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[Federal Register Volume 66, Number 119 (Wednesday, June 20, 2001)]
[Notices]
[Pages 33099-33100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15440]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0051]

Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Adverse Event Pilot Program for Medical 
Devices and Blood Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written or electronic comments on the collection of 
information by July 20, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Office of Information and Regulatory Affairs, OMB, 
New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 
20503, Attn: Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (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 and Blood Products

    Under section 519 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360i), FDA is authorized to require manufacturers to 
report medical device related deaths, serious injuries, and 
malfunctions and to require user facilities to report device-related 
deaths directly to FDA and to manufacturers, and to report serious 
injuries to the manufacturer. Section 213 of the FDA Modernization Act 
of 1997 (FDAMA) amended section 519(b) of the act relating to mandatory 
reporting by user facilities of deaths and serious injuries and serious 
illnesses associated with the use of medical devices. This amendment 
required FDA to, by regulation, replace universal user-facility 
reporting with 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 Federal agency charged with the responsibility for 
ensuring that marketed medical products are safe and effective. To 
carry out its responsibilities, the agency needs to be informed 
whenever an adverse event or product problem occurs. Only if FDA is 
provided with such information will it be able to evaluate the risk, if 
any, associated with the product and take whatever action is necessary 
to reduce or eliminate the public's exposure to this risk. Data 
collected from user facilities about problems with medical devices 
assist FDA to carry out that mission as it pertains to medical devices. 
Prior to implementing the regulation to change from universal user-
facility reporting to reporting by a subset of user facilities, FDA is 
planning to conduct a pilot program to evaluate various aspects of the 
new program. The new user-facility program that will be

[[Page 33100]]

comprised of a subset of user facilities is called the Medical Product 
Surveillance Network (MedSuN). The 60-day Federal Register notice 
announced that two FDA Centers, the Center for Devices and Radiological 
Health (CDRH) and the Center for Biologics Evaluation and Research 
(CBER) would be participating in this project. However, CBER will no 
longer participate in this project; CDRH will be the sole participant. 
Data collected from the pilot will aid FDA in fulfilling its mission to 
monitor the safety and effectiveness of marketed medical devices as 
they are used in clinical settings and to determine what aspects of the 
pilot program should be implemented in the national program. The 
current FDA universal user-facility reporting system remains in place 
during the piloting of the new program, and will remain until FDA 
implements the new MedSuN national system by regulation.
    An electronic format of the medical device related sections of the 
mandatory MedWATCH form (form 3500A; OMB Control number 0910-0291) will 
be accessible to the participating medical device user facilities. The 
facilities participating in the collection of medical device-related 
adverse events will use this electronic format in reporting to FDA. The 
electronic format will include some additional items that are not on 
the 3500A form. These will be voluntary for participants to complete, 
such as hospital profile information and several questions related to 
the use of medical devices.
    Participation in this pilot will be voluntary and will initially 
include 25 hospitals that will respond to the medical device questions. 
It is anticipated that during this pilot the number of participants 
will increase to approximately 250 facilities reporting medical device 
problems. The electronic version will take approximately 45 minutes, or 
less, to complete.
    In the Federal Register of February 8, 2001 (66 FR 9580), the 
agency requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1.--Estimated Annual Reporting Burden\1\
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                                                                    Annual Frequency        Total Annual
                       No. of Respondents                              perResponse            Responses         Hoursper Response        Total Hours
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Medical devices: 83.............................................          15                 1,245                      .75                934
  Total.........................................................                                                                           934
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents for medical devices was determined by the 
average number of respondents given that 25 facilities will be enrolled 
in the first year, up to 100 the second year, and up to 250 the third 
year. Eighty-three is the average of the final complement of 250 
facilities. The annual frequency of response is based on FDA's 
experience with its mandatory and voluntary reporting systems.

    Dated: June 14, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15440 Filed 6-19-01; 8:45 am]
BILLING CODE 4160-01-S
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