Notice2021-12191
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
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
June 10, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 110 (Thursday, June 10, 2021)</title>
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[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30958-30960]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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: 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,
<a href="/cdn-cgi/l/email-protection#48181a091b3c292e2e082e2c296620203b662f273e"><span class="__cf_email__" data-cfemail="59090b180a2d383f3f193f3d387731312a773e362f">[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.
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
<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 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
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