[Federal Register Volume 74, Number 191 (Monday, October 5, 2009)]
[Notices]
[Pages 51161-51163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23916]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Food and Drug Administration Transparency Task Force; Public 
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a second 
public meeting to discuss issues related to transparency at the agency. 
The purpose of this public meeting is to receive detailed and in-depth 
comments on three specific issues related to

[[Page 51162]]

transparency at FDA. The topics to be covered are early communication 
about emerging safety issues concerning FDA-regulated products, 
disclosure of information about product applications that are abandoned 
(which means that no work is being done or will be undertaken to have 
the application approved) or withdrawn by the applicant before 
approval, and communication of agency decisions about pending product 
applications.

DATES: The public meeting will be held on November 3, 2009, from 9 a.m. 
to 3 p.m. Persons interested in attending and/or participating in the 
meeting must register by 5 p.m. on October 27, 2009. Submit electronic 
or written comments by November 6, 2009.

ADDRESSES: The public meeting will be held at the National 
Transportation Safety Board Conference Center, 429 L'Enfant Plaza, SW., 
Washington, DC 20594. 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. 
Submit electronic registration by e-mail to 
[email protected].
    For Registration to Attend and/or to Participate in the Meeting: If 
you wish to attend the public meeting, you must register by e-mail (see 
ADDRESSES) by close of business on October 27, 2009. When registering, 
you must provide the following information: (1) Your name, (2) title, 
(3) company or organization (if applicable), (4) mailing address, (5) 
telephone number, and (6) e-mail address.
    At the time of registration, if you wish to participate in one of 
the three planned discussion groups, you must indicate which discussion 
group(s), in rank order (see section III. Issues for Discussion). 
Please also submit a brief statement that describes your experience 
with the discussion topic and/or the general nature of what you would 
like to present about the discussion topic. The Transparency Task Force 
(``Task Force'') is seeking participants interested in engaging in an 
in-depth discussion about the considerations and principles the agency 
should consider with respect to communicating to the public about each 
of the issues outlined below (see section III. Issues for Discussion).
    Each discussion group will include 4 to 6 people. Only one 
participant from an organization or company will be assigned to a 
discussion group. FDA will attempt to have a range of stakeholders 
participate in each discussion group. Participants will be contacted 
prior to the meeting with the approximate time the discussion group is 
scheduled to begin. Others in attendance at the public meeting will 
have an opportunity to listen to the discussion and comment on the 
issues discussed during the public comment period that will occur after 
each discussion group.
    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.
    If you need special accommodations due to a disability, please 
contact Afia Asamoah (see FOR FURTHER INFORMATION CONTACT) by October 
27, 2009.

FOR FURTHER INFORMATION CONTACT: Afia Asamoah, Office of the 
Commissioner, Food and Drug Administration, Bldg. 1, rm. 2220, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4625, FAX: 
301-847-3531, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On January 21, 2009, President Obama's first full day in office, 
the President issued a memorandum to the heads of executive departments 
and agencies on transparency and openness in government. The memorandum 
expressed the Administration's commitment to achieve ``an unprecedented 
level of openness in Government'' and instructed executive departments 
and agencies to solicit public input to identify information of 
greatest use to the public. Executive departments and agencies were 
also charged with harnessing new technologies to make information about 
agency operations and decisions available online and readily available 
to the public.
    In response to the Administration's commitment to promote 
transparency in government, FDA formed an internal Task Force to 
consider how to make FDA and its processes more transparent to the 
public. The Task Force is soliciting input from the public 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, while appropriately 
protecting confidential information. To solicit public input on 
improving agency transparency, the Task Force established a public 
docket, launched an online blog, and held a public meeting in June. At 
the first public meeting, the Task Force posed six questions about 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.\1\
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    \1\ See 74 FR 26712, June 3, 2009.
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    Based on the comments received to date, the Task Force is holding a 
second public meeting to solicit in-depth and detailed comments on 
three specific issues related to transparency at the agency.

