3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder

Authorization of Medical Products for Use Emergencies

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0595 can be found here:

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

IC Title:	3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder	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	Instrument File	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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 635	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	1,270	1,270
Annual IC Time Burden (Hours)	6,350	6,350
Annual IC Cost Burden (Dollars)	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.