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, 7745-7747 [2018-03613]
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
will discuss and make
recommendations regarding the device
reclassification from Class III to Class II
of nucleic acid and serology-based
point-of-care and laboratory-based in
vitro diagnostic devices indicated for
use as aids in the diagnosis of human
immunodeficiency virus (HIV)
infection. In the afternoon session, the
Committee will hear an overview of the
research presentations on the research
programs of the Laboratory of Emerging
Pathogens, the Laboratory of Bacterial
and Transmissible Spongiform
Encephalopathy Agents, and the
Laboratory of Molecular Virology in the
Division of Emerging TransfusionTransmitted Diseases, Office of Blood
Research and Review Center for
Biologics Evaluation and Research.
After the open session, the meeting will
be closed to the public to permit
discussion where disclosure would
constitute an unwarranted invasion of
personal privacy in accordance with 5
U.S.C 552b(c)(6).
On March 22, 2018, the Joint
Committee will discuss and make
recommendations regarding the
reclassification from Class III to Class II
of nucleic acid and serology-based in
vitro diagnostic devices indicated for
use as aids in diagnosis of hepatitis C
virus (HCV) infection and/or for use as
aids in the management of HCV infected
patients.
All the devices that will be discussed
by the Committee during the 2-day
meeting are post-amendment devices
that currently are classified into Class III
under section 513(f)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360c(f)(1)).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 14, 2018.
Oral presentations from the public will
be scheduled between approximately
12:25 p.m. to 1:25 p.m. and from 4:25
p.m. to 4:40 p.m. on March 21, 2018,
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and between approximately 11:15 a.m.
to 12:15 p.m. on March 22, 2018. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before March 6, 2018. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 7, 2018.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Bryan Emery
at least 7 days in advance of the meeting
(See, FOR FURTHER INFORMATION
CONTACT).
Closed Committee Deliberations: On
March 21, 2018, between 4:40 p.m. and
5:15 p.m., the meeting will be closed to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The recommendations of the
advisory committee regarding the
progress of the investigator’s research
will, along with other information, be
used in making decisions regarding pay
adjustments of service fellows or
promotion of individual scientists who
are permanent CBER staff.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app.)
Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03614 Filed 2–21–18; 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 or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by April 23, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 23, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0115 for ‘‘Guidance for
Industry and FDA Staff—Class II Special
Controls Guidance Document:
Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration
Separation Principle.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
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second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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
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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
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 as the special
control for the automated blood cell
separator device operating by
centrifugal or filtration separation
principle intended for the routine
collection of blood and blood
components (§ 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 (FD&C Act) (21 U.S.C.
360(k)) 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
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
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. The report should
also include any subsequent change to
the preamendments class III device
requiring a 30-day notice in accordance
with 21 CFR 814.39(f).
Reclassification of this device from
class III to class II 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 21
CFR part 814, subpart E, including the
submission of periodic reports under 21
CFR 814.84.
Collecting or transfusing facilities, the
intended users of the device, and the
device manufacturers have certain
responsibilities under the 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 device manufacturer
is responsible for conducting an
investigation of each event that is
7747
reasonably known to the manufacturer
and evaluating the cause of the event
(§ 803.50(b) (21 CFR 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.
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 ......................................................................
3
1
3
5
15
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are
approximately three manufacturers of
automated blood cell separator devices.
We estimate that the manufacturers will
spend approximately 5 hours preparing
and submitting the annual report. The
total burden hours are reduced from
previous collections due to a decrease in
the number of manufacturers.
Other burden hours required for
§ 864.9245 are reported and approved
under OMB control number 0910–0120
(premarket notification submission
510(k), 21 CFR part 807, subpart E), and
OMB control number 0910–0437 (MDR,
part 803).
Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03613 Filed 2–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2015–E–4020]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; OFEV
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
SUMMARY:
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determined the regulatory review period
for OFEV and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 23, 2018. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 23, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by August 21, 2018. See
‘‘Petitions’’ in the SUPPLEMENTARY
INFORMATION section for more
information.
ADDRESSES: You may submit comments
as follows:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
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]]>Agencies
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7745-7747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03613]
-----------------------------------------------------------------------
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 April 23, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to
[[Page 7746]]
the docket unchanged. Because your comment will be made public, you are
solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0115 for ``Guidance for Industry and FDA Staff--Class II
Special Controls Guidance Document: Automated Blood Cell Separator
Device Operating by Centrifugal or Filtration Separation Principle.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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 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 as the special control for the automated blood
cell separator device operating by centrifugal or filtration separation
principle intended for the routine collection of blood and blood
components (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 (FD&C Act) (21 U.S.C. 360(k)) 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
[[Page 7747]]
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. The report should also include any subsequent change to the
preamendments class III device requiring a 30-day notice in accordance
with 21 CFR 814.39(f).
Reclassification of this device from class III to class II 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 21 CFR part 814, subpart E, including
the submission of periodic reports under 21 CFR 814.84.
Collecting or transfusing facilities, the intended users of the
device, and the device manufacturers have certain responsibilities
under the 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 device
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) (21 CFR 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Reporting activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Annual Report...................................................... 3 1 3 5 15
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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 three manufacturers
of automated blood cell separator devices. We estimate that the
manufacturers will spend approximately 5 hours preparing and submitting
the annual report. The total burden hours are reduced from previous
collections due to a decrease in the number of manufacturers.
Other burden hours required for Sec. 864.9245 are reported and
approved under OMB control number 0910-0120 (premarket notification
submission 510(k), 21 CFR part 807, subpart E), and OMB control number
0910-0437 (MDR, part 803).
Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03613 Filed 2-21-18; 8:45 am]
BILLING CODE 4164-01-P