II. Second Public Meeting

    The objective of the second public meeting on transparency is for 
the Task Force to receive public input and hear different points of 
view about the agency's communications about, and public disclosures of 
information about, the following issues:
    (1) Emerging safety issues concerning FDA-regulated products,
    (2) Product applications that are abandoned (no work is being done 
or will be undertaken to have the application approved) or withdrawn by 
the applicant before approval, and
    (3) Agency decisions about pending product applications.
    The Task Force is interested in focused, detailed comments about 
the considerations and principles the agency should assess regarding 
its communications to the public about the topics outlined in the 
previous paragraphs.
    The second public meeting will be conducted as a series of three 
moderated discussion groups covering these three topics. The specific 
topic for each discussion will be presented in the form of a case 
study. Only one discussion group will be held at a time. Following each 
moderated discussion, Task Force members may ask questions of the 
participants in each discussion group. Others in attendance at the 
public meeting then will have an opportunity to comment on the issues 
discussed during the public comment period that will occur after each 
discussion group.
    At least 7 days in advance of the meeting, the initial scenarios of 
the case studies for each of the three topics will be made available on 
the Internet. The initial scenarios will be placed on file in the 
public docket (docket number found in brackets in the heading of this 
document), which is available at http://www.regulations.gov. The 
initial scenarios will also be available on

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FDA's Web site at http://www.fda.gov/transparency along with the agenda 
for this meeting. The complete case studies will be available in the 
same locations after the public meeting.

III. Issues for Discussion

    The discussion of the three issues described in the following 
section of this document should not be limited by current statutes or 
regulations, as the proposals the Task Force develops may include 
recommendations for changes to current law.

A. Emerging Safety Issues Concerning FDA-Regulated Products

    When FDA receives safety information associated with a marketed 
FDA-regulated product, e.g., medical device, drug, biologic, dietary 
supplement, cosmetic, or food (including ingredients and food 
additives), FDA evaluates the information in deciding whether and what 
actions to take, such as regulatory action regarding the product. FDA 
will continue to receive, gather, and evaluate additional information 
to further inform its decisions.
    During this process, while still evaluating the situation, FDA may 
communicate with the public based on the agency's current analysis of 
the available information about the situation. For example, the agency 
may issue an early communication about its ongoing safety review of a 
drug, device, or biologic, or may issue an early communication advising 
consumers not to eat a certain type of food that may be linked to a 
foodborne illness or to stop using a certain dietary supplement that 
may be associated with adverse events.
    The Task Force is interested in discussing the principles the 
agency should use when deciding whether to issue an early communication 
about a potential problem with an FDA-regulated product. For example, 
when is it appropriate, or not appropriate for the agency to advise the 
public about a possible, but unconfirmed foodborne illness outbreak or 
to issue an early communication about an emerging safety issue with a 
medical product, dietary supplement, or cosmetic? If appropriate, how 
should this information be conveyed to the public so that it is useful 
and does not cause unfounded or unnecessary concern about the product? 
And what mechanisms (e.g., Internet, mass media, cell phones, direct 
outreach to health professional and patient organizations) should FDA 
use to effectively reach the target audiences in a timely manner?

B. Product Applications That Are Abandoned (Which Means That No Work is 
Being Done or Will Be Undertaken to Have the Application Approved) or 
Withdrawn By the Applicant Before Approval

    The Task Force is interested in discussing the principles and 
considerations the agency should apply to disclosure of data contained 
in product applications that are abandoned during the approval process 
or withdrawn before approval by the applicant. The Task Force would 
also like to receive comments on whether the considerations governing 
treatment of these data should depend on the reason the product 
application was abandoned or withdrawn.

C. Communicating Agency Decisions About Pending Product Applications

    The Task Force is interested in discussing what information about 
pending product applications should be disclosed. Should the agency 
inform the public when:
     A marketing application seeking approval of a drug or 
biologic is submitted to the agency for review?
     A marketing application seeking approval or clearance of a 
medical device is submitted to the agency for review?
    When the agency does not approve a marketing application for a drug 
or biologic, it issues a letter that informs the applicant of FDA's 
determination not to approve the application in its current form, 
identifying all apparent deficiencies in the application. Should the 
agency disclose to the public a determination not to approve a 
marketing application for a drug or biologic? What, if any, information 
should the agency disclose about the determination not to approve the 
application? What, if any, information contained in the response letter 
should the agency disclose? What principles should the agency apply in 
making these determinations?
    When the agency does not approve a premarket application (PMA) for 
a medical device, it may issue a ``not approvable'' letter that informs 
the applicant of FDA's determination not to approve the application in 
its current form. When the agency does not clear a device submitted 
through the 510(k) process, a ``not substantially equivalent'' (NSE) 
letter is issued to the applicant. Should the agency disclose to the 
public a determination not to approve or clear a marketing application 
for a medical device? What, if any, information should the agency 
disclose about the determination not to approve or clear the 
application? What, if any, information contained in the not approvable 
letter or the NSE letter should the agency disclose? What principles 
should the agency apply in making these determinations?

IV. 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 to http://www.regulations.gov or two 
paper copies of any mailed comments, except that individuals may submit 
one paper copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

V. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23916 Filed 10-2-09; 8:45 am]
BILLING CODE 4160-01-S