RECORDKEEPING: State and local Public Health Authorities

Authorization of Medical Products for Use Emergencies

Documents and Forms

Document Name Document Type
0910-0595_Guidance; Emergency Use Authorization of Medical Products and Related Authorities.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-relate Other-Guidance; Emergency Use Author
21 USC 360bbb-3 FFDCA Section 564.pdf Other-Statutory Authority - Authoriz
21 USC 360bbb-3a FFDCA Section 564A.pdf Other-Statutory Authority - Emergenc
21 USC 360bbb-3b FFDCA Section 564B.pdf Other-Statutory Authority - Products

Information Collection (IC) Details

IC Title:	RECORDKEEPING: State and local Public Health Authorities	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance; Emergency Use Authorization of Medical Products and Related Authorities	0910-0595_Guidance; Emergency Use Authorization of Medical Products and Related Authorities.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities	Yes	No	Fillable Printable
Other-Statutory Authority - Authorization for medical products for use in emergencies	21 USC 360bbb-3 FFDCA Section 564.pdf		Yes	Yes	Fillable Fileable
Other-Statutory Authority - Emergency use of medical products	21 USC 360bbb-3a FFDCA Section 564A.pdf		Yes	Yes	Fillable Fileable
Other-Statutory Authority - Products held for emergency use	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: 1	Number of Respondents for Small Entity: 0

Affected Public: State, Local, and Tribal Governments

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	1	0	1
Annual IC Time Burden (Hours)	3	1	2
Annual IC Cost Burden (Dollars)	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.