Information Collection

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

IC 235376 under ICR 201903-0910-014 · OMB 0910-0256.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0811 Exempt IF Production Guidance 2019.pdf www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm384451.htm	Other-Agency Guidance

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:

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			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 %

table that charts list of burden
	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

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.