[Federal Register Volume 72, Number 213 (Monday, November 5, 2007)]
[Notices]
[Pages 62481-62482]
From the Federal Register Online via the Government Publishing 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 http://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: [email protected].

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 http://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