Document ID: FDA-2012-N-0115-0011
Agency: fda
Document Type: Notice
Title: Agency Information Collection 
Activities; Submission for Office of 
Management and Budget Review; 
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: 2021-06-10T04:00Z

[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30958-30960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12191]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0115]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 we) 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 July 12, 2021.

[[Page 30959]]

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: 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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, 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.
    In the Federal Register of February 18, 2021 (86 FR 10108), 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
                              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).
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

[[Page 30960]]

    Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12191 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P