[Federal Register: January 27, 2004 (Volume 69, Number 17)]
[Page 3922-3923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0425]

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting requirements related 
to the adverse event pilot program for medical devices.

DATES: Submit written or electronic comments on the collection of 
information byMarch 29, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on the 

collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 3923]]

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. 360(i)(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 manufacturer. Section 213 of 
FDAMA amended section 519(b) of the Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360i(b)). This amendment legislated the replacement of 
a universal user facility reporting by a system that is limited to a 
``* * * subject 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 
    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 3 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 3 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 other.
    FDA estimates the burden of this collection of information as 

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

    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 6 is the actual 
average for submissions, FDA hopes to increase this number to 8 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 1/3 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: January 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1587 Filed 1-26-04; 8:45 am]