Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting, 15419-15420 [E6-4426]
Download as PDF
<![CDATA[
15419
Federal Register / Vol. 71, No. 59 / Tuesday, March 28, 2006 / Notices
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–4425 Filed 3–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0484]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Reporting: Manufacturer Reporting,
Importer Reporting, User Facility
Reporting, and Distributor Reporting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Fax written comments on the
collection of information by April 27,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
DATES:
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.
Medical Device Reporting:
Manufacturer Reporting, Importer
Reporting, User Facility Reporting, and
Distributor Reporting—21 CFR Part 803
(OMB Control Number 0910–0437)—
Extension
Section 519(a), (b), and (c) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360i(a), (b), and (c))
requires user facilities, manufacturers,
and importers of medical devices to
report adverse events involving medical
devices to FDA. On December 11, 1995
(60 FR 63578 at 63597), FDA issued part
803 (21 CFR part 803) that implemented
section 519 of the act. The regulation
was amended to conform to the changes
reflected in the FDA Modernization Act
of 1997.
Information from these reports will be
used to evaluate risks associated with
medical devices and to enable FDA to
take appropriate regulatory measures to
protect the public health.
Respondents to this collection of
information are businesses or other for
profit and nonprofit organizations
including user facilities, manufacturers,
and importers of medical devices.
In the Federal Register of December
23, 2005 (70 FR 76318), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
803.19
55
4
220
3
660
803.30
700
5
3,500
1
3,500
803.33, FDA Form 3419
700
1
700
1
700
803.40
40
17
680
1
680
803.50
1,465
57
83,505
1
83,505
700
5
3,500
1
3,500
803.55, FDA Form 3417
Total
1There
92,545
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
803.17
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
220
1
220
3.3
726
30,000
803.18(c) and (d)
1
30,000
1.5
45,000
cprice-sewell on PROD1PC66 with NOTICES
Total
1There
Total Hours
45,726
are no capital costs or operating and maintenance costs associated with this collection of information.
Part 803 requires user facilities to
report to the device manufacturer, and
to FDA in the case of a death, incidents
VerDate Aug<31>2005
15:19 Mar 27, 2006
Jkt 208001
where a medical device caused or
contributed to a death or serious injury.
Manufacturers of medical devices are
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
required to report to FDA when they
become aware of information indicating
that one of their devices may have
E:\FR\FM\28MRN1.SGM
28MRN1
cprice-sewell on PROD1PC66 with NOTICES
15420
Federal Register / Vol. 71, No. 59 / Tuesday, March 28, 2006 / Notices
caused or contributed to death or
serious injury or has malfunctioned in
such a way that should the malfunction
recur, it would be likely to cause or
contribute to a death or serious injury.
Device importers report deaths and
serious injuries to the manufacturers
and FDA. Importers report malfunctions
only to the manufacturers, unless they
are unknown, then the reports are sent
to FDA.
The number of respondents for each
CFR section in table 1 of this document
is based upon the number of
respondents entered into FDA’s internal
databases. FDA estimates, based on its
experience and interaction with the
medical device community, that all
reporting CFR sections are expected to
take 1 hour to complete, with the
exception of § 803.19. Section 803.19 is
expected to take approximately 3 hours
to complete, but is only required for
reporting the summarized data quarterly
to FDA. By summarizing events, the
total time used to report for this section
is reduced because the respondents do
not submit a full report for each event
they report in a quarterly summary
report.
The agency believes that the majority
of manufacturers, user facilities, and
importers have already established
written procedures to document
complaints and information to meet the
medical device reporting (MDR)
requirements as part of their internal
quality control system. There are an
estimated 30,000 medical device
distributors. Although they do not
submit MDR reports, they must
maintain records of complaints, under
§ 803.18(d).
The agency has estimated that on
average, 220 user facilities, importers,
and manufacturers would annually be
required to establish new procedures, or
revise existing procedures, in order to
comply with this provision.
Therefore, FDA estimates the onetime burden to respondents for
establishing or revising procedures to be
2,200 hours (220 respondents x 10
hours). For those entities, a one-time
burden of 10 hours is estimated for
establishing written MDR procedures.
The remaining manufacturers, user
facilities, and importers, not required to
revise their written procedures to
comply with this provision, are
excluded from the burden because the
recordkeeping activities needed to
comply with this provision are
considered ‘‘usual and customary’’
under 5 CFR 1320.3(b)(2).
The annual burden for recordkeeping
to respondents follows. Under § 803.17,
FDA estimates 220 respondents will
spend approximately 3.3 hours to
VerDate Aug<31>2005
15:19 Mar 27, 2006
Jkt 208001
complete the requirements for this
section. The number of respondents was
estimated by consolidating the total of
all new reporting entities together. The
3.3 hours was estimated by FDA, as this
section deals with a respondent creating
new MDR procedures and is a one-time
function. The ‘‘total hours’’ for this
section equals approximately 726 hours.
Under § 803.18, 30,000 respondents
represent distributors, importers, and
other respondents to this information
collection. FDA estimates that it should
take them approximately 1 1/2 hours to
complete the recordkeeping requirement
for this section. Total hours for this
section equal 45,000 hours.
