Notice2024-11237
Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
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Published
May 22, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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.
Full Text
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<title>Federal Register, Volume 89 Issue 100 (Wednesday, May 22, 2024)</title>
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[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44991-44993]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11237]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2019]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Class II Special Controls: 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, Agency, or we) 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: Either electronic or written comments on the collection of
information must be submitted by July 22, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 22, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2024-N-2019 for ``Class II Special Controls: 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#ce9e9c8f9dbaafa8a88ea8aaafe0a6a6bde0a9a1b8"><span class="__cf_email__" data-cfemail="a2f2f0e3f1d6c3c4c4e2c4c6c38ccacad18cc5cdd4">[email protected]</span></a>.
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
[[Page 44992]]
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.
Class II Special Controls: Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration Separation Principle
OMB Control Number 0910-0594--Extension
This information collection helps to support Agency regulations and
guidance. Under Section 513(a)(1)(B) of the Federal Food, Drug and
Cosmetics Act (FD&C Act) (21 U.S.C. 360c(a)(1)(B)), 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'' (March 2011) is
available at <a href="https://www.fda.gov/media/124263/download">https://www.fda.gov/media/124263/download</a>.
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 FD&C Act (21 U.S.C. 360(k))
clearance. These annual reports are submitted as supplements to the
original 510(k) via the electronic submission gateway at <a href="https://www.fda.gov/electronic-submissions-gateway">https://www.fda.gov/electronic-submissions-gateway</a>. The reports can also be
submitted in paper format and sent to the CBER Document Control Center
at <a href="https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper">https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper</a>.
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.
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.
In the special control guidance document, FDA recommends that
manufacturers include in their annual reports a summary of adverse
reactions maintained by the blood collection establishment or
transfusion service 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
Recommended activity; guidance section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Annual Report; Section VI, Special Controls........................ 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 submissions to FDA over the last few years, there are
three manufactures of automated blood cell separator devices. We
estimate that the manufacturers will spend approximately 5 hours
preparing and submitting the annual report.
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).
Blood collection establishments and transfusion services, the
intended users of the device, and the device manufacturers have certain
responsibilities under the Federal regulations. For example, collection
establishments and or transfusion services 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
[[Page 44993]]
addition, manufacturers of medical devices are required to submit to
FDA individual adverse event reports of death, serious injury, and
malfunctions (Sec. 803.50).
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).
Based on a review of the information collection from our last
request for OMB approval, we estimate that the number of manufacturers
of automated blood cell separator devices remains unchanged. As a
result, we have made no adjustments to our burden estimates.
Dated: May 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11237 Filed 5-21-24; 8:45 am]
BILLING CODE 4164-01-P
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