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Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
and Cosmetic Act FD&C Act 21 U.S.C.
360k clearance. Any subsequent change to the device requiring the submission of a premarket notification in accordance with section 510k 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 814.39f.
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 803.50b 21 CFR 803.50b. In addition, manufacturers of medical devices are required to submit to FDA
individual adverse event reports of death, serious injury, and malfunctions 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.
FDA estimates the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of respondents
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
Annual Report

3

1

3

5

15

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 864.9245 are reported and approved under OMB control number 09100120
premarket notification submission 510k, 21 CFR part 807, subpart E, and OMB control number 09100437 MDR, part 803.
Dated: February 11, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management Agency Internal Agency Docket No. FEMA4533
DR; Docket ID FEMA20210001

Alaska; Amendment No. 2 to Notice of a Major Disaster Declaration Federal Emergency Management Agency, DHS.
ACTION: Notice.
AGENCY:

This notice amends the notice of a major disaster declaration for the State of Alaska FEMA4533DR, dated April 9, 2020, and related determinations.
DATES: This change occurred on January 20, 2021.
FOR FURTHER INFORMATION CONTACT:
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, 202 6462833.
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency FEMA hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Vincent J.
SUMMARY:

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Maykovich, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.
This action terminates the appointment of Michael F. OHare as Federal Coordinating Officer for this disaster.
The following Catalog of Federal Domestic Assistance Numbers CFDA are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance DUA;
97.046, Fire Management Assistance Grant;
97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and HouseholdsOther Needs; 97.036, Disaster GrantsPublic Assistance Presidentially Declared Disasters; 97.039, Hazard Mitigation Grant.
Robert J. Fenton, Senior Official Performing the Duties of the Administrator, Federal Emergency Management Agency.
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