Infant Formula Requirements

ICR 201702-0910-006

OMB: 0910-0256

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2017-02-13
Justification for No Material/Nonsubstantive Change
2017-02-13
Supporting Statement A
2015-03-03
IC Document Collections
IC ID
Document
Title
Status
5835
Unchanged
212810
Unchanged
212809
Unchanged
212808
Unchanged
212807
Unchanged
212806
Unchanged
212805
Unchanged
212804
Unchanged
212803
Unchanged
212802
Unchanged
212801
Unchanged
212800
Unchanged
212799
Unchanged
212798
Unchanged
212797
Unchanged
212796
Unchanged
212795
Unchanged
212794
Unchanged
212793
Unchanged
212792
Unchanged
212791
Unchanged
212790
Unchanged
212789
Unchanged
212788
Unchanged
212787
Unchanged
212786
Unchanged
212785
Unchanged
212211
Unchanged
212208
Unchanged
212207
Unchanged
212205
Unchanged
212202
Unchanged
212201
Unchanged
212200
Unchanged
212199
Unchanged
212198
Unchanged
212197
Unchanged
212196
Unchanged
212194
Unchanged
179355
Unchanged
179354
Unchanged
179353
Unchanged
179352
Unchanged
179351
Unchanged
179350
Unchanged
ICR Details
0910-0256 201702-0910-006
Historical Active 201502-0910-012
HHS/FDA CFSAN
Infant Formula Requirements
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 03/01/2017
Retrieve Notice of Action (NOA) 02/15/2017
Given that draft electronic Form FDA 3978 is being deployed as a pilot, if FDA decides to continue use of the electronic form the agency must report findings of the pilot to OMB as part of the renewal request.
  Inventory as of this Action Requested Previously Approved
04/30/2018 04/30/2018 04/30/2018
16,901 0 16,901
78,536 0 78,536
765,439 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 343 Name of Law: FFDCA
   US Code: 21 USC 350a Name of Law: FFDCA
  
None

0910-AF27 Final or interim final rulemaking 79 FR 7933 02/10/2014

Yes

45
IC Title Form No. Form Name
Controls to prevent adulteration by equipment or utensils
Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)
Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)
Controls to prevent adulteration by equipment or utensils (sanitation)
Controls to prevent adulteration by equipment or utensils (maintenance schedule)
Controls to prevent adulteration due to automatic equipment
Controls to prevent adulteration due to automatic equipment (revalidation)
Controls to prevent adulteration caused by ingredients, containers, and closures
Controls to prevent adulteration during manufacturing
Controls to prevent adulteration from microorganisms
Controls to prevent adulteration during packaging and labeling
General quality control; testing
Quality control; nutrients
Quality control; sampling
Quality control; shelf-life substantiation
Audit plan; ongoing review and updating
Infant Formula; Ingredient Control
Exampt Infant Formula; Terms and Conditions
Exempt Infant Formula; Notification Requirements
Exempt Infant Formula; Recordkeeping Requirements
Infant Formula; Recordkeeping Requirements
Infant Formula; Labeling (3rd Party Disclosure) Requirements
Requirements for Quality Factors GMS Exemption
Requirements for Quality Factors -- PER Exemption
New Infant Formula Submission
Production and In-process Control System (first year only)
Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (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 Infant Formulas - Formula Intake (first year only)
Quality Factors -- Records (first year only)
Controls to prevent adulteration caused by facilties; testing for radiological contaminants
Controls to prevent adulteration; water testing for radiological contaminants
Controls to prevent adulteration; testing for bacteriological contaminants
Audit plan; regular audits
Quality factors; written study report
Quality factors; anthropometric data
Quality factors; formula intake
Quality factors; data plotting
Quality factors; data comparisons
Quality factors; PER data collection
Quality factors; PER written report
Controls to prevent adulteration; bacteriological contaminants in water
Requirements for Infant Formula
New Infant Formula Registration

  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 16,901 16,901 0 0 0 0
Annual Time Burden (Hours) 78,536 78,536 0 0 0 0
Annual Cost Burden (Dollars) 765,439 765,439 0 0 0 0
No
No
Burden increase of 23 hours reflects one-time burden for respondents to include selenium content in nutrient labeling. This is discussed in the accompanying supporting statement.

$696,673
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.
02/15/2017


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