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 

1There 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] 

BILLING CODE 4164–01–P 

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] 

BILLING CODE 9111–23–P 


jbell on DSKJLSW7X2PROD with NOTICES