Alaska; Amendment No. 2 to Notice of a Major Disaster Declaration, 10110 [2021-03328]

Download as PDF 10110 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 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 (§ 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 (§ 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 1—ESTIMATED 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 0910–0120 (premarket notification submission 510(k), 21 CFR part 807, subpart E), and OMB control number 0910–0437 (MDR, part 803). Dated: February 11, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–03258 Filed 2–17–21; 8:45 am] jbell on DSKJLSW7X2PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 17:47 Feb 17, 2021 Jkt 253001 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–4533– DR; Docket ID FEMA–2021–0001] 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 (FEMA–4533–DR), 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) 646–2833. 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: PO 00000 Frm 00077 Fmt 4703 Sfmt 9990 Maykovich, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster. This action terminates the appointment of Michael F. O’Hare 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 Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant. Robert J. Fenton, Senior Official Performing the Duties of the Administrator, Federal Emergency Management Agency. [FR Doc. 2021–03328 Filed 2–17–21; 8:45 am] BILLING CODE 9111–23–P E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03328]


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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4533-DR; Docket ID FEMA-2021-0001]


Alaska; Amendment No. 2 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration 
for the State of Alaska (FEMA-4533-DR), 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) 646-2833.

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. 
Maykovich, of FEMA is appointed to act as the Federal Coordinating 
Officer for this disaster.
    This action terminates the appointment of Michael F. O'Hare 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 Households--Other 
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially 
Declared Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal 
Emergency Management Agency.
[FR Doc. 2021-03328 Filed 2-17-21; 8:45 am]
BILLING CODE 9111-23-P