Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle, 4927-4928 [2015-01626]
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4927
Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Program Status Report ....................................................................................
Community Impact Report ...............................................................................
Demographic ....................................................................................................
Estimated Total Annual Burden
Hours: 132 hours.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–01643 Filed 1–28–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0115]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff—Class II Special
Controls Guidance Document:
Automated Blood Cell Separator
Device Operating by Centrifugal or
Filtration Principle
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 collection of information concerning
class II special controls for an
automated blood cell separator device
operating by centrifugal or filtration
separation principle.
DATES: Submit either electronic or
written comments on the collection of
information by March 30, 2015.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
2
2
2
Average
burden
hours per
response
Total
burden
hours
1
1
1
44
44
44
Colesville Rd., COLE–14526, Silver
Springs, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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
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.
Guidance for Industry and FDA Staff—
Class II Special Controls Guidance
Document: Automated Blood Cell
Separator Device Operating by
Centrifugal or Filtration Separation
Principle (OMB Control Number 0910–
0594)—Extension
Under the Safe Medical Devices Act
of 1990 (Pub. L. 101–629), FDA may
E:\FR\FM\29JAN1.SGM
29JAN1
4928
Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
establish special controls, including
performance standards, postmarket
surveillance, patient registries,
guidelines, and other appropriate
actions it believes necessary to provide
reasonable assurance of the safety and
effectiveness of the device. The special
control guidance serves to support the
reclassification from class III to class II
of the automated blood cell separator
device operating on a centrifugal
separation principle intended for the
routine collection of blood and blood
components as well as the special
control for the automated blood cell
separator device operating on a filtration
separation principle intended for the
routine collection of blood and blood
components reclassified as class II
(§ 864.9245 (21 CFR 864.9245)).
For currently marketed products not
approved under the premarket approval
process, the manufacturer should file
with FDA, for 3 consecutive years, an
annual report on the anniversary date of
the device reclassification from class III
to class II or on the anniversary date of
the 510(k) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360) clearance. Any subsequent
change to the device requiring the
submission of a premarket notification
in accordance with section 510(k) of the
FD&C Act should be included in the
annual report. Also, a manufacturer of a
device determined to be substantially
equivalent to the centrifugal or
filtration-based automated cell separator
device intended for the routine
collection of blood and blood
components should comply with the
same general and special controls.
The annual report should include, at
a minimum, a summary of anticipated
and unanticipated adverse events that
have occurred and that are not required
to be reported by manufacturers under
Medical Device Reporting (MDR) (part
803 (21 CFR part 803)). The reporting of
adverse device events summarized in an
annual report will alert FDA to trends
or clusters of events that might be a
safety issue otherwise unreported under
the MDR regulation.
Reclassification of this device from
class III to class II for the intended use
of routine collection of blood and blood
components relieves manufacturers of
the burden of complying with the
premarket approval requirements of
section 515 of the FD&C Act (21 U.S.C.
360e), and may permit small potential
competitors to enter the marketplace by
reducing the burden. Although the
special control guidance recommends
that manufacturers of these devices file
with FDA an annual report for 3
consecutive years, this would be less
burdensome than the current
postapproval requirements under part
814, subpart E (21 CFR part 814, subpart
E), including the submission of periodic
reports under § 814.84.
Collecting or transfusing facilities and
manufacturers have certain
responsibilities under Federal
regulations. For example, collecting or
transfusing facilities are required to
maintain records of any reports of
complaints of adverse reactions (21 CFR
606.170), while the manufacturer is
responsible for conducting an
investigation of each event that is
reasonably known to the manufacturer
and evaluating the cause of the event
(§ 803.50(b)). In addition, manufacturers
of medical devices are required to
submit to FDA individual adverse event
reports of death, serious injury, and
malfunctions (§ 803.50).
In the special control guidance
document, FDA recommends that
manufacturers include in their three
annual reports a summary of adverse
reactions maintained by the collecting
or transfusing facility, or similar reports
of adverse events collected, in addition
to those required under the MDR
regulation. The MedWatch medical
device reporting code instructions
(https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm106737.htm)
contains a comprehensive list of adverse
events associated with device use,
including most of those events that we
recommend summarizing in the annual
report.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Reporting activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Annual Report ......................................................................
4
1
4
5
20
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are
approximately four manufacturers of
automated blood cell separator devices.
The estimated average burden per
response is based on the time that the
manufacturers will spend preparing and
submitting the annual report.
