Food and Drug Administration's Communication of Drug Safety Information; Public Hearing, 57607-57609 [05-19759]
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Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices
NOTIFICATION PROCEDURE:
For the purpose of access, the subject
individual should write to the system
manager who will require the system
name, address, age, gender type, and, for
verification purposes, the subject
individual’s name (woman’s maiden
name, if applicable).
care funds. The duration of the grant is
12 months.
Statutory Authority: This award will be
made pursuant to the Child Care and
Development Block Grant Act of 1990 as
amended (CCDBG Act); section 418 of the
Social Security Act; Consolidated
Appropriations Act, 2001 (Pub. L. 106–554).
FOR FURTHER INFORMATION CONTACT:
RECORD ACCESS PROCEDURE:
Shannon Rudisill, Director of Technical
Assistance, Child Care Bureau, at 202–
205–8051.
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR
5b.5(a)(2)).
Dated: September 27, 2005.
Joan E. Ohl,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. 05–19650 Filed 9–30–05; 8:45 am]
BILLING CODE 4184–01–P
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005P–0376]
Iceberg Water Deviating From Identity
Standard; Temporary Permit for Market
Testing
AGENCY:
Food and Drug Administration,
HHS.
None.
Notice.
[FR Doc. 05–19676 Filed 9–30–05; 8:45 am]
ACTION:
BILLING CODE 4120–03–P
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a temporary permit has been issued
to Canada’s Original ICEBERG Water
Corp., to market a product designated as
‘‘Canada’s Original Iceberg Water’’ that
deviates from the U.S. standard of
identity for bottled water. The purpose
of the temporary permit is to allow the
applicant to measure consumer
acceptance of the product, identify mass
production problems, and assess
commercial feasibility.
DATES: This permit is effective for 15
months, beginning on the date the
permit holder introduces or causes the
introduction of the test product into
interstate commerce, but not later than
January 3, 2006.
FOR FURTHER INFORMATION CONTACT:
Loretta A. Carey, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–2371.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 130.17
concerning temporary permits to
facilitate market testing of foods
deviating from the requirements of the
standards of identity issued under
section 401 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341), FDA
is giving notice that a temporary permit
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Administration on Children, Youth, and
Families; Notice of Award of NonCompetitive Grant
Administration on Children,
Youth and Families, ACF, HHS.
ACTION: Award announcement.
AGENCY:
SUMMARY: The Administration on
Children, Youth and Families herein
announces an urgent grant award to the
National Association of Child Care
Resource and Referral Agencies
(NACCRRA) to provide technical
assistance to reestablish the operations
of the resource and referral agencies in
Mississippi and Louisiana whose
operations have been disrupted by
Hurricane Katrina. This grant will help
to re-establish child care referral
services so that families along the Gulf
Coast can find child care. This grant
will also support local and Statewide
inventories of child care need and
availability.
The amount of the proposed grant to
NACCRRA is $99,500 in FY 2005 child
VerDate Aug<31>2005
17:26 Sep 30, 2005
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57607
has been issued to Canada’s Original
ICEBERG Water Corp., 23 Lesmill Rd.,
suite 304, Toronto, Ontario Canada,
M3B–3P6.
The permit covers limited interstate
marketing tests of products identified as
‘‘Canada’s Original Iceberg Water’’ that
deviate from the U.S. standard of
identity for bottled water (§165.110 (21
CFR 165.110)) in that the source of the
water is an iceberg. The test product
meets all the requirements of the
standard with the exception of the
source definition. The purpose of this
permit is to test the product throughout
the United States, in order to allow the
applicant to measure consumer
acceptance of the product, identify mass
production problems, and assess
commercial feasibility.
This permit provides for the
temporary marketing of 500,000 cases of
the 24 x 500 milliliter bottles and
500,000 cases of the 12 x 1 liter bottles,
totaling 1 million cases per year. The
total fluid quantity covered by this
application is 12 million liters
(3,170,065 gallons). The test product
will be manufactured for Canada’s
Original ICEBERG Water Corp., by
Discovery Springs, Daniel’s Point Rd.,
Trepassey, Newfoundland, Canada
A0A–4B0. Canada’s Original ICEBERG
Water Corp. will distribute the test
products throughout the United States.
