Information Collection

Manufacture amounts and exemption from reporting - drug shortage determinations

IC 250057 under ICR 202408-0910-003 · OMB 0910-0045.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0045 can be found here:

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.