Document ID: FDA-2012-N-0115-0010
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2021-02-18T05:00Z

[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Pages 10108-10110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03258]

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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.

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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 19, 2021.

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 19, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 19, 2021. 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.

[[Page 10109]]

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 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

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. 3501-3521), 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

    This information collection supports Agency regulations. 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)). The guidance entitled ``Guidance 
for Industry and FDA Staff--Class II Special Controls Guidance 
Document: Automated Blood Cell Separator Device Operating by 
Centrifugal or Filtration Separation Principle'' is available at 
https://www.fda.gov/media/124263/download.
    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,

[[Page 10110]]

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 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
                              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 manufactures of 
automated blood cell separator devices. We estimate that the 
manufacturers will spend approximately 5 hours preparing and submitting 
the annual report. Based on a review of the information collection 
since our last request for OMB approval, we have made no adjustments to 
our burden estimates.
    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 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03258 Filed 2-17-21; 8:45 am]
BILLING CODE 4164-01-P