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RECORDKEEPING: EUA holders
Authorization of Medical Products for Use Emergencies
OMB: 0910-0595
IC ID: 254791
OMB.report
HHS/FDA
OMB 0910-0595
ICR 202209-0910-008
IC 254791
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0595 can be found here:
2024-05-30 - No material or nonsubstantive change to a currently approved collection
2022-12-29 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
21 USC 360bbb-3 FFDCA Section 564.pdf
Other-Statutory Authority
21 USC 360bbb-3 FFDCA Section 564.pdf
Other-Statutory Authority
21 USC 360bbb-3a FFDCA Section 564A.pdf
Other-Statutory Authority
21 USC 360bbb-3a FFDCA Section 564A.pdf
Other-Statutory Authority
21 USC 360bbb-3b FFDCA Section 564B.pdf
Other-Statutory Authority
21 USC 360bbb-3b FFDCA Section 564B.pdf
Other-Statutory Authority
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
RECORDKEEPING: EUA holders
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Required to Obtain or Retain Benefits
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Statutory Authority
21 USC 360bbb-3 FFDCA Section 564.pdf
Yes
Yes
Fillable Fileable
Other-Statutory Authority
21 USC 360bbb-3a FFDCA Section 564A.pdf
Yes
Yes
Fillable Fileable
Other-Statutory Authority
21 USC 360bbb-3b FFDCA Section 564B.pdf
Yes
Yes
Fillable Fileable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
648
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
95 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
1,296
0
0
0
0
1,296
Annual IC Time Burden (Hours)
32,400
0
0
0
0
32,400
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.