Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
200703-0910-015
Status:
Historical Active
Previous ICR Reference No:
200401-0910-009
Agency/Subagency:
HHS/FDA
Agency Tracking No:
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 without change
Conclusion Date:
06/06/2007
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/29/2007
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2010
36 Months From Approved
06/30/2007
Responses
218
0
40
Time Burden (Hours)
30,202
0
25,968
Cost Burden (Dollars)
0
0
0
Abstract:
Statutory requirements for infant formula under the Federal Food, Drug, and Cosmetic Act (the act) are intended to protect the health of infants and include a number of reporting and recordkeeping requirements. Among other things, section 412 of the act (21 U.S.C. 350a), which was added by the Infant Formula Act of 1980 (IFA), requires manufacturers of infant formula to establish and adhere to quality control procedures, notify FDA when a batch of infant formula that has left the manufacturers' control may be adulterated or misbranded, and keep records of distribution. FDA has issued regulations to implement the act's requirements for infant formula in 21 CFR part 106 and part 107 (21 CFR parts 106 and 107). FDA also regulates the labeling of infant formula under the authority of section 403 of the act (21 U.S.C. 343). Under the labeling regulations for infant formula in part 107, the label of an infant formula must include nutrient information and directions for use. The purpose of these labeling requirements is to ensure that consumers have the information they need to prepare and use infant formula appropriately. FDA's regulations in part 106 require maintenance and retention of records associated with microbiological/nutrient testing, quality control procedures, audits and investigation of consumer complaints. The part 106 regulations also require that manufacturers notify the agency when there is an infant formula that is adulterated or misbranded that may pose a risk to human health. FDA's regulations in part 107 require specific nutrient information and specific directions for use to be displayed on infant formula labeling. The part 107 regulations require that manufacturers notify the agency when there is an exempt infant formula that is adulterated or misbranded that may present risk to human health. The regulations also require manufacturers to inform FDA when there is a change in ingredients or processes, and to use specified labeling, in order to maintain exempt status of infant formula. Manufacturers of infant formula may submit infant formula notifications in electronic format. The labeling information is used by consumers when purchasing, storing and preparing infant formulas. The recordkeeping and notification information is used by firms and FDA to confirm that the nutrient requirements of the IFA have been met. Due to the required testing by the manufacturers, discrepancies in nutrient levels have been found quickly and no illnesses have been reported to FDA resulting from inappropriate nutrient levels found in infant formulas since passage of the IFA.
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:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
72 FR 1539
01/12/2007
30-day Notice:
Federal Register Citation:
Citation Date:
72 FR 14116
03/26/2007
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Infant Formula Requirements
Infant Formula Requirements
Infant Formula Requirements
Infant Formula Requirements
Infant Formula Requirements
Infant Formula Requirements
Infant Formula Requirements
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
218
40
0
178
0
0
Annual Time Burden (Hours)
30,202
25,968
0
4,234
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The total annual burden has increased from 25,968 hours to 30,202 hours. This increase is due to an increase in the estimated number of recordkeepers.
Annual Cost to Federal Government:
$573,172
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Saleda Perryman
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:
03/29/2007
An official website of the United States government
The .gov means it's official.
The site is secure.
