Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority, 7165-7166 [2012-3098]
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7165
Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Notices
Dated: February 6, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office Centers for Disease Control and
Prevention.
[FR Doc. 2012–3114 Filed 2–9–12; 8:45 am]
OMB control number 0910–0432. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0793]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Recall Authority
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 Recall Authority—21
CFR Part 810 (OMB Control Number
0910–0432)—Extension
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 March 12,
2012.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
SUMMARY:
This collection of information
implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360h(e)) and part
810 (21 CFR part 810), medical device
recall authority provisions. Section
518(e) of the FD&C 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 FD&C Act set out the
following three-step procedure for
issuance of a mandatory device recall
order:
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:
• Cease distribution of the device,
• Notify health professionals and
device user facilities of the order, and
• 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 do the following: (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.
In the Federal Register of November
16, 2011 (76 FR 71041), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
srobinson on DSK4SPTVN1PROD with NOTICES
810.10(d) ..............................................................................
810.11(a) ..............................................................................
810.12(a) and (b) .................................................................
810.14 ..................................................................................
810.15(a), (b), and (c) ..........................................................
810.15(d) ..............................................................................
810.15(e) ..............................................................................
810.16(a) and (b) .................................................................
810.17(a) ..............................................................................
2
1
1
2
2
2
10
2
2
1
1
1
1
1
1
1
12
1
2
1
1
2
2
2
10
24
2
8
8
8
16
12
4
1
40
8
16
8
8
32
24
8
10
960
16
Total Hours ...................................................................
........................
........................
........................
........................
1,082
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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7166
Federal Register / Vol. 77, No. 28 / Friday, February 10, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
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.
The burden estimates for tables 1 and
2 of this document 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 has
been one mandatory recall.
Dated: February 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3098 Filed 2–9–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0096]
Draft Guidance for Industry on
Determining the Extent of Safety Data
Collection Needed in Late Stage
Premarket and Postapproval Clinical
Investigations; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Determining the
Extent of Safety Data Collection Needed
in Late Stage Premarket and
Postapproval Clinical Investigations.’’
This guidance is intended to assist
sponsors of clinical investigations in
determining the amounts and types of
safety data to collect in trials conducted
late in the development of a drug for
marketing approval or after approval
based on what is already known about
a drug’s safety profile. Extensive safety
data are collected in clinical trials of
investigational drugs to support
marketing approval (premarket) and
trials conducted after approval
(postmarket). FDA believes that more
selective or targeted safety data
collection may be possible for some late
stage premarket trials and postmarket
trials because certain aspects of a drug’s
safety profile will be sufficiently wellestablished that comprehensive data
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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21:29 Feb 09, 2012
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collection is not needed. FDA believes
more selective or targeted safety data
collection in appropriate circumstances
may improve the quality of the safety
assessment without compromising the
integrity of the trial results.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 10, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; or Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
Bickel, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6353, Silver Spring,
MD 20993, 301–796–0210; or Stephen
Ripley, Center for Biologics Evaluation
and Research (HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Determining the Extent of Safety Data
Collection Needed in Late Stage
Premarket and Postapproval Clinical
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Investigations.’’ This guidance is
intended to assist clinical trial sponsors
in determining the amounts and types of
safety data that should be collected
during late-stage premarket and
postmarket clinical investigations of a
drug product based on what is already
known about the safety profile of the
drug.
To meaningfully weigh the risks and
benefits of a drug, it is important to
collect a broad range of safety-related
data and develop a comprehensive
safety profile of a drug. In some cases,
however, certain aspects of the safety
profile may be well-established prior to
the completion of clinical trials to
support marketing approval of an
investigational drug. Similarly, for a
marketed drug being studied for a new
use, much of the existing safety profile
for the approved use may be relevant to
the new use. If certain aspects of a safety
profile are well-established, it may not
be necessary to collect certain types of
safety data in clinical trials because the
data would not contribute anything
additional to the safety profile and may
even have negative consequences (e.g.,
serve as a disincentive to clinical
investigators). In those settings, more
targeted or selective data collection can
be used to focus on collecting data that
will further contribute to the safety
profile.
The draft guidance identifies the
types of safety data collected and
recommends more selective or targeted
safety data collection in a variety of
circumstances, offers suggestions on
methods that may be used to conduct
selective or targeted data collection
where appropriate, and highlights
circumstances in which comprehensive
data collection is generally needed.
This draft guidance is being
developed consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the Agency’s
current thinking on determining the
extent of safety data collection needed
in late stage premarket and postapproval
clinical investigations. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
E:\FR\FM\10FEN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Notices]
[Pages 7165-7166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0793]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device Recall
Authority
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 March
12, 2012.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0432.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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 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 (FD&C Act) (21 U.S.C. 360h(e)) and
part 810 (21 CFR part 810), medical device recall authority provisions.
Section 518(e) of the FD&C 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 FD&C Act set
out the following three-step procedure for issuance of a mandatory
device recall order:
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:
Cease distribution of the device,
Notify health professionals and device user facilities of
the order, and
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 do the following: (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.
In the Federal Register of November 16, 2011 (76 FR 71041), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
810.10(d)....................... 2 1 2 8 16
810.11(a)....................... 1 1 1 8 8
810.12(a) and (b)............... 1 1 1 8 8
810.14.......................... 2 1 2 16 32
810.15(a), (b), and (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) and (b)............... 2 12 24 40 960
810.17(a)....................... 2 1 2 8 16
-------------------------------------------------------------------------------
Total Hours................. .............. .............. .............. .............. 1,082
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 7166]]
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
The burden estimates for tables 1 and 2 of this document 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 has been one mandatory recall.
Dated: February 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3098 Filed 2-9-12; 8:45 am]
BILLING CODE 4160-01-P
