Manufacture amounts and exemption from reporting - drug shortage determinations

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

Documents and Forms

Document Name Document Type
CARES Act PL116-136.pdf Other-Public Law: CARES Act
Guidance-FDA-DrugAmountReporting-2023-394-revision-1-clean.pdf Other-Procedural Guidance

Information Collection (IC) Details

IC Title:	Manufacture amounts and exemption from reporting - drug shortage determinations	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 207

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Public Law: CARES Act			CARES Act PL116-136.pdf		Yes	Yes	Fillable Fileable
Other-Procedural Guidance			Guidance-FDA-DrugAmountReporting-2023-394-revision-1-clean.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: 8,700	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	195,750	-92,250	288,000
Annual IC Time Burden (Hours)	195,750	123,750	72,000
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.