Infant Formula Requirements

ICR 201804-0910-005

OMB: 0910-0256

Federal Form Document

IC Document Collections
IC ID
Document
Title
Status
5835 Modified
212810
Removed
212809
Removed
212808
Removed
212807
Removed
212806
Removed
212805
Removed
212804
Removed
212803
Removed
212802
Removed
212801
Removed
212800
Removed
212799
Removed
212798
Removed
212797
Removed
212796
Removed
212795
Removed
212794
Removed
212793
Removed
212792
Removed
212791
Removed
212790
Removed
212789
Removed
212788
Removed
212787
Removed
212786
Removed
212785
Removed
212211
Removed
212208
Removed
212207
Removed
212205
Removed
212202
Removed
212201
Removed
212200
Removed
212199
Modified
212198 Modified
212197 Modified
212196 Modified
212194 Modified
179355
Modified
179354
Modified
179353
Modified
179352 Modified
179351 Modified
179350 Modified
ICR Details
0910-0256 201804-0910-005
Historical Active 201702-0910-006
HHS/FDA CFSAN
Infant Formula Requirements
Extension without change of a currently approved collection   No
Regular
Approved with change 05/16/2018
Retrieve Notice of Action (NOA) 04/11/2018
  Inventory as of this Action Requested Previously Approved
05/31/2021 36 Months From Approved 05/31/2018
6,092 0 16,901
42,940 0 78,536
0 0 765,439

This ICR supports the recordkeeping, reporting, and labeling requirements for the manufacture and distribution of infant formula. Respondents to this collection are infant formula manufacturers who must ensure that their products adhere to the quality control provisions and procedures found in FDA regulations, and that nutrient information and directions for use are disclosed in their product labeling.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act (FFDCA)
  
None

Not associated with rulemaking

  82 FR 52927 11/15/2017
83 FR 15148 04/09/2018
No

12
IC Title Form No. Form Name
Quality control; nutrients
Controls to prevent adulteration caused by ingredients, containers, and closures
Controls to prevent adulteration during packaging and labeling
Quality factors; formula intake
Quality factors; written study report
Quality factors; PER written report
Quality factors; PER data collection
Quality factors; data comparisons
Quality Factors -- Records (first year only)
Quality factors; data plotting
Controls to prevent adulteration due to automatic equipment (revalidation)
General quality control; testing
Controls to prevent adulteration from microorganisms
Part 106; Subpart B - CGMP Requirements (records)
Reports under FFDCA section 412(d) Form FDA 3978 Infant Formula Tracking System
Notifications under 106.120(b) Form FDA 3978 Infant Formula Tracking System
Reports for exampt Infant Formula Form FDA 3978 Infant Formula Tracking System
Exempt Infant Formula; Notification Requirements Form FDA 3978 Infant Formula Tracking System
Part 107; Subpart C - Exempt Infant Formulas (records)
Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records
Infant Formula; Labeling (3rd Party Disclosure) Requirements
Requirements for Quality Factors GMS Exemption Form FDA 3978 Infant Formula Tracking System
Requirements for Quality Factors -- PER Exemption Form FDA 3978 Infant Formula Tracking System
New Infant Formula Submission Form FDA 3978 Infant Formula Tracking System
New Infant Formula Registration Form FDA 3978 Infant Formula Tracking System
Quality factors; anthropometric data
Requirements for Quality Factors for Eligible Infant Formulas - Formula Intake (first year only)
Controls to prevent adulteration caused by facilties; testing for radiological contaminants
Audit plan; regular audits
Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (first year only)
Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)
Requirements for Quality Factors for Eligible Infant Formulas -- Written Study Report (first year only)
Requirements for Quality Factors for Eligible Infant Formulas - Anthropometric Data (first year only)
Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)
Controls to prevent adulteration; water testing for radiological contaminants
Controls to prevent adulteration; testing for bacteriological contaminants
Controls to prevent adulteration; bacteriological contaminants in water
Controls to prevent adulteration during manufacturing
Controls to prevent adulteration by equipment or utensils
Controls to prevent adulteration by equipment or utensils (sanitation)
Controls to prevent adulteration by equipment or utensils (maintenance schedule)
Audit plan; ongoing review and updating
Quality control; shelf-life substantiation
Controls to prevent adulteration due to automatic equipment
Quality control; sampling

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 6,092 16,901 0 0 -10,809 0
Annual Time Burden (Hours) 42,940 78,536 0 0 -35,596 0
Annual Cost Burden (Dollars) 0 765,439 0 0 -765,439 0
No
No
We have consolidated individual ICs as appropriate. This is discussed more fully at Q15. of the supporting statement.

$981,052
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
04/11/2018


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