[Federal Register Volume 62, Number 34 (Thursday, February 20, 1997)]
[Notices]
[Pages 7790-7791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4161]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97N-0042]


Review of the Adverse Event Reporting System for Postmarketing 
Surveillance; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to provide the pharmaceutical industry and other interested 
persons with information on the plans, progress, and technical 
specifications developed under the reengineering of the Center for Drug 
Evaluation and Research's (CDER's) postmarketing surveillance program. 
The primary focus of the meeting will be the electronic submission of 
adverse drug reaction (ADR) reports under the new adverse event 
reporting system (AERS), which is currently under development as a 
major component of the reengineering effort.

DATES: The public meeting will be held on Monday, March 17, 1997, from 
9:30 a.m. to 5 p.m. There is no registration fee for the meeting. 
Because space is limited, interested persons are encouraged to register 
by March 7, 1997.

ADDRESSES: The public meeting will held at the DoubleTree Hotel, 1750 
Rockville Pike, Rockville, MD 20852. Persons interested in attending 
should fax their registration to Robert Nelson at 301-480-2825. The 
facsimile should include the participant's name and title; organization 
name, if any; address; and telephone and fax numbers.

    Three weeks prior to the public meeting, a copy of the meeting 
agenda will be available through CDER's Fax-on-Demand, 301-827-0577 or 
800-342-

[[Page 7791]]

 2722, under the index ``AERS Public Meeting,'' document No. 0510. 
Information about the meeting will be available via Internet using the 
World Wide Web (WWW). To connect to the CDER home page, type <a href="http://
www.fda.gov/cder">http://
www.fda.gov/cder</a> and go to the ``What's Happening'' section. Also 
available on the CDER home page is a link to the new AERS home page, 
which contains a brief summary of the materials that will be discussed 
at the meeting. Information distributed at the public meeting will be 
available from the Freedom of Information Office (HFI-35), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 10 business days after the meeting at a cost of 10 cents 
per page.
    The agenda will be placed on display, under the docket number found 
in brackets in the heading of this document, at the Dockets Management 
Branch (HFA-305), 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Robert C. Nelson, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-700), 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3206.

SUPPLEMENTARY INFORMATION: The primary purpose of FDA's postmarketing 
surveillance program is to identify potentially serious drug safety 
problems, focusing especially on newly marketed drugs. Although 
premarket testing discloses a general safety profile of a new drug's 
comparatively common adverse effects, the larger and more diverse 
patient populations exposed to the marketed drug provides, for the 
first time, the opportunity to collect information on rare, latent, and 
long-term effects. Reports are obtained from a variety of sources, 
including patients, treating physicians, foreign regulatory agencies, 
and clinical investigators. Over 75 percent of the ADR reports that FDA 
receives are routed from health care practitioners through 
pharmaceutical companies. The remainder of the reports come directly to 
FDA through the agency's MedWatch program.
    FDA's computerized spontaneous reporting system (SRS) contains 1.4 
million ADR reports for human drugs and therapeutic biologics. FDA 
plans to replace SRS with AERS by September 1997. All SRS historical 
data will be migrated to AERS. AERS will enable FDA to receive reports 
from pharmaceutical companies by electronic submission, transmitted 
data base to data base through standardized pathways. The technical 
specifications of the AERS computerized system will be described at the 
public meeting and made available to participants, especially as they 
relate to the electronic submission of expedited and periodic ADR 
reports.
    FDA has participated in the development of several guidelines by 
the International Conference on Harmonisation of Technical Requirements 
for Registration of Pharmaceuticals for Human Use (ICH) that relate to 
the submission of ADR reports under the AERS system: ``Clinical Safety 
Data Management: Definitions and Standards for Expedited Reporting'' 
(E2A); ``Clinical Safety Data Management: Data Elements for 
Transmission of Individual Case Safety Reports'' (E2B); and ``Clinical 
Safety Data Management: Periodic Safety Update Reports for Marketed 
Drugs'' (E2C). In addition, two other guidelines are currently under 
development by ICH: ``Medical Terminology (MEDDRA)'' (M1) and 
``Electronic Standards for the Transfer of Regulatory Information 
(ESTRI)'' (M2).
     At the public meeting, FDA will explain how it intends to 
incorporate these recommended standards into the requirements for the 
electronic submission of ADR reports under AERS. The meeting will 
include a general discussion of CDER's plans to propose revisions to 
its postmarketing ADR reporting regulations. The goals of this 
rulemaking are to implement the recommendations in the ICH guidelines 
and to enhance the quality of ADR reports received by the agency. The 
agency hopes to familiarize the pharmaceutical industry with the 
procedures for the electronic submission of ADR reports under AERS so 
that they are prepared to comply with any revised regulations that may 
issue as a result of the rulemaking initiative.
    Additional information on the technical specifications of the AERS 
system will be placed on display, as they are available in final form, 
at the Dockets Management Branch (address above) between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: February 13, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-4161 Filed 2-19-97; 8:45 am]
BILLING CODE 4160-01-F