Other burden hours required for
§ 864.9245 are reported and approved
under OMB control number 0910–0120
(premarket notification submission
501(k), 21 CFR part 807, subpart E), and
OMB control number 0910–0437 (MDR,
part 803).
Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01626 Filed 1–28–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1048]
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 2,
2015.
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 0910–0485. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Labeling Regulations
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
SUMMARY:
PO 00000
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Fmt 4703
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FDA
PRA Staff, Office of Operations, Food
FOR FURTHER INFORMATION CONTACT:
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29JAN1
]]>Agencies
[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4927-4928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01626]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0115]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff--Class II Special Controls Guidance Document: Automated Blood
Cell Separator Device Operating by Centrifugal or Filtration Principle
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 collection of information
concerning class II special controls for an automated blood cell
separator device operating by centrifugal or filtration separation
principle.
DATES: Submit either electronic or written comments on the collection
of information by March 30, 2015.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Springs, MD 20993-0002, PRAStaff@fda.hhs.gov.
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 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.
Guidance for Industry and FDA Staff--Class II Special Controls Guidance
Document: Automated Blood Cell Separator Device Operating by
Centrifugal or Filtration Separation Principle (OMB Control Number
0910-0594)--Extension
Under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), FDA
may
[[Page 4928]]
establish special controls, including performance standards, postmarket
surveillance, patient registries, guidelines, and other appropriate
actions it believes necessary to provide reasonable assurance of the
safety and effectiveness of the device. The special control guidance
serves to support the reclassification from class III to class II of
the automated blood cell separator device operating on a centrifugal
separation principle intended for the routine collection of blood and
blood components as well as the special control for the automated blood
cell separator device operating on a filtration separation principle
intended for the routine collection of blood and blood components
reclassified as class II (Sec. 864.9245 (21 CFR 864.9245)).
For currently marketed products not approved under the premarket
approval process, the manufacturer should file with FDA, for 3
consecutive years, an annual report on the anniversary date of the
device reclassification from class III to class II or on the
anniversary date of the 510(k) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360) clearance. Any subsequent change to
the device requiring the submission of a premarket notification in
accordance with section 510(k) of the FD&C Act should be included in
the annual report. Also, a manufacturer of a device determined to be
substantially equivalent to the centrifugal or filtration-based
automated cell separator device intended for the routine collection of
blood and blood components should comply with the same general and
special controls.
The annual report should include, at a minimum, a summary of
anticipated and unanticipated adverse events that have occurred and
that are not required to be reported by manufacturers under Medical
Device Reporting (MDR) (part 803 (21 CFR part 803)). The reporting of
adverse device events summarized in an annual report will alert FDA to
trends or clusters of events that might be a safety issue otherwise
unreported under the MDR regulation.
Reclassification of this device from class III to class II for the
intended use of routine collection of blood and blood components
relieves manufacturers of the burden of complying with the premarket
approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e),
and may permit small potential competitors to enter the marketplace by
reducing the burden. Although the special control guidance recommends
that manufacturers of these devices file with FDA an annual report for
3 consecutive years, this would be less burdensome than the current
postapproval requirements under part 814, subpart E (21 CFR part 814,
subpart E), including the submission of periodic reports under Sec.
814.84.
Collecting or transfusing facilities and manufacturers have certain
responsibilities under Federal regulations. For example, collecting or
transfusing facilities are required to maintain records of any reports
of complaints of adverse reactions (21 CFR 606.170), while the
manufacturer is responsible for conducting an investigation of each
event that is reasonably known to the manufacturer and evaluating the
cause of the event (Sec. 803.50(b)). In addition, manufacturers of
medical devices are required to submit to FDA individual adverse event
reports of death, serious injury, and malfunctions (Sec. 803.50).
In the special control guidance document, FDA recommends that
manufacturers include in their three annual reports a summary of
adverse reactions maintained by the collecting or transfusing facility,
or similar reports of adverse events collected, in addition to those
required under the MDR regulation. The MedWatch medical device
reporting code instructions (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm106737.htm) contains a
comprehensive list of adverse events associated with device use,
including most of those events that we recommend summarizing in the
annual report.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Reporting activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Report...................................................... 4 1 4 5 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are approximately four manufacturers of
automated blood cell separator devices. The estimated average burden
per response is based on the time that the manufacturers will spend
preparing and submitting the annual report.
Other burden hours required for Sec. 864.9245 are reported and
approved under OMB control number 0910-0120 (premarket notification
submission 501(k), 21 CFR part 807, subpart E), and OMB control number
0910-0437 (MDR, part 803).
Dated: January 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01626 Filed 1-28-15; 8:45 am]
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