The information panel of the labels will
bear nutrition labeling in accordance
with 21 CFR 101.9. The bottled water
will be manufactured in accordance
with the quality standards in §165.110
and the requirements for processing and
bottling of bottled drinking water in 21
CFR part 129. This permit is effective
for 15 months, beginning on the date the
food is introduced or caused to be
introduced into interstate commerce,
but not later than January 3, 2006.
Dated: September 22, 2005.
Barbara Schneeman,
Director, Office of Nutritional Products,
Labeling, and Dietary Supplements, Center
for Food Safety and Applied Nutrition.
[FR Doc. 05–19728 Filed 9–30–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0394]
Food and Drug Administration’s
Communication of Drug Safety
Information; Public Hearing
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\03OCN1.SGM
03OCN1
57608
Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices
Notice of public hearing; request
for comments.
ACTION:
SUMMARY: The Center for Drug
Evaluation and Research (CDER) of the
Food and Drug Administration (FDA) is
announcing a public hearing on the
Center’s current risk communication
strategies for human drugs. The public
hearing announced in this notice is part
of the agency’s ongoing effort to
improve CDER’s risk communication.
The purpose of the public hearing is to
obtain public input on CDER’s current
risk communication tools, identify
stakeholders for collaboration and
implementation of additional tools, and
obtain greater understanding of the
strengths and weaknesses of CDER’s
existing risk communication.
DATES: The public hearing will be held
on December 7 and 8, 2005, from 8 a.m.
to 4:30 p.m. Submit written or
electronic notices of participation and
comments for consideration at the
hearing by November 7, 2005. Written
or electronic comments will be accepted
after the hearing until January 9, 2006.
The administrative record of the hearing
will remain open until January 9, 2006.
ADDRESSES: The public hearing will be
held at the National Transportation and
Safety Board Boardroom and Conference
Center, 429 L’Enfant Plaza, SW.,
Washington, DC 20594 (Metro: L’Enfant
Plaza Station on the Green, Yellow,
Blue, and Orange Lines). Submit written
or electronic notices of participation
and comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852;
https://www.fda.gov/dockets/ecomments.
Transcripts of the hearing will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.fda.gov/ohrms/
dockets/default.htm approximately 30
days after the hearing.
FOR FURTHER INFORMATION CONTACT: Lee
Lemley, Office of Executive Programs
(HFD–006), Center for Drug Evaluation
and Research, Food and Drug
Administration, 5515 Security Lane, rm.
5107, Rockville, MD 20852, 301–443–
5575.
SUPPLEMENTARY INFORMATION:
I. Background
FDA approves human drugs and
therapeutic biologics when the agency
determines that the benefits of using a
product outweigh the risks for the
intended population and use. Once a
drug product is marketed, however,
ensuring its safety becomes a
complicated responsibility shared by
many parties. These include health care
VerDate Aug<31>2005
17:26 Sep 30, 2005
Jkt 205001
professionals (who must weigh both the
risks and the benefits of drugs in
deciding whether to prescribe a
particular drug for a particular patient to
achieve an optimal therapeutic
outcome); patients and caregivers (who
must understand both the benefits and
risks of drugs so they can have informed
discussions with their health care
professionals about their medicines and
make informed decisions about their
use); manufacturers, and others.
Therefore, it is critical that risk
communication be timely, accurate, and
easily accessible. Information must also
be communicated in a way that
recognizes health literacy limitations,
including the needs of a multicultural
population.
In May 1999, FDA published
‘‘Managing the Risks From Medical
Product Use,’’ which laid a framework
for the agency’s efforts to reduce the
risks involved with medical product
use. In February 2005, the Department
of Health and Human Services Secretary
Mike Leavitt and former FDA
Commissioner Lester Crawford
announced plans to establish new
communication channels and expand
existing channels to provide targeted
drug safety information to the public.
