Adolescent Over-the-Counter Drug Product Use; Public Workshop, 62481-62482 [E7-21713]
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Federal Register / Vol. 72, No. 213 / Monday, November 5, 2007 / Notices
Dated: October 25, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–21666 Filed 11–2–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0412]
Adolescent Over-the-Counter Drug
Product Use; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA), the National
Institutes of Health (NIH), and the
Consumer Healthcare Product
Association (CHPA) are announcing a
public workshop entitled ‘‘Adolescent
Over-the-Counter (OTC) Drug Product
Use.’’ The purpose of the workshop is
to gain an understanding of current use
of OTC drug products by adolescents,
including adolescent decisionmaking
skills (compared with adult skills) and
other factors influencing adolescent
OTC drug product use. Information
gathered at the workshop and from
submitted comments will be used to
identify when it would be most
appropriate for consumer studies on
OTC drugs to enroll adolescents, and to
define the type of consumer research
and study designs needed to support
OTC drug product approval in the
adolescent population. The workshop is
intended to help inform FDA in its
effort to assure the safe and effective use
of OTC drug products by adolescents.
DATES: The public workshop will be
held on December 6, 2007, from 8:30
a.m. to 5:30 p.m. and on December 7,
2007, from 8:30 a.m. to 3:30 p.m.
Register to make an oral presentation
during the open public session by
November 21, 2007. Submit written or
electronic comments by January 31,
2008.
The public workshop will
be held at the Natcher Conference
Center, National Institutes of Health, 45
Center Dr., Bethesda, MD 20892.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.fda.gov/ohrms/dockets/
ecomments.
ycherry on PRODPC74 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
15:04 Nov 02, 2007
Jkt 214001
FOR FURTHER INFORMATION CONTACT:
Faith Dugan, Center for Drug Evaluation
and Research (HFD–6), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–6779,
FAX: 301–827–4312, e-mail:
Faith.Dugan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
We are announcing a public
workshop on adolescent use of OTC
drug products. OTC drugs are FDAregulated drug products that are
available without a prescription. Other
health care products (e.g., dietary
supplements) are beyond the scope of
the workshop. Adolescents use OTC
drug products from a wide range of
therapeutic categories (including
fluoride toothpastes, acne drug
products, and pain relievers) and with
varying degrees of parental oversight.
While clinical and consumer behavior
studies for OTC drugs have enrolled
various populations, few studies have
included adolescents. Therefore, limited
information on adolescents’ use of OTC
drug products has been collected
regarding the magnitude of their use, the
types of products they use, factors that
influence their use, or their ability to
understand and follow directions
provided on OTC labels.
The desire to learn more about
adolescent decisionmaking skills as they
relate to the use of OTC drug products
has generated interest in holding a
public workshop that would convene a
group of scientific experts and solicit
input from the public. Information
gathered at the workshop would help
identify methods for assessing
adolescent OTC drug use and identify
information useful to regulatory
decisionmaking.
II. Why Are We Holding This Public
Workshop?
This workshop has been developed to
further our understanding of the
physiological and psychological
differences and similarities between
adolescents and adults, which may have
an impact on adolescents’ decisions
about OTC drug use and also may define
research priorities for assessing the
differences in drug use decisions. The
workshop is also aimed at designing
efforts to encourage appropriate OTC
drug product use by adolescents. It is
hoped that such efforts will foster
appropriate use when adolescents
become adults.
III. What Are the Topics We Intend to
Address at the Workshop?
We will address the following topics
at the workshop:
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Fmt 4703
Sfmt 4703
62481
• OTC drug product use by
adolescents;
• Discussion of adolescent
neurocognitive development and
decisionmaking skills;
• Discussion of how best to
communicate product information
directed toward adolescents;
• Discussion of future actions and
research agendas, including studies
regarding consumer behavioral issues;
and
• Discussion of mechanisms to
promote appropriate and optimal use of
OTC drugs by adolescents.
We are interested in hearing
comments at the public workshop or
receiving written or electronic
comments (see section V of this
document) on the following questions:
1. What is known about current OTC
drug product use by adolescents? Focus
on the following information:
• Magnitude of current use of OTC
drugs by adolescents;
• Product categories commonly used
by adolescents;
• Market use data for such drugs;
• Consumer behavior studies that
have enrolled adolescents; and
• Factors that influence adolescent’s
use of OTC products, such as drug class,
age, parental involvement and
influence, household dynamics, social
circumstances, and gender.
2. How does adolescent neurocognitive
development influence decisionmaking
and behavior as they relate to OTC drug
product use?
• Identify known factors that
contribute to how adolescents make
health-related decisions;
• Discuss adolescent behavior
patterns, decisionmaking skills, and
predictors of risk-taking behavior as
they relate to purchase and use of OTC
drugs; and
• Discuss differences between
adolescent and adult risk perceptions
and decisionmaking and discuss the
ages at which identifiable
developmental transitions generally
occur.
