Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program), 32670-32672 [E7-11400]
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Federal Register / Vol. 72, No. 113 / Wednesday, June 13, 2007 / Notices
have reported experiencing illnesses or
injuries during their time in the
backcountry.
Such a high burden of disease has
significant medical and economic
implications given the increasing
popularity of backcountry use. In 2004,
an estimated 12% of Americans age 16
years and older (about 26 million
persons) went backpacking in the
previous 12 months, which involved
camping for one or more nights along a
trail and carrying food, shelter, and
utensils with them. In the same period
of time, about 15% (or 33 million
persons) camped in primitive settings
that usually lacked restrooms, hookups,
and most facilities and services. In fact,
camping in backcountry areas grew by
about 184% from 1982–83 to 2004.
While people can travel in the
backcountry in many locations and on
both private and public lands, many
travelers hike, backpack, and camp in
the backcountry in national parks. In
2006, there were more than 272 million
recreational visits to national parks with
more than 1.6 million overnight stays in
the backcountry. Yellowstone National
Park alone had 12,673 persons visit the
backcountry in 2006, accounting for
more than 37,000 overnight stays.
Because little is known about the
health outcomes for visitors who use the
backcountry areas of our nation’s parks,
advice to park managers and the public
is currently general in nature, based
only on standard disease prevention
principles. Furthermore, some outdoor
use groups have recently questioned
some of this standard advice, such as
the universal need for careful filtration
and disinfection of backcountry
drinking water. This study will
investigate behavioral and
environmental risk factors that may be
associated with illness and injury
among persons who require park
permits to travel into backcountry areas
in Yellowstone National Park during the
backcountry season from May 1–Oct. 31,
2008. The data collected will be used to
provide an estimate of the burden of
illness and injury among backcountry
users and will also provide information
about a variety of risk factors for illness
and injury in the backcountry, including
the risks associated with drinking
untreated water from lakes and streams.
With this information, the National Park
Service (NPS) will be able to address
many of the questions raised by outdoor
users and public health officials, and
improve and strengthen evidence-based
NPS guidelines for backcountry health
and sanitation practices. To gather this
information, consent to contact after the
conclusion of the backcountry trip will
be requested from an estimated 10,138
adult backcountry users when they
present to the Yellowstone National
Park’s permit offices prior to entering
the backcountry. A questionnaire (in
either Internet-based or paper-based
format) will then be offered to an
estimated 3,532 adult backcountry users
who consent to be contacted.
Participants will be asked about their
health (before, during and after
backcountry travel), water consumption,
water preparation habits, food
consumption, food preparation habits,
sanitation practices, recreational water
use, animal exposure, and
demographics.
This study is the beginning of what
will be an on-going effort to improve the
science-basis of the NPS
recommendations and policies related
to protecting human health in the
backcountry. This effort seeks to begin
to identify disease transmission
pathways and assess disease and injury
risks associated with specific activities,
choices, and behaviors of backcountry
visitors, such as water purification,
sanitation practices, and hygiene.
Thoroughly understanding transmission
pathways and the interactions of agent,
environment, and host will enable the
NPS to effectively and efficiently
improve visitor protection efforts. There
will be no cost to respondents other
than their time. Participation is
voluntary and will not affect the
application process for the backcountry
use permit. The total estimated
annualized hours requested are 2,141.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Consent to Further Contact .........................................................................................................
Web-Based Questionnaire ...........................................................................................................
Paper-Based Questionnaire ........................................................................................................
Dated: June 7, 2007.
Maryam Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–11384 Filed 6–12–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse Event
Pilot Program for Medical Products
(Formally Medical Device Adverse
Event Reporting Program)
Food and Drug Administration
[Docket No. 2007N–0218]
AGENCY:
Food and Drug Administration,
sroberts on PROD1PC70 with NOTICES
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed continuing collection of
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18:30 Jun 12, 2007
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10,138
3,423
109
Number
responses per
respondent
1
1
1
Average
burden per
response
(in hours)
2/60
30/60
50/60
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
E:\FR\FM\13JNN1.SGM
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32671
Federal Register / Vol. 72, No. 113 / Wednesday, June 13, 2007 / Notices
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: https://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 BURDEN1
No. of
Respondents
sroberts on PROD1PC70 with NOTICES
Section of the Act
519(b) Facilities participating in
the electronic reporting of adverse events program
519 (b) Facilities participating in
DS–X (not used by all sites)
Total
1There
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
400
15
6,000
.75
4,500
200
5
1,000
.50
500
5,000
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total Hours
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32672
Federal Register / Vol. 72, No. 113 / Wednesday, June 13, 2007 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sroberts on PROD1PC70 with NOTICES
National Institutes of Health
National Cancer Institute, Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Advisory Board, June 14, 2007, 1:15
VerDate Aug<31>2005
18:30 Jun 12, 2007
Jkt 211001
p.m. to June 15, 2007, 11:45 a.m.
National Institutes of Health, Building
31, 31 Center Drive, Bethesda, MD
20892 which was published in the
Federal Register on May 21, 2007, 72
FR 28512.
This notice is amended to add the
NCAB Ad Hoc Subcommittee on
Experimental Therapeutics meeting on
June 14, 2007 from 8:30 p.m. to 10:30
p.m. at the Bethesda Hyatt Hotel, One
Metro Center, Bethesda, MD 20814. The
meeting is open to the public.
Dated: June 6, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–2902 Filed 6–12–07; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center on Minority Health and
Health Disparities; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in section 552b(c)(4)
and 552b(c)(6), Title 5 U.S.C., as
amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center on
Minority Health and Health Disparities
Special Emphasis Panel; Research
Infrastructure in Minority Institutions (RIMI)
Meeting.
Date: July 22–24, 2007.
Time: 5 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Robert Nettey, MD,
Scientific Review Administrator, National
Institute on Minority Health and Health
Disparities, 6707 Democracy Blvd., Suite 800,
Bethesda, MD 20892, (301) 496–3996.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Dated: June 6, 2007.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 07–2903 Filed 6–12–07; 8:45 am]
BILLING CODE: 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel,
Autism Centers Review.
Date: July 9, 2007.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Vinod Charles, PhD,
Scientific Review Administrator, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6151, MSC 9606,
Bethesda, MD 20892–9606, 301–443–1606.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel,
Disaster Mental Health Centers Review.
Date: July 26, 2007.
Time: 10 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Marina Broitman, PhD,
Scientific Review Administrator, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6153, MSC 9608,
Bethesda, MD 20892–9608, 301–402–8152,
mbroitma@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
E:\FR\FM\13JNN1.SGM
13JNN1
]]>Agencies
[Federal Register Volume 72, Number 113 (Wednesday, June 13, 2007)]
[Notices]
[Pages 32670-32672]
From the Federal Register Online via the Government Printing 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: https://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
