Abbreviated Supporting Statement

Abbreviated SS.doc

Data to Support Drug Product Communications as Used by the FDA

Abbreviated Supporting Statement

OMB: 0910-0695

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FDA DOCUMENTATION FOR THE GENERIC CLEARANCE

on “TESTING COMMUNICATIONS ON DRUGS”

(0910-####)

TITLE OF INFORMATION COLLECTION: [insert]


DESCRIPTION OF THIS SPECIFIC COLLECTION

  1. Statement of need:

[insert]


  1. Intended use of information:

[insert]


  1. Description of respondents:

[insert]


  1. Date(s) to be Conducted:

[insert]


  1. How the Information is being collected:

[insert]


  1. Confidentiality of Respondents:

[insert]


  1. Amount and justification for any proposed incentive

[insert]


  1. Questions of a Sensitive Nature

[insert]


  1. Description of Statistical Methods

[insert]


BURDEN HOUR COMPUTATION (Number of responses (X) estimated response or participation time in minutes (/60) = annual burden hours):

Type/Category of Respondent

No. of Respondents

Participation Time (minutes)

Burden

(hours)






REQUESTED APPROVAL DATE: [insert]


NAME OF PRA ANALYST & PROGRAM CONTACT: [insert]

FDA CENTER: [insert]

File Typeapplication/msword
File TitleFDA DOCUMENTATION FOR THE GENERIC CLEARANCE
Authorila.mizrachi
Last Modified ByBridget C.E. Dooling
File Modified2011-09-27
File Created2011-09-27

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