Although outside the scope of this
hearing, FDA-approved human drug
labeling is the primary tool the agency
uses to communicate risk and benefit to
the public. However, CDER also
provides drug safety information to the
public through a variety of other risk
communication tools. For example, FDA
has recently initiated communication
tools called Patient and Healthcare
Professional Information Sheets. In
addition, FDA releases Talk Papers,
Public Health Advisories, Press
Releases, MedWatch Safety Updates and
a monthly video news program for
health professionals called the Patient
Safety News. FDA also conducts
educational campaigns and conveys
drug safety information through the
CDER Internet site (https://www.fda.gov/
cder).
II. Scope of the Hearing
FDA is interested in obtaining public
comment on the following risk
communication tools:
• Patient Information Sheets (for
example, see: https://www.fda.gov/cder/
drug/infosheets/patient/adderallpt.htm)
• Healthcare Professional Information
Sheets (for example, see: https://
www.fda.gov/cder/drug/infosheets/hcp/
fluoxetinehcp.htm)
• Talk Papers (for example see: https://
www.fda.gov/opacom/hpnews.html)
PO 00000
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Fmt 4703
Sfmt 4703
• Public Health Advisories (for
example, see: https://www.fda.gov/cder/
news/pubpress.htm)
• Press Releases (for example, see:
https://www.fda.gov/opacom/
hpnews.html)
• MedWatch Listserv Safety Updates
(https://www.fda.gov/medwatch/
index.html)
• Patient Safety News (https://
www.fda.gov/psn)
• CDER Educational Campaigns (for
example see: https://www.fda.gov/cder/
drug/analgesics/default.htm)
• CDER Internet site (https://
www.fda.gov/cder)
Specifically, FDA is inviting public
comment from external stakeholders on
the following issues:
1. What are the strengths and
weaknesses of the communication tools
listed previously in this section of the
document?
2. What information is available about
awareness, use, and perceptions of the
effectiveness of these communication
tools by health care professionals and by
the public in general?
3. Do these tools provide the right
kind and amount of risk and other
information that health care
professionals need to make informed
decisions about whether to prescribe
drug products, and that the public needs
to make informed decisions about
whether to use those products?
4. How easily accessible and
understandable are FDA’s Internetbased sources of drug information?
5. To what extent do CDER’s patientfocused communication tools provide
useful information for people with low
health literacy skills?
6. What mechanisms should CDER
consider to convey risk information to
special populations (e.g., elderly, nonEnglish speaking)?
The following topics are outside the
scope of this hearing: Consumer
medication information (and the draft
guidance entitled ‘‘Useful Written
Consumer Medication Information
[CMI]’’); industry promotional materials,
including Direct to Consumer
Advertising; drug labeling (including
Medication Guides and patient package
inserts); and the draft guidance entitled
‘‘FDA’s ‘Drug Watch’ for Emerging Drug
Safety Information.’’ Comments have
been solicited on these issues at other
times in separate proceedings.
III. Notice of Hearing Under 21 CFR
Part 15
The Acting Commissioner of Food
and Drugs (the Acting Commissioner) is
announcing that the public hearing will
be held in accordance with part 15 (21
CFR part 15). The presiding officer will
E:\FR\FM\03OCN1.SGM
03OCN1
Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices
be the Acting Commissioner or his
designee. The presiding officer will be
accompanied by a panel of FDA
employees with relevant expertise.
