[Federal Register Volume 66, Number 27 (Thursday, February 8, 2001)]
[Notices]
[Pages 9580-9582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3321]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0051]


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

AGENCY:  Food and Drug Administration, HHS.

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ACTION:  Notice.

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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, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments concerning a pilot project FDA plans to 
conduct to obtain adverse event reports from user facilities.

DATES: Submit written or electronic comments on the collection of 
information by April 9, 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 Dockets Management Branch (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 Schlosburg, Office of 
Information Resources Management (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 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: (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.

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 comprised of a 
subset of user facilities is called the Medical Product Surveillance 
Network (MedSuN). Two FDA Centers, the Center for Devices and 
Radiological Health (CDRH) and the Center for Biologics Evaluation and 
Research (CBER) are participating in this project. 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 and 
the participating blood establishments. 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.
    During this pilot project, FDA is planning to include the 
electronic collection of voluntary information related to blood 
products. Currently blood establishments and transfusion centers must 
investigate and keep records of adverse events regarding blood or blood 
products arising as a result of blood collection or transfusion 
(Sec. 606.170(a) (21 CFR 606.170(a))). In addition, when the event is 
fatal, FDA must be notified immediately (by phone, fax, express mail, 
or email) and a written report must be submitted within 7 days of the 
transfusion (Sec. 606.170(b). Deviations in the manufacturing of 
biological products, including blood and blood components, according to 
the recently published rule entitled ``Biological Products: Reporting 
of Biological Product Deviations in Manufacturing'' (November 7, 2000, 
65 FR 66621), must also be reported to FDA when the product is 
distributed (21 CFR 606.171). The form for these reports is pending OMB 
approval.
    However, these mandatory reports do not include errors related to 
the use of the product and do not include ``near-miss'' errors, an 
important way of analyzing weaknesses in the systems. The ``Medical 
Event Reporting System for Transfusion Medicine'' (MERS-TM) has been 
designed to provide this type of information. For this pilot program, 
blood transfusion centers and blood establishment centers who currently 
use

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the MERS-TM to track internal events will be recruited to participate. 
These facilities will be asked to fill in the textual description of 
the blood-product related adverse event and to transfer the two outcome 
codes from the MERS-TM concerning problems with blood products to two 
additional data fields in the electronic format that will be dedicated 
to collecting this coded information. FDA will compare the information 
obtained in this reporting system with that obtained under existing 
mandatory and voluntary systems that are in place for transfusion-
related fatalities, product deviations, and clinical adverse events. 
FDA will consider the information that is voluntarily reported under 
this pilot program to design a system that will assist FDA in gathering 
the most useful data, in the least burdensome manner, for its 
regulation (including packaging and labeling provisions) of 
establishments and products used in transfusion medicine.
    Participation in this pilot will be voluntary and will initially 
include 25 hospitals that will respond to the medical device questions. 
At the same time, an initial nine blood establishments and transfusion 
services sites, which currently use the MERS-TM, will be recruited to 
participate. It is anticipated that during this pilot the number of 
participants will increase to approximately 250 facilities reporting 
medical device problems and the number of blood establishments and 
transfusion-services sites is anticipated to increase to 30. The 
electronic version will take approximately 45 minutes, or less, to 
complete. For the blood centers that are participating, the burden of 
participation will be approximately 15 minutes.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
               No. of  Respondents                 Frequency per   Total Annual      Hours per      Total Hours
                                                     Response        Responses       Response
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Medical devices: 83                                    15           1,245                .75          934
Blood transfusions: 10                                150           1,500                .25         375
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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.
    The number of respondents for blood transfusions was determined by 
the average number of respondents given that a total of 30 blood 
establishments will be enrolled at the end of 3 years. The annual 
frequency of response was based on the information that the American 
Red Cross submits about 15 reports per establishment per year. The 
MERS-TM will yield about a tenfold higher than the American Red Cross 
rate since it will include close-calls as well as actual adverse 
events.

    Dated: February 2, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-3321 Filed 2-7-01; 8:45 am]
BILLING CODE 4160-01-F