies have been instructed to solicit public input to identify information of greatest use to the public.

In the Transparency and Open Government memorandum, President Obama directed the Chief Technology Officer, in coordination with the Director of the Office of Management and Budget (OMB) and the Administrator of General Services, to coordinate the development of recommendations for an Open Government Directive. This Directive, to be issued by the Director of the OMB, is to instruct executive departments and agencies to take specific actions implementing the principles set forth in this memorandum.

In the memorandum on the Freedom of Information Act (FOIA) (“FOIA memorandum”), the Administration noted that principles embodied in the FOIA express our Nation's commitment to an open government. Executive agencies were instructed to adopt a presumption in favor of disclosure with respect to all decisions involving the FOIA. The Attorney General was directed to issue new guidelines governing the FOIA to the heads of executive departments and agencies. On March 19, 2009, the Attorney General issued guidelines for implementing the FOIA in a memorandum for heads of executive departments and agencies.² Regarding the presumption of openness, the Attorney General strongly encouraged agencies to make discretionary disclosures, but also noted that the FOIA's disclosure obligation is not absolute and provides exemptions to protect, for example, national security, personal privacy, privileged records, and law enforcement interests.

In response to both Presidential memoranda, FDA has formed an internal Transparency Task Force to develop recommendations for making useful and understandable information about FDA activities and decisionmaking more readily available to the public in a timely manner and in a user-friendly format, in a manner compatible with the agency's goal of protecting confidential information, as appropriate. As a part of this process, the Task Force is holding two public meetings and establishing a public docket to seek public input on these issues. The first public meeting to solicit input from interested stakeholders on improving agency transparency, the subject of this meeting notice, will be held on June 24, 2009. The Task Force is exploring additional ways to seek input through the Internet, and is planning to hold a second public meeting in the fall of 2009. A meeting announcement describing the scope of the second meeting will be published in the Federal Register.

II. Scope of Meeting

FDA is interested in receiving comments from the public on issues related to transparency. The comments should focus on ways in which the agency should provide information to the public about what FDA is doing, the bases for the agency's decisions, and the processes used to make agency decisions. In addition to general suggestions about the ways the agency can inform the public, we are specifically interested in soliciting input on the following questions:

1. How can the agency better explain its operations, activities, processes, and decisionmaking?

2. What specific information should FDA provide about agency operations, activities, processes, and decisionmaking, including:

a. Enforcement actions?

b. Product approvals?

c. Recalls?

d. Other actions?

3. What tools, techniques, processes, or other mechanisms should FDA use to be more effective in providing useful and understandable information?

a. Internet tools?

b. Tools to improve targeting and effectiveness of communications, including risk communication?

c. Improvements to the Freedom of Information Act processes?

d. Other?

4. What, if any, legislative or regulatory changes are needed to improve FDA's ability to provide useful and understandable information to the public?

5. As FDA becomes more transparent, what information should remain confidential in order to promote key internal and external policy goals, such as preserving patient privacy, and how, in these cases, should FDA explain the importance of confidentiality?

6. What metrics should FDA use to gauge the effectiveness of its transparency efforts?

III. Request for Comments

Regardless of attendance at the public meeting, interested persons may submit written or electronic comments (see ADDRESSES). Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. To permit time for interested persons to submit data, information, or views on this subject, submit comments by August 7, 2009. Where relevant, you should annotate and organize your comments to identify the specific question addressed by the question number referenced in the previous text. Please identify comments with the docket number assigned to this notice, which is found at the heading of this document. Received comments may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. FDA is also exploring additional electronic means for the public to provide comments and feedback on this topic.

IV. Transcripts

Transcripts of the meeting will be available for review approximately 30 days after the meeting at http://www.regulations.gov and at the Division of Dockets Management (see ADDRESSES).

Dated: May 29, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

Footnotes

1.  Presidential Documents, Memorandum for the Heads of Executive Departments and Agencies on Transparency and Open Government (January 21, 2009) (74 FR 4685, January 26, 2009), available at http://www.whitehouse.gov/​open/​; Presidential Documents, Memorandum for the Heads of Executive Departments and Agencies on Freedom of Information Act (January 21, 2009) (74 FR 4683, January 26, 2009), available at http://www.gpo.gov/​fdsys/​pkg/​FR-2009-01-26/​pdf/​E9-1773.pdf.

2.  Office of the Attorney General, Memorandum for the Heads of Executive Departments and Agencies on The Freedom of Information Act (March 19, 2009), available at http://www.usdoj.gov/​ag/​foia-memo-march2009.pdf.