3. What future actions will help
promote safe and effective use of OTC
drugs by adolescents?
• Discuss drug categories (e.g.,
analgesics, acne drugs) for which it
would be appropriate to enroll
adolescents in clinical and behavioral
studies and identify related study
design issues (e.g., design, age, informed
consent, parental assent, compliance);
• Assess the need for consumer
behavior studies targeted toward
adolescents;
• Explore alternate and effective
means of communicating with
adolescents, including need for labels
E:\FR\FM\05NON1.SGM
05NON1
62482
Federal Register / Vol. 72, No. 213 / Monday, November 5, 2007 / Notices
directed toward adolescent age groups;
and
• Discuss other potential future
actions to promote safe and effective use
of OTC drugs by adolescents.
IV. Workshop Attendance and
Registration
The Natcher Conference Center is a
Federal facility with security procedures
for entrance. Workshop attendees will
be required to show proper
identification and are asked to allow
ample time to enter the NIH campus.
There is no fee to attend the
workshop, and attendees who do not
wish to make an oral presentation do
not need to register. Seating will be on
a first-come, first-served basis.
If you would like to make an oral
presentation during the workshop, you
must register by close of business on
November 21, 2007. You must provide
your name, title, business affiliation (if
applicable), address, and type of
organization you represent (e.g.,
industry, consumer organization) to Lee
Lemley or Faith Dugan at 301–594–6779
(see FOR FURTHER INFORMATION CONTACT).
Persons registered to make an oral
presentation should check in before the
workshop.
If you need special accommodations
because of disability, please contact Lee
Lemley (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
workshop.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding the issues and
questions presented in 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.
ycherry on PRODPC74 with NOTICES
VI. Workshop Transcripts
We will prepare a transcript of the
workshop. The transcript will be
available for review approximately 30
days after the workshop at the Division
of Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday. The transcript will also
be available on the Internet at https://
www.fda.gov/ohrms/dockets.
VerDate Aug<31>2005
15:04 Nov 02, 2007
Jkt 214001
Dated: October 30, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–21713 Filed 11–2–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 5, 2007, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD. The
hotel phone number is 301–977–8900.
Contact Person: Nicole Vesely, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane, (for express delivery,
5630 Fishers Lane, rm. 1093) Rockville,
MD 20857, 301–827–6793, FAX: 301–
827–6776, e-mail:
nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On December 5, 2007, from
8 a.m. to 3 p.m., the committee will
discuss supplemental biologics license
application (sBLA) 125085/91,
AVASTIN (bevacizumab), Genentech,
Inc., proposed indication, in
combination with paclitaxel, for the
treatment of patients who have not
PO 00000
Frm 00055
Fmt 4703
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received chemotherapy for their locally
recurrent or metastatic, HER2 negative
breast cancer. From 3:30 p.m. to 5 p.m.,
the committee will meet in closed
session.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: On December 5, 2007,
from 8 a.m. to 3 p.m., the meeting is
open to the public. Interested persons
may present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 21, 2007.
Oral presentations from the public will
be scheduled between approximately 11
a.m. and 12 noon. Those desiring to
make formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before November 13, 2007. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
November 14, 2007.
Closed Committee Deliberations: On
December 5, 2007, from 3:30 p.m. to 5
p.m., the meeting will be closed to
permit discussion and review of trade
secret and/or confidential information
(5 U.S.C. 552b(c)(4)). During this
session, the committee will be briefed
on recent and upcoming applications
within the Office of Oncology Products.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
E:\FR\FM\05NON1.SGM
05NON1
]]>Agencies
[Federal Register Volume 72, Number 213 (Monday, November 5, 2007)]
[Notices]
[Pages 62481-62482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21713]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0412]
Adolescent Over-the-Counter Drug Product Use; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), the National
Institutes of Health (NIH), and the Consumer Healthcare Product
Association (CHPA) are announcing a public workshop entitled
``Adolescent Over-the-Counter (OTC) Drug Product Use.'' The purpose of
the workshop is to gain an understanding of current use of OTC drug
products by adolescents, including adolescent decisionmaking skills
(compared with adult skills) and other factors influencing adolescent
OTC drug product use. Information gathered at the workshop and from
submitted comments will be used to identify when it would be most
appropriate for consumer studies on OTC drugs to enroll adolescents,
and to define the type of consumer research and study designs needed to
support OTC drug product approval in the adolescent population. The
workshop is intended to help inform FDA in its effort to assure the
safe and effective use of OTC drug products by adolescents.
DATES: The public workshop will be held on December 6, 2007, from 8:30
a.m. to 5:30 p.m. and on December 7, 2007, from 8:30 a.m. to 3:30 p.m.
Register to make an oral presentation during the open public session by
November 21, 2007. Submit written or electronic comments by January 31,
2008.
