Exempt Infant Formula Production; GMP; Audits, Records & Records

Infant Formula Requirements

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0256 can be found here:

Documents and Forms

Document Name Document Type
0811 Exempt IF Production Guidance 2019.pdf www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm384451.htm Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Exempt Infant Formula Production; GMP; Audits, Records & Records	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 107.50

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0811 Exempt IF Production Guidance 2019.pdf	https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm384451.htm	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 3	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1,903	1,903
Annual IC Time Burden (Hours)	85,890	85,890
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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.