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

Documents and forms in this information collection
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

IC Title:

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:

table that charts list of 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 %

table that charts list of burden
	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

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.