Information Collection

Guidance on Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300

IC 187166 under ICR 202104-0910-006 · OMB 0910-0633.

Documents and Forms

Document Name Document Type
0633_Guidance.pdf www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/labeling-natural-rubber-l Instruction
0633_Guidance.pdf www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/labeling-natural-rubber-l Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Guidance on Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

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
Instruction			0633_Guidance.pdf	https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/labeling-natural-rubber-latex-condoms-classified-under-21-cfr-8845300-class-ii-special-controls	Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Previously Approved
Annual Number of Responses for this IC	5	5
Annual IC Time Burden (Hours)	60	60
Annual IC Cost Burden (Dollars)	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.