Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority, 77719-77721 [E8-30280]
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Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices
know. At this time, the need-to-know
senior management personnel are
limited to 5 senior managers. Further,
the data are used by this defined group
only for decisionmaking and planning
in the context of a federally-declared
disaster/emergency, an official
emergency preparedness exercise, or a
potential public health risk posed by
nondisaster-related device shortage.
The data procurement process
consists of an initial scripted telephone
call to a regulatory officer at a registered
manufacturer of one or more key
medical devices being tracked in the
emergency shortages data collection
system. In this initial call, the intent and
goals of the data collection effort are
described, and the specific data request
is made. After the initial call, one or
more additional followup calls and/or
electronic mail correspondence may be
required to verify/validate data sent
from the manufacturer, confirm receipt
and/or request additional detail.
Although the regulatory officer is the
agent who is initially contacted, they
may designate an alternate
representative within their organization
to correspond subsequently with the
CDRH EST member who is collecting or
verifying/validating the data.
Because of the dynamic nature of the
medical device industry, particularly
with respect to specific product lines,
manufacturing capabilities and raw
material/subcomponent sourcing, it is
necessary to update the data in the
ESDCS at regular intervals. This is done
on a weekly basis, but efforts are made
to limit the frequency of outreach to a
specific manufacturer to no more than
every 4 months.
The ESDCS will only include those
medical devices for which there will
likely be high demand during a specific
emergency/disaster, or for which there
are sufficiently small numbers of
manufacturers such that disruption of
manufacture or loss of one or more of
these manufacturers would create a
shortage.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Section of the Act
No. of
Respondents
903(d)(2)
1 There
Annual Frequency per
Response
125
Total Annual
Responses
3
Hours per
Response
375
Total Hours
0.5
188
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in
Table 1 of this document on past
experience with direct contact with the
medical device manufacturers, and
anticipated changes in the medical
device manufacturing patterns for the
specific devices being monitored. FDA
estimates that approximately 125
manufacturers would be contacted by
telephone and/or electronic mail 3 times
per year to either obtain primary data or
to verify/validate data. Because the data
being requested represent data elements
that are monitored or tracked by
manufacturers as part of routine
inventory management activities, it is
anticipated that for most manufacturers,
the estimated time required of
manufacturers to complete the data
request will not exceed 30 minutes per
request cycle.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–30155 Filed 12–18–08; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
17:29 Dec 18, 2008
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0631]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Recall Authority
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 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
information collection requirements for
medical device recall authority.
DATES: Submit written or electronic
comments on the collection of
information by February 17, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
PO 00000
Frm 00129
Fmt 4703
Sfmt 4703
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 Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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 collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
E:\FR\FM\19DEN1.SGM
19DEN1
77720
Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices
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.
Medical Device Recall Authority—21
CFR Part 810 (OMB Control Number
0910–0432)—Extension
This collection of information
implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360h) and part 810
(21 CFR part 810) for the medical device
recall authority provisions. Section
518(e) of the act provides FDA with the
authority to issue an order requiring an
appropriate person, including
manufacturers, importers, distributors,
and retailers of a device, if FDA finds
that there is reasonable probability that
the device intended for human use
would cause serious adverse health
consequences or death to: (1)
Immediately cease distribution of such
device, (2) immediately notify health
professionals and device-user facilities
of the order, and (3) instruct such
professionals and facilities to cease use
of such device.
Further, the provisions under section
518(e) of the act sets out a three-step
procedure for issuance of a mandatory
device recall order which are: (1) If
there is a reasonable probability that a
device intended for human use would
cause serious, adverse health
consequences or death, FDA may issue
a cease distribution and notification
order requiring the appropriate person
to immediately: (a) Cease distribution of
the device, (b) notify health
professionals and device user facilities
of the order, and (c) instruct those
professionals and facilities to cease use
of the device, (2) FDA will provide the
person named in the cease distribution
and notification order with the
opportunity for an informal hearing on
whether the order should be modified,
vacated, or amended to require a
mandatory recall of the device and, (3)
after providing the opportunity for an
informal hearing, FDA may issue a
mandatory recall order if the agency
determines that such an order is
necessary.
