Information Collection

Requirements for Submission of In Vivo Bioequivalence Data

IC 186746 under ICR 201110-0910-004 · OMB 0910-0630.

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Information Collection (IC) Details

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IC Title:	Requirements for Submission of In Vivo Bioequivalence Data	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 320 21 CFR 314.94(a)(7) 21 CFR 314.96(a)(1) 21 CFR 314.97

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 72	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	Previously Approved
Annual Number of Responses for this IC	72	72
Annual IC Time Burden (Hours)	3,672	3,672
Annual IC Cost Burden (Dollars)	243,648	243,648

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