View Information Collection Request (ICR) Package

OMB Control No:	ICR Reference No: 199703-0910-006
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: OTC Human Drugs, Proposed Labeling Requirements
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 04/21/1997
	Date Received in OIRA: 03/28/1997
Terms of Clearance: OMB does not approve the package and files the following comment. OMB is concerned that the reporting and recordkeeping requirements in the NPRM are overly burdensome and wishes to allow the private sector the opportunity to consider the NPRM. Specifically, OMB has concerns about the utility of various label formats to inform consumers about purchasing and using OTC drug products in a manner that will improve their health. When the paperwork package is re-submitted for OMB approval at the final rule stage, FDA will directly address OMB's concerns and all comments received on these issues in the preamble of the rule and in the paperwork submission package.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		04/30/2000
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

Abstract: The proposal is intended to enable consumers to better read and understand OTC drug product labeling and to apply this information to the safe and effective use of OTC drug products.

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
OTC Human Drugs, Proposed Labeling Requirements

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

View ICR - OIRA Conclusion