[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61429-61430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16831]



[[Page 61429]]

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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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 https://www.fda.gov/media/124263/download. 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 https://www.fda.gov/electronic-submissions-gateway. The reports can also be 
submitted in paper format and sent to the CBER Document Control Center 
at https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper.
    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]
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