Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300

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Documents and Forms

Document Name Document Type
Guidance Condom labeling 7-2-08.doc Guidance Condom labeling 7-2-08 IC Document

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IC Title:	Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300	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 884.5300

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 35	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to New Statute
Annual Number of Responses for this IC	1,190	1,190
Annual IC Time Burden (Hours)	15,504	15,504
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
Guidance Condom labeling 7-2-08	Guidance Condom labeling 7-2-08.doc	11/05/2008

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.