Persons who wish to participate in the
part 15 hearing must file a written or
electronic notice of participation with
the Division of Dockets Management
(see ADDRESSES and DATES). To ensure
timely handling, any outer envelope
should be clearly marked with the
docket number listed in brackets in the
heading of this notice along with the
statement ‘‘FDA’s Communication of
Drug Safety Information; Public
Hearing.’’ Groups should submit two
written copies. The notice of
participation should contain the
potential presenter’s name; address;
telephone number; affiliation, if any; the
sponsor of the presentation (e.g., the
organization paying travel expenses or
fees), if any; a brief summary of the
presentation; and the approximate
amount of time requested for the
presentation. The agency requests that
interested persons and groups having
similar interests consolidate their
comments and present them through a
single representative. After reviewing
the notices of participation and
accompanying information, FDA will
schedule each appearance and notify
each participant of the time allotted to
the presenter and the approximate time
that presenter’s oral testimony is
scheduled to begin. If time permits, FDA
may allow interested persons attending
the hearing who did not submit a
written or electronic notice of
participation in advance to make an oral
presentation at the conclusion of the
hearing. The hearing schedule will be
available at the hearing. After the
hearing, the schedule will be placed on
file in the Division of Dockets
Management (see ADDRESSES) under the
docket number listed in brackets in the
heading of this notice.
Under § 15.30(f), the hearing is
informal, and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation.
Public hearings under part 15 are
subject to FDA’s policy and procedures
for electronic media coverage of FDA’s
public administrative proceedings (21
CFR part 10, subpart C). Under § 10.205
(21 CFR 10.205), representatives of the
electronic media may be permitted,
subject to certain limitations, to
videotape, film, or otherwise record
FDA’s public administrative
proceedings, including presentations by
participants. The hearing will be
VerDate Aug<31>2005
17:26 Sep 30, 2005
Jkt 205001
transcribed as stipulated in § 15.30(b).
The transcript will be available on the
Internet at https://www.fda.gov/ohrms/
dockets/default.htm, and orders for
copies of the transcript can be placed at
the meeting or through the Division of
Dockets Management (see ADDRESSES).
Any handicapped persons requiring
special accommodations to attend the
hearing should direct those needs to the
contact person (see FOR FURTHER
INFORMATION CONTACT).
To the extent that the conditions for
the hearing, as described in this notice,
conflict with any provisions set out in
part 15, this notice acts as a waiver of
these provisions as specified in
§ 15.30(h).
IV. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic notices
of participation and comments for
consideration at the hearing (see DATES).
Submit a single copy of written or
electronic notices of participation and
comments, or two paper copies of any
mailed notices of participation and
comments, except that individuals may
submit one 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.
Dated: September 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–19759 Filed 9–30–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0330]
Draft Guidance for Industry and FDA
Review Staff on Collection of Platelets
by Automated Methods; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry and FDA
Review Staff: Collection of Platelets by
Automated Methods’’ dated September
2005. The draft guidance provides blood
establishments and FDA staff revised
recommendations for the collection of
Platelets by automated methods
(plateletpheresis). The draft guidance is
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57609
intended to help blood establishments
ensure donor safety and the safety,
purity, and potency of Platelets
collected by an automated blood cell
separator device. For the purpose of this
document, Platelets collected by
automated methods will be referred to
by the product name ‘‘Platelets,
Pheresis.’’ The draft guidance contains
recommendations for appropriate
criteria for a biologics license
application or supplement for
manufacturing Platelets, Pheresis. When
finalized, this draft guidance will
replace the October 1988 ‘‘Revised
Guideline for the Collection of Platelets,
Pheresis.’’
DATES: Submit written or electronic
comments on the draft guidance by
January 3, 2006, to ensure their
adequate consideration in preparation of
the final guidance. General comments
on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Brenda R. Friend, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry and FDA Review Staff:
Collection of Platelets by Automated
Methods’’ dated September 2005. The
draft guidance provides blood
establishments and FDA staff revised
recommendations for the collection of
Platelets by automated methods
(plateletpheresis). FDA has received
new information since the issuance of
the October 1998 ‘‘Revised Guideline for
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 70, Number 190 (Monday, October 3, 2005)]
[Notices]
[Pages 57607-57609]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19759]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0394]
Food and Drug Administration's Communication of Drug Safety
Information; Public Hearing
AGENCY: Food and Drug Administration, HHS.
