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.
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.
$573,172
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
Reginfo record details
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.
0256 cover memo to OMB 3-2007.doc
0256 21cfr107.20.pdf
Infant Formula Requirements