[Federal Register: June 14, 2004 (Volume 69, Number 113)]
[Page 33034-33035]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0017]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Adverse Event Pilot 
Program for Medical Devices

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES:  Fax written comments on the collection of information by July 
14, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857,301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Adverse Event Pilot Program for Medical Devices--(OMB Control Number 

    FDA is requesting approval from OMB for clearance to continue to 
conduct a pilot project to evaluate aspects of a national reporting 
system mandated by the Food and Drug Modernization Act (FDAMA) of 1997. 
Under section 519(b) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360i(b)), FDA is authorized to require manufacturers to 
report medical device related deaths, serious injuries, and 
malfunctions; user facilities (hospitals, nursing homes, ambulatory 
surgical facilities and outpatient diagnostic and treatment facilities) 
to report device-related deaths directly to FDA and to manufacturers, 
and to report serious injuries to the

[[Page 33035]]

manufacturer. Section 213 of FDAMA amended section 519(b) of the act. 
This amendment legislated the replacement of a universal user facility 
reporting by a system that is limited to a ``* * * subset of user 
facilities that constitutes a representative profile of user reports'' 
for device related deaths and serious injuries. This amendment is 
reflected in section 519(b)(5)(A) of the act.
    FDA is the regulatory agency responsible for the safety and 
effectiveness of medical products including medical devices and 
radiological products. Important questions about medical devices, such 
as those concerning user experience, durability, and rare effects may 
not be answered until after the device has been marketed. To protect 
the public health, FDA must be able to rapidly collect information 
pertaining to adverse events associated with medical devices after they 
have been marketed. This system is called the Medical Product 
Surveillance Network (MedSun). The current universal reporting system 
remains in place during the pilot stages of the new program, and until 
FDA implements the new national system by regulation. This legislation 
provides FDA with the opportunity to design and implement a national 
surveillance network, composed of well-trained clinical facilities, to 
provide high quality data on medical devices in clinical use.
    Before writing a regulation to implement the large-scale national 
MedSun reporting system, FDA has been conducting a pilot project to 
ensure all aspects of the new system address the needs of both the 
reporting facilities and FDA. This pilot project began with a small 
sample (approximately 25) and was planned to increase to a larger 
sample of approximately 250 facilities over a period of approximately 3 
years. Data collection began in February 2002 and has been increasing 
since that time. FDA has achieved its recruitment goals each year, 
reaching 180 sites at the end of fiscal year (FY) 2003. FDA will reach 
a total of 240 for FY 2004 and will reach the final goal of 250 by FY 
2005. The program has proven to be very popular with sites as FDA has 
gained a national reputation, with hospitals waiting in line to join.
    However, FDA's current resources will not permit FDA to expand 
beyond 250 sites at this time.
    The pilot originally had the following three parts to the data 
collection: (1) Collecting demographic profile information about the 
participation facilities, (2) implementing an electronic version of the 
portions of the MedWatch form (FDA Form No. 3500A, OMB control number 
0910-0291) used to report adverse events occurring with medical 
devices, and (3) adding additional voluntary questions to the data 
collection. To date, these three features remain unchanged. However, 
there has been an addition to the data collection that was approved by 
OMB in the spring of 2004. Therefore, the fourth part of the collection 
system is the Medical Device Engineering Network (M-DEN)--a place on 
the MedSun software for the reporters to share information with each 
    In the Federal Register of January 27, 2004 (69 FR 3922), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                  Annual Frequency per      Total Annual
                 Data Type                   No. of Respondents         Response              Responses        Hours per Response        Total Hours
MedSun\2\                                          250                     8                 2,000                      .75              1,500
M-DEN\3\                                            83                    10                   830                      .50                415
Total                                       ....................  ....................  ....................  ....................       1,915
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
\2\ MedSun means Medical Product Surveillance Network.
\3\ M-DEN means Medical Device Engineering Network.

    Currently, FDA has 180 sites participating in MedSun pilot program, 
but expects to have 250 sites over the next 2 years. The frequency of 
response reflects what FDA has actually been receiving as the average 
number of submissions in the MedSun Program. While six is the actual 
average for submissions, FDA hopes to increase this number to eight 
once their educational materials reach potential respondents. The time 
estimated to respond is based on feedback FDA has received from current 
MedSun reporters.
    At this time, FDA estimates that one-third of the total number of 
respondents will access M-DEN aspect of the MedSun software, or 
approximately 83 persons per year. Each respondent is expected to post 
5 problems and respond to 5 problems posted by other MedSun 
participants for a total of 10 responses per year. It is expected that 
each visit to the bulletin will not take longer than 30 minutes.

    Dated: June 4, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-13211 Filed 6-10-04; 8:45 am]