Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking, 26304-26305 [2011-11072]
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26304
Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0555]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Device Tracking
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
(the PRA).
DATES: Fax written comments on the
collection of information by June 6,
2011.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0442. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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 Devices; Device Tracking—21
CFR Part 821 OMB Control Number
0910–0442—Extension
Section 211 of the Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115) became
effective on February 19, 1998. FDAMA
amended the previous medical device
tracking provisions under section
519(e)(1) and (e)(2) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360i(e)(1) and (e)(2)) and
were added by the Safe Medical Devices
Act of 1990 (SMDA) (Pub. L. 101–629).
Unlike the tracking provisions under
SMDA, which required tracking of any
medical device meeting certain criteria,
FDAMA allows FDA discretion in
applying tracking provisions to medical
devices meeting certain criteria and
provides that tracking requirements for
medical devices can be imposed only
after FDA issues an order. In the Federal
Register of February 8, 2002 (67 FR
5943), FDA issued a final rule that
conformed existing tracking regulations
to changes in tracking provisions
effected by FDAMA under part 821 (21
CFR part 821).
Section 519(e)(1) of the FD&C Act, as
amended by FDAMA, provides that
FDA may require by order that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s-l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
patients possessing those devices, to the
extent that patients permit the
collection of identifying information.
Manufacturers and FDA (where
necessary) use the data to: (1) Expedite
the recall of distributed medical devices
that are dangerous or defective and (2)
facilitate the timely notification of
patients or licensed practitioners of the
risks associated with the medical
device.
In addition, the regulations include
provisions for: (1) Exemptions and
variances; (2) system and content
requirements for tracking; (3)
obligations of persons other than device
manufacturers, e.g., distributors; records
and inspection requirements; (4)
confidentiality; and (5) record retention
requirements.
Respondents for this collection of
information are medical device
manufacturers, importers, and
distributors of tracked implants or
tracked l/s-l/s devices used outside a
device user facility. Distributors include
multiple and final distributors,
including hospitals.
The annual hourly burden for
respondents involved with medical
device tracking is estimated to be
604,279 hours per year. The burden
estimates cited in tables 1, 2, and 3 of
this document are based on the number
of device tracking orders issued in the
last 3 years.
This regulation also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by Office of
Management and Budget under the PRA
(44 U.S.C. 3501–3520). The collections
of information found in §§ 821.2(b),
821.25(e), and 821.30(e) have been
approved under OMB control number
0910–0183.
In the Federal Register of November
12, 2010 (75 FR 69447), 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
emcdonald on DSK2BSOYB1PROD with NOTICES
21 CFR section
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
responses
Total hours
821.1(d) ................................................................................
821.2 and 821.30(e) ............................................................
821.25(a) ..............................................................................
821.25(d) ..............................................................................
1
1
12
1
1
1
1
1
1
1
12
1
1
1
76
1
1
1
912
1
Total ..............................................................................
........................
........................
........................
........................
915
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Mar<15>2010
17:26 May 05, 2011
Jkt 223001
PO 00000
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Fmt 4703
Sfmt 4703
E:\FR\FM\06MYN1.SGM
06MYN1
26305
Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
(in hours)
Total annual
records
Total hours
821.25(b) ..............................................................................
821.25(c) 2 ............................................................................
821.25(c)(3) ..........................................................................
12
12
12
46,260
1
1,124
555,120
12
13,488
1
63
1
555,120
756
13,488
Total ..............................................................................
........................
........................
........................
........................
569,364
1 There
2 One
are no capital costs or operating and maintenance costs associated with this collection of information.
time burden.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per
respondent
Average
burden per
disclosure
(in hours)
Total annual
disclosures
Total hours
821.30(a) and (b) .................................................................
821.30(c)(2) and (d) .............................................................
17,000
17,000
1
1
17,000
17,000
1
1
17,000
17,000
Total ..............................................................................
........................
........................
........................
........................
34,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–11072 Filed 5–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0275]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Certification To
Accompany Drug, Biological Product,
and Device Applications or
Submissions (Form FDA 3674)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 requirements for certain FDA
applications or submissions to be
accompanied by a certification, Form
emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:58 May 05, 2011
Jkt 223001
FDA 3674, to ensure all applicable
statutory requirements have been met.
DATES: Submit either electronic or
written comments on the collection of
information by July 5, 2011.
