[Federal Register Volume 74, Number 191 (Monday, October 5, 2009)]
[Notices]
[Pages 51161-51163]
From the Federal Register Online via the Government Printing 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
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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the application approved) or withdrawn by the applicant before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
Transparency.Meeting@fda.hhs.gov.
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, Afia.Asamoah@fda.hhs.gov.
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