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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0256
ICR Reference No:
201804-0910-005
Status:
Historical Active
Previous ICR Reference No:
201702-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Infant Formula Requirements
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
05/16/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/11/2018
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2021
36 Months From Approved
05/31/2018
Responses
6,092
0
16,901
Time Burden (Hours)
42,940
0
78,536
Cost Burden (Dollars)
0
0
765,439
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 301 et seq.
Name of Law: Federal Food, Drug, and Cosmetic Act (FFDCA)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
82 FR 52927
11/15/2017
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 15148
04/09/2018
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
12
IC Title
Form No.
Form Name
Audit plan; ongoing review and updating
Audit plan; regular audits
Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (first year only)
Controls to prevent adulteration by equipment or utensils
Controls to prevent adulteration by equipment or utensils (maintenance schedule)
Controls to prevent adulteration by equipment or utensils (sanitation)
Controls to prevent adulteration caused by facilties; testing for radiological contaminants
Controls to prevent adulteration caused by ingredients, containers, and closures
Controls to prevent adulteration due to automatic equipment
Controls to prevent adulteration due to automatic equipment (revalidation)
Controls to prevent adulteration during manufacturing
Controls to prevent adulteration during packaging and labeling
Controls to prevent adulteration from microorganisms
Controls to prevent adulteration; bacteriological contaminants in water
Controls to prevent adulteration; testing for bacteriological contaminants
Controls to prevent adulteration; water testing for radiological contaminants
Exempt Infant Formula; Notification Requirements
Form FDA 3978
Infant Formula Tracking System
General quality control; testing
Infant Formula; Labeling (3rd Party Disclosure) Requirements
New Infant Formula Registration
Form FDA 3978
Infant Formula Tracking System
New Infant Formula Submission
Form FDA 3978
Infant Formula Tracking System
Notifications under 106.120(b)
Form FDA 3978
Infant Formula Tracking System
Part 106; Subpart B - CGMP Requirements (records)
Part 107; Subpart C - Exempt Infant Formulas (records)
Quality Factors -- Records (first year only)
Quality control; nutrients
Quality control; sampling
Quality control; shelf-life substantiation
Quality factors; PER data collection
Quality factors; PER written report
Quality factors; anthropometric data
Quality factors; data comparisons
Quality factors; data plotting
Quality factors; formula intake
Quality factors; written study report
Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records
Reports for exampt Infant Formula
Form FDA 3978
Infant Formula Tracking System
Reports under FFDCA section 412(d)
Form FDA 3978
Infant Formula Tracking System
Requirements for Quality Factors -- PER Exemption
Form FDA 3978
Infant Formula Tracking System
Requirements for Quality Factors GMS Exemption
Form FDA 3978
Infant Formula Tracking System
Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)
Requirements for Quality Factors for Eligible Infant Formulas - Anthropometric Data (first year only)
Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)
Requirements for Quality Factors for Eligible Infant Formulas - Formula Intake (first year only)
Requirements for Quality Factors for Eligible Infant Formulas -- Written Study Report (first year only)
ICR Summary of Burden
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
We have consolidated individual ICs as appropriate. This is discussed more fully at Q15. of the supporting statement.
Annual Cost to Federal Government:
$981,052
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
04/11/2018