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Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Proposed Rule
Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Proposed Rule
OMB: 0910-0624
IC ID: 185243
OMB.report
HHS/FDA
OMB 0910-0624
ICR 200806-0910-002
IC 185243
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0624 can be found here:
2018-02-27 - Extension without change of a currently approved collection
2014-12-11 - New collection (Request for a new OMB Control Number)
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Proposed Rule
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
New
Obligation to Respond:
Required to Obtain or Retain Benefits
CFR Citation:
21 CFR 314.50
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Public Health Monitoring
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
885
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
0 %
Requested
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
1,613
1,613
0
0
0
0
Annual IC Time Burden (Hours)
32,260
32,260
0
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
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.