[Federal Register Volume 72, Number 113 (Wednesday, June 13, 2007)]
[Notices]
[Pages 32670-32672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11400]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0218]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Adverse Event Pilot Program for Medical Products 
(Formally Medical Device Adverse Event Reporting Program)

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 continuing 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 collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the continuation of a pilot 
project to evaluate the electronic collection of the 3500A form for 
adverse events related to the use of medical products to obtain data 
from user facilities participating in the Medical Device Safety Network 
(MedSun). Additionally, the electronic form will include hospital 
profile information and several other questions

[[Page 32671]]

related to the use of medical products. A portion of the MedSun 
software, called Device-Safety Exchange (DS-X) (formerly called M-Den), 
is a moderated site where MedSun members may share information with 
each other.

DATES: Submit written comments on the collection of information by 
August 13, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 continuing 
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 Products--21 U.S.C. 360(i) (OMB 
Control Number 0910-0471)--Extension

    Under section 519 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360(i)), FDA is authorized to require: Manufacturers to 
report medical device related deaths, serious injuries, and 
malfunctions; and user facilities to report device-related deaths 
directly to manufacturers and FDA, 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 (21 U.S.C. 360i(b)) relating 
to mandatory reporting by user facilities of deaths and serious 
injuries and serious illnesses associated with the use of medical 
devices. This amendment legislated the replacement of 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. 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. This system is called MedSun.
    FDA is continuing to conduct a pilot of the MedSun system before 
the agency issues a regulation to change from universal mandatory 
reporting for medical device user facilities to reporting by a 
representative sample of facilities. This data collection has been 
ongoing since February 20, 2002, and this notice is for continuation of 
this data collection.
    FDA is seeking OMB clearance to continue to use electronic data 
collection to obtain the information on the 3500A Form related to 
medical devices and tissue products from the user facilities 
participating in MedSun, to obtain a demographic profile of the 
facilities, and to pilot a few additional questions which will permit 
FDA to better understand the cause of the reported adverse event. 
During the pilot program, participants will be asked to complete an 
annual outcome measures form to aid FDA in evaluating the effectiveness 
of the program. Participation in this pilot is voluntary and currently 
includes 400 facilities and over 100 beds. The use of an interactive 
electronic data collection system is easier and more efficient for the 
participating user facilities to use than the alternative paper system. 
The paper form takes approximately 1 hour to complete and the 
electronic version takes approximately 45 minutes, or less, to 
complete. Much of the data which must be filled in by hand on the paper 
system is automatically filled in by the electronic version.
    In addition to collecting data on the electronic adverse event 
report form, MedSun also collects data electronically in DS-X. This 
data collection is also voluntary, and is an FDA moderated site. MedSun 
sites may send in ``success stories'' describing quality improvement 
initiatives they have implemented to improve patient safety with 
medical products and also may send in medical product related questions 
to which other sites may respond. The maximum time it takes to enter a 
story or write or respond to a question is 30 minutes.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                  Section of the Act                       Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
519(b) Facilities participating in the electronic                     400                    15              6,000                .75              4,500
 reporting of adverse events program
519 (b) Facilities participating in DS-X (not used by                 200                     5              1,000                .50               500
 all sites)
Total                                                                                                                                             5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 32672]]

    The burden estimate for the electronic reporting of adverse events 
is based on the number of facilities currently participating in MedSun 
(400) and the number of sites (50) expected to be added to the program 
over the next 3 years. The current average number of reports per site 
is 7 reports annually. For purposes of this renewed data collection, we 
are estimating an average of 15 reports per site annually. This 
increase is expected since MedSun is working to promote reporting in 
general from the sites, as well as promoting reporting from specific 
parts of the hospitals, such as the pediatric intensive care units, 
electrophysiology laboratories, and the hospital laboratories.
    Therefore, this yields a total annual responses of 6,000 (400 
facilities x 15 data entries = 6,000.) The participating MedSun 
reporters tell FDA that it typically takes 20 to 45 minutes to fill out 
the online form. Using the high end of that timeframe, the overall 
annual burden hours will be 4,500 hours (6,000 report entries x 0.75 
hours = 4,500 hours).
    Determining burden for the DS-X portion of MedSun: Not all sites 
use this part of the software. To determine the total annual responses 
for DS-X: 200 participants multiplied by the number of times each will 
access DS-X yields annual responses of 1,000 reports.
    It typically takes an average of 30 minutes to enter data into DS-
X, given that there are various types of data entries which are 
possible, some of which are lengthier than others. The number of burden 
hours for DS-X is determined by multiplying the expected 1,000 times 
the site will be accessed by the average amount of time it takes to 
make a DS-X data entry (30 minutes). This equals a burden of 500 hours 
(1,000 x 0.50 = 500).
    The total burden hours for MedSun and DS-X data entry equals 8,000 
hours (7,500 for MedSun and 500 for DS-X).

    Dated: June 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11400 Filed 6-12-07; 8:45 am]
BILLING CODE 4160-01-S