[[Page 57608]]
ACTION: Notice of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Center for Drug Evaluation and Research (CDER) of the Food
and Drug Administration (FDA) is announcing a public hearing on the
Center's current risk communication strategies for human drugs. The
public hearing announced in this notice is part of the agency's ongoing
effort to improve CDER's risk communication. The purpose of the public
hearing is to obtain public input on CDER's current risk communication
tools, identify stakeholders for collaboration and implementation of
additional tools, and obtain greater understanding of the strengths and
weaknesses of CDER's existing risk communication.
DATES: The public hearing will be held on December 7 and 8, 2005, from
8 a.m. to 4:30 p.m. Submit written or electronic notices of
participation and comments for consideration at the hearing by November
7, 2005. Written or electronic comments will be accepted after the
hearing until January 9, 2006. The administrative record of the hearing
will remain open until January 9, 2006.
ADDRESSES: The public hearing will be held at the National
Transportation and Safety Board Boardroom and Conference Center, 429
L'Enfant Plaza, SW., Washington, DC 20594 (Metro: L'Enfant Plaza
Station on the Green, Yellow, Blue, and Orange Lines). Submit written
or electronic notices of participation and comments to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852; https://www.fda.gov/
dockets/ecomments. Transcripts of the hearing will be available for
review at the Division of Dockets Management and on the Internet at
https://www.fda.gov/ohrms/dockets/default.htm approximately 30 days
after the hearing.
FOR FURTHER INFORMATION CONTACT: Lee Lemley, Office of Executive
Programs (HFD-006), Center for Drug Evaluation and Research, Food and
Drug Administration, 5515 Security Lane, rm. 5107, Rockville, MD 20852,
301-443-5575.
SUPPLEMENTARY INFORMATION:
I. Background
FDA approves human drugs and therapeutic biologics when the agency
determines that the benefits of using a product outweigh the risks for
the intended population and use. Once a drug product is marketed,
however, ensuring its safety becomes a complicated responsibility
shared by many parties. These include health care professionals (who
must weigh both the risks and the benefits of drugs in deciding whether
to prescribe a particular drug for a particular patient to achieve an
optimal therapeutic outcome); patients and caregivers (who must
understand both the benefits and risks of drugs so they can have
informed discussions with their health care professionals about their
medicines and make informed decisions about their use); manufacturers,
and others. Therefore, it is critical that risk communication be
timely, accurate, and easily accessible. Information must also be
communicated in a way that recognizes health literacy limitations,
including the needs of a multicultural population.
In May 1999, FDA published ``Managing the Risks From Medical
Product Use,'' which laid a framework for the agency's efforts to
reduce the risks involved with medical product use. In February 2005,
the Department of Health and Human Services Secretary Mike Leavitt and
former FDA Commissioner Lester Crawford announced plans to establish
new communication channels and expand existing channels to provide
targeted drug safety information to the public.
Although outside the scope of this hearing, FDA-approved human drug
labeling is the primary tool the agency uses to communicate risk and
benefit to the public. However, CDER also provides drug safety
information to the public through a variety of other risk communication
tools. For example, FDA has recently initiated communication tools
called Patient and Healthcare Professional Information Sheets. In
addition, FDA releases Talk Papers, Public Health Advisories, Press
Releases, MedWatch Safety Updates and a monthly video news program for
health professionals called the Patient Safety News. FDA also conducts
educational campaigns and conveys drug safety information through the
CDER Internet site (https://www.fda.gov/cder).
II. Scope of the Hearing
FDA is interested in obtaining public comment on the following risk
communication tools:
Patient Information Sheets (for example, see: https://
www.fda.gov/cder/drug/infosheets/patient/adderallpt.htm)
Healthcare Professional Information Sheets (for example,
see: https://www.fda.gov/cder/drug/infosheets/hcp/fluoxetinehcp.htm)
Talk Papers (for example see: https://www.fda.gov/opacom/
hpnews.html)
Public Health Advisories (for example, see: https://
www.fda.gov/cder/news/pubpress.htm)
Press Releases (for example, see: https://www.fda.gov/
opacom/hpnews.html)
MedWatch Listserv Safety Updates (https://www.fda.gov/
medwatch/)
Patient Safety News (https://www.fda.gov/psn)
CDER Educational Campaigns (for example see: https://
www.fda.gov/cder/drug/analgesics/default.htm)
CDER Internet site (https://www.fda.gov/cder)
Specifically, FDA is inviting public comment from external
stakeholders on the following issues:
1. What are the strengths and weaknesses of the communication tools
listed previously in this section of the document?
