[Federal Register Volume 74, Number 105 (Wednesday, June 3, 2009)]
[Pages 26712-26713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12902]



Food and Drug Administration

[Docket No. FDA-2009-N-0247]

Food and Drug Administration Transparency Task Force; Public 

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 Transparency.Meeting@fda.hhs.gov 
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 
Transparency.Meeting@fda.hhs.gov 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: 301-847-3531, e-
mail: Afia.Asamoah@fda.hhs.gov.


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.

    \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.

    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

[[Page 26713]]

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.

    \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.

    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 

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 
    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.
[FR Doc. E9-12902 Filed 6-2-09; 8:45 am]