The information collected under the
recall authority provisions will be used
by FDA to: (1) Ensure that all devices
entering the market are safe and
effective, (2) accurately and
immediately detect serious problems
with medical devices, and (3) remove
dangerous and defective devices from
the market.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Annual Frequency per
Response
No. of Respondents
Total Annual
Responses
Hours per
Response
Total Hours
810.10(d)
2
1
2
8
16
810.11(a)
1
1
1
8
8
810.12(a-b)
1
1
1
8
8
810.14
2
1
2
16
32
810.15(a-c)
2
1
2
12
24
810.15(d)
2
1
2
4
8
810.15(e)
10
1
10
1
10
810.16(a-b)
2
12
24
40
960
810.17(a)
2
1
2
8
16
Total
1 There
1,082
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
No. of Recordkeepers
Annual Frequency per
Recordkeeping
2
21 CFR Section
1
810.15(b)
1 There
Total Annual
Records
Hours per
Record
1
Total Hours
8
8
are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation for Burden Estimates:
The burden estimates for Tables I and
II are based on FDA’s experience with
voluntary recalls under part 810 of the
regulations. FDA expects no more than
two mandatory recalls per year, as most
recalls are done voluntarily. Since the
last time this collection of information
was submitted to OMB for renewal/
VerDate Aug<31>2005
17:29 Dec 18, 2008
Jkt 217001
approval, there have been no mandatory
recalls.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
PO 00000
Frm 00130
Fmt 4703
Sfmt 4703
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
E:\FR\FM\19DEN1.SGM
19DEN1
Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices
Dated: December 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–30280 Filed 12–18–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0641]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary Hazard
Analysis and Critical Control Point
Manuals for Operators and Regulators
of Retail and Food Service
Establishments
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 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 information collection provisions of
the agency’s Voluntary Hazard Analysis
and Critical Control Point Manuals for
Operators and Regulators of Retail and
Food Service Establishments.
DATES: Submit written or electronic
comments on the collection of
information by February 17, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
VerDate Aug<31>2005
17:29 Dec 18, 2008
Jkt 217001
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 collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (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.
Voluntary Hazard Analysis and Critical
Control Point Manuals for Operators
and Regulators of Retail and Food
Service Establishments (OMB Control
Number 0910–0578)—Extension
The Operator’s Manual contains
information and recommendations for
operators of retail and foodservice
establishments who wish to develop
and implement a voluntary food safety
management system based on Hazard
Analysis and Critical Control Point
(HACCP) principles. Operators may
decide to incorporate some or all of the
principles presented in the manual into
their existing food safety management
systems. The recordkeeping practices
discussed in the manual are voluntary
and may include documenting certain
activities, such as monitoring and
verification, which the operator may or
may not deem necessary to ensure food
safety. The manual includes optional
worksheets to assist operators in
developing and validating a voluntary
food safety management system.
PO 00000
Frm 00131
Fmt 4703
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77721
The Regulator’s Manual contains
recommendations for State, local, and
tribal regulators on conducting riskbased inspections of retail and
foodservice establishments, including
recommendations about recordkeeping
practices that can assist operators in
preventing foodborne illness. These
recommendations may lead to voluntary
actions by operators based on
consultation with regulators. For
example, an operator may develop a risk
control plan as an intervention strategy
for controlling specific out-of-control
foodborne illness risk factors identified
during an inspection. Further, the
manual contains recommendations to
assist regulators when evaluating
voluntary food safety management
systems in retail and foodservice
establishments. Such evaluations
typically consist of the following two
components: (1) Validation (assessing
whether the establishment’s voluntary
food safety management system is
adequate to control food safety hazards)
and (2) verification (assessing whether
the establishment is following its
voluntary food safety management
system). The manual includes a sample
entitled ‘‘Verification Inspection
Checklist’’ to assist regulators when
conducting verification inspections of
establishments with voluntary food
safety management systems.