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–4426 Filed 3–27–06; 8:45 am]
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–4427 Filed 3–27–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0508]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey of Health
Care Practitioners Regarding Their
Preferences for Public Health
Notifications
AGENCY:
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0118]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Reagents for Detection of
Specific Novel Influenza A Viruses
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Reagents for Detection of
Specific Novel Influenza A Viruses’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
An agency
may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0584. The
approval expires on September 30,
2006. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.fda.gov/ohrms/dockets.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00049
Fmt 4703
Food and Drug Administration,
HHS.
BILLING CODE 4160–01–S
Sfmt 4703
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 April 27,
2006.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
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.
ADDRESSES:
Survey of Health Care Practitioners
Regarding Their Preferences for Public
Health Notifications (PHNs)
The PHN is one of the tools that the
Center for Devices and Radiological
Health (CDRH) uses to get an important
message to the user community about
risks associated with the use of medical
devices. This particular tool is meant to
serve a specific purpose not served by
the other communication tools at our
E:\FR\FM\28MRN1.SGM
28MRN1
]]>Agencies
[Federal Register Volume 71, Number 59 (Tuesday, March 28, 2006)]
[Notices]
[Pages 15419-15420]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4426]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0484]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Reporting: Manufacturer Reporting, Importer Reporting, User Facility
Reporting, and Distributor Reporting
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 April
27, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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.
Medical Device Reporting: Manufacturer Reporting, Importer Reporting,
User Facility Reporting, and Distributor Reporting--21 CFR Part 803
(OMB Control Number 0910-0437)--Extension
Section 519(a), (b), and (c) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360i(a), (b), and (c)) requires user
facilities, manufacturers, and importers of medical devices to report
adverse events involving medical devices to FDA. On December 11, 1995
(60 FR 63578 at 63597), FDA issued part 803 (21 CFR part 803) that
implemented section 519 of the act. The regulation was amended to
conform to the changes reflected in the FDA Modernization Act of 1997.
Information from these reports will be used to evaluate risks
associated with medical devices and to enable FDA to take appropriate
regulatory measures to protect the public health.
Respondents to this collection of information are businesses or
other for profit and nonprofit organizations including user facilities,
manufacturers, and importers of medical devices.
In the Federal Register of December 23, 2005 (70 FR 76318), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.19 55 4 220 3 660
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.30 700 5 3,500 1 3,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.33, FDA Form 3419 700 1 700 1 700
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.40 40 17 680 1 680
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.50 1,465 57 83,505 1 83,505
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.55, FDA Form 3417 700 5 3,500 1 3,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 92,545
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.17 220 1 220 3.3 726
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.18(c) and (d) 30,000 1 30,000 1.5 45,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 45,726
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Part 803 requires user facilities to report to the device
manufacturer, and to FDA in the case of a death, incidents where a
medical device caused or contributed to a death or serious injury.
Manufacturers of medical devices are required to report to FDA when
they become aware of information indicating that one of their devices
may have
[[Page 15420]]
caused or contributed to death or serious injury or has malfunctioned
in such a way that should the malfunction recur, it would be likely to
cause or contribute to a death or serious injury. Device importers
report deaths and serious injuries to the manufacturers and FDA.
Importers report malfunctions only to the manufacturers, unless they
are unknown, then the reports are sent to FDA.
The number of respondents for each CFR section in table 1 of this
document is based upon the number of respondents entered into FDA's
internal databases. FDA estimates, based on its experience and
interaction with the medical device community, that all reporting CFR
sections are expected to take 1 hour to complete, with the exception of
Sec. 803.19. Section 803.19 is expected to take approximately 3 hours
to complete, but is only required for reporting the summarized data
quarterly to FDA. By summarizing events, the total time used to report
for this section is reduced because the respondents do not submit a
full report for each event they report in a quarterly summary report.
The agency believes that the majority of manufacturers, user
facilities, and importers have already established written procedures
to document complaints and information to meet the medical device
reporting (MDR) requirements as part of their internal quality control
system. There are an estimated 30,000 medical device distributors.
Although they do not submit MDR reports, they must maintain records of
complaints, under Sec. 803.18(d).
The agency has estimated that on average, 220 user facilities,
importers, and manufacturers would annually be required to establish
new procedures, or revise existing procedures, in order to comply with
this provision.
Therefore, FDA estimates the one-time burden to respondents for
establishing or revising procedures to be 2,200 hours (220 respondents
x 10 hours). For those entities, a one-time burden of 10 hours is
estimated for establishing written MDR procedures. The remaining
manufacturers, user facilities, and importers, not required to revise
their written procedures to comply with this provision, are excluded
from the burden because the recordkeeping activities needed to comply
with this provision are considered ``usual and customary'' under 5 CFR
1320.3(b)(2).
The annual burden for recordkeeping to respondents follows. Under
Sec. 803.17, FDA estimates 220 respondents will spend approximately
3.3 hours to complete the requirements for this section. The number of
respondents was estimated by consolidating the total of all new
reporting entities together. The 3.3 hours was estimated by FDA, as
this section deals with a respondent creating new MDR procedures and is
a one-time function. The ``total hours'' for this section equals
approximately 726 hours.
Under Sec. 803.18, 30,000 respondents represent distributors,
importers, and other respondents to this information collection. FDA
estimates that it should take them approximately 1 1/2 hours to
complete the recordkeeping requirement for this section. Total hours
for this section equal 45,000 hours.
Dated: March 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4426 Filed 3-27-06; 8:45 am]
BILLING CODE 4160-01-S
