[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Notices]
[Pages 73029-73030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0480]


Maximizing the Public Health Benefit of Adverse Event Collection 
Throughout a Product's Marketed Life Cycle; Public Workshop; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER) at the Food and 
Drug Administration (FDA) are announcing a public workshop entitled 
``Maximizing the Public Health Benefit of Adverse Event Collection 
Throughout a Product's Marketed Life Cycle.'' The purpose of the public 
workshop is to solicit information and views from interested persons on 
research approaches and methods associated with the best ways to assess 
the public health benefit of collecting and reporting all adverse 
events (AEs). The input from this workshop will be used to publish a 
request for information to determine the types of outside organizations 
that would be interested in, and have the capability to conduct, the 
research described in this paragraph, followed by a request for 
proposal (RFP).

DATES: The public workshop will be held on January 29, 2008, from 8:30 
a.m. to 5 p.m. Individuals who wish to speak during the public workshop 
must register on or before January 15, 2008. See section III of this 
document for information on how to attend or present at the meeting.
    We are opening a docket to receive your written or electronic 
comments. Written or electronic comments must be submitted to the 
docket by February 29, 2008.

ADDRESSES:  The public workshop will be held at The Conference Facility 
(terrace level) located at 5635 Fishers Lane, Rockville, MD 20857 
(Metro: Twinbrook Station on the Red Line).
    Submit written or electronic 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 either 
http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. 
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.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

FOR FURTHER INFORMATION CONTACT: Lana Pauls, Center for Drug Evaluation 
and Research (HFD-006), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-796-0518, FAX: 301-827-1069, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The collection of information relating to AEs is an integral part 
of understanding the safety of a product throughout its marketed life 
cycle. FDA is committed to maximizing the public health benefit of 
collecting and reporting serious and non-serious AEs. Central to 
addressing this question is determining the number and type of safety 
concerns discovered by AE collection, the age of products at the time 
safety concerns are detected by AE collection, and the types of actions 
that are subsequently taken to protect patient safety.
    The workshop objectives are as follows: (1) Initiate constructive 
dialogue and information-sharing among regulators, researchers, the 
pharmaceutical industry, health organizations, and individuals affected 
by postmarketing AE collection, reporting, and evaluation; (2) share 
current FDA practices regarding postmarketing AE collection and 
reporting; and (3) obtain input on the questions and methods that will 
be used to conduct research on this topic.
    Two panel discussions will focus on how FDA currently uses 
spontaneous reports and other methods of signal detection, the key 
research questions that should be addressed by the RFP, and appropriate 
research approaches and methods including, but not limited to, 
hypothesis, study design, data sources, outcome measures, and analytic 
methods. Panel one will focus on the key research questions; panel two 
will discuss research approaches and methods.
    Some of the key questions to be addressed in the RFP include the 
following:
    (1) What is the value to patient safety of collecting AEs through a 
passive surveillance system over the marketed life cycle of a product? 
How are these data best used in regulatory decision-making?
    (2) How can safety issue identification and subsequent regulatory 
action be characterized in relation to time elapsed following product 
approval? Is this influenced by the type of regulatory action and/or 
the nature of the safety signal?
    (3) What are the roles of serious and non-serious outcome reports 
in safety issue identification and subsequent regulatory action? How do 
the roles of

[[Page 73030]]

these report types change over the product's marketed life cycle?
    (4) What are the roles of reports by health care professionals and 
consumers in safety signal detection?
    (5) Are there any types of AE reports that are not helpful to 
safety signal detection?
    (6) What do we know about non-reported AEs or characteristics 
associated with non-reporting?
    FDA is working to refine the workshop agenda and to invite panel 
members. We are seeking broad participation by safety researchers, 
health system officials, the pharmaceutical industry, and others. We 
anticipate issuing a summary of the workshop findings, including a 
discussion of implications and next steps for further development.

II. Comments

    The agency is interested in hearing comments at the public workshop 
or receiving written comments (see ADDRESSES) on the issues described 
previously. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Attendance and Registration

    The Conference Facility (terrace level) located at 5635 Fishers 
Lane is a Federal facility with limited seating and security procedures 
for entrance. Workshop attendees will be required to show proper 
identification and are asked to allow time for security procedures. 
Seating will be made available on a first-come basis. Individuals who 
wish to speak during the public workshop must register on or before 
January 15, 2008. You should identify the subject matter you wish to 
address during the public workshop. Please specify either panel one or 
panel two (see section I of this document). To register to speak, 
please contact Lana Pauls (see FOR FORTHER INFORMATION CONTACT).
    Ample time will be allowed during the scheduled agenda for 
attendees to ask questions of panelists. In addition, we strongly 
encourage written comments to the docket.
    If you need special accommodations because of disability, please 
contact Lana Pauls (see FOR FURTHER INFORMATION CONTACT) at least 7 
days before the workshop.

IV. Workshop Transcripts

    The workshop will be transcribed. The transcript will be available 
for review at the Division of Dockets Management (see ADDRESSES) and on 
the Internet at http://www.fda.gov/ohrms/dockets, approximately 30 days 
after the workshop.

    Dated: December 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24960 Filed 12-21-07; 8:45 am]
BILLING CODE 4160-01-S