Notice2024-16831
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 31, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 147 (Wednesday, July 31, 2024)</title>
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[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61429-61430]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2019]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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.
DATES: Submit written comments (including recommendations) on the
collection of information by August 30, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0594. Also include the FDA docket
number found in brackets in the heading of this document.
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#bfefedfeeccbded9d9ffd9dbde91d7d7cc91d8d0c9"><span class="__cf_email__" data-cfemail="1f4f4d5e4c6b7e79795f797b7e3177776c31787069">[email protected]</span></a>.
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.
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 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>. 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 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.
In the Federal Register of May 22, 2024, (89 FR 44991), 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\
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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 manufacturers 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
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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 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: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16831 Filed 7-30-24; 8:45 am]
BILLING CODE 4164-01-P
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