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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:
201411-0910-006
Status:
Historical Inactive
Previous ICR Reference No:
201407-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Infant Formula Requirements
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Comment filed on proposed rule and continue
Conclusion Date:
12/18/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/14/2014
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2017
36 Months From Approved
10/31/2017
Responses
16,901
0
16,901
Time Burden (Hours)
78,513
0
78,513
Cost Burden (Dollars)
0
0
0
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 350a
Name of Law: FFDCA
US Code:
21 USC 343
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AF27
Proposed rulemaking
78 FR 22442
04/16/2013
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
46
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
Exampt Infant Formula; Terms and Conditions
Exempt Infant Formula; Notification Requirements
Exempt Infant Formula; Recordkeeping Requirements
General quality control; testing
Infant Formula; Ingredient Control
Infant Formula; Labeling (3rd Party Disclosure) Requirements
Infant Formula; Recordkeeping Requirements
Minimum and maximum levels of selenium to infant formula and related labeling
New Infant Formula Registration
New Infant Formula Submission
Production and In-process Control System (first year only)
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
Requirements for Infant Formula
Requirements for Quality Factors -- PER Exemption
Requirements for Quality Factors GMS Exemption
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)
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Burden increase reflects a one-time burden that will allow respondent(s) to comply with additional third-party labeling requirements of the proposed rule. This adjustment is explained more fully in the supporting statement.
Annual Cost to Federal Government:
$696,673
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
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:
11/14/2014
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