Requirements for Submission of In Vivo Bioequivalence Data; final rule

Requirements for Submission of In Vivo Bioequivalence Data; Final Rule

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0630 can be found here:

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Requirements for Submission of In Vivo Bioequivalence Data; final rule	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 314 21 CFR 320

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	Program Change Due to Agency Discretion
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

Documents for IC

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