2. What information is available about awareness, use, and
perceptions of the effectiveness of these communication tools by health
care professionals and by the public in general?
3. Do these tools provide the right kind and amount of risk and
other information that health care professionals need to make informed
decisions about whether to prescribe drug products, and that the public
needs to make informed decisions about whether to use those products?
4. How easily accessible and understandable are FDA's Internet-
based sources of drug information?
5. To what extent do CDER's patient-focused communication tools
provide useful information for people with low health literacy skills?
6. What mechanisms should CDER consider to convey risk information
to special populations (e.g., elderly, non-English speaking)?
The following topics are outside the scope of this hearing:
Consumer medication information (and the draft guidance entitled
``Useful Written Consumer Medication Information [CMI]''); industry
promotional materials, including Direct to Consumer Advertising; drug
labeling (including Medication Guides and patient package inserts); and
the draft guidance entitled ``FDA's `Drug Watch' for Emerging Drug
Safety Information.'' Comments have been solicited on these issues at
other times in separate proceedings.
III. Notice of Hearing Under 21 CFR Part 15
The Acting Commissioner of Food and Drugs (the Acting Commissioner)
is announcing that the public hearing will be held in accordance with
part 15 (21 CFR part 15). The presiding officer will
[[Page 57609]]
be the Acting Commissioner or his designee. The presiding officer will
be accompanied by a panel of FDA employees with relevant expertise.
Persons who wish to participate in the part 15 hearing must file a
written or electronic notice of participation with the Division of
Dockets Management (see ADDRESSES and DATES). To ensure timely
handling, any outer envelope should be clearly marked with the docket
number listed in brackets in the heading of this notice along with the
statement ``FDA's Communication of Drug Safety Information; Public
Hearing.'' Groups should submit two written copies. The notice of
participation should contain the potential presenter's name; address;
telephone number; affiliation, if any; the sponsor of the presentation
(e.g., the organization paying travel expenses or fees), if any; a
brief summary of the presentation; and the approximate amount of time
requested for the presentation. The agency requests that interested
persons and groups having similar interests consolidate their comments
and present them through a single representative. After reviewing the
notices of participation and accompanying information, FDA will
schedule each appearance and notify each participant of the time
allotted to the presenter and the approximate time that presenter's
oral testimony is scheduled to begin. If time permits, FDA may allow
interested persons attending the hearing who did not submit a written
or electronic notice of participation in advance to make an oral
presentation at the conclusion of the hearing. The hearing schedule
will be available at the hearing. After the hearing, the schedule will
be placed on file in the Division of Dockets Management (see ADDRESSES)
under the docket number listed in brackets in the heading of this
notice.
Under Sec. 15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (21 CFR part 10, subpart C). Under Sec. 10.205 (21 CFR
10.205), representatives of the electronic media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b). The transcript will be available on the Internet at https://
www.fda.gov/ohrms/dockets/default.htm, and orders for copies of the
transcript can be placed at the meeting or through the Division of
Dockets Management (see ADDRESSES).
Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the contact person (see FOR
FURTHER INFORMATION CONTACT).
To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of these provisions as specified in Sec.
15.30(h).
IV. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic notices of participation and
comments for consideration at the hearing (see DATES). Submit a single
copy of written or electronic notices of participation and comments, or
two paper copies of any mailed notices of participation and comments,
except that individuals may submit one 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.
Dated: September 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19759 Filed 9-30-05; 8:45 am]
BILLING CODE 4160-01-S