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
Office of Management and Budget
(OMB) control number 0910–0616. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
3794,
jonnalynn.capezzuto@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
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 extension of an existing
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 extension of the 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.
Certification To Accompany Drug,
Biological Product, and Device
Applications or Submissions (Form
FDA 3674)—(OMB Control Number
0910–0616)—Extension
The information required under
section 402(j)(5)(B) of the Public Health
Service Act (PHS Act) (42 U.S.C.
282(j)(5)(B)) is submitted in the form of
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Pages 26304-26305]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11072]
[[Page 26304]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0555]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Device Tracking
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 (the PRA).
DATES: Fax written comments on the collection of information by June 6,
2011.
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0442.
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 Devices; Device Tracking--21 CFR Part 821 OMB Control Number
0910-0442--Extension
Section 211 of the Food and Drug Administration Modernization Act
(FDAMA) (Pub. L. 105-115) became effective on February 19, 1998. FDAMA
amended the previous medical device tracking provisions under section
519(e)(1) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360i(e)(1) and (e)(2)) and were added by the Safe
Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629). Unlike the
tracking provisions under SMDA, which required tracking of any medical
device meeting certain criteria, FDAMA allows FDA discretion in
applying tracking provisions to medical devices meeting certain
criteria and provides that tracking requirements for medical devices
can be imposed only after FDA issues an order. In the Federal Register
of February 8, 2002 (67 FR 5943), FDA issued a final rule that
conformed existing tracking regulations to changes in tracking
provisions effected by FDAMA under part 821 (21 CFR part 821).
Section 519(e)(1) of the FD&C Act, as amended by FDAMA, provides
that FDA may require by order that a manufacturer adopt a method for
tracking a class II or III medical device, if the device meets one of
the three following criteria: (1) The failure of the device would be
reasonably likely to have serious adverse health consequences, (2) the
device is intended to be implanted in the human body for more than 1
year (referred to as a ``tracked implant''), or (3) the device is life-
sustaining or life-supporting (referred to as a ``tracked l/s-l/s
device'') and is used outside a device user facility.
Tracked device information is collected to facilitate identifying
the current location of medical devices and patients possessing those
devices, to the extent that patients permit the collection of
identifying information. Manufacturers and FDA (where necessary) use
the data to: (1) Expedite the recall of distributed medical devices
that are dangerous or defective and (2) facilitate the timely
notification of patients or licensed practitioners of the risks
associated with the medical device.
In addition, the regulations include provisions for: (1) Exemptions
and variances; (2) system and content requirements for tracking; (3)
obligations of persons other than device manufacturers, e.g.,
distributors; records and inspection requirements; (4) confidentiality;
and (5) record retention requirements.
Respondents for this collection of information are medical device
manufacturers, importers, and distributors of tracked implants or
tracked l/s-l/s devices used outside a device user facility.
Distributors include multiple and final distributors, including
hospitals.
The annual hourly burden for respondents involved with medical
device tracking is estimated to be 604,279 hours per year. The burden
estimates cited in tables 1, 2, and 3 of this document are based on the
number of device tracking orders issued in the last 3 years.
This regulation also refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by Office of Management and Budget under the PRA
(44 U.S.C. 3501-3520). The collections of information found in
Sec. Sec. 821.2(b), 821.25(e), and 821.30(e) have been approved under
OMB control number 0910-0183.
In the Federal Register of November 12, 2010 (75 FR 69447), 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\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
821.1(d)........................ 1 1 1 1 1
821.2 and 821.30(e)............. 1 1 1 1 1
821.25(a)....................... 12 1 12 76 912
821.25(d)....................... 1 1 1 1 1
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 26305]]
Table 2--Estimated Average Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
821.25(b)....................... 12 46,260 555,120 1 555,120
821.25(c) \2\................... 12 1 12 63 756
821.25(c)(3).................... 12 1,124 13,488 1 13,488
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 569,364
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One time burden.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of disclosures Total annual burden per
21 CFR section respondents per disclosures disclosure Total hours
respondent (in hours)
----------------------------------------------------------------------------------------------------------------
821.30(a) and (b)............... 17,000 1 17,000 1 17,000
821.30(c)(2) and (d)............ 17,000 1 17,000 1 17,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 34,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: May 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11072 Filed 5-5-11; 8:45 am]
BILLING CODE 4160-01-P
