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