Information Collection

Subpart D Design and Development Controls Recordkeeping (One-Time)

IC 257003 under ICR 202211-0910-006 · OMB 0910-0913.

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IC Title:

Subpart D Design and Development Controls Recordkeeping (One-Time)

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:

table that charts list of 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 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	4,234	4,234
Annual IC Time Burden (Hours)	136,212	136,212
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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