Information Collection

Guidance documents issued in accordance with 601.29

IC 261932 under ICR 202606-0910-003 · OMB 0910-0338.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0338 GFI VCS SEPT 2023.docx	Other-Agency Guidance
Cooperative Manufacturing Arrangements for Licensed Biologics; Guidance for Industry.pdf	Other-Agency Guidance

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 601.29; Guidance documents

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
Other-Agency Guidance					Yes	Yes	Fillable Fileable
Other-Agency Guidance					Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 9

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	9	9
Annual IC Time Burden (Hours)	27	27
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

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

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