Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program), 51231-51232 [E7-17562]
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Federal Register / Vol. 72, No. 172 / Thursday, September 6, 2007 / Notices
and run the grant day-to-day.
Administrative expenses will be capped
at .5 percent for the State and 5 percent
for the local partner.
The State of Louisiana, in
consultation with its local partner, has
flexibility subject to approval by the
Centers for Medicare & Medicaid
Services (CMS) in determining the
funding allocation methodology to
grantee clinics/subawardees, as long as
it includes a standardization of ‘‘units of
care’’ across all grantee clinics, and
includes a base award and
supplementary payments that meet the
intent of the grant.
This award was made based on the
authority granted by section 6201 of the
Deficit Reduction Act (DRA). In
particular, section 6201(a)(4) of the DRA
provides authority to the Secretary,
Department of Health and Human
Services (DHHS), to make payments to
States to restore access to health care in
communities impacted by Hurricane
Katrina.
Under the authority of section
6201(a)(4) of the DRA of 2005, the
Secretary has invoked his authority to
restore health care in impacted
communities affected by Hurricane
Katrina by offering this unique funding
opportunity to stabilize primary health
care access to the Greater New Orleans
area, which is facing inadequate
primary care access as a result of
Hurricane Katrina and its subsequent
floods.
Louisiana is the only State with the
knowledge and ability to administer a
grant designed to affect impacted
Louisiana communities. For this reason,
the Secretary has directed CMS to offer
a single-source award to the State of
Louisiana to help strengthen and
increase primary care access to the
Greater New Orleans area and by
helping to increase the supply of health
care providers negatively impacted as a
result of this hurricane.
FOR FURTHER INFORMATION CONTACT:
Wendy J. Taparanskas, Ph.D., Health
Insurance Specialist, Finance, Systems,
and Budget Group, Center for Medicaid
and State Operations, Centers for
Medicare & Medicaid Services, Mail
Stop S3–13–15, 7500 Security
Boulevard, Baltimore, MD 21244, (410)
786–5245.
mstockstill on PROD1PC66 with NOTICES
Authority: Section 6201(a)(4) of the Deficit
Reduction Act of 2005 (DRA).
Dated: August 30, 2007.
Herb B. Kuhn,
Acting Deputy Administrator, Centers for
Medicare & Medicaid Services.
[FR Doc. E7–17560 Filed 9–5–07; 8:45 am]
BILLING CODE 4120–01–P
VerDate Aug<31>2005
18:25 Sep 05, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0218]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 9,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0471. Also
include the FDA 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–
1427.
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 Products—21 U.S.C. 360(i)
(OMB Control Number 0910–0471)—
Extension
Under section 519 of the 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
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
51231
519(b) of the act (21 U.S.C. 360 i(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 the
Medical Product Safety Network
(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 the Device-Safety Exchange (DS-X).
E:\FR\FM\06SEN1.SGM
06SEN1
51232
Federal Register / Vol. 72, No. 172 / Thursday, September 6, 2007 / Notices
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.
In the Federal Register of June 13,
2007 (72 FR 32670), FDA published a
60-day notice requesting public
comment on the information collection
provisions. In response to that notice,
no comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Section of Act
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
519(b) Facilities participating in the
electronic reporting of adverse
event programs.
400
15
6,000
.75
4,500
Section 519 (b) Facilities participating
in DS-X ( not used by all sites)
200
5
1,000
.50
500
Total
mstockstill on PROD1PC66 with NOTICES
1 There
5,000
are no capital costs or operating and maintenance costs associated with this collection of information.
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 seven reports
annually. For purposes of the renewal
for this data collection, we are
estimating an average of 15 reports per
site annually. This increase is expected
because 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. Thus, the total
annual responses is calculated to be
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 on-line
form. Using the high end of that time
frame, the total burden estimate for
facilities participating in the electronic
reporting of adverse event programs, is
estimated to be 4,500 hours (6,000
report entries x .75 hours = 4,500
hours).
Determination of burden estimate for
the DS-X portion of MedSun: All sites
do not use this part of the software. To
determine the total annual responses for
DS-X, 200 participants are multiplied by
the number of times each will access
DS-X. Thus the total annual responses
are calculated to be 1,000 reports (200
x 5 = 1,000). It typically takes an average
of 30 minutes to enter data into the DSX, 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
VerDate Aug<31>2005
18:25 Sep 05, 2007
Jkt 211001
1,000 times the site will be accessed by
the average amount of time it takes to
make a DS-X entry (30 minutes). Thus
the total burden estimate for DS-X is
calculated to be 500 hours (1,000 x 0.5
= 500). Therefore, the combined total
burden estimate for MedSun and DS-X
is calculated to be 5,000 hours (4,500 +
500 = 5,000).
Dated: August 29, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–17562 Filed 9–5–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0329]
Determination That MILTOWN
(Meprobamate) Tablets and Five Other
Drug Products Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that the six drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
the drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products.
FOR FURTHER INFORMATION CONTACT:
Mary Catchings, Center for Drug
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20855,301–594–
2041.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is a version of the drug that was
previously approved. Sponsors of
ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06SEN1.SGM
06SEN1
]]>Agencies
[Federal Register Volume 72, Number 172 (Thursday, September 6, 2007)]
[Notices]
[Pages 51231-51232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17562]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0218]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by October
9, 2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0471. Also
include the FDA 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, 301-827-1427.
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 Products--21 U.S.C. 360(i) (OMB
Control Number 0910-0471)--Extension
Under section 519 of the 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. 360 i(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 the Medical Product
Safety Network (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 the Device-
Safety Exchange (DS-X).
[[Page 51232]]
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.
In the Federal Register of June 13, 2007 (72 FR 32670), FDA
published a 60-day notice requesting public comment on the information
collection provisions. In response to that notice, no comments were
received.
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 Act Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
519(b) Facilities 400 15 6,000 .75 4,500
participating in
the electronic
reporting of
adverse event
programs.
----------------------------------------------------------------------------------------------------------------
Section 519 (b) 200 5 1,000 .50 500
Facilities
participating in
DS-X ( not used
by all sites)
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 5,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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 seven reports annually. For purposes of the renewal for this data
collection, we are estimating an average of 15 reports per site
annually. This increase is expected because 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. Thus, the total annual responses is calculated to be
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 on-line form. Using the high end of that time frame, the
total burden estimate for facilities participating in the electronic
reporting of adverse event programs, is estimated to be 4,500 hours
(6,000 report entries x .75 hours = 4,500 hours).
Determination of burden estimate for the DS-X portion of MedSun:
All sites do not use this part of the software. To determine the total
annual responses for DS-X, 200 participants are multiplied by the
number of times each will access DS-X. Thus the total annual responses
are calculated to be 1,000 reports (200 x 5 = 1,000). It typically
takes an average of 30 minutes to enter data into the 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 entry
(30 minutes). Thus the total burden estimate for DS-X is calculated to
be 500 hours (1,000 x 0.5 = 500). Therefore, the combined total burden
estimate for MedSun and DS-X is calculated to be 5,000 hours (4,500 +
500 = 5,000).
Dated: August 29, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-17562 Filed 9-5-07; 8:45 am]
BILLING CODE 4160-01-S
