Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority, 33523-33524 [2015-14359]
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33523
Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@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.
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.
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 July 13,
2015.
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: FDA
PRA Staff, Office of Operations, Food
SUMMARY:
Medical Device Recall Authority—21
CFR 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:
• 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:
Æ Cease distribution of the device,
Æ notify health professionals and
device user facilities of the order, and
Æ instruct those professionals and
facilities to cease use of the device;
• 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
• 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 March 11,
2015 (80 FR 13586), 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
Collection activity—21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Collections Specified in the Order—810.10(d) ....................
Request for Regulatory Hearing—810.11(a) .......................
Written Request for Review—810.12(a–b) ..........................
Mandatory Recall Strategy—810.14 ....................................
Periodic Status Reports—810.16(a–b) ................................
Termination Request—810.17(a) .........................................
Total Hours ...................................................................
2
1
1
2
2
2
........................
1
1
1
1
12
1
........................
2
1
1
2
24
2
........................
8
8
8
16
40
8
........................
1 There
Total hours
16
8
8
32
960
16
1,040
are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Collection activity—21 CFR Section
Documentation of Notifications to Recipients—810.15(b) ...
1 There
Number of
records per
recordkeeper
2
Average
burden per
recordkeeping
Total annual
records
1
1
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
19:05 Jun 11, 2015
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Total hours
8
33524
Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Collection Activity—21 CFR Section
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Notification to Recipients—810.15(a)–(c) ........................
Notification to Recipients; Followup—810.15(d) ..............
Notification of Consignees by Recipients—810.15(e) .....
Total ..........................................................................
2
2
10
........................
1
1
1
............................
2
2
10
........................
12
4
1
........................
1 There
collection of information to OMB for
review and clearance.
Reclassification Petitions for Medical
Devices (OMB Control Number 0910–
0138)—Extension
[FR Doc. 2015–14359 Filed 6–11–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0776]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reclassification
Petitions for Medical Devices
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 July 13,
2015.
SUMMARY:
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 0910–0138. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK4VPTVN1PROD with NOTICES
24
8
10
42
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Total hours
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
20:18 Jun 11, 2015
Jkt 235001
Under sections 513(e) and (f), 514(b),
515(b), and 520(l) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360c(e) and (f), 360d(b),
360e(b), and 360j(l)) and part 860 (21
CFR part 860), subpart C, FDA has
responsibility to collect data and
information contained in
reclassification petitions. The
reclassification provisions of the FD&C
Act allow any person to petition for
reclassification of a device from any of
the three classes, i.e., I, II, and III, to
another class. The reclassification
content regulation (§ 860.123) requires
the submission of valid scientific
evidence demonstrating that the
proposed reclassification will provide a
reasonable assurance of safety and
effectiveness of the device type for its
indications for use.
The reclassification procedure
regulation requires the submission of
specific data when a manufacturer is
petitioning for reclassification. This
includes a ‘‘Supplemental Data Sheet,’’
Form FDA 3427, and a ‘‘General Device
Classification Questionnaire,’’ Form
FDA 3429. Both forms contain a series
of questions concerning the safety and
effectiveness of the device type.
In the Federal Register of March 25,
2014 (79 FR 16252), FDA issued a
proposed rule that would eliminate the
need for Forms FDA 3427 and FDA
3429. However, because the proposed
rule has not been finalized, we continue
to include the forms in the burden
estimate for this information collection.
The reclassification provisions of the
FD&C Act serve primarily as a vehicle
for manufacturers to seek
reclassification from a higher to a lower
class, thereby reducing the regulatory
requirements applicable to a particular
device type, or to seek reclassification
from a lower to a higher class, thereby
increasing the regulatory requirements
applicable to that device type. If
approved, petitions requesting
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
classification from class III to class II or
class I provide an alternative route to
market in lieu of premarket approval for
class III devices. If approved, petitions
requesting reclassification from class I
or II, to a different class, may increase
requirements.
In the Federal Register of March 10,
2015 (80 FR 12642), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was
received.
The comment refers to changes to the
form FDA 3429 as proposed by the
commenter in a citizen petition (FDA–
2014–P–0283–0001), which was
subsequently denied by FDA in a final
response letter to the petitioner (FDA–
2014–P–0283–0003). Because the
proposed changes have already been
denied through the citizen petition
process, we have not made changes to
this information collection based on the
comment.
The Center for Devices and
Radiological Health (CDRH) has
continually maintained contact with
industry. Informal communications
concerning the importance and effect of
reclassification are provided primarily
through trade organizations, and via
CDRH’s Web site. The consensus from
the Agency’s most recent contact with
these trade organizations is that they are
in favor of the program. The trade
organizations involved are AdvaMed,
the Food and Drug Law Institute (FDLI),
and the National Electrical
Manufacturers Association (NEMA):
AdvaMed, Tara Federici, 1030 15th
Street NW., suite 1100, Washington, DC
20005, 202–452–8240;
Food and Drug Law Institute (FDLI),
1000 Vermont Ave. NW., suite 1200,
Washington, DC 20005, 202–371–1420;
and National Electrical Manufacturers
Association (NEMA), 1300 North 17th
Street, suite 1847, Rosslyn, VA 22209,
703–841–3200.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\12JNN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33523-33524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14359]
[[Page 33523]]
-----------------------------------------------------------------------
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 July
13, 2015.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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 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:
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:
[cir] Cease distribution of the device,
[cir] notify health professionals and device user facilities of the
order, and
[cir] instruct those professionals and facilities to cease use of
the device;
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
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 March 11, 2015 (80 FR 13586), 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
Collection activity--21 CFR Number of responses per Total annual burden per Total hours
Section respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Collections Specified in the 2 1 2 8 16
Order--810.10(d)...............
Request for Regulatory Hearing-- 1 1 1 8 8
810.11(a)......................
Written Request for Review-- 1 1 1 8 8
810.12(a-b)....................
Mandatory Recall Strategy-- 2 1 2 16 32
810.14.........................
Periodic Status Reports-- 2 12 24 40 960
810.16(a-b)....................
Termination Request--810.17(a).. 2 1 2 8 16
Total Hours................. .............. .............. .............. .............. 1,040
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Collection activity--21 CFR Number of records per Total annual burden per Total hours
Section recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Documentation of Notifications 2 1 1 8 8
to Recipients--810.15(b).......
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 33524]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Collection Activity--21 CFR Number of disclosures per Total annual burden per Total hours
Section respondents respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Notification to Recipients-- 2 1 2 12 24
810.15(a)-(c)................
Notification to Recipients; 2 1 2 4 8
Followup--810.15(d)..........
Notification of Consignees by 10 1 10 1 10
Recipients--810.15(e)........
Total..................... .............. ................ .............. .............. 42
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14359 Filed 6-11-15; 8:45 am]
BILLING CODE 4164-01-P