Types of operator records discussed
in the manuals and listed in the
following burden estimates include: (1)
Food safety management systems (plans
that delineate the formal procedures to
follow to control all food safety hazards
in an operation); (2) risk control plans
(HACCP-based, goal-oriented plans for
achieving active managerial control over
specific out-of-control foodborne illness
risk factors); (3) hazard analysis (written
assessment of the significant food safety
hazards associated with foods prepared
in the establishment); (4) prerequisite
programs (written policies or
procedures, including but not limited
to, standard operating procedures,
training protocols, and buyer
specifications that address maintenance
of basic operational and sanitation
conditions); (5) monitoring (records
showing the observations or
measurements that are made to help
determine if critical limits are being met
and maintained); (6) corrective action
(records indicating the activities that are
completed whenever a critical limit is
not met); (7) ongoing verification
(records showing the procedures that
are followed to ensure that monitoring
and other functions of the food safety
management system are being
implemented properly); and (8)
E:\FR\FM\19DEN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77719-77721]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30280]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0631]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Recall Authority
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 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 information collection
requirements for medical device recall authority.
DATES: Submit written or electronic comments on the collection of
information by February 17, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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 collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether
[[Page 77720]]
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.
Medical Device Recall Authority--21 CFR Part 810 (OMB Control Number
0910-0432)--Extension
This collection of information implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360h) and
part 810 (21 CFR part 810) for the medical device recall authority
provisions. Section 518(e) of the act provides FDA with the authority
to issue an order requiring an appropriate person, including
manufacturers, importers, distributors, and retailers of a device, if
FDA finds that there is reasonable probability that the device intended
for human use would cause serious adverse health consequences or death
to: (1) Immediately cease distribution of such device, (2) immediately
notify health professionals and device-user facilities of the order,
and (3) instruct such professionals and facilities to cease use of such
device.
Further, the provisions under section 518(e) of the act sets out a
three-step procedure for issuance of a mandatory device recall order
which are: (1) If there is a reasonable probability that a device
intended for human use would cause serious, adverse health consequences
or death, FDA may issue a cease distribution and notification order
requiring the appropriate person to immediately: (a) Cease distribution
of the device, (b) notify health professionals and device user
facilities of the order, and (c) instruct those professionals and
facilities to cease use of the device, (2) FDA will provide the person
named in the cease distribution and notification order with the
opportunity for an informal hearing on whether the order should be
modified, vacated, or amended to require a mandatory recall of the
device and, (3) after providing the opportunity for an informal
hearing, FDA may issue a mandatory recall order if the agency
determines that such an order is necessary.
The information collected under the recall authority provisions
will be used by FDA to: (1) Ensure that all devices entering the market
are safe and effective, (2) accurately and immediately detect serious
problems with medical devices, and (3) remove dangerous and defective
devices from the market.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual Hours per
21 CFR Section No. of Respondents Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
810.10(d) 2 1 2 8 16
----------------------------------------------------------------------------------------------------------------
810.11(a) 1 1 1 8 8
----------------------------------------------------------------------------------------------------------------
810.12(a-b) 1 1 1 8 8
----------------------------------------------------------------------------------------------------------------
810.14 2 1 2 16 32
----------------------------------------------------------------------------------------------------------------
810.15(a-c) 2 1 2 12 24
----------------------------------------------------------------------------------------------------------------
810.15(d) 2 1 2 4 8
----------------------------------------------------------------------------------------------------------------
810.15(e) 10 1 10 1 10
----------------------------------------------------------------------------------------------------------------
810.16(a-b) 2 12 24 40 960
----------------------------------------------------------------------------------------------------------------
810.17(a) 2 1 2 8 16
----------------------------------------------------------------------------------------------------------------
Total .................... .................... .................. ............... 1,082
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual Hours per
21 CFR Section No. of Recordkeepers Recordkeeping Records Record Total Hours
----------------------------------------------------------------------------------------------------------------
810.15(b) 2 1 1 8 8
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Explanation for Burden Estimates:
The burden estimates for Tables I and II are based on FDA's
experience with voluntary recalls under part 810 of the regulations.
FDA expects no more than two mandatory recalls per year, as most
recalls are done voluntarily. Since the last time this collection of
information was submitted to OMB for renewal/approval, there have been
no mandatory recalls.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
[[Page 77721]]
Dated: December 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30280 Filed 12-18-08; 8:45 am]
BILLING CODE 4160-01-S
