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Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are regulated under a Biologics License Application, and Animal Drugs; Proposed Rule

IC 45561 under ICR 200610-0910-001 · OMB 0910-0829.

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Information Collection (IC) Details

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IC Title:	Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are regulated under a Biologics License Application, and Animal Drugs; Proposed 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 601.2(f) 21 CFR 207.25 21 CFR 207.33 21 CFR 207.65 21 CFR 314.81(b)(2) 21 CFR 514.80(b)(4) 21 CFR 607.40 21 CFR 1271.25

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: 10,364	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	55,862	55,862	0
Annual IC Time Burden (Hours)	18,155	-163,000	181,155
Annual IC Cost Burden (Dollars)	0	0	0

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