Information Collection

Proposed Verification Requirements for NDA and BLA Holders Under 314.70(c)(8) and 601.12(f)(2)(iii)

IC 209606 under ICR 201312-0910-001 · OMB 0910-0757.

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IC Title:

Proposed Verification Requirements for NDA and BLA Holders Under 314.70(c)(8) and 601.12(f)(2)(iii)

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 314.70(c)(8)&601.12(f)(2)(iii)

Information Collection Instruments:

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Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 173

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 75 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	230	230
Annual IC Time Burden (Hours)	115	115
Annual IC Cost Burden (Dollars)	0	0

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