ADDRESSES: The public workshop will be held at the Natcher Conference
Center, National Institutes of Health, 45 Center Dr., Bethesda, MD
20892.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/
ohrms/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Faith Dugan, Center for Drug
Evaluation and Research (HFD-6), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-6779, FAX: 301-827-4312, e-
mail: Faith.Dugan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
We are announcing a public workshop on adolescent use of OTC drug
products. OTC drugs are FDA-regulated drug products that are available
without a prescription. Other health care products (e.g., dietary
supplements) are beyond the scope of the workshop. Adolescents use OTC
drug products from a wide range of therapeutic categories (including
fluoride toothpastes, acne drug products, and pain relievers) and with
varying degrees of parental oversight. While clinical and consumer
behavior studies for OTC drugs have enrolled various populations, few
studies have included adolescents. Therefore, limited information on
adolescents' use of OTC drug products has been collected regarding the
magnitude of their use, the types of products they use, factors that
influence their use, or their ability to understand and follow
directions provided on OTC labels.
The desire to learn more about adolescent decisionmaking skills as
they relate to the use of OTC drug products has generated interest in
holding a public workshop that would convene a group of scientific
experts and solicit input from the public. Information gathered at the
workshop would help identify methods for assessing adolescent OTC drug
use and identify information useful to regulatory decisionmaking.
II. Why Are We Holding This Public Workshop?
This workshop has been developed to further our understanding of
the physiological and psychological differences and similarities
between adolescents and adults, which may have an impact on
adolescents' decisions about OTC drug use and also may define research
priorities for assessing the differences in drug use decisions. The
workshop is also aimed at designing efforts to encourage appropriate
OTC drug product use by adolescents. It is hoped that such efforts will
foster appropriate use when adolescents become adults.
III. What Are the Topics We Intend to Address at the Workshop?
We will address the following topics at the workshop:
OTC drug product use by adolescents;
Discussion of adolescent neurocognitive development and
decisionmaking skills;
Discussion of how best to communicate product information
directed toward adolescents;
Discussion of future actions and research agendas,
including studies regarding consumer behavioral issues; and
Discussion of mechanisms to promote appropriate and
optimal use of OTC drugs by adolescents.
We are interested in hearing comments at the public workshop or
receiving written or electronic comments (see section V of this
document) on the following questions:
1. What is known about current OTC drug product use by adolescents?
Focus on the following information:
Magnitude of current use of OTC drugs by adolescents;
Product categories commonly used by adolescents;
Market use data for such drugs;
Consumer behavior studies that have enrolled adolescents;
and
Factors that influence adolescent's use of OTC products,
such as drug class, age, parental involvement and influence, household
dynamics, social circumstances, and gender.
2. How does adolescent neurocognitive development influence
decisionmaking and behavior as they relate to OTC drug product use?
Identify known factors that contribute to how adolescents
make health-related decisions;
Discuss adolescent behavior patterns, decisionmaking
skills, and predictors of risk-taking behavior as they relate to
purchase and use of OTC drugs; and
Discuss differences between adolescent and adult risk
perceptions and decisionmaking and discuss the ages at which
identifiable developmental transitions generally occur.
3. What future actions will help promote safe and effective use of OTC
drugs by adolescents?
Discuss drug categories (e.g., analgesics, acne drugs) for
which it would be appropriate to enroll adolescents in clinical and
behavioral studies and identify related study design issues (e.g.,
design, age, informed consent, parental assent, compliance);
Assess the need for consumer behavior studies targeted
toward adolescents;
Explore alternate and effective means of communicating
with adolescents, including need for labels
[[Page 62482]]
directed toward adolescent age groups; and
Discuss other potential future actions to promote safe and
effective use of OTC drugs by adolescents.
IV. Workshop Attendance and Registration
The Natcher Conference Center is a Federal facility with security
procedures for entrance. Workshop attendees will be required to show
proper identification and are asked to allow ample time to enter the
NIH campus.
There is no fee to attend the workshop, and attendees who do not
wish to make an oral presentation do not need to register. Seating will
be on a first-come, first-served basis.
If you would like to make an oral presentation during the workshop,
you must register by close of business on November 21, 2007. You must
provide your name, title, business affiliation (if applicable),
address, and type of organization you represent (e.g., industry,
consumer organization) to Lee Lemley or Faith Dugan at 301-594-6779
(see FOR FURTHER INFORMATION CONTACT). Persons registered to make an
oral presentation should check in before the workshop.
If you need special accommodations because of disability, please
contact Lee Lemley (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the workshop.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the issues and
questions presented in 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.
VI. Workshop Transcripts
We will prepare a transcript of the workshop. The transcript will
be available for review approximately 30 days after the workshop at the
Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday. The transcript will also be available on
the Internet at https://www.fda.gov/ohrms/dockets.
Dated: October 30, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21713 Filed 11-2-07; 8:45 am]
BILLING CODE 4160-01-S
