Food and Drug Administration Transparency Task Force; Public Meeting; Request for Comments, 51161-51163 [E9-23916]
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Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
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.
Dated: September 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23866 Filed 9–30–09; 11:15 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0447]
Draft Guidance for Industry on
Helicobacter pylori-Associated
Duodenal Ulcer Disease in Adults:
Developing Drugs for Treatment;
Availability
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Helicobacter pyloriAssociated Duodenal Ulcer Disease in
Adults: Developing Drugs for
Treatment.’’ The purpose of this draft
guidance is to assist sponsors in clinical
drug development for the treatment of
adults with duodenal ulcers caused by
H. pylori for the reduction of duodenal
ulcer recurrence. Specifically, this
guidance addresses FDA’s current
thinking regarding the overall
development program and clinical trial
designs to support antimicrobialcontaining H. pylori treatment regimens.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by January 4, 2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. See the
VerDate Nov<24>2008
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51161
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
FOR FURTHER INFORMATION CONTACT:
Joette M. Meyer, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6130,
Silver Spring, MD 20993–0002, 301–
796–1600.
SUPPLEMENTARY INFORMATION:
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Helicobacter pylori-Associated
Duodenal Ulcer Disease in Adults:
Developing Drugs for Treatment.’’ The
purpose of this draft guidance is to
assist sponsors in clinical antimicrobial
drug development for the treatment of
adults with duodenal ulcers caused by
H. pylori for the reduction of duodenal
ulcer recurrence. This guidance, when
finalized, will supersede advice given in
the draft guidance for industry entitled
‘‘Evaluating Clinical Studies of
Antimicrobials in the Division of AntiInfective Drug Products,’’ published in
1997, which contains section V,
regarding indication 25 H. pylori.
This draft guidance pertains to
development of drugs for the treatment
of adults with duodenal ulcers. It does
not address treatment of children, or
those with other conditions also
associated with H. pylori, including
gastric ulcers and non-ulcer dyspepsia.
Currently approved regimens for the
treatment of adults with duodenal
ulcers consist of multiple drugs used in
combination. We anticipate that drug
development for new drugs or regimens
will occur in one of three ways: (1)
Substitution of a new drug for one
component of an approved regimen, (2)
addition of a new drug to an approved
regimen, and (3) development of a new
regimen not studied previously. The
draft guidance provides information on
the type of study design and supportive
information that should be provided for
each of these development paths.
Information is also provided regarding
microbiological procedures and use of
diagnostic testing to determine subject
evaluability.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on developing drugs for the treatment of
H. pylori-associated duodenal ulcer
disease in adults. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
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III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23875 Filed 10–2–09; 8:45 am]
BILLING CODE 4160–01–S
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.
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
E:\FR\FM\05OCN1.SGM
05OCN1
cprice-sewell on DSK2BSOYB1PROD with NOTICES
51162
Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
transparency at FDA. The topics to be
covered are early communication about
emerging safety issues concerning FDAregulated 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
https://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
VerDate Nov<24>2008
14:59 Oct 02, 2009
Jkt 220001
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
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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
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 https://
www.regulations.gov. The initial
scenarios will also be available on
1 See
E:\FR\FM\05OCN1.SGM
74 FR 26712, June 3, 2009.
05OCN1
Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
FDA’s Web site at https://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.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
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 FDAregulated 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?
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51163
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 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?
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.
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 https://
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.
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
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V. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://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
DEPARTMENT OF HOMELAND
SECURITY
Customs and Border Protection
Agency Information Collection
Activities: Delivery Ticket
AGENCY: U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 60-Day Notice and request for
comments; Extension of an existing
collection of information: 1651–0081.
SUMMARY: As part of its continuing effort
to reduce paperwork and respondent
burden, CBP invites the general public
and other Federal agencies to comment
on an information collection
requirement concerning the Delivery
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
---------------------------------------------------------------------------
\1\ See 74 FR 26712, June 3, 2009.
---------------------------------------------------------------------------
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 https://www.regulations.gov. The
initial scenarios will also be available on
[[Page 51163]]
FDA's Web site at https://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 https://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 https://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
