Information Collection

Specifies Recordkeeping Requirements for Establishment of Laboratory Controls to Ensure that Adequate Specifications and Test Procedures Conform to Appropriate Standards

IC 197520 under ICR 201707-0910-002 · OMB 0910-0154.

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IC Title:

Specifies Recordkeeping Requirements for Establishment of Laboratory Controls to Ensure that Adequate Specifications and Test Procedures Conform to Appropriate Standards

Agency IC Tracking Number:

CVM

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 226.58

Information Collection Instruments:

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

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 65

Number of Respondents for Small Entity: 49

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 90 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	16,900	16,900
Annual IC Time Burden (Hours)	29,575	29,575
Annual IC Cost Burden (Dollars)	0	0

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