Information Collection

Label Comprehension Study

IC 181099 under ICR 200707-0910-003 · OMB 0910-0612.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Label Comp. Study Questionnaire Current Label ( revision).DOC	Other-Study Questionnaire
Label Comp. Study Proposed Label ( Revision).DOC LABEL COMP STUDY QUESTIONNAIRE PROPOSED LABEL	IC Document
Informed Consent- Label Comp Study.DOC Informed Consent- Label Comp Study	IC Document
Label Comp. Study Power Analysis ( Revision).DOC LABEL COMP STUDY POWER ANALYSIS	IC Document
LABEL COMP STUDY CURRENT PKG INSERT.DOC LABEL COMP STUDY CURRENT PKG INSERT	IC Document
LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE.DOC LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE	IC Document

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 393

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
Other-Study Questionnaire			Label Comp. Study Questionnaire Current Label ( revision).DOC		No	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 1,200

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1,200	1,200
Annual IC Time Burden (Hours)	705	705
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
LABEL COMP STUDY QUESTIONNAIRE PROPOSED LABEL	Label Comp. Study Proposed Label ( Revision).DOC	10/10/2007
Informed Consent- Label Comp Study	Informed Consent- Label Comp Study.DOC	07/02/2007
LABEL COMP STUDY POWER ANALYSIS	Label Comp. Study Power Analysis ( Revision).DOC	10/10/2007
LABEL COMP STUDY CURRENT PKG INSERT	LABEL COMP STUDY CURRENT PKG INSERT.DOC	07/02/2007
LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE	LABEL COMP STUDY PROPOSED PKG INSERT-DRAFT GUIDANCE.DOC	07/02/2007

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