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
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