Information Collection

Subpart D Design and Development Controls Annual Recordkeeping

IC 257019 under ICR 202211-0910-006 · OMB 0910-0913.

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IC Title:	Subpart D Design and Development Controls Annual Recordkeeping	Agency IC Tracking Number:	CTP

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1120.42 21 CFR 1120.44

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: 4,234	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	4,234	4,234
Annual IC Time Burden (Hours)	41,196	41,196
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.