Information Collection

Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

IC 178669 under ICR 201008-0910-003 · OMB 0910-0530.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0530 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
praeleclabel-0530 ss (2).doc	Other-Other

IC Title:

Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Removed

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 314.94

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-Other			praeleclabel-0530 ss (2).doc		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 189

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
	Program Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	-3,209	3,209
Annual IC Time Burden (Hours)	-802	802
Annual IC Cost Burden